The EU pharmaceutical industry landscape is in significant flux. There are many pressures to provide new therapies and to make them available more early and for as many qualifying patients as possible. In that context, the industry model and the role of exclusivity rights as a tool to stimulate innovation are being discussed. At the same time, discovering and developing new products is more complex and requires a collaborative effort. This happens against the background of new rules on medical devices and the protection of personal data, which are, for instance, relevant in assessing clinical effectiveness and relying on real world evidence.
Three members of the Covington European Life Sciences team will be speaking on these topics at the EU Pharmaceutical Law Forum being held in Brussels on 16-18th May.
On Wednesday 17th May, Peter Bogaert, a regulatory life sciences partner, in the Brussels office, will participate in a panel discussion that will discuss regulatory IP rights and their role in supporting innovation. Later that day he will organise an evening seminar on the new medical devices rules, together with David Van Passel, Assistant General Counsel at Johnson & Johnson.
On Thursday, Lucinda Osborne, a partner in our life sciences transactional team, based in London, teams up with Matthew Bowden, Senior Counsel at AstraZeneca, to discuss potential pitfalls in early stage collaborations. They will flag issues to consider when drafting core provisions such as the licence grants, diligence obligations, the governance framework and termination, with an eye to how such provisions may play out in practice.
Also on Thursday, Kristof Van Quathem, Special Counsel in Covington’s Privacy & Data Security practice will discuss aspects of the General Data Protection Regulation. Right in the middle the two-year transition period (the new regime will apply as from 25th May 2018), he will speak in particular about the appointment of a Data Protection Officer, various reporting requirements, and sanctions.