Europe’s biopharma SMEs endorse further clinical data sharing but with reservations

European Biopharmaceutical Enterprises (EBE), a specialized group of the European Federation of Pharmaceutical Industries and Associations (EFPIA), says it recognizes the potential for scientific and public health benefits of providing greater access to information from clinical trials as proposed by the European Medicines Agency.

The majority of EBE members, which are small and medium sized (SME) biopharmaceutical companies, share the EFPIA’s concerns that this could put at risk the promotion of public health, both in Europe and internationally: risks of de-identification of patient data, sharing of companies’ commercially confidential information, and commercial consequences of secondary analysis of data for approved products.

“SMEs fear that certain measures suggested in the EMA draft policy could provoke consequences on their business models and impact on their ability to continue researching in what could become an insufficiently protected/regulated landscape,” stated EBE president Roberto Gradnik.