WHO Good governance for medicines- Assessment Instrument

Publication date: 2007

Corruption has been identified as one of the major hurdles for development. The World Health Organization (WHO) has initiated the Good Governance for Medicines (GGM) programme in an attempt to curb corruption in pharmaceutical sector systems by increasing transparency and ac- countability and promoting ethical practices. The GGM programme offers a three-step technical support package (as shown in Figure 1): • National transparency assessment • Development of national GGM programme • Implementation What is the objective of the National Assessment? To obtain a picture of the level of transparency and potential vulnerability to corruption in the public pharmaceutical sector using WHO’s assessment instrument.1 The assessment looks at six functions: registration of medicines, control of medicines promotion, inspection of establishments, selection of essential medicines, procurement and distribution. Licensing of establishments and control of clinical trials will be added soon. The national assessment represents a baseline to monitor the country’s progress over time in terms of transparency. However, by dealing with unethical practices, concepts of transparency and accountability, the assessment raises sensitive issues and it is imperative that it should be con- ducted in a constructive manner. The GGM goal is not to measure corruption; but to examine how resistant or vulnerable the system is towards unethical practices. The assessment is an entry point for the development and promotion of a national programme on GGM and should not be seen as an end in itself. It is the beginning of a process aimed at bringing long-lasting efforts to promote good governance in the pharmaceutical sector. This exciting chal- lenge has already been accepted by an increasing number of countries. Good Governance for Medicines Assessment Instrument September 2007 The national assessment phase has now been completed by eight countries from the Asia-Pacific Region, one from Latin America and one from Africa. A comparative analysis of the assessments conducted in Lao People’s Democratic Republic, Malaysia, the Philippines and Thailand has already been published.2 PHASE I PHASE II PHASE III National assessment Development national GGM programme Implementation national GGM programme> > > Assessment report GGM officially adopted Communication plan Clearance MOH Figure 1 How to carry out the national assessment At least two national assessors (NAs), from well-known and trusted organizations independent of the Ministry of Health and the private sector, with good knowledge of the country’s pharmaceuti- cal sector, will be responsible for the entire assessment. Government approval and commitment will be crucial. NAs will firstly research the country’s public and private pharmaceutical sectors. Thorough prepa- ration will be critical for the success of the assessment. Government websites and other relevant sources should be used to check the availability of guidelines, procedures and other documents. At least 10 key interviewees (KIs) should be selected for each function, coming from the govern- ment, public hospitals, private sector (pharmacies, companies, wholesalers and manufacturers), professional associations, civil society, nongovernmental and international organizations. It is es- sential to interview various stakeholders to obtain different perspectives and as full a picture of the situation as possible. Information is collected using “yes/no” and open questions. Interviewees will be asked to justify some answers with evidence. The answers are scored and then converted into a 0 to 10 scale representing vulnerability (minimal to extreme) to corruption. NAs will analyse the results and present a complete summary report, including recommendations. This must also be presented to government officials and validated in national and regional work- shops by key stakeholders. Which aspects are measured by the assessment instrument? The national assessment emphasizes the system’s actual structures, particularly the mechanisms to prevent unethical practices and the administrative procedures to measure transparency and accountability. It also looks at how different procedures and mechanisms are known by those involved in the pharmaceutical sector. Elements targeted include: • Country regulations and official documents • Written procedures and decision-making processes • Committees, criteria for membership and declaration of interest policy • Appeals mechanisms and other monitoring systems How do countries benefit from such assessment? Assessment findings will help a country to identify its vulnerable aspects that could lead to cor- ruption and unethical practices. They will also determine what can be done to increase system transparency and accountability. In this way a well-run national GGM programme can restore ac- cess to medicines for millions of people in the poorest countries – returning diverted health care resources to their intended purpose. Additional information: http://www.who.int/medicines/areas/policy/goodgovernance/home/en/index.html Or contact: Dr Guitelle Baghdadi-Sabeti – Email: psminfo@who.int Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals 1 World Health Organization. Measuring transparency to improve good governance in the public pharmaceutical sector. Working document. January 2007. 2 Baghdadi-Sabeti G, Wondemagegnehu E. Measuring transparency in medicines registration, selection and procurement: Four country assessment studies. Geneva, World Health Organization, 2006. © World Health Organization 2007

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