Biomedical Research in Developing Countries - UNICRI

Consequently, these authorities rarely perform GCP trial inspection in developing
countries, except in case the results are to be submitted for an EU marketing
authorization. At the same time, developing countries registration authorities,
where in place, are called to be primarily responsible for licensing of priority drugs
in their countries, when, in the past, they used to rely on the regulatory evaluation
of the agency in the country of origin.
Ethical Aspects of Clinical Research in Developing Countries (2003)
This is an opinion prepared by the European Group on Ethics 17 (EGE, formerly
GAEIB), an independent body created in 1991 to support and advise the European
Commission on ethical values and aspects of science and new technologies, in view
of the preparation and implementation of Community policy and legislation. 15
members that participate in their personal capacities and belong to various
disciplines, such as ethics, law, science, philosophy, theology, political science,
medicine etc, compose the EGE. The EGE issues Opinions after hearings, roundtables
and discussions with the main experts in the fields 18 . Opinion n.17 “Ethical
aspects of clinical research in developing countries” was issued in February 2003, at
the request of the then President of the Commission, Romano Prodi, to provide
advise on the ethics of carrying out EU funded research in economically
disadvantaged countries, in view of the major investments of the EU in the fight
against poverty linked disease such as malaria, AIDS and tuberculosis (see the
EDCPT) as well as to the new possibilities opened by the 6 th Framework Programme
that allows developing countries to apply for EU funds in the area of research.
The EGE opinion mainly stresses the complexities and consequences of social
inequality, poverty and cultural diversity in developing countries and how these
factors can influence research. The opinion states that EU-funded research should
always be based on the fundamental principles of justice, beneficence and nonmaleficence,
should be driven by solidarity and can never be assimilated to an
economic activity. The EGE stresses the investigator’s moral duty to make a concrete
contribution to overcome these inequalities and to ensure that “the fundamental
ethical rules applied to clinical trials in industrialized countries are to be applicable
everywhere” 19 . In addition, research should comply with the health priorities of the
host countries. However, research should not be considered charity assistance. To
this end, partnership with local expertise should be developed at all stages of
17 The European Group on Ethics in Science and New Technologies to the European Commission (EGE), Opinion
No.17, Ethical aspects of clinical research in developing countries, Luxembourg, 4 February 2003
18 European Group on Ethics in Science and New Technologies to the European Commission (EGE) The Ethical
aspects of biomedical research in developing countries. Proceedings of the Round Table debate, Brussels, October 1 st ,
2002, European Commission, February 2003
19 Ibidem, p.12
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