• Today, the complex legal framework for pharmaceuticals was reviewed by authorities, lawyers and industry leaders at the 14th Medicines for Europe Legal Affairs Conference.
  • Among other issues, the conference underlined the importance of the SPC manufacturing waiver to encourage investment in pharmaceutical production and R&D in Europe and to foster high-skill job creation and economic growth.

Key authorities, lawyers and industry leaders discussed today in London the key issues in the spotlight for the pharmaceutical industry legal framework: Brexit, the SPC regulation and changes in the EPO. The high level event assessed how various aspects of law affect access to generic, biosimilar and value added medicines in Europe.

The fast changing legal environment was assessed in areas such as the impact of Brexit on the industry, competition in pharmaceuticals including the European incentives review and biosimilar medicines litigation. Interactive expert roundtables covered highly technical topics including second medical use patents, paediatric extensions, statute of limitations in nullity actions, the falsified medicines directive, the role of competition policy to ensure free markets, the concept of plausibility, the practice of search and seizure, and disclosure and data protection and industry codes of conduct.

The anticipated Commission proposal for an SPC manufacturing waiver for pharmaceutical production and R&D in Europe and to foster high-skill job creation and economic growth was discussed in depth. According to a report published by the European Commission, the SPC manufacturing waiver would:

  • Create 20,000 to 25,000 additional manufacturing jobs in Europe by 2025;
  • Increase the net sales for the EU based pharmaceutical industry by €7.3 to €9.5 billion by 2025;
  • Ensure faster entry of generic & biosimilar competition in the EU after SPC expiry – thus, improving access for patients;
  • Enable savings in pharmaceutical expenditures of €1.6 to €3.1 billion thanks to competition;
  • Generate, together with a broader Bolar exemption, additional EU active pharmaceutical ingredient (API) sales of €211.8 to €254.3 million by 2030 creating an additional 2000 jobs in that sector.

“Today’s conference reviewed pathways to encourage competition as well as innovation and growth in the pharmaceutical sector. Patients, governments and healthcare systems rely on a strong generic, biosimilar and value added medicines industry to increase access to medicines and to create jobs for Europe”, said Sergio Napolitano, Legal and External Affairs Director at Medicines for Europe, speaking ahead of the 14th Legal Affairs Conference, “an efficient, pro-competitive legal environment that includes the SPC manufacturing waiver will boost investments in our sector, facilitate faster access to medicines for patients, contribute to the sustainability of healthcare systems across Europe and we stand ready to support these positive measures”.