Healthy Skepticism Library item: 7092

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Publication type: report

WHO
Measuring transparency in medicines registration, selection and procurement: Four country assessment studies.
Geneva: WHO 2006 Jul
http://www.who.int/medicines/areas/policy/goodgovernance/WHO_PSM_PAR_2006.7.pdf

Abstract:

Despite revolutionary scientific progress and the sustained efforts of the development community, access to good quality essential medicines remains very limited in many parts of the world. This health crisis has many complex causes, including poverty, under-investment in health systems and war. Corruption is another cause currently gaining increasing attention, as growing numbers of public health officials in ministries of health and national medicines regulatory authorities are recognizing the need for their institutions and personnel to work in a transparent and accountable environment.

The pharmaceutical sector is particularly vulnerable to corruption, which manifests itself in various forms, including bribery, fraud, favouritism, collusion and embezzlement at different levels of the medicines chain. The impact on people’s health should not be underestimated, as children and adults may end up taking unsafe or low-quality medicines.

In addition waste of public or private resources can have an enormous impact on the economy at national, hospital and household levels. Corruption also reduces the credibility of public institutions and the health profession, and erodes public trust.
Recognizing this long-standing problem, in 2004 WHO initiated the Good Governance for Medicines Project, which offers a technical support package for tackling unethical issues in the public pharmaceutical sector. Initially the countries implementing this project conduct an assessment measuring the transparency of national medicines regulatory agencies and public procurement systems. This is followed by a process of policy reform, promoting good governance and the application of ethical principles.

This report summarizes the findings of the transparency assessments carried out in the first four countries participating in the project, Lao People’s Democratic Republic, Malaysia, the Philippines and Thailand. It provides a comprehensive picture of the level of transparency and potential vulnerability to corruption in three essential functions of the public pharmaceutical sector – registration, selection and procurement of medicines. The methodology provides both qualitative and quantitative information. In each country two national investigators collected data, conducting a series of interviews with carefully selected key informants.

General findings

Qualitative information revealed that although the four countries have different public sector procurement and medicines regulation profiles, they have some common strengths and weaknesses. For example, all countries have transparent (written and publicly available) procurement Standard Operating Procedures, but none required a conflict of interest form to be completed for members of the registration or selection committees.

The information collected and then converted using a rough quantification method into a zero to 10 scale, provides a score for each country and each function in terms of vulnerability to corruption (minimally to extremely). The scoring shows the vulnerabilities in the policy, regulatory and administrative structures and procedures at the time of the survey, but in no way implies the level of possible existing corruption in the countries reviewed.

Registration

All four countries were reported to have a list of registered pharmaceutical products, written procedures and a standard application form for submission of applications, and a committee responsible for registration of pharmaceutical products. However, at the time of the assessment none of the countries had a written document describing the composition and the terms of reference of the registration committee, nor a conflict of interest form for committee members.
The decision-making process appeared to vary greatly between countries, but each provides an official written document for all decisions regarding applications. An appeals process for those who have their applications rejected exists in most countries, but the level at which it functions varies.

Selection

All countries were reported to have a national essential medicines list, and publicly available criteria and transparent procedures for the selection process for inclusion in or deletion from the list. As with registration committee members, the members of the selection committee were not required to fill in a conflict of interest form. In general, the criteria for choosing members of the selection committee scored quite low in all countries, but with a degree of variation. Terms of reference for the selection committee existed in some but not all countries, and they were not always publicly available. The decision-making processes were also found to have different levels of clarity and transparency.

Procurement

All four countries are reported to use competitive and transparent procedures to procure pharmaceutical products, with some variation in their practices. They also used an objective quantification method to determine the quantity of products to be purchased. The posttender system to monitor and report suppliers’ performance scored generally high in all four countries. However, the appeals process for applicants who have their bids rejected will need to be either instigated or strengthened, depending on the country. The indicator related to the audits of procurement offices scored low in most countries, showing the need to strengthen this service.

The existence and use of criteria for tender committee membership varied greatly between countries. In some countries membership is based on function, in others by field of expertise. Similarly, the management information system used to report product problems is different, manually documented in some countries and computerized in others, at central level in some countries and decentralized in others.

Conclusions and recommendations

Experience in promoting good governance shows that two basic strategies are needed, a “discipline approach” based on the legislative and administrative reforms necessary to establish transparent systems, and a “values approach”, building institutional integrity through the promotion of moral values and ethical principles. The first strategy is by nature top-down, whereas the latter tends to be a bottom-up approach.

The results of the transparency assessments will provide the evidence for countries to revise and adjust their laws and policies as well as the administrative structures and processes in place to ensure transparency in medicines regulation and public procurement. The assessments will also provide a platform for discussion at national level on developing a national ethical framework and for implementing a strategy promoting good governance in medicines regulation and procurement. The strategy needs to include the development of codes of conduct, socializing the national ethical framework through a systematic process of reflection and training of government officials and health professionals. A whistle-blowing protection mechanism should also be established and a working group for coordinating and managing strategy implementation should be nominated.

Keywords:
developing countries government agencies laws policy ethical guidelines reform schedules