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Advancing healthcare policy

Via its policy advocacy, Prescrire acts as a force for change in health policies, first and foremost in the interest of patients.

Advancing healthcare policy

Chronological recap of actions
Actions presented by theme

Transparent, independent health authorities: The worldwide debate on access to clinical trial data

From around 2010 on, the debate around public access to clinical trial data has intensified. In order to block transparency, pharmaceutical companies often invoke notions of intellectual property.

Prescrire's analysis of EMA's transparency policy over the last 10 years: EMA's reply with Prescrire's comments (6/2022)
Corporate influence on medicines policy and on regulatory decision-making needs more scrutiny (2/2020)
Independent information does exist, but deserves more attention and visibility (2/2020)
Access to clinical study reports: EMA's transparency policy and disclosure of vital documents should not be scaled back (12/2019)
EMA's independence is paramount: concrete alternatives to the fee-for-service system must be found (10/2019)
Prescrire's response to the EMA Regulatory Science strategy to 2025: refocus on public health mission as gatekeeper and strengthen pharmacovigilance (6/2019)
It is high time to put an end to EMA's opaque and confidential practice of early scientific advice (1/2019)
Public funding is key for the independence of the EMA (7/2018)
No to EMA's provision of confidential scientific advice to drug companies (11/2017)
Prescrire applauds the work of the European Ombudsman over the past several years (7/2017)
Proposed changes to EMA's access to documents policy fall short on proactive disclosure (5/2017)
Antidiabetic drugs: demand clinical endpoints that are useful to patients, and evaluate risks before, not after, MA (10/2016)
EMA's report on adaptive pathways: little data and much ado about nothing (8/2016)
Joint response to the EMA public consultation on "Scientific guidance on post-authorisation efficacy studies" (1/2016)
A PRIME example of how EMA is pushing for accelerated market approvals, but at what cost for patients? (12/2015)
"Adaptive licensing" or "adaptive pathways": Deregulation under the guise of earlier access (10/2015)
Marketing authorisation flexibilities should only respond to true needs and must protect patients' safety (9/2015)
European medicines agencies must address independence and transparency problems (7/2015)
EU Clinical Trials Regulation: EMA steers away from transparency (2/2015)
European Directive on trade secrets: A threat to access to public health data (2/2015)
EMA softens its conflict of interest policy (11/2014)
WHO statement on public disclosure of clinical data: joint response (11/2014)
EMA's final policy on access to clinical data (10/2014)
Clinical trials regulation: a major advance in transparency (9/2014)
EMA's policy on pharmacovigilance data (9/2014)
Providing "scientific advice" to pharma industry undermines the independence of regulatory authorities (7/2014)
EMA's new policy on access to clinical data (6/2014)
Backpedalling on EMA’s "proactive publication of clinical-data" draft policy (5/2014)
The US-EU Trade Agreement Proposals by the pharmaceutical industry undermine European public policy making and public health (3/2014)
Is the EMA's window of opportunity as widely open as described? (1/2014)
Transparency in the public interest: How the EMA policy on publication and access to clinical-trial data could help save lives (9/2013)
Transparency in the public interest: How the EMA policy on publication and access to clinical-trial data could help save lives (9/2013)
EMA refusing access to administrative documents: Prescrire denounces an unacceptable retrogression (6/2013)
Clinical trials regulation: choose transparency! (4/2013)
Access to EU's documents is essential (6/2012)
EU Parliament says no and no again to EMA (5/2012)
Fingolimod (Gilenya°): EMA's lack of transparency spells danger for patients (2/2012)
Response to HMA/EMA on identification of commercially confidential information (8/2011)
Pioglitazone: EMA fails again to be transparent (7/2011)
Prescrire maintains 5 complaints against EMA for refusal to provide information (3/2011)
EMA road map: independence should be the priority (4/2010)
Transparency at EMEA: Prescrire's assessment over 4 years (9/2009)
In brief
Why it matters
Actions vis-à-vis regulatory agencies
The worldwide debate on access to data
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