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Today [May 29, 2013] the European Parliament’s ENVI committee voted on the draft report on the Clinical Trials Regulation. EFPIA welcomes the European Parliament’s support of the Commission proposal for an effective, safe, simplified and robust clinical trials authorisation process in Europe (Single Portal, Single Submission, and Single Decision at Member State level) which will ensure patients’ early access to new and innovative treatments. As an industry we are concerned about the unbalanced approach adopted by the Committee on the issue of confidentiality of clinical data. All EFPIA member companies support enhanced sharing of their clinical trial information as a tool to broaden knowledge about our medicines in the best interest of patients and public health. At the same time, there is a need to protect patient confidentiality and commercially sensitive information in this process. Several of the amendments supported by the ENVI committee will jeopardize patient privacy, the integrity of regulatory systems, and incentives for investment in biomedical research in Europe. The issue of data sharing has complex implications for patients, researchers, industry and our legislative and regulatory framework. These need to be fully understood before the issue can be addressed in legislation.
“EFPIA member companies support ongoing efforts to continue improving the diverse means of sharing clinical trial data to benefit patients, foster scientific discovery and support ongoing investment into innovation. This requires industry, regulators, researchers and society to work together to ensure that patient privacy, the integrity of regulatory systems, and incentives to invest in biomedical research are maintained. Together with our international colleagues, we are now working to enhance data sharing with researchers and to enhance access to clinical study results after approval in the interests of advancing science and patient health. The details and mechanisms will be developed in the next few months in close collaboration with stakeholders including the scientific and patient community”, said Richard Bergström, Director General of EFPIA.
EFPIA will work in close collaboration with the scientific community and all interested stakeholders to ensure that the sharing of data will be of the highest quality and that will not result in bad science harming public health. EFPIA is looking forward to a continued and constructive dialogue with policymakers and stakeholders.