Brussels, 27 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.

> Click here to download the complete response (pdf, 540 Ko)

Joint Press Release

On 22 November 2012, building on its previous efforts to increase transparency, the EMA organised a workshop on clinical-trial data and transparency. Following that workshop, the Agency established advisory groups to help develop a policy on publication of and access to clinical-trial data, which has recently been released for public consultation

In its draft, the EMA proposes "proactive publication of clinical-trial data" submitted in support of a marketing-authorisation application. Many elements from clinical study reports (CSRs) would finally become publicly available. This is a step in the right direction, as there is currently a lack of public access to the full body of available scientific evidence about the effects of medicines on human health (with data frequently being withheld or manipulated when results do not favour the trial sponsor's product, as shown during recent litigation brought against pharmaceutical companies). Clinical trials have to comply with the Declaration of Helsinki, which explicitly mentions the ethical obligation to disclose research results.

A critical time for clinical-trial data. Earlier this year, seizing the opportunity provided by the ongoing discussions on the European Commission's proposal for a new regulation on clinical trials, the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) aligned the proposed clinical trials regulation with the EMA's 2010 policy, and publicly supported the Agency's commitment to transparency

Not surprisingly, the news of the EU Parliament's endorsement of the EMA's efforts has travelled far beyond Europe. In a move to maintain data secrecy, pharmaceutical industry trade associations in the EU and US are counteracting the EMA's initiatives by supporting the litigation initiated by two pharmaceutical companies against the EMA at the European Court of Justice. Among other measures, these trade associations are seeking to prevent data transparency by "mobilizing patient groups to express concern about the risk to public health by non-scientific re-use of data" and by proposing deficient and non-binding self-regulation principles that would maintain the status quo

The EMA's transparency efforts are in the interests of public health. Having actively participated in the Agency's policy development process, our organisations re-iterate their commitment to full transparency and urge the EMA to:

• Extend the scope of its transparency policy to provide access, retrospectively, to clinical-trial data concerning all medicines approved over the last 10 years (2004 to 2014), whether centrally (by the EMA) or through the decentralised procedure or mutual recognition (by the CMDh);
• Introduce a more stringent definition of "commercially confidential information" in order to ensure that transparency remains the rule rather than the exception. Any exception to disclosure should only involve the removal of specific elements within a document and should never be applied to entire sections or certain types of documents;
• Beware of the use of "patient confidentiality" as a pretext to prevent the disclosure of clinical data;
• Incorporate access to data concerning medicines into other EMA processes, particularly pharmacovigilance (e.g. European public assessments reports (EPARs) should be immediately updated and made available, particularly in the case of a "variation" prompted by safety issues).

By proactively granting public access to information on the efficacy and safety of medicines, the EMA new draft policy could prevent drug-induced harm and help save patients' lives, provided that it is properly structured and implemented.

Association Internationale de la Mutualité (AIM)        
Health Action International (HAI) Europe           
International Society of Drug Bulletins (ISDB)
Medicines in Europe Forum (MiEF)

©Prescrire September 2013

> Click here to download this Joint Press Release (pdf, 178 Ko)

> Click here to download the complete response (pdf, 540 Ko)