Submission of comments on the European Commission’s strategy to better protect health by strengthening and rationalising EU pharmacovigilance


Submission of comments on the European Commission’s strategy to better protect health by strengthening and rationalising EU pharmacovigilance 


EuropaBio welcomes the opportunity to comment on the European Commission’s comprehensive set of proposals which once implemented will have a very positive impact of the pharmacovigilance system in the European Union.

EuropaBio is the European Association for Bioindustries, solely and uniquely bringing together bioscience companies from all fields of research and development, testing, manufacturing and distribution of biotechnology products. It has 84 corporate members operating worldwide, 12 associate members and 5 BioRegions, as well as 25 national biotechnology associations representing some 1800 small and medium sized enterprises involved in research.

Healthcare biotechnology has already had a tremendous impact on meeting the needs of patients and their families, and will continue to represent the state-of-the-art evolution of science as applied to human medicine. Significant advances in biosciences and in manufacturing technologies have led to a steady increase of biopharmaceuticals and advanced bio-therapies that are depending on a regulatory framework that supports innovation.

The Biotech industry has extensive experience with manufacturing processes specific to biotech products and potential safety issues related to changing of production systems. We consider it as important to share our experiences and knowledge to develop adequate tools for managing risks related to adverse events emerging from specific conditions of the manufacturing of biotech products or the specific nature of such products and are ready to engage our efforts together with authorities and other stakeholders for a simplification, harmonisation, and transparency of the Community system. Those challenges have to be tackled in order to contribute to the efficiency of the systems, maintaining the safety of products in the market. The unique objective is to contribute safety of patients in the EU community system. Biotech companies recognise in terms of pharmacovigilance their public health responsibilities especially because they develop complex products.

We believe that the current EU pharmacovigilance system has important public health challenges where the industry is committed to deliver. Duplication of efforts, insufficient transparency, new healthcare technologies to be delivered to patients and realisation of innovative European tools such as the EudraVigilance projects provide excellent opportunities to rationalize the current system.