POVERTY DISEASES New ‘clinical partnership’ to fight a triple plague
Six million deaths – that is the terrible toll suffered by Africans every year due to the ravages of Aids, tuberculosis and malaria. Yet most terrible of all is that this is an avoidable disaster, if only clinical research could develop treatment policies that are appropriate to the precarious living conditions of Africa’s populations. Through the European and Developing Countries Clinical Trials Partnership (EDCTP), allocated funding of €600 million over five years, Europe is making an important and original contribution to combating these poverty diseases.
The main problem facing the fight against poverty diseases is the fragmentation of the research effort and the enormous financial and technical difficulties involved in organising clinical trials in Africa.
A century ago, tuberculosis was one of the biggest killers in Europe and malaria was present in many of its southern regions. Vaccination and the invention of antibiotics in the former case and clean water in the latter changed all that. Thus, Aids, tuberculosis and malaria are not plagues in the face of which medicine is powerless. In Africa, however, health care policies are often unsuited to the context in which these three diseases occur – and are continuing to put a brake on development and to pose a threat to the future.
Deciding priorities Approved unanimously by the European Council and Parliament in 2003, and officially launched this year by the Commission on 22 February in Dakar (Senegal), the EDCTP initiative is the fruit of a lucid analysis of the situation. While fundamental research to develop future vaccines against Aids or malaria is most certainly a necessity, given the terrible toll exacted by current pandemic diseases the first target must be effective treatment. Yet progress in this field often struggles to get beyond the stage of organising clinical trials for potential medicines or vaccines.
To ensure that any conclusions drawn have a sound scientific basis, clinical trials must respect very systematic procedures that require considerable resources and a medical scientific infrastructure of a very high standard. How many promising potential treatments against Aids, tuberculosis or malaria have failed to be explored in the context of African living conditions due to a lack of the necessary financing or organisation? What is more, international co-operation in this field too often produces “the construction of infrastructures showing no regard for local needs, thus bringing no public health benefits, the over-dependence of African countries on developed countries and the brain drain,” says Dicky Akanmori of the University of Ghana, president of the EDCTP’s Developing Countries Coordinating Committee.
The main problem currently facing the fight against diseases of poverty is therefore the fragmentation of the research effort and the enormous financial and technical difficulties of organising clinical trials in Africa. This is essentially the analysis that led to the creation of the EDCTP and which forms the basis of its action and its organisation. Its philosophy can be summed up in one word: partnership.
First there is the partnership between African and European countries (14 EU states plus Norway). Far from adopting an approach of paternalistic assistance, the EDCTP has opted for co-management by Africans, with their irreplaceable knowledge of local situations, and Europeans. The Partnership Board is a symbol of this parity and openness, and functions as a type of scientific board responsible for setting the EDCTP priorities. It is made up of four African scientists, four European scientists and four international experts. The mission of this North-South partnership is to finance – on the dual basis of calls for proposals and project piloting –development of the medical and scientific bases necessary to carry out clinical trials in Africa. Staff training, study grants for African scientists, and the modernisation of medical centres are examples of actions being implemented.
"Our needs lie mainly in the acquisition of new skills. Many care staff have no idea how to carry out a clinical trial in accordance with the criteria required by the international scientific community. We are more than 850 kilometres from the capital here and have to count on our local teams,” says Doctor Leonard Maboko of the Mbeya Medical Centre (Tanzania). Allocated two-thirds of the €600 million available over five years (€200 million from the Union, €200 million from the partner states, and €200 million from other sources, private or international), the development of the material and human infrastructure needed for clinical trials in Africa will absorb the lion’s share of the EDCTP’s provisional budget.
Multiple partnerships In addition to the North-South partnership, there is also the partnership between southern countries. Insufficient means of communication mean that promising experiences in certain parts of Africa – in preventing HIV infection in Uganda, for example, or treating opportunistic infections among Aids sufferers on the Ivory Coast – fail to receive the attention they deserve. The EDCTP is therefore working on setting up a network of African clinical research centres, operating through regular meetings, joint seminars and satellite connection systems.
The northern countries have also entered into a partnership among themselves, so as to avoid unnecessary duplication and regrettable competition between teams pursuing similar projects. One of the EDCTP’s first tasks was to compile a register listing all the clinical trials in Africa that deal with Aids, tuberculosis and malaria as a basis for harmonising trial procedures.
Finally, there are the public-private partnerships. The pharmaceutical industry is often accused of ignoring poverty diseases because they lack profit potential. No doubt there is an element of truth in this criticism, but in a market economy it is difficult to ask companies to work at a loss. Hence, the EDCTP proposes to get round the problem by suggesting the co-financing of trials, to which companies could contribute either by providing the molecules tested free of charge or by granting preferential licences on some of their patents.
This list of partnerships would not be complete without mention of the close relations the EDCTP plans to establish with organisations pursuing similar aims (especially the United Nations Global Fund, the World Health Organisation, and the Bill and Melinda Gates Foundation) – proof that there can be no question of rivalry on such a serious subject.
Efficiency and ethics
The EDCTP is a partnership co-managed by Africans, with their irreplaceable knowledge of local situations, and Europeans.
It is too soon to assess the results of an initiative that has only just started up and whose action will extend over a decade. Nonetheless, nine projects have already been approved for financing, and Pascoal Mocumbi, high representative of the EDCTP, was recently able to welcome the publication of the results of a promising trial in the medical journal The Lancet . Carried out by an international team of several African researchers, this clinical trial involved the vaccination of Mozambican children against malaria and seemed to confirm that the right strategy had been chosen. “This study shows that obtaining a vaccine against malaria is an objective within our reach and has caused us to step up our efforts,” he stated.
Such a complex administrative machinery as that of the EDCTP is always going to suffer from some initial teething problems, especially when seeking to work in partnership with scientists from several dozen countries on two continents. Also, the regrettable and repeated controversies over the ethics of clinical trials in developing countries during the 1990s have not been without their consequences, certain scientists being accused of running trials under conditions that would be judged unacceptable in the industrialised world. The lessons of these controversial issues have now been learned and the EDCTP programme will not finance any project that has not been evaluated in ethical terms and authorised by the health authorities in the countries in question.
"The EDCTP attaches great importance to ethical considerations. Countries without them need to be encouraged to acquire ethical committees, develop the training of researchers, and provide them with on-line access to the necessary documentation,” explains Souleymane Mboup of the Le Dantec Hospital in Dakar (Senegal), member of the EDCTP Partnership Board. In thus affirming the universal nature of medical ethics and working for research on disease and poverty to be undertaken by and for Africans, the European contribution through the EDCTP marks a major and noted change of tone in the fight against diseases of poverty.
New ‘clinical partnership’ to fight a triple plague
The creation of the EDCTP was made possible by virtue of Article 169 of the Treaty of Amsterdam. This article stipulates that “in implementing the multiannual Framework Programme, the Community may make provision, with the agreement of the Member States concerned, for participation in research ...
The creation of the EDCTP was made possible by virtue of Article 169 of the Treaty of Amsterdam. This article stipulates that “in implementing the multiannual Framework Programme, the Community may make provision, with the agreement of the Member States concerned, for participation in research and development programmes undertaken by several Member States, including participation in the structures created for the execution of those programmes”. This article had not been applied previously. The launch of the EDCTP is therefore an important step towards the construction of the European Research Area. With the legal form of European economic interest grouping under Dutch law, the EDCTP is a flexible structure that is open to private partners and able to evolve in line with the new needs in combating poverty diseases that will certainly be felt in the course of the coming years.