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Health: programme for accelerated action on HIV/AIDS, malaria and tuberculosis (2001-2006)
The European Union is drawing up a programme for action aimed at accelerated action against the three main communicable diseases, HIV/AIDS, malaria and tuberculosis, in developing countries. It is based on three major objectives: to increase the impact of existing interventions, make key pharmaceuticals more affordable, and support research and development of specific global public goods to confront these diseases.
Communication from the Commission to the Council and the European Parliament of 21 February 2001 - Programme for Action: accelerated action on HIV/AIDS, malaria and tuberculosis in the context of poverty reduction [COM(2001)96 final - Not published in the Official Journal].
This programme for action sets out the political framework presented in the Commission communication on the same subject of September 2000 also concerning the fight against the main communicable diseases. It aims to accelerate action against the three major communicable diseases (HIV/AIDS, malaria and tuberculosis) which kill 5 million people every year, particularly in developing countries, and which represent a substantial obstacle to development. In line with the policy set out in the previous communication, the programme for action is based on the same key objectives: to improve the effectiveness of existing initiatives, make pharmaceuticals more affordable and support the research and development of global public goods to confront these diseases.
OPTIMISING THE IMPACT OF EXISTING INITIATIVES
Optimising the impact of health, AIDS and population (HAP) interventions targeted at the major communicable diseases and poverty reduction
The Commission considers that priority must be given to HAP interventions in the total budget for development cooperation for the period 2000-2006. As far as financial aid is concerned, a reform of aid management is required in order to allow more rapid disbursement. Consideration should be given to opportunities to direct unspent resources within country programmes and to use African, Caribbean and Pacific states (ACP) funds and other regional resources.
The importance of close cooperation with other international organisations is again emphasised. The Commission plans to conclude agreements with many organisations such as the World Health Organisation (WHO) and with the Member States to provide necessary technical and normative input to country programming and identification exercises.
Strengthening of pharmaceutical policies and capacity building
This action will be launched through national and regional cooperation, capacity building and financial assistance. Efforts will focus on the practical aspects such as budget management, purchasing, etc. The Commission will support, in particular, the development of quality control capacities, especially with regard to local production and the use of generics.
The Commission aims to accelerate the registration and marketing approvals of key pharmaceuticals in developing countries based on existing registration in developed countries, particularly via the existing programmes for key pharmaceuticals.
It also aims to promote closer cooperation between the pharmaceutical sector in developed countries and developing countries by encouraging the manufacturers of generic products and research laboratories to enter into licensing agreements and joint ventures with partners in developing countries. These activities require adequate protection, particularly in relation to intellectual property rights.
Making key pharmaceuticals more affordable
Tiered pricing: the high price of key pharmaceuticals is an enormous obstacle to progress in this area for developing countries. A global tiered pricing system aimed at providing these pharmaceuticals at lower prices in developing countries is essential for success in the fight against the three major communicable diseases. Such a system should be established following consultation with all the actors at global level: governments, the private sector (especially the pharmaceutical industry) and NGOs. It should also be accompanied by effective safeguards to ensure that these pharmaceuticals are actually delivered to the poorest developing countries (for example, technical measures such as differential labelling and trademarks).
Tariffs and taxes: there are other factors that can increase the price of these pharmaceuticals: tariffs, taxes, importation, distribution and local registration fees, etc. The effect of these elements is being analysed but importing countries (particularly the developing countries themselves) should perhaps be encouraged to reduce or abolish these factors.
Intellectual property legislation: there is a strong link between intellectual property and public health since the pharmaceuticals are protected by patents and their unauthorised production is forbidden. The Commission proposes helping World Trade Organisation (WTO) developing country members to implement the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which should facilitate the sale of key pharmaceuticals whilst protecting manufacturers. It is important to note that there is a certain degree of flexibility within this Agreement. Compulsory licences may be issued in certain circumstances, in particular to address urgent public health concerns.
Research and Development (R&D)
Strengthening and increasing support for research and development at Community level: action against communicable diseases in developing countries is becoming increasingly important in the context of the Community's research tools. The Commission plans to commit EUR 130 million in research on the three major communicable diseases under the 5th Framework Programme for Research. Furthermore, a new major initiative is envisaged to support and accelerate clinical development and new interventions. The Commission is currently in the process of drawing up a communication on a European research strategy for global public goods to confront these three diseases. The Commission's assistance aims mainly to increase support for basic and strategic research with greater coordination at European and international level and to create a European clinical trials platform.
Capacity building in developing countries: developing countries will be involved at all stages of the research process. The Community expects vocational training and advanced scientific and technical training for researchers in developing countries to have a lasting impact. There will be close cooperation with the Community on specific studies.
Incentives for the development of global public goods: this involves, in particular, measures to encourage private investment in R&D activities and work on regulatory aspects in relation to new products. The Community will also continue the work of the Community research team on an AIDS vaccine.
Participation in global partnerships: within the framework of close cooperation at global level, it is important to promote the reform of the international financial architecture to foster increased availability and development of specific global public goods. In addition to strengthening partnerships with United Nations agencies and the WHO in particular, there should be closer cooperation with the United States and Japan.
The instrument chosen depends on the entry level. The main instruments are:
- unspent reserves from the 8th European Development Fund (EDF) and resources from geographic budget lines (ALA-MEDA): these funds will be used for specific actions in support of initiatives, technical assistance for tax reforms and technical support for the implementation of the TRIPS Agreement;
- resources from the 9th EDF (from 2004), ALA-MEDA and thematic budget lines:
these resources will be used in particular for non-traditional partnerships (local, private sector, etc.) and to form a partnership with the WHO in relation to pharmaceutical policies;
- feasibility studies and other support measures in cooperation with the World Bank;
- extension of the ACP regime to non-ACP regions for actions to make key pharmaceuticals more affordable allowing all countries to bid for tenders, etc.;
- research programmes.
Funds will also be available from the private sector and other partners.
The Commission must develop specific efficient financial instruments for investing in global initiatives. The current financing system based on thematic budget lines is far from efficient.
The establishment of an institutional framework to facilitate political dialogue on this subject is also strongly advised.
This programme comes under the framework of the Community's global development policy, priority being given to poverty reduction and special support for the areas of health, AIDS and population (HAP). From this point of view, the programme must respect the basic principles for support for operations that require, inter alia, the adoption of a specific approach for the context and the environment and the involvement of the various actors.
The interdependence of the three objectives requires coherent, collective and simultaneous action at all levels. Progress will be followed up at two levels: global follow-up with the international partners and Community follow-up of the direct actions of the European Community.