Later this week in Brussels, Belgium, the European Generic and Biosimilars Medicines Association (EGA) will host its 11th Legal Affairs Forum. The Forum will be held on March 26-27, 2015 utilizing an interactive format that provides ample opportunities for learning from each other and networking. This year the Forum features the following topics:
- EGA 2020: where are the latest trends leading this sector?
The Forum will kick off with a panel discussion between the general counsels of several EGA member companies. The themes that will be discussed include the opportunities and threats that the sector is going to face in the next five years in light of the latest developments in the industry.
- Export exception during the Supplementary Protection Certificate (SPC)
Next, the EGA will explore with the European Commission the legal angles of the proposal to manufacture in European Union (EU) for export to non-EU countries during the SPC period. The SPC export exception proposal aims to stimulate pharmaceutical production in Europe, insource thousands of highly skilled jobs, manufacturing science and know-how, and to provide the European generic and biosimilar medicine industries a boost for global leadership.
- Interplay between Intellectual Property (IP) and regulatory protections
On the second day, the conference further will address a series of topics of regulatory nature that have an IP relevance, from second medical use patents to orphan drug exclusivities, from the issues around the “sunset clause” to the situation regarding the “Bolar” clause and the European Medicines Agency (EMA) policy on clinical trials transparency. A panel debate involving industry experts and the head of the legal department of the EMA will follow.
- Latest developments in EU and global patent litigations and their impact on the European industry
Next, the conference will address the main developments in patent litigations in the EU and worldwide with a particular attention to the impacts on the European industry.