Healthy Skepticism Library item: 14998

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: media release

Plugging the ethics gap in European medicines’ authorisation
HAI Europe 2009 Feb 5
http://www.haiweb.org/

Full text:

Today, Health Action International (HAI) member organisation, Wemos launched its European campaign on unethical clinical trials in developing countries (http://www.fairdrugs.org/). HAI Europe warmly welcomes this vital initiative to promote the use of ethically and scientifically sound clinical trials that fully respect the human rights of both trial participants and potential patients.

Unethical science serves no purpose and unethical conduct in clinical trials poses safety risks both for participants and patients. The pharmaceutical industry has to be accountable for how its trials are conducted in developing countries, even when trials are outsourced to third-party researchers. Furthermore, European citizens are entitled to know if the medicines they take have been tested ethically. The public should also be made fully aware of the rationale supporting the agencies’ decisions when approving a medicine for the European market. We should not tolerate a status quo where national and European regulatory authorities can grant authorisations based on
evidence from unethical clinical trials.

This campaign calls on policy makers, regulators and pharmaceutical companies to adhere to existing international guidelines that were formulated to protect the rights oftrial subjects. The Helsinki Declaration is the most widely recognised document for ethical standards and yet, as Teresa Alves of HAI Europe points out “as it stands, there is no ‘translation’ of the Helsinki Declaration provisions and EU regulations into a coherent ethical framework at European level. Clearly, in addition to the standard requirements on efficacy safety and quality, we need a simple set of ethical criteria that can be used by the agencies when evaluating drug trials. We can no longer afford this regulatory gap.”

The Call for Ethical Clinical Trials in Developing Countries initiative will play a valuable role in calling for concrete action, while promoting greater awareness of the issues surrounding medical research today.

For more information, please see the Call for Ethical Clinical Trials in Developing Countries website: http://www.FairDrugs.org/
Joint statement from the Call for Ethical Clinical Trials in Developing Countries initiative:
http://www.fairdrugs.org/uploads/files/Call_for_Ethical_Clinical_Trials_in_Developing