The local manufacturing of pharmaceuticals is a hotly contested issue in many countries. It runs to the heart of key concerns such as quality, availability, and price of medicines. Some of the arguments of the local manufacturers are set out in this article by one of the co-chairs of the Medicines Transparency Alliance Uganda Council and Chairman of the Uganda Pharmaceutical Manufacturer's Association (UPMA)
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 paper is about substances that are sold as medicines yet are not what they purport to be. Some of these substances are deliberately mislabeled, i.e. counterfeit. Others may have been inadvertently mislabelled or the pills contaminated during manufacture. Others may originally have been exactly as they claim, but due to poor storage have degraded and are consequently substandard. The paper is composed of four parts. The first looks at the scope of the problem in less developed countries; the second examines the health impacts of fake medicines; the third section considers the main causes of the problem; and the final section offers some possible solutions
"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"
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 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 report is intended to assist organisations purchasing pharmaceutical products, vaccines or other health sector goods, or who are otherwise involved in the prequalification, purchasing, storage and distribution of such products. It addresses the general requirement for the quality assurance system that needs to be in place at all procurement agencies and sets out recommendations that these agencies should implement when evaluating product needs, assessing the products offered and the manufacturing and supply arrangements. It also describes principles of purchasing pharmaceutical products, how to receive and store them; good distribution practices; and monitoring and reassessment of products and contracted-out activities. This document was previously published as Annex 6 of the 40th Report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations (Technical report 937, 2006).
This report considers the extent to which the government’s legislative and policy programme has furthered access to essential medicines in Malawi and, in particular, has taken advantage of the flexibilities under the Trade Related Aspects of Intellectual Property Rights (TRIPs) agreement
The publication provides an accessible source of information on the pharmaceutical situation at global and national levels. It assembles the available evidence regarding the production and consumption of medicines, and a range of issues in national medicines policies, including the level of people's access, patterns of use, the challenges of medicines regulation and promoting rational use. Numerous different sources of data are used. A 32-page annex of statistics is included. The target readers are researchers, academics and analysts concerned with medicines and public health
This study addresses the question of whether access to medicines can be improved in sub-Saharan Africa by producing them locally. For this production to be sustainable, it must be both economically viable while meeting quality standards, and result in the improvement of access along one or more of the following dimensions: geographical accessibility, physical availability, affordability and acceptability
This policy includes the following sections: a situational analysis of drug selection; drug procurement, storage and distribution; drug financing; quality assurance; local manufacture of pharmaceutical and traditional medicinal products; rational drug use; global trade and pharmaceuticals; emerging diseases and pharmaceuticals; human resource development for drug management; traditional medicinal products; research and development; and implementation of the policy
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
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