The framework for the European Community’s approach to the three major communicable diseases (HIV/AIDS, malaria and tuberculosis (TB)) in third countries is the EC Programme for Action on Communicable Diseases, which is based on the September 2000 Communication “Accelerated Action targeted at major communicable diseases within the context of poverty reduction”.
The Programme establishes for 2001-2006 and as part of an expanded international effort, a broad and coherent Community response to the global emergency caused by HIV/AIDS, malaria and TB. The three diseases kill more than 6 million people per year, affect the poorest populations most and undermine global health and sustainable development.
The Community response entails a comprehensive set of actions to increase: (i) the impact of existing interventions; (ii) the affordability of key pharmaceuticals; (iii) research and development of specific global public goods to confront HIV/AIDS, malaria and TB at the regional, national and global levels (such as an AIDS vaccine); and (iv) the effectiveness of global partnerships and regional co-operation.
Within this framework the following actions and engagements have been taken:
A. Ensure adequate financial support to implement the Programme of Action.
With the full support of the Member States and the European Parliament (EP), the EC has allocated in total more than € 1 billion to fight the three poverty diseases (HIV/AIDS, TB and Malaria) from 2003 - 2006.
- €351 million allocated (2003-06) to the implementation of the Programme for Action.
6 September 2003 the Council and the EP adopted a proposal from the EC for a regulation on aid to HIV/AIDS, TB and Malaria in developing countries. Funds will be given to concrete projects designed to achieve the first three key priorities of the action programme (see above). €170 million will be channelled through the Global Fund to fight HIV/AIDS, TB and Malaria (see below).
- €400 million allocated (2003-2006) through the 6th Research framework programme to a significant increase in the EC’s to research and development:
- €200 million allocated to the European and Developing Countries Clinical Trials Partnership (EDCTP). The objective of this pilot R&D initiative is to accelerate the development of new medicines, vaccines and therapeutic tools against HIV/AIDS, malaria and tuberculosis tailored to the developing countries. This includes taking into account: (i) local virus strains; (ii) cultural habits and traditions in order to ensure that treatment is properly followed by patients; (iii) specificity’s of local health-care systems including distribution and refrigeration chain problems.
Research projects are now coming on stream particularly concerning: Prevention of mother to child transmission of HIV/AIDS; increasing effectiveness of anti-retroviral drugs; identifying markers of anti-Tuberculosis drug efficacy; phase II-III of tuberculosis and malaria drug trials, and capacity building for HIV/AIDS vaccine and microbicide trials (a female controlled HIV prevention technology).
- €200 million allocated to basic research on HIV/AIDS, TB and Malaria. More than 40 projects on HIV/AIDS vaccines and drugs are currently being funded, both in Europe, Africa, Asia and South-America. Projects include development of: (i) new anti-retroviral treatments to overcome growing resistance of the virus; (ii) new interventions for the treatment of HIV-infected infants, pregnant women and adults; (iii) HIV microbicides to allow women that do not have the capacity to impose HIV prevention measures (safer sex through condom use) on their partners to protect themselves against HIV transmission; (iv) new and promising HIV vaccine candidates not only to prevent the HIV infection, but also to treat infected people; (v) new anti-HIV drugs against hidden virus that can not be accessed by other drugs, and against the escape of the virus from infected cells, (vi) vaccine delivery systems to fight viruses; and (vi) specific support actions for standardising clinical tests and monitoring HIV resistance.
- €70 million is allocated from intra-ACP funds of the 9th European Development Fund (EDF) to target HIV/AIDS, TB and Malaria.
Majority of the funds are dedicated to a World Health Organisation (WHO) programme aimed at improving access to medicine in developing countries. Objectives include strengthening developing countries’ pharmaceutical policies. All aspects from procurement to distribution of medicine will be addressed. Remaining funds will be dedicated to reproductive health programmes and to the provision of malaria bed nets.
- € 340 million will be allocated (2003-06) to the Global Fund (GFATM) to fight HIV/AIDS, TB and Malaria.
The GFATM is a financing mechanism to attract, manage and disburse additional resources to the fight against HIV/AIDS, tuberculosis and malaria in developing countries. Through its activities the GFTAM should contribute to poverty reduction as part of the Millennium Development Goals. The EC holds a seat on the GFATM governing board together with Belgium and Austria.
The EC’s pledge of €340 million for 2003-06 (170 from the budget and 170 from the European development fund - EDF) comes in addition of €120 million allocated in 2002. With a total contribution of €460 million the EC is the second largest single contributor to the GFATM. The EC has accelerated its payments to the Global Fund and has already honoured over 70 pct. of its pledges. 15 July 2004 the Commission is expected to adopt a decision on the payment of an additional €42 million to the Global Fund bringing its total contribution so far to €375 million (over 80 pct of its pledges). This would also make the EC the single largest contributor to the Global Fund.
EU member states and the EC have pledged a total of 2.8 billion USD to the Global Fund until 2007 or more than 55% of all pledges made to the Global Fund.
- €200 million are programmed for country, NGO co-financing and ECHO support specifically targeting HIV/AIDS, TB and Malaria.
Over 140 projects in the context of EC financed NGO activities, humanitarian aid financed through the EC’s humanitarian aid office ECHO and in the framework of various country programmes. These projects all target HIV/AIDS, TB and Malaria specifically.
Overall EC support to Health, AIDS and Population in third countries
In addition to the above mentioned more targeted programmes the EC is providing support to health sector programs in a number of developing countries EC as an integral part of its development corporation with these countries. The objective is to increase the effectiveness of health care systems and health services as an central element in the general poverty alleviation strategy. Improvement of these services is key if HIV/AIDS, TB and Malaria are to be combated effectively. EC has given support to health, HIV/AIDS and population in more than 100 developing countries from 1994 to 2001 amounting €5 billion. This makes an average annual expenditure of €625 million.
B. Promoting access to affordable medicine:
- The EU was at the forefront of efforts within the World Trade Organisation (WTO) to ensure access to cheap medicines for developing countries. A first step was the adoption of the Doha Declaration on the TRIP’s Agreement (agreement on the trade related aspects of intellectual property) and Public Health in November 2001. This declaration called for rules protecting intellectual property rights (TRIPS) to be supportive of the right to protect public health and, in particular, to promote access to medicines for all. In August 2003 the WTO finally agreed on a scheme giving poor countries without production capacity access to generics to tackle their public health problems. The Commission is now preparing a proposal for a Regulation to implement the August 2003 Decision into EU law by creating a legal basis for the granting of compulsory licenses for the production and export of medicines for developing and least-developed countries.
- The EU has also adopted a new legislation ensuring the delivery of cheap medicines (tiered priced) to developing countries. This legislation encourages the pharmaceutical industry to make products available at near to cost of production price, preventing the re-importation of reduced-price medicines into Europe, thus ensuring that the medicines reach populations in need. In February 2004 GlaxoSmithKline was the first European pharmaceutical company to notify a set of products under article 4 of this Regulation. The Commission has subsequently placed 7 anti-retrovirals on the list of medicines under EU protection against trade diversion. The products on the list will bear a logo allowing customs to easily identify them. Imports of these products into the EU for free circulation, re-exportation, warehousing or trans-shipment will be prohibited.
C. Assuming a strong voice in policy dialogue:
The EC has fostered a strengthened policy dialogue with partners in developing countries; strengthened its partnership with WHO and other multilateral agencies, the private sector and civil society; had a strong voice in international fora, including the G8, the EU/African Union dialogue and the Global Fund to Fight HIV/AIDS, TB and malaria; and developed a specific focus on the enhancement of capacity for the local production of essential medicines in a number of developing countries.
Fighting HIV/AIDS in the EU and its neighbourhood
The HIV/AIDS epidemic has been an important focus of concern and action of the EU’s public health activities since the late 1980’s. During this time, Europe has been insulated from the worst ravages of the disease – in part due to the effective action taken during the 1980s.
A particular focus of EU action has been, and continues to be, to address the prevention challenges set by vulnerable groups like migrant populations, sex workers, and young people. This year, the Commission focuses on best practice in HIV/AIDS prevention and sex education, as a Eurobarometer survey in 2003 showed that there is still some confusion among Europeans about possible means of infection.
The European Union and its neighbouring countries now face the threat of a ‘new epidemic’. Parts of Europe have the fastest rate of new HIV/AIDS cases in the world. Latest figures released recently by UNAIDS confirmed that the numbers of new infections are increasing throughout the 25 EU Member States, and in particular in the EU neighbourhood. The transmission pattern is also changing. While sexually transmitted infections remain predominant in some parts of the European Continent many of the rapid rises in infections are due to intravenous drug users.
The Commission has intensified its efforts to coordinate activities to fully contribute to the fight against HIV/AIDS in effective partnership with Member States, neighbouring countries, and international organisations and other partners. The Irish Council Presidency hosted the Dublin Ministerial Conference in February 2004 entitled “Breaking the barriers – Partnership to fight HIV/AIDS in Europe and Central Asia” in order to highlight the worsening situation. In June 2004 the European Council called for vigorous follow up by the Union and relevant regional bodies on the outcome of this conference.
Against this background, the Commission is co-organising with the Lithuanian Government a follow-up Ministerial Conference “Europe and HIV/AIDS: New Challenges’ New Opportunities” in Vilnius on 17 September 2004. In this meeting the Commission will present a set of concrete actions it is ready to implement in the following 18 months. These activities will be under the categories of prevention, support, treatment, and care, and building partnerships.