The European Group on Ethics makes public its Opinion on the Ethical aspects of clinical research in developing countries

Brussels, 5 th February 2003

The European Group on Ethics in Science and New Technologies (EGE), chaired by the Swedish Philosopher, Göran Hermerén, has presented to the European Commission on February 4 th 2003 its Opinion n° 17 on the Ethical aspects of clinical research in developing countries. The EGE, with this opinion, welcomes the EU policy of funding research in developing countries to fight against poverty-linked diseases.

The EGE is an independent, multidisciplinary and pluralist instance, composed of twelve members. Its role is to advise the Commission on how the ethical values of the European society can be taken into consideration in the scientific and technological development promoted by Community policies.

This Opinion of the Group aims at providing advise to the Commission on the ethical aspects of implementing EU-funded research activities in countries which culturally or economically differ from the West European context.

Indeed, the 6 th Framework Programme, launched by Commissioner Busquin, opens the possibility for developing countries to get EU funding in all research areas. Furthermore, a long-term partnership between Europe and developing countries to join efforts to combat poverty-linked diseases such as AIDS, malaria and tuberculosis has been initiated, for a budget of €600 million.

Clinical trials in developing countries give rise to ethical questions specifically linked to socio-economic inequalities, poverty and cultural diversity. The EGE stresses that the huge economic inequalities are the cause of most of the problems raised in this Opinion and that " the private or public investigators who do their research in developing countries have a moral duty to make a concrete contribution to overcome inequalities ".

The Group stresses that the implementation of EU research programmes in developing countries should be based on solidarity , in line with the Charter of Fundamental Rights . "Therefore, research activities involving human subjects cannot exclusively be assimilated to an economic activity subject to market rules. Health should be regarded as a public good rather than a commodity."

The general approach chosen in this Opinion is that "the fundamental ethical rules applied to clinical trials in industrialised countries are to be applicable everywhere" , namely:

• the principle of respect for human dignity and the principles of non-exploitation, non-discrimination and non-instrumentalisation,

• the principle of individual autonomy, entailing the giving of free and informed consent by each individual involved in a trial,

• the principle of justice and the principle of beneficence and non-maleficence, namely with regard to the improvement and protection of health,

• the principle of proportionality, between methods and aims of research.

• The Group stresses that clinical research should only be carried out in developing countries with good justification ; when the research has a specific interest and complies with the health priorities of the host country and not for reasons of pure convenience.

• The Group underlined the importance of partnership stating that "the involvement of local scientists from the host country at the very early stage of the planning and implementation of the research activities is crucial to develop a culture of collaboration which is different from charity help".

• The Group insists that the evaluation both scientific and ethical of research protocol should involve local committees, or local independent experts. The Group states that "Where it is not possible to involve such an independent local representative in the evaluation, then no clinical trial should be implemented in the country".

• Concerning the use of placebo in clinical trials, the Group considers that the use of placebos should be regulated in developing countries in principle by the same rules as in European countries. Any exception must be justified and "the justification clearly demonstrated in the research protocol submitted to the ethical committees and especially approved by the local committee". For instance, a justification could be that the goal of the research is to develop low cost treatment when the existing standard treatment is unaffordable to poor countries. Nevertheless, two members of the Group consider that the use of a placebo for the purpose of developing low cost treatment could mean accepting a "double standard" for poor and rich countries.

• In the context of cultural diversity, the Group emphasized that "both the values and ethical principles of the funding agencies and of the host country have to be considered" and "in the case of conflicting views between parties, every effort should be made to negotiate solutions but without compromising the respect of fundamental ethical principles".

http://europa.eu.int/comm/european_group_ethics

DN: IP/03/193 Date: 05/02/2003