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Advancing healthcare policy

Clinical trials and Europe

Advancing healthcare policy

Clinical trials and Europe: Actions

At certain key points, citizens can bring their actions to bear upon European deputies and upon the ministers of Member States.
Below is a recap of our actions.

EU Clinical Trials Regulation: EMA steers away from transparency by misinterpreting exception provisions (February 2015)

Joint response to an EMA public consultation. The European Medicines Agency (EMA) must stay true to the Clinical Trials Regulation: non-disclosure has to remain the exception, not become the norm! Read on...
New EU Clinical Trials Regulation: a major advance in transparency, to be confirmed (September 2014)

Joint briefing paper by 7 organisations. The major advance in transparency brought by the adoption of the EU regulation on clinical trials needs to be preserved from neutralisation by industry lobbies. Read on...
EU Regulation on clinical trials: close to the finish line (March 2014)

If adopted in early April 2014, the new Regulation on clinical trials should bring greater transparency concerning clinical trial data and results. However, the proposed Trade Secrets directive (published in November 2013) may curb the advances gained in the Clinical Trials regulation. Read on...
EU Regulation on clinical trials: The protection of clinical trial participants must not be undermined (December 2013)

In a joint letter, six organisations call upon the Permanent Representatives of the Member States to ensure that the new Clinical Trials Regulation does not undermine the protection of participants in clinical trials. Read on...
EU Regulation on clinical trials: An urgent call for support to clinical data transparency (November 2013)

Despite the clear stance of the Members of the European Parliament (MEPs) in favour of clinical data transparency, the Ministers of Health of the EU Member States seem reluctant to support greater public access to clinical data. In a joint letter, 6 organisations call upon the Council to choose transparency. Read on...
EU Regulation on clinical trials: the Council must further enhance transparency and participants' protection (July 2013)

In a joint letter, 7 organisations urge the Permanent Representatives (CoRePers) and the Member States' ministers of health to make some needed improvements to the proposed EU Regulation on clinical trials.
Read on...
The debate over EU Clinical Trials Regulation: towards a model that meets real public health needs (July 2013)

In a text published in The Lancet (Vol 381, p1719-1720), Prescrire observes that the debate on proposed European clinical trials regulation offers a major opportunity to redirect clinical research and development towards a model that meets real public health needs. Improved access to clinical trial data would allow independent analysis and early detection of safety problems. Read on...
Clinical Trials Regulation (amendment analysis): ignorance = harm! (May 2013)

A joint open letter by AIM, ISDB and MiEF urges Members of the European Parliament to support the inclusion of strong transparency provisions in the Clinical Trial Regulation that is currently being discussed, and to amend the confusing new definitions proposed by the EU Commission, including that of ‘Low-intervention’ clinical trials. Read on...
Clinical trials regulation: protect public health, choose transparency! (April 2013)

A joint open letter by 11 European or International Organisations urges members of the European Parliament to support the inclusion of strong transparency provisions in the Clinical Trial Regulation that is currently being discussed. Plus, a joint briefing paper debunks secrecy myths that hinder transparency.
Read on...
New proposal for a Regulation on clinical trials: The protection of human subjects must be upheld; Citizens' right to information must be strengthened (February 2013)

In a joint analysis, the Association Internationale de la Mutualité, the Medicines in Europe Forum, the International Society of Drug Bulletins and Wemos argue that, with its proposed new Regulation on clinical trials, the European Commission has overlooked important improvements provided by Directive 2001/20/EC for the protection of subjects enrolled in clinical trials. Most notably, the proposed Regulation could seriously undermine Member States' subsidiarity on ethical matters.
Read on...