Brussels, 24 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.

> Click here to download the press release (pdf, 560 Ko)

Press release

The European Medicines Agency (EMA) has made known that its controversial policy on access to clinical data is to be adopted by mid-July 2014. In the aftermath of a public outcry that criticised the reversal of the draft policy proposal, the agency now claims that it will implement a more "user-friendly" system for researchers. Yet, serious concerns remain as other restrictive measures and legal loopholes are left unaddressed.

In mid-May 2014, the EMA shared documents during a stakeholder consultation that indicated a watering down of its 2013 draft policy on access to clinical data by imposing systematic censorship by pharmaceutical companies, strict confidentiality requirements and wider restrictions on the use of the data (1).

According to the European Ombudsman, such a policy reversal would provide a level of transparency inferior to what is currently guaranteed by Regulation (EC) N°1049/2001 (a) (2). Glenis Willmott, European Parliament Rapporteur for the EU Clinical trials Regulation (adopted in April 2014), has highlighted that "the draft policy represents (…) a step away from the provision of the newly agreed clinical trials regulation" and urged "EMA to work in the spirit of the measures laid down in the Regulation and not to set a worrying precedent by setting up a separate system" (3).

Researchers and civil society groups have also called on the EMA not to backtrack on its previous commitments (1,4to8). Others have investigated the backdrop for such a reversal, questioning the appointment of a new head of legal services with a long career in the pharmaceutical industry (9), and the similarities between the new EMA policy and the out-of-court agreement that the agency had just reached with AbbVie, a pharmaceutical company that had challenged the implementation of EMA's 2010 access to document policy (10) (b). 

A more "user-friendly" system? Improvements for some users
yet legal loopholes remain
Following the public outcry, the EMA announced on 12 June that the management board has asked for the removal of the screen-only restrictions, granting the "possibility to download, save and print the trial data to academic and non-commercial research purposes" (11). The policy is expected to be adopted through written procedure by mid-July 2014. While some might herald these changes as a victory, we advise caution and continue to have serious concerns about the proposed EMA's "redaction principles" and "terms of use", which underlie this new policy.

"Terms of use": forcing data users to enter into legal agreements with pharmaceutical companies. According to health law and policy experts, the EMA's "Terms of Use" document contains several serious legal loopholes (12). For example, users would have to "acknowledge […] that the Information is protected by copyright and proprietary rights (…) and can be considered commercially valuable", even though the notion of clinical data being protected by copyright is highly doubtful. In fact, case law supports access to data on the grounds of health-related human rights (12). Moreover, the EMA is also asking researchers to contractually agree that they can be sued under UK law, making it particularly easy for pharmaceutical companies to challenge them directly in court for violation of the EMA's terms of use (12). As MEP Willmott noted, "Forcing users into legal agreements with pharmaceutical companies could be very problematic" (13).

"Redaction principles": allowing censorship by pharmaceutical companies. According to EMA's proposed "Redaction Principles", companies would submit two different clinical study reports to EMA: a full report that will be kept hidden by the agency; and a redacted report under the guise of protecting "commercial confidentiality" that will be publicly available (1). Pharmaceutical companies are thereby granted the right to choose which data they wish to censor from public scrutiny. Moreover, the application of a "commercially confidential information" status grants the pharmaceutical industry wide and far-reaching data protection (12). For example, companies will be able to withhold information on adverse reactions collected during clinical trials. This leaves European citizens at greater risk for otherwise preventable harm.

The EMA must uphold transparency to defend public health
Having actively participated in the Agency's policy development process, our organisations re-iterate their commitment to full transparency. We provide our rationale below in an effort to encourage the EMA not to succumb to pressures from pharmaceutical companies and the European Commission. We also urge the EMA and the European Commission to respect the political will for increased transparency of clinical trials data in the European Union, which was clearly demonstrated during the legislative process leading to the adoption of the clinical trials regulation.

Clinical study reports (CSRs) are not third-party documents. The rationale behind the proactive draft policy from 2013 was to help interested parties, so that they would no longer need to invoke the European Freedom of Information Regulation (Regulation (EC) N°1049/2001), when exercising their fundamental right to access documents held by the EMA (2).

At present, one of the arguments used by the EMA to hinder full disclosure of clinical study reports (CSRs) is to claim that CSRs are a "third-party document". This is disputable. Even if prepared by the marketing authorisation holder, using data collected from clinical trial participants, patients and healthcare professionals, CSRs comply with regulatory requirements as to content and format and are a key component of marketing authorisation procedures. These data are in essence regulatory data, created for public interest use. When clinical study reports are received at the EMA, they become a "document held by the Agency". As the EMA is a European Institution, Regulation (EC)
N°1049/2001 applies (1,2).

Clinical trial data are public goods. Clinical trial data are public goods that belong to society, not to a particular company (14). Patients taking part in clinical trials are willing to put themselves at risk also in the hope that their participation will benefit society through the advancement of science. The Declaration of Helsinki explicitly states: "Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. (…) Negative and inconclusive as well as positive results must be published or otherwise made publicly available." (15, article 36).

Public access to clinical study reports allows for independent analysis, enhancing knowledge about the real benefits and harms of medicines, and helps prevent fraud and publication bias (examples of Tamiflu°, duloxetine, etc.) (16to18). If pharmaceutical companies, which have huge financial conflicts of interest, control access to the data, then the reliability and reproducibility of science cannot be assured.

Commercial agreements (TRIPS) do not prevent from public access to data. In its response to the EU Ombudsman, EMA's executive director, Guido Rasi, explained the reversal of the policy to be aligned with "the commission's clear message that we would also have to assure compliance with national and international obligations (…) including but not limited to the TRIPS [Trade Related Aspects of Intellectual Property Rights] agreements and copyright laws" (19).

The EU Commission misinterprets article 39(3) of the TRIPS agreements. This article simply precludes competitors from using clinical data collected by other companies when applying for a marketing authorisation for their own product. In case of non-compliance, the dispute is to be settled at the World Trade Organization's dispute settlement body. Under no circumstances should article 39(3) be used to prevent public access to scientific data. In fact, an exception foresees the disclosure of commercially confidential information on the grounds of public interest (20).

In summary. The EMA is a key public institution whose decisions have worldwide implications. We call on the EMA to ensure that its final policy on access to clinical data improves public access to scientific evidence about the effects of medicines on human health.

We also urge the EMA management board members to:

• postpone the adoption of this policy pending the outcome of the Ombudsman's enquiries;
• refuse the move to privatise pharmaceutical knowledge and decline contractual agreements that establish companies' rights over clinical data;
• reject the release of censored documents, a practice which will prevent citizens access to the original documents under Regulation (EC) N°1049/2001, thereby undermining EU citizens' fundamental right of public access to documents. Alternatively, redirect EMA's human and financial resources to the truthful and lawful implementation of Regulation (EC) N°1049/2001;
• ensure that access to the data is guaranteed to the wider public, not only researchers and academics. If the EMA limits access to a selected group of users, it will de facto be maintaining data secrecy.

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

©AIM, HAI Europe, ISDB, MiEF, NCC 24 June 2014

Notes:
a- Regulation (EC) No 1049/2001 establishes the fundamental right for EU citizens to access documents held by the European institutions. It is a reactive policy: the applicant must request access to documents. Through the application of this legislation, the EMA has released 2 million pages of clinical study reports and other internal documents, without requesters having to sign any confidentiality agreement or a restrictive contract such as EMA's proposed "terms of use".
b- Several sections in the clinical study reports that were considered to be "open" in the 2013 draft policy are being considered as "may be commercially confidential information" in the new policy (ref. 21,10). After gaining access to documents, researchers have confirmed that there is "a significant overlap" between what the EMA has accepted to redact in its compromise agreement with AbbVie, and the agency's draft policy on providing public access to drug company data" (ref. 10). The Ombudsman is investigating whether the settlement has indeed directly affected the policy (ref. 22).

References:
1- AIM, HAI, ISDB, MiEF, NCC"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?" Joint Press Release; 20 May 2014: 4 pages. > Pdf
2- European Ombudsman "Ombudsman concerned about change of policy at Medicines Agency as regards clinical trial data transparency" 16 May 2014: 1 page.
3- "Mrs Willmott's Open letter to Executive Director of the European Medicines Agency on clinical trial transparency" 6 June 2014.
4- IQWIG "Just look, but don't touch: EMA terms of use for clinical study data are impracticable" Press release; 27 May 2014: 2 pages.
5- BEUC "EMA must not roll back clinical trial transparency policy" Press Release 12 June 2014: 1 page.
6- HAI Europe "HAI Europe urges EMA not to backtrack on commitments to clinical trial data transparency" Press Release 22 May 2014: 2 pages.
7- Jefferson T, Doshi P "Tamiflu correspondence with the European ombudsman - Letter from Jefferson and Doshi to the European Ombudsman regarding access to EMA held data" BMJ 28 May 2014: 6 pages.
8- Jefferson T, Doshi P "EMA's double U-turn on its Peeping Tom policy for data release" BMJ Blog 13 June 2014: 2 pages.
9- Corporate Europe Observatory "EMA's revolving door with Big Pharma - alive and well" 12 June 2014 : 2 pages.
10- Doshi P "EMA policy on transparency is "strikingly" similar to deal struck with drug company, say experts" BMJ 2014;348:g3852.
11- European Medicines Agency "European Medicines Agency agrees policy on publication of clinical trial data with more user-friendly amendments" Press release 12 June 2014: 1 page.
12- Lemmens T "EMA's Proposed Data Release Policy: Promoting Transparency or Expanding Pharma Control over Data?" Plos Blog 30 May 2014: 3 pages.
13- Willmott G "Reaction to European Medicine Agency's transparency policy" 13 June 2013: 1 page.
14- Lemmens T "Access to pharmaceutical data, not data secrecy, is an Essential Component of Human Rights" 8 April 2014: 3 pages.
15-World Medical Association "Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects" (October 2013) www.wma.net: 8 pages.
16- The Cochrane Collaboration & BMJ "Tamiflu & Relenza: how effective are they?" News release; 10 April 2014: 2 pages.
17- Maund E et coll. "Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder: comparison of clinical study reports, trial registries, and publications" BMJ 2014;348:g3510.
18- Prescrire Editorial Staff "Research scientists: endemic fraud" Prescrire International 2013; 22 (138): 116. > Pdf
19- Rasi G "European Medicines Agency response to European ombudsman letter regarding proactive publication of and access to clinical trial data" 22 May 2014: 2 pages.
20- Wadlow C "Regulatory data protection under TRIPs Article 39(3) and Article 10bis of the Paris Convention: Is there a doctor in the house?" January 2008: 56 pages.
21- European Medicines Agency "EMA Draft policy on publication and access to clinical-trial data": 24 June 2013: 16 pages.
22- Silverman E "Europe Does a U-Turn on Trial Data Policy, Says Ombudsman" Pharmalot 4 June 2014: 2 pages.

> Click here to download the press release (pdf, 560 Ko)