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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 2014

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

Impending approval of a dangerous amphetamine drug for use in weight control? An unacceptable EMA recommendation that must be overturned (December 2014)

Press release. Prescrire denounces the unacceptable decision of the European Medicines Agency (EMA) to recommend that marketing authorisation be granted for the dangerous combination naltrexone + amfebutamone (Mysimba°/Contrave°). EMA's recommendation can still and must be overturned. Read on...
EU trade secrets directive a threat to health, environment, free speech and worker mobility (December 2014)

Joint statement. The proposed trade secrets directive could obstruct recent EU developments on transparency and endangers freedom of information and expression of European citizens. A multi-sectoral NGO coalition calls for greater protections for consumers, journalists, whistleblowers, researchers and workers. Read on...
Medicinal products used in weight control: first, do no harm (follow-up) (December 2014)

Prescrire's response to a European Medicines Agency (EMA) consultation on the evaluation of medicinal products used in weight control. A transitory weight loss of a few kilograms does not justify exposing patients to a disproportionate risk of adverse drug reactions. Read on...
European Medicines Agency (EMA) softens its conflict of interest policy: Does this further open the door to undue influence instead of closing it? (November 2014)

Joint press release (AIM, ISDB, MiEF, NCC). The European Medicines Agency (EMA) has weakened its position in relation to the conflicts of interest of experts implicated in EMA's activities. The Agency's integrity is at stake.
Read on...
WHO statement on public disclosure of clinical trial results: a welcome commitment on transparency (November 2014)

Joint response to World Health Organisation (WHO) public consultation (HAI Europe, ISDB, MiEF, Nordic Cochrane Centre, Public Citizen). In order to achieve ambitious global standards, this comprehensive WHO statement should capitalise even more on the significant recent advancements on data transparency. Read on...
Medicines are not just a commodity: decision to leave responsibility for medicinal products with Health Commissioner welcomed (October 2014)

Joint press release (ISDB, MiEF, NCC). EU Commission President Jean-Claude Juncker has reconsidered: competence for medicinal products is finally to remain with the Health Commissioner. Read on...
EMA's final policy on access to clinical data: proactive access to some data, but strings attached (October 2014)

A disapointing policy, far from the "full transparency" announced by the EMA in November 2012. Redacting to uphold commercial confidentiality gives companies the upper hand on the content of clinical reports that are made publicly available.Read on...
EU Pharmacovigilance public hearings should be as transparent and independent as in the US (October 2014)

In their joint comments to EMA's public consultation, Health Action International (HAI) Europe, the International Society of Drug Bulletins (ISDB), the Medicines in Europe Forum and the Nordic Cochrane Center (NCC) call for more independence and transparency to make the most of EU pharmacovigilance public hearings. 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...
INNs of biologics and biosimilars: consistency must be preserved (September 2014)

Joint response by HAI, ISDB and MiEF to a WHO public consultation. The WHO proposal to assign a "biological qualifier" after the International Nonproprietary Name (INN) of glycosylated biosimilars offers an acceptable solution at global level. Read on...
Mr Juncker, medicines are not just a commodity... (September 2014)

Prescrire and the British Medical Journal send a letter to Jean-Claude Juncker, President of the European Commission. Read on...
A step backwards on pharmaceutical policy at the EU Commission: the move to directorate general (DG) Enterprise and Industry is unacceptable (September 2014)

Joint open letter to President Juncker by 28 organisations. Promoting profit over public health puts European citizens at risk. No, medicinal products are not just a commodity like any other. Read on...
EMA's policy on pharmacovigilance: access to qualitative data is needed, pharmacovigilance data are not "trade secrets" (September 2014)

Joint response to the EMA consultation by the Cochrane AEMG, HAI Europe, ISDB and MiEF. "Protection of personal data" must not be used as a pretext to strengthen intellectual property over pharmacovigilance data. Read on...
Providing "scientific advice" to pharma industry undermines the independence of regulatory authorities (July 2014)

Joint consultation response by AIM, HAI Europe, ISDB and MiEF. Confidential discussions between pharma, EMA and health technology assessment (HTA) bodies threaten independence of pricing and reimbursement decisions. Read on...
'Investor-to-state dispute settlement' in EU–US trade deal threatens access to affordable medicines (July 2014)

Joint response to EU Commission consultation. Non-governmental organisations (NGOs) coalition urges European Commission to exclude mechanism from Transatlantic Trade and Investment "Partnership" (TTIP). Read on...
EMA's new policy on access to clinical data: About to privatise pharmaceutical knowledge? The proof will be in the pudding (June 2014)

EMA's controversial policy on access to clinical data is to be adopted by mid-July 2014 while restrictive measures and legal loopholes are left unaddressed. AIM, ISDB, MiEF and the Nordic Cochrane Centre call on the EMA to not succomb to pressures from pharmaceutical companies and the European Commission. Read on...
Backpedalling on EMA’s "proactive publication of clinical-data" draft policy: Was it all just a window-dressing exercise? Who or what is the EMA afraid of? (May 2014)

In a Joint Press Release, AIM, ISDB, MiEF and the Nordic Cochrane Centre call on the European Medicines Agency to ensure that its long-awaited policy on proactive publication of clinical data actually improves public access to scientific evidence about the effects of medicines on human health. Read on...
Clinical trial data disclosure protects the public from preventable harm (April 2014)

In their Joint Response to a consultation by the US Institute of Medicine (IOM), HAI Europe, ISDB, MiEF and TACD encourage the active implementation of a data sharing policy that ensures full public access to clinical data in the US, in alignment with the new European requirements. Read on...
The US-EU Trade Agreement Proposals by the pharmaceutical industry undermine European public policy making and public health (March 2014)

A report by the Commons Network and civil society partners shows that the pharmaceutical industry's wish list for the Transatlantic Trade and Investment Partnership (TTIP) is detrimental for public health, will increase the cost of medicines and undermines democratic processes. 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...
Is the EMA's window of opportunity as widely open as described? (January 2014)

In a published response to the article in the BMJ "Clinical trial data: get them while you can" (BMJ 2014; 348 g63), Prescrire observes that the European Medicines Agency is not fully meeting its transparency obligations established in EU legislation. Read on...
EU trade secrets directive a threat to health, environment, free speech and worker mobility (December 2014)

Joint statement. The proposed trade secrets directive could obstruct recent EU developments on transparency and endangers freedom of information and expression of European citizens. A multi-sectoral NGO coalition calls for greater protections for consumers, journalists, whistleblowers, researchers and workers. 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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