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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 2011

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

Packaging of medicines for paediatric use: Prescrire's response to EMA (December 2011)

Prescrire’s response to the public consultation on EMA/CHMP/QWP/180157/2011
"Draft -Guideline on Pharmaceutical Development of Medicines for Paediatric Use":
a pragmatic overview and 20 constructive proposals. Read on...
Signal detection left to pharmaceutical companies: danger! (November 2011)

In its answer to the "Concept paper on pharmacovigilance implementing measures", the International Society of Drug Bulletins points out that the first and critical step in pharmacovigilance, namely the detection of safety signals, is left to pharmaceutical companies, despite their conflict of interest. Full transparency is key to avoid missing safety assessment opportunities. Read on...
Revised proposals on "information" to patients: Still an open door to advertising of prescription-only medicines by pharmaceutical companies (October 2011)

In a joint analysis, the International Society of Drug Bulletins (ISDB) and the Medicines in Europe Forum argue that direct-to-consumer "information" on prescription medicines by manufacturers exposes citizens to misleading messages, puts public health at risk and threatens Member States’s social protection systems. Read on...
Simplified examination of variations to the terms of purely national marketing authorisations? Yes, but first re-evaluate "old national marketing authorisations"! (October 2011)

In its response to the public consultation on variations to the terms of national marketing authorisations, Prescrire draws attention to the urgent need to organise a systematic re-assessment of all old national marketing authorisations, to prevent scandals similar to the benfluorex (Mediator°) scandal in France from occurring in other countries of the European Union. Read on...
Response to the HMA/EMA Guidance document on the identification of Commercially Confidential Information and Protection of Personal Data within the structure of the Marketing Authorisation Dossier (August 2011)

In their joint response, HAI Europe and the Medicines in Europe Forum identify several serious shortcomings in the HMA/EMA Guidance Document. They argue in favour of a precise and limited definition of commercial confidentiality, along with regulatory procedures that make transparency the norm and secrecy the exception. Read on...
Packaging for non-prescription medicines: Prescrire's response to EMA (June 2011)

Prescrire's response to the public consultation on EMA/275297/2010 "Draft - QRD recommendations on pack design and labelling for centrally authorised non-prescription human medicinal products" argues that the EMA and the European Commission need to rethink the regulations governing self-medication and safe, easy-to-use medicines. This consultation does not go far enough, as it seeks to accommodate the pharmaceutical companies. Read on...
EMA suggestions on comparative clinical trials fall back behind ethical and scientific standards (March 2011)

A reflection paper from the European Medicines Agency (EMA) outlines proposals on clinical trials procedures that does not properly fulfil its duty to protect European citizen from inferior medicines. A broad coalition of AIM, ISDB and MiEF demands that the EMA adheres to agreed ethical and scientific standards and requests comparative evaluation of new medicines against standard treatment. 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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