European-Developing Countries Clinical Trials Programme (EDCTP)

Bruxelles, le 19 avril 2002

QUESTIONS AND ANSWERS

What is the EDCTP?

EDCTP is a new programme to facilitate and accelerate clinical trials for drugs and vaccines against the 3 poverty- related diseases: malaria, tuberculosis and AIDS, for which there is currently no vaccine and often no medicines adapted to local health and economic conditions. It brings together for the first time European countries and Developing Countries (DCs, initially in sub-Saharan Africa) in a partnership of equals.

Why is the programme focussed on these 3 diseases?

These three diseases are associated to a vicious circle of disease and poverty in many Developing Countries. AIDS is still spreading and Tuberculosis has not ceased to expand since the appearance of AIDS. Together with malaria, these diseases cause more than 5 million victims each year and are a huge economic burden in sub-Saharan Africa. It is estimated that gross national product (GNP) could increase by 1.5% a year with a 50% reduction in morbidity caused by malaria alone.

What will European countries do that they have not done before?

For the first time they will pool and co-ordinate their research activities to find long term solutions to poverty-related diseases, because no single European country possesses all the necessary expertise.

Why is this new initiative being launched now?

The European Commission, as well as the Members states and other European countries, have been doing research on these three diseases for many years. For instance under the Community's Fifth Framework programme (1998-2002) over €100 million has been devoted to research on these diseases. However, it is now time to adopt a more coherent strategy to combat these diseases towards a common goal: the reduction of suffering and poverty.

What will be the role of the European Commission and the Member States?

The European Commission initiated the project and is acting as a catalyst to facilitate the establishment of a joint programme involving the Member States. The Member States and Norway will strive to ensure the coherence of their research activities, identifying synergies and avoiding duplication, even if a measure of competitiveness is desirable.

What will be the role of African countries / Developing Countries within EDCTP?

There are African scientists on the Steering Committee of EDCTP. They are taking part in the design of the programme, the definition of priorities, the definition of criteria for the selection and development of sites. They will take part in the project with their European counterparts, from the initial phase and will drive the following phases up to the conduction of clinical trials on site. They have been chosen based on their experience with the three diseases, their involvement in existing African networks and European research programmes and, of course, their desire to be part of this initiative.

"It is essential that both southern countries and northern countries include this clinical trials programme as one of the priorities for the fight against poverty. EDCTP needs clear political support from now and for several years", said Commissioner for Research Busquin at the launch conference of the EDCTP.

Given the initial focus on sub-Saharan Africa, it is significant that African representatives have been involved in the design of EDCTP initiative from the onset. "This is a great opportunity. This has never happened in the past. Programmes have always been drawn and we have been invited to participate. In this case, we are bringing our knowledge and our knowledge of local institutions to design things right from scratch. This programme is not yet launched so this is a big opportunity to draw on the African experience and make sure that this programme is designed in such a way that it satisfies our all needs and aspirations," said EDCTP member Prof. Fred Binka, School of Public Health, University of Ghana.

What will be the cost, where will the money come from and how will it be used?

The cost of a clinical trial is huge, probably the most expensive part of drug/vaccine development. This is what often prevents companies for developing medicines for countries where they are unlikely to recoup their investment. The overall cost is difficult to assess as it will depend on the level of activity, i.e. the number and scale of trials conducted.

The initial investment to establish EDCTP, set up sites in Developing Countries, training, etc will be provided by the European Commission with a €200 million allocation over 5 years through the Sixth Framework programme (2002-2006). European Countries will contribute in kind through their national research activities. Additional funds may come from Development programmes and donations. However, it is foreseen that actual clinical trials should be funded partly by industry in public-private partnerships intended to share cost and risks.

How will drugs and vaccines candidates be chosen?

The EDCTP will set up an assessment procedure based on principles of impartiality, fairness and transparency, and avoiding possible conflicts of interest, to select the drug and vaccine candidates most appropriate to the needs and conditions in Developing countries.Are there specific needs for drugs and vaccines in Developing Countries?

The drugs or vaccines to be tested in clinical trials will be chosen carefully to take into account the needs and means of the populations concerned, particularly in terms of affordability, ease of use and storage.

Taking an example in vaccines: "… the malaria vaccine candidates that have received a lot of attention by industry have been the vaccines for short term travellers to Africa. For example: business people, tourists and investors. Those people can pay but the types of vaccines that are targeted to assist our poor population received hardly any attention.

What are you doing to take ethical issues into account?

Regarding the clinical trials themselves, it is of utmost importance that they are undertaken in full accordance with recommendations of clinical and ethical good practice. One of the priorities of the EDCTP steering committee will be to ensure that best practice is followed. In addition the Commission has asked the European Group on Ethics in Science and New Technologies to consider this issue and give its opinion.

Commenting on this aspect EDCTP member Dr. Ricardo Thompson, of the National Institute of Health in Mozambique said: "Whenever trials are to be started, a fundamental aspect must be taken into account this is the ethical aspect. The populations must be asked to collaborate and must accept inoculation of a specific product or specific medicine. The ethical aspect includes all these propositions. Moreover, the process of obtaining ethical consent requires clear information of communities on the objectives of the intervention, the advantages that they can expect, the benefits for themselves as well as for developing countries in general."

Is there a role for the pharmaceutical industry?

The participation of the pharmaceutical industry is vital for the success of EDCTP. It supplies more than 60% of vaccines used in DCs and is the main producer of anti-infectious drugs. Many drug and vaccine candidates stem from private research laboratories and the know-how for the development, testing, manufacture and distribution is largely in the private sector. However, the economic conditions in Developing Countries do not make it viable for full commitment of industry. This is where Europe sees its role through EDCTP: to bridge the gap between dispersed research efforts in Europe and the production of drugs and vaccines for Developing Countries.

Emphasising the need to involve the pharmaceutical industry by creating appropriate conditions and incentives, European Commissioner for Research Philippe Busquin said: "It is important for public authorities to initiate the process because clearly there will not necessarily be an industrial return at the first level. If we want this to be affordable for everyone, a co-ordinated effort must support the development of medicines and the implementation of clinical tests, which of course also interest those who will be asked to produce these medicines tomorrow. So that they can be distributed under the best possible conditions."

The EDCTP will go a large step in that direction by providing a platform for clinical trials to be conducted under the best possible conditions for both industry and populations concerned.

The form of the partnership remains to be defined. Many, sometimes contradictory, objectives must be taken into account. Drugs and vaccines should be made available at an affordable price by acting on pricing policies, customs and excise duties, intellectual property rights and the development of local production facilities.

How does this relate to other initiatives in this area?

There has been very little done in the area of research and certainly not on this scale. Most aid is directed at development or on primary care, direct supply and distribution of medicines and massive vaccination campaigns. EDCTP is therefore complementary and directed at providing long-term solutions through research.

When can we expect to see results of this initiative?

Given the different degrees of advancement and taking into account the very long development times for drugs and vaccines, the most optimistic predictions is for suitable malaria drugs in 3-5 years and vaccines for some diseases in 5-10 years.

DN: MEMO/02/77 Date: 19/04/2002