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Brussels, 2 April 2014
Statement by Health Commissioner Tonio Borg following the vote in Parliament on the Clinical Trials Regulation
"I welcome the Parliament’s positive vote on the revised rules for clinical trials, and thank the rapporteur Ms Glenis Willmott for her commitment and hard work.
This endorsement brings us one step closer to ensuring an environment that is favourable for conducting clinical trials, with the highest standards of patient safety, for all EU Member States. Intrinsic to this is the simplification of current rules, featuring a ‘one-stop’ portal and database for submitting applications, a quick and flexible assessment procedure, a simplified reporting system and clearer, simpler rules for running multinational trials.
Clinical trials are a vital step in the development of new and safe medicines and in the improvement of existing treatments. That's why today’s vote is especially good news for patients - the main beneficiaries of clinical trials. They are crucial for patients affected by serious or rare diseases, as often they are the only way for them to have access to the most advanced, life-saving treatments.
Moreover, taken together, the new measures should save research institutions and companies conducting clinical trials in the EU € 800 million per year in regulatory costs – removing the most significant barrier to keeping clinical research within EU borders.
With over € 20 billion spent annually in the EU on pharmaceutical innovation and health-related research & development, it is vital for the EU economy that we remain major players in this booming sector.
I am convinced that the new rules will ensure a big boost for research & development in the EU for the benefit of patients, and contribute to the Europe 2020 objectives of smart, sustainable growth.
I would like to thank the Parliament and the Council for their work which will enable the Regulation to enter into force in the coming months.”
For more information: MEMO/14/254
Follow me on Twitter: @borgton