Out-Law News 4 min. read

European Medicines Agency rejects Ombudsman's concerns on public access to clinical trial data

The European Medicines Authority (EMA) has rejected suggestions by the European Ombudsman that the EMA could undermine the public's right of access to clinical trial data if it proceeds with its draft policy relating to public access to the data. 

The move comes after European Ombudsman Emily O'Reilly, who is responsible for investigating alleged maladministration in EU institutions and bodies, wrote to the EMA expressing concern at "what appears to be a significant change of policy concerning clinical trial data transparency".

After examining the EMA's draft policy relating to public access to the data, the Ombudsman's office said the EMA is envisaging limiting access to clinical trial data by imposing "strict confidentiality requirements". According to the Ombudsman, this would include allowing data only to be seen on screen using an interface provided by the EMA. The Ombudsman also said that the EMA also envisages imposing "wide restrictions" on the use of such data.

The EMA has denied this is the case, saying it intends to make the information publicly accessible online, and that restrictions are designed to prevent those who access the information using it for commercial gain by.

According to O'Reilly, the content of EMA's draft policy are at odds with the "fundamental rights of public access" which people enjoy under Regulation 1049/2001 of the European Parliament and the Council of the European Union, which deals with issues relating to public access to European Parliament, Council and Commission documents. Because the EMA is the agency of the EU which has responsibility for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU, its documents are also subject to Regulation 1049/2001.

O'Reilly's office also pointed out to the EMA that the European Parliament last month voted in favour of draft legislation which would require pharmaceutical companies and other medical researchers to post results of all their European clinical trials on a publicly-accessible online database.

O'Reilly has now asked EMA director Guido Rasi to inform her by 31 May how the EMA intends to deal with requests for public access to existing clinical trial data. She has also asked Rasi to outline the reasons and the legal basis for the agency's policy.  

The EMA has denied attempting to undermine rights in relation to accessing documents It told Out-Law.com that it provided the Ombudsman with a number of documents relating to its draft policy on publication of and access to clinical trial data earlier this month, after inviting the Ombudsman and other stake-holders to a meeting which the Ombudsman was not able to attend. The EMA said these included a slide presentation, and draft documents entitled 'Redaction principles' and 'Terms of use'.

In her letter to Guido Rasi, director of the EMA, on 13 May, O'Reilly wrote: "In your letter of 31 July 2012 to my predecessor, you had pointed out that EMA was moving ahead with its plans 'proactively to publish clinical trial data and enable access to full data sets to interested parties'. I had understood that EMA's intention was to give proactive access to the relevant documents in order to make it unnecessary for interested parties to exercise the fundamental right of access to documents by making requests under Regulation 1049/2001."

"However, from the documents that I received, it appears that EMA now envisages a policy that very much differs from what I had understood to be EMA's initial approach," O'Reilly wrote. "In fact, on the basis of these documents, it appears that EMA envisages to make available clinical-trial data, with the exception of what it considers to constitute 'Commercial confidential Information', to natural or legal persons or organisations that have registered with EMA and that agree to the conditions for such access that are set down in the 'Terms of use'."

"Unless I am very much mistaken, the relevant documents do not contain any reference to Regulation 1049/2001,"O'Reilly's letter said. "However, it cannot be excluded that EMA considers that its proposed new policy provides the same level of transparency that would also be guaranteed by the said regulation."

"I think it is obvious that such an assumption would not be well-founded," the letter said. "To highlight just one fundamental difference, a person exercising the fundamental right of public access under Regulation 1049/2001 does not have to state any reasons for his or her application. Nor does Regulation 1049/2001 foresee any conditions that an applicant would have to accept as regards the use he or she intends to make of the documents to which access is requested. It may be useful to recall that, according to Article 73 of Regulation 726/2004, Regulation 1049/2001 shall apply to documents held by EMA."

"I should therefore be grateful if you could inform me, by 31 May 2014, about how EMA proposes to deal with requests for public access, submitted under Regulation 1049/2001, to clinical-trial data in the future," O'Reilly wrote. "I would also very much appreciate it if you could explain to me the reasons, and the legal basis, for what appears to be an important change in direction as regards EMA's approach to transparency in this area."

The EMA spokesman told Out-Law.com that it intends to make clinical trials data available online, accessible from anywhere and denied that terms of access and conditions are designed to restrict public access to the information.

The spokesman added: "There will be terms and conditions relating to access. Individuals will be given a user identity, a password and will be asked to accept terms and conditions of use, such as agreeing not to use the information for commercial purposes such as making medicines."

"This is a draft policy, it has not been finalised. It is about facilitating proactive access to clinical trials data," said the EMA spokesman. "We are not seeking to undermine rights in relation to access to documents."

According to O'Reilly's office, the Ombudsman has conducted more than a dozen inquiries into EMA during the past five years. Many concerned refusals to make public documents regarding the authorisation and regulation of medicines by the EMA, including medicines for treating multiple sclerosis, acne, bacterial infections, and obesity.

"The EMA is striving to balance the interests of all stakeholders and is adopting a step wise approach to the roll out of its new policy," said life sciences expert Helen Cline of Pinsent Masons, the law firm behind Out-Law.com.

"In the first instance only parts of the Clinical Study Reports (CSRs) will be released to test drive and establish trust and confidence in the new system. The Redaction Principles clarify that only under limited circumstances may Clinical Study Reports (CSRs) be considered commercially confidential information (CCI)," she said. 

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