Pharmacovigilance

Produced in partnership with Eveline Van Keymeulen of Latham & Watkins , Jeanne Fabre of Latham & Watkins , Oliver Mobasser of Latham & Watkins and Ranulf Barman of Latham & Watkins

Practice notes

Pharmacovigilance

Produced in partnership with Eveline Van Keymeulen of Latham & Watkins , Jeanne Fabre of Latham & Watkins , Oliver Mobasser of Latham & Watkins and Ranulf Barman of Latham & Watkins

Practice notes

Pharmacovigilance is the process of collecting and understanding information relating to the adverse effects of medicinal product throughout their use in patients.

Before medicinal products are authorised for use, information regarding their safety and efficacy is obtained from clinical trials.

It is essential, however, that safety continues to be monitored throughout patient use because post-authorisation medicinal products will typically be used in a larger number of patients, for a longer period of time and in combination with other medicinal products, meaning that adverse effects may occur that were not apparent during clinical trials.

Consequently, EU law requires Marketing Authorisation holders (MAH), the European Medicines Agency (EMA), and national Competent Authorities (ie the medicines regulatory authorities in EU Member States) to operate a pharmacovigilance system. Following Brexit, the Medicines and Healthcare products Regulatory Agency (MHRA) is the UK’s standalone regulatory authority.

The overall EU pharmacovigilance system operates through co-operation between EU Member States, the EMA and the

Eveline Van Keymeulen

Partner, Latham & Watkins

Eveline Van Keymeulen is a partner in Latham & Watkins’ Brussels and Paris offices and a member of the firm’s healthcare and life sciences practice.

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Ms Van Keymeulen advises multinational companies and start-ups in the pharmaceutical, biotech, medical devices, cosmetics, and food and beverage sectors on a broad variety of complex European, domestic and cross-border regulatory matters, including clinical trials, product approvals, regulatory incentives, market access, promotion and advertising, post-market obligations, and general compliance matters.

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In addition, Ms Van Keymeulen has extensive experience advising on medical cannabis and hemp-based product regulations. She successfully challenged the legality of French hemp regulations in the first case related to cannabidiol (CBD) products before the Court of Justice of the European Union (Case C-663/18, Kanavape). This landmark judgment had a major impact on the development of the European CBD industry.��

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Ms Van Keymeulen is ranked in Chambers for Life Sciences Regulatory (since 2020) and recognised as a Legal 500 Rising Star / Next Generation Lawyer in Healthcare and Life Sciences (since 2018). She is considered a National and Global Leader by Who’s Who Legal Life Sciences (since 2016) and is further recognised as one of the leading life sciences practitioners in France by Legal Media Group 2021, Best Lawyers 2021 and Euromoney’s Women in Business Law Expert Guide 2021. Ms Van Keymeulen was also recognised as European Advisory Lawyer of the Year (2021) by, and won Impact Deal of the Year at, the prestigious Europe LMG Life Sciences Awards (2021-2022). Clients particularly value her “high level of energy”, and appreciate her for “being extremely flexible and genuinely engaged” as well as having a “can do attitude” while some have even called her a “rockstar”.��

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Ms Van Keymeulen has authored numerous articles and has been a featured speaker on EU regulatory matters at prominent conferences such as the Pharmaceutical Law Academy in Cambridge. Ms Van Keymeulen also serves on the editorial board of the European Pharmaceutical Law Review. In addition, Ms Van Keymeulen has been quoted in BBC Business Daily, Bloomberg, The Times, Les Echos and other leading international business journals on life sciences regulatory and policy matters.

Jeanne Fabre

Associate, Latham & Watkins

Jeanne Fabre is an associate in the Paris office of Latham & Watkins and a member of the firm’s healthcare and life sciences practice. She advises multinational companies and start-ups in the pharmaceutical, biotech, medical devices, cosmetics, and food and beverage sectors on a broad variety of complex European, domestic and cross-border regulatory matters, including clinical trials, product approvals, market access, promotion and advertising, post-market obligations, contracts and general compliance matters.

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Ms Fabre has significant experience working in pharmaceutical companies. Since her Master’s in Life Sciences Law, she has worked for more than three years for several companies, both for local affiliates and parent companies. She was seconded for 18 months part-time to a pharmaceutical company specialising in rare diseases, and a further three months for another pharmaceutical company. During that time she advised on a wide range of day-today regulatory topics (such as observational, (former) ATU and post-ATU studies, contractual relationships with service providers, consultancy and pay for performance agreements and pricing and reimbursement topics).

Oliver Mobasser

Solicitor, Latham & Watkins

Oliver Mobasser is a Senior Associate in the Healthcare and Life Sciences group of the London office of Latham & Watkins. He advises clients in the healthcare and life sciences industry on a range of technology, intellectual property, and data-focused transactions and matters.

Mr Mobasser helps emerging and established multinational pharmaceutical, biotechnology, digital health, and medical technology companies as well as their investors navigate:��

• Strategic licenses and collaborations

• Product acquisitions, divestments, and carve-outs

• Manufacturing, supply, distribution, and other commercial agreements

• Data protection, as well as data use, re-use, and exploitation

• Research and development and clinical trials

He has particular expertise and has contributed to a number of publications and conferences in complex data protection matters in the life sciences sector, including matters related to use of data in the context of clinical trials and other research, anonymisation, pseudonymisation, digital health and AI solutions.

Prior to joining Latham, Mr. Mobasser practised at a leading law firm in Dublin, Ireland, and completed a secondment as in-house counsel for Shire Pharmaceuticals. He brings a multifaceted, multijurisdictional perspective to his work for clients across Europe and North America. He regularly writes about topics at the intersection of healthcare, technology, and regulation.

Ranulf Barman

Solicitor, Latham & Watkins

Mr. Barman has unique experience in the life science sector, previously holding a number of positions in the UK government, including at the Medicines and Healthcare products Regulatory Agency (MHRA) and the Food Standards Agency (FSA), respectively. Mr. Barman has represented the UK government at EU level on a broad range of compliance and regulatory issues concerning food and medical devices.

Mr. Barman focuses on matters in the life science sector, advising public and private multinational pharmaceutical, biotechnology, medical technology, diagnostics, food, and cosmetic companies and their investors on complex licenses, collaborations, acquisitions, divestments, commercial contracts, intellectual property matters, and regulatory and privacy matters.

Mr. Barman maintains an active pro bono practice, regularly advising international charities in relation to their regulatory and commercial needs.

Prior to joining Latham, Mr. Barman was a solicitor at an International law firm, where he also trained, as well as completing an in-house secondment at a US energy company.

Jurisdiction(s):

United Kingdom

Key definition:

Pharmacovigilance definition

What does Pharmacovigilance mean?

The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.

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Pharmacovigilance

Produced in partnership with Eveline Van Keymeulen of Latham & Watkins , Jeanne Fabre of Latham & Watkins , Oliver Mobasser of Latham & Watkins and Ranulf Barman of Latham & Watkins