Madrid, 9 July 2014 – The European Medicines Agency (EMA) is considering adopting a policy on access to clinical trials data which imposes stricter confidentiality requirements and restricts citizens’ ability to exercise the right of access to documents.
The proposed policy on proactive publication of clinical trial data has caused concern for Access Info Europe and other civil society organizations, who fear that the EMA’s ‘Terms of Use’ and ‘Redaction Principles’ would constitute a step backwards for EU transparency. Health organisations and the European Ombudsman were some of the first to express their concerns on the matter [1].
This controversy has led the EMA to delay its final decision on the new transparency policy until 2 October 2014 due to a lack of agreement amongst EMA board members on the final wording of the policy.
The EMA’s draft transparency proposal, presented to stakeholders in May 2014, suggested that data on clinical trials should only be seen on screen through a specific interface provided by the EMA. The proposal also sought to add wide restrictions on the re-use of the data and strict confidentiality requirements.
“The European Medicines Agency takes decisions that affect public health in Europe. Instead of defending the copyright and proprietary rights of pharmaceutical companies, it should work to be as open and transparent as possible”, stated Pam Bartlett Quintanilla of Access Info Europe.
Access Info Europe recalls that access to the EMA’s documents falls under Regulation 1049/2001, which makes clear that “in principle, all documents of the institutions should be available to the public”.
Access Info calls on the EMA to fully commit to proactive transparency by providing access to its documents though an ambitious policy that fulfills the fundamental right of access to information. Given the high public interest in clinical trials data, this information should be made readily accessible online, with no restrictions on its access, re-use and dissemination.
For more information, please contact:
Pam Bartlett Quintanilla | Accesss Info Europe
pam@access-info.org +34 699 354 215 or +34 91 365 6558
References
[1]• European Ombudsman: EMA policy on publication of and access to clinical trial data. 13 May 2014 http://www.ombudsman.europa.eu/en/resources/otherdocument.faces/en/54347/html.bookmark
• European Ombudsman: Ombudsman concerned about change of policy at Medicines Agency as regards clinical trial data transparency at http://www.ombudsman.europa.eu/en/press/release.faces/en/54348/html.bookmark, 16 May 2014
• Health Action International Europe, press release dated 22 May 2014:http://haieurope.org/wp-content/uploads/2014/05/Statement-HAI-Europe-urges-EMA-not-to-backtrack-on-commitments-to-clinical-trial-data-transparency-22-May-2014.pdf