• Monday, January 29, 2018 @ 12:00 am

29 January 2018, Brussels: EuropaBio publishes today a study, which questions a key report used by the European Commission to assess the effects of changing fundamental aspects of the EU patent protection for innovative biologic medicines – an exemption to the rights of patent holders provided by Supplementary Protection Certificates (SPCs) for manufacturing purposes.

Europe Economics reviewed the report that Charles River Associates (CRA) developed for the European Commission and identified a number of areas of concern within CRA’s methodology.

The Europe Economics’ analysis concludes that the report:

  • Does not provide sufficient evidence that the benefits of an SPC exemption for stockpiling outweigh the costs and that other innovative industries would not be affected by such changes;
  • Over-estimates the gains to the EU economy from an SPC exemption for export and disregards the relative value added of the generic and innovator sectors.

“We hope the European Commission will carefully consider the findings of the Europe Economics report. Tackling what is essentially a trade issue by tweaking patent law may have many significant unintended consequences for the EU society and economy. We hope that the report helps the Commission take the time and the effort to make a full and complete impact assessment”, said John Brennan, EuropaBio Secretary General.

EuropaBio will continue to contribute to sound policy-making with valuable insights in the biopharmaceutical ecosystem and business decision-making of our member companies, developing both originator biologics and biosimilars.

Available downloads: