|
European and Developing countries Clinical Trials programme - EDCTP
(Debate: Thursday 27 March 2003 - Vote: 27 March 2003)
SUMMARYMEPs approved a research and development programmes aimed at combating HIV/AIDS, malaria, tuberculosis in developing countries (in particular sub-Saharan Africa), to run alongside the Global Fund. The programme brings together all 15 Member States and sets up a research and development programme called "The European and Developing countries Clinical Trials programme" (EDCTP). The five-year budget is some €600 million, with up to €200 million coming from the EU, €200 million from national research programmes and the final €200 million from the private sector - these however are target figures. The programme is to be administered by a partnership board with experts from Member States and from participating developing countries. As to the actions envisaged, Parliament stressed that R&D activities linked directly to the development of new products and the improvement of existing products against HIV/AIDS, malaria and tuberculosis should be suited to the specific requirements of developing countries: effective, easy to use and as affordable as possible. A further compromise amendment stated that support should also give due consideration to sexual and reproductive health. Parliament expects the swift adoption of the programme at first reading, following informal agreements with Council and Commission on a series of compromise amendments. The text adopted by Parliament is at this link.
[ top ]
MAIN EP AMENDMENTS VOTED, AMENDING COMMISSION TEXTAm 37 This action programme has various closely linked and interdependent parts: promoting prevention, encouraging treatment and making essential medicinal products more affordable, and stepping up research and development. Am 44 The objective of the EDCTP Programme, for the total cost of which a target figure is estimated at Euro 600 million over a five year period, is to accelerate the development of new clinical interventions to fight HIV/AIDS, malaria and tuberculosis in the developing countries, particularly in Sub Saharan Africa and to improve generally the quality of research in relation to these diseases. The EDCTP Programme has been drawn up with a view to stepping up cooperation and the networking of European national programmes, accelerating clinical trials of new products, in particular drugs and vaccines, in the developing countries, helping to develop and strengthen capacities in the developing countries, including the promotion of technology transfer where appropriate and encouraging the participation of the private sector and mobilising additional funds to fight these diseases, including those of the private sector. Due to the nature of the Programme, a significant part of the funding would be spent in the developing countries. Am 64 RTD activities linked directly to the development of new products and the improvement of existing products against the three diseases (HIV/AIDS, malaria and tuberculosis), suited to the specific requirements of the developing countries i.e. that they are effective, easy to use and as affordable as possible:
Ams 60 et sq principles of good administration [ top ]
Debate (excerpts)[ Link to full record of debate ] Hudghton (Verts/ALE, SNP, Scotland, ) Draftsman of the opinion of the Committee on Budgets . - Mr President, I would like to thank Mr Caudron, the general rapporteur, for his work on this very important report. It sets up a new fund for a new project, but it is designed to be tied together with the existing work which is already going on in the participating Member States and Norway as regards research into these diseases. The statistics are quite horrifying - 90% of the world's HIV virus carriers live in developing countries and 95% of TB sufferers are in developing countries. So clearly, a significant amount of work is required to be done to tackle these problems. The Committee on Budgets - without dissent - approved the proposed EUR 200 million contribution from the EU which, of course, is in addition to the EUR 60 million which the EU has pledged to the global health fund. The global health fund, of course, is not available for research. It is important that any new work - or the consolidation and coordination of existing work - in the field of research into these diseases must be focused upon the needs and conditions existing in developing countries. That is the idea behind the proposal. I am glad to see that Parliament, at various stages, has spelled out how this project could and should be managed and how the progress can and will - I hope - be reported. If we have to apply a total of EUR 600 million as this project envisages - EUR 200 million from the EU, EUR 200 million from existing Member State funds and, hopefully, EUR 200 million from other donors and industry - then it is important that it be spent wisely and successfully. I would hope that since a significant proportion of that is public funding - taxpayer's money - the ownership of new procedures can remain with the public sector and be made available cheaply to the people who really need it most.
Sandbæk (EDD, DK) Draftsman of the opinion of the Committee on Development and Cooperation . - Mr President, exceptionally I will speak in English because at the end of my speech I am going to ask Mr Busquin a question which I want to be sure he understands and I expect a very clear answer. First, I want to say that this programme is very laudable and commendable. It is a highly-needed initiative which deserves a lot of attention and support. To enhance the impact of the European contribution, we must improve what is already being done, and this must entail more coordination and consultation. Material and non-material investment in the control of the major communicable diseases in poverty-ridden countries must be increased and, most importantly, new tools to prevent and combat the three diseases are needed here and now. Affordable, effective, accessible and safe vaccines, drugs and microbicides are urgently required to prevent or ameliorate malaria, HIV and tuberculosis. It is imperative to ensure that the beneficiaries, the end-users of these new tools, are fully involved in their clinical evaluation and application. It is therefore heartening that the Commission's proposal for a European Developing Countries Clinical Trials programme (EDCTP) addresses the important issue of human capacity development in the societies most affected by the three diseases. It is, however, very disheartening that the Commission, after two years, has still not provided any substantial information about the Member States' common activity, the very activity which forms the basis for mobilising Article 169. As far as I know, the European Economic Interest Group is currently a structure which lacks defined programmatic content. So here is my question: can the Commission provide me with any examples of how Member States have so far collaborated and jointly implemented activities within the EDCTP concept? Have any of the Member States so far committed - and I mean committed and not identified, because I know that all the Member States have identified programmes - to any of the identified programmes so far? We need to have credible examples of Member States' joint achievements in order to avoid the sustainability of the initiative coming into question, and a proposal being seen as merely wishful thinking.
Evans, Jillian (Verts/ALE, Plaid Cymru, Wales) Draftsman of the opinion of the Committee on Women's Rights and Equal Opportunities . - I very much welcome this initiative, which could be a real step forward in the battle against HIV/Aids, malaria and TB in the developing countries. As has already been said, it is a rapidly growing problem, usually affecting the poorest and most vulnerable in society who have less access to health care and education - many of whom are women. In fact, they make up two thirds of the world's poor and bear the main burden of poverty. Therefore, the role of women as sufferers, main carers, educators and as active members of communities in the developing countries is key to finding the right solutions. If we look at HIV/Aids, by the year 2000, 9 million women and 4.3 million children had died of Aids, and these figures are going up. In sub-Saharan Africa, 55% of HIV infected adults are women. Women face greater danger of HIV infection for biological and social reasons, because of lack of control of their sexual health and lack of access to preventative information. So the focus of the opinion of the Women's Rights and Equal Opportunities Committee was on ensuring that drugs and treatment are affordable, that people in developing countries are central to the programmes and that the products developed and used in trials are suitable for local use. Simple practical matters such as how to store drugs safely and how to administer or take drugs are crucial. That is why grass-roots groups such as women's organisations must be fully involved in developing programmes and ensuring that training is given to health care providers in the use of products - whether in the home, the community or in institutions. Training, capacity-building and infrastructure must be developed to enable these clinical trials to be carried out effectively and to ensure the long-term success of this programme.
Ó Neachtain (UEN, IRL). - Mr President, there are currently over 40 million people in the world who are suffering from AIDS. For the continent of Africa this pandemic is already amplifying the impact of famine which is now threatening so many countries in Africa itself. Only USD 3 billion a year is being spent globally in trying to halt the spread of AIDS. This figure must increase to at least USD 10 billion a year if we are to combat the disease effectively. We have the technology and the treatments available to combat diseases such as AIDS. However, governments in the developing countries cannot afford to pay the high prices for the medicines needed to combat the disease. Developing countries must be given the right to distribute these much-needed medicines to their own people under their own licensing terms. This can only be achieved if agreement can be reached by member countries of the World Trade Organisation. The European Union must remain at the forefront in ensuring that the American Government comes to an agreement which will guarantee the distribution of drugs which, in developing countries, could tackle, head on, diseases such as AIDS, malaria and tuberculosis. Time is of the essence in this regard, as the more we delay the more lives are lost.
McNally (PSE, Lab, Eastern). - Mr President, congratulations to Mr Busquin and Mr Gérard Caudron. Gérard has worked quickly but he has not been sloppy or careless. We have been able to put across important points despite working quickly. This is innovation. This is a new use of Article 169 which will lead to considerable leverage, with EUR 200 million from the EU plus EUR 200 million from Member States and we hope for at least that much from industry. In this area the market has failed, as it so often does, and there has been, until now, a certain lack of public leadership, with a particular bottleneck in the clinical trials aspect of finding new products. We have heard that it is the biggest killer, that 5 million people die a year, 95% of them in poor countries. Yesterday, we grieved publicly for the victims of the irresponsible and immoral war in Iraq by wearing black armbands. We should be wearing them every day for the victims of these killer diseases. There is, of course, a multi-pronged attack. This point has been made by other speakers. Other actions are needed but this particular action is research. It is for clinical trials which will lead to the development of new products, in particular a new vaccine for tuberculosis, much better diagnostic tools, and combined medicines for HIV/AIDS which are easier to take and have fewer side effects. That is what we want at the end. That will be the outcome of these clinical trials. We have made the point that they must be targeted. Despite the complexity of the problem let us keep in mind the whole time what we want at the end. We must strengthen the clinical research capacities in developing countries. One of the tragedies of our planet is the waste of human intelligence and creativity in countries which have been politically discriminatory or else riven by poverty. We must encourage that intelligence and creativity by having infrastructure, training and everything else. Everything must be anchored in the developing countries with an understanding that, should we find these things, should we find a better vaccine for tuberculosis, better drugs for HIV/AIDS and better diagnostic tests, they will be available to those that need them. It would be the greatest obscenity to do this work, discover the products and then find that those who need them cannot use them. I am very pleased that has been emphasised and I thank Gérard Caudron very much for his work as well as, of course, Commissioner Busquin.
Hyland (UEN, IRL). - Mr President, there are occasions when words are meaningless and when failure to act undermines the credibility of what we say. Let us hope that this is not another such occasion. If politics is the art of the possible let us now challenge ourselves to do better, to respond in a more positive and caring way to the helpless pleas of those destined to die of AIDS, disease and hunger. Let us give meaningful expression to Article 2 of the European Convention on Human Rights which is the right to life. To me it sounds incredible that we can find billions to inflict the torture of war on humanity and still not have the resources to address the basic human needs of those living in the depths of poverty and despair. Is politics really the art of the possible or have we lost sight of the core values of the society that we purport to represent? [ top ]
What happens nextAwaiting Council common position Parliament expects the swift adoption of the programme at first reading by the Council of Minister. Indeed, the legislative resolution takes the form of a series of compromise amendments agreed after several meetings with Council and Commission. [ top ]
Where the money goes1. Management of the programmeA European Economic Interest Grouping, the «EDCTP-EEIG», will be created by the participating States to provide a legal structure which is responsible to execute the EDCTP Programme. An EDCTP 'Partnership Council' shall define, develop and plan the implementation of strategy. Parliaments wants it to ensure a high level of involvement of developing countries. The EDCTP-EEIG shall be the executive structure and the body responsible for receiving, allocating and monitoring financial contributions from the Community, and shall manage the programme through its secretariat. Community funding is supplemented by national governments or organisations, and industry. Provisions relating to intellectual property rights will be negotiated between the European Commission and the EDCTP-EEIG, and will aim at ensuring that the people of developing countries have an easy and affordable access to research results. 2. Breakdown of the budget according to type of activity:Source: http://europa.eu.int/comm/research/fp6/pdf/edctp_en.pdf
- Basic operation of the EDCTP Programme
- Activities linked to networking and coordination:
- Activities linked directly to the development of new products to combat HIV/AIDS, malaria and tuberculosis, and coexisting infections
- Activities to ensure the development, visibility and sustainability of the programme (€ 10 million):
(Online June 3rd, 2003)
[ top ] |
|||||||
| This page is part of a frameset - click here to reload the index page of the frameset or here for the homepage of the website. |