Falsified medicines

Produced in partnership with Fabien Roy of Hogan Lovells , Jane Summerfield of Hogan Lovells , Grégoire Paquet of Hogan Lovells International LLP, Anastasia Vernikou of Hogan Lovells and Elisabethann Wright BL of Cooley (UK) LLP

Practice notes

Falsified medicines

Produced in partnership with Fabien Roy of Hogan Lovells , Jane Summerfield of Hogan Lovells , Grégoire Paquet of Hogan Lovells International LLP, Anastasia Vernikou of Hogan Lovells and Elisabethann Wright BL of Cooley (UK) LLP

Practice notes

A worldwide problem, for developed and developing countries alike, is the trade of falsified medicinal products. The terms ‘falsified medicines’ and ‘counterfeit medicines’ are not interchangeable—falsified medicines refers to fake products designed to mimic actual medicines, whereas counterfeit medicines refers to products that infringe trademarks or other Intellectual Property Rights.

This Practice Note explores the changes introduced to the regulation of medicinal products by Directive 2011/62/EU on the prevention of the entry into the legal supply chain of falsified medicinal products (Falsified Medicines Directive or FMD) to combat the increase in the incidence of falsified medicines. First, the Practice Note considers what is meant by the term ‘falsified medicinal product’, before looking at the measures introduced by the FMD: greater control of active substances, obligations for actors in the supply chain, the introduction of safety features on the Packaging of medicinal products and the common logo for websites selling medicinal

Fabien Roy

Hogan Lovells

As a partner of our Life Sciences practice, Fabien Roy focuses his practice at Hogan Lovells on advising Clients on European Union and national regulatory matters applicable to medical devices, medicinal products and combination products throughout their entire life cycle. With a practice entirely focusing on complex regulatory issues faced by Life Sciences clients, he can quickly address and anticipate complex challenges and propose innovative solutions enabling Clients to focus on their business.

Fabien focuses particularly on guiding Clients through the regulatory and technical regulatory requirements applicable to the CE marking of medical devices. He assists clients in addressing a range of complex issues during clinical investigation procedures, conformity assessment and registration procedures and post-market activities.

Fabien is also a qualified lead auditor for ISO 13485 quality management systems. He consequently has a deep understanding of the range of quality issues encountered by medical device Clients. Fabien also assists Life Sciences Clients in the preparation, drafting and review of numerous agreements including clinical study agreements, sponsor's representative agreements, registry agreements, CRO agreements, European Authorised Representative Agreements and distribution agreements.

Jane Summerfield

Solicitor, Hogan Lovells

Jane Summerfield is Co-Head of our Life Sciences and Health Care sector and leads the Hogan Lovells life sciences regulatory and commercial practice in London. She advises life sciences companies on a wide range of regulatory matters, including clinical trials, early access, marketing authorisations, manufacturing and distribution licences, CE/UKCA marking, digital health, advertising and marketing activities, HCP compliance, and pricing and reimbursement.

Jane also advises on commercial contractual arrangements, including consultancy, sponsorship, co-promotion, collaboration, manufacturing, distribution, services, quality and pharmacovigilance agreements.

Jane works with clients to resolve issues with UK enforcement authorities and regulatory bodies, including the Medicines and Healthcare products Regulatory Agency (MHRA), Prescription Medicines Code of Practice Authority (PMCPA) and Advertising Standards Authority (ASA).

Jane combines a scientific background with deep regulatory knowledge and a commercial approach, providing "clear responses with business impact".

Grégoire Paquet

Associate, Hogan Lovells International LLP

Grégoire Paquet is an associate in the Life Sciences Practice of Hogan Lovells’ Brussels office. A Belgian-qualified lawyer, he assists clients across a wide range of regulatory, legal and procedural matters for pharmaceuticals, biotechnologies, medical devices, and other health-related regulated products in the EU.

He assists companies in the entire lifecycle of products, from early development and design stages, to marketing, and post-marketing issues. His practice also covers a broad array of regulatory questions in EU and Belgian law.

Grégoire has been involved in litigation mandates before the Court of Justice of the European Union, where he leverages his background in EU Law to provide insightful and pragmatic input.

Prior to joining Hogan Lovells, Grégoire was a Pro Bono Lawyer in another international law firm in Brussels.

Anastasia Vernikou

Associate, Hogan Lovells

Anastasia Vernikou advises life sciences companies on EU law and regulation governing medical devices, digital health solutions, biotechnology, and medicinal products. Anastasia is a member of the Global Regulatory Life Sciences team of Hogan Lovells and is qualified to practice law in Greece.

Elisabethann Wright, BL

Barrister, Cooley (UK) LLP

Elisabethann Wright specializes in EU law and regulation of pharmaceuticals and medical devices and is regularly sought-after and praised for her knowledge of the legislation, technical competence and commercial acumen. She has been practicing in the life sciences sector for over 35 years in private practice and international institutions. Elisabethann helps clients navigate the process and regulations to place and keep their products on the European Union market through strategic advice, advocacy before institutions and agencies and litigation before EU courts.

Jurisdiction(s):

United Kingdom

Key definition:

Intellectual property definition

What does Intellectual property mean?

The trade secrets of an employer that are normally protected as registered trade marks, designs or copyright.

Falsified medicines

Produced in partnership with Fabien Roy of Hogan Lovells , Jane Summerfield of Hogan Lovells , Grégoire Paquet of Hogan Lovells International LLP, Anastasia Vernikou of Hogan Lovells and Elisabethann Wright BL of Cooley (UK) LLP