Submission of comments on 'Policy 0070 on publication and access to clinical-trial data'

BIO Deutschland, the German Biotech Association, representing research-based biotech SMEs, welcomes the opportunity to submit comments on the draft ‘Policy 0070 on publication and access to clinical-trial data’.

The small and medium-sized research companies are the backbone of the EU. With their innovative ideas and research driven approach they are fostering the development of new product that lead to significant improvements for patients. This R&D should not be slowed down or made impossible by regulations.

BIO Deutschland supports responsible transparency. However, we feel that the current proposal diminishes the protection of personal data and of commercially confidential information (CCI), in a way which would be detrimental to the innovation and growth potential of European biotech companies, large and small. The data from pre-clinical and clinical development are the core value of a drug approval. To gain such data costs hundreds of millions, if not billions, and this process are therefore the most important investment in the industry. Most of the SME active in the field of pharma biotechnology Many SMEs are dependent on venture capital to fund this costly research and development. Therefore the obtained data are of great importance for these companies. By publishing this data the Agency could destroy the business model of innovative biotech SMEs. No investor would provide money if the intellectual property and know-how couldn’t be protected.

The sharing of clinical-trial data with qualified scientific and medical researchers for conducting legitimate research is clearly an issue that needs to be discussed and requires a solid regulatory framework. In this regard it has to be observed that, at the time being, two court cases are pending with the General Court of the European Union, which, inter alia, address the question of the legal definition of commercial confidentiality and whether or not EMA was entitled to give access to clinical trials documents submitted in the marketing authorisation dossiers for Humira (adalimumab) by AbbVie and Esbriet (perfidenone) by InterMune. In April, the Court granted interim injunctions to AbbVie and InterMune, preventing the disclosure of those documents to third parties. It has to be expected that the Court will give in its decision in the main proceedings of these cases general guidance on the publication of clinical-trial data by the Agency.

In order to avoid a situation where the EMA has to revise its Policy on the publication and access to clinical-trial data after these decisions have been taken and becomes liable to damages, BIO Deutschland strongly suggests to pause the development of the new Policy until the ruling of the court are into force. In case the Agency believes that it is necessary to have a Policy in backhand we strongly suggest to let the new Policy only enter into force after the court proceedings are finalised.