MeTA - Policy and regulation in medicines supply

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: sourceassistant@hi-uk.org

Selected resources

Analyses and case studies

Effective drug regulation : a multicountry study

RATANAWIJITRASIN, Sauwakon
WONDEMAGEGNEHU, Eshetu
2002

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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

Measuring private sector corruption

ROSE-ACKERMAN, Susan
September 2007

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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

Measuring transparency in medicines registration, selection and procurement : four country assessment studies

BAGHDADI-SABETI, Guitelle
WONDEMAGEGNEHU, Eshetu
2006

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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

Measuring transparency to improve good governance in the public pharmaceutical sector : Jordan

NUSEIRAT, Adi
2009

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"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"

Measuring transparency to improve good governance in the public pharmaceutical sector : Syrian Arab Republic

AL MARDINI, Amer
AL HAKEEM, Souheila
2009

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"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"

Medicine prices surveys and proposed interventions to improve sustainable access to affordable medicines in 6 sub-Saharan African countries|Etudes des prix des medicaments et interventions proposeees pur ameliorer durablement l'acces aux medicaments dan

WORLD HEALTH ORGANIZATION (WHO)
2006

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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

Official, unofficial and informal fees for health care

KILLINGSWORTH, James R.
2002

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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

Pain relieving drugs in 12 African PEPFAR countries : mapping current providers, identifying current challenges, and enabling expansion of pain control provision in the management of HIV/AIDS

HARDING, Richard
et al
January 2007

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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

Public and private sector approaches to improving pharmaceutical quality in Bangladesh

KOSTERMANS, Kees
et al
March 2008

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"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"

Social enterprise as market regulation : non-governmental interventions in essential medicines wholesaling to low income countries

MACKINTOSH, Maureen
2008

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"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"

Special issue on access to medicines, pricing and generics

September 2009

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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

Thailand's experience with compulsory licensing

MSF CAMPAIGN FOR ACCESS TO ESSENTIAL MEDICINES
2009

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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

The influence of the pharmaceutical industry

HOUSE OF COMMONS SELECT COMMITTEE ON HEALTH
April 2005

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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"

The push for local production, costs and benefits - a case study of Uganda’s Quality Chemicals|Africa Fighting Malaria policy paper

TAYLOR, James
et al
September 2009

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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"

Regulation

Containing antimicrobial resistance

WORLD HEALTH ORGANIZATION (WHO)
April 2005

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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

Effective drug regulation : what can countries do?

WONDEMAGEGNEHU, Eshetu
1999

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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

Pharmacovigilance : ensuring the safe use of medicines

WORLD HEALTH ORGANIZATION (WHO)
October 2004

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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

Promoting safety of medicines for children

WORLD HEALTH ORGANIZATION
2007

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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

Safety of medicines : a guide to detecting and reporting adverse drug reactions|Why health professionals need to take action

LEPAKHIN, V.K.
et al
2002

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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

National policy

Ethical infrastructure for good governance in the public pharmaceutical sector

ANELLO, Eloy
November 2006

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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

Guidelines on policies that affect medicine prices

HEALTH ACTION INTERNATIONAL (HAI)
WORLD HEALTH ORGANIZATION(WHO)
2008

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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

Mainstreaming health into public policies : report on the Prince Mahidol award conference 2009

2009

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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

Price, availability and affordability : an international comparison of chronic disease medicines

GELDERS, Susanne
et al
2006

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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

Strenthening service accountability and community participation in health sector reforms

MURTHY, Ranjani K
July 2005

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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

Uganda national drug policy

MINISTRY OF HEALTH, UGANDA
October 2002

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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"

International collaboration

Access to essential medicines as a human right

HOGERZEIL, Hans
2003

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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

Counterfeit drugs kill

INTERNATIONAL MEDICAL PRODUCTS ANTI-COUNTERFEITING TASKFORCE (IMPACT)
May 2008

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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

Focus on pricing policies : EMRO ministers confront high prices

HEALTH ACTION INTERNATIONAL (HAI)
WORLD HEALTH ORGANIZATION (WHO)
2007

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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

Human rights and essential medicines : what can they learn from each other?

HOGERZEIL, Hans V.
May 2006

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"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"

Multi-country regional pooled procurement of medicines|Identifying key principles for enabling regional pooled procurement and a framework for inter-regional collaboration in the African, Caribbean and Pacific Island Countries

TECHNICAL COOPERATION FOR ESSENTIAL DRUGS AND TRADITIONAL MEDICINE, WORLD HEALTH ORGANISATION (WHO)
2007

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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

Tools

A model quality assurance system for procurement agencies : recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products

WORLD HEALTH ORGANIZATION (WHO)
2007

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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

How to investigate drug use in health facilities : selected drug use indicators

WORLD HEALTH ORGANIZATION (WHO)
Action Programme on Essential Drugs
1993

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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

Improving transparency in pharmaceutical systems : strengthening critical decision points against corruption

COHEN, Jillian Clare
CERCONE,James A.
MACAYA, Roman
October 2002

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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

Measuring medicine prices, availability, affordability and price components

WORLD HEALTH ORGANIZATION (WHO)
HEALTH ACTION INTERNATIONAL (HAI)
2008

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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

Measuring transparency in the distribution of pharmaceuticals : assessment instrument

DEPARTMENT OF MEDICINES POLICY AND STANDARDS, WORLD HEALTH ORGANIZATION (WHO)
September 2007

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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

Medicine prices : a new approach to measurement

HEALTH ACTION INTERNATIONAL (HAI)
WORLD HEALTH ORGANIZATION (WHO)
2003

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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

SUPPORT tools for evidence-informed health policymaking (STP)

OXMAN, Andy
HANNEY, Stephen
Eds
December 2009

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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