These resources cover different aspects of medicine policy and regulation, which span more than one of the key topic areas for MeTA - Availability, Multi-stakeholder working, Prices, Promotion, Quality, and Transparency and accountability. Some of these resources relate to national policy, others to sector regulation.
We will add to this key list over time and would welcome suggestions or additions. Please send these to: firstname.lastname@example.org
Analyses and case studies
This publication presents a synthesis of studies on drug regulation carried out in ten countries: Australia, Cuba, Cyprus, Estonia, Malaysia, the Netherlands, Tunisia, Uganda, Venezuela, and Zimbabwe in 1998-1999. It gives an overview of the development of drug regulation in these countries as well as the resources available and the strategies applied in drug regulation implementation at the time the studies were conducted. An analysis of the strengths and weaknesses in drug regulation in these countries is also provided
This article considers the responsibilities of public pharmaceutical policies and the need to strengthen health systems to improve access, regulation, equitable distribution, quality, affordability and sustainability of essential medicines, which are important for the health of mothers and children
This study looks at current policies and practices in pharmaceutical supply and reimbursement in Ghana, and considers the options for a more efficient, effective, and equitable pharmaceutical pricing policy
This paper looks at the role of donors in curtailing corrupt behaviour in the private sector, such as commercial bribery - particularly in developing and emerging countries where the sector is growing in importance
This report summarises the findings of the transparency assessments carried out in the first four countries participating in the WHO-initiated Good Governance for Medicines Project, which offers a technical support package for tackling unethical issues in the public pharmaceutical sector. 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
"This report presents the findings of the first phase of the [World Health Organization's] national Good Governance for Medicines programme in Jordan. The assessment aims to obtain a picture of the level of transparency and potential vulnerability to corruption in the public pharmaceutical sector using WHO’s assessment instrument. In Jordan, the assessment looked at six functions: medicines registration, inspection of pharmaceutical establishments, promotion, selection, procurement and distribution"
"This report presents the findings of the first phase of the [World Health Organization's] national Good Governance for Medicines programme in the Syrian Arab Republic. The assessment aims to obtain a picture of the level of transparency and potential vulnerability to corruption in the public pharmaceutical sector using WHO’s assessment instrument. In the Syrian Arab Republic, the assessment looked at eight functions: medicines registration, licensing of pharmaceutical establishments, inspection of pharmaceutical establishments, promotion, selection, clinical trials, procurement and distribution"
This document brings together the outcomes of six surveys into medicine prices - for Ghana, Kenya, Mali, Tanzania, Chad and Uganda - and one for the East African Community (Kenya, Uganda and Tanzania) . The reports for Mali and Chad are written in French and the others in English
This discussion note re-explores the distinction between official, unofficial and informal fees to health workers and argues that unofficial and informal fees should be separated from official and formal fees. In considering these points, examples from reports about China, Bangladesh, and Central Asia/East Europe and the former Soviet Union are summarised and analysed
This study aims to identify current opioid prescribing services and regulatory bodies within 12 African PEPFAR (Presidents Emergency Plan for AIDS Relief ) countries, and to examine the barriers to, and appraise the potential for, expansion in the number of opioid providers, for people with HIV and AIDS according to the World Health Organization pain ladder. It concludes that while there are common issues raised by services and International Narcotics Control Board competent authorities, it is clear that these key stakeholders have concerns regarding the potential roll-out of opioids
"Low-cost high-quality drugs benefit society and helps provide pharmaceutical companies a competitive edge. This study presents the issues that must be considered to achieve these common objectives in Bangladesh and explores options that the Government and the local industry could pursue. "Previous efforts to improve the drug quality in Bangladesh focused, without much success, on stricter regulation of the public market. This paper addresses this issue from a more private sector approach. The existing quality and price of pharmaceuticals are analysed and alternative mechanisms are explored to improve the quality and cost competitiveness of Bangladesh’s pharmaceuticals domestically and internationally"
"This paper explores the under-studied role of social enterprise as traders and regulatory actors in the international wholesale markets for essential medicines and their impact on accessibility, quality and prices in these perverse markets, drawing on an interview survey of European-based socially oriented wholesalers supplying the medicines market for sub-Saharan Africa. The paper argues that these enterprises play an important role in regulating price and quality and hence in improving access to medicines by the poor. However they face challenging market and political conditions. The paper analyses the motivations and organisational structures that sustain social and ethical commitment in this market, drawing on theories of social enterprise and non-profit business, and surveys the challenges and constraints. It then examines the formal international and national regulatory interventions in the international markets and their effects on social enterprise, in the context of a substantial institutional divide between the medicines-related campaigning of the large international NGOs and the activities of these market-oriented social enterprises"
This is a peer reviewed, open access international journal to promote and publish commentary and research on the rational use of and access to medicines
This issue has articles about medicine prices in Vietnam, Thailand and South Africa, generic medicines in Malaysia and Australia, anti-retroviral therapy in South Africa, and legislation and regulation in the retail pharmacy sector in low-income countries.
Southern Med Review : Vol 2, Issue 2
This project aims to strengthen health systems for malaria management by improving the supply and quality of antimalarials and related supplies; and by improving the management and use of antimalarials
This report assesses the quality of antiretroviral medicines obtained at accredited public and private sector antiretroviral procurement and treatment sites in selected African countries. The aim is to help with the development of appropriate quality assurance strategies for antiretrovirals
This article reviews the experiences of the previous decade in order to identify which interventions to address the problems of inappropriate prescribing have proven effective in developing countries, and suggests a range of policy options for health planners and managers
In this recording Dr Suwit Wibulpolprasert of the Thai Ministry of Public Health talks about Thailand's experience when it issued compulsory licenses for two antiretroviral medicines in order to be able to treat more patients. Despite being put on a 'trade black list' by the US Government, the move was a success in public health terms, enabling the Thai Government to purchase more medicines and dramatically increase the availability of treatment for people living with AIDS
This paper looks at initiatives in Argentina and Bolivia to curb corruption in the procurement of hospital supplies, with varying degrees of success
This is the fourth report of session 2004-2005 and includes both the report and formal minutes. The committee considered increasing sale in the UK of patent and proprietary remedies and appliances and medicated wines, noting that while some were genuine scientific preparations, other were "unobjectionable remedies for simple ailments" and others still were "secret remedies making grossly exaggerated claims of efficacy"
This research report considers the challenges faced by a local pharmaceutical firm - Quality Chemicals - in Uganda, which was started up as a 'solution' to reducing the high cost of medicines and improving access to medicines. "...many burdens and barriers to access continue to seriously hinder the success of such enterprises. Indirect government subsidies to exporters selling into African markets, and pressure by donors and lobbyists on innovator producers to offer developing countries subsidised prices, actually undermine the competitiveness and viability of these nascent firms. Furthermore, the focus on drug pricing and local production can actually undermine the overall aim to increase access to medicines"
"This article focuses on Ghana, a developing country that recently changed its patent laws to conform to TRIPS standards. While Ghana has made strides in improving public health, the country has urgent and serious health needs that cannot be met by the existing system. Improving pharmaceutical access is one of the core challenges facing the Government"
The emergence of antimicrobial resistance is a natural phenomenon that follows use of antimicrobial drugs but it is being accelerated by inappropriate antimicrobial use. This leaflet considers various methods that can be used to help contain antimicrobial resistance
This paper presents an overview of the development of drug regulation and the rationale for drug regulation. It also reviews the drug regulation situation in selected countries, examines key contributing factors to observed drug regulation weaknesses, and identifies the measures that must be taken to improve drug regulation
This leaflet looks at why medicines need to be regulated and the elements involved in making sure that regulation is effective
This leaflet looks at the need for pharmacovigilance to prevent or reduce the harm to patients caused by adverse effects of some medication. Pharmacovigilance is considered in terms of a national drugs policy, the regulation of medicines, clinical practice and disease control in public health programmes
This leaflet defines rational drug use and identifies core policies which would help promote a more rational use of medicines
These guidelines are intended to improve awareness of medicine safety issues among everyone who has an interest in the safety of medicines in children and to provide guidance on effective systems for monitoring medicine safety in the paediatric populations. The document will be of interest to all healthcare professionals, medicine regulatory authorities, pharmacovigilance centres, academia, the pharmaceutical industry and policy-makers
This guide raises awareness about the magnitude of the drug safety problem and seeks to convince health professionals that reporting adverse reactions is their moral and professional obligation. The ultimate goal of the guide is to reduce drug morbidity and drug mortality by early detection of drug safety problems in patients and improving selection and rational use of drugs by health professionals
This paper focuses on the values approach for promoting ethical practices in the governance and management of pharmaceuticals within ministries of health. It recognises the need to coordinate and integrate such endeavours with existing legislative efforts to establish a legal framework and ethical infrastructure that adequately address the problem of corruption within the context of each country. The paper is a working draft for field testing and revision
At a time when over 50 medicines pricing surveys had been completed around the world using the HAI/WHO methodology, the lead article to this edition of the medicines pricing survey bulletin considers the need for guidelines to assist in the creation of policy changes that will help to reduce the price of essential medicines
Healthy public policy is an explicit concern for health promotion and development and requires the commitment of a number of partners from different sectors. This conference reviewed the evidence and examined concrete examples of the health impacts that stem from public policies in non-health sectors. It also sought discussion and agreement on tangible policy recommendations on establishing, strengthening, and sustaining mechanisms in mainstreaming health into all public policies at all levels
This paper considers the importance of national-level action on policy and practical measures that are needed to ensure poor people have access to medicines. It details examples of the use of Trade-related Intellectual Property Rights (TRIPS) flexibilities in Malaysia, Indonesia, Thailand, Zimbabwe and Ghana
This is an analysis of the data collected in recent surveys of originator and generic medicines used to treat chronic diseases, and demonstrates that the price, availability and affordability are optimal for neither product types in most of the countries surveyed. The report is intended to be used by policy-makers and programme managers responsible for pricing, price regulation, procurement and other regulatory affairs related to chronic diseases, and can also be used for civil society groups wanting to advocate for pricing policies to make medicines more affordable and available
This policy brief focuses on the need for community participation in the design of policies, legislation and the allocation of budgets as well as the more expected areas of health programme management and service delivery. It is based on a review of community participation and sexual and reproductive health service accountability in World Bank-supported health sector reforms in Africa, Asia and Latin America and the Caribbean
The Uganda national drug policy has been created to help ..."contribute to the attainment of a good standard of health by the population of Uganda, through ensuring the availability, accessibility and affordability of essential drugs of appropriate quality, safety and efficacy and by promoting their rational use"
This article looks at the right to health enshrined within the Universal Declaration on Human Rights and the obligations that states have to individuals to create policies to fulfil that right, both generally and with particular with regard to essential medicines
This paper argues that, between North and South, there are more common health interests in pharmaceutical policies, within broader global public policies, than are currently articulated
This leaflet describes how counterfeit medicines may endanger people's health because their quality is unpredictable. It also considers the challenges faced in combating counterfeit medicines and the role of the IMPACT coalition
This is the WTO ministerial agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) with regard to public health and the promotion of medicines for all
The focus of this edition of HAI and WHO's bulletin for medicines prices surveys is a meeting of the regional committee of the WHO's Eastern Mediterranean region (EMRO) at which the results of 11 medicines pricing surveys carried out in the region were compared and discussed and it was decided to share information regionally
"This paper provides a brief overview of what the international human rights instruments mention about access to essential medicines, and proposes five assessment questions and practical recommendations for governments. These recommendations cover the selection of essential medicines, participation in programme development, mechanisms for transparency and accountability, equitable access by vulnerable groups, and redress mechanisms"
This is the report of the Department of Technical Cooperation for Essential Drugs and Traditional Medicine, WHO meeting which provided a forum for sharing experiences from the ongoing regional and global pooled procurement programmes and explored priority areas for inter-regional collaboration. The meeting brought together experts from various regional and global initiatives, representatives of sub-regional economic groups and development partners interested in pooled procurement and was organised to include plenary presentations on lessons learnt, i.e. strategies, achievements and constraints, and group work and discussions on the key principles of effective pooled procurement
Basic questions and answers about the World Trade Organization agreement on Trade Related Intellectual Property Rights (TRIPS)
This document provides information on WHO's policy and strategy towards traditional medicine. It also highlights key sources of further information
The long-term goal of these recommendations is the design and implementation of a uniform and harmonised system that will ensure procurement of pharmaceutical products of defined quality for supply to patients, based on a mutually recognised process of prequalification of products and manufacturers by means of product dossier evaluation and inspection of manufacturing sites. This document was previously published as Annex 6 of the WHO Technical Report Series No. 937, 2006
In an attempt to curb corruption...the WHO initiated the Good Governance for Medicines programme in 2004. The programme’s goal is to reduce corruption in pharmaceutical sector systems through the application of transparent, accountable administrative procedures and the promotion of ethical practices among health professionals
These guidelines suggest criteria and methods which drug regulatory authorities can employ in determining the suitability of medicinal products for use in self medication
This manual defines a limited number of objective measures that can describe the drug use situation in a country, region or individual health facility. Such measures, or indicators, will allow health planners, managers and researchers to make basic comparisons between situations different areas or at different times. In addition, when an intervention is undertaken to improve aspects of drug use, the indicators can be used to measure impact. Indicators can also serve as simple supervisory tools to detect problems in performance by individual providers or health facilities
This is a diagnostic framework and methodology to evaluate a pharmaceutical system’s vulnerability to corruption and to determine which corrupt practices can have a major impact on the system’s ultimate efficiency. While developed in the context of the health systems of Latin America and the Caribbean (and implemented in a pilot study in Costa Rica), the methodology can be modified with ease so that it is applicable to other regions
This manual is to help governments, civil society groups and others concerned about the prices of medicines to collect and analyse: medicine prices (patient prices and government procurement prices) across sectors and regions in a country; medicine availability; treatment affordability; and all price components in the supply chain from manufacturer to patient (taxes, mark-ups etc.). It is accompanied by a CD-ROM which contains a more extensive collection resources and tools, such as sample training materials, frequently asked questions, and a report template for use in developing national survey reports
Distribution is an important activity in the management of pharmaceuticals involving a number of steps between arrival in the port of entry to the point of supply to health establishment, each of which can present various opportunities for lack of transparency and invites corruption. Published standard operating procedures which specify the roles and responsibilities of all staff involved in each of these steps are important tools that promote transparency and accountability
This manual describes a new approach to measuring the prices people have to pay for a selection of important medicines in different medicine outlets. The manual also describes how to collect information on price composition (taxes, mark-ups, fees) and assess the affordability and availability of medicines
This is a set of 18 tools that can be used by those involved in finding and using research evidence to support evidence-informed health policy making. The series addresses four broad areas: supporting evidence-informed policymaking; identifying needs for research evidence; finding and assessing research evidence; and, going from research evidence to decisions