Sources and prices of selected medicines and diagnostics for people living with HIV/AIDS

Publication date: 2005

WHO Library Cataloguing-in-Publication Data Sources and prices of selected medicines and diagnostics for people living with HIV/AIDS / a joint UNICEF, UNAIDS, WHO, MSF project. — 6th ed. 1.Pharmaceutical preparations – supply and distribution 2.Reagent kits, Diagnostic – supply and distribution 3.HIV infections – diagnosis 4.HIV infections – drug therapy 5.Price lists 6.Catalogs, Drug I.World Health Organization. ISBN 92 4 159334 2 (LC/NLM classification: QV 772) This report is also available On the following web pages: UNICEF: www.unicef.org/supply UNAIDS: www.unaids.org WHO/ Department of Medicines Policy and Standards: www.who.int/medicines WHO/AIDS Medicines and Diagnostics Service (AMDS): www.who.int/3by5/amds/en WHO/Department of Essential Health Technologies: www.who.int/diagnostics_laboratory Médecins Sans Frontières (MSF): www.accessmed-msf.org Or by contacting: Pharmaceuticals and Micronutrients Team UNICEF Supply Division Fax: +45 35 269421 © World Health Organization, United Nations Children’s Fund, Joint United Nations Programme on HIV/AIDS (UNAIDS), Médecins Sans Frontières, 2005. All rights reserved. Published by WHO on its own behalf and for UNICEF, the UNAIDS Secretariat, and Médecins Sans Frontières. WHO, UNICEF, the UNAIDS Secretariat, and Médecins Sans Frontières, have made every effort to ensure the accuracy of price, supplier, and other information presented in this report. However, the reader’s attention is drawn to the introduction, which describes the specific sources and limitations of information provided in this report. The reader’s attention is also drawn to the importance of quality assurance for pharmaceutical products. Licensing authorities in the respective countries of manufacture are responsible for the review and approval of the detailed composition and formulation when authorizing a pharmaceutical product to be marketed, including the specifications of its ingredients, as submitted by the manufacturer of the dosage form, and to oversee compliance with Good Manufacturing Practice requirements as recommended by WHO. This publication is intended to provide information on the prices and sources of products regardless of quality, efficacy and safety. Annexes 2A and 2B provide information on the countries in which the products listed in this publication are currently registered and on those products that have been found to meet WHO recommended standards under the WHO Prequalification Procedure. It should be noted, however, that this information is subject to change, and should therefore be verified before a decision on procurement from a particular source is taken. This list is not an exhaustive list of all available products for the diagnosis and treatment of HIV/AIDS-related illness. It includes only those products which were known to WHO, UNICEF, the UNAIDS Secretariat, and Médecins Sans Frontières as being commercially available at the time of publication and for which the manufacturer has (on a voluntary basis) agreed to complete a questionnaire and provide related information and documentation. The manufacturers listed will be regularly requested to provide UNICEF with updated information and it is hoped that the number of manufacturers reached and participating will increase over time. This publication does not constitute an endorsement or warranty of the fitness of any product for a particular purpose. This publication is not based on an active assessment of, and does not therefore constitute an acceptance or recommendation in regard to, any product’s quality, safety or efficacy for the treatment of HIV/ AIDS-related illness. WHO, UNICEF, the UNAIDS Secretariat, and Médecins Sans Frontières do not furthermore warrant that the use of the products mentioned is in accordance with the national laws and regulations of any country, including but not limited to patent laws. It is recommended that readers intending to use this publication familiarize themselves with all pertinent aspects, such as quality, safety and efficacy as well as quantification, patents, financial stability and standing of the supplier, ability to supply the required quantities, delivery time and other related aspects. Bearing in mind that the data and information provided for a product depends largely on the manufacturer, these data and information are being provided as is, and WHO, UNICEF, the UNAIDS Secretariat, and Médecins Sans Frontières make no representations or warranties, either express or implied, as to their accuracy, completeness or fitness for a particular purpose. WHO, UNICEF, the UNAIDS Secretariat, and Médecins Sans Frontières accept no responsibility or liability for the reliance on, or use of, such data and information. This list may not be used by manufacturers and suppliers for commercial or promotional purposes. The mention of specific companies and certain of their products does not imply that they are recommended by the WHO, UNICEF, the UNAIDS Secretariat, and Médecins Sans Frontières in preference to others of a similar nature that are not mentioned. The designations employed and the presentation of the material in this report, including tables and maps, do not imply the expression of any opinion whatsoever on the part of the WHO, UNICEF, the UNAIDS Secretariat, and Médecins Sans Frontières concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent border lines for which there may not yet be full agreement. Designed by minimum graphics Printed in France Department of Policy, Evidence and Partnerships, UNAIDS Fax: +41 22 7914741 Medicines Policy and Standards (PSM), World Health Organization Fax: +41 22 7914167 Campaign for Access to Essential Medicines, Médecins Sans Frontières Fax: +41 22 8498404 Information on HIV/AIDS diagnostic support, HIV test kit evaluations and bulk procurement is available on the WHO/ Department of Essential Health and Technologies website: www.who.int/eht Information on HIV/AIDS and substance abuse is available from www.who.int/substance_abuse iii Contents Glossary v 1. Introduction 1 2. Price information projects 7 3. Paediatric formulations and diagnostics 8 4. Access to quality HIV/AIDS medicines and diagnostics 10 5. Prices of medicines and diagnostics 12 6. List of manufacturers – medicines and diagnostics 25 Annex 1 A. Summary of CD4+ T-cell enumeration technologies 34 B. Summary of main characteristics of Viral Load Technologies 37 Annex 2 A. Registration status of products included in the sources and prices survey (CD-ROM only) B. Sources of medicines 39 Annex 3 Further reading, references and contacts 49 Annex 4 Untangling the web of price reductions: a pricing guide for the purchase of ARVs for developing countries 53 Feedback, application and correction form 77 Tables 1. Anti-infective medicines 12 Anthelminthics – Antifilarials 12 Anthelminthics – Intestinal anthelminitcs 12 Antibacterials, beta lactam medicines 12 Antibacterials, others 13 Antifungal medicines 15 Antiprotozoal medicines 15 Antiviral medicines 16 Antiviral medicines – Antiretrovirals 17 Antiviral medicines – Antiretrovirals (combinations) 18 2. Antineoplastic medicines 19 Cytotoxic medicines 19 CONTENTS SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDSiv 3. Psychotherapeutic medicines 20 Medicines used in depressive disorders 20 Medicines used in generalized anxiety and sleep disorders 20 Medicines used in substance dependence programmes 20 4. Analgesics 20 Opioid analgesics 20 5. Gastrointestinal medicines 21 Antacids and other antiulcer medicines 21 Antiemetic medicines 21 Laxatives 21 vGLOSSARY 1 AIDS Education Global Information System. 2 International Chamber of Commerce. 3 Quality Assurance of Pharmaceuticals. A compendium of guide- lines and related materials, Volume 1. WHO, Geneva, 1997. Glossary AIDS1 Acquired Immune Deficiency Syndrome – the late stage of HIV disease. AIDS involves the loss of function of the immune system as CD4 cells are infected and destroyed, allowing the body to succumb to opportunistic infections (e.g., Pneumocystis jiroveci Pneumonia (PCP), toxoplas- mosis) that are generally not pathogenic in people with intact immune systems. CE CE Marking on a product indicates that the product com- plies with the essential requirements of the relevant Euro- pean health, safety and environmental protection legislations. CIF2 Cost Insurance and Freight – (…named port of destina- tion) the seller delivers when the goods pass the ship’s rail in the port of shipment. The seller must pay the cost of freight if necessary to bring the goods to the named port of destination but the risk of loss or damage to the goods, as well as any additional costs due to events occurring after the time of delivery, are transferred from the seller to the buyer. This term can be used only for sea or inland waterway transport. COF Consejo General de Colegios Oficiales de Farmacéuticos (General Spanish Council of Pharmacists and Pharmaceu- tical Associations) – Spanish organization of Pharmaceu- tical Colleges, which represents all colleges in the national and international forum, develops norms, rules, and pro- fessional policy, and acts as the interlocutor with Spanish Ministries. Diagnostics Laboratory tests used in the diagnosis of infec- tion. ELISA Enzyme-linked immunosorbent assay – HIV antibody test which requires a machine to measure color change in test wells. Endemic1 The continuous presence of a disease in a geo- graphic location, community or population. Epidemic1 An outbreak of a disease within a population. See also pandemic. EXW2 Ex-works – (. named place) the seller’s only responsi- bility is to make the goods available at the seller’s premises, i.e., the works or factory. The seller is not re- sponsible for loading the goods on the vehicle provided by the buyer unless otherwise agreed. The buyer bears the full costs and risk involved in transporting the goods from there to the desired destination. Ex-works represents the minimum obligation of the seller. FCA (nearest port)2 Free Carrier – (. named place) This term has been designed to meet the requirements of multimodal transport, such as container or roll-on, roll-off traffic by trailers and ferries. It is based on the same name principle as F.O.B. (free on board), except the seller fulfils its obligations when the goods are delivered to the custody of the carrier at the named place. If no precise place can be named at the time of the contract of sale, the parties should refer to the place where the carrier should take the goods into its charge. The risk of loss or damage to the goods is transferred from the seller to the buyer. FOB2 Free-on-board – (. named port of shipment) Under ‘F.O.B’ the goods are placed on board the ship by the seller at a port of shipment named in the sales agree- ment. The risk of loss of or damage to the goods is trans- ferred to the buyer when the goods pass the ship’s rail (i.e., off the dock and placed on the ship). The seller pays the cost of loading the goods. Generic medicine3 The term ‘generic product’ has some- what different meaning in different jurisdictions. In many technical documents, use of this term is avoided, and the term ‘multisource pharmaceutical product’ is used instead. In this document, where the term generic medicine is used, it means a pharmaceutical product intended to be inter- changeable with the originator product, which is manu- factured without a license from the originator company and marketed after expiry of patent or other exclusivity rights where these have previously existed. Generic prod- ucts may be marketed either under the non-proprietary approved name or under a new brand (proprietary) name. They may sometimes be marketed in dosage forms and/ or strengths different from those of the originator prod- ucts. SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDSvi 1 AIDS Education Global Information System. 2 Council on palliative care, Canada. GMP Good Manufacturing Practice HAART Highly Active Antiretroviral Therapy. The use of 3 or more antiretroviral compounds in the management of HIV disease. HDI Human Development Index HIV Human Immunodeficiency Virus – a slow-acting retrovirus of the lentivirus family, believed to be the sole or primary cause of AIDS. HIV is transmitted sexually, through blood or vertically (from mother to child). There are 2 known types: HIV-1 and HIV-2. HIV Test kit There are 3 main types of test for detecting the presence of HIV antibodies: simple/rapid tests, ELISA tests, and confirmatory tests. Innovator pharmaceutical product A product which was first authorized for marketing (usually as a patented prod- uct) on the basis of documentation of efficacy, safety and quality (according to requirements at the time of the au- thorization). International Drug Price Indicator Guide 2004 A joint publication by the World Health Organization and Manage- ment Sciences for Health (MSH). Provides a spectrum of prices from non-profit drug suppliers, procurement agen- cies, and ministries of health, based on their current catalogs or price lists. INN International Nonproprietary Names (INN) identify phar- maceutical substances or active pharmaceutical ingredi- ents. Each INN is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name. The INN system as it exists today was initiated in 1950 by a World Health Assembly resolution WHA3.11 and began operating in 1953, when the first list of International Nonproprietary Names for pharmaceutical substances was published. The cumula- tive list of INN now stands at some 7000 names desig- nated since that time, and this number is growing every year by some 120–150 new INN. ITC International Trade Centre – technical cooperation agency of the United Nations Conference on Trade and Develop- ment (UNCTAD) and the World Trade Organization (WTO) for operational, enterprise-oriented aspects of trade de- velopment since 1964. Manufacturing license Granted by national licensing authori- ties and gives authorization to manufacture a specific product in a specified manufacturing plant. MSF Médecins Sans Frontières is an international humani- tarian aid organization that provides emergency medical assistance to populations in danger in more than 80 coun- tries, since 1971. MSH Management Sciences for Health is a private, nonprofit educational and scientific organization. Since 1971, MSH has worked with its worldwide partners to improve the management of, and access to, public health services. MTCT Mother-to-child transmission (of HIV) Opportunistic infection1 (OI) An illness caused by a micro- organism that usually does not cause disease in persons with healthy immune systems, but which may cause seri- ous illness when the immune system is suppressed. Com- mon OIs in HIV positive people include Pneumocystis jiroveci Pneumonia (PCP), Mycobacterium avium complex (MAC) disease and cytomegalovirus (CMV) disease. Palliative care2 Pain and symptom management, and psy- cho-social support for persons living with a terminal ill- ness, as well as for their families and caregivers. Pandemic1 A widespread disease outbreak affecting the population of an extensive area of the world. See also epidemic. Patents A title granted by public authorities conferring time- limited exclusive rights for the exploitation of an invention upon the person who reveals this invention, furnishes a sufficiently clear and full description of it and is found to meet the legal requirements for such rights. PEPFAR The President’s Emergency Plan for AIDS Relief, an- nounced in 2003, is a five-year, $15 billion US initiative to turn the tide in combating the global HIV/AIDS pandemic. Protease inhibitor (PI) Type of antiretroviral medicine Proprietary medicines Medicines that are under patent. Reverse transcriptase inhibitor Type of ARV medicine. Can be divided into two classes: Nucleoside Reverse Tran- scriptase Inhibitor (NRTI) and Non Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Simple/rapid test Can generally be carried out in 15 min- utes and results are read with the naked eye. The tests are easy to use and require limited training and little or no equipment, making them particularly suitable for use in Voluntary Counselling and Testing (VCT) centres. The Global Fund to Fight AIDS, TB, and Malaria (GFATM) Created in 2002, the Global Fund’s purpose is to attract and disburse additional resources to prevent and treat AIDS, tuberculosis (TB) and malaria. As a partnership be- tween governments, civil society, the private sector and affected communities, the Global Fund represents a new approach to international health financing. GLOSSARY vii The World Bank Group Established in 1944, it is one of the world’s largest sources of development assistance. In fiscal year 2004, the institution provided more than US$20.1 billion in loans to its client countries. TRIPS1 Agreement on Trade Related Aspects of Intellectual Property Rights UNAIDS The Joint United Nations Programme on HIV/ AIDS advocates for accelerated, comprehensive and co- ordinated global action on the epidemic. The Programme brings together the efforts and resources of ten UN system organizations to help the world prevent new HIV infections, care for those already infected, and mitigate the impact of the epidemic. The ten UNAIDS cosponsoring organizations are: Office of the United Nations High Com- missioner for Refugees (UNHCR), United Nations Children’s Fund (UNICEF), World Food Programme (WFP), United Nations Development Programme (UNDP), United Nations Population Fund (UNFPA), United Nations Office on Drugs and Crime (UNODC), International Labour Organization (ILO), United Nations Educations, Scientific and Cultural Organization (UNESCO), the World Health Organization (WHO) and the World Bank. UNCTAD United Nations Conference on Trade and Develop- ment, established in 1964, aims at the development- friendly integration of developing countries into the world economy. It is the focal point within the United Nations for the integrated treatment of trade and development and the interrelated issues in the areas of finance, technol- ogy, investment and sustainable development. UNFPA United Nations Population Fund – began operations in 1969. It is the largest international source of popula- tion assistance. About a quarter of all population assist- ance from donor nations to developing countries is channelled through UNFPA. UNICEF With its strong presence in 157 countries and terri- tories, the United Nations Children’s Fund (UNICEF) is the world’s leading advocate for children. Its action, guided by children’s rights, focuses on giving children the best start in life (including through immunization), promoting girls’ education, fighting HIV/AIDS and protecting children. WHO World Health Organization – Founded in 1948, the World Health Organization acts as the directing and coordina- tion or authorities in international health work. WHO pro- motes technical cooperation for health among nations, carries out programmes to control and eradicate disease and strives to improve the quality of human life. It is gov- erned by 192 Member States and operates through its headquarters in Geneva and six regional offices and 141 country offices. WIPO World Intellectual Property Organization – Founded in 1970, WIPO administers 23 international treaties dealing with different aspects of intellectual property protection. WTO World Trade Organization – succeeded the General Agreement on Tariffs and Trade (GATT), first signed in 1947 by 23 countries and aimed at protecting and regu- lating international trade. WTO now has 147 members, three quarters of which are developing or least developed countries. 1 http://www.wto.org 1 1. Introduction 1.1 Background Antiretroviral therapy, prevention and treatment of opportun- istic infections and cancers, as well as palliative care are important elements of HIV/AIDS care and support. HIV/AIDS care hence requires a wide range of essential medicines. If available, these effective medicines can prevent, treat, or help manage HIV/AIDS and most of the common HIV-related dis- eases. It is estimated that 1 million people who require antiretroviral (ARV) medicines now have access to these medicines through various national and international treatment programmes.1 This represents 15% of the nearly 6.5 million people living with HIV/AIDS (People Living with HIV/AIDS) needing treatment in developing and transitional countries as of 2005. The high price of many of the HIV-related medicines and diag- nostics offered by common suppliers – especially antiretroviral and anti-cancer medicines – is one of the main barriers to their availability and affordability in developing countries. There are several other important barriers, including a lack of the basic components required for care, treatment, and support of people living with HIV/AIDS, such as sufficient num- bers of trained staff in health facilities; availability of labora- tory equipment and supplies; sufficient funding; efficient pharmaceutical supply and distribution services; strong political will and government commitment. Demand fore- casting and supply planning in countries remains inadequate, which may also lead to erratic supply. Wider availability of information on prices of medicines and diagnostic tools can help those responsible for procurement make better deci- sions. Since 2000, prices of important first-line ARVs have fallen considerably. This trend is attributable to a cumulation of fac- tors including advocacy, competition from generic manufac- turers, sustained public pressure, corporate responsiveness, and the growing political attention paid to the AIDS epidemic. In addition, originator and generic companies began announc- ing lower prices for the benefit of the poorest countries or those where HIV prevalence is highest.2 Furthermore, the availability of additional funding from financ- ing mechanisms such as the Global Fund to fight AIDS, Tuber- culosis and Malaria (GFATM) and The President’s Emergency Plan for AIDS Relief (PEPFAR) has lead to increased volumes of medicine purchases. In addition to the data found in this report the AIDS Medicines and Diagnostics Service (AMDS) has, within the “3by5” framework, published reports on the regulatory status of anti- retroviral drugs,3 and sources and prices of Active Pharma- ceutical Ingredients (API).4 The GFATM has also set up the Price Reporting Mechanism (PRM),5 a tool used to gather in- formation about product prices, product quality and supplier performance. 1.2 Aim This report provides market information that can be used by agencies wishing to procure HIV/AIDS medicines and diag- nostics, and may serve as the basis for negotiating afford- able prices. The data provided by the manufacturers highlight the multi- plicity of suppliers and the variation in price of some essen- tial HIV/AIDS-related medicines on the international market. Without this information, there is a risk that low-income coun- tries may be paying more than necessary to obtain HIV/AIDS- related medicines and diagnostics. Price variations are highlighted through the tables in chapter 5 of this report, as well as in Annex 4. 1.3 Target audience This report is intended for use primarily by national procure- ment agencies in resource-limited countries that lack easily accessible information on sources and prices of medicines and diagnostics. It may also be useful to others involved in the procurement of medicines and diagnostics, such as not- for-profit organizations, distributors, importers and whole- 1. INTRODUCTION 1 See: WHO/UNAIDS, “3 by 5” Progress report, Dec 2004, http:// www.who.int/3by5/progressreport05/en/ 2 HIV prevalence status of countries see www.who.int/emc-hiv/ fact_sheets/All_countries.html 3 See: http://www.who.int/3by5/amds/en 4 See: http://www.who.int/3by5/amds/en/API.pdf 5 See: http://web.theglobalfund.org/prm/index.jsp SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS2 salers or public health professionals interested in current price levels of medicines and diagnostics for people living with HIV/ AIDS. 1.4 Generating the report This is the sixth in a series of annual reports commenced in 1999, providing information on sources and prices of medi- cines and diagnostics commonly required by people living with HIV/AIDS, but difficult to obtain locally due to a small number of producers, the lack of distribution channels, or high prices. The information in this report is based on sur- veys that we expect will be continued and the report updated and made available regularly. A survey was carried out between December 2004 and Janu- ary 2005. The responses of 76 manufacturers in 28 different countries, 39% of which had not previously participated in the survey, as well as those manufacturers whose HIV test kits have been successfully evaluated by WHO (see Chapter 3) formed the basis of this report. The number of manufac- turers reached has greatly increased since the first survey in 1999 as more resources became available. Manufacturers that participated in previous surveys, those held in various databases, and those belonging to national pharmaceutical associations were contacted for voluntary participation and completion of a questionnaire. The UNAIDS Secretariat, UNICEF, MSF, and WHO have worked jointly to conduct this price survey and have compiled the results into a comprehensive publication, whilst respecting the manufacturers’ requests for confidentiality in relation to their individual pricing information. It must be pointed out that the companies included in this report have been screened only through the completeness of the requested documents they have provided, such as the questionnaire, a national GMP certificate, and associated documents relating to the company and their products. Inclu- sion in this report does not necessarily constitute pre- qualification or endorsement of any sort by UNICEF, WHO, UNAIDS or MSF. Only those products identified in Annex 2B in bold and with an asterisk (*) have (at the time of publication of this document) been found to meet WHO recommended standards through the ongoing Pre-qualification Project (see Chapter 4). 1.4.1 Additional requests for expressions of interest From the recent survey, we have been unable to obtain price information on the following dosage forms of medicines due to lack of response from manufacturers. Medicine name (INN) Dosage Form ivermectin scored tablet, 6 mg cefixime powder for injection, 250 mg (as sodium salt) chloramphenicol oily suspension for injection, 0.5 g/ml (as sodium succinate) in 2-ml ampoule; oral suspension, 150 mg/5 ml (as palmitate) clarithromycin oral suspension, 125 mg/5 ml erythromycin powder for injection, 500 mg (as lactobionate) in vial metronidazole suppository, 500 mg rifabutin capsule, 150 mg silver nitrate solution (eye drops), 1% sulfadiazine injection, 250 mg (sodium salt) in 4-ml ampoule sulfamethoxazole+ injection, 80+16 mg/ml in 10-ml ampoule trimethoprim amphotericin B IV infusion, powder for reconstitution 50 mg vial; liposomal IV infusion, 5 mg/ml in vial; powder for injection, 50 mg in vial fluconazole oral suspension, 50 mg/5 ml itraconazole oral solution, 10 mg/ml ketoconazole oral suspension, 100 mg/5 ml tinidazole tablet, 2 g cidofovir IV infusion, 75 mg/ml in 5-ml vial famciclovir tablet, 125 mg; tablet, 250 mg; tablet, 500 mg foscarnet sodium IV infusion, 24 mg/ml ganciclovir capsule, 250 mg; capsule, 500 mg imiquimod cream, 5% podofilox cream, 0.15%, 5 g tube; solution or gel, 0.5% podophyllum resin solution, 10–25% valacyclovir tablet, 500 mg valganciclovir tablet, 450 mg atazanavir (ATV) capsule, 200 mg didanosine (ddI) unbuffered enteric coated capsule, 125 mg emtricitabine (FTC) capsule, 200 mg indinavir (IDV) capsule, 333 mg (as sulphate) lamivudine (3TC) tablet, 300 mg 3 We would therefore welcome expressions of interest from manufacturers of medicines on this list. 1.5 Format of this report This report has thus far been published in hard-copy format only. However, owing to the additional information provided in this 2005 edition (e.g. registration status of medicines by country) certain parts of the report are available only the CD- ROM attached to the inside back cover. A web site is also currently under development, which will house a searchable version of this report, as well as in-country registration infor- mation that will be regularly updated. It will also contain di- rect links to other relevant on-line resources and tools. 1.6 Theme of the report: Paediatric formulations and diagnostics The estimated number of children living with HIV worldwide was over 2.2 million for 2004. In the same year, 640,000 children under the age of 15 were newly infected with HIV.1 Approximately 50% of children with HIV die before the age of two. Unfortunately, children with AIDS are dying needlessly 1. INTRODUCTION Medicine name (INN) Dosage Form lopinavir+ capsule, 133.3+33.3 mg ; oral solution, ritonavir (LPV/r) 400 mg+100 mg/5 ml saquinavir (SQV) soft gel capsule, 200 mg tenofovir (TDF) tablet, 300 mg ABC+3TC tablet, 600+150 mg FTC+TDF tablet, 200+300 mg calcium folinate injection, 3 mg/ml in 10-ml ampoule (leucovorin) liposomal conc. for IV infusion, 2 mg/ml in vial doxorubicine HCl levomepromazine tablet, 25 mg buprenorphine sublingual tablet, 2 mg (hydrochloride); sublingual tablet, 8 mg (hydrochloride) methadone HCl oral solution, 10 mg/5 ml; powder for oral concentrate, 10 mg/ml; powder for oral concentrate, 5 mg/ml; tablet, 5 mg morphine oral solution, 10 mg/5 ml (sulfate or HCl); tablet, modified release, 10 mg (sulfate) pethidine tablet, 100 mg prochlorperazine tablet, 10 mg docusate sodium capsule, 100 mg; paediatric oral solution, 12.5 mg/5 ml because of a lack of suitable medicines and diagnostic tools.2 Simplified methods of treating AIDS in adults are increasingly becoming available to patients in developing countries, more so within the past year. In many treatment programmes in developing countries, adult patients are now able to take a single pill, twice daily, as triple fixed-dose combination (FDC) formulations are available at a lower price than other less adapted formulations. Similar options are not yet available in paediatric doses. Moreover, it can cost over 6 times more to treat a child compared with an adult. Most of the currently available paediatric ARV formulations require children to take frequent doses of unpalatable syrups, many of which need cold chain storage, have limited shelf life and stability once opened, and are very costly. Chapter 3 of this publication looks more closely at the constraints in treating children with AIDS and urges manufacturers to strengthen their efforts in producing appropriate paediatric formulations. 1.7 How to use this report 1.7.1 Information on prices Chapter 5 provides prices of medicines and diagnostic tests based on data obtained from the survey. Official UN exchange rates for the month of January 2005 were used to convert local currencies into US dollars. The prices you will find listed in section 5.1 are provided as statistical ranges explained below. The distribution and range of prices indicate what a purchaser should expect to pay when planning procurement. Section 5.2 provides prices of HIV test kits as given by the manu- facturers at the time of the WHO evaluation. UN negotiated prices for selected HIV/AIDS diagnostics may be obtained from UNICEF and WHO for those eligible to procure under the UN system.3 Annex 4 contains the latest version of the MSF bi-annual pub- lication Untangling the Web of Price Reductions: a Pricing Guide for the Purchase of ARVs for Developing Countries. Most of the prices in this report are ex-works (EXW) or Free Carrier (FCA). They do not include added costs such as freight, insurance, import duties or taxes. For this reason the prices in this report cannot be compared with final consumer prices. Many countries continue to impose considerable import du- ties, tariffs and taxes on the price of essential medicines.4 In addition, wholesale and retail mark-ups vary from one coun- 1 See http://www.unaids.org/wad2004/EPI_1204_pdf_en/ EpiUpdate04_en.pdf 2 More information can be found at http://www.who.int/3by5/ paediatric/en/ 3 See http://www.who.int/diagnostics_laboratory/procurement/en/ hiv_bulk_flyer_EN.pdf 4 See Policy and Programming Options for Reducing the Procure- ment Costs of Essential Medicines in Developing Countries, Levinson L, Boston University School of Public Health, 2003. SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS4 try to another. As a result, the EXW price is often less than half the end-price to the consumer. The above structure is used for reporting the price informa- tion: (a) Therapeutic category (according to the WHO Model List of Essential Medicines) (b) The number of manufacturers that provided an indica- tive price and the number of countries they represent (c) The indicative price unit The price quoted relates to the unit described. For exam- ple, if the unit is “tablet” the price quoted is for one single tablet. max The maximum price listed represents the highest price among products in this category, with no differentiation between originator or generic products. min The minimum price listed represents the lowest price among products in this category, with no differentiation between originator or generic products. median The median price is the middle price, or when there is an even number of prices listed, it is the mean of the two middle numbers. This means that half the prices quoted are above this median price, and the other half are below it. 25th perc The 25th percentile is the value point representing the first quartile of quoted prices in ascending order. It is used to give some indication of the dispersion of prices for a given product. For example, if four suppliers were identified as manufac- turing cefixime paediatric oral suspension, 100 mg/5 ml, and the 25th percentile is US$ 0.023 per ml of suspen- sion: one out of the four (a quarter) manufacturers sur- veyed offer a price equal to or less than US$ 0.023. (d) The List prices are used to indicate the difference in price, if any, between a developing and a developed country. Brazilian and Spanish prices are selected to give a point of comparison with current market prices in a developing and a developed country with considerable manufactur- ing capacity. Brazilian list price The Brazilian list price included in this report represents the minimum price payable by Brazilian health institutions, be- tween 01/01/2004 and 01/01/2005, for the product and is taken from the Brazilian databank of health purchases (refer to http://bpreco.saude.gov.br/pls/BPREFD/consulta.inicio). Where the entry reads ‘none’, this indicates no purchase has been made for that product, and therefore no minimum price is available. Spanish list price This EXW price has been calculated by applying the regu- lated margins to the consumer price as published by The General Spanish Council of Pharmacists and Pharmaceutical Associations (www.portalfarma.com). It should be noted that Spanish list prices are generally considered the lowest in Europe. In most cases, the indicative prices listed in the re- port are a fraction of the comparative prices in the Spanish list. (a) (b) (c) (d) Therapeutic Manufacturer Indicative prices, List prices, category US$ US$ NO. OF NO. OF UNIT MAX MIN MEDIAN 25TH BRAZIL SPAIN MANU- COUNTRIES PERC FACTURERS 5 1.7.2 Information on sources Lists of manufacturers, their contact information, and the HIV/ AIDS-related medicines and diagnostics they manufacture are given in Chapter 6. Annex 2B lists the sources identified in the survey for each of these medicines. 1.7.3 Selection of medicines and diagnostics This report includes antiretroviral medicines, medicines used to treat a range of opportunistic infections, medicines for use in palliative care, medicines for the treatment of AIDS- related cancers, and medicines for the management of opioid dependence. It also provides information on a range of test kits available for diagnosis of HIV infection and for monitoring the efficacy of antiretroviral therapy. The medicines included in the report were selected based on recommendations from available WHO treatment guidelines. The list is not intended to be exhaustive but to broadly cover the most commonly used medicines or medicine categories. The report also includes medicines not in WHO treatment guidelines as they may be helpful for the following reasons: — Greater cost offset by greater safety, e.g. fluconazole instead of ketoconazole; — Fewer unwanted adverse effects, e.g. alternatives to amitriptyline. Paediatric formulations have been included wherever possi- ble. Antiretroviral therapy This report includes information on the availability and price range of antiretroviral medicines for use in Highly Active Antiretroviral Therapy. In resource – poor settings, it is criti- cal that these medicines are used in conjunction with WHO treatment guidelines intended to support and facilitate the proper management and scale-up of HAART in the years to come, by proposing a public health approach to achieve these goals. The topics addressed in the treatment guidelines include when to start HAART, which antiretroviral regimens to start, rea- sons for changing ARVs, and what regimens to continue if treatment needs to be changed. They also address how treat- ment should be monitored, with specific reference to the side effects of ARVs, and make specific recommendations for certain categories of patients. The recommended first-line ARV regimens in adults and ado- lescents consist of a thymidine analog nucleoside reverse transcriptase inhibitor (NRTI) [stavudine (d4T) or zidovudine (ZDV)], a thiacytidine NRTI [lamivudine (3TC)] and a non-nucleoside reverse transcriptase inhibitor (NNRTI) [nevirapine (NVP) or efavirenz (EFV)]. The full text of the treatment guidelines can be found at: http://www.who.int/3by5/publications/docu- ments/arv_guidelines/en/ Antituberculosis medicines This report does not include data on sources and prices of medicines for first-line treatment of tuberculosis (TB) as this information is available on the website of the International Price Indicator Guide 20041 or of the Global Drug Facility.2 In addition, further information on sources of first-line tubercu- losis medicines is available through the prequalification of TB medicines.3 Further resources for information on TB can be found in Annex 3, including links to the DOTS-plus for multidrug resist- ant TB website and the prequalification of TB medicines. 1.8 Medicine donations and price offers Public pressure, advocacy, competition from generic manu- facturers and initiatives from pharmaceutical companies have led to reduced prices of some HIV-related medicines in devel- oping countries. There is no systematic approach to setting prices for developing countries. Each company determines its own eligibility criteria for countries, sectors and institu- tions that may benefit from a reduced price. Manufacturers of innovator products do not generally offer across-the- border discounts, and low- and middle-income countries have to pay close to full price for a number ARVs. In most cases, only those countries which come under UNCTAD’s least-de- veloped country category benefit from such discounts. Some companies offer donations of medicines for specific indica- tions such as to prevent mother-to-child transmission of HIV, or to treat certain opportunistic infections affecting People Living with HIV/AIDSs. These donations are not monitored and hence their scope and success is not known yet. The prices quoted in Chapter 5 of this report do not neces- sarily reflect all agreements that may have been negotiated with individual countries. Information on price offers for ARVs publicly announced by pharmaceutical manufacturers, includ- ing information on countries eligible for the offers and other conditions, can be found in the MSF report Untangling the Web of Price Reductions: A Pricing Guide for the Purchase of ARVs for Developing Countries (see Annex 4). Apart from pro- viding prices of ARVs as offered by originator companies and selected generic companies, it highlights the lack of stand- ardization among different companies on eligibility, and terms 1. INTRODUCTION 1 The International Price Indicator Guide 2004 is a joint publication of WHO and Management Sciences for Health. For more informa- tion refer to Annex 4, Websites: Drug Prices. 2 See http://www.stoptb.org/GDF/drugsupply/drugs.available.html 3 See http://mednet3.who.int/prequal/ SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS6 and conditions of price offers. For example, some compa- nies use UNCTAD classification (Least Developed Countries), or the World Bank classification (Low Income/ Middle Income Countries) or a combination of UNDP classification (Human Development Index) and UNAIDS prevalence data. 1.9 Additional methods of price reduction In addition to generic competition and advocacy for reduced pricing in line with the purchasing power of countries, other important options for price reduction which may be consid- ered by governments include compulsory licensing, govern- ment use licences and parallel importation1 in accordance with the provisions in the TRIPS Agreement. As agreed by the WTO Ministerial Conference in 2001, Least Developed Countries (LDCs) are not obliged to grant or en- force pharmaceutical product patents until at least 2016.2 LDCs can make use or avail themselves of this provision to purchase medicines at the lowest prices on the world mar- ket. As of January 2005, non-LDC Members of the WTO must be fully TRIPS-compliant and provide patent protection for pharmaceuticals. See Annex 3 for details and references on the impact of these changes. A briefing note is also available on the MSF website.3 Additional information on the TRIPS Agreement, please see the joint WHO/UNAIDS/MSF report: Determining the patent status of essential medicines in developing countries. The Global Fund to Fight AIDS, Tuberculosis and Malaria “en- courages recipients to comply with national laws and applica- ble international obligations in the field of intellectual property including the flexibilities provided in the TRIPS agreement and referred to in the Doha Declaration in a manner that achieves the lowest possible price for products of assured quality.”4 Other measures may include reducing or eliminating import duties and taxes. As data clearly demonstrate, these factors can severely distort the prices patients will pay for medicines compared with the price at which they were sold by the manu- facturer. Increasing demand through pooled procurement may also be an option for purchasers to explore. Countries could also take advantage of programs such as The Clinton Foundation HIV/AIDS Initiative which has negoti- ated price ceilings with generic suppliers for some single-, double-, and triple-combination ARVs as well as diagnostic equipment. Governments are required to first sign a memo- randum of understanding with The Clinton Foundation, in order to obtain the lower prices for these products and serv- ices. The Foundation has also set up two new programmes to help expand AIDS care and treatment to children and to people living in rural areas.5 1 As described in chapter 2 of HIV/AIDS Medicines and Related Sup- plies: Contemporary Context and Procurement. The World Bank, Washington, D.C., 2004. 2 Doha Declaration on the TRIPS agreement and Public Health, para- graphs 6 & 7. 3 See: http://www.accessmed-msf.org/prod/ 4 The Global Fund to Fight AIDS, Tuberculosis and Malaria, Report of the Third Board Meeting, GF/B4/2, page 25, para 10 (a). 5 http://www.clintonfoundation.org/041105-nr-cf-hs-ai-pr-treatment- for-ten-thousand-children.htm 7 2. Price information projects 2.2 Price monitoring of pharmaceutical starting materials The Market News Service (MNS) of the International Trade Centre UNCTAD/WTO provides detailed price and market in- formation on selected primary and semi-processed products of particular interest to developing countries and economies in transition, including a monthly report Pharmaceutical Start- ing Materials of Essential Medicines. The report is an infor- mation source with the sole aim of improving market transparency and encouraging price and quality competition for the benefit of all market players. It covers the main trad- ing centres in Europe and Asia and draws information from a network of price information providers. The prices of active pharmaceutical ingredients used in manu- facturing antiretrovirals have been significantly reduced dur- ing the last two years as shown in figure 1. 2.1 Medicine Prices: a new approach to measurement The Medicines Prices project1 has developed technical guid- ance for a standard approach to the measurement of the prices people pay for key medicines. Availability and retail prices are recorded for a core list of 30 widely used medi- cines in their originator brand and lowest-priced generic ver- sions. Supplementary lists with different medicines can be tailored to meet local needs using the same method. The method described also assesses availability in the different sectors and for different medicines as well as assessing affordability for the treatment of common conditions. Price information is collected for procurement prices and at a sample set of pharmacies in public, private and one other sector which can be defined to fit local conditions (eg. NGO agencies, faith-based or other charity organizations, or other types of not for profit service providers). The method uses median prices provided by Management Sciences for Health (MSH) for the core medicines as a benchmark and the Excel spreadsheet provided helps calculate price ratios for each medicine to the MSH ‘reference’ price. The spreadsheet pro- gramme also analyzes the input data to generate standard report tables. The HAI website contains an open-access re- pository of data from studies undertaken so far, national and regional reports and a synthesis of results from the various studies. 1 http://www.who.int/medicines/library/prices.shtml; http://www.haiweb.org/medicineprices/ As part of its effort to provide information to improve market transparency, MNS reports are now directly available on-line through ITC’s market analysis tool, Product Map, www.p- maps.org, a subscription-based service. Subscribers from LDCs, WHO Regional and Country Offices receive the report via E-mail and printed copies free-of-charge. Sub-Saharan African users now have free access to the MNS reports through www.p-maps.org. The Product Map on Pharmaceuti- cals combines quantitative market information in relation to international trade statistics and macroeconomic indicators, qualitative market intelligence – such as market briefs and published market studies – and networking links to key mar- ket players in the Pharmaceuticals industry. FIGURE 1. Price trends for various active pharmaceutical ingredients used in manufacturing antiretroviral medicines Av er ag e in di ca tiv e pr ic es , U S$ /k g 3600 3000 2400 1800 1200 600 0 Abacivir Didanosine Indinavir Lamivudine Nelfinavir Nevirapine Ritonavir Saquinavir Stavudine Zidovudine 2003 2004 Jan–Feb 05 2. PRICE INFORMATION PROJECTS 3. Paediatric formulations and diagnostics children. Furthermore, the price is always as high as treating adults using FDCs. There are many challenges in the provision of ARV treatment for children infected with HIV, many of them not exclusive to HIV infection. To address some of these issues, UNICEF and WHO co-hosted a technical consultation in November 2004.1 It was widely recognised that children can and should be treated with existing formulations. Prices of currently avail- able paediatric formulations can be found in Chapter 5. In addition, some generic companies are in the process of developing paediatric FDCs, and WHO is working on the prepa- ration of clear treatment guidelines. 1 Please visit the WHO website for the full report: http://www.who.int/ 3by5/en/finalreport.pdf FIGURE 2. Grandmother with her grandchild at an MSF project clinic in Khayelitsha, South Africa. The medicines on the table are the monthly treatment for the children. Many prac- titioners are obliged to use liquids for children as better adapted paediatric formulations are unavailable. This means huge volumes of formulations that are difficult to manage and transport. In addition, the price normally increases consider- ably. Photo: MSF FIGURE 3. Evolution on price for pediatric treatment (d4T+3TC+NVP) according to the weight US $/ ye ar 1400 1200 1000 800 600 400 200 0 7 10 14 20 25 30 60 Weight (kg) best generic best originator Adult formulation The following chart shows the evolution in price of a treat- ment regimen consisting of the three ARVs, stavudine/ lamivudine/nevirapine (d4T/3TC/NVP). The price falls when treatment is switched to a single adult formulation (above 14 kg). In most cases, however, these adult formulations are unsuitable for children. For instance, lamivudine, as marketed by most of the manufactures, is not scored, which makes it difficult to break accurately in half. Additionally, the use of adult formulations makes it difficult to adjust the dose for Recommendations for paediatric ARVs required in resource-poor settings Syrups and solutions should be reserved for infants weighing <10–12kg. Where possible, sachets gran- ules, or dispersible tablets would be preferred. Liquid formulations: ■ Should be stable at room temperature; have small dose/volume; have a long shelf life at high humidity and temperature ■ Be available in suitable dosage forms to provide appropriate dose ranges by 2–3kg weight band for smallest infants. ■ Be packaged to provide for 28–30 treatment days ■ Have suitable masking of unpleasant taste (e.g. AZT) Solid formulations ■ For use as soon as a child can swallow (usually for children weighing >10kg) ■ Be available in suitable dosage forms to provide appropriate dose ranges by 2–3kg weight band for smaller infants and by 10kg weight band for older ones: — Crushable, granulate or dispersible tablets — Stable product with longer shelf life at high room temperatures and humidity — Scored tablets — Have suitable masking of bad taste — Innovative delivery systems for reduced dose fre- quency SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS8 The early diagnosis of infants born to HIV-seropositive moth- ers is difficult as traditional HIV serological tests cannot be used with certainty before the age of 12–18 months owing to interference with maternal HIV antibodies. Earlier detection of HIV infection is possible after 6–12 weeks by using either DNA or RNA nucleic-acid-based technologies, which detect parts of the virus instead of antibodies against HIV. However, these technologies are technically sophisticated, and require excellent laboratory facilities and expensive equipment not commonly available in resource-limited settings. In some countries an alternative approach could be to collect a blood or plasma sample on filter paper and send it for cen- tralized testing. Once infants have been diagnosed as being infected with HIV and requiring ARV therapy, the challenge is to monitor the effectiveness of the treatment regimen. The measurement of CD4 percentages is quite feasible when using flow cytometry. However, most of the smaller CD4 tech- nologies, which are more appropriate for use in resource- limited settings, do not yet have a protocol for measuring CD4 percentages or their application has not yet been vali- dated. Manufacturers of CD4 technologies are aware of this issue and efforts are being made to resolve it. The lack of appropriate diagnostic tools to diagnose HIV infection early in infants and to monitor the efficacy of ARV treatment for paediatrics hampers the roll out of care and support to this patient group. 3. PAEDIATRIC FORMULATIONS AND DIAGNOSTICS 9 4. Access to quality HIV/AIDS medicines and diagnostics 4.2 Product registration In order to guide procurement, governments must ensure they have well-functioning national drug regulatory authorities (DRAs) with a clear mandate and legal authority, appropriate organizational structure, adequate number of qualified staff, sufficient resources and a sustainable financing mechanism. The primary objective of DRAs is to safeguard public health by ensuring that all medicines circulating in the markets meet appropriate standards of safety, quality and efficacy. Safety aspects cover potential or actual harmful effects; quality re- lates to development and manufacture of products; and effi- cacy is a measure of the beneficial effect of the medicine on patients. To assist procurement agencies with regulatory as- pects of medicines, Annex 2A (see attached CD-ROM) pro- vides information on countries in which products listed in this report are currently registered. This information is provided by manufacturing companies and is subject to change. Any updates in information will be placed on partner websites. To improve the accuracy of this publication, DRAs are strongly encouraged to submit any known changes or corrections to the data provided to: UNICEF Supply Division in Copenhagen, Denmark, e-mail supply@unicef.org, fax +45 35 269421. 4.3 Diagnostics In parallel to the scale-up efforts and roll-out programmes of ARVs in countries with limited resources there is an increased demand for HIV/AIDS related diagnostics and laboratory sup- port. Access to appropriate and cost-effective diagnostics can make a difference. HIV tests are crucial tools for ensur- ing blood safety, gathering surveillance data and to identify individuals infected with HIV. Qualitative nucleic acid-based tests, such as DNA or RNA PCR, or alternative methods, such as heat denaturated p24 antigen, are key in early detection of HIV infection in infants born to HIV positive mothers. Diag- nostic technologies, measuring CD4 counts and to a lesser extent viral load tests are important for making decisions about when to start, substitute, switch or stop ARV treatment. A wide range of tests that can be used for the above-men- tioned purposes is available in the global market and many more tests are under development. Yet their quality, affordability and suitability for use in settings with limited re- sources need to be assessed and validated. SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS10 4.1 Prequalification project1 This project evaluates pharmaceutical products according to WHO recommended standards of safety, efficacy and quality and compliance with good manufacturing practices (GMP), as well as good clinical practices (GCP). The prequalification process follows a standard procedure developed through WHO’s Expert Committee on Specifications for Pharmaceuti- cal Preparations. A medicine is added to the list of prequalified products only when the products and manufacturing sites are found to meet the required standards. A list of HIV-related products/manufacturers that have been found acceptable, in principle, for procurement by UN agencies is available on the web sites of collaborating UN agencies, such as UNICEF, UNFPA and the UNAIDS Secretariat. As of January 2005, 285 product dossiers for various prod- ucts and dosage forms from over 40 manufacturers were received: only 85 of these products, from 26 manufacturing sites have been listed as prequalified products. The products evaluated are ARVs (including fixed dose combinations), and medicines for the treatment of opportunistic infections and cancers. A list of products evaluated under this project is regularly updated through the websites of collaborating UN agencies. This report provides pricing information and does not prequalify any products. Every effort has been made to en- sure the accuracy of the price information presented and screening of the products included in this survey has been carried out as indicated on page 2. However, this screening in no way constitutes an in-depth review of product quality, safety or efficacy. Products that have been prequalified are marked in Annex 2B of this report in bold and with an asterisk (*). The information contained in Annex 2B is, however, sub- ject to change and should therefore be verified before a deci- sion on procurement is taken. Products not included in the list of prequalifed products should, in relation to purchase, be subject to prequalification review as indicated in the WHO General Procedure for Prequalification of Suppliers of Phar- maceutical Products. Manufacturers are encouraged to ap- ply for WHO prequalification for their HIV-related products. In scaling up access to ARVs, it is not only the quantity of medi- cines that is important, but also their quality. 1 http://mednet3.who.int/prequal/default.shtml 114. ACCESS TO QUALITY HIV/AIDS MEDICINES AND DIAGNOSTICS The Department of Essential Health Technologies at WHO provides information to Member States on the quality and operational characteristics of diagnostics for HIV prevention, care and treatment. As part of this effort, several types of diagnostic equipment and assays have already been assessed or are scheduled for an evaluation. In general the evaluation process consists of five steps: (1) WHO receives a request from a manufacturer or the request is initiated by WHO; (2) WHO reviews independent data on performance generated in trials, and reviews existing certifi- cations, such as FDA approval or CE mark). (3) An original equipment manufacturer (OEM) investigation is pursued. OEM represents the repackaging of an assay sourced from a sin- gle manufacturer under a different label that does not involve alterations in the production of the assay components. (4) Assay and/or equipment performance is evaluated at WHO collaborating centers around the world. (5) The data from each stage of the evaluation is analyzed, and the information is disseminated. Slightly different approaches are used for the validation proc- ess, depending on the technologies assessed. HIV serology: Evaluation of HIV serological assays, relies on a well characterized WHO reference panel of specimens, and a standardized algorithm. Minimal performance criteria have been established in terms of: sensitivity [>99% for rapid, 100% for ELISA]; specificity [>98%]; inter-reader variability [<4%]; seroconversion sensitivity. The clarity of the test kit insert, the labeling of the component of the kit and the easy of the test procedure are also assessed. CD4 technologies: The validation of CD4 technologies are conducted in several sites according to one protocol. Speci- mens are collected in a prospective manner and a certain number of control specimens are included in the assessment, the results are compared to gold standard methods. Perform- ance criteria include: accuracy; linearity, reproducibility/pre- cision; inter/intra run variability and technician variability. Viral load: The assessment of the viral load assays includes the sensitivity to the various HIV subtypes, reproducibility/ precision and accuracy. Data are compared to gold standard methods for these assays. The ExaVir v2.0 (Cavidi) and the Retina Rainbow assay (Primagen) are currently under evalua- tion. The main focus of WHO is on diagnostics and equipment ap- propriate for use in resource-limited settings. Assays that have been successfully evaluated are eligible to tender for bulk procurement through the UN. The one year procurement agreements made with companies by WHO cover the other UN organizations (e.g. UNAIDS, UNDP, UNFPA, UNICEF, World Bank etc). Hence, access to quality diagnostics at reason- able cost are made available to Member States. Please note that this and additional information is regularly updated and available on the WHO website at www.who.int/ diagnostics_laboratory (follow the links to Diagnostics, HIV or Bulk Procurement Scheme, HIV). More information related to diagnostics is provided in Annex 1A and 1B of this docu- ment. 5. Prices of medicines and diagnostics 5.1 Medicines TABLE 1. ANTI-INFECTIVE MEDICINES Manufacturer Indicative price, US$ List prices, US$ No. of No. of 25th Anthelminthics – Antifilarials manufacturers countries unit max min median perc Brazil Spain crotamiton cream/lotion 10% 1 1 ml 0.010 0.010 0.010 0.010 n/a 0.877 ivermectin scored tablet, 3 mg 1 1 tablet 0.530 0.530 0.530 0.530 n/a n/a scored tablet, 6 mg* — — tablet — — — — n/a n/a lindane cream, lotion or powder, 0.3% 1 1 gram 0.122 0.122 0.122 0.122 n/a n/a permethrin cream, 5% 1 1 gram 0.152 0.152 0.152 0.152 n/a 0.175 lotion, 1% 1 1 ml 0.019 0.019 0.019 0.019 n/a n/a Anthelminthics – Intestinal anthelminthics albendazole chewable tablet, 400 mg 13 8 tablet 0.420 0.007 0.045 0.022 0.048 0.929 Antibacterials, beta lactam medicines benzathine benzylpenicillin powder for injection, 1.44 g (=2.4 million IU) 3 3 vial 1.300 0.170 0.278 0.224 n/a n/a in 5-ml vial benzylpenicillin powder for injection, 3 g (=5 million IU) 3 2 vial 1.200 0.180 0.350 0.265 0.619 1.284 (as sodium or potassium salt) in vial powder for injection, 600 mg (=1 million IU) 2 2 vial 0.200 0.146 0.173 0.160 n/a 1.765 (as sodium or potasium salt) in vial cefixime paediatric oral suspension, 100 mg/5 ml 2 2 ml 0.163 0.034 0.098 0.066 n/a 0.075 paediatric oral suspension, 40 mg/5 ml 1 1 ml 0.098 0.098 0.098 0.098 n/a n/a powder for injection, 250 mg (as sodium salt)* — — vial — — — — n/a n/a tablet, 200 mg 5 4 tablet 0.975 0.186 0.343 0.291 n/a 0.749 tablet, 400 mg 2 2 tablet 0.400 0.165 0.283 0.224 n/a 1.373 SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS12 * No price information; n/a – not available. Manufacturer Indicative price, US$ List prices, US$ No. of No. of 25th manufacturers countries unit max min median perc Brazil Spain ceftriaxone powder for injection, 1 g (as sodium salt) in vial 18 10 1 g vial 4.613 0.109 1.170 0.900 0.687 6.237 powder for injection, 250 mg (as sodium salt) in vial 13 7 vial 2.917 0.270 0.700 0.470 n/a 1.840 powder for injection, 500 mg (as sodium salt) in vial 14 10 vial 3.664 0.085 0.800 0.700 n/a 3.462 procaine benzylpenicillin powder for injection, 1 g (=1 million IU) in vial 1 1 vial 0.134 0.134 0.134 0.134 n/a n/a powder for injection, 3 g (=3 million IU) in vial 2 2 vial 0.240 0.144 0.192 0.168 n/a n/a Antibacterials, others azithromycin oral suspension, 200 mg/5 ml (dihydrate) 4 2 ml 0.133 0.040 0.042 0.040 0.078 0.226 tablet/capsule, 250 mg (dihydrate) 7 3 tablet/ 0.890 0.117 0.152 0.121 n/a n/a capsule tablet/capsule, 500 mg (dihydrate) 7 4 tablet/ 2.714 0.247 0.667 0.275 0.447 2.175 capsule capreomycin1 powder for injection, 1 g in vial 1 1 1 g vial 5.000 5.000 5.000 5.000 n/a 2.074 chloramphenicol capsule, 250 mg 3 3 capsule 0.028 0.014 0.020 0.017 n/a n/a oily suspension for injection, 0.5 g/ml (as sodium — — ampoule — — — — n/a n/a succinate) in 2-ml ampoule* oral suspension, 150 mg/5 ml (as palmitate)* — — ml — — — — n/a n/a powder for injection, 1 g (sodium succinate) in vial 5 3 1 g vial 1.440 0.175 0.280 0.231 0.371 n/a ciprofloxacin tablet, 250 mg (as hydrochloride) 25 14 tablet 0.658 0.008 0.028 0.020 0.048 0.151 tablet, 500 mg (as hydrochloride) 24 12 tablet 1.289 0.013 0.044 0.034 0.058 0.295 clarithromycin oral suspension, 125 mg/5 ml* — — ml — — — — n/a 0.061 powder for injection, 500 mg 1 1 vial 0.700 0.700 0.700 0.700 n/a 11.105 tablet, 250 mg 14 9 tablet 0.472 0.105 0.160 0.133 0.296 0.582 clindamycin capsule, 150 mg 4 4 capsule 0.113 0.033 0.058 0.035 0.660 0.131 cream, 2% (as phosphate) 1 1 gram 0.125 0.125 0.125 0.125 n/a n/a injection, 150 mg/ml (as phosphate) in 2-ml ampoule 1 1 ampoule 2.008 2.008 2.008 2.008 0.464 1.206 cycloserine1 capsule, 250 mg 1 1 capsule 0.466 0.466 0.466 0.466 n/a n/a doxycycline capsule/tablet, 100 mg (hydrochloride) 12 6 capsule/ 0.025 0.008 0.016 0.014 0.052 0.090 tablet 5. PRICES OF MEDICINES AND DIAGNOSTICS 13 * No price information; n/a – not available. 1 Please visit http://www.stoptb.org/gdf/ for a comprehensive list of TB medicines and pricing strategies SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS14 Manufacturer Indicative price, US$ List prices, US$ No. of No. of 25th manufacturers countries unit max min median perc Brazil Spain erythromycin powder for injection, 500 mg (as lactobionate) in vial* — — vial — — — — n/a n/a powder for oral suspension, 125 mg (as stereate 8 7 ml 0.977 0.006 0.011 0.009 0.010 n/a or ethylsuccinate) tablet/capsule, 250 mg 15 8 tablet/ 0.049 0.021 0.030 0.025 n/a n/a (as stearate or ethylsuccinate) capsule tablet/capsule, 500 mg 12 7 tablet/ 0.090 0.043 0.051 0.047 0.099 0.162 (as stearate or ethylsuccinate) capsule gentamicin injection, 10 mg/ml (as sulfate) in 2-ml vial 1 1 vial 0.109 0.109 0.109 0.109 0.072 0.357 injection, 40 mg/ml (as sulfate) in 2-ml vial 4 3 vial 0.370 0.058 0.118 0.101 0.065 0.402 metronidazole injection, 500 mg in 100-ml vial 6 5 vial 2.880 0.570 0.700 0.651 0.189 2.434 oral suspension, 200 mg (as benzoate)/5 ml 6 5 ml 0.008 0.003 0.005 0.004 n/a n/a suppository, 1 g 1 1 suppository 0.450 0.450 0.450 0.450 n/a n/a suppository, 500 mg* — — suppository — — — — n/a n/a tablet, 200 mg 7 6 tablet 0.011 0.003 0.007 0.005 n/a n/a tablet, 500 mg 6 6 tablet 0.093 0.009 0.022 0.019 n/a n/a vaginal gel, 0.75% 1 1 gram 0.025 0.025 0.025 0.025 n/a 0.108 ofloxacin IV infusion, 2 mg/ml (hydrochloride) 2 2 ml 0.032 0.012 0.022 0.017 n/a n/a tablet, 200 mg 11 7 tablet 0.713 0.024 0.063 0.044 n/a 0.412 tablet, 400 mg 7 4 tablet 0.158 0.062 0.120 0.097 1.014 n/a rifabutin capsule, 150 mg* — — capsule — — — — n/a 2.118 silver nitrate solution (eye drops), 1%* — — ml — — — — n/a n/a spectinomycin powder for injection, 2 g (as hydrochloride) in vial 1 1 vial 4.000 4.000 4.000 4.000 n/a n/a sulfadiazine injection, 250 mg (sodium salt) in 4-ml ampoule* — — ampoule — — — — n/a n/a tablet, 500 mg 3 3 tablet 0.324 0.041 0.149 0.095 0.018 0.060 sulfamethoxazole+trimethoprim injection, 80+16 mg/ml in 10-ml ampoule* — — ampoule — — — — n/a n/a oral suspension, 200+40 mg/5 ml 15 9 ml 0.149 0.003 0.005 0.003 0.002 0.012 tablet, 100+20 mg 7 5 tablet 0.015 0.001 0.007 0.004 n/a 0.021 tablet, 400+80 mg 21 13 tablet 0.027 0.005 0.010 0.008 0.016 0.039 tablet, 800+160 mg 13 8 tablet 0.066 0.011 0.018 0.014 0.069 0.098 * No price information; n/a – not available. 15 Manufacturer Indicative price, US$ List prices, US$ No. of No. of 25th manufacturers countries unit max min median perc Brazil Spain Antifungal medicines amphotericin B IV infusion, powder for reconstitution 50 mg vial* — — vial — — — — n/a 133.166 liposomal IV infusion, 5 mg/ml in vial* — — vial — — — — n/a 0.584 powder for injection, 50 mg in vial 2 2 vial 9.000 3.664 6.332 4.998 2.426 1.910 clotrimazole cream, 1% 13 11 gram 0.133 0.009 0.026 0.016 0.653 1.194 pessary, 500 mg 2 2 pessary 0.600 0.400 0.500 0.450 n/a 1.619 fluconazole capsule, 150 mg 10 7 capsule 1.300 0.028 0.225 0.066 0.151 3.438 capsule, 200 mg 8 6 capsule 1.406 0.036 0.233 0.170 n/a 4.590 capsule, 50 mg 7 5 capsule 0.500 0.043 0.163 0.094 n/a 1.143 injection, 2 mg/ml in ampoule 4 3 ml 0.046 0.008 0.039 0.027 0.014 0.049 oral suspension, 50 mg/5 ml* — — ml — — — — n/a 0.234 itraconazole capsule, 100 mg 4 4 capsule 0.550 0.132 0.406 0.266 0.292 0.806 oral solution, 10 mg/ml* — — ml — — — — n/a 0.968 ketoconazole cream, 2% 7 7 gram 2.510 0.016 0.024 0.020 n/a 2.335 oral suspension, 100 mg/5 ml* — — ml — — — — n/a n/a tablet, 200 mg 13 10 tablet 0.188 0.006 0.040 0.032 n/a 0.426 miconazole cream/ointment 2% (as nitrate) 15 g tube 5 4 tube 0.700 0.258 0.455 0.380 n/a n/a cream/ointment 2% (as nitrate) 20 g tube 4 4 tube 1.357 0.200 0.545 0.410 n/a n/a cream/ointment 2% (as nitrate) 30 g tube 8 4 tube 0.980 0.026 0.490 0.438 0.618 1.918 cream/ointment 2% (as nitrate) 40 g tube 1 1 tube 0.669 0.669 0.669 0.669 n/a 1.792 nystatin lozenge, 100,000 IU 1 1 lozenge 0.030 0.030 0.030 0.030 n/a n/a pessary, 100,000 IU 6 5 pessary 0.030 0.019 0.024 0.022 n/a 0.093 tablet, 100,000 IU 4 3 tablet 0.025 0.017 0.023 0.020 n/a n/a tablet, 500,000 IU 9 6 tablet 0.075 0.028 0.040 0.036 n/a 0.061 Antiprotozoal medicines pentamidine powder for injection, 200 mg (isetionate) in vial 1 1 vial 9.000 9.000 9.000 9.000 n/a n/a powder for injection, 300 mg (isetionate) in vial 3 3 vial 48.400 5.020 24.700 14.860 36.948 7.039 5. PRICES OF MEDICINES AND DIAGNOSTICS * No price information; n/a – not available. SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS16 Manufacturer Indicative price, US$ List prices, US$ No. of No. of 25th manufacturers countries unit max min median perc Brazil Spain pyrimethamine tablet, 25 mg 2 2 tablet 0.187 0.050 0.119 0.084 0.017 0.062 tinidazole tablet, 2 g* — — tablet — — — — n/a n/a tablet, 500 mg 4 3 tablet 0.058 0.012 0.016 0.014 n/a 0.663 Antiviral medicines aciclovir cream, 5% 5 4 gram 0.936 0.026 0.102 0.041 0.409 1.048 powder for injection, 250 mg (as sodium salt) 7 5 vial 14.286 0.170 2.000 1.882 1.457 4.133 tablet, 200 mg 16 12 tablet 0.435 0.025 0.045 0.031 0.086 0.576 tablet, 400 mg 11 6 tablet 0.350 0.048 0.086 0.059 n/a n/a tablet, 800 mg 10 6 tablet 1.370 0.098 0.366 0.180 n/a 1.818 cidofovir IV infusion, 75 mg/ml in 5-ml vial* — — vial — — — — n/a 117.572 famciclovir tablet, 125 mg* — — tablet — — — — n/a 2.349 tablet, 250 mg* — — tablet — — — — n/a 4.744 tablet, 500 mg* — — tablet — — — — n/a n/a foscarnet sodium IV infusion, 24 mg/ml* — — ml — — — — n/a 0.122 ganciclovir capsule, 250 mg* — — capsule — — — — n/a n/a capsule, 500 mg* — — capsule — — — — n/a n/a powder for IV infusion, 500 mg in vial 1 1 vial 42.520 42.520 42.520 42.520 17.337 19.990 imiquimod cream, 5%* — — gram — — — — n/a n/a podofilox cream, 0.15%, 5 g tube* — — tube — — — — n/a 13.036 solution or gel, 0.5%* — — ml — — — — n/a 8.379 podophyllum resin solution, 10 – 25%* — — ml — — — — n/a n/a valacyclovir tablet, 500 mg* — — tablet — — — — n/a 1.745 valganciclovir tablet, 450 mg* — — tablet — — — — n/a 21.630 * No price information; n/a – not available. 17 Manufacturer Indicative price, US$ List prices, US$ No. of No. of 25th Antiviral medicines – Antiretrovirals manufacturers countries unit max min median perc Brazil Spain abacavir (ABC) syrup, 20 mg/ml 1 1 ml 0.131 0.131 0.131 0.131 n/a 0.253 tablet, 300 mg 3 3 tablet 2.962 1.018 1.215 1.116 n/a 3.914 atazanavir (ATV) capsule, 200 mg* — — capsule — — — — n/a 7.500 didanosine (ddI) buffered chewable tablet, 100 mg 5 4 tablet 0.271 0.024 0.191 0.165 0.317 1.097 buffered chewable tablet, 25 mg 3 3 tablet 0.117 0.090 0.103 0.097 n/a 0.274 buffered chewable tablet, 50 mg 2 2 tablet 0.158 0.136 0.147 0.141 n/a 0.622 syrup, 2 g 1 1 ml 0.088 0.088 0.088 0.088 n/a 21.949 (bottle) unbuffered enteric coated capsule, 125 mg* — — capsule — — — — n/a 1.623 unbuffered enteric coated capsule, 250 mg 3 3 capsule 0.557 0.430 0.543 0.486 n/a 3.432 unbuffered enteric coated capsule, 400 mg 2 2 capsule 0.764 0.543 0.653 0.598 n/a 5.401 efavirenz (EFZ) capsule, 100 mg 2 2 capsule 1.001 0.231 0.616 0.424 n/a 1.450 capsule, 200 mg 5 4 capsule 0.463 0.188 0.421 0.399 n/a 2.982 capsule, 50 mg 1 1 capsule 0.116 0.116 0.116 0.116 n/a 0.725 oral solution, 150 mg/5 ml 1 1 ml 0.094 0.094 0.094 0.094 n/a n/a tablet, 600 mg 5 3 tablet 1.312 0.950 1.189 1.003 2.182 9.165 emtricitabine (FTC) capsule, 200 mg* — — capsule — — — — n/a n/a indinavir (IDV) capsule, 200 mg (as sulphate) 2 2 capsule 0.170 0.137 0.153 0.145 n/a 0.754 capsule, 333 mg (as sulphate)* — — capsule — — — — n/a n/a capsule, 400 mg (as sulphate) 5 4 capsule 1.058 0.002 0.294 0.274 0.404 1.509 lamivudine (3TC) oral solution, 50 mg/5 ml 3 3 ml 0.028 0.021 0.025 0.023 0.035 0.032 tablet, 150 mg 10 6 capsule/ 0.398 0.094 0.118 0.097 0.237 2.476 tablet tablet, 300 mg* — — capsule/ — — — — n/a 4.952 tablet lopinavir+ritonavir (LPV/r) capsule, 133.3+33.3 mg* — — capsule — — — — n/a 2.087 oral solution, 400 mg+100 mg/5 ml* — — ml — — — — n/a 1.252 nelfinavir (NFV) oral powder, 50 mg/g 1 1 gram 0.243 0.243 0.243 0.243 n/a 0.354 tablet, 250 mg 4 4 tablet 0.921 0.290 0.480 0.405 0.611 1.132 * No price information; n/a – not available. 5. PRICES OF MEDICINES AND DIAGNOSTICS SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS18 Manufacturer Indicative price, US$ List prices, US$ No. of No. of 25th manufacturers countries unit max min median perc Brazil Spain nevirapine (NVP) syrup, 50 mg/5 ml 4 3 ml 0.073 0.013 0.018 0.014 0.143 0.171 tablet, 200 mg 9 6 tablet 3.306 0.122 0.195 0.171 n/a 4.336 saquinavir (SQV) hard gel capsule, 200 mg 1 1 capsule 0.294 0.294 0.294 0.294 n/a 1.036 soft gel capsule, 200 mg* — — capsule — — — — n/a 0.733 stavudine (d4T) capsule, 15 mg 1 1 capsule 0.058 0.058 0.058 0.058 n/a 2.089 capsule, 20 mg 3 3 capsule 0.094 0.056 0.070 0.063 n/a 2.167 capsule, 30 mg 9 6 capsule 1.345 0.043 0.068 0.056 0.093 2.267 capsule, 40 mg 10 7 capsule 1.427 0.055 0.075 0.065 0.182 2.343 syrup, 1 mg/ml 2 2 ml 0.048 0.011 0.029 0.020 n/a 0.095 tenofovir (TDF) tablet, 300 mg* — — tablet — — — — n/a 9.970 zalcitabine (ddC) tablet, 0.375 mg 1 1 tablet 0.251 0.251 0.251 0.251 n/a n/a tablet, 0.75 mg 2 2 tablet 0.865 0.425 0.645 0.535 n/a 1.393 zidovudine (AZT or ZDV) oral solution, 50 mg/5 ml 6 5 ml 0.300 0.016 0.025 0.021 0.015 0.060 solution for IV infusion/injection, 10 mg/ml 2 2 vial 41.000 5.000 23.000 14.000 1.443 6.474 in 20-ml vial tablet/capsule, 100 mg 9 8 capsule/ 0.617 0.076 0.140 0.115 0.114 0.659 tablet tablet/capsule, 250 mg 5 5 capsule/ 1.450 0.315 0.360 0.332 n/a 1.643 tablet tablet/capsule, 300 mg 10 6 tablet/ 0.475 0.005 0.250 0.218 n/a 1.972 capsule Antiviral medicines – Antiretrovirals (combinations) 3TC+AZT tablet, 150+300 mg 9 6 tablet 2.951 0.007 0.313 0.271 0.471 5.014 3TC+d4T tablet, 150+30 mg 3 2 tablet 0.174 0.107 0.158 0.139 n/a n/a tablet, 150+40 mg 5 2 tablet 0.267 0.117 0.175 0.159 n/a n/a 3TC+d4T+NVP tablet, 150+30+200 mg 7 4 tablet 0.650 0.237 0.317 0.264 n/a n/a tablet, 150+40+200 mg 7 4 tablet 0.650 0.246 0.358 0.289 n/a n/a ABC+3TC tablet, 600+150 mg* — — tablet — — — — n/a n/a * No price information; n/a – not available. 19 Manufacturer Indicative price, US$ List prices, US$ No. of No. of 25th manufacturers countries unit max min median perc Brazil Spain ABC+3TC+ZDV tablet, 300+150+300 mg 2 2 tablet 1.700 1.683 1.692 1.687 n/a 8.414 AZT+3TC+NVP tablet, 300+150+200 mg 2 2 tablet 0.500 0.452 0.476 0.464 n/a n/a FTC+TDF tablet, 200+300 mg* — — tablet — — — — n/a n/a TABLE 2. ANTINEOPLASTIC MEDICINES Manufacturer Indicative price, US$ List prices, US$ No. of No. of 25th Cytotoxic medicines manufacturers countries unit max min median perc Brazil Spain bleomycin powder for injection, 15 mg (as sulfate) in vial 5 4 vial 21.000 12.429 20.000 18.000 22.515 11.158 calcium folinate (leucovorin) injection, 3 mg/ml in 10-ml ampoule* — — ampoule — — — — n/a n/a tablet, 15 mg 4 4 tablet 3.799 0.014 1.047 0.328 n/a 0.582 doxorubicine HCl powder for injection, 10 mg in 5-ml vial 6 4 vial 25.780 2.940 4.591 3.375 3.196 5.836 powder for injection, 50 mg in 25-ml vial 5 4 vial 120.760 10.660 18.159 15.000 14.739 23.008 etoposide capsule, 100 mg 1 1 capsule 10.000 10.000 10.000 10.000 n/a 9.264 injection, 20 mg/ ml in 5-ml ampoule 7 5 ampoule 33.921 1.723 6.000 3.857 2.921 6.607 liposomal doxorubicine HCl conc. for IV infusion, 2 mg/ml in vial* — — vial — — — — n/a 38.192 methotrexate injection, 25 mg/ml (as sodium salt) in 2-ml vial 3 3 vial 18.100 1.400 1.800 1.600 2.062 1.443 powder for injection, 50 mg (as sodium salt) 3 3 vial 4.310 2.000 3.360 2.680 n/a 2.989 in 2-ml vial tablet, 2.5 mg 5 4 tablet 0.188 0.034 0.070 0.065 n/a 0.043 vinblastine powder for injection, 10 mg (sulfate) in 10-ml vial 4 3 vial 14.260 1.400 5.254 3.281 11.684 5.170 vincristine powder for injection, 1 mg (sulfate) in 1-ml vial 3 2 vial 2.000 1.550 1.600 1.573 2.405 4.024 powder for injection, 5 mg (sulfate) in vial 1 1 vial 4.500 4.500 4.500 4.500 2.405 8.118 vinorelbine injection concentrate, 10 mg/ml in vial 2 2 ml 23.230 19.500 21.365 20.433 143.086 16.201 * No price information; n/a – not available. 5. PRICES OF MEDICINES AND DIAGNOSTICS SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS20 TABLE 3. PSYCHOTHERAPEUTIC MEDICINES Manufacturer Indicative price, US$ List prices, US$ No. of No. of 25th Medicines used in depressive disorders manufacturers countries unit max min median perc Brazil Spain amitriptyline tablet, 25 mg (as hydrochloride) 5 5 tablet 0.078 0.003 0.007 0.004 0.010 0.026 fluoxetine tablet, 20 mg 8 6 tablet 0.626 0.015 0.073 0.044 0.034 0.329 Medicines used in generalized anxiety and sleep disorders diazepam injection, 5 mg/ml in 2-ml ampoule 5 5 ampoule 0.298 0.090 0.120 0.110 n/a n/a tablet, 5 mg 6 6 tablet 0.020 0.002 0.004 0.003 n/a 0.016 lorazepam injection, 4 mg/ml in 1-ml ampoule 1 1 ampoule 0.008 0.008 0.008 0.008 n/a n/a tablet, 1 mg 2 2 tablet 0.047 0.006 0.027 0.016 n/a 0.022 methotrimepazine/levomepromazine powder for injection, 10 mg (sulfate) in 10-ml vial 2 2 tablet 0.108 0.033 0.070 0.052 n/a 0.229 tablet, 25 mg* — — tablet — — — — 0.038 0.047 Medicines used in substance dependence programmes methadone HCl oral solution, 10 mg/5 ml* — — ml — — — — n/a n/a oral solution, 5 mg/5 ml 1 1 ml 0.020 0.020 0.020 0.020 n/a n/a powder for oral concentrate, 10 mg/ml* — — ml — — — — n/a n/a powder for oral concentrate, 5 mg/ml* — — ml — — — — n/a n/a tablet, 5 mg* — — tablet — — — — n/a 0.044 buprenorphine sublingual tablet, 2 mg (hydrochloride)* — — tablet — — — — n/a 0.280 sublingual tablet, 8 mg (hydrochloride)* — — tablet — — — — n/a n/a naltrexone HCl tablet, 50 mg 2 2 tablet 1.388 0.969 1.178 1.074 n/a 1.911 TABLE 4. ANALGESICS Manufacturer Indicative price, US$ List prices, US$ No. of No. of 25th Opioid analgesics manufacturers countries unit max min median perc Brazil Spain codeine tablet, 30 mg (phosphate) 3 3 tablet 0.062 0.033 0.036 0.034 0.232 0.079 morphine injection, 10 mg/ml (sulfate or HCl), in 1-ml ampoule 2 2 ampoule 0.439 0.307 0.373 0.340 0.495 0.240 oral solution, 10 mg/5 ml (sulfate or HCl)* — — ml — — — — n/a 0.130 tablet, modified release, 10 mg (sulfate)* — — tablet — — — — n/a 0.123 * No price information; n/a – not available. 21 Manufacturer Indicative price, US$ List prices, US$ No. of No. of 25th manufacturers countries unit max min median perc Brazil Spain pethidine injection, 50 mg/ml (hydrochloride) in 1-ml ampoule 2 2 ampoule 0.390 0.360 0.375 0.368 0.344 n/a injection, 50 mg/ml (hydrochloride) in 2-ml ampoule 4 4 ampoule 0.600 0.374 0.476 0.401 n/a 0.666 tablet, 100 mg* — — tablet — — — — n/a n/a tablet, 50 mg 1 1 tablet 0.130 0.130 0.130 0.130 n/a n/a TABLE 5. GASTROINTESTINAL MEDICINES Manufacturer Indicative price, US$ List prices, US$ No. of No. of 25th Antacids and other antiulcer medicines manufacturers countries unit max min median perc Brazil Spain omeprazole capsule, 10 mg 4 4 capsule 0.339 0.015 0.057 0.041 0.028 0.086 capsule, 20 mg 21 12 capsule 0.368 0.011 0.075 0.021 0.034 0.168 capsule, 40 mg 3 3 capsule 0.601 0.140 0.563 0.143 n/a 0.372 powder for injection, 40 mg (as sodium salt) in vial 1 1 vial 3.000 3.000 3.000 3.000 1.371 7.282 powder for IV infusion, 40 mg (as sodium salt) in vial 1 1 vial 3.000 3.000 3.000 3.000 n/a n/a Antiemetic medicines dimenhydrinate tablet, 50 mg 5 5 tablet 0.041 0.005 0.009 0.008 n/a 0.199 metoclopramide injection 5 mg/ml in 2-ml ampoule 6 3 ampoule 0.200 0.041 0.103 0.065 0.062 0.171 tablet, 10 mg (as hydrochloride) 6 6 tablet 0.072 0.004 0.008 0.005 0.005 0.038 prochlorperazine injection, 12.5 mg/ml 1 1 ml 0.359 0.359 0.359 0.359 n/a n/a tablet, 10 mg* — — tablet — — — — n/a n/a tablet, 5 mg 1 1 tablet 0.008 0.008 0.008 0.008 n/a n/a promethazine elixir or syrup, 5 mg/5 ml (HCl) 3 3 ml 0.008 0.005 0.006 0.005 n/a n/a injection, 25 mg/ml (hydrochloride) in 2-ml ampoule 3 3 ampoule 0.200 0.176 0.188 0.182 n/a n/a tablet, 10 mg 1 1 tablet 0.008 0.008 0.008 0.008 n/a n/a tablet, 25 mg 3 3 tablet 0.010 0.004 0.008 0.006 n/a n/a Laxatives docusate sodium capsule, 100 mg* — — capsule — — — — n/a 0.063 paediatric oral solution, 12.5 mg/5 ml* — — ml — — — — n/a n/a senna capsule, 7.5 mg 1 1 capsule 0.017 0.017 0.017 0.017 n/a n/a 5. PRICES OF MEDICINES AND DIAGNOSTICS * No price information; n/a – not available. SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS22 * Company order code may vary from country to country 1 This is a list of HIV test kits evaluated by WHO and which are still commercially available. Therefore, the list may include test kits not currently on the UN Bulk Procurement Scheme. 2 Assays denoted as HIV 1 HIV 2 are capable of discrimination between HIV-1 and HIV-2, those denoted HIV 1+2 are not capable of discrimina- tion 3 Equipment Requirements – A: ELISA reader, B: ELISA washer, C: Consumables, D: Pipette, E: Power supply, F: For large volume testing more than 40 samples daily, G: For small volume testing 1 to 40 samples daily 4 Report numbers in italics are currently in publication 5 Indicative pricing only, price stated by the company in original WHO test kit evaluation 5.2 HIV Test Kits – Simple/Rapid, EIA and Confirmatory Assays1 SIMPLE/RAPID TEST KITS Company Test Shelf Life/ Assay Name Order per Storage HIV Assay Type/ Sample Equip- WHO Indicative (Manufacturer) Code* Kit Temp (°C) Type2 Antigen Type Type ment3 Report4 Price5 Advanced Quality™ ITP02002- 40 18 months/ HIV lateral flow/ serum/ plasma G 12 & US$0.80– Rapid HIV Test TC40 2°–30° 1+2 recombinant whole blood 16 $1.20 (InTec Products) proteins Bionor HIV-1&2 40 6 months/ HIV magnetic beads/ serum/ plasma C,D,E,G 11 US$2.50 (Bionor) 200 2°–8°C 1+2 synthetic peptides whole blood Bionor Testing Station (US$1000) Capillus™ HIV-1/HIV-2 6048G 100 9 months/ HIV agglutination/ serum/ plasma G 12 US$2.20 (Trinity Biotech) 2°–8° 1+2 recombinant proteins whole blood Determine™ HIV-1/2 7D23-13 100 6–9 HIV lateral flow/ serum/ plasma D,G 12 US$1.20 Serum/Plasma Assay months/ 1+2 recombinant protein, whole blood (Abbott Diagnostics) 2°–30° synthetic peptide Determine™ HIV-1/2 7D23-33 100 Whole Blood Assay (Abbott Diagnostics) Diagnostic Kit for KH-R-02 50 15 months/ HIV lateral flow/ serum/ plasma D,G 14 US$0.60 HIV (1+2) Antibody 4°–30° 1+2 recombinant protein, whole blood (Colloidal Gold) synthetic peptide (Shanghai Kehua) DoubleCheck 60332000 40 15 months/ HIV lateral flow/ serum/plasma G 11 US$2.00 HIV 1&2 4°–8° 1+2 recombinant proteins, (Orgenics) synthetic peptides First Response™ I05FRC30 30 15 months/ HIV lateral flow/ serum/plasma D,G 12 US$1.15 HIV 1-2-0 Card Test 2°–30° 1+2 recombinant proteins whole blood (Premier Medical Corp) Genedia® HIV 1/2 F3302 30 14 months/ HIV1 lateral flow/ serum/plasma D,G 14 US$0.93– Rapid 3.0 2°–30° 1+2 recombinant proteins whole blood 1.15 (Green Cross Medical Science) Genie II HIV-1/HIV-2 72323 40 12 months/ HIV lateral flow/ serum/plasma D, G 14 US$2.55 (Bio-Rad 2°–8° 1+2 recombinant proteins, Laboratories) synthetic peptides HIV 1/2 Stat-Pak HIV101 20 18 months/ HIV lateral flow/ serum/plasma G 14 & US$1.45 (Chembio Diagnostics) HIV133 Bulk 8°–30° 1+2 synthetic peptides whole blood 16 HIV 1/2 Stat-Pak HIV301 20 18 months/ HIV lateral flow dipstick/ serum/plasma C,G 16 US$1.15 Dipstick HIV333 Bulk 8°–30° 1+2 synthetic peptides whole blood (Chembio Diagnostics) HIV Tridot IR130050 50 10 months/ HIV 1 flow through/ serum/plasma G 11 US$2.00 (J Mitra & Co) IR130100 100 4°–8° HIV 2 recombinant proteins IR130200 200 23 * Company order code may vary from country to country 1 Assays denoted as HIV 1 HIV 2 are capable of discrimination between HIV-1 and HIV-2, those denoted HIV 1+2 are not capable of discrimina- tion 2 Equipment Requirements – A: ELISA reader, B: ELISA washer, C: Consumables, D: Pipette, E: Power supply, F: For large volume testing more than 40 samples daily, G: For small volume testing 1 to 40 samples daily 3 Report numbers in italics are currently in publication 4 Indicative pricing only, price stated by the company in original WHO test kit evaluation Company Test Shelf Life/ Assay Name Order per Storage HIV Assay Type/ Sample Equip- WHO Indicative (Manufacturer) Code* Kit Temp (°C) Type1 Antigen Type Type ment2 Report3 Price4 Immunocomb® II 60432002 36 15 months/ HIV 1 dipstick/ serum/plasma D,G 9 US$1.70 BiSpot 4°–8° HIV 2 synthetic peptides HIV 1 & 2 (Orgenics) Instant Chek™ HIV 8-1003-40 40 16 months/ HIV lateral flow/ serum/plasma G 14 US$1.00 1+2 Rapid Test 8-1003-100 100 4°–25° 1+2 recombinant protein whole blood (EY Laboratories) OraQuick® HIV-1/2 - 5X4-0012 100 8 months/ HIV lateral flow/ serum/plasma G 14 & US$4.00 Rapid HIV-1/2 5X4-0010 500 2°–30° 1+2 synthetic peptides whole blood 18 Antibody Test oral fluid (OraSure Technologies) Retrocheck HIV 40501050 50 24 months/ HIV lateral flow/ serum/plasma G 16 US$0.75 (Qualpro Diagnostics) 40501100 100 4°–30° 1+21 recombinant protein, whole blood US$0.70 also marketed Core™ synthetic peptides HIV 1&2 (Core Diagnostics) SD BIOLINE HIV-1/2 3.0 03FK10 30 16 months/ HIV 1 lateral flow/ serum/plasma D,G 14 US$1.10 (Standard Diagnostics) 2°–30° HIV 2 recombinant proteins whole blood Serocard HIV 1200100 40 15 months/ HIV lateral flow/ serum/plasma G 11 US$4.00 (Trinity Biotech) 2°–8° 1+2 synthetic peptides whole blood Serodia® HIV 224557 100 12 months/ HIV 1 agglutination/ serum/plasma C,D,G 1 US$0.88 (Fujirebio) 224564 220 2°–10° recombinant proteins Serodia® HIV-1/2 220658 100 12 months/ HIV agglutination/ serum/plasma C,D,G 8 US$2.80 (Fujirebio) 226063 220 2°–10° 1+2 recombinant proteins Uni-Gold™ 1206502 20 9 months/ HIV lateral flow/ serum/plasma G 12 US$2.34 HIV-1/HIV-2 2°–27° 1+2 recombinant proteins whole blood (Trinity Biotech) EIA TEST KITS Company Test Shelf Life/ Assay Name Order per Storage HIV Antigen Type/ Sample Equip- WHO Indicative (Manufacturer) Code* Kit Temp (°C) Type1 Wavelength Type ment2 Report3 Price4 Anti-HIV 1+2 Antibodies KH-T-10 96 5 months/ HIV recombinant proteins, serum/ plasma A,B,C,D,E,F 17 US$0.27 ELISA Diagnostics Kit 2°–8° 1+2 synthetic peptides/ (Shanghai Kehua) 450/620nm Enzygnost Anti-HIV OQFK135 192 12 months/ HIV recombinant serum/ plasma A,B,C,D,E,F 11 US$1.00 1/2 Plus OQFK215 960 2°–8° 1+2 O proteins/ (Dade Behring) 450/650nm Reagent Kit OUVP175 Gratis Genedia® HIV Ag-Ab D1305 480 15 months HIV recombinant proteins serum/ plasma A,B,C,D,E,F 15 US$0.35 ELISA 2°–8° 1+2 O synthetic peptides (Green Cross) HIV Ag monoclonal antibody/ 450/620nm 5. PRICES OF MEDICINES AND DIAGNOSTICS SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS24 Company Test Shelf Life/ Assay Name Order per Storage HIV Antigen Type/ Sample Equip- WHO Indicative (Manufacturer) Code* Kit Temp (°C) Type1 Wavelength Type ment2 Report3 Price4 Genscreen® Plus HIV 72375 96 9 months/ HIV recombinant proteins serum/ plasma A,B,C,D,E,F 15 US$0.35 Ag-Ab 72376 480 2°–8° 1+2 O synthetic peptides (BioRad Laboratories) HIV Ag monocolonal antibody/ 450/620nm HIV EIA 6111011 96 12 months/ HIV synthetic peptides/ serum/ plasma A,B,C,D,E,F 10 US$0.60 (AniLabsystems OY) 6111012 480 4°–8° 1+2 450nm 6111013 960 IMx HIV-1/HIV-2 100 3 months/ HIV recombinant proteins serum/ plasma A,B,C,D,E,F 11 US$3.00 3rd generation Plus 2°–8° 1+2 synthetic peptides IMx Instru- (Abbott Diagnostics) mentation Murex HIV Ag/Ab L/N7G79-01 96 6 months/ HIV recombinant proteins serum/ plasma A,B,C,D,E,F 15 US$1.20 Combination L/N7G79-02 480 2°–8° 1+2 O synthetic peptides, US$0.80 (Abbott/Murex) HIV Ag monoclonal antibody/ 450/620nm UBI HIV 1/2 EIA 680328 192 14 months/ HIV synthetic peptides/ serum/ plasma A,B,C,D,E,F 9 US$1.00 (United Biomedical Inc) 2°–8° 1+2 492 492/620-690 Vironostika Uni-Form II 284017 192 12 months/ HIV recombinant proteins serum/ plasma A,B,C,D,E,F 11 US$1.50 plus O 284018 576 2°–8° 1+2 O synthetic peptides/ (bioMérieux bv) 450/620nm Vironostika® HIV 285046 192 9 months/ HIV recombinant proteins serum/ plasma A,B,C,D,E,F 15 US$1.48 Uni-Form II Ag/Ab 285047 576 2°–8° 1+2 O synthetic peptides, (bioMérieux bv) HIV Ag monoclonal antibody/ 450/620nm CONFIRMATORY TEST KITS Company Test Shelf Life/ Assay Name Order per Storage HIV Assay Type/ Sample Equip- WHO Indicative (Manufacturer) Code* Kit Temp (°C) Type1 Antigen Type Type ment2 Report3 Price4 Genelabs Diagnostics 11031-036 36 15 months/ HIV 1 Western blot/ serum/plasma C,D,E N/A US$10.97 HIV BLOT 2.2 2°–8° HIV 2 viral lysate, (M P Biomedicals synthetic peptide Asia Pacific) INNO-LIA™ HIV I/II 80540 20 ?/ HIV 1 line immunoassay/ serum/plasma C, D, E N/A €15.50 SCORE 2°–8° HIV 2 recombinant proteins, (Innogenetics) synthetic peptides PEPTI-LAV 1-2 72253 10 9 months/ HIV 1 line immunoassay/ serum/plasma C, D, E N/A €15.00 (Bio-Rad Laboratories) 2°–8° HIV 2 synthetic peptides NEW LAV BLOT I 72251 18 9 months/ HIV 1 Western blot/ serum/plasma D, E N/A €13.00 (Bio-Rad Laboratories) 2°–8° viral lysate NEW LAV BLOT II 72252 18 9 months/ HIV 2 Western blot/ serum/plasma D, E N/A €13.00 (Bio-Rad Laboratories) 2°–8° viral lysate * Company order code may vary from country to country 1 Assays denoted as HIV 1 HIV 2 are capable of discrimination between HIV-1 and HIV-2, those denoted HIV 1+2 are not capable of discrimina- tion 2 Equipment Requirements – A: ELISA reader, B: ELISA washer, C: Consumables, D: Pipette, E: Power supply, F: For large volume testing more than 40 samples daily, G: For small volume testing 1 to 40 samples daily 3 Report numbers in italics are currently in publication 4 Indicative pricing only, price stated by the company in original WHO test kit evaluation N/A – Not applicable 255. PRICES OF MEDICINES AND DIAGNOSTICS 6. L is t o f m an u fa ct u re rs – m ed ic in es a n d d ia g n o st ic s 6 .1 M a n u fa ct u re rs o f m e d ic in e s M an uf ac tu re r A dd re ss Te le ph on e Fa x Em ai l/ W eb si te P ro du ct s Al em bi c Lt d. Al em bi c Ro ad , + 91 2 65 2 28 40 74 + 91 2 65 2 28 0 33 1 na vn ee tb at tu @ al em bi c. co .in az ith ro m yc in , b en za th in e be nz yl pe ni ci l l i n, b en zy lp en ic i l l in , Va do da ra 5 51 45 5, w w w .a le m bi c. co m ce ftr ia xo ne , c ip ro flo xa ci n, c la rit hr om yc in , e ry th ro m yc in , Va do da ra , I nd ia om ep ra zo le , p ro ca in e be nz yl pe ni ci l l i n Al ph ar m a Jl , R ay a Bo go r km 2 8 + 62 2 1 87 1 03 11 + 62 2 1 87 1 00 44 he rn y. pr as et ya @ al ph ar m a. no ci pr of lo xa ci n, c la rit hr om yc in , d ia ze pa m , m et oc lo pr am id e, P. O . B ox 1 04 4 JA T w w w .a lp ha rm a. no m et ro ni da zo le , s ul fa m et ho xa zo le + tr im et ho pr im 13 71 0 Ja ka rt a, In do ne si a Ap ex D ru g Ho us e 28 , M ah en dr a M an si on , + 91 2 2 22 07 7 26 6 + 91 2 2 22 08 6 90 0 ap ex 19 @ vs nl .c om al be nd az ol e, a zi th ro m yc in , b en za th in e be nz yl pe ni ci l l i n, Ba bu G en u Ro ad , w w w .a pe xd ru gs in di a. co m be nz yl pe ni ci l l i n, c ef tr ia xo ne , c hl or am ph en ic ol , c ip ro flo xa ci n, 40 00 02 , M um ba i, In di a cl ot rim az ol e, d ox yc yc l in e, e ry th ro m yc in , f lu co na zo le , g en ta m ic in , ke to co na zo le , m et oc lo pr am id e, m et ro ni da zo le , m ic on az ol e, om ep ra zo le , s ul fa m et ho xa zo le + tr im et ho pr im , t in id az ol e Ar is to P ha rm ac eu tic al s Lt d. 23 -A S ha h In du st ria l E st at e, + 91 2 2 26 73 0 00 1 + 91 2 2 26 73 4 79 2 ar is to ex p@ vs nl .n et ce ftr ia xo ne , c ip ro flo xa ci n, d ox yc yc lin e, m et ro ni da zo le , o flo xa ci n, O ff Ve er a D es ai R oa d, w w w .a ris to ph ar m a. or g om ep ra zo le , s ul fa m et ho xa zo le + tr im et ho pr im An dh er i W es t, 40 00 53 , M um ba i, In di a Ar te sa n Ph ar m a O st er br oo ks w eg , 1 5, + 49 4 05 4 22 70 + 49 4 05 4 22 83 j.a hl er s@ ph ar m a- ai d. de al be nd az ol e, e ry th ro m yc in , k et oc on az ol e, n ys ta tin , p ro m et ha zi ne , G m bH & C o. 22 86 9, S ch en ef el d, w w w .p ha rm a- ai d. de su lfa m et ho xa zo le + tr im et ho pr im G er m an y Av en tis In te rc on tin en ta l 20 , A ve nu e Ra ym on d + 33 1 55 7 17 6 37 + 33 1 55 7 17 4 47 sa nd rin e. gi ra rd ot @ av en tis .c om be nz at hi ne b en zy lp en ic ill in , b le om yc in , c ef ix im e, m et ho tr ex at e, Ar on /T ri E1 /3 60 , 9 21 65 , w w w .s an of i-a ve nt is .c om m et ho tr im ep az in e/ le vo m ep ro m az in e, m et ro ni da zo le , o flo xa ci n, An to ny C ed ex , F ra nc e pe nt am id in e B. B ra un B io te ch Sc hw ar ze nb er ge r + 49 5 66 1 71 39 00 + 49 5 66 1 71 37 02 jo er g. gr ie se l@ bb ra un .c om m et ro ni da zo le In te rn at io na l G m bH W eg 7 3- 79 , 3 50 8, w w w .B Br au n. co m M el su ng en , G er m an y Ba ye r He al th ca re A G Ph ar m a D iv is io n, 4 20 96 , + 49 2 02 3 6 58 69 + 49 2 02 3 6 58 80 m ic ha el a. ox fo rt @ ci pr of lo xa ci n W up pe rt al , G er m an y b ay er he al th ca re .c om w w w .b ay er he al th ca re .c om Be lta ph ar m S pA Vi a St el vi o, 6 6, 2 00 95 , + 39 0 2 66 40 12 16 + 39 0 2 61 96 71 4 f.p an se ra @ be lta ph ar m .c om al be nd az ol e, e ry th ro m yc in , k et oc on az ol e, m et ro ni da zo le , Cu sa no M ila ni no , I ta ly w w w .b el ta ph ar m .c om m ic on az ol e, n ys ta tin , p ro m et ha zi ne , s ul fa m et ho xa zo le + tri m et ho pr im Bi lim P ha rm ac eu tic al In d. Ay az ag a Ko yu Y ol u N o: 6, + 90 2 12 3 65 1 5 00 + 90 2 12 2 86 94 72 in fo @ bi lim ph ar m a. co m ce fix im e, c ef tr ia xo ne , c la rit hr om yc in , c lin da m yc in , f lu co na zo le , 34 39 8, M as la k, T ur ke y w w w .b ili m ph ar m a. co m ke to co na zo le Bi ol og ic i I ta lia L ab or at or ie s Vi a Ca vo ur 4 1- 43 , 2 00 26 , + 39 0 2 35 4 8 45 1 + 39 0 2 35 4 2 95 6 in fo @ bi lit al ia .c om ac ic lo vi r SR L N ov at e M ila ne se , I ta ly w w w .b io lo gi ci .c om SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS26 M an uf ac tu re r A dd re ss Te le ph on e Fa x Em ai l/ W eb si te P ro du ct s Bo eh rin ge r In ge lh ei m G m bH Bi ng er S tr aß e 17 3, + 49 6 13 2 77 0 + 49 6 13 2 77 3 00 0 cl ar yh @ ne vi ra pi ne (N VP ) 55 21 6, In ge lh ei m a m R he in , in g. bo eh rin ge r-i ng el he im .c om G er m an y w w w .b oe hr in ge r-i ng el he im .c om Br is to l-M ye rs S qu ib b 3 Ru e Jo se ph M on ie r + 33 1 58 8 3 60 0 0 + 33 1 58 8 3 65 65 m ar ie -a st rid .m er ci er @ bm s. co m di da no si ne (d dI ), st av ud in e (d 4T ) (A fr ic a Ex po rt D iv is io n) BP 3 25 , 9 25 06 Ru ei l -M al m ai so n Ce de x, Fr an ce Ca di la P ha rm ac eu tic al s Lt d. Ca di la C or po ra te C am pu s + 91 2 7 18 22 5 00 1 + 91 2 71 8 22 50 35 w eb si te @ ca di la ph ar m a. co .in ac ic lo vi r, al be nd az ol e, a zi th ro m yc in , c ef tr ia xo ne , c ip ro flo xa ci n, Sa rk he j – D ho lk a Ro ad , B ha t, w w w .c ad ila ph ar m a. co .in er yt hr om yc in , f lu co na zo le , f lu ox et in e, o m ep ra zo le , 38 2 21 0, A hm ed ab ad , I nd ia su lfa m et ho xa zo le + tr im et ho pr im , t in id az ol e Ci br o 56 3 So ng ta o Ro ad , B 10 7, + 86 2 1 50 80 85 16 + 86 2 1 50 80 42 08 in fo @ ci br op ha rm .c om ac ic lo vi r, ci pr of lo xa ci n, m et ro ni da zo le , 20 12 03 , S ha ng ha i, Ch in a w w w .c ib ro ph ar m .c om su lfa m et ho xa zo le + tr im et ho pr im Ci pl a Lt d. 28 9, B el as is R oa d, + 91 2 2 23 02 1 39 7 + 91 2 2 23 07 0 01 3 ci pl ae xp @ ci pl a. co m 3T C/ AZ T, 3 TC /d 4T , 3 TC /d 4T /N VP , a ba ca vi r (A BC ), ac ic lo vi r, M um ba i C en tr al , 5 47 64 9, w w w .c ip la .c om al be nd az ol e, a zi th ro m yc in , A ZT /3 TC /N VP , b le om yc in , c ef ix im e, M um ba i, In di a ce ftr ia xo ne , c ip ro flo xa ci n, c lo tr im az ol e, d id an os in e (d dI ), do xo ru bi ci ne H Cl , d ox yc yc lin e, e fa vi re nz (E FZ ), er yt hr om yc in , et op os id e, fl uc on az ol e, in di na vi r (ID V) , l am iv ud in e (3 TC ), m et ho tr ex at e, m et ro ni da zo le , m ic on az ol e, n el fin av ir (N FV ), ne vi ra pi ne (N VP ), ny st at in , o flo xa ci n, o m ep ra zo le , s ta vu di ne (d 4T ), su lfa m et ho xa zo le + tr im et ho pr im , v in bl as tin e, v in cr is tin e, zi do vu di ne (A ZT o r ZD V) CL AR IS L ife sc ie nc es L td . Co rp or at e To w er s, + 91 7 9 65 6 33 31 + 91 7 9 65 6 58 79 aid su pp or t.c or p@ c la ris life s c ien ce s .c om ce ftr ia xo ne , f lu co na zo le , m et oc lo pr am id e, m et ro ni da zo le , o flo xa ci n N ea r Pa rim al C ro ss in g, w w w .c la ris lif es ci en ce s. co m El lis br id ge , 5 55 01 5, Ah m ed ab ad , I nd ia Co m bi no P ha rm , S .L . Ca rr er F ru ct uó s G el ab er t, + 34 9 3 48 0 88 33 + 34 9 3 48 0 88 32 in fo @ co m bi no -p ha rm .e s ac ic lo vi r, am ph ot er ic in B , c ef tr ia xo ne , c lin da m yc in , f lu ox et in e, 6– 8 Ed ifi ci o Co na ta 2 , w w w .c om bi no -p ha rm .e s pe nt am id in e, z id ov ud in e (A ZT o r ZD V) 08 97 0, S an t J oa n D es pí , Sp ai n Co sm os L im ite d P. O . B ox 4 14 33 + 25 42 5 50 7 00 + 25 42 5 50 6 80 co sm os ltd @ fo rm -n et .c om 3T C/ AZ T, 3 TC /d 4T , 3 TC /d 4T /N VP , a ci cl ov ir, a lb en da zo le , Ra ng w e Ro ad , am itr ip ty lin e, a zi th ro m yc in , c hl or am ph en ic ol , c ip ro flo xa ci n, O ff Lu ng a Lu ng a Ro ad cl ot rim az ol e, c od ei ne , d ia ze pa m , d ox yc yc lin e, e fa vi re nz (E FZ ), N ai ro bi In du st ria l A re a, er yt hr om yc in , f lu co na zo le , k et oc on az ol e, la m iv ud in e (3 TC ), 10 0, N ai ro bi , K en ya m et oc lo pr am id e, m et ro ni da zo le , m ic on az ol e, n ev ira pi ne (N VP ), ny st at in , o m ep ra zo le , p ro m et ha zi ne , p yr im et ha m in e, s en na , st av ud in e (d 4T ), su lfa m et ho xa zo le + tr im et ho pr im , t in id az ol e, zi do vu di ne (A ZT o r ZD V) Ec ob i F ar m ac eu tic i S .a .s . Vi a En ric o Ba zz an o, 2 6, + 39 0 10 9 35 2 80 + 39 0 10 9 35 0 67 9 ec ob i@ al ep h. it ac ic lo vi r, ca lc iu m fo lin at e (le uc ov or in ), m ic on az ol e, s ul fa di az in e, 16 01 9, R on co S cr iv ia , I ta ly w w w .e co bi .c om su lfa m et ho xa zo le + tr im et ho pr im 276. LIST OF MANUFACTURERS – MEDICINES AND DIAGNOSTICS M an uf ac tu re r A dd re ss Te le ph on e Fa x Em ai l/ W eb si te P ro du ct s Em cu re P ha rm ac eu tic al s Em cu re H ou se , + 91 2 0 30 61 00 00 + 91 2 0 30 61 02 00 ex po rt s@ em cu re .c o. in 3T C/ AZ T, 3 TC /d 4T , 3 TC /d 4T /N VP , a lb en da zo le , A ZT /3 TC /N VP , Li m ite d T- 18 4, M .I. D .C . B ho sa ri, w w w .e m cu re .c o. in ce fix im e, c ef tr ia xo ne , c ip ro flo xa ci n, c la rit hr om yc in , c lo tr im az ol e, 41 10 26 , P un e, In di a di da no si ne (d dI ), ef av ire nz (E FZ ), la m iv ud in e (3 TC ), ne vi ra pi ne (N VP ), om ep ra zo le , s ta vu di ne (d 4T ), su lfa m et ho xa zo le + tr im et ho pr im , z id ov ud in e (A ZT o r ZD V) F. H of fm an n- La R oc he L td . Ph ar m a In te rn at io na l, + 41 6 1 68 8 92 91 + 41 6 1 68 8 27 78 m ar ia .v ig ne au @ ro ch e. co m ne lfi na vi r (N FV ), sa qu in av ir (S Q V) CH -4 07 0, B as el , w w w .ro ch e- hi v. co m Sw itz er la nd FD C Lt d. 14 2- 48 , S .V . R oa d, + 91 2 2 67 8 06 52 + 91 2 2 67 8 09 67 rs @ fd ce xp or t.c om ac ic lo vi r, az ith ro m yc in , c ip ro flo xa ci n, d ox yc yc l in e, fl uc on az ol e, Jo ge sh w ar i i (W ), 40 01 02 , w w w .fd ci nd ia .c om m et ro ni da zo le , o flo xa ci n, s ul fa m et ho xa zo le + tr im et ho pr im M um ba i, In di a G en ep ha rm S A 18 th K m . M ar at ho n Av e. , + 30 2 10 6 03 93 36 /8 + 30 2 10 6 03 94 02 in fo @ ge ne ph ar m .g r ce fix im e, c ef tr ia xo ne , c ip ro flo xa ci n, c la rit hr om yc in , c l in da m yc in , 15 35 1, P al l in i, G re ec e w w w .g en ep ha rm .g r do xy cy cl in e, fl uc on az ol e, k et oc on az ol e, o flo xa ci n G la xo Sm ith Kl in e Ex po rt L td . G SK H ou se , + 44 2 0 80 47 5 00 0 + 44 2 0 80 47 6 95 7 is ab el le .s .g ira ul t@ gs k. co m 3T C/ AZ T, a ba ca vi r (A BC ), AB C/ 3T C/ ZD V, la m iv ud in e (3 TC ), 98 0 G re at W es t R oa d, w w w .g sk .c om zi do vu di ne (A ZT o r ZD V) TW 8 9G S, B re nt fo rd , U K G ru po R ei g Jo fre G ra n Ca pi ta n 10 , 0 89 70 , + 34 9 3 48 0 67 1 5 + 34 9 3 48 0 67 2 1 rje xp or t@ re ig jo fre .c om ac ic lo vi r, ce ftr ia xo ne , f lu co na zo le , s ul fa di az in e Sa n Jo an D es pi , S pa in w w w .re ig jo fr e. co m He yl C he m is ch .- G oe rz al le e 25 3, + 49 3 0 81 6 96 17 + 49 3 0 81 7 40 49 in fo @ he yl -b er lin .d e su lfa di az in e ph ar m az eu tis ch e Fa br ik 14 16 7, B er lin , G er m an y w w w .h ey l-b er lin .d e G m bH & C o KG Hu m an P ha rm ac eu tic al Ta nc si cs M ih ál y út 8 2, + 36 2 8 53 2 10 3 + 36 2 8 42 0 59 4 pa llo s@ hu m an .h u m et ro ni da zo le W or ks C o. L td . 21 00 , G od ol lo , H un ga ry w w w .h um an .h u In st itu to Q ui m io te ra pi co Av en id a Sa nt a Ro sa 3 50 , + 51 3 62 0 21 0 + 51 3 62 0 21 0 iq fa rm a@ te rr a. co m .p e ac ic lo vi r, am itr ip ty lin e, c ip ro flo xa ci n, c lo tr im az ol e, d im en hy dr in at e, S. A. (IQ FA RM A) 43 S an ta A ni ta , P er u er yt hr om yc in , f lu co na zo le , i tr ac on az ol e, k et oc on az ol e, m et oc lo pr am id e, m et ro ni da zo le , o m ep ra zo le , su lfa m et ho xa zo le + tr im et ho pr im In ta s Ph ar m ac eu tic al s Lt d 2n d flo or , C hi nu bh ai C en tr e, + 91 7 9 26 57 6 65 5 + 91 7 9 26 57 8 86 2 al ke sh _s ha h@ in ta sp ha rm a. co m al be nd az ol e, a m itr ip ty lin e, c ip ro flo xa ci n, c la rit hr om yc in , d ia ze pa m , As hr am R oa d, 5 54 92 3, w w w .in ta sp ha rm a. co m do xo ru bi ci ne H Cl , d ox yc yc lin e, e ry th ro m yc in , e to po si de , Ah m ed ab ad , I nd ia flu co na zo le , f lu ox et in e, it ra co na zo le , k et oc on az ol e, la m iv ud in e (3 TC ), m et ho tr ex at e, m et oc lo pr am id e, n al tr ex on e HC l, of lo xa ci n, om ep ra zo le , s ul fa m et ho xa zo le + tr im et ho pr im , t in id az ol e, v in cr is tin e Ko re a Un ite d Ph ar m . I nc . 15 4– 8, N on hy n- D on g + 82 2 5 12 9 98 2 + 82 2 5 12 0 14 4 tr ad e@ ku p. co .k r ac ic lo vi r, al be nd az ol e, b le om yc in , c al ci um fo lin at e (le uc ov or in ), Ka ng na m -K u, 1 35 01 0, w w w .k up .c o. kr ce fix im e, c ef tr ia xo ne , c ip ro flo xa ci n, c la rit hr om yc in , c lin da m yc in , Se ou l, Re pu bl ic o f K or ea cl ot rim az ol e, d ia ze pa m , d ox or ub ic in e HC l, do xy cy cl in e, e to po si de , flu co na zo le , f lu ox et in e, it ra co na zo le , k et oc on az ol e, m et ho tr ex at e, m et ro ni da zo le , o flo xa ci n, o m ep ra zo le , v in bl as tin e, v in cr is tin e SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS28 M an uf ac tu re r A dd re ss Te le ph on e Fa x Em ai l/ W eb si te P ro du ct s La b. F ila xi s Pa na m a 21 21 , B 16 40 D KC , + 54 1 1 45 13 8 00 9 + 54 1 1 45 13 8 00 4 lil ia na .b .m en de z@ fil ax is .c om 3T C/ AZ T, a ba ca vi r (A BC ), ac ic lo vi r , ca lc iu m fo lin at e (le uc ov or in ), In te rn at io na l S .A . M ar tin ez , A rg en tin a w w w .fi la xi s. co m di da no si ne (d dI ), do xo ru bi ci ne H Cl , e fa vi r e nz (E FZ ), et op os id e, ga nc ic lo vi r, in di na vi r (ID V) , l am iv ud in e (3 TC ), m et ho tr ex at e, ne lfi na vi r (N FV ), ne vi ra pi ne (N VP ), pe nt am id in e, s ta vu di ne (d 4T ), vi nb la st in e, v in or el bi ne , z al ci ta bi ne (d dC ), zi do vu di ne (A ZT o r ZD V) La b. R en au di n 12 5, B ur ea ux d e la C ol l in e, + 33 1 4 11 2 03 82 + 33 1 4 11 2 03 77 fp et it@ la bo -re na ud in .c om di az ep am , m et oc lo pr am id e, m or ph in e, p et hi di ne , p ro m et ha zi ne F- 92 21 3, S ai nt -C lo ud C ed ex , w w w .la bo -re na ud in .c om Fr an ce La bo ra to rio s Av en id a Q ui l ín , 5 27 3, + 56 2 51 0 85 00 + 56 2 51 0 85 02 in fo @ an dr om ac o. cl om ep ra zo le An dr óm ac o S. A. Pe ña lo lé n, C hi le w w w .a nd ro m ac o. cl La bo ra to rio s Ci nf a S. A. O la z- Ch ip i, 10 P ol ig on o Ar et a, + 34 9 48 3 3 51 0 2 + 34 9 48 3 3 03 6 7 bs an ad o@ ci nf a. co m ac ic lo vi r, az ith ro m yc in , c ip ro flo xa ci n, d im en hy dr in at e, fl uo xe tin e, E– 31 62 0, H ua rt e, w w w .c in fa .c om om ep ra zo le Pa m pl on a, S pa in La bo ra to rio s Ju ve nt us S .A . Ju l iá n Ca m ar il l o, 3 7, + 34 9 1 37 5 22 0 0 + 34 9 1 37 5 22 3 3 ex po rt @ ju ve nt us .e s az ith ro m yc in , c ip ro flo xa ci n, c la rit hr om yc in , o m ep ra zo le 28 03 7, M ad rid , S pa in w w w .ju ve nt us .e s La ch ifa rm a, S RL S. S. 1 6 Zo na In du st ria le + 39 0 83 6 60 0 66 1 + 39 0 83 6 60 0 66 2 in fo @ la ch ifa rm a. co m al be nd az ol e, e ry th ro m yc in , k et oc on az ol e, m ic on az ol e, n al tr ex on e Zo lli no , 7 30 10 , w w w .la ch ifa rm a. co m HC l, su lfa m et ho xa zo le + tr im et ho pr im Zo lli no (L E) , I ta ly Li lly E sp añ a Av . d e la In du st ria 3 0, + 34 9 1 66 3 50 28 + 34 9 1 62 3 33 91 he rn an de z_ vi ce nt e@ lil ly. co m flu ox et in e E- 28 10 8, A lc ob en da s, S pa in w w w .li lly .e s Li sa ph ar m a Vi a Li ci ni o 11 , 2 20 36 , + 39 0 31 6 41 25 7 + 39 0 31 6 44 1 82 lis ap ha rm @ lis ap ha rm a. it ac ic lo vi r, ce ftr ia xo ne , f lu ox et in e Er ba , I ta ly w w w .li sa ph ar m a. it Lo m ap ha rm , R ud ol f La ng es F el d 5, 3 18 60 , + 49 5 15 5 63 20 0 + 49 5 15 5 63 25 6 i.w ilp er t@ lo m ap ha rm .d e co de in e, d ia ze pa m , d im en hy dr in at e, e ry th ro m yc in , l or az ep am , Lo hm an n G m bH K G Em m er th al , G er m an y w w w .lo m ap ha rm .d e m et oc lo pr am id e, m et ro ni da zo le , n ys ta tin , su lfa m et ho xa zo le + tr im et ho pr im M ar tin da le Hu be rt R oa d, C M 14 4 LZ , + 44 1 27 7 26 6 60 0 + 44 1 27 7 26 6 68 8 m at t.b ar tle tt@ m et ha do ne H Cl , m or ph in e, p et hi di ne Ph ar m ac eu tic al s Lt d. Br en tw oo d, U K m ar tin da le ph ar m a. co .u k w w w .m ar tin da le ph ar m a. co .u k M ed ac G m bH , Th ea te rs tr aß e 6, D -2 28 80 , + 49 4 10 3 80 06 1 45 + 49 4 10 3 80 06 1 53 d. re hd er @ m ed ac .d e ca lc iu m fo lin at e (le uc ov or in ), do xo ru bi ci ne H Cl , e to po si de In te rn at io na l O pe ra tio ns W ed el , G er m an y w w w .m ed ac .d e M ep ha L td D or na ch er st ra ss e 11 4, + 41 6 1 70 5 42 19 + 41 6 1 70 5 43 38 st ef an .m ue hl @ m ep ha .c h ce ftr ia xo ne , c ip ro flo xa ci n, o m ep ra zo le CH -4 14 7, A es ch , S w itz er la nd w w w .m ep ha .c om M er ck & C o. , I nc . O ne M er ck D riv e, + 1 90 8 42 3 10 00 + 1 90 8 73 5 18 39 sa m ir_ kh al il@ m er ck .c om ef av ire nz (E FZ ), in di na vi r (ID V) , i ve rm ec tin P. O . B ox 1 00 , N J 08 88 9- 01 00 , w w w .m er ck .c om W hi te ho us e St at io n, U SA 29 M an uf ac tu re r A dd re ss Te le ph on e Fa x Em ai l/ W eb si te P ro du ct s N eo n An tib io tic s PV T. L td . 14 6A , D am ji Sh am ji + 91 2 2 26 87 5 36 6 + 91 2 2 26 87 3 50 2 ne on @ bo m 1. vs nl .n et .in ac ic lo vi r, am ph ot er ic in B , b le om yc in , c ap r e om yc in , d ox or ub ic in e In du st ria l C om pl ex , w w w .n eo ng ro up .c om HC l, et op os id e, m et ho tr ex at e, o m ep ra zo le , p en ta m id in e, M . C av es R oa d, sp ec tin om yc in , v in bl as tin e, v in cr is tin e, v in or el bi ne 28 M ah al In d. E st at e, M ah ak al i C av es R oa d, 40 0 09 3, A nd he ri (E as t), In di a N ip po n Ka ya ku To ky o Fu jim i B ld g, + 81 3 3 23 7 50 72 + 81 3 3 23 7 50 93 ko uh o@ ni pp on ka ya ku .c o. jp bl eo m yc in , e to po si de 11 –2 , F uj im i 1 c ho m e, w w w .n ip po nk ay ak u. co .jp Ch iy od a- ku , 1 02 -8 17 2, To ky o, J ap an N ue va s Te cn ol og ía s Al fo ns o XI I, 22 , 4 d ch a. , + 34 9 1 53 1 02 1 7 + 34 9 1 53 1 96 4 8 ax is @ co rr eo .in te rl i nk .e s 3T C/ AZ T, 3 TC /d 4T /N VP , a ci cl ov ir, a lb en da zo le , c ip ro flo xa ci n, Fa rm ac eu tic as 28 01 4, M ad rid , S pa in cl ar ith ro m yc in , c l in da m yc in , d id an os in e (d dI ), do xy cy cl in e, ef av ire nz (E FZ ), er yt hr om yc in , f lu co na zo le , i nd in av ir (ID V) , ke to co na zo le , l am iv ud in e (3 TC ), of lo xa ci n, o m ep ra zo le , s ta vu di ne (d 4T ), su lfa m et ho xa zo le + tr im et ho pr im , z id ov ud in e (A ZT o r ZD V) O ve lle L im ite d Co e’ s Ro ad , D un da lk , + 35 3 42 9 33 2 30 4 + 35 3 42 9 33 2 00 8 jg ar di ne r@ ov el le .ie cl ot rim az ol e, k et oc on az ol e, m ic on az ol e, p er m et hr in Ire la nd w w w .o ve lle .ie Ph ar m ad ru g Sa se le r Ch au se e 19 1a , + 49 4 0 60 1 79 3 7 + 49 4 0 60 1 63 5 8 in fo @ ph ar m ad ru g. de ac ic lo vi r, cl ot rim az ol e, c yc lo se rin e, d ox yc yc lin e, e ry th ro m yc in , 22 39 3, H am bu rg , G er m an y w w w .p ha rm ad ru g. de ke to co na zo le , m et ho tr im ep az in e / le vo m ep ro m az in e, m ic on az ol e, ny st at in , p et hi di ne , p ro ch lo rp er az in e Ph ar m at he n 6, D er ve na ki on s tr. , + 30 2 10 6 66 56 7 + 30 2 10 6 66 67 49 in fo @ ph ar m at he n. gr ce ftr ia xo ne , c ip ro flo xa ci n, fl uc on az ol e, fl uo xe tin e, lo ra ze pa m , Ph ar m ac eu tic al s S. A. 15 3 51 , P al lin i, G re ec e w w w .p ha rm at he n. gr om ep ra zo le Pr ot ei n S. A. D E C. V . (A po te x) D am as 1 20 , 3 90 0, + 52 5 55 48 29 03 5 + 52 5 55 48 29 00 2 rji m en ez @ ap ot ex .c om .m x ac ic lo vi r, ci pr of lo xa ci n, d id an os in e (d dI ), di m en hy dr in at e, fl uo xe tin e, M ex ic o D .F , M ex ic o w w w .a po te x. co m .m x ke to co na zo le , m et oc lo pr am id e, m ic on az ol e, n ys ta tin , o m ep ra zo le , st av ud in e (d 4T ), su lfa m et ho xa zo le + tr im et ho pr im , z al ci ta bi ne (d dC ), zi do vu di ne (A ZT o r ZD V) Pu rn a Ph ar m ac eu tic al s N V K. M .O . Z on e “P ul la ar ”, + 32 3 88 6 00 85 + 32 3 88 6 25 38 in fo @ pu rn a. be cl ot rim az ol e, e ry th r o m yc in , k et oc on az ol e, m et ro ni da zo le , Ri jk sw eg 1 7, 2 87 0, P uu rs , w w w .p ur na .b e m ic on az ol e, p ro m et ha zi ne , s ul fa m et ho xa zo le + tr im et ho pr im Be lg iu m Ra nb ax y La bo ra to rie s Lt d 13 th F lo or , 6 D ev ik a To w er s, + 91 1 1 26 00 2 1 20 + 91 1 1 26 00 2 1 21 sa nd ee p. ju ne ja @ ra nb ax y. co m 3T C/ AZ T, 3 TC /d 4T , 3 TC /d 4T /N VP , a ba ca vi r (A BC ), AB C/ 3T C/ ZD V, 6 N eh ru P la ce , 1 10 0 19 , w w w .r an ba xy .c om ac ic lo vi r, ce ftr ia xo ne , c ip ro flo xa ci n, c la rit hr om yc in , d id an os in e N ew D el hi , I nd ia (d dI ), ef av ire nz (E FZ ), in di na vi r (ID V) , l am iv ud in e (3 TC ), ne vi ra pi ne (N VP ), of lo xa ci n, s ta vu di ne (d 4T ), zi do vu di ne (A ZT o r ZD V) Re m ed ic a Lt d. Ac ha rn on S tr ee t, + 35 7 25 5 53 00 0 + 35 7 25 3 90 19 2 re m ed ic a@ cy ta ne t.c om .c y ac ic lo vi r, al be nd az ol e, a m itr ip ty lin e, c ef ix im e, c ip ro flo xa ci n, Yp so na s In du st ria l E st at e, w w w .r em ed ic a. co m .c y cl ar ith ro m yc in , c lo tr im az ol e, c od ei ne , d ia ze pa m , d ox yc yc lin e, PO B ox 5 17 06 , C Y- 35 08 , er yt hr om yc in , f lu co na zo le , f lu ox et in e, k et oc on az ol e, lo ra ze pa m , Li m as so l, Cy pr us m et ho tr ex at e, m et oc lo pr am id e, m et ro ni da zo le , n ys ta tin , o flo xa ci n, om ep ra zo le , p ro ch lo rp er az in e, p ro m et ha zi ne , s en na , su lfa m et ho xa zo le + tr im et ho pr im , t in id az ol e 6. LIST OF MANUFACTURERS – MEDICINES AND DIAGNOSTICS SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS30 M an uf ac tu re r A dd re ss Te le ph on e Fa x Em ai l/ W eb si te P ro du ct s Ro te xm ed ic a Bu ns en st ra ss e 4, + 49 4 1 54 86 20 + 49 4 1 54 86 21 55 or un ge @ ro te xm ed ic a. co m di az ep am , g en ta m ic in , m et ro ni da zo le Po st fa ch 1 26 6, 2 29 46 , w w w .ro te xm ed ic a. co m Tr itt au , G er m an y Sa m ch ul ly P ha rm . C o. , L td . 94 7– 7, D ae ch i-D on g, + 82 2 5 27 6 30 0 + 82 2 5 61 6 00 6 sh ki m @ sa m ch ul ly ph ar m .c om ac ic lo vi r, st av ud in e (d 4T ), zi do vu di ne (A ZT o r ZD V) G an gn am -G u, 1 35 –7 35 , w w w .s am ch ul ly ph ar m .c om Se ou l, Re pu bl ic o f K or ea Sa na vi ta A kt ie ng es el ls ch af t Am B ah nh of 1 –3 , + 49 2 38 9 79 72 0 + 49 2 38 9 79 72 59 th ea .d ad ric h@ sa na vi ta .n et be nz at hi ne b en zy lp en ic i l l in , b en zy lp en ic i l l in , c hl or am ph en ic ol , & C o. 59 36 8, W er ne , G er m an y w w w .s an av ita .n et do xy cy cl in e, e ry th ro m yc in , g en ta m ic in , n ys ta tin , p ro ca in e be nz yl pe ni ci l l i n, s ul fa m et ho xa zo le + tr im et ho pr im Sh an gh ai D es an o N o. 7 8, 8 87 + 86 2 1 50 80 61 18 + 86 2 1 50 80 65 58 fa ny i@ de sa no .c om di da no si ne (d dI ), ne vi ra pi ne (N VP ), st av ud in e (d 4T ) Bi op ha rm ac eu tic al C o. , L td Zu ch on gz hi R oa d, w w w .d es an o. co m Zh an gj ia ng H ite ch P ar k, Pu do ng , 2 01 20 3, Sh an gh ai , C hi na Sh ib a Ph ar m ac eu tic al s P. O . B ox 4 26 5, S ei f S tr ee t, + 96 7 1 21 8 45 1/ 2/ 3 + 96 7 1 21 8 45 4 sh ib a@ y. ne t.y e al be nd az ol e, a zi th ro m yc in , c hl or am ph en ic ol , c ip ro flo xa ci n, & C he m ic al s M fg . C o. L td . 9t h Br an ch B ld g. N o. 7 , cl in da m yc in , d ox yc yc lin e, e ry th ro m yc in , f lu co na zo le , m et ro ni da zo le , Sa na ’a , R ep ub lic o f Y em en om ep ra zo le , o flo xa ci n, p ro m et ha zi ne , p yr im et ha m in e, su lfa m et ho xa zo le + tr im et ho pr im SM P ha rm ac eu tic al s Lo t 8 8, S un ga i P et an i + 60 4 44 11 80 1 + 60 4 44 11 34 1 sm fo rm u@ po .ja rin g. m y ac ic lo vi r, ch lo ra m ph en ic ol , c ip ro flo xa ci n, c la rit hr om yc in , Sd n Bh d In du st ria l E st at e, 8 00 0, cl ot rim az ol e, c ro ta m ito n, d ia ze pa m , e ry th ro m yc in , i tr ac on az ol e, Su ng ai P et an i, M al ay si a ke to co na zo le , n ys ta tin , o m ep ra zo le , s ul fa m et ho xa zo le + tri m et ho pr im St rid es A rc ol ab L td . St rid es H ou se , + 91 8 0 65 81 3 43 + 91 8 0 65 84 3 30 in fo @ st rid es ar co .c om 3T C/ AZ T, 3 TC /d 4T , 3 TC /d 4T /N VP , a lb en da zo le , a zi th ro m yc in , Bi le ka ha lli O pp . I IM B, w w w .s tr id es ar co .c om ce ftr ia xo ne , c hl or am ph en ic ol , c ip ro flo xa ci n, c la rit hr om yc in , Ba nn er gh at ta R d. , er yt hr om yc in , i nd in av ir (ID V) , k et oc on az ol e, la m iv ud in e (3 TC ), 56 0 07 6, B an ga lo re , I nd ia ne vi ra pi ne (N VP ), om ep ra zo le , s ta vu di ne (d 4T ), su lfa m et ho xa zo le + tr im et ho pr im , z id ov ud in e (A ZT o r ZD V) Th e G ov er nm en t 75 /1 R am a VI R d. , + 66 2 35 48 85 7 + 66 2 35 48 85 8 su kh um @ he al th .m op h. go .th 3T C/ AZ T, 3 TC /d 4T /N VP , a m itr ip ty lin e, c la rit hr om yc in , c lo tr im az ol e, Ph ar m ac eu tic al Ra tc ha th ew i, 54 75 88 , w w w .g po .o rg .th di m en hy dr in at e, fl uc on az ol e, k et oc on az ol e, la m iv ud in e (3 TC ), O rg an iz at io n Ba ng ko k, T ha ila nd m et oc lo pr am id e, n el fin av ir (N FV ), ne vi ra pi ne (N VP ), st av ud in e (d 4T ), su lfa m et ho xa zo le + tr im et ho pr im , z id ov ud in e (A ZT o r ZD V) Vi ta fa rm a S. L. Fl or id a 29 , 2 01 20 , + 34 9 43 3 35 05 7 + 34 9 43 3 35 26 9 ex po rt @ vi ta fa rm a. es cl ot rim az ol e, m ic on az ol e He rn an i, Sp ai n W ar sa w P ha rm ac eu tic al Ka ro lk ov a St re et 2 2/ 24 , + 48 2 26 9 13 8 25 + 48 2 26 9 13 8 27 zo i@ po lfa w ar .c om .p l di az ep am , m or ph in e W or ks P ol fa , S .A . 61 83 54 , W ar sa w , P ol an d w w w .p ol fa w ar .c om .p l 31 6 .2 M a n u fa ct u re rs o f d ia g n o st ic s1 M an uf ac tu re r A dd re ss Te le ph on e Fa x Em ai l/ W eb si te P ro du ct s Ab bo tt G m bH D ia gn os tik a M ax -P la nc k- Ri ng 2 , + 49 6 12 2 58 1 6 23 + 49 6 12 2 58 1 6 12 Ka m le sh .k um ar @ ab bo tt. co m D et er m in e™ H IV -1 /2 , A bb ot t H IV -1 /H IV -2 g O E IA , I M x HI V- 65 20 5 W ie sb ad en , G er m an y w w w .a bb ot t.c om 1/ HI V- 2 3r d ge ne ra tio n Pl us , M ur ex H IV A g- Ab , R ea l T im e HI V- 1 3. 0 As sa y An iL ab sy st em s Lt d M us eo ka tu 1 3B + 35 8 20 1 55 7 52 0 + 35 8 20 1 55 7 52 1 w w w .a ni la bs ys te m s. co m HI V EI A 01 00 H el si nk i, Fi nl an d Ba ye r (D ia gn os tic s) W er k Le ve rk us en ; D -5 13 68 + 49 6 41 40 0 34 48 w w w .b ay er .c om Ve rs an t H IV -1 R N A 3. 0 As sa y Le ve rk us en , G er m an y Be ck m an C ou lte r 22 , R ue J us te O liv ie r, + 41 2 2 99 4 08 3 3 + 41 2 2 99 4 34 6 7 w w w .b ec km an co ul te r.c om Cy to -S ph er es ; C D 4 re ag en ts , E PI CS X L Fl ow C yt om et er , CH -1 26 0 N yo n, S w itz er la nd Po in tC ar e BD 86 , E re m bo de ge m -D or p, + 32 5 3 72 0 21 1 + 32 53 7 20 4 50 Ja n_ St ra gi er @ eu ro pe .b d. co m Fa cs Ca lib ur , F ac sC ou nt , C D 4 re ag en ts (B ec to n D ic ki ns on ) B- 93 20 E re m bo de ge m , B el gi um w w w .b d. co m Bi oM ér ie ux S .A . 69 28 0 M ar cy - l ’E to i le , + 33 7 8 87 2 0 00 + 33 7 8 87 2 0 90 ja cq ue sl em iu s@ eu .b io m er ie ux .c om Vi ro no st ik a® H IV U ni -F or m I I p lu s O , V iro no st ik a® H IV Fr an ce w w w .b io m er ie ux .c om Un ifo rm II A g/ Ab , V id as D uo Q ui ck , V id as D uo U ltr a, N uc lis en s Ea sy Q H IV , N uc lis en s HI V- 1 Q T BI O N O R A/ S P. O . B ox 1 86 8, + 47 3 5 53 8 4 88 + 47 3 5 53 7 1 30 G un na r.f la te n@ bi on or .n o Bi on or H IV -1 & 2 N -3 70 5 Sk ie n, N or w ay w w w .b io no r.n o Bi o- Ra d La bo ra to rie s 3, b ou le va rd R ay m on d + 33 1 4 7 95 6 0 00 + 33 1 4 7 41 9 1 33 ch ris tin e_ he in en @ bi o- ra d. co m G en sc re en H IV 1 /2 , G en sc re en P lu s HI V Ag /A b, G en ie II Po in ca ré , 9 24 30 w w w .b io -ra d. co m HI V- 1/ HI V- 2, P ep ti- LA V 1- 2, N ew L AV B LO T I, N ew L A V M ar ne s- la -C oq ue tte , F ra nc e BL O T II Ca vi di T ec h AB 32 A , D ag H am m ar sk jo ld sv ., + 46 18 55 2 0 40 + 46 1 8 55 2 0 41 in fo @ ca vi di .s e Ex a Vi r Lo ad Q ua nt ita tiv e HI V- RT Up ps al a Sc ie nc e Pa rk , w w w .c av id i.c om SE -7 51 8 3 Sw ed en Ch em bi o D ia gn os tic s 36 61 H or se bl oc k Ro ad + 1 63 1 92 4 11 35 + 1 63 1 92 4 60 33 av i@ ch em bi o. co m HI V 1/ 2 St at -P ak , H IV 1 /2 S ta t-P ak D ip st ic k M ed fo rd , N Y 11 76 5 US A w w w .c he m bi o. co m D ad e Be hr in g M ar bu rg Po st fa ch 1 14 9, + 49 6 42 1 39 4 47 8 + 49 6 42 1 66 06 4 Ec kh ar dt _P et ri@ da de be hr in g. co m En zy gn os t® A nt i-H IV 1 /2 P lu s G m bH 35 00 1 M ar bu rg , G er m an y w w w .d ad eb eh rin g. co m D YN AL B IO TE CH A S 66 , A ve nu e de L an ds hu t + 3 3 3 44 2 3 45 9 5 + 33 3 4 4 23 1 6 24 frc us ts er v@ dy na lb io te ch .c om D yn ab ea ds T 4- T8 q ua nt ifi ca tio n (C en tr e de tr an sf er t d e L’ U. T. C. ), w w w .d yn al bi ot ec h. co m F- 60 20 0 Co m pi eg ne , F ra nc e EY L ab or at or ie s, In c. P. O . B ox 1 78 7, + 1 65 0 34 2 32 96 + 1 65 0 34 2 26 48 sa le s@ ey la bs .c om In st an tC HE K™ H IV 1 + 2 10 7 N . A m ph le tt Bl vd ., w w w .e yl ab s. co m Sa n M at eo , C A 94 40 1, U SA 1 Pl ea se n ot e: P ro du ct li st g iv es a n ov er vi ew o f m os t r el ev an t p ro du ct s av ai la bl e. T hi s lis t i s no t i nt en de d to b e co m pr eh en si ve , t he re fo re a dd iti on al in fo rm at io n sh ou ld b e ob ta in ed fr om c om pa ny w eb si te s w he re n ee de d. 6. LIST OF MANUFACTURERS – MEDICINES AND DIAGNOSTICS SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS32 M an uf ac tu re r A dd re ss Te le ph on e Fa x Em ai l/ W eb si te P ro du ct s Fu jir eb io In c. 19 th fl oo r, Sh in ju ku D ai ic hi + 81 3 3 34 8 09 47 + 81 3 3 34 2 62 20 w w w .fu jir eb io .c o. jp /e ng lis h Se ro di a® H IV -1 /2 Se im ei B ui ld in g, 7 –1 N is hi - Sh in ju ku 2 -C ho m e, S hi nj uk u- Ku , To ky o 16 3- 07 , J ap an G en el ab s D ia gn os tic s Ha lle d e Fr êt , P . O . B ox 1 01 5, + 41 22 7 88 1 90 8 + 41 22 7 88 1 98 6 m m oo re @ m pb io .c om G en el ab s D ia gn os tic s HI V- Bl ot 2 .2 (n ow M P B io m ed ic al s 12 15 G en ev a 15 A irp or t, w w w .g en el ab s. co m .s g As ia P ac ifi c) Sw itz er la nd G re en C ro ss L ife S ci en ce 22 7– 3, G ug al - l i , G ih eu ng -e up , + 82 3 1 26 0 93 00 + 82 3 1 26 0 94 91 su ji2 @ gr ee nc ro ss .c om G en ed ia ® H IV A g- Ab ; G en ed ia ® H IV 1 /2 R ap id 3 .0 Co rp or at io n Yo ng in -s hi , K yo ng gi -d o, K or ea w w w .g re en cr os s. co m G ua va T ec hn ol og ie s 25 80 1, In du st ria l B lv d. , H ay w ar d, + 1 51 0 57 6 14 41 + 1 51 0 57 6 15 00 tb au m ga rt ne r@ gu av at ec hn ol og ie s. co m Ea sy CD 4 CA 9 45 45 , U SA w w w .g ua va te ch no lo gi es .c om In no ge ne tic s S. A. Te ch no lo gi ep ar k 6, + 32 9 32 9 13 29 + 32 9 32 9 19 11 Ro la nd _g ee rs @ in no ge ne tic s. be IN N O -L IA H IV C on fir m at io n 90 52 G he nt , B el gi um w w w .in no ge ne tic s. co m In Te c Pr od uc ts 33 2 Xi ng ua ng R d, X in ya ng + 86 5 92 6 8 07 16 2 + 86 5 92 6 51 91 59 je an _z ha o@ as in te c. co m Ad va nc ed Q ua lit y™ R ap id H IV T es t In du st ry A re a, H ai ca ng , X ia m en , w w w .in te ca si .c om 36 10 22 C hi na J. M itr a & C o. L td A- 18 0, O kh la In du st ria l A re a, + 91 1 1 68 1 89 71 + 91 1 1 68 1 09 45 jm itr a@ de l2 .v sn l.c om .in HI V TR I-D O T Ph as e- 1, N ew D el hi -1 10 0 20 , + 91 1 1 68 1 89 73 + 91 1 1 68 1 89 70 In di a + 91 1 1 68 1 39 95 + 91 1 1 68 1 39 89 KH B Sh an gh ai K eh ua 11 89 N Q in zh ou R oa d, + 86 2 1 64 85 11 88 + 86 2 1 64 85 40 51 cs hk h@ on lin e. cn An ti- HI V 1+ 2 an tib od ie s EL IS A di ag no st ic K it; D ia gn os tic Bi o- en gi ne er in g Co . L td . Sh an gh ai , 2 00 23 3, + 86 2 1 64 85 33 70 ki t f or H IV (1 + 2) A nt ib od y (c ol lo id al g ol d) Pe op le ’s R ep ub lic o f C hi na + 86 2 1 82 03 37 0 O ra Su re T ec hn ol og ie s, In c. 15 0 W eb st er S tr ee t, Be th le he m , + 1 61 0 88 2 18 20 + 1 6 10 8 82 1 83 0 do xl ey @ or as ur e. co m O ra Q ui ck ® H IV -1 /2 - Ra pi d HI V- 1/ 2 An tib od y te st PA 1 80 15 , U SA w w w .o ra su re .c om O rg en ic s Lt d. P. O . B ox 3 60 , Y av ne 7 06 50 , + 97 2 8 94 29 21 2 + 97 2 8 94 38 75 8 ba ru ch @ or ge ni cs .c o. il Im m un oc om b® II B is po t H IV 1 & 2, H IV 1 & 2 D ou bl eC he ck Is ra el w w w .o rg en ic s. co m Pa rt ec G m bH 32 , O tto H ah n st ra ss e, + 49 2 53 4 80 08 -0 + 49 2 53 4 80 08 -9 0 in fo @ pa rt ec .d e Cy Fl ow G re en , C yf lo w C ou nt er D -4 81 61 , M ün st er , G er m an y w w w .p ar te c. de Pe rk in E lm er L ife S ci en ce s 8, Im pe ria st ra at , + 39 3 35 8 03 15 79 + 39 0 33 1 37 67 02 w w w .p er ki ne lm er .c om HI V- 1p 24 U ltr a EL IS A , E LA ST E LI SA a m pl ifi ca tio n sy st em B 19 30 Z av en te m , B el gi um Pr em ie r M ed ic al C or po ra tio n 25 9, A m he rs t A ve nu e, C ol on ia , + 1 73 2 81 5 04 62 + 1 53 0 86 9 79 66 ni le sh m et a@ ve riz on .n et Fi rs t R es po ns e™ H IV -1 -2 O C ar d Te st N J 07 06 7, U SA w w w .p re m ie rm ed co rp .c om Pr im ag en 59 , M ei be rg dr ee f, N -1 10 5 BA + 31 2 0 56 6 85 6 9 + 31 2 0 56 6 90 81 w w w .p rim ag en .c om Re tin a Ra in bo w Am st er da m , T he N et he rla nd s 33 M an uf ac tu re r A dd re ss Te le ph on e Fa x Em ai l/ W eb si te P ro du ct s Q ua lp ro D ia gn os tic s 88 /8 9, P ha se II C , + 91 8 32 2 78 3 14 0 + 91 8 32 2 78 3 13 9 qu al pr o@ tu lip gr ou p. co m Re tr oc he ck H IV Ve rn a In du st ria l E st at e, w w w .tu lip gr ou p. co m /Q ua lp ro Ve rn a, G oa , 4 03 7 22 In di a Ro ch e D ia gn os tic s 11 6, S an dh of er s tr as se , + 49 6 21 7 59 8 7 85 + 49 6 21 7 59 4 0 68 w w w .r oc he -d ia gn os tic s. co m Am pl ic or H IV -1 D N A as sa y ve rs io n 1. 5, A m pl ic or H IV -1 D -6 83 05 M an nh ei m , G er m an y M on ito r Te st v er si on 1 .5 , T aq m an St an da rd D ia gn os tic s, In c. 57 5– 34 P aj an g- do ng , J an ga n- ku , + 82 3 1 25 8 29 94 + 82 3 1 25 8 29 95 jo hn ki m @ st an da rd ia .c om SD B IO LI N E HI V 1/ 2 3. 0 Su w on -s i, Ky on gg i-d o, 4 40 -2 90 , w w w .s ta nd ar di a. co m Ko re a Tr in ity B io te ch p lc ID A Bu si ne ss P ar k, B ra y, + 35 3 12 76 9 80 0 + 35 3 12 76 9 88 8 To m Li nd sa y@ co m pu se rv e. co m Ca pi l lu s™ H IV -1 /H IV -2 , U ni -G ol d™ H IV Co . W ic kl ow , I re la nd w w w .tr in ity bi ot ec h. co m Un ite d Bi om ed ic al In c 25 , D av id s D riv e, H au pp au ge , + 1 51 6 27 3 28 28 + 1 51 6 27 3 17 17 w w w .u ni te db io m ed ic al .c om UB I® H IV -1 /2 E IA N Y 11 78 8, U SA 6. LIST OF MANUFACTURERS – MEDICINES AND DIAGNOSTICS ANNEX 1A Summary of CD4+ T-cell enumeration technologies FLOW CYTOMETRY Parameter Double-platforma Single-platform Volumetricb Bead-basedc Instruments Flow cytometer Flow cytometer Flow cytometer Manufacturers Partec GmbH (Munster, Germany) Partec GmbH (Munster, Germany)d Becton Dickinson (CA, USA) Becton Dickinson (CA, USA) Guava Technologiesd (CA,USA) Coulter Corporation (FL, USA) Coulter Corporation (FL, USA) Cost of instrument (US$) 20–95 000 20–70 000 20–95 000 Cost of reagents/test 2–11 1–10 3–25 (US$) Specimen Whole blood Whole blood Whole blood Results Absolute CD4 count Absolute CD4 count Absolute CD4 count Absolute CD8 count Absolute CD8 count Absolute CD8 count CD4% and CD8% among lymphocytes CD4% and CD8% among lymphocytes CD4% and CD8% among lymphocytes CD4/CD8 ratio CD4/CD8 ratio CD4/CD8 ratio B and NK cells are possible B and NK cells are possible B and NK cells are possible Throughput (samples/day) Up to 250 Up to 250 Up to 250 Advantages One tube assay possible without No need for extra beads or No need for haematology analyser QC problems haematology analyser Protocols for aged samples available EQA available Protocols for aged samples available EQA available EQA available Disadvantages Requires the use of a haematology Internal QC for pipetting requires Internal QC for pipetting requires two analyser two tubes assay tubes assay More prone to clerical errors Instruments not yet proven in an Beads are expensive and require Fresh samples needed in order to independent multi centre study careful handling obtain absolute counts B and NK cells – subsets of lymphocytes; QC – quality control; EQA – external quality assessment a Any flow cytometer from any of the three manufacturers can operate with this method to provide absolute counts. The results of flow cytometry are combined with those from haematology to calculate absolute counts. b Volumetric instruments have the inherent hardware property of measuring the volume of the sample, providing direct absolute counts without the use of haematology analysers or beads. c Any flow cytometer from any of the three manufacturers can operate with this method to provide absolute counts. d Instruments from these manufacturers, are being validated as volumetric absolute CD4 T cell counters by independent investigators in multicentre studies. SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS34 DEDICATED AND MANUAL ASSAYS Dedicated Technology FACSCount CyFlow Counter CyFlow SL PointCare Manufacturer Becton Dickinson Partec GmbH Partec GmbH Beckman Coulter Inc. (CA, USA) (Munster, Germany) (Munster, Germany) (CA, USA) Instrumentation Dedicated CD4 counter Dedicated CD4 counter Dedicated CD4 and PointCare System CD4%counter Assay principle Flow cytometry Flow cytometry Flow cytometry Flow cytometric detection of CD4+ T-cells Detection system Fluorochrome labelled Fluorochrome labeled, Fluorochrome labeled, Anti-CD4 MAb conjugated with anti-CD3, CD4 and CD8 anti-CD4, (CD45, CD3, anti-CD4 /anti CD45 MAbs, colloidal gold particles MAb CD8) MAb (CD3/CD4),(CD3CD8), (CD4/ CD8 Specimen Whole blood Whole blood Whole blood Whole blood Results Absolute CD4 and CD8 Absolute CD4 count Absolute CD4 count Absolute and % CD4 count count Absolute CD8 count Absolute CD45 count WBC absolute count CD4/CD8 ratio Absolute CD3 count Absolute lymphocyte count Absolute and % lymphocyte CD4% and CD8% among Absolute CD45 count CD4% among lymphocytes count T cells CD4% among T-lymphocytes Correlation with flow 0.93–0.98 0.92–0.99 0.95–0.99 0.95 and 0.97 cytometrya (r value) (several international studies) (international studies ongoing) (international studies ongoing) (international studies ongoing) Cost of instrument 27 000 21 800 26 975 16 500 (US$) Cost of reagents/test 5–20 2.26 2.26–3.23 5.5–7.8 (US$)c Advantages Automated, fewer steps, Reagents available at low Reagents available at low Simple, no manual gating less human error, low cost cost No manual sample biohazard risk Equipment includes reagents Equipment includes reagents preparation Absolute CD4 and CD8 for 1000 CD4 tests for 200 CD4 % tests counts Quick results Quick results Quick results EQA available EQA available EQA available Disadvantages Reagent prices vary widely CD4% among lymphocytes Limited data available One sample processed at a CD4% among lymphocytes not reported time 17 min. not reported, can be Limited data available No EQA available calculated from haemato- No published data available logy parameters yet MAb – monoclonal antibody; EQA – external quality assessment a The analysis of correlation using linear regression is not appropriate to study method comparison. Instead, the analysis of agreement should be performed. Unfortunately, few of the published studies has used this analysis to compare these methods with flow cytometry. Therefore, here the ‘r’ values are still reported. b Depending on if a light or fluorescence microscope is used. c Instrument costs may vary, reagent cost may decrease substantially in the near future. ANNEX 1A. SUMMARY OF CD4+ T-CELL ENUMERATION TECHNOLOGIES 35 SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS36 MANUAL ASSAYS Manual Assays Cyto-Spheres Dynabeads Manufacturer Beckman Coulter (FL, USA) Dynal AS (Oslo, Norway) Instrumentation Haemocytometer Magnet Light microscope Haemocytometer Light or fluorescence microscope Assay principle Direct observation of bead-rosetted cells Direct observation of immunocaptured cells Detection system Latex beads conjugated to anti-CD4 MAb Magnetic beads conjugated to anti-CD4 and CD8 MAb Specimen Whole blood Whole blood Results Absolute CD4 count Absolute CD4 count Absolute CD8 count CD4/CD8 ratio Correlation with flow cytometrya 0.67–0.93 0.94 and 0.96 (r value) (several international studies) (several international studies) Cost of instrument (US$) 2000 2–10 000b Cost of reagents/test (US$)c 4–8 3–5 Advantages Simple and rapid Simple and rapid Absolute CD4 and CD8 counts Disadvantages 10 samples processed at a time 6 samples processed at a time Subjectivity in visual counting Subjectivity in visual counting CD4% among CD4% among lymphocytes or CD8 counts lymphocytes not reported not reported No EQA available No EQA available MAb – monoclonal antibody; EQA – external quality assessment a The analysis of correlation using linear regression is not appropriate to study method comparison. Instead, the analysis of agreement should be performed. Unfortunately, few of the published studies has used this analysis to compare these methods with flow cytometry. Therefore, here the ‘r’ values are still reported. b Depending on if a light or fluorescence microscope is used. c Instrument costs may vary, reagent cost may decrease substantially in the near future 37 ANNEX 1B Summary of main characteristics of viral load technologies NUCLEIC ACID BASED COMPANY ROCHE ROCHE ROCHE ROCHE Assay Name AMPLICORTM HIV-1 COBAS AMPLICORTM TaqMan HIV-1 Monitor AMPLICORTM HIV-1 Monitor® Test v1.5 HIV-1 Monitor® Test v1.5 Test v1.5 DNA Test v1.5* Type of assay RT-PCR, quantitative RT-PCR, quantitative Real-Time RT-PCR, PCR, qualitative quantitative Dynamic Range 50–100,000 (UltraSensitive) 50–100,000 (UltraSensitive) 40–10 Million copies/ml N/A (copies/ml) 400–750,000 (Standard) 500–1,000,000 (Standard) (95% confidence) Specimen Type Plasma, Serum Plasma, Serum Plasma, Serum Whole Blood, DBS Specimen volume 200 µl (UltraSensitive) 500 µl (US. Manual 500 µl (Manual Extraction) 200–500 µl 500 µl (Standard) Extraction) 1 ml (Automated Extraction) 750 µl (US, Automated Extraction) 200 µl (Std, Manual Extraction) 350 µl (Std, Automated Extraction) Area of HIV genome Gag Gag Gag Gag amplified HIV-1 subtypes Group M, subtypes A–H Group M, subtypes A–H Group M, subtypes A–H Group M, subtypes A–H amplified Time for result 7–8 hours 6–8 hours 5–6 hours 7–8 hours Cost/test1 $ 17–35/test $ 17–35/test $ 17–35/test $ 10–15 / test $ 35–90/ test $ 35–90/test $ 35–90/test $ 15–30 / test Number of 9–21 9–21 21–84 9–21 samples/run (COBAS TaqMan 48 or 96) Equipment Thermocycler, COBAS AMPLICOR (PCR) COBAS TaqMan 48 or 96 Thermocycler, required2 ELISA Reader/Washer, COBAS Ampliprep – COBAS AmpliPrep – ELISA Reader/Washer, Microcentrifuge automated extraction automated extraction Microcentrifuge Not supplied by Roche (Optional) (Optional) Not supplied by Roche Total approx $25,000. Total approx $25,000. Equipment cost (US$) COBAS AMPLICOR: COBAS TaqMan 48 or 96: $35,000–45,000 $45,000–$60,000/ AmpliPrep: $80,000– $120,000 100,000 AmpliPrep: $80,000– $100,000 * Research use only 1 Prices will vary considerably depending on quantities, infrastructure and support required plus special negotiations, first price bracket for the least developed countires. 2 All assays require pipettes, vortex mixers (and refrigerator for all but Primagen). ANNEX 1A. SUMMARY OF CD4+ T-CELL ENUMERATION TECHNOLOGIES SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS38 NUCLEIC ACID BASED COMPANY ABBOTT BAYER BIOMÉRIEUX PRIMAGEN Assay Name Abbott RealTime HIV-1 Versant® HIV-1 RNA NucliSens EasyQ® RetinaTM Rainbow 3.0 Assay HIV-1 Type of assay Real Time PCR bDNA RT-NASBA NASBA Dynamic Range 40–10,000,000 75–500,000 50–3,000,000 500–50,000,000 (copies/ml) Specimen Type Plasma Plasma Plasma, Serum, Plasma, Serum, Whole Blood, Dried Blood Spots Dried Fluid Spots Specimen volume 200–500–1,000 µl 1,000–2,000 µl 10–2,000 µl 200 µl Area of HIV genome Pol Pol Gag LTR amplified HIV-1 subtypes Group M (subtypes A–G) Group M All All amplified and Group O (subtypes A-G) Time for result 5 hours 22 hours 2.5–3 hours 1.5 hours Cost/test1 $20–70 $87 $38–76 $17–23 Number of 21–95 (+3 controls) 12–168 8–48 96 samples/run Equipment required2 M2000sp Bayer System 340 (bDNA NucliSens miniMAG system RetinAlyser $100,000 Analyzer, Data or Nuclisens easyMAG Heatblock Or magnetic racks, plate Management Software, system Computer cooler $500 and computer system) NucliSens EasyQ Analyser Centrifuge Centrifuge Strip centrifuge Heatblock Waterbath Vacuum system Equipment cost (US$) M2000rt: $50,250 $10 000 + Bayer $63,000 $23 000 System Analyzer NON NUCLEIC ACID BASED COMPANY CAVIDI PERKIN ELMER Assay Name ExaVir™Load Quantitative HIV-RT Load Kit HIV-1 p24 Ultra ELISA ELAST ELISA amplification system Type of Assay Enzyme immunoassay for quantitation of Enzyme immunoassay for quantitation of p24 antigen Reverse Transcriptase activity Dynamic Range 750 – over 50,000 copies/ml 400 copies/ml Specimen Type Plasma Plasma, Serum or Cell Culture Supernatant Specimen Volume 1000 µl 100 µl Area of HIV Genome Selected Reverse Transcriptase (RT) activity p24 antigen for Amplification HIV-1 Subtypes Amplified All, plus HIV-2 HIV-1 Time for Result 24 hours 6 hours Cost/Test1 $13–15 $10 Number of Samples/Run 30 96 Equipment required2 Incubator (33 °C), Freezer, ELISA Reader, Computer Incubator, ELISA Reader, Refrigerator Equipment cost (US$) $9,000–$10,000 (start up pack includes other $7,000–$9,000 necessary equipment and 3 kits) 1 Prices vary considerably with quantities and special negotiations. 2 All assays require pipettes, vortex mixers (and refrigerator for all but Primagen). 39 ANNEX 2B† Sources of medicines Prequalified sources of specific products are marked in bold with an asterisk TABLE 1. ANTI-INFECTIVE MEDICINES Anthelminthics – Antifilarials Manufacturer CROTAMITON cream/lotion 10% SM Pharmaceuticals SDN BHD IVERMECTIN scored tablet, 3 mg Merck & Co., Inc. LINDANE cream, lotion or powder, 0.3% Ovelle Limited PERMETHRIN cream, 5% Ovelle Limited lotion, 1% Ovelle Limited Anthelminthics – Intestinal anthelminthics albendazole chewable tablet, 400 mg Apex Drug House, Artesan Pharma GmbH & Co. KG, Beltapharm SpA, Cadila Pharmaceuticals Ltd., Cipla Ltd., Cosmos Limited, Emcure Pharmaceuticals Limited, Korea United Pharm. Inc., Lachifarma, SRL, Nuevas Tecnologías Farmaceuticas, Remedica Ltd., Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd., Strides Arcolab Ltd. Antibacterials, beta lactam medicines benzathine benzylpenicillin powder for injection, 1.44 g (=2.4 million IU) Alembic Ltd., Aventis Intercontinental, Sanavita Aktiengesellschaft & Co. in 5-ml vial benzylpenicillin powder for injection, 3 g (=5 million IU) Alembic Ltd., Apex Drug House, Sanavita Aktiengesellschaft & Co. (as sodium or potassium salt) in vial powder for injection, 600 mg (=1 million IU) Apex Drug House, Sanavita Aktiengesellschaft & Co. (as sodium or potasium salt) in vial cefixime paediatric oral suspension, 100 mg/5 ml Aventis Intercontinental, Bilim Pharmaceutical Ind. paediatric oral suspension, 40 mg/ 5 ml Aventis Intercontinental tablet, 200 mg Aventis Intercontinental, Cipla Ltd., Emcure Pharmaceuticals Limited, Korea United Pharm. Inc., Remedica Ltd. tablet, 400 mg Bilim Pharmaceutical Ind., Genepharm SA ANNEX 2B. SOURCES OF MEDICINES † Annex 2A. Registration status of products included in the sources and prices survey on CD-ROM only. SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS40 ceftriaxone powder for injection, 1 g (as sodium salt) in vial Alembic Ltd., Apex Drug House, Aristo Pharmaceuticals Ltd., Bilim Pharmaceutical Ind., Cadila Pharmaceuticals Ltd., Cipla Ltd., CLARIS Lifesciences Ltd., Pharmaceutical Industry, Emcure Pharmaceuticals Limited, F. Hoffmann-La Roche Ltd.NPI, Genepharm SA, Grupo Reig Jofre, Korea United Pharm. Inc., Lisapharma, Mepha Ltd, Neon Laboratories Limited, Pharmathen Pharmaceuticals S.A., Ranbaxy Laboratories Ltd, Strides Arcolab Ltd. powder for injection, 250 mg (as sodium salt) in vial Aristo Pharmaceuticals Ltd., Cadila Pharmaceuticals Ltd., Cipla Ltd., CLARIS Lifesciences Ltd., Combino Pharm, S.L., Pharmaceutical Industry, Emcure Pharmaceuticals Limited, *F. Hoffmann-La Roche Ltd.NPI, Korea United Pharm. Inc., Mepha Ltd, Neon Laboratories Limited, Pharmathen Pharmaceuticals S.A., Ranbaxy Laboratories Ltd, Strides Arcolab Ltd. powder for injection, 500 mg (as sodium salt) in vial Aristo Pharmaceuticals Ltd., Bilim Pharmaceutical Ind., Cadila Pharmaceuticals Ltd., Cipla Ltd., CLARIS Lifesciences Ltd., Pharmaceutical Industry, Emcure Pharmaceuticals Limited, *F. Hoffmann-La Roche Ltd.NPI, Grupo Reig Jofre, Korea United Pharm. Inc., Lisapharma, Mepha Ltd, Neon Laboratories Limited, Pharmathen Pharmaceuticals S.A., Strides Arcolab Ltd. procaine benzylpenicillin powder for injection, 1 g (=1 million IU) in vial Sanavita Aktiengesellschaft & Co. powder for injection, 3 g (=3 million IU) in vial Alembic Ltd., Sanavita Aktiengesellschaft & Co. Antibacterials, others azithromycin oral suspension, 200 mg/5 ml (dihydrate) Alembic Ltd., Cadila Pharmaceuticals Ltd., FDC Ltd., Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd. tablet/capsule, 250 mg (dihydrate) Alembic Ltd., Cadila Pharmaceuticals Ltd., Cipla Ltd., Cosmos Limited, FDC Ltd., Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd., Strides Arcolab Ltd. tablet/capsule, 500 mg (dihydrate) Alembic Ltd., Cadila Pharmaceuticals Ltd., Cosmos Limited, FDC Ltd., Laboratorios Cinfa S.A., Laboratorios Juventus S.A., Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd. capreomycin powder for injection, 1 g in vial Neon Antibiotics PVT. Ltd. chloramphenicol capsule, 250 mg Apex Drug House, Cosmos Limited, Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd. powder for injection, 1 g (sodium succinate) in vial Apex Drug House, Neon Laboratories Limited, Sanavita Aktiengesellschaft & Co., SM Pharmaceuticals Sdn Bhd, Strides Arcolab Ltd. ciprofloxacin tablet, 250 mg (as hydrochloride) Alembic Ltd., Alpharma, Apex Drug House, Bayer Healthcare AG, Cadila Pharmaceuticals Ltd., Cibro, *Cipla Ltd., Cosmos Limited, Emcure Pharmaceuticals Limited, FDC Ltd., Genepharm SA, Instituto Quimioterapico S.A.(IQFARMA), Intas Pharmaceuticals Ltd, Korea United Pharm. Inc., *Laboratorios Cinfa S.A., Laboratorios Juventus S.A., Mepha Ltd, Nuevas Tecnologías Farmaceuticas, Pharmathen Pharmaceuticals S.A., Protein S.A. DE C.V. (Apotex), *Ranbaxy Laboratories Ltd, Remedica Ltd., Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd., SM Pharmaceuticals Sdn Bhd, Strides Arcolab Ltd. tablet, 500 mg (as hydrochloride) Alembic Ltd., Alpharma, Apex Drug House, Aristo Pharmaceuticals Ltd., Bayer Healthcare AG, Cadila Pharmaceuticals Ltd., *Cipla Ltd., Cosmos Limited, Pharmaceutical Industry, Emcure Pharmaceuticals Limited, FDC Ltd., Instituto Quimioterapico S.A.(IQFARMA), Intas Pharmaceuticals Ltd, Korea United Pharm. Inc., *Laboratorios Cinfa S.A., Laboratorios Juventus S.A., Mepha Ltd, Nuevas Tecnologías Farmaceuticas, Pharmathen Pharmaceuticals S.A., Protein S.A. DE C.V. (Apotex), *Ranbaxy Laboratories Ltd, Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd., SM Pharmaceuticals Sdn Bhd, Strides Arcolab Ltd. clarithromycin powder for injection, 500 mg Strides Arcolab Ltd. tablet, 250 mg Alembic Ltd., Alpharma, Bilim Pharmaceutical Ind., Emcure Pharmaceuticals Limited, Genepharm SA, Intas Pharmaceuticals Ltd, Korea United Pharm. Inc., Laboratorios Juventus S.A., Nuevas Tecnologías Farmaceuticas, *Ranbaxy Laboratories Ltd, Remedica Ltd., SM Pharmaceuticals Sdn Bhd, Strides Arcolab Ltd., The Government Pharmaceutical Organization 41ANNEX 2B. SOURCES OF MEDICINES clindamycin capsule, 150 mg Bilim Pharmaceutical Ind., Korea United Pharm. Inc., Nuevas Tecnologías Farmaceuticas, Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd. cream, 2% (as phosphate) Genepharm SA injection, 150 mg/ml (as phosphate) in Combino Pharm, S.L. 2-ml ampoule cycloserine capsule, 250 mg Pharmadrug doxycycline capsule/tablet, 100 mg (hydrochloride) Apex Drug House, Aristo Pharmaceuticals Ltd., Cipla Ltd., Cosmos Limited, FDC Ltd., Intas Pharmaceuticals Ltd, Korea United Pharm. Inc., Nuevas Tecnologías Farmaceuticas, Pharmadrug, Remedica Ltd., Sanavita Aktiengesellschaft & Co., Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd. erythromycin powder for oral suspension, 125 mg Beltapharm SpA, Cosmos Limited, Instituto Quimioterapico S.A.(IQFARMA), Lachifarma, SRL, (as stereate or ethylsuccinate) Pharmadrug, Purna Pharmaceuticals NV, Remedica Ltd., Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd. tablet/capsule, 250 mg Alembic Ltd., Artesan Pharma GmbH & Co. KG, Beltapharm SpA, Cadila Pharmaceuticals Ltd., (as stearate or ethylsuccinate) Cipla Ltd., Cosmos Limited, Instituto Quimioterapico S.A.(IQFARMA), Intas Pharmaceuticals Ltd, Lachifarma, SRL, Lomapharm, Rudolf Lohmann GmbH KG, Remedica Ltd., Sanavita Aktiengesellschaft & Co., Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd., SM Pharmaceuticals Sdn Bhd, Strides Arcolab Ltd. tablet/capsule, 500 mg Alembic Ltd., Artesan Pharma GmbH & Co. KG, Cipla Ltd., Cosmos Limited, Instituto (as stearate or ethylsuccinate) Quimioterapico S.A.(IQFARMA), Intas Pharmaceuticals Ltd, Lomapharm, Rudolf Lohmann GmbH KG, Nuevas Tecnologías Farmaceuticas, Remedica Ltd., Sanavita Aktiengesellschaft & Co., Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd., Strides Arcolab Ltd. gentamicin injection, 10 mg/ml (as sulfate) in 2-ml vial Rotexmedica injection, 40 mg/ml (as sulfate) in 2-ml vial Apex Drug House, Neon Laboratories Limited, Rotexmedica, Sanavita Aktiengesellschaft & Co. metronidazole injection, 500 mg in 100-ml vial Aventis Intercontinental, B. Braun Biotech International GmbH, CLARIS Lifesciences Ltd., Pharmaceutical Industry, Human Pharmaceutical Works Co. Ltd., Rotexmedica oral suspension, 200 mg (as benzoate)/5 ml Beltapharm SpA, Cipla Ltd., Cosmos Limited, FDC Ltd., Purna Pharmaceuticals NV, Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd. suppository, 1 g Aventis Intercontinental tablet, 200 mg Apex Drug House, Aristo Pharmaceuticals Ltd., Cibro, Cosmos Limited, Lomapharm, Rudolf Lohmann GmbH KG, Remedica Ltd., Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd. tablet, 500 mg Alpharma, Aventis Intercontinental, FDC Ltd., Instituto Quimioterapico S.A.(IQFARMA), Lomapharm, Rudolf Lohmann GmbH KG, Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd. vaginal gel, 0.75% Korea United Pharm. Inc. ofloxacin IV infusion, 2 mg/ml (hydrochloride) CLARIS Lifesciences Ltd., Genepharm SA tablet, 200 mg Aristo Pharmaceuticals Ltd., Aventis Intercontinental, Cipla Ltd., FDC Ltd., Genepharm SA, Intas Pharmaceuticals Ltd, Korea United Pharm. Inc., Nuevas Tecnologías Farmaceuticas, Ranbaxy Laboratories Ltd, Remedica Ltd., Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd. tablet, 400 mg Aristo Pharmaceuticals Ltd., Cipla Ltd., FDC Ltd., Korea United Pharm. Inc., Ranbaxy Laboratories Ltd, Remedica Ltd., Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd. spectinomycin powder for injection, 2 g (as hydrochloride) in vial Neon Antibiotics PVT. Ltd. SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS42 sulfadiazine tablet, 500 mg *Doms RecordatiNPI, Ecobi Farmaceutici S.a.s., Grupo Reig Jofre, Heyl Chemisch.- pharmazeutische Fabrik GmbH & Co KG sulfamethoxazole+trimethoprim oral suspension, 200+40 mg/5 ml Apex Drug House, Aristo Pharmaceuticals Ltd., Beltapharm SpA, Cadila Pharmaceuticals Ltd., Cipla Ltd., Cosmos Limited, Ecobi Farmaceutici S.a.s., Emcure Pharmaceuticals Limited, *F. Hoffmann-La Roche Ltd.NPI, Instituto Quimioterapico S.A.(IQFARMA), Lachifarma, SRL, Protein S.A. DE C.V. (Apotex), Purna Pharmaceuticals NV, Remedica Ltd., Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd., SM Pharmaceuticals Sdn Bhd tablet, 100+20 mg Artesan Pharma GmbH & Co. KG, Cosmos Limited, Ecobi Farmaceutici S.a.s., FDC Ltd., Lachifarma, SRL, Lomapharm, Rudolf Lohmann GmbH KG, Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd. tablet, 400+80 mg Alpharma, Apex Drug House, Aristo Pharmaceuticals Ltd., Artesan Pharma GmbH & Co. KG, Cadila Pharmaceuticals Ltd., Cibro, Cosmos Limited, Ecobi Farmaceutici S.a.s., Emcure Pharmaceuticals Limited, *F. Hoffmann-La Roche Ltd.NPI, FDC Ltd., Instituto Quimioterapico S.A.(IQFARMA), Intas Pharmaceuticals Ltd, Lomapharm, Rudolf Lohmann GmbH KG, Nuevas Tecnologías Farmaceuticas, Protein S.A. DE C.V. (Apotex), Remedica Ltd., Sanavita Aktiengesellschaft & Co., Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd., SM Pharmaceuticals Sdn Bhd, Strides Arcolab Ltd., The Government Pharmaceutical Organization tablet, 800+160 mg Alpharma, Apex Drug House, Aristo Pharmaceuticals Ltd., Cadila Pharmaceuticals Ltd., Cosmos Limited, Emcure Pharmaceuticals Limited, *F. Hoffmann-La Roche Ltd.NPI, FDC Ltd., Instituto Quimioterapico S.A.(IQFARMA), Nuevas Tecnologías Farmaceuticas, Protein S.A. DE C.V. (Apotex), Remedica Ltd., Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd., Strides Arcolab Ltd. Antifungal medicines amphotericin B powder for injection, 50 mg in vial Combino Pharm, S.L., Neon Antibiotics PVT. Ltd. clotrimazole cream, 1% Apex Drug House, Cipla Ltd., Cosmos Limited, Emcure Pharmaceuticals Limited, Instituto Quimioterapico S.A.(IQFARMA), Korea United Pharm. Inc., Ovelle Limited, Pharmadrug, Purna Pharmaceuticals NV, Remedica Ltd., SM Pharmaceuticals Sdn Bhd, The Government Pharmaceutical Organization, Vitafarma S.L. pessary, 500 mg Korea United Pharm. Inc., Remedica Ltd. fluconazole capsule, 150 mg Bilim Pharmaceutical Ind., Cadila Pharmaceuticals Ltd., *Cipla Ltd., Cosmos Limited, FDC Ltd., Instituto Quimioterapico S.A.(IQFARMA), Intas Pharmaceuticals Ltd, Pharmathen Pharmaceuticals S.A., *Ranbaxy Laboratories LtdNPI, Remedica Ltd., Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd. capsule, 200 mg Cadila Pharmaceuticals Ltd., *Cipla Ltd., Cosmos Limited, FDC Ltd., Pharmathen Pharmaceuticals S.A., *Ranbaxy Laboratories LtdNPI, Remedica Ltd., Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd., The Government Pharmaceutical Organization capsule, 50 mg *Cipla Ltd., Cosmos Limited, FDC Ltd., Genepharm SA, Korea United Pharm. Inc., Nuevas Tecnologías Farmaceuticas, Pharmathen Pharmaceuticals S.A., *Ranbaxy Laboratories LtdNPI injection, 2 mg/ml in ampoule CLARIS Lifesciences Ltd., Genepharm SA, Grupo Reig Jofre, Pharmathen Pharmaceuticals S.A. itraconazole capsule, 100 mg Instituto Quimioterapico S.A.(IQFARMA), Intas Pharmaceuticals Ltd, Korea United Pharm. Inc., SM Pharmaceuticals Sdn Bhd ketoconazole cream, 2% Apex Drug House, Genepharm SA, Instituto Quimioterapico S.A.(IQFARMA), Laboratorios Juventus S.A., Ovelle Limited, Protein S.A. DE C.V. (Apotex), Purna Pharmaceuticals NV tablet, 200 mg Artesan Pharma GmbH & Co. KG, Beltapharm SpA, Bilim Pharmaceutical Ind., Cosmos Limited, Intas Pharmaceuticals Ltd, Korea United Pharm. Inc., Lachifarma, SRL, Nuevas Tecnologías Farmaceuticas, Pharmadrug, Remedica Ltd., SM Pharmaceuticals Sdn Bhd, Strides Arcolab Ltd., The Government Pharmaceutical Organization 43 miconazole cream/ointment 2% (as nitrate) 15 g tube Beltapharm SpA, Cipla Ltd., Cosmos Limited, Lachifarma, SRL, Purna Pharmaceuticals NV cream/ointment 2% (as nitrate) 20 g tube Apex Drug House, Ovelle Limited, Protein S.A. DE C.V. (Apotex), Purna Pharmaceuticals NV cream/ointment 2% (as nitrate) 30 g tube Beltapharm SpA, Ecobi Farmaceutici S.a.s., Lachifarma, SRL, Pharmadrug, Purna Pharmaceuticals NV, Vitafarma S.L. cream/ointment 2% (as nitrate) 40 g tube Purna Pharmaceuticals NV nystatin lozenge, 100,000 IU Cosmos Limited pessary, 100,000 IU Artesan Pharma GmbH & Co. KG, Beltapharm SpA, Cipla Ltd., Cosmos Limited, Pharmadrug, SM Pharmaceuticals Sdn Bhd tablet, 100,000 IU Artesan Pharma GmbH & Co. KG, Beltapharm SpA, Cipla Ltd., Lomapharm, Rudolf Lohmann GmbH KG tablet, 500,000 IU Artesan Pharma GmbH & Co. KG, Beltapharm SpA, Cipla Ltd., Cosmos Limited, Lomapharm, Rudolf Lohmann GmbH KG, Pharmadrug, Protein S.A. DE C.V. (Apotex), Remedica Ltd., Sanavita Aktiengesellschaft & Co. Antiprotozoal medicines pentamidine powder for injection, 200 mg (isetionate) in vial Neon Antibiotics PVT. Ltd. powder for injection, 300 mg (isetionate) in vial Aventis Intercontinental, Combino Pharm, S.L., Lab. Filaxis International S.A. pyrimethamine tablet, 25 mg Cosmos Limited, Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd. tinidazole tablet, 500 mg Cadila Pharmaceuticals Ltd., Cosmos Limited, Intas Pharmaceuticals Ltd, Remedica Ltd. Antiviral medicines aciclovir cream, 5% *Cipla Ltd., Cosmos Limited, Ecobi Farmaceutici S.a.s., Instituto Quimioterapico S.A.(IQFARMA), Lisapharma powder for injection, 250 mg (as sodium salt) Biologici Italia Laboratories SRL, Combino Pharm, S.L., Grupo Reig Jofre, Korea United Pharm. Inc., Lab. Filaxis International S.A., Neon Antibiotics PVT. Ltd., Neon Laboratories Limited tablet, 200 mg Cadila Pharmaceuticals Ltd., Cibro, *Cipla Ltd., Cosmos Limited, FDC Ltd., Instituto Quimioterapico S.A.(IQFARMA), Korea United Pharm. Inc., Lab. Filaxis International S.A., Lisapharma, Nuevas Tecnologías Farmaceuticas, Pharmadrug, Protein S.A. DE C.V. (Apotex), *Ranbaxy Laboratories Ltd., Remedica Ltd., Samchully Pharm. Co., Ltd., SM Pharmaceuticals Sdn Bhd tablet, 400 mg Cadila Pharmaceuticals Ltd., *Cipla Ltd., Ecobi Farmaceutici S.a.s., FDC Ltd., Instituto Quimioterapico S.A.(IQFARMA), Korea United Pharm. Inc., Lisapharma, *Ranbaxy Laboratories Ltd, Remedica Ltd., Samchully Pharm. Co., Ltd., SM Pharmaceuticals Sdn Bhd tablet, 800 mg *Cipla Ltd., Combino Pharm, S.L., Ecobi Farmaceutici S.a.s., FDC Ltd., Korea United Pharm. Inc., Lab. Filaxis International S.A., Laboratorios Cinfa S.A., Lisapharma, *Ranbaxy Laboratories Ltd., Remedica Ltd. ganciclovir powder for IV infusion, 500 mg in vial *F. Hoffmann-La Roche Ltd.NPI, Lab. Filaxis International S.A. Antiviral medicines – Antiretrovirals abacavir (ABC) syrup, 20 mg/ml *GlaxoSmithKline Export Ltd. tablet, 300 mg Cipla Ltd., *GlaxoSmithKline Export Ltd., Lab. Filaxis International S.A. ANNEX 2B. SOURCES OF MEDICINES SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS44 didanosine (ddI) buffered chewable tablet, 100 mg *Bristol-Myers Squibb (Africa Export Division), Cipla Ltd., Emcure Pharmaceuticals Limited, Nuevas Tecnologías Farmaceuticas, Protein S.A. DE C.V. (Apotex) buffered chewable tablet, 25 mg *Bristol-Myers Squibb (Africa Export Division), Cipla Ltd., Protein S.A. DE C.V. (Apotex) buffered chewable tablet, 50 mg *Bristol-Myers Squibb (Africa Export Division), Cipla Ltd. syrup, 2 g Bristol-Myers Squibb (Africa Export Division) unbuffered enteric coated capsule, 250 mg Bristol-Myers Squibb (Africa Export Division), Cipla Ltd., Shanghai Desano Biopharmaceutical Co., Ltd unbuffered enteric coated capsule, 400 mg Bristol-Myers Squibb (Africa Export Division), Cipla Ltd. efavirenz (EFZ) capsule, 100 mg Lab. Filaxis International S.A., Merck & Co., Inc. capsule, 200 mg Cipla Ltd., Cosmos Limited, Merck & Co., Inc., Nuevas Tecnologías Farmaceuticas, Ranbaxy Laboratories Ltd capsule, 50 mg Merck & Co., Inc. oral solution, 150 mg/5 ml Merck & Co., Inc. tablet, 600 mg Cipla Ltd., Cosmos Limited, Emcure Pharmaceuticals Limited, Merck & Co., Inc., Ranbaxy Laboratories Ltd indinavir (IDV) capsule, 200 mg (as sulphate) Cipla Ltd., Merck & Co., Inc. capsule, 400 mg (as sulphate) Cipla Ltd., Lab. Filaxis International S.A., Merck & Co., Inc., Nuevas Tecnologías Farmaceuticas, Strides Arcolab Ltd. lamivudine (3TC) oral solution, 50 mg/5 ml *Cipla Ltd., *GlaxoSmithKline Export Ltd., The Government Pharmaceutical Organization tablet, 150 mg *Cipla Ltd., Cosmos Limited, Emcure Pharmaceuticals Limited, *GlaxoSmithKline Export Ltd., Intas Pharmaceuticals Ltd, Lab. Filaxis International S.A., Nuevas Tecnologías Farmaceuticas, Ranbaxy Laboratories Ltd, *Strides Arcolab Ltd., The Government Pharmaceutical Organization nelfinavir (NFV) oral powder, 50 mg/g *F. Hoffmann-La Roche Ltd. tablet, 250 mg Cipla Ltd., *F. Hoffmann-La Roche Ltd., Lab. Filaxis International S.A., The Government Pharmaceutical Organization nevirapine (NVP) syrup, 50 mg/5 ml *Boehringer Ingelheim GmbH, Cipla Ltd., Emcure Pharmaceuticals Limited, The Government Pharmaceutical Organization tablet, 200 mg *Boehringer Ingelheim GmbH, *Cipla Ltd., Cosmos Limited, Emcure Pharmaceuticals Limited, *Hetero Drugs LtdNPI, Lab. Filaxis International S.A., Ranbaxy Laboratories Ltd, Shanghai Desano Biopharmaceutical Co., Ltd, *Strides Arcolab Ltd., The Government Pharmaceutical Organization saquinavir (SQV) hard gel capsule, 200 mg *F. Hoffmann-La Roche Ltd. 45 stavudine (d4T) capsule, 15 mg *Bristol-Myers Squibb (Africa Export Division)NPI, The Government Pharmaceutical Organization capsule, 20 mg *Bristol-Myers Squibb (Africa Export Division), Shanghai Desano Biopharmaceutical Co., Ltd, The Government Pharmaceutical Organization capsule, 30 mg *Bristol-Myers Squibb (Africa Export Division), Cipla Ltd., Cosmos Limited, Emcure Pharmaceuticals Limited, Lab. Filaxis International S.A., Nuevas Tecnologías Farmaceuticas, Ranbaxy Laboratories Ltd, Strides Arcolab Ltd., The Government Pharmaceutical Organization capsule, 40 mg *Bristol-Myers Squibb (Africa Export Division), Cipla Ltd., Cosmos Limited, Emcure Pharmaceuticals Limited, Lab. Filaxis International S.A., Protein S.A. DE C.V. (Apotex), Ranbaxy Laboratories Ltd, Samchully Pharm. Co., Ltd., *Strides Arcolab Ltd., The Government Pharmaceutical Organization syrup, 1 mg/ml Bristol-Myers Squibb (Africa Export Division), The Government Pharmaceutical Organization zalcitabine (ddC) tablet, 0.375 mg *F. Hoffmann-La Roche Ltd.NPI, Protein S.A. DE C.V. (Apotex) tablet, 0.75 mg *F. Hoffmann-La Roche Ltd.NPI, Lab. Filaxis International S.A., Protein S.A. DE C.V. (Apotex) zidovudine (AZT or ZDV) oral solution, 50 mg/5 ml *Cipla Ltd., *Combino Pharm, S.L., Emcure Pharmaceuticals Limited, *GlaxoSmithKline Export Ltd., Lab. Filaxis International S.A., The Government Pharmaceutical Organization solution for IV infusion/injection, 10 mg/ml *GlaxoSmithKline Export Ltd., Lab. Filaxis International S.A. in 20-ml vial tablet/capsule, 100 mg *Cipla Ltd., *Combino Pharm, S.L., Cosmos Limited, Emcure Pharmaceuticals Limited, *GlaxoSmithKline Export Ltd., Lab. Filaxis International S.A., Protein S.A. DE C.V. (Apotex), Samchully Pharm. Co., Ltd., The Government Pharmaceutical Organization tablet/capsule, 250 mg *Combino Pharm, S.L., *GlaxoSmithKline Export Ltd., Lab. Filaxis International S.A., Protein S.A. DE C.V. (Apotex), Samchully Pharm. Co. tablet/capsule, 300 mg *Cipla Ltd., *Combino Pharm, S.L., Cosmos Limited, Emcure Pharmaceuticals Limited, *GlaxoSmithKline Export Ltd., Nuevas Tecnologías Farmaceuticas, Ranbaxy Laboratories Ltd, Samchully Pharm. Co., Ltd., Strides Arcolab Ltd., The Government Pharmaceutical Organization Antiviral medicines – Antiretrovirals (combinations) 3TC+AZT tablet, 150+300 mg *Cipla Ltd., Cosmos Limited, Emcure Pharmaceuticals Limited, *GlaxoSmithKline Export Ltd., Lab. Filaxis International S.A., Nuevas Tecnologías Farmaceuticas, Ranbaxy Laboratories Ltd, Strides Arcolab Ltd., The Government Pharmaceutical Organization 3TC+d4T tablet, 150+30 mg Cosmos Limited, Emcure Pharmaceuticals Limited, Ranbaxy Laboratories Ltd tablet, 150+40 mg Cipla Ltd., Cosmos Limited, Emcure Pharmaceuticals Limited, Ranbaxy Laboratories Ltd, *Strides Arcolab Ltd. 3TC+d4T+NVP tablet, 150+30+200 mg *Cipla Ltd., Cosmos Limited, Emcure Pharmaceuticals Limited, Nuevas Tecnologías Farmaceuticas, Ranbaxy Laboratories Ltd, Strides Arcolab Ltd., The Government Pharmaceutical Organization tablet, 150+40+200 mg *Cipla Ltd., Cosmos Limited, Emcure Pharmaceuticals Limited, Nuevas Tecnologías Farmaceuticas, Ranbaxy Laboratories Ltd, Strides Arcolab Ltd., The Government Pharmaceutical Organization ABC+3TC+ZDV tablet, 300+150+300 mg *GlaxoSmithKline Export Ltd., Ranbaxy Laboratories Ltd AZT+3TC+NVP tablet, 300+150+200 mg Cipla Ltd., Emcure Pharmaceuticals Limited ANNEX 2B. SOURCES OF MEDICINES SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS46 TABLE 2. ANTINEOPLASTIC MEDICINES Cytotoxic medicines bleomycin powder for injection, 15 mg (as sulfate) in vial Aventis Intercontinental, Cipla Ltd., Korea United Pharm. Inc., Neon Antibiotics PVT. Ltd., Nippon Kayaku calcium folinate (leucovorin) tablet, 15 mg Ecobi Farmaceutici S.a.s., Korea United Pharm. Inc., Lab. Filaxis International S.A., Medac GmbH, International Operations doxorubicine HCl powder for injection, 10 mg in 5-ml vial Cipla Ltd., Intas Pharmaceuticals Ltd, Korea United Pharm. Inc., Lab. Filaxis International S.A., Medac GmbH, International Operations, Neon Antibiotics PVT. Ltd. powder for injection, 50 mg in 25-ml vial Cipla Ltd., Intas Pharmaceuticals Ltd, Korea United Pharm. Inc., Lab. Filaxis International S.A., Medac GmbH, International Operations, Neon Antibiotics PVT. Ltd. etoposide capsule, 100 mg Nippon Kayaku injection, 20 mg/ ml in 5-ml ampoule Cipla Ltd., Intas Pharmaceuticals Ltd, Korea United Pharm. Inc., Lab. Filaxis International S.A., Medac GmbH, International Operations, Neon Antibiotics PVT. Ltd., Nippon Kayaku methotrexate injection, 25 mg/ml (as sodium salt) in 2-ml vial Aventis Intercontinental, Korea United Pharm. Inc., Neon Antibiotics PVT. Ltd. powder for injection, 50 mg (as sodium salt) Aventis Intercontinental, Lab. Filaxis International S.A., Neon Antibiotics PVT. Ltd. in 2-ml vial tablet, 2.5 mg Aventis Intercontinental, Cipla Ltd., Korea United Pharm. Inc., Neon Antibiotics PVT. Ltd., Remedica Ltd. vinblastine powder for injection, 10 mg (sulfate) in 10-ml vial *Cipla Ltd., Korea United Pharm. Inc., Lab. Filaxis International S.A., Neon Antibiotics PVT. Ltd. vincristine powder for injection, 1 mg (sulfate) in 1-ml vial *Cipla Ltd., Korea United Pharm. Inc., Neon Antibiotics PVT. Ltd. powder for injection, 5 mg (sulfate) in vial Korea United Pharm. Inc. vinorelbine injection concentrate, 10 mg/ml in vial Lab. Filaxis International S.A., Neon Antibiotics PVT. Ltd. TABLE 3. PSYCHOTHERAPEUTIC MEDICINES Medicines used in depressive disorders amitriptyline tablet, 25 mg (as hydrochloride) Cosmos Limited, Instituto Quimioterapico S.A.(IQFARMA), Intas Pharmaceuticals Ltd, Remedica Ltd., The Government Pharmaceutical Organization fluoxetine tablet, 20 mg Cadila Pharmaceuticals Ltd., Combino Pharm, S.L., Korea United Pharm. Inc., Laboratorios Cinfa S.A., Lilly España, Lisapharma, Pharmathen Pharmaceuticals S.A., Remedica Ltd. Medicines used in generalized anxiety and sleep disorders diazepam injection, 5 mg/ml in 2-ml ampoule F. Hoffmann-La Roche Ltd.NPI, Lab. Renaudin, Neon Laboratories Limited, Rotexmedica, SM Pharmaceuticals Sdn Bhd, Warsaw Pharmaceutical Works Polfa, S.A. tablet, 5 mg Alpharma, Cosmos Limited, F. Hoffmann-La Roche Ltd.NPI, Intas Pharmaceuticals Ltd, Korea United Pharm. Inc., Lomapharm, Rudolf Lohmann GmbH KG, Remedica Ltd. 47 lorazepam injection, 4 mg/ml in 1-ml ampoule Remedica Ltd. tablet, 1 mg Lomapharm, Rudolf Lohmann GmbH KG, Pharmathen Pharmaceuticals S.A. methotrimepazine/levomepromazine tablet, 25 mg Aventis Intercontinental, Pharmadrug TABLE 4. ANALGESICS Medicines used in substance dependence naltrexone HCl tablet, 50 mg Intas Pharmaceuticals Ltd, Lachifarma, SRL Opioid analgesics codeine tablet, 30 mg (phosphate) Cosmos Limited, Lomapharm, Rudolf Lohmann GmbH KG, Remedica Ltd. methadone HCl oral solution, 5 mg/5 ml Martindale Pharmaceuticals Ltd. morphine injection, 10 mg/ml (sulfate or HCl), in 1-ml ampoule Lab. Renaudin, Warsaw Pharmaceutical Works Polfa, S.A. pethidine injection, 50 mg/ml (hydrochloride) in 1-ml ampoule Martindale Pharmaceuticals Ltd., Neon Laboratories Limited injection, 50 mg/ml (hydrochloride) in 2-ml ampoule Lab. Renaudin, Martindale Pharmaceuticals Ltd., Neon Laboratories Limited, Pharmadrug tablet, 50 mg Martindale Pharmaceuticals Ltd. TABLE 5. GASTROINTESTINAL MEDICINES Antacids and other antiulcer medicines omeprazole capsule, 10 mg Cipla Ltd., Mepha Ltd, Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd., SM Pharmaceuticals Sdn Bhd capsule, 20 mg Alembic Ltd., Apex Drug House, Aristo Pharmaceuticals Ltd., Cadila Pharmaceuticals Ltd., Cipla Ltd., Cosmos Limited, Pharmaceutical Industry, Emcure Pharmaceuticals Limited, Instituto Quimioterapico S.A.(IQFARMA), Intas Pharmaceuticals Ltd, Korea United Pharm. Inc., Laboratorios Andrómaco S.A., Laboratorios Cinfa S.A., Laboratorios Juventus S.A., Mepha Ltd, Nuevas Tecnologías Farmaceuticas, Pharmathen Pharmaceuticals S.A., Protein S.A. DE C.V. (Apotex), Remedica Ltd., Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd., SM Pharmaceuticals Sdn Bhd, Strides Arcolab Ltd. capsule, 40 mg Laboratorios Andrómaco S.A., Mepha Ltd, Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd. powder for injection, 40 mg (as sodium salt) in vial Neon Antibiotics PVT. Ltd. powder for IV infusion, 40 mg (as sodium salt) Neon Antibiotics PVT. Ltd. in vial Antiemetic medicines dimenhydrinate tablet, 50 mg Instituto Quimioterapico S.A.(IQFARMA), Laboratorios Cinfa S.A., Lomapharm, Rudolf Lohmann GmbH KG, Protein S.A. DE C.V. (Apotex), The Government Pharmaceutical Organization ANNEX 2B. SOURCES OF MEDICINES SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS48 metoclopramide injection 5 mg/ml in 2-ml ampoule Apex Drug House, CLARIS Lifesciences Ltd., Intas Pharmaceuticals Ltd, Lab. Renaudin, Neon Laboratories Limited, The Government Pharmaceutical Organization tablet, 10 mg (as hydrochloride) Alpharma, Cosmos Limited, Instituto Quimioterapico S.A.(IQFARMA), Lomapharm, Rudolf Lohmann GmbH KG, Protein S.A. DE C.V. (Apotex), Remedica Ltd. prochlorperazine injection, 12.5 mg/ml Pharmadrug tablet, 5 mg Remedica Ltd. promethazine elixir or syrup, 5 mg/5 ml (HCl) Beltapharm SpA, Purna Pharmaceuticals NV, Shiba Pharmaceuticals & Chemicals Mfg.Co.Ltd. injection, 25 mg/ml (hydrochloride) in 2-ml ampoule Pharmaceutical Industry, Lab. Renaudin, Neon Laboratories Limited tablet, 10 mg Remedica Ltd. tablet, 25 mg Artesan Pharma GmbH & Co. KG, Cosmos Limited, Remedica Ltd. Laxatives senna capsule, 7.5 mg Cosmos Limited 49 ANNEX 3 Further reading, reference and contacts General – HIV/AIDS • Progress on global access to HIV antiretroviral therapy: an update on “3 by 5”, June 2005. UNAIDS/WHO, Geneva, 2005. • Forecasting of antiretrovirals and diagnostics: Report of a WHO-UNICEF technical consultation. WHO, Geneva, 2004. • Two pills a day saving lives: Fixed-dose combinations (FDCs) of antiretroviral drugs. MSF, Geneva, 2004. • Treating 3 million by 2005: Making it happen. UNAIDS/ WHO, Geneva, 2003. • Human capacity-building plan for scaling up HIV/AIDS treat- ment. WHO, Geneva, 2003. • A public health approach for scaling up antiretroviral (ARV) treatment. A toolkit for programme managers. WHO, Geneva, 2003. • Handbook on access to HIV/AIDS-related treatment. A collection of information, tools and resources for NGOs, CBOs and PLWA groups. Joint publication UNAIDS, WHO and International AIDS Alliance, Geneva, 2003. • Monitoring and evaluating of national ART programmes in the rapid scale-up to 3 by 5. Draft document. WHO, Geneva, 2003. • Guidelines for surveillance of HIV drug resistance. Draft document. WHO, Geneva, 2003. • A commitment to action for expanded access to HIV/AIDS treatment. International HIV Treatment Access Coalition. WHO, Geneva, 2002 (WHO/HIV/2002.24). • Berwick D. “We All Have AIDS”: The case for reducing the cost of HIV medicines to zero”. British Medical Journal, 2002, 324:214–218. General – Medicines • The selection and use of essential medicines. Report of the WHO Expert Committee, 2005 (including the 14th Model List of Essential Medicines). WHO, Geneva, 2005. • WHO Model Formulary 2004. WHO, Geneva, 2004. • Guidelines for price discounts of single-source pharma- ceuticals (interagency document). WHO, Geneva, 2003. (WHO/EDM/PAR/2003.3). • Levison L. Policy and programming options for reducing the procurement costs of essential medication in devel- oping countries. Boston University School of Public Health, 2003. • Guidelines for drug donations (interagency document). WHO, Geneva, 1999 (WHO/EDM/PAR/99.4). • Guidelines for Safe Disposal of Unwanted Pharmaceuti- cals in and after Emergencies (interagency guidelines). WHO, Geneva, 1999 (WHO/EDM/PAR/99.2). Procurement guides • HIV/AIDS Medicines and related supplies: Contemporary context and procurement. Technical Guide. World Bank, Washington, DC, 2004. • Surmounting challenges: Procurement of antiretroviral medicines in low- and middle-income countries. WHO/MSF, Geneva, 2003. • Managing Drug Supply. 2nd edition. WHO and Manage- ment Sciences for Health, Arlington, VA, 2003. http:/www. kpbooks.com/details.asp?title=Managing+Drug+Supply • WHO HIV test kit bulk procurement scheme. Flyer, 2002. • Operational principles for good pharmaceutical procure- ment (interagency document). WHO, Geneva, 1999 (WHO/ EDM/PAR/99.5). Intellectual property rights and pharmaceuticals • HIV/AIDS medicines and related supplies: Contemporary context and procurement. Technical guide. Chapter 2 and Annex B. World Bank, Washington, DC, 2004. • Determining the patent status of essential medicines in developing countries. Health economics and drugs. EDM series number 17. WHO, Geneva, 2004 (WHO/EDM/PAR/ 2004.6). • Drug patents under the spotlight: sharing practical knowl- edge about pharmaceutical patents. MSF, Geneva, 2004. ANNEX 3. FURTHER READING, REFERENCE AND CONTACTS SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS50 • Globalization, patents and drugs. An annotated bibliogra- phy. Health Economics and Drugs series number 9. WHO, Geneva, 2002 (EDM/PAR/2001.1). • Implications of the DOHA Declaration on the TRIPS Agree- ment and public health. WHO, Geneva, 2002. (WHO/EDM/ PAR/2002.3). • Network for monitoring the impact of globalization and TRIPS on access to medicines. Health Economics and Drugs series number 11. WHO, Geneva, 2002 (WHO/ EDM/PAR/2002.1). • Globalization, TRIPS and access to pharmaceuticals. WHO Policy Perspectives on Medicines number 3. WHO, Geneva, 2001. • Patent situation of HIV/AIDS-related drugs in 80 countries. UNAIDS/WHO, Geneva, 2000. • Globalization and access to drugs: Perspectives on the WTO/TRIPS Agreement. Health Economics and Drugs Series number 7 (revised). WHO, Geneva, 1999 (WHO/ DAP/98.9 Rev). Pricing strategies • Drug Price Information Services: What is WHO doing to improve drug price information? WHO Information Sheet. • Medicine prices: a new approach to measurement. WHO and Health Action International, Geneva,2003 (WHO/EDM/ PAR/2003.2). • Medicines prices: data base with survey results. WHO and Health Action International: http://www.haiweb.org/ medicineprices/ • Cost-containment mechanisms for essential medicines, including antiretrovirals, in China. WHO, Geneva, 2003 (WHO/EDM/PAR/2003.6). • Public-private roles in the pharmaceutical sector. Implica- tions for equitable access and rational drug use. WHO, Geneva, 1997 (WHO/DAP/97.12). • Alternative drug pricing policies in the Americas. WHO, Geneva, 1995 (WHO/DAP/95.6). • Essential Drugs Monitor. Number 33. WHO, Geneva, 2003. Treatment guidelines • Antiretroviral drugs for treating pregnant women an pre- venting HIV infection in infants. WHO, Geneva, 2004. • Antiretroviral drugs and the prevention of mother-to-child transmission of HIV infection in resource-limited settings. Draft document. WHO, Geneva, 2004. • Integrated management of adolescent and adult illness (IMAI) modules. WHO, Geneva, 2004 (WHO/CDS/IMAI/ 2004.1). • Saving mothers, saving families: The MTCT-Plus Initiative. Perspectives and practice in antiretroviral treatment. Case study. WHO, Geneva, 2003. • Guidelines for the management of sexually transmitted infections. WHO, Geneva, 2003. • Scaling up antiretroviral therapy in resource limited set- tings: Treatment guidelines for a public health approach. WHO, Geneva, 2003. • Provision of antiretroviral therapy in resource-limited set- tings: A review of experience up to August 2003. WHO and UK Department for International Development, 2003. • HIV/AIDS care and treatment: A clinical course for people caring for people living with HIV/AIDS. Family Health Inter- national, Arlington, VA, 2003. • AIDS Palliative Care: UNAIDS. Technical Update, October 2000. Substance abuse • Evidence for action: Effectiveness of community-based outreach in preventing HIV/AIDS among injecting drug users. WHO, Geneva, 2004. • Practices and context of pharmacotherapy of opioid de- pendence in Central and Eastern Europe. • Training guide for HIV prevention outreach to injecting drug users. Workshop Manual. WHO, Geneva, 2004. • Substitution maintenance therapy in the management of opioid dependence and HIV/AIDS prevention. WHO/ UNODC/UNAIDS position paper. WHO, Geneva, 2004. • Neuroscience of psychoactive substance use and depend- ence. HIV testing • HIV simple/rapid assays: operational characteristics. Report 14. WHO/UNAIDS, Geneva, 2004. • Rapid HIV tests. Guidelines for use in HIV testing and coun- selling services in resource-constrained settings. WHO, Geneva, 2004. • Increasing access to HIV testing and counselling. Report of a WHO Consultation, 19–21 November 2002. WHO, Geneva, 2003. • The right to know. New approaches to HIV testing and counselling. WHO, Geneva, 2003 (WHO/HIV/2003.08). 51 • Increasing Access to Knowledge of HIV Status. Conclu- sions of a WHO Consultation, 3–4 December 2001. WHO, Geneva, 2002 (WHO/HIV/2002.09). TB/HIV • Interim policy on collaborative TB/HIV activities. WHO, Geneva, 2004 (WHO/HTM/TB/2004.330). • Guidelines for HIV surveillance among tuberculosis patients. Second edition. WHO, Geneva, 2004 (WHO/HTM/ TB/2004.339). • TB/HIV clinical manual. WHO, Geneva, 2004 (WHO/HTM/ TB/2004.329). Websites Partner sites • UNAIDS: www.unaids.org • UNICEF: www.unicef.org • WHO: www.who.int • MSF: www.msf.org Other websites for information related to HIV/AIDS activities • UNAIDS/WHO Global HIV/AIDS Online Database: http://www.who.int/globalatlas/default.asp • The Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM): http://www.theglobalfund.org/en/ • The President’s Emergency Plan for AIDS Relief (PEPFAR): http://www.usaid.gov/our_work/global_health/aids/ pepfar.html and on http://www.avert.org • Clinton Foundation: http://www.clintonfoundation.org/ • AIDS Education Global Information System: http://www.aegis.com • International HIV/AIDS Alliance: http://www.aidsalliance.org/ • John Snow Inc/DELIVER: http://deliver.jsi.com • Management Sciences for Health: http://www.msh.org/ Other websites for information related to STI activities • Sexually transmitted infections: http://www.who.int/ topics/sexually_transmitted_infections/en/ • Sexually transmitted diseases and diagnostics initiative: http://www.who.int/std_diagnostics/ Other websites for information related to TB activities • The Global TB Drug Facility: http://www.stoptb.org/GDF/ • DOTS-plus for multidrug resistant TB: http://www.who.int/gtb/policyrd/DOTSplus.htm • Stop TB Partnership: http://www.stoptb.org Contacts For further information about suppliers or products, please contact: Sources of Medicines for HIV/AIDS Survey Pharmaceutical and Micronutrients Team UNICEF Supply Division Fax: +45 35 269421 E-mail: supply@unicef.org For further information on HIV test kit evaluation or the bulk procurement scheme, please contact: Essential Health and Technologies (EHT) World Health Organization Fax +41 22 791 4836 For any comments on this document, or additional information that could be useful to this project, please complete the feedback form, Annex 5. ANNEX 3. FURTHER READING, REFERENCE AND CONTACTS ANNEX 4 Untangling the web of price reductions: a pricing guide for the purchase of ARVs for developing countries 53ANNEX 3. FURTHER READING, REFERENCE AND CONTACTS June 2005 a pricing guide for the purchase of ARVs for developing countries price Untangling the web of price reductions: 8th Edition cou ntri es reductions pr ic e el ig ib ili ty pr ice countries reductions com pan y 3 Table of contents 4 General background and objectives 5 Methodology 6 Analysis of current offers limitations: are products getting to patients in need? 8 Graph 1: Comparison between prices published in this report and prices reported by Global Fund 9 Graph 2: Prices of medicines recommended as 1st and 2nd line by WHO, January 2005 10 Graph 3: The Effects of Generic Competition 12 Table 1: 1st and 2nd category of prices offered by manufacturers for the different countries (yearly and unit price) 15 Table 2: Summary table for conditions 17 Annexes 17 Annex 1: Least Developed Countries (LDCs) 17 Annex 2: Human Development Index (HDI) 17 Annex 3: Sub-Saharan countries 18 Annex 4: World Bank low-income and low-middle-income countries 18 Annex 5: Company contacts 20 Glossary Table of contents MŽdecins Sans Frontires ¥ www.accessmed-msf.org ¥ June 2005 ¥ Untangling the Web of Price Reductions ¥ 3 1. General background and objectives This is the eighth edition of Untangling the web of price reductions: a pricing guide for the purchase of ARVs for developing countries. The report was first published by MŽdecins Sans Frontires (MSF) in October 2001[1] in response to the lack of transparent and reliable information about prices of pharmaceutical products on the international market — a factor which significantly hampers access to essential medicines in developing countries. The situation is particularly complex in the case of antiretrovirals (ARVs). The purpose of this document is to provide information on prices and suppliers that will help purchasers make informed decisions when buying ARVs. Since the first edition of ÒUntanglingÓ, prices of some first-line ARVs have fallen significantly due to competition between multiple producers. However, not all countries are able to benefit from these lower prices because of patent barriers to accessing generic versions. Price and availability of newer ARVs are still significant obstacles to access to treatment. This report shows that the compulsory licensing to override patents or intellectual property barriers. These mechanisms are in- built flexibilities of the World Trade OrganizationÕs TRIPS Agreement and have been affirmed in the Doha Declaration on TRIPS and Public Health in 2001[2]. Following the adoption of the Doha Declaration, Least Developed Countries (LDCs) are no longer obliged under the WTO rules to grant or enforce pharmaceutical product patents until at least 2016. The use of these flexibilities and safeguards is particularly important since India, the biggest producer of generic drugs, is now obligated to grant patents on new pharmaceutical products. The new Indian Patents Act will not affect medicines that were invented before 1995. However, patent applications filed between 1995 and 2005 will be reviewed by Indian patent authorities and patents may subsequently be granted. If a patent is granted, it will not stop a generic manufacturer from continuing to produce and market the drug in India if they have made a prices of second-line drugs are six to twelve times1 higher than those of older first-line treatments, in Least Developed Countries (LDCs) and sub- Saharan Africa. In the case of some of the second-line ARVs, it is lack of competition that has led to high prices (see graph 2). In some developing countries outside sub- Saharan Africa, the prices of both first- and second-line drugs mirror those charged in wealthy countries. MSF has found that problems fall into three categories: 1) some single- source drugs are very expensive, 2) differential prices are not really available as advertised in developing countries because some companies do not register their products in poor countries, and 3) some companies do not offer discounted prices in middle- income countries. Brazil is a good illustration of problems encountered in middle- income countries. Brazil currently spends 63% percent of its total ARV drug budget on three products (AbbottÕs lopinavir/ritonavir, GileadÕs tenofovir and MerckÕs efavirenz). In theory, a government such as BrazilÕs can overcome this problem by using Òsignificant investmentÓ, as the new Indian law stipulates an automatic licensing system which will allow for the continued production of the generic version if a Òreasonable royaltyÓ is paid. But when patents are granted for applications submitted after January 2005, only patent holders will have the right to produce these drugs unless India and other countries issue compulsory licenses to give others the right to produce, market and export the product[3,4]. Treatment of HIV/AIDS in children deserves special attention: most companies produce syrups and oral solutions, which are ill-adapted for use in developing countries because caregivers have problems reconstituting syrups, as well as measuring and preserving them. Pharmaceutical companies are not investing enough resources in the development of paediatric formulations, since it is a small and risky market that is also of diminishing importance in Western countries[5]. In addition to this, the price of liquid and solid drugs in paediatric formulations is higher than that of their adult equivalents. For instance, treating a child weighing 10 4 ¥ Untangling the Web of Price Reductions ¥ June 2005 ¥ www.accessmed-msf.org ¥ MŽdecins Sans Frontires 1 Comparison between the triple fixed-dose combination (3TC/d4T/NVP) and best available prices for WHO recommended 2nd line regimens. Only WHO prequalified products or products registered in highly regulated countries were compared. MŽdecins Sans Frontires ¥ www.accessmed-msf.org ¥ June 2005 ¥ Untangling the Web of Price Reductions ¥ 5 2. Methodology To obtain accurate information, MSF has contacted both originator and generic companies and asked them to provide the following information about the ARVs offered to developing countries: dosage and pharmaceutical form, price per unit (or daily dose), restrictions that apply to the offers (eligibility), and any additional specificity of the offers. Products listed here have been approved for marketing at least in their countries of origin. The list of generic producers included in this report is by no means exhaustive[8]. These companies were mostly chosen because they have publicly announced price offers to developing countries. All prices are quoted in US dollars and conversions have been made on the day the price information was received using the currency converter site: www.oanda.com. We acknowledge the difficulties and inaccuracies when establishing price comparisons across different countries and purchasers, and therefore recommend that these prices be considered in relative and not absolute terms. Table 1: First and Second Category of Prices offered by manufacturers for the different countries (yearly and unit prices) Generic companies do not apply any geographical restriction. Most originator companies offer their discounted prices only to a certain group of countries, normally only to LDCs and sub-Saharan African countries. These prices are referred to as FIRST CATEGORY PRICES. See table 2 for details. There are exceptions such as Gilead and Bristol-Myers Squibb that have recently, for example, extended their first category of price to some middle-income countries, or Merck, which applies first category prices also to medium human development index countries when the countryÕs HIV prevalence is greater than 1%, or GlaxoSmithKline, which has offered their products for all Global Fund recipient countries. Finally, companies like Merck and Roche offer a SECOND CATEGORY OF PRICES for middle-income countries (almost twice as much as the first category price). When these second kg for one year with stavudine, nevirapine and lamivudine can cost up to US$816, while treating an adult with the same drugs costs US$182. This document complements the information in the pricing guide Sources and Prices of selected medicines and diagnostics for People living with HIV/AIDS published by UNICEF/UNAIDS/WHO/MSF[6]. Products included in the last edition of the WHO prequalification list (23rd edition, April 4th 2005) appear in bold in the tables. Please consult the WHO website (http://mednet3.who.int/ prequal/) for the latest information. Prices listed are selling prices as quoted from the manufacturers and constitute an indication for procurement departments of eligible organisations. In any case, the prices listed here are not necessarily the same as the final prices paid by either patients or their health care providers. For example, in some countries there are local add-ons such as import taxes and distribution mark-ups that are not included in the comparisons. In addition, the information on prices in this report only relates to the price of medicines: it does not include other costs linked to antiretroviral treatment, such as diagnostics and monitoring. This report is a pricing guide and does not include information about the quality of the products listed. But price should not be the only factor determining procurement decisions. Readers and purchasers wishing to obtain more information about drug quality are encouraged to consult ÒPilot Procurement, Quality and Sourcing Project: Access to HIV/AIDS Drugs and Diagnostics of Acceptable QualityÓ (known as WHO prequalification list), a project initiated by the World Health Organization (WHO) and developed in collaboration with other United Nations Organizations[7]. This project evaluates pharmaceutical manufacturers and products according to WHO recommended standards of quality and compliance with Good Manufacturing Practices. It is part of an ongoing process that will expand as the participation of suppliers increases. Not all the products listed in this report have been prequalified by WHO, and only some of them are used by MSF in its own projects. 6 ¥ Untangling the Web of Price Reductions ¥ June 2005 ¥ www.accessmed-msf.org ¥ MŽdecins Sans Frontires category prices exist, they have been included in the table. Prices are rounded up to the third decimal for unit price and to the nearest whole number for yearly price per patient. Prices quoted by the different companies are not always directly comparable since companies use different trade terms (incoterms[9]). Prices quoted by Roche, all generic companies, Abbott and Gilead are so- called ÒFCAÓ or ÒFOBÓ prices which means that transport, international freight and insurance costs are not included; the other companies mentioned in this report do include freight and insurance in their prices. Despite this fact, in this edition the prices have not been adjusted, following the methodology used in the US General Accountability Office (GAO) report[10]. For all paediatric treatments, prices are calculated for a 10 kg child using WHO treatment guidelines. This is an estimate since the weight of a child increases during any given year. The annual cost of treatment has been calculated according to WHO dosing schedules[11] multiplying the unit price (price of e.g. one tablet or capsule) by the number of units required for the daily dose and by 365 days in a year. Price is then presented in USD/year, and in brackets, the price per smallest unit is quoted. The price of products prequalified by WHO are based on the 23rd edition of the WHO prequalification list (April 4th 2005) and appear in bold. Please consult the latest WHO prequalification list for more details regarding manufacturing sites. Table 2: Conditions of offer by company Conditions applying to each companyÕs offer were quoted directly by companies. There is no uniformity concerning geographical restrictions to the offers but rather each originator company establishes different limits to their offer for different categories of countries (annex 1-4). Some companies use UNCTAD (Least Developed Countries) criteria, others the UNDP Human Development index, and yet others the World Bank classification. There are significant differences between categories used by companies. For instance, 15 countries are considered Least Developed Countries (LDCs) by UNCTAD, but are placed in the medium level by UNDP. These include Bangladesh, Cambodia, Laos and Sudan. Six other LDCs do not appear in the UNDP classification at all, including Democratic Republic of Congo, Liberia and Somalia. Furthermore, many developing countries are left out of the differential pricing scheme altogether. These include Bolivia, Nicaragua, Thailand, Ukraine and Vietnam for the UNDP classification, China, Honduras and Sri Lanka for the World Bank classification, and all Latin American countries except Haiti for the UNCTAD classification. 3. Analysing the limitations of current offers: are products getting to patients in need? 3.1. Availability in countries? The products listed in this report are not always available in every country. There are several reasons for this: Even when price reductions have been announced, the products are not necessarily marketed in all the eligible countries ¥ MSF projects have experienced this situation in many cases, even in the poorest nations such as Mozambique or Cambodia, where some ARVs coming from originator companies must be bought in neighbouring countries with all the additional expenses and investment in human and administrative resources that this implies. Registration of products is a major problem ¥ Companies have varying policies on product registration. Some companies offer discounted prices but do not register their products in specified countries. This practice makes the discounted price unattainable for everyone except those that have the possibility of asking for special authorisation from the Ministry of Health. ¥ National Drug Regulatory AuthoritiesÕ procedures for registering the products are sometimes slow, even if companies do everything necessary to get approval. ¥ The investment needed to import drugs that are not registered is enormous. MSF has had to request special authorisation for MerckÕs efavirenz, GSKÕs abacavir, AbbottÕs lopinavir/ritonavir, CiplaÕs lamivudine/stavudine/nevirapine or GileadÕs tenofovir in several countries, such as Cambodia, Uganda, Guatemala, Honduras, Laos or Ethiopia. The channel chosen by the companies to distribute the products priced at lower price is too complex. ¥ For example, to benefit from the differential price from AbbottÕs products, the orders must be placed with Axios, an Irish NGO that works as intermediary. According to our staff, this is a burdensome procedure even for MSF procurement centers. ¥ RocheÕs products have to be ordered from Basel, and paid in Swiss francs, which is in practice difficult for procurement centres in developing countries. 3.2. At what price? Even when the product is available on the market, prices quoted by manufacturers for this report may not represent the actual price for the following reasons: ¥ Excessive mark-ups by company local representatives in some countries; ¥ Lack of interest from companies to invest in exporting their products to small markets, for instance, generic companies in Latin America. In these cases, prices are often higher than those announced internationally by the companies; ¥ Lack of monitoring by responsible entities and donors of the prices paid by the different programmes for the same product; ¥ In countries outside sub-Saharan Africa and not classified as LDCs, prices can be as high as they are in Western countries, despite the fact that large numbers of people in these countries live below the poverty line. Generic companies have no geographical limits, but they do have quantity-related conditions in certain cases. Despite the exemptions and the existence of specific second category prices for some products, prices paid in middle-income countries are still much higher than the offers published in this report (graph 1). MŽdecins Sans Frontires ¥ www.accessmed-msf.org ¥ June 2005 ¥ Untangling the Web of Price Reductions ¥ 7 ¥ A good example of pricing problems is China, a non-LDC, non-African country, with an estimated one million people infected with HIV. There are very few generic products in the country, mainly due to intellectual property restrictions. Originator products are expensive and not always marketed in all dosages. For instance, stavudine from BMS is only marketed at the dosage of 20 mg. This makes it very difficult to treat children and doubles the pill burden for adults. Other important ARVs like lopinavir/ritonavir from Abbott are offered to MSF projects at US$ 5,000 per year — this is ten times more than the price for developing countries. ¥ Other middle-income countries, such as Ecuador or Georgia, pay unacceptably high prices for some products. For instance, Guatemala is paying US$ 2,500 per year for GSKÕs abacavir. The lack of competition for these new drugs lies behind high prices and lack of availability in the market. For reasons described above, the current Òdifferential pricingÓ practice cannot alone be considered the solution for increasing access to all needed ARVs worldwide. Access to life-saving medicines by the poorest populations should not depend on the goodwill of private companies. Making drugs affordable and available is a government responsibility. Where the political will exists, people pay less for their drugs and more people have access to them. International institutions and governments must work together to ensure that poor populations systematically benefit from lower prices which can be attained when sourcing from all available quality manufacturers. 8 ¥ Untangling the Web of Price Reductions ¥ June 2005 ¥ www.accessmed-msf.org ¥ MŽdecins Sans Frontires Graph 1: The chart shows the differences in prices paid in different countries. Although prices paid by the poorest countries are indeed very close to the prices announced by companies, prices paid in middle- income countries are far too high compared with the offers. This is particularly true for most prices of the originator products applicable in middle-income countries. Source: Global Fund Price reporting Mechanism. The GF pricing reporting site was consulted from June 6th to June 14th 2005[12], taking the minimum and the maximum reported prices from 2004 onwards. Minimum prices correspond with orders made by sub-Saharan African countries or LDCs outside Africa. Maximum prices correspond to non- African, non-LDC recipient countries. 6000 5000 4000 3000 2000 1000 0 Comparison between prices published in this report and prices reported by Global Fund U SD /y ea r GSK AZT/3TC d4T 40 EVF 200 NFV ritonavir Cipla BMS Hetero Merck Cipla Roche Cipla Abbott Strides Lowest price offered by companies Highest price reported to GF Lowest price reported to GF MŽdecins Sans Frontires ¥ www.accessmed-msf.org ¥ June 2005 ¥ Untangling the Web of Price Reductions ¥9 1400 1200 1000 800 600 400 200 0 Prices of medicines recommended as 1st and 2nd line by WHO. June 2005 U SD p er p at ie nt p er y ea r d4T 3TC NVP AZT ddl 100 3TC/ d4T/NVP ddl 400 EC AZT/3TC TDF EFV 600 EFV 200 LPV/r ABC SQV/r Graph 2: The chart shows the best prices for most drugs used in WHO recommended 1st (shaded bars) and 2nd line (solid bars) drugs. Prices indicated in the graph are the lowest amongst all surveyed manufacturers for this report. The figure over the columns shows the number of producers included in this report and having answered to Sources and Prices survey (Sources and prices of selected medicines and diagnostics for people living with HIV/AIDS, UNICEF-UNAIDS-WHO-MSF, June 2004). There are other reasons lying behind the high prices of some ARVs that are not included in this graph. 16 14 11 10 9 6 4 12 0 5 6 2 4 2 10 ¥ Untangling the Web of Price Reductions ¥ June 2005 ¥ www.accessmed-msf.org ¥ MŽdecins Sans Frontires Sample of ARV tiple-combination: stavudine (d4T) + lamivudine (3TC) + nevirapine (NVP). Lowest world prices per patient per year. Generic competition has shown to be the most effective means of lowering drug prices. During the last four years, originator companies have often responded to generic competition. The Effects of Generic Competition June 00 Aug 00 Sept 00 Jan 01 Feb 01 March 01 July 01 March 02 Nov 02 April 03 Nov 03 Dec 03 June 04 Dec 04 June 05 May 2000-June 2005 12000US$ 10000US$ 8000US$ 6000US$ 4000US$ 2000US$ Lowest Originator $10439 Brasil $2767 Lowest Originator $727 Lowest Originator $562 Aurobindo $209 Hetero $201 Hetero $152 Cipla $350 [1] To see previous editions, please consult www.accessmed-msf.org [2] HIV/AIDS medicines and related supplies: Contemporary context and procurement. Technical guide. Chapter 2 and Annex B. World Bank, Washington, DC, 2004 http://siteresources.worldbank.org/INT PROCUREMENT/Resources/Technical- Guide-HIV-AIDS.pdf [3] ÒDetermining the patent status of essential medicines in developing countriesÓ, Health Economies and Drugs, EDM Series No. 17, UNAIDS/WHO/MSF, 2004 [4] ÒDrug patents under the spotlight. Sharing practical knowledge about pharmaceutical patentsÓ MSF, June 2004 [5] Pediatric HIV/AIDS Factsheet, MSF, June 2005, www.accessmed-msf.org [6] ÒSources and prices of selected drugs and diagnostics for people living with HIV/AIDSÓ. A joint UNICEF, UNAIDS Secretariat, WHO, MSF project. May 2004 (WHO/EDM/PAR/2003.2). http://www.who.int/medicines/organiza tion/par/ipc/sources-prices.pdf [7] Pilot Procurement, Quality and Sourcing Project: Access to HIV/AIDS drugs and diagnostics of acceptable quality, 23rd edition 4 April 2005. http://www.who.int/medicines/organiza tion/qsm/activities/pilotproc/pilotproc. shtml [8] Other generic manufacturers known to be producing one or more ARVs but not included in this document are: Richmond Laboratorios, Panalab, Filaxis (Argentina); Pharmaquick (Benin); Far Manguinhos, FURP, Lapefe, Laob, Iquego, IVB (Brazil); Apotex, Novopharm (Canada); Shanghai Desano Biopharmaceutical company, Northeast General Pharmaceutical Factory (China); Biogen (Colombia); Stein (Costa Rica); Zydus Cadila Healthcare, SunPharma, EAS-SURG, Mac Leods, IPCA (India); LG Chemicals, Samchully, Korea United Pharm Inc. (Korea); Protein, Pisa (Mexico); Andromaco (Spain); Aspen (South Africa); T.O. Chemecal (Thailand); Laboratorio Dosa S.A. (US), Varichem (Zimbabwe). This list is not exhaustive. [9] Incoterms are standard trade definitions most commonly used in international sales contracts, as published by the International Chamber of Commerce, http://www.iccwbo.org/index_incoterm s.asp [10] ÒGAO Reprot to Congressional Requesters. GLOBAL HIV/AIDS EPIDEMIC. Selection of Antiretroviral Medications Provided under U.S. Emergency Plan is LimitedÓ, page 24, GAO, January 2005.ÓIn some cases a manufacturerÕs prices include costs that other manufacturers do not include — such as shipping and insurance charges. We note where these differences exist, and have determined that they do not undermine the essential comparability of the prices presented in our reportÓ [11] Scaling up antiretroviral therapy in resource-limited settings: Treatment guidelines for a public health approach, WHO, 2003 Revision. http://www.who.int/hiv/pub/prev_care/ en/ARVGuidelinesRevised2003.pdf [12] Global Fund Price Reporting Mechanism. http://www.theglobalfund.org/en/ MŽdecins Sans Frontires ¥ www.accessmed-msf.org ¥ June 2005 ¥ Untangling the Web of Price Reductions ¥ 11 Cipla 584 (0.8) 292 (0.1) AAuurroobbiinnddoo 11sstt ccaatteegg 197 (0.135) 39 (2.160) AAuurroobbiinnddoo 438 (0.4) 472 (1.292) 227 (0.069) GGiilleeaadd 11sstt ccaatteegg n/a AAuurroobbiinnddoo 432 (0.296) AAuurroobbiinnddoo 66 (0.09) 61 (0.021) Cipla 766 (2.1) 839 (2.3) Unit tab ml tab cap cap g cap cap tab ml cap cap tab tab ml 3 cap 3 cap Ranbaxy 321 (0.22) 146 (0.4) 219 (0.6) Ranbaxy 405 (0.37) 358 (1.17) RRaannbbaaxxyy 336 (0.23) HHeetteerrooDDrruuggss LLttdd 53 (0.073) GSK 1st categ 887 (1.215) 382 (0.131) BBMMSS 11sstt ccaatteegg 310 (0.212) 198 (0.543) 279 (0.764) 133 (7.370) CCiippllaa 372 (0.34) 347 (0.95) GGiilleeaadd 22nndd ccaatteegg n/a CCiippllaa 321 (0.220) Cipla 73 (0.1) 85 (0.233) 58 (0.02) GSK 2nd categ n/a n/a BBMMSS 22nndd ccaatteegg n/a n/a n/a n/a HHeetteerroo DDrruuggss LLttdd 316 (0.289) 355 (0.917) HHeetteerroo DDrruuggss LLttdd 217 (0.149) GGSSKK 11sstt ccaatteegg 69 (0.095) n/a 82 (0.028) Ranbaxy 664 (0.91) HHeetteerroo DDrruuggss LLttdd 280 (0.192) MMeerrcckk 22nndd ccaatteegg 311 (0.113) 920 (0.840) 766 (2.1) 496 (0.151) MMeerrcckk 22nndd ccaatteegg 686 (0.470) GPO 171 (0.234) 76 (0.026) Hetero Drugs Ltd 773 (1.058) CCiippllaa 234 (0.16) 106 (0.29) 142 (0.39) MMeerrcckk 11sstt ccaatteegg 169 (0.116) 500 (0.457) 347 (095) 309 (0.094) MMeerrcckk 11sstt ccaatteegg 400 (0.274) GGSSKK 22nndd ccaatteegg n/a n/a n/a Strides 453 (0.31) RRaannbbaaxxyy 69 (0.095) 69 (0.19) SSttrriiddeess 73 (0.10) Table 1: 1st and 2nd category of prices offered by manufacturers for the different countries (yearly and unit prices) 12 ¥ Untangling the Web of Price Reductions ¥ June 2005 ¥ www.accessmed-msf.org ¥ MŽdecins Sans Frontires abacavir 300mg, tablet 20mg/ml, oral solution didanosine 100mg, tablets 250mg, enter0coated caps 400mg, enteric-coated caps 2g powder for reconstitution with water and with antiacids eeffaavviirreennzz 50mg 200mg 600mg 30mg/ml suspension eemmttrriicciittaabbiinnee 200mg iinnddiinnaavviirr 400mg lamivudine 150mg 300mg 10mg/ml oral solution and syrup and dry syrup lamivudine + efavirenz + didanosine 150+600+250 (EC) 150+600+400 (EC) MŽdecins Sans Frontires ¥ www.accessmed-msf.org ¥ June 2005 ¥ Untangling the Web of Price Reductions ¥ 13 GSK 1st categ 1241 (1.7) AAuurroobbiinnddoo 72 (0.099) 80 (0.109) AAuurroobbiinnddoo 144 (0.198) 152 (0.208) AAuurroobbiinnddoo 204 (0.28) AAuurroobbiinnddoo 257 (0.352) Abbott 1st categ 500 (0.228) 152 (0.139) Aurobindo 1533 (0.42) Aurobindo 112 (0.153) 411 (0.075) Abbott 1st categ 83 (0.114) 79 (0.93) Unit tab tab tab tab tab tab tab cap ml tab g tab ml cap ml Strides 168 (0.23) 175 (0.24) HHeetteerrooDDrruuggss LLttdd 190 (0.260) RRoocchhee 22nnddccaatteegg 2211 (0.606) 2243 (0.256) Hetero Drugs Ltd 77 (0.106) Strides 438 (0.6) GSK 2nd categ n/a CCiippllaa 79 (0.108) 85 (0.117) Cipla 175 (0.24) 182 (0.25) Cipla 182 (0.25) Cipla 255 (0.35) Abbott 2nd categ n/a n/a Cipla 1423 (0.39) Boehringer 1st categ 438 (0.6) 400 (0.073) Abbott 2nd categ n/a n/a Hetero Drugs Ltd 992 (1.358) HHeetteerroo DDrruuggss LLttdd 74 (0.101) 81 (0.111) GGPPOO 341 (0.467) 375 (0.514) GSK 1st categ 237 (0.325) HHeetteerroo DDrruuggss LLttdd 281 (0.385) Hetero Drugs Ltd 1898 (0.867) GPO 1599 (0.438) Boehringer 2nd categ n/a n/a AAuurroobbiinnddoo 336 (0.46) Strides 113 (0.155) 120 (0.165) RRaannbbaaxxyy 219 (0.3) 234 (0.32) GGPPOO 426 (0.584) Roche 1st categ 978 (0.268) 1962 (0.224) GPO 255 (0.35) 82 (0.015) Hetero Drugs Ltd 196 (0.269 Ranbaxy 1095 (1.5) Ranbaxy 124 (0.17) 131 (0.18) HHeetteerroo DDrruuggss LLttdd 147 (0.201) 161 (0.221) GSK 2nd categ n/a Ranbaxy 292 (0.4) HHeetteerroo DDrruuggss LLttdd 1217 (0.333) Cipla 73 (0.1) 137 (0.025) Cipla 339 (0.464)) RRaannbbaaxxyy 197 (0.27) Ranbaxy 84 (0.115) Strides 204 (0.280) SSttrriiddeess 80 (0.11) lamivudine/zidovudine/ abacavir 300 + 150 + 300mg lamivudine/stavudine 150 + 30mg 150 + 40mg lamivudine/stavudine/ nevirapine 150 + 30 + 200mg 150 + 40 + 200mg lamivudine/zidovudine 150 + 300mg lamivudine/zidovudine/ nevirapine 150 + 300 + 200mg lopinavir/ritonavir 133.3 + 33.3mg 80 + 20mg/ml oral solution nelfinavir 250mg (3) 50mg/g oral powder nevirapine 200mg 10mg/ml suspension ritonavir 100mg 80mg/ml oral solution Hetero Drugs Ltd 1022 (0.28) AAuurroobbiinnddoo 14 (0.019) 31 (0.043) GGiilleeaadd 11sstt ccaatteegg 301 (0.824) GGiilleeaadd 11sstt ccaatteegg 362 (0.991) AAuurroobbiinnddoo 140 (0.192) Unit cap cap cap cap cap ml ml tab tab cap cap tab ml HHeetteerrooDDrruuggss LLttdd 21 (0.029) 25 (0.035) GPO 277 (0.38) 130 (0.021) saquinavir hard caps 200mg (5) stavudine 15mg 20mg 30mg 40mg 1mg/ml powder for syrup 5mg/ml powder for syrup tenofovir disoproxil fumarate 300mg tenofovir disoproxil fumarate/emtricitabine 300 + 200mg zidovudine 100mg 250mg 300mg 10mg/ml syrup and 50mg/5ml oral solution Roche 1st categ 989 (0.271) BMS 1st categ n/a 0.094 48 (0.066) 55 (0.075) 358 (0.048) GGiilleeaadd 22nndd ccaatteegg n/a GGiilleeaadd 22nndd ccaatteegg n/a CCiippllaa 131 (0.18) 93 (0.015) Roche 2nd categ 1327 (0.606) BMS 2nd categ n/a n/a n/a n/a n/a CCoommbbiinnoo PPhhaarrmm 285 (0.39) 130 (0.021) GPO 0.058 0.07 60 (0.082) 77 (0.105) 80 (0.011) 23 (0.016) GGSSKK 22nndd ccaatteegg n/a n/a n/a n/a CCiippllaa 0.04 0.045 36 (0.05) 39 (0.054) 153 (0.021) GGSSKK 11sstt ccaatteegg 241 (0.33) 117 (0.16) 212 (0.29) 223 (0.036) RRaannbbaaxxyy 36 (0.049) 47 (0.064) HHeetteerroo DDrruuggss LLttdd 134 (0.183) Strides 35 (0.048) 46 (0.063) RRaannbbaaxxyy 161 (0.22) n/a = discounted price not available. Price of products pre-qualified by WHO (23rd edition of WHO Pre-Qualified List) appear in bold. BMS sells ddI in other doses (per mg price remains the same). The daily dose referred to is 800mg IDV twice daily with ritonavir 100mg twice daily as booster as recommended by WHO. The prescribing information given by the manufacturer is 800mg three times daily (price US$ 600/year). The daily dose referred to is 1250 mg twice daily although the dosage of 9 tablets (3 tablets three times a day) can also be used. Cipla PMTCT a 0.080 ml en envase de 25 ml. The daily dose referred to is 100mg twice daily, for use as booster medication. This dose is not indicated in the manufacturerÕs label. Saquinqvir should be used in combination with low-dose ritonavir as Saquinavir/Ritonavir 1000mg/100mg twice daily. Not possible to use stavudine 15 mg capsule for 15 kg patient. Not possible to use zidovudine 100 mg capsule for 15 kg patient. GPO, has AZT at 0.021 in 60 ml bottle. According to WHO treatment guidelines, the pediatric dosage of NVP is 120 to 200 mg/m2/dose, twice daily. For these calcilations we considered 160mg/m2. According to WHO treatment guidelines, the pediatric dosage of NfV is 55 to 65 mg/m2/dose, twice daily. For these calcilations we considered 60mg/m2. Gilead 1st category price applies to some middle-income countries. See Table 2 for conditions. 14 ¥ Untangling the Web of Price Reductions ¥ June 2005 ¥ www.accessmed-msf.org ¥ MŽdecins Sans Frontires Company Abbott Aurobindo BMS Boehringer- Ingelheim Cipla Combino Pharm Gilead GlaxoSmithKline Table 2: Summary table for conditions Eligibility (countries) All African countries and LDCs outside of Africa No restriction Sub-Saharan Africa, Haiti, Mauritius, Cambodia, Vietnam (For other developing countries, prices negotiated on a case by case basis with BMS local market representative.) All World Bank low-income countries and sub-Saharan Africa. (Other countries on a case-by-case basis.) No restriction No restriction 95 nations including all of Africa and 15 other UN-designated Ôleast developedÕ countries. Least Developed Countries (LDCs) plus sub-Saharan Africa. All projects fully financed by the Global Fund to fight AIDS, TB and Malaria as well as projects funded by PEPFAR. Eligibility (body) Governments, NGOs, UN system organizations and other national and international health institutions NGOs and Governmental Organizations Both private and public sector organizations that are able to provide effective, sustainable and medically sound care and treatment of HIV/AIDS are eligible. Governments, NGOs and other partners who can guarantee that the programme is run in a responsible manner. No restriction No restriction Organizations that provide HIV treatment in the 68 countries covered by the Gilead Global Access programme will be able to receive Viread at the access price. Applications will go through a review process. Governments, aid organizations, charities, UN agencies, other not-for-profit organizations and international procurement agencies. Delivery of goods[6] FOB Payment by letter of credit. FOB Hyderabad (India) DDU to French Speaking Africa and CIF incoterm for English Speaking Africa (Kenya, Uganda, Tanzania, Ethiopia, Nigeria, Ghana, Eritrea) CIF FOB Mumbai (India) or CIF — Freight charges separately on actual. FOB Barcelona (Spain) FOB CIP Additional comments Prices available for at least 1,000,000 units for each product per single shipment. No quantity related conditions. Prices are as per table 1 however for larger quantities the prices are negotiable. Delivery terms 120 days. No minimum order required unless any special labeling is required (standard labeling is in Spanish): order of a complete batch. Pack of 60 or 300 capsules available for ZDV. Gilead works with several distributors in Africa to facilitate low cost local distribution channels. In sub-Saharan Africa employers there who offer HIV/AIDS care and treatment directly to their staff through workplace clinics or similar arrangements are also eligible. In sub-Saharan Africa employers there who offer HIV/AIDS care and treatment directly to their staff MŽdecins Sans Frontires ¥ www.accessmed-msf.org ¥ June 2005 ¥ Untangling the Web of Price Reductions ¥ 15 Company GPO Hetero Drugs Ltd Merck & Co. Inc Ranbaxy Roche Strides Arcolab Ltd Eligibility (countries) (For middle income developing countries public sector prices negotiated on a case-by-case basis bilaterally through the AAI). No restriction No restriction First category of countries: Low Human Development Index (HDI) countries plus medium HDI countries with adult HIV prevalence of 1% or greater10. Second category of countries: Medium HDI countries with adult HIV prevalence less than 1%10. No restriction FFiirrsstt ccaatteeggoorryy ooff ccoouunnttrriieess:: All countries in sub-Saharan Africa and all UN defined Least Developed Countries SSeeccoonndd ccaatteeggoorryy ooff ccoouunnttrriieess:: Low income countries and lower middle income countries — as classified by the World Bank. No restriction Eligibility (body) Not-for-profit organizations and governments Private sector, public sector and NGOs Governments, international organizations, NGOs, private sector organizations (e.g. employers, hospitals and insurers). NGOs and Governments or Programs supported by them Governments, Non Profit Institutional Providers of HIV care, NGOs. Governments, non profit institutional providers of HIV treatment, NGOs Delivery of goods[6] FOB Bangkok (Thailand) FOB Mumbai (India) CIP FOB Delhi/Mumbai (India) FCA Basel (CH), FOB Bangalore (India) Additional comments through workplace clinics or similar arrangements are also eligible. All organizations must supply the preferentially priced products on a not for profit basis. Supply Agreement required (For NGOs requiring less than 10 patient packs per month, this requirement may be waived). The manufacturer recommends that Ôprescribers must ensure that patients are fully informed regarding hypersensitivity reaction to abacavir. Patients developing signs or symptoms must contact their doctor immediately for advice.Õ Payment by signed letter of credit. Prices could be negotiated on individual basis according commercial terms. Merck & Co. Inc does not rule out supplying ARVs to patients through retail pharmacies. Although Romania does not fall under these categories it also benefits from these prices due to a government commitment to a programme of universal access. Confirmed letter of credit or advance payment preferred for new customers CAD (Cash Against Documents) 30 days at sight. Minimum order and delivery amount per shipment is CHF 10,000 (US$ 8,179) Payment by signed letter of credit 16 ¥ Untangling the Web of Price Reductions ¥ June 2005 ¥ www.accessmed-msf.org ¥ MŽdecins Sans Frontires MŽdecins Sans Frontires ¥ www.accessmed-msf.org ¥ June 2005 ¥ Untangling the Web of Price Reductions ¥ 17 AAnnnneexxeess Annex 1: Least Developed Countries (LDCs) Source: UNCTAD http://www.unctad.org/Templates/We bFlyer.asp?intItemID=2161&lang=1 Fifty countries are currently designated least developed countries (LDCs). The list is reviewed every three years. Afghanistan; Angola; Bangladesh; Benin; Bhutan; Burkina Faso; Burundi; Cambodia; Cape Verde; Central African Republic; Chad; Comoros; Democratic Republic of Congo; Djibouti; Equatorial Guinea; Eritrea; Ethiopia; Gambia; Guinea; Guinea Bissau; Haiti; Kiribati; Lao PeopleÕs Democratic Republic; Lesotho; Liberia; Madagascar; Malawi; Maldives; Mali; Mauritania; Mozambique; Myanmar; Nepal; Niger; Rwanda; Samoa; Sao Tome and Principe; Senegal; Sierra Leone; Solomon Islands; Somalia; Sudan; Timor-Leste; Togo; Tuvalu; Uganda; United Republic of Tanzania; Vanuatu; Yemen; Zambia. Annex 2: Human Development Index (HDI) Source: Human Development Report 2004, Cultural Liberty in TodayÕs Diverse World, UNDP, 2004. For full list of Human Development Index ranking see: http://hdr.undp.org/docs/statistics/ind ices/index_tables.pdf Low human development Angola; Benin; Burkina Faso; Burundi; Central African Republic; Chad; Congo; Congo (Dem. Rep. of the); C™te dÕIvoire; Djibouti; Eritrea; Ethiopia; Gambia; Guinea; Guinea- Bissau; Haiti; Kenya; Lesotho; Madagascar; Malawi; Mali; Mauritania; Mozambique; Niger; Nigeria; Pakistan; Rwanda; Senegal; Sierra Leone; Tanzania (U. Rep. of ); Timor-Leste; Togo; Uganda; Yemen; Zambia; Zimbabwe. Medium human development Albania; Algeria; Armenia; Azerbaijan; Bangladesh; Belarus; Belize; Bhutan; Bolivia; Bosnia and Herzegovina; Botswana; Brazil; Bulgaria; Cambodia; Cameroon; Cape Verde; China; Colombia; Comoros; Dominica; Dominican Republic; Ecuador; Egypt; El Salvador; Equatorial Guinea; Fiji; Gabon; Georgia; Ghana; Grenada; Guatemala; Guyana; Honduras; India; Indonesia; Iran (Islamic Rep. of ); Jamaica; Jordan; Kazakhstan; Kyrgyzstan; Lao PeopleÕs Dem.Rep; Lebanon; Libyan Arab Jamahiriya; Macedonia (TFYR); Malaysia; Maldives; Mauritius; Moldova (Rep. of ); Mongolia; Morocco; Myanmar; Namibia; Nepal; Nicaragua; Occupied Palestinian Territories; Oman; Panama; Papua New Guinea; Paraguay; Peru; Philippines; Romania; Russian Federation; Saint Lucia; Saint.Vincent and the Grenadines; Samoa (Western); S‹o TomŽ & Principe; Saudi Arabia; Solomon Islands; South Africa; Sri Lanka; Sudan; Suriname; Swaziland; Syrian Arab Republic; Tajikistan; Thailand; Tonga; Tunisia; Turkey; Turkmenistan; Ukraine; Uzbekistan; Vanuatu; Venezuela; Viet Nam. Annex 3: Sub-Saharan countries Source: World Bank (May 2005) http://www.worldbank.org/data/count ryclass/classgroups.htm#Sub_Sahara n_Africa Angola; Benin; Botswana; Burkina Faso; Burundi; Cameroon; Cape Verde; Central African Republic; Chad; Comoros; Congo (Dem. Rep); Congo (Rep.); C™te dÕIvoire; Equatorial Guinea; Eritrea; Ethiopia; Gabon; Gambia; Ghana; Guinea; Guinea-Bissau; Kenya; Lesotho; Liberia; Madagascar; Malawi; Mali; Mauritania; Mauritius; Mayotte; Mozambique; Namibia; Niger; Nigeria; Rwanda; S‹o TomŽ and Principe; Senegal; Seychelles; Sierra Leone; Somalia; South Africa; Sudan; Swaziland; Tanzania; Togo; Uganda; Zambia; Zimbabwe. Annex 4: World Bank low-income economies Source: World Bank (May 2005) http://www.worldbank.org/data/count ryclass/classgroups.htm Low-income economies Afghanistan; Angola; Bangladesh; Benin; Bhutan; Burkina Faso; Burundi; Cambodia; Cameroon; Central African Republic; Chad; Comoros; Congo (Dem. Rep.), Congo (Rep.); C™te dÕIvoire; Equatorial Guinea; Eritrea; Ethiopia; Gambia, The; Ghana; Guinea; Guinea-Bissau; Haiti; India; Kenya; Korea, Dem. Rep.; Kyrgyz Republic; Lao PDR; Lesotho; Liberia; Madagascar; Malawi; Mali; Mauritania; Moldova; Mongolia; Mozambique; Myanmar; Nepal; Nicaragua; Niger; Nigeria; Pakistan; Papua New Guinea; Rwanda; S‹o TomŽ and Principe; Senegal; Sierra Leone; Solomon Islands; Somalia; Sudan; Tajikistan; Tanzania; Timor-Leste; Togo; Uganda; Uzbekistan; Vietnam; Yemen (Rep.), Zambia; Zimbabwe. Lower-middle-income economies Albania; Algeria; Armenia; Azerbaijan; Belarus; Bolivia; Bosnia and Herzegovina; Brazil; Bulgaria; Cape Verde; China; Colombia; Cuba; Djibouti; Dominican Republic; Ecuador; Egypt, Arab Rep.; El Salvador; Fiji; Georgia; Guatemala; Guyana; Honduras; Indonesia; Iran, Islamic Rep.; Iraq; Jamaica; Jordan; Kazakhstan; Kiribati; Macedonia, FYR; Maldives; Marshall Islands; Micronesia, Fed. Sts.; Morocco; Namibia; Paraguay; Peru; Philippines; Romania; Russian Federation; Samoa; Serbia and Montenegro ; South Africa; Sri Lanka; Suriname; Swaziland; Syrian Arab Republic; Thailand; Tonga; Tunisia; Turkey; Turkmenistan; Ukraine; Vanuatu; West Bank and Gaza. Upper-middle-income economies American Samoa; Antigua and Barbuda; Argentina; Barbados; Belize; Botswana; Chile; Costa Rica; Croatia; Czech Republic; Dominica; Estonia; Gabon; Grenada; Hungary; Latvia; Lebanon; Libya; Lithuania; Malaysia; Mauritius; Mayotte; Mexico; Northern Mariana Islands; Oman; Palau; Panama; Poland; Saudi Arabia; Seychelles; Slovak Republic; St. Kitts and Nevis; St. Lucia; St. Vincent and the Grenadines; Trinidad and Tobago; Uruguay; Venezuela, RB. Annex 5: Company contacts AAbbbbootttt:: Rob Dintruff Email: rob.dintruff@abbott.com AXIOS International manages the request process: The Programme Manager Access to HIV Care Programme AXIOS International P.O. Box 6924 Kampala, Uganda. Tel: +256 75 693 756 Fax:+256 41 543 021 Email: AccesstoHIVCare@axiosint.com Website : www.accesstohivcare.org AAuurroobbiinnddoo PPhhaarrmmaa LLttdd:: Mr. A.Vijaykumar Head —Anti Retrovirals Project Tel: +91 40 2304 4070 Or +91 98481 10877 (Mobile) Fax: +91 40 23044058 Email: vk_akula@aurobindo.com BBrriissttooll--MMyyeerrss SSqquuiibbbb CCoo:: All countries with the exception of Southern Africa: information can be obtained from Mrs Marie-Astrid Mercier, BMS Access Coordinator in BMS Paris office (marie- astrid.mercier@bms.com) Southern Africa: information can be obtained from Mrs Tamany Geldenhuys in BMS offices in Johannesburg (tamany.geldenhuys@bms.com). BBooeehhrriinnggeerr IInnggeellhheeiimm:: Helmut Leuchten CD Marketing Prescription Medicines Head of Corporate Department HIV Virology Phone: + 49 6132 77-8486 Fax: +49 6132 77-3829 Email: helmut.leuchten@ing.boehringer- ingelheim.com Michael Rabbow (for the Viramune MTCT donation program) Marketing Prescription Medicines CG HIV-Specialists/Virologists Tel: + 49 6132 77- 92701 Fax: + 49 6132 77-38 29 Email: rabbow@ing.boehringer- ingelheim.com 18 ¥ Untangling the Web of Price Reductions ¥ June 2005 ¥ www.accessmed-msf.org ¥ MŽdecins Sans Frontires CCiippllaa LLttdd:: Mr. Sanjeev Gupte, General Manager- Exports Mr. Shailesh Pednekar Executive-Exports, Cipla Limited Tel: +91 22 23021397 (Direct) 23095521 23092891 Fax: +91 22 23070013/23070393/23070385 Email: exports@cipla.com and ciplaexp@cipla.com CCoommbbiinnoopphhaarrmm:: Ms. Silvia Gil Managing Director Combinopharm Tel: + 34 93 48 08 833 Fax: + 34 93 48 08 832 Email : sgil@combino-pharm.es GGiilleeaadd PPrrooggrraammmmee AAcccceessss Deborah Ovadia Gilead Global Access Program Manager Gilead Sciences, Inc 333 Lakeside Drive Foster City, California 94404 USA Tel: 1-800-G I L E A D-5, Option 1 Fax: +1-650-522-5870 Email: ARVaccess@gilead.com www.gileadaccess.org CCoommppaannyy ccoonnttaacctt:: Sheryl Meredith Associate Director International Operations Gilead Sciences 333 Lakeside Drive Foster City, California 94404 USA 1-650-522-5505 Email: smeredith@gilead.com www.gileadaccess.org GGllaaxxooSSmmiitthhKKlliinnee:: Isabelle Girault Director, Government Affairs HIV & AIDS Tel: + 44 (0) 20 8047 5488 Fax: + 44 (0) 20 8047 6957 Email: isabelle.s.girault@gsk.com GGPPOO:: Mr. Sukhum Virattipong International Business Director Tel: +662 3545587, 2038850 Fax: +662 3548858, 3548777 HHeetteerroo DDrruuggss LLiimmiitteedd:: Hetero House, H.No.:8-3-166/7/1, Erragadda, Hyderabad-500 018 India. Tel: 0091-40-23704923 / 24 Tel (Direct):0091-40-23818029 Email: msreddy@heterodrugs.com MMeerrcckk && CCoo. IInncc:: Samir A. Khalil Executive Director HIV Policy & External Affairs Human Health Europe, Middle East & Africa Merck & Co., Inc/WS2A-55 One Merck Drive, Whitehouse Station NJ 08889-0100 USA Tel: +1 908 423 6440 Fax: +1 908 735 1839 Email: samir_khalil@merck.com RRaannbbaaxxyy:: Mr. Sandeep Juneja Ranbaxy Laboratories Limited Tel: + 91 124 518 59 06 (Direct) or + 91 124 513 50 00 Fax: + 91 124 516 60 35 Email: sandeep.juneja@ranbaxy.com www.aidonaids.com www.ranbaxy.com RRoocchhee:: For information regarding quotations and deliveries to customers contact: Hanspeter WŠlchli Logistics Sales International Customers Dept. PTGS-I 4303 Kaiseraugst / Switzerland Tel: +41 61 688 1060 Fax: +41 61 687 1815 Email: hanspeter.waelchli@roche.com SSttrriiddeess AArrccoollaabb LLttdd:: Mrs. Aloka Sengupta Asst. Vice President ATM Strides House, Bilekahalli Bannerghatta Road Bangalore 560 076, INDIA Tel: +91-80-57580748 Mobile : +91 98450 24470 Fax: 91-80-26583538 Email: aloka.sengupta@stridesarco.com Asst. Vice President ATM Strides House, Bilekahalli Bannerghatta Road Bangalore 560 076, INDIA Tel: 91-80-26581343/44/46, +91-80-26584529(Direct) Fax: 91-80-26583538/26584330 Email: aloka@stridesarco.com MŽdecins Sans Frontires ¥ www.accessmed-msf.org ¥ June 2005 ¥ Untangling the Web of Price Reductions ¥ 19 3TC lamivudine; nucleoside analogue reverse transcriptase Inhibitor ABC abacavir; nucleoside analogue reverse transcriptase inhibitor AIDS Acquired Immune Deficiency Syndrome ARVs Antiretroviral drugs BMS Bristol-Myers Squibb CDC Centres for Disease Control and Prevention CIF[10] ÔCost Insurance and FreightÕ means that the seller delivers when the goods pass the shipÕs rail in the port of shipment. The seller must pay the costs and freight necessary to bring the goods to the named port of destination BUT the risk of loss or damage to the goods, as well as any additional costs due to events occurring after the time of delivery, are transferred from the seller to the buyer. CIP[10] ÔCarriage and Insurance paid to.Õ means that the seller delivers the goods to the carrier nominated by him but the seller must in addition pay the cost of carriage necessary to bring the goods to the named destination. This means that the buyer bears all the risks and any additional costs occurring after the goods have been so delivered. However, in CIP the seller also has to procure insurance against the buyerÕs risk of loss of or damage to the goods during the carriage. Consequently, the seller contracts for insurance and pays the insurance premium. d4T stavudine; nucleoside analogue reverse transcriptase inhibitor ddI didanosine; nucleoside analogue reverse transcriptase inhibitor DDU[10] ÔDelivered duty unpaidÕ means that the seller delivers the goods to the buyer, not cleared for import, and not unloaded from any arriving means of transport at the named place of destination. The seller has to bear the costs and risks involved in bringing the goods thereto, other than, where applicable, any ÔdutyÕ (which term includes the responsibility for the risks of the carrying out of the customs formalities, and the payment of formalities, customs duties, taxes and other charges) for import in the country of destination. Such ÔdutyÕ has to be borne by the buyer as well as any costs and risks caused by his Glossary failure to clear the goods for theimport time. EML Essential Medicines List. First published by WHO in 1977, it is meant to identify a list of medicines, which provide safe and effective treatment for the infectious and chronic diseases, which affect the vast majority of the worldÕs population. The 12th Updated List was published in April 2002 and includes 12 antiretrovirals. EFV or EFZ efavirenz; non-nucleoside analogue reverse transcriptase inhibitor EXW[10] ÔEx-worksÕ means that the seller delivers when he places the goods at the disposal of the buyer at the sellerÕs premises or another named place (i.e. works, factory, warehouse etc.) not cleared for export and not loaded on any collecting vehicle. FOB[10] ÔFree on boardÕ means that the seller delivers when the goods pass the shipÕs rail at the named port of shipment. This means that the buyer has to bear all costs and risks of loss or damage to the goods from that point. The FOB term requires the seller to clear the goods for export. 20 ¥ Untangling the Web of Price Reductions ¥ June 2005 ¥ www.accessmed-msf.org ¥ MŽdecins Sans Frontires WHO World Health Organization ZDV zidovudine; nucleoside analogue reverse transcriptase inhibitor GGeenneerriicc ddrruugg According to WHO, a pharmaceutical product usually intended to be interchangeable with the originator product, which is usually manufactured without a license from the originator company. GPO The Government Pharmaceutical Organization (Thailand) GSK GlaxoSmithKline HIV Human Immunodeficiency Virus IDV indinavir; protease inhibitor LDCs Least Developed Countries, according to United Nations classification MSD Merck Sharp & Dome (Merck & Co., Inc.) MSF MŽdecins Sans Frontires NGO Non Governmental Organization NFV nelfinavir; protease inhibitor NNRTI Non-Nucleoside Reverse Transcriptase Inhibitor NRTI Nucleoside Analogue Reverse Transcriptase Inhibitor NtRTI Nucleotide Reverse Transcriptase Inhibitor NVP nevirapine; non-nucleoside analogue reverse transcriptase inhibitor PMTCT Prevention of Mother-To-Child Transmission r low dose ritonavir used as a booster; protease inhibitor SQV hgc saquinavir hard gel capsules; protease inhibitor SQV sgc saquinavir soft gel capsules; protease inhibitor TDF tenofovir; nucleotide reverse transcriptase inhibitor UNAIDS United Nations Joint Co- sponsored Programme on HIV/AIDS, created in 1996, to lead, strengthen and support an expanded response to the HIV/AIDS epidemic. The six original Cosponsors are UNICEF, UNDP, UNFPA, UNESCO, WHO and the World Bank. UNDCP joined in April 1999 UNDP United Nations Development Programme MŽdecins Sans Frontires ¥ www.accessmed-msf.org ¥ June 2005 ¥ Untangling the Web of Price Reductions ¥ 21 Campaign for Access to Essential Medicines MŽdecins Sans Frontires Rue de Lausanne 78, CP 116 CH-1211 Geneva 21, Switzerland Tel: + 41 (0) 22 849 84 05 Fax: + 41 (0) 22 849 84 04 email: access@geneva.msf.org http://www.accessmed-msf.org Design and artwork: Twenty 3 Crows Ltd +44 (0) 1848 200401 a pricing guide for the purchase of ARVs for developing countries price Untangling the web of price reductions: 8th Edition cou ntri es reductions pr ic e el ig ib ili ty pr ice countries reductions com pan y ANNEX 3. FURTHER READING, REFERENCE AND CONTACTS Feedback, application and corrections form Please complete the sections relevant to you and fax it to UNICEF Supply Division +45 35 26 94 21, e-mail: supply@unicef.org, or post it to: UNICEF SD, Pharmaceuticals and Micronutrients Team – HIV/AIDS Survey, Freeport DK-2100 Copenhagen Ø, Denmark 1. GENERAL INFORMATION Your name Occupation Company name/Organization name Address Telephone Fax Email (required) Internet address 2. FEEDBACK What did you think of the publication in general? ■ Excellent, very useful ■ Good, quite useful ■ Satisfactory, reasonably useful ■ Poor, not useful—please indicate why: What did you think of the medicines included in the publication? ■ Good selection of medicines ■ More medicines required, for example: ■ Fewer medicines required, remove: What did you think of the pricing information? ■ Good, enough information on the prices of medicines of interest ■ Poor, not enough information Have you contacted any of the manufacturers listed? ■ Yes ■ No 77 3. APPLICATION ■ I would like to participate in the next Survey (Manufacturing companies only) 4. ENQUIRY ■ I would like to receive more copies of this publication ■ I would like to receive more information on safeguards stipulated under the TRIPS Agreement ■ Other enquiry: 5. CORRECTIONS I would like to provide the following changes or corrections for this publication: SOURCES AND PRICES OF SELECTED MEDICINES AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS78

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