english.prescrire.org > Topics > Advancing healthcare policy > Advancing healthcare policy in Europe: a chronological recap of actions > 2019 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 2019

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

Access to clinical study reports: EMA's transparency policy and disclosure of vital documents should not be scaled back (December 2019)

Prescrire and 40 other organisations argue in a joint open letter that EMA’s transparency and access to documents policy should not be watered down: instead it deserves greater attention as it is a cornerstone for enlightened research and decision making, public scrutiny and trust in the European regulator. Read on...
The European Medicines Agency's independence is paramount: concrete alternatives to the fee-for-service system must be found (October 2019)

Prescrire's response to a public consultation from the European Commission on the revision of the EMA fee system emphasises that EMA needs to be weaned off a fee-for-service relationship with pharmaceutical companies and funded through public funding from the European Union. Prescrire also called on for adequate public funding for independent post-marketing studies. Read on...
Drug-device combinations: EMA's consultation on quality requirements is an opportunity to strengthen patient safety (August 2019)

Drug-device combinations play a major role in preventing medication errors. The public consultation relating to the draft Guideline for the quality requirements for drug-device combinations is an opportunity for EMA to significantly strengthen its expertise in these health products and patient safety. Prescrire offers a series of recommendations mainly aimed at protecting children, elderly patients, and patients undergoing high-risk hospital care. Read on...
Electronic product information: EMA and competent authorities must guarantee public access to quality information, and uphold the ban on direct-to-consumer advertising (July 2019)

In its response to the EMA consultation on key principles for electronic product information (ePI) for human medicines in the EU, Prescrire underscores the responsibility of EMA and other competent authorities to guarantee the quality of the dissemination of ePI, to avoid any deregulation and to uphold the EU’s ban on direct-to-consumer advertising for medicines. Any ePI should always be considered as option in addition to the printed version of the patient leaflet provided within the product packaging. Read on...
Prescrire's response to the EMA Regulatory Science strategy to 2025: refocus on public health mission as gatekeeper and strengthen pharmacovigilance (June 2019)

Prescrire called on the Agency to refocus its activities on its public health mission as an independent and impartial gatekeeper by requiring robust evidence for the pre-approval process, strengthened monitoring of approved medicines and pharmacovigilance activities and to guarantee full access to data and transparency. Prescrire invites EMA to require robust proof of evidence for the marketing authorisation based on comparative randomised clinical trials with meaningful endpoints. Read on...
Orphan drugs: affordability is at risk due to abuse of orphan drug incentives (April 2019)

In its response to the public consultation on the European Commission's guideline on orphan drugs, Prescrire encourages the Commission to pay particular attention to the extreme profitability of certain orphan products, and to better consider alternative treatments such as off-label use or magistral formulations. Read on...
Patient-centered authorisation and supervision of health products cannot be based on hope and promises: the use of big data needs to rely on facts, trustworthy evidence and transparency (April 2019)

In its response to the public consultation on big data organised by the HMA-EMA Joint Big Data Taskforce, Prescrire considers that regulation on the authorisation and supervision of health products cannot be based on hope and promises but needs to rely on facts, trustworthy evidence and transparency. Read on...
Last chance to safeguard citizens' protections by removing "Innovation Principle" from Horizon Europe (March 2019)

A joint declaration, signed by Prescrire, calls for the immediate and complete removal of the "innovation principle" from Horizon Europe, the next EU Framework Programme for Research and Innovation, because it threatens the Precautionary Principle and is nothing more than an attempt to keep regulation of dangerous products at bay. Read on...
A call for timely application of the new rules on medical devices and complete transparency concerning high-risk medical devices with public access to Eudamed (February 2019)

The European Association of Hospital Pharmacists (EAHP), the European Hospital and Healthcare Federation (HOPE), the European Social Insurance Platform (ESIP), the International Association of Mutual Benefit Societies (AIM), Prescrire and the Standing Committee of European Doctors (CPME) call for timely application of the new rules on medical devices and complete transparency concerning high-risk medical devices with public access to Eudamed. Read on...
It is high time to put an end to EMA's opaque and confidential practice of early scientific advice (January 2019)

In their joint response to the EU Ombudsman's consultation on the pre-submission "scientific advice" provided by EMA to pharmaceutical companies, ISDB and Prescrire argue that it is high time to put an end to EMA's opaque and confidential practice of early scientific advice and to take resolute action to promote independence and transparency. Read on...

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2019 Recap
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2015 Recap
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The 2002-2004 campaign

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