english.prescrire.org > Topics > Advancing healthcare policy > Advancing healthcare policy in Europe: a chronological recap of actions > 2013 Recap

Advancing healthcare policy

Advancing healthcare policy in Europe: a chronological recap of actions

Advancing healthcare policy

Chronological recap of actions
Actions presented by theme

A recap of actions in 2013

Working together with other organisations, Prescrire's policy advocacy is a source of constructive proposals, counterbalancing the influence of purely commercial interests.

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 Medical Devices: Patient safety should be of paramount importance (November 2013)

In a joint letter, AIM, the ISDB and MiEF call upon the Representatives of Health Ministers of Member States to improve the EU Medical Devices Regulation in order to better protect patients’ safety. 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...
Copies of biotechnology-derived medicinal products ("biosimilars"): the European Medicines Agency (EMA) makes a timid shift towards a more pragmatic approach (October 2013)

In their joint response to the European Medicines Agency (EMA) consultation on its draft revised guideline on biosimilars, ISDB and the Medicines in Europe Forum argue that the costly requirements imposed on biosimilars primarily serve to defend companies' intellectual property, not public health. Read on...
EU Parliament missed needed improvements in the medical devices legislation (October 2013)

In a common press release, AIM, l'ISDB and the Medicines in Europe Forum observe that, although some small improvements have been made on the assessment of high-risk medical devices, major flaws remain in the legislation. Read on...
Transparency in the public interest: How the EMA policy on publication and access to clinical-trial data could help save lives (September 2013)

In their response to a public consultation, Prescrire and its allies welcome the draft policy on "publication and access to clinical-trial data" of the European Medicines Agency (EMA), which could pave the way to a new era in the disclosure of clinical data on medicines. Read on...
Confusion between commercial names: EMA more concerned with defending trademarks than patient safety (August 2013)

Prescrire’s response to the EMA consultation on drug brand names. 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...
Medical devices: joint communication campaign (July 2013)

True or false? Four factsheets answering some key questions on medical devices. A joint communication campaign by ESIP, AIM, ISDB and MiEF. Read on...
Revision of the World Medical Association Helsinki Declaration on ethical principles: Prescrire's response (June 2013)

Prescrire makes 2 crucial points in response to the public consultation on the review of the Helsinki Declaration – Ethical principles for medical research involving human subjects. First, transparency of clinical trial results must be enhanced (articles 23, 24 & 26). Second, caution is needed with the use of placebo (article 32). Read on...
The European Medicines Agency refusing access to administrative documents: Prescrire denounces an unacceptable retrogression (June 2013)

In a letter to the director of the European Medicines Agency, Prescrire makes the case that an ambitious EMA access-to-documents policy is essential if the EMA is to effectively implement the European Regulation on freedom of information (Regulation (EC) No 1049/2001) and in order to ensure that European citizens benefit from the best possible healthcare. 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...
Medical devices legislation: regaining the trust of European citizens (May 2013)

A joint press release by AIM, ISDB and MiEF supports the draft report by MEP Roth-Berendt, rapporteur for the Environnent and public health (ENVI) Commmittee, as this draft report improves upon the European Commission’s proposal for a Regulation on medical devices. Notably, the draft report includes greater protection for patients by strengthening the evaluation of high-risk medical devices before marketing approval. Read on...
Amended proposal for a new directive on transparency measures regulating the prices of medicinal products: still threatening Member States' health systems (April 2013)

The Commission's amended proposal still threatens the structure and quality of Member States' health systems. 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...

2025 Recap
- Errors related to brand names: the EMA can still do more (march 2025)
2024 Recap
2023 Recap
2022 Recap
2021 Recap
2020 Recap
2019 Recap
2018 Recap
2017 Recap
2016 Recap
2015 Recap
2014 Recap
2013 Recap
2012 Recap
2011 Recap
2008-2010 Recap
2005-2007 Recap
The 2002-2004 campaign

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