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.

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Photo of Peter Bogaert Peter Bogaert

Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EU and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the EU Courts in Luxembourg and in…

Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EU and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the EU Courts in Luxembourg and in local litigation in Belgium. Peter’s practice covers pharmaceuticals, biotechnology, medical devices, special foods and feed, cosmetics and other consumer products and he represents numerous innovative life sciences companies, including start-ups, as well as several industry associations.

Chambers Global notes that a client said: “He is an extremely experienced professional with broad expertise and provides sensible and well-balanced solutions.” He is consistently ranked by PLC as one of the leading life sciences lawyers globally and Legal 500 EMEA and Chambers Europe note Peter’s prominent regulatory pharmaceutical and environmental practice. Legal 500 EME noted that he is “a superb lawyer who is very pleasant to work with.” Peter regularly writes and speaks on life sciences issues. He is a founding member of the Brussels Pharma Law Group and also served for fifteen years as Managing Partner of the firm’s Brussels office.

Photo of Kristof Van Quathem Kristof Van Quathem

Kristof Van Quathem advises clients on information technology matters and policy, with a focus on data protection, cybercrime and various EU data-related initiatives, such as the Data Act, the AI Act and EHDS.

Kristof has been specializing in this area for over twenty…

Kristof Van Quathem advises clients on information technology matters and policy, with a focus on data protection, cybercrime and various EU data-related initiatives, such as the Data Act, the AI Act and EHDS.

Kristof has been specializing in this area for over twenty years and developed particular experience in the life science and information technology sectors. He counsels clients on government affairs strategies concerning EU lawmaking and their compliance with applicable regulatory frameworks, and has represented clients in non-contentious and contentious matters before data protection authorities, national courts and the Court of the Justice of the EU.

Kristof is admitted to practice in Belgium.

Photo of Lucinda Osborne Lucinda Osborne

Lucinda Osborne specializes in technology transactions in the life science sector with a particular emphasis on complex strategic collaborations as well as technology and product transfers and licensing arrangements in the context of mergers and acquisitions.

Chambers UK states that Lucinda “has devoted…

Lucinda Osborne specializes in technology transactions in the life science sector with a particular emphasis on complex strategic collaborations as well as technology and product transfers and licensing arrangements in the context of mergers and acquisitions.

Chambers UK states that Lucinda “has devoted her career to life sciences collaboration and licence agreements” and notes that “[o]ne key client said: ‘She is great – she always delivers, the client care is fantastic, and she gives really pragmatic, speedy and good advice.’”

Lucinda is a UK qualified Solicitor who regularly advises on cross border transactions. She has particular experience structuring and documenting global collaborations to reflect market practices and requirements in the U.S. Her expertise also includes the full range of commercial agreements that span the product life-cycle in the life sciences sector including clinical trial agreements, evaluation agreements, manufacturing and supply arrangements, distribution and other marketing agreements, and tenders.