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Advancing healthcare policy

Transparent, independent health authorities

Advancing healthcare policy

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Transparent, independent health authorities: Actions vis-à-vis regulatory agencies

Prescrire regularly calls upon regulatory agencies to fulfil their obligations of transparency and independence, thus helping to instill better practices day to day.

Prescrire's analysis of EMA's transparency policy over the last 10 years: EMA's reply with Prescrire's comments (June 2022)

Prescrire sent a copy of its article "European Medicines Agency: transparency policy marred by too many failings" (Prescrire Int 2022; 31 (237): 130-138) to Emer Cooke, Executive Director of the European Medicine Agency. In this article, Prescrire calls for an official inquiry in order to analyse the causes EMA's failings, and to enable Members of the European Parliament to take appropriate steps. Here is Emer Cooke's reply (20 May 2022), with comments added by Prescrire. Learn more...
Corporate influence on medicines policy and on regulatory decision-making needs more scrutiny (February 2020)

In a published response to the article "Pathways to independence: towards producing and using trustworthy evidence" published online at bmj.com (BMJ 2019;367:l6576), Prescrire argues that public funding and elimination of industry capture of medicines agencies are crucial pathways to independence, essential to better serve patients, healthcare professionals and the public. > Learn more
Independent information does exist, but deserves more attention and visibility (February 2020)

In a published response to the article "Pathways to independence: towards producing and using trustworthy evidence" published online at bmj.com (BMJ 2019;367:l6576), Prescrire points out that independent sources of information do exist, and many, like Prescrire, are members of the International Society of Drug Bulletins. > Learn more
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...
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...
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...
Public funding is key for the independence of the European Medicines Agency (EMA) (July 2018)

Prescrire's contribution to a public consultation on the EMA fee system for the approval and monitoring of medicines calls for a ban on any direct financial relationship between the Agency and pharmaceutical companies. To guarantee the EMA's independence, and to make sure that the agency is acting as a regulator protecting public health rather than industry interests, EMA should solely be financed through public funding. Read on...
No to EMA's provision of confidential scientific advice to drug companies (November 2017)

Prescrire, along with around 20 civil society organisations, has signed a joint declaration drawing attention to potential problems posed by the provision of confidential scientific advice by the European Medicines Agency to pharmaceutical companies, in particular a lowering of the regulatory bar, a risk of regulatory capture, and a total lack of transparency surrounding the activity of European regulatory authorities. Read on...
Prescrire applauds the work of the European Ombudsman over the past several years (July 2017)

In its response to the public consultation on strategy "Towards 2019", Prescrire applauds the European Ombudsman's work over the past several years, particularly as regards transparency, access to documents and prevention of conflicts of interest at the level of the European Medicines Agency. Read on...
Proposed changes to EMA's access to documents policy fall short on proactive disclosure (May 2017)

In a joint response to the EMA's consultation on its policy on access to documents, Health Action International, the International Society of Drug Bulletins, NoGracias, the Nordic Cochrane Centre and Prescrire called for a comprehensive public register of all the documents the EMA produces and receives. The coalition also strongly encourages the EMA to increase resources so it can more efficiently handle access requests to documents. Read on...
Antidiabetic drugs: demand clinical endpoints that are useful to patients, and evaluate risks before, not after, market authorisation (October 2016)

In its response to an EMA consultation, Prescrire underscores the importance of evaluating the efficacy of antidiabetics using clinical endpoints useful to patients, and of evaluating their risks properly, in particular their cardiovascular risks, before authorisation rather than afterwards. Read on...
EMA's report on adaptive pathways: little data and much ado about nothing (August 2016)

In a joint press release, the International Society of Drug Bulletins, the Medicines in Europe Forum and the Nordic Cochrane Centre observe that EMA's report on "adaptive pathways" delivers little factual data but seems to indicate disappointing results for the controversial pilot project. Read on...
Joint response to the EMA public consultation on "Scientific guidance on post-authorisation efficacy studies" (January 2016)

Joint Response by Prescrire, The International Society of Drug Bulletins and the Nordic Cochrane Centre. Paving the way to faster approvals but at what cost? Read on...
A PRIME example of how EMA is pushing for accelerated market approvals, but at what cost for patients? (December 2015)

Joint response by ISDB, HAI, MiEF, the Mario Negri Institute, Nordic Cochrane Centre and WEMOS to the European Medicines Agency public consultation on the Draft Reflection paper on a proposal to enhance early dialogue to facilitate accelerated assessment of priority medicines (PRIME). Read on...
"Adaptive licensing" or "adaptive pathways": Deregulation under the guise of earlier access (October 2015)

Joint briefing paper. "Adaptive pathways" raise numerous concerns from a public health perspective. The organisations that endorse this statement have closely monitored developments in EU pharmaceutical regulation for many years and put forward a critique of the "adaptive pathways concept". Implementing adaptive pathways could lead to a situation where premature marketing authorisations become the rule, even when no genuine public health need exists, therefore putting EU citizens' health unnecessarily at risk. Read on...
Marketing authorisation flexibilities that enable early access to medicines should only respond to true unmet medical needs and must protect patients' safety (September 2015)

Joint response to an EMA public consultation on the Guidelines to implement accelerated assessment and conditional marketing authorisation for medicinal products for human use. Read on...
Health groups call on European medicines agencies to address independence and transparency problems (July 2015)

Joint response to an EMA public consultation. The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) are in danger of failing to address urgent public health needs due to a lack of independence and transparency.
Read on...
EU Clinical Trials Regulation: EMA steers away from transparency by misinterpreting exception provisions (February 2015)

Joint response to an EMA public consultation. The European Medicines Agency (EMA) must stay true to the Clinical Trials Regulation: non-disclosure has to remain the exception, not become the norm! 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...
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...
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...
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...
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...
Access to EU's documents is essential to advance transparency and to serve public health (June 2012)

In a joint letter to the EU Commission, the Medicines in Europe Forum (MiEF), the International Society of Drug Bulletins (ISDB) and Health Action International (HAI) Europe call on Members States and on the Commission to take a clear and unequivocal position in favour of strengthened transparency in Europe. Read on...
EU Parliament says no and no again to EMA: Independent groups echo decision (May 2012)

Health Action International (HAI) Europe, the International Society of Drug Bulletins (ISDB) and the Medicines in Europe Forum (MiEF) welcome and support the European Parliament's decision to postpone the discharge of the European Medicines Agency's (EMA) accounts (2012). For the second year in a row, the Parliament has postponed this decision due to concerns, among others, about the management of conflict of interest risks at the Agency. Read on...
Fingolimod (Gilenya°): European Medicines Agency's lack of transparency spells danger for patients (February 2012)

The European Medicines Agency (EMA) has refused to supply Prescrire with the detailed data in its possession on cases of death which occurred following the first dose of fingolimod (Gilenya°). This lack of transparency spells danger for patients. 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...
Pioglitazone (Actos°): the European Medicines Agency (EMA) fails yet again to be transparent (July 2011)

The European Medicines Agency (EMA) has refused to provide Prescrire with the detailed data in its possession concerning the risk of bladder cancer with pioglitazone (Actos°).It is time that the European Commission firmly redirects EMA back to its mission of protecting the public, in particular by insisting on a major clean-up in the Agency's conflicts of interest with pharmaceutical companies. Read on...
Prescrire maintains its 5 complaints against the European Medicines Agency for refusal to provide information (March 2011)

Prescrire filed 5 complaints with the European Ombudsman on 30 August 2010, citing repeated refusals by the European Medicines Agency (EMA) to provide documents and information, in particular concerning drugs with a negative risk-benefit balance. After EMA's response in January 2011, Prescrire decided to maintain all 5 of its complaints. Read on...
The European Medicines Agency Road Map to 2015: Independence should be the priority (Joint Contribution to EMA Consultation, April 2010)

HAI Europe, ISDB and the Medicines in Europe Forum have jointly answered the EMA's public consultation on its road map to 2015. They decry a number of practices that create conflicts of interest, and argue that the Agency’s financial and intellectual independence from pharmaceutical companies should be the priority if the EMA is to improve its accountability to citizens. Read on...
Legal obligations for transparency at the European Medicines Agency: Prescrire’s assessment over four years (September 2009)

Prescrire and the Medicines in Europe Forum contributed jointly to reinforcing the transparency rules that apply to EU drug regulatory agencies, now enshrined in the 2004 Directive and Regulation. Prescrire assessed how the European Medicines Agency (EMEA) implemented its legal obligations for transparency over a four-year period. Read on...

In brief
Why it matters
Actions vis-à-vis regulatory agencies
The worldwide debate on access to data
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