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Office of Technology Assessment at the German Bundestag Office of Technology Assessment at the German Bundestag

Information on the project

Medicines for Africa

Measures to improve the health situation

Thematic area: Environment and health
Analytical approach: TA project
Topic initiative: Committee on Economic Cooperation and Development
Status: ongoing
Duration: 2012 till 2014

Background and central aspects of the topic

Some diseases which rarely occur in highly developed countries or which can be remedied effectively in different ways are particularly raging in developing countries and have far more severe consequences in these countries. These diseases are also referred to as poverty-related diseases and/or as neglected diseases which – besides the »big three« (HIV/AIDS, malaria and tuberculosis) – include a variety of other diseases. The reasons for the severe health situation especially in Africa are manifold. On the one hand, different mechanisms of the international pharmaceutical market, which is particularly influenced by industrialized countries, are accentuated. On the other hand, the insufficient supply structures of the health systems in the affected countries are emphasized.

Against the background of the complex regulations of the pharmaceutical sector with their different intended effects and supported by the formulation of the Millennium Development Goals of the United Nations in the year 2000, a multitude of various measures has been agreed upon in order to cease the propagation particularly of poverty-related diseases by 2015, to achieve a trend reversal and to improve the access to medical care. But as it becomes apparent for some time now that especially in sub-Saharan developing countries these goals will not be achieved, the effects of the measures taken up to now as well as possible improvements are being discussed intensively and controversially.

It is widely agreed that neither the public sector nor the private sector alone have the necessary capacities to develop medicines to combat diseases which mostly affect poor countries. As a result, the international trade rights have been adapted (transboundary compulsory licenses and flexibilities in the TRIPS agreement) as well as new and innovative financing models and international partnerships in the field of health-related development policy have been created (e.g. GFATM [The Global Fund to Fight AIDS, Tuberculosis and Malaria], BMGF [Bill and Melinda Gates Foundation], GAVI [Global Alliance for Vaccines and Immunisation], UNITAID [Increasing Treatment Coverage for HIV/AIDS, Malaria and TB through Market Solutions], DNDI [Drugs for Neglected Diseases Initiative], MVI [Malaria Vaccines Initiative]). The EU adopted several action programs, particularly with regard to an improved access to medicines against HIV/AIDS, malaria and tuberculosis as well as the »European and Development Countries Partnership« program in 2003, in order to advance clinical research in developing countries in a targeted way. The Federal Government as well launched several programs intended to improve the health situation in Africa in a sustainable way (e.g. "German Development Policy in the Health Sector" sector strategy by the BMZ , "Neglected and poverty-related diseases" research funding concept by the BMBF).

In spite of – and because of – the multitude of these measures, there are critical voices as well. Thus, it is referred to a lack of transparency, to an increasing effort regarding a coordination of activities as well as to possible parallel activities. Another point of criticism concerns the different protective mechanisms intended to preserve intellectual property. It is particularly emphasized that the flexibilities and compulsory licenses provided within the framework of the TRIPS agreement might be undermined by bilateral trade agreements (TRIPS-plus provisions). Moreover, strict protective mechanisms regarding intellectual property rights might obstruct the technology transfer particularly in developing countries.

Objectives and approach

The objective of the project is to give an overview of the manifold programs and concepts aiming at an improved and more targeted research, development and provision of medicines for developing countries. Particular attention will be paid to alternative incentive mechanisms possibly involved and to the emerging consequential effects (e.g. for alternative financing models, a rapid provision of medicines or a potential technology transfer). Moreover, the EU strategies for the protection of intellectual property and particularly the bilateral trade agreements negotiated by the European Commission shall be verified with regard to the question of to what extent they restrict again the exceptions of the TRIPS agreement which are possible in the context of health care.

Based on a detailed presentation of the individual activities and the assessment of the situation, options for action addressing particularly German decision-makers will be elaborated. They should aim at improving the provision of medicines in the least developed countries in a sustainable way while safeguarding the German R&D location.