Brussels, 21 May 2003
The Council today agreed on two draft Regulations providing for 351 million euros of aid for measures to combat poverty diseases ñ HIV/AIDS, malaria and tuberculosis ñ and 73.95 million euros of aid for policies and actions on reproductive and sexual health and rights in developing countries.
"Today's agreement will enable the Union to take concrete steps to help save thousands of lives by improving maternal health and by helping in the fight against poverty diseases in some of the world's poorest countries", declared Andreas Loverdos, President of the Council.1 "It brings to over one billion euros the total money for these initiatives, including 400 million euros to be contributed by the Member States and other public and private sources for research and development in poverty diseases".
The political agreement, approved without discussion by the Council at its session on External Relations, takes on board all of the amendments voted by the European Parliament in first reading. The Council will adopt the two Regulations at its session on 17 and 18 June, after finalisation of the texts.
The two Regulations are part of the European Union's contribution to meeting two of the eight Millennium Development Goals adopted by Heads of State and Government at the United Nations in 2000. These include targets aimed at:
- Halting the spread of HIV/AIDS, malaria and other major diseases by 2015 and beginning their reverse.
- Reducing the maternal mortality ratio by threeñquarters between 1990 and 2015.
The two Regulations lay down financial frameworks, applicable until 31 December 2006, to replace those laid down by Regulation 550/97 on HIV/AIDSñrelated operations in developing countries and Regulation 1484/97 on aid for population policies and programmes in developing countries.
The Regulation on poverty diseases is central to implementation of the Council Resolution, "Programme of action: accelerated action on HIV/AIDS, malaria and tuberculosis in the context of poverty reduction", adopted in May 2001, which focuses on three objectives, namely improving impact, affordability of pharmaceuticals and research and development.
The two latter objectives will be implemented by means of:
- a Regulation aimed at improving the availability of key medicines, which the Council is due to adopt at its session on 26 and May;
- a Decision on Community participation in an R&D programme on clinical interventions, adopted on 13 May.
HIV/AIDS, malaria and tuberculosis
The so-called poverty diseases ñ HIV/AIDS, malaria and tuberculosis ñ kill more than six million people each year2, essentially in developing countries where they have destabilising effects on society and are wiping out years of development efforts.
The UN Secretary General's proposal to establish a Global Fund to fight HIV/AIDS, malaria and tuberculosis came into operation on 29 January 2002 on the basis of contributions that are additional to existing resources to fight these diseases. Roughly half of the 351 million euros provided for under the Regulation on poverty diseases will contribute to the Global Fund.
Financing provided for by the Regulation will include the following priority areas:
- Technology transfer and local production of key pharmaceuticals and commodities for the prevention, treatment and care of poverty diseases: use of condoms (HIV/AIDS); insecticideñ treated nets (malaria); effective and affordable medicines.
- Preventive and treatment protocols, such as: antiñretroviral combination regimes and diagnosis, monitoring and followñup protocols; change of malaria protocols; change of tuberculosis protocols.
- Initiatives aimed at increasing careñseeking patterns, access to prevention and care services and coverage of essential services, particularly for the poorest and most vulnerable, including:
- HIV: voluntary counselling and testing;
- Malaria: treatment of uncomplicated cases, detection and early treatment of severe cases, preventive treatment of pregnant women and reduced anaemia in children living in highly endemic regions;
- Tuberculosis: increased detection rates.
Besides the spread of HIV/AIDS, the lack of safe and reliable reproductive and sexual health care and services are undermining efforts to eradicate poverty and safeguard livelihoods in developing countries.
Much remains to be done to ensure that every woman has the chance of a healthy pregnancy and of giving birth in safe conditions, that the health needs of young people are met and that the violence and abuse suffered by women, including in refugee and conflict situations, is stopped.
The Regulation on reproductive and sexual health implements the EU's commitment to upholding the principles agreed at the International Conference on Population and Development (ICPD) at Cairo in 1994 and at the ICPD+5 at New York in 1999.
Financing will aim at ensuring the sustained supply, availability and affordability of more effective and acceptable methods of contraception and protection from sexually transmitted infection, including HIV/AIDS. It will include the following priority areas:
ñ Increased use of interventions that are known to be effective, such as those for the prevention of postpartum haemorrhage, the prevention and treatment of sexually transmitted infections and treatment of eclampsia.
ñ Improving rates of skilled attendance at childbirth.
ñ Prevention of unwanted pregnancies through increased availability of family planning services.
Availability of key medicines in the poorest countries
The Council is due also to adopt, without discussion at its session on 26 and May, a Regulation aimed at encouraging the pharmaceutical industry to offer essential medicines against HIV/AIDS, malaria and tuberculosis at reduced prices in favour of the poorest developing countries.
The Regulation, on which the Permanent Representatives Committee reached agreement on 14 May, also provides for safeguard measures to avoid trade distortions that would be caused by the reñimport of such medicines onto the EU market.
Adoption of this Regulation will represent a positive development in view of the broader debate that will take place at the Group of Eight industrialised countries' meeting, at Evian (France) at the beginning of June, on the global financing of medicines for developing countries.
Many of the poorest countries are in urgent need of access to affordable essential medicines for the treatment of communicable diseases, and are heavily dependent on imports of such medicines.
The Regulation sets tiered medicine prices using two alternative options ñ either a maximum of 25 percent of the weighted average exñfactory price charged by manufacturers in OECD markets, or the manufacturer's direct production costs with the addition of a maximum percentage of 15%. It also establishes a list ñ which will be kept under review ñ of 72 countries initially that may benefit from the tiered prices.
HIV/AIDS, malaria and tuberculosis - research and development programme
Approval of the two Regulations follows adoption by the "Competitiveness" Council on 13 May of a Decision on Community participation in a research and development programme aimed at developing new clinical interventions to combat HIV/AIDS, malaria and tuberculosis.
This R&D programme involves a long-term partnership between Europe and the developing countries, undertaken by most of the EU's Member States plus Norway. The Community will make a financial contribution of a maximum of 200 million euros, in addition to an estimated 200 million euros being contributed by the Member States and 200 million euros from other private and public sources.
In 2000, only 10% of all R&D in diseases covered 90% of the world's disease burden. The R&D partnership programme is aimed at compensating for the market failure in drug development through increased public funding.
This will include support for the research and development of effective methods of prevention and treatment to confront poverty diseases in developing countries and to encourage the private sector to invest accordingly.
The text adopted takes on board all of the amendments voted by the European Parliament in first reading.