E-DRUG: 20 May: International Clinical Trials Day 2009
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dear e-Druggers,
Today marks International Clinical Trials Day 2009. Wemos would like to
take this opportunity to thank you for your support for the Call for
Ethical Clinical Trials in Developing Countries and give you an update
on FairDrugs.org, the campaign against unethical testing.
The European Medicines Agency (EMEA) recently announced its intention to
improve supervision of compliance with ethical guidelines in clinical
drug trials conducted outside the European Union. This marks a major
success in our lobbying. But continued pressure will remain necessary.
FairDrugs.org
On 5 February of this year, a research report was published by the
Indian Centre for Studies in Ethics and Rights which again demonstrated
that various pharmaceutical companies continue to flout ethical rules.
People in developing countries continue to be exposed to health risks as
pharmaceutical companies test medicines for the western market on them,
concluded Wemos and the Centre for Research on Multinational
Corporations (SOMO), who commissioned the study.
To coincide with the report, a worldwide coalition of health and human
rights organizations and scientists led by Wemos launched the
FairDrugs.org campaign. In the accompanying Call for Ethical Clinical
Trials in Developing Countries, we appealed to policymakers, legislators
and pharmaceutical companies to respect the rights of trial subjects. In
February, Wemos also sent letters to all public health ministers across
Europe. The letters called on ministers to ensure that the drug
registration authorities in their countries submit any medicines tested
in developing countries to a thoroughgoing ethical evaluation.
In the Netherlands, the Indian report and the campaign attracted
considerable attention across the media. Requests for interviews were
also received from Switzerland, Sweden, the United Kingdom and India.
Dutch ministers Klink (Public Health) and Koenders (Development
Cooperation) were questioned by members of the Dutch parliament.
Professor Marleen Temmerman, senator in the Belgian Parliament and
member of the Committee of Recommendation of the Call for Ethical
Clinical Trials in Developing Countries, questioned the Belgian minister
of Health. Dorette Corbey, Member of the European Parliament, has been
asking questions to the European Commission in Brussels.
EMEA
In mid-February, EMEA announced its intention to pay serious attention
to ethics when approving medicines tested outside Europe. The agency
intends to begin operationalizing international ethical guidelines, such
as the Declaration of Helsinki, particularly in the context of
developing countries. This is a positive development, according to
Wemos Annelies den Boer. We have been expressing our concern about the
increasing number of medicines being tested on people in developing
countries since 2006. We have called for thoroughgoing ethical
evaluations before medicines are given market approval. EMEA now intends
to actually do this.
We are especially interested in how EMEA will tackle the practical
application of international ethical guidelines. We hope that the latest
version of the Declaration of Helsinki will be used as the starting
point and that EMEA will consult experts in developing countries for
advice. We ourselves have already made a start by identifying the most
important bottle necks of the Declaration of Helsinki such as placebo
controlled drugs trials and the right to post-trial treatment. We intend
to make further progress in the upcoming period, along with our partner
organizations in India and Latin America.
Den Boer points out that the registration authorities in European member
states such as the Netherlands Medicines Evaluation Board will also
need to take action. Den Boer: Political support is essential, both at
European level and within member states, if the steps proposed by EMEA
are to be implemented. We see our role as one of mobilizing support and
creating momentum, for example by means of the FairDrugs.org campaign.'
International Clinical Trials Day 2009
On International Clinical Trials Day 2009, a group of European
organizations led by Wemos will again draw attention to the situation of
human subjects taking part in clinical drug trials in developing
countries. The partners will write letters to public health ministers
across Europe, calling for measures to prevent further abuses and for
thoroughgoing ethical checks by the drug registration authorities.
Tomorrow, you will find a copy of the letters on www.FairDrugs.org.
Also, Sandhya Srinivasan, editor of the Indian Journal of Medical Ethics
and author of the research report published in February, will be
visiting Amsterdam to talk to the media about the risks of drug testing
in developing countries. She will join Wemos in discussing ways in which
the position of vulnerable test subjects can be improved.
In the coming period, we aim to collect as many expressions of support
for the Call for Ethical Clinical Trials in Developing Countries as
possible. Numerous health and human rights organizations, students,
scientists, parliamentarians, health workers and other stakeholders have
already added their digital signature at www.FairDrugs.org. You have
also pledged your support. We warmly thank you and encourage you to
think about mobilizing support in your field (student association,
professional organization, hospital, pharmacy, university, research
institute, civil society organization, company, etcetera). Wemos will be
happy to provide ideas. We will keep you informed about how your support
will help exert pressure on politicians and policymakers to safeguard
the rights of trials subjects in developing countries.
Regards
Leontien Laterveer
Senior Communications Officer
Tel: +31 (0)20 435 2062
Wemos Foundation, P.O. Box 1693, 1000 BR Amsterdam, The Netherlands.
Tel: +31 (0)20 435 2050 / fax +31 (0)20 468 6008 / web site www.wemos.nl