Biomedical Research in Developing Countries - UNICRI

irregularities, EMEA can advise the European Commission to refuse authorization
or withdraw it after the medical product has been put in the market.
The EU Regulation 726/2004 12 lays down the procedures for the supervision and
the authorization by EMEA of medicinal products for human and veterinary use 13 .
In the opening, the Regulation calls upon the need to ensure the ethical requirements
of Directive 2001/20/EC 14 “In particular, with respect to clinical trials conducted
outside the Community on medicinal products to be authorised within the
Community, at the time of the evaluation of the application for authorisation, it
should be verified that these trials were conducted in accordance with the principles
of good clinical practice and the ethical requirements equivalent to the provisions of
the said Directive” 15 .
However, a recent report by the Wemos Foundation 16 shows that most European
registration authorities do very little to ascertain whether clinical trials of drugs
conducted in developing countries for subsequent marketing authorization in the
EU, are actually conducted in an ethical manner. Of the 25 EU registration
authorities to which Wemos submitted a questionnaire based on the Declaration of
Helsinki, only 12 responded, representing both the old and the new EU Member
States. The results show very little concern, on the part of registration authorities,
as to the form and independency of the local Ethical Review Committees, poor
attention to the trial’s relevance for the research population, little concern over the
treatment of vulnerable groups, no automatic rejection in case of overall
consideration of unethical conduct. The report finds that European registration
authorities place most of the responsibility for compliance with the ethical
provisions, with the initial review by the local ethical committee, without any
investigation, however, into its actual composition or performance.
For the evaluation of drugs for human use that are only for export, (such as
malaria vaccines, for ex.) or for clinical trials applications done outside the EU,
Regulation 726/2004, at article 58, envisages the possibility of issuing a scientific
opinion by the EMEA. This provision was included by request of the WHO to
prevent a reduction of R&D of new drugs (especially vaccines) as well as a reduction
in their supply to developing countries. Current legislation, in fact, does not obligate
US, European and other countries regulatory authorities to review clinical trials
applications done outside their countries or if the products are only for export.
12 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down
Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and
establishing a European Medicines Agency, OJEU 31 March 2004
13 See also Directive 2005/28/EC of 8 April 2005 by the Commission of the European Union, laying down principles
and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as
the requirements for authorisation of the manufacturing or importation of such products. L 91/13 of 9 April 2005.
14 Directive 2001/20/EC of 4 April 2001 of the European Parliament and of the Council on the approximation of the
laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical
practice in the conduct of clinical trials on medicinal products for human use, OJEU 1 May 2001
15 See also Directive 2003/63/EC, OJEU 27 June 2003
16 The Wemos Foundation, Do European registration authorities ascertain whether clinical trial in developing countries
have been conducted in an ethical manner?, Amsterdam, June 2007
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