Brussels, 20/12/2013 (Agence Europe) - On Friday 20 December, the Committee of Permanent Representatives (Coreper) reached an agreement with the European Parliament on the proposed regulation on clinical trials on products for human use. This agreement enshrines the compromise reached on 12 December by the trialogue of the Council of Ministers, EP and European Commission. The Lithuanian minister for health, Vytennis Povilas Andriukaitis, who led the discussions on behalf of the Council, welcomed the agreement, which marks a major step towards a more innovative and competitive Europe in the healthcare sector, whilst maintaining a high degree of safety for patients. “This legislative act paves the way for the completion of the single market on clinical trials and medicines for human use with, at its basis, a high degree of protection for health. It also provides high standards of quality and safety for medicines, in order to respond to challenges in terms of safety”, the minister said. Health Commissioner Tonio Borg also welcomed the agreement reached. “The agreement reached today makes the adoption of this regulation possible before the end of the current term in office of the European Parliament”, he said.
In July 2012, the Commission adopted a proposal on clinical trials aiming to breathe new life into clinical research in Europe by improving the authorisation process, which is long and fairly opaque (see EUROPE 10657). The objective was to make the European Union more attractive for clinical research, whilst maintaining rigourous standards in terms both of patient safety and reliability of data. The agreement concluded stipulates that the member states will continue to carry out independent assessments into ethical issues, whilst common rules will govern the protocol followed to carry out clinical trials and publish the data stemming from these, which must be reliable and solidly documented. (IL/transl.fl)