Same law, different lawyers
29 March 2019

While EMA is operating from Amsterdam as of March, we present Alexander Roussanov who joined Hogan Lovells from EMA

As of 11 March 2019, the European Medicines Agency (EMA) is operating from Amsterdam. EMA's seat formally changes from London to Amsterdam on 30 March. A week after starting operations from Amsterdam, EMA was visited by European Commissioner for Health and Food Safety, Mr. Andriukaitis, and Minister for Medical Care of the Netherlands, Mr. Bruins. At its first meeting in Amsterdam, the EMA Management Board re-elected Christa Wirthumer-Hoche as its chair. Dr. Wirthumer-Hoche is also the head of the Austrian Medicines and Medical Devices Agency.

Brief update on the EMA activities in March: 

  • New time zone: from 11 March 2019, the EMA's business hours and submission deadlines, switched from Greenwich Mean Time (GMT) to Central European Time (CET).
  • EMA published a Q&A document on the preparatory work EU authorities are doing to prevent medicine shortages due to the UK's withdrawal from the EU (Brexit).
  • EMA published the annual report on Eudravigilance, the EU system for managing and analyzing information on suspected adverse reactions to medicines.
  • As EMA's resources are diverted to prepare for Brexit and the EMA relocation, EMA will continue to operate under business continuity conditions, to safeguard core activities related to the evaluation and supervision of medicinal products.

Hogan Lovells presents Alexander Roussanov, former Legal Adviser in the EMA Legal Department, who re-joined our Brussels office:

Prior to re-joining Hogan Lovells Life Sciences team, Alexander was a Legal Adviser in the EMA Legal Department for more than four years. During his time at the EMA, Alexander acquired extensive practical first-hand experience with the work of the EMA.

Alexander has substantial understanding and experience of EMA and European Commission decision-making processes, including the issues on which the Institutions focus. This experience was acquired through regular direct contact with key decision-makers, including members of the EMA Scientific Committees.

Alexander was, in particular, the lead lawyer in the EMA in a number of referral procedures from EU Member States that resulted in the suspension of marketing authorisations for medicinal products and the variation of others. Alexander provided legal advice to both EMA internal teams and the EMA Scientific Committees, including the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC).

As a member of the EMA Legal Department, Alexander has provided legal advice concerning actions before the European Court of Justice challenging European Commission decisions adopted as an outcome of the referral procedures.

Alexander has also advised on issues concerning the legal requirements applicable to medical devices included in the packaging of medicinal products, companion diagnostics and products that combine a medical device and advanced therapy medicinal product. He interacted directly with the EMA Committee for Advanced Therapies (CAT) in relation to classification of borderline products and assessment of highly innovative advanced therapy medicinal products. He also provided legal advice to the Agency concerning the internal implementation of the EU Medical Devices Regulations and, in particular, the new consultation procedures involving the EMA.

Alexander was the lead EMA legal adviser in all pre-litigation activities and litigation involving EMA decisions relating to requests for access to documents. He pleaded four cases brought against EMA decisions in the General Court of the European Court of Justice all of which were dismissed.

Alexander's extensive involvement in EMA’s transparency activities, including the development of new policies, allowed him to acquire detailed understanding of EMA’s approach to transparency. This includes EMA’s practical implementation of the concept of commercially confidential information.

This newsletter was published by the Life Sciences Regulatory team. For further information or additional input please contact Hein van den Bos or Alexander Roussanov.