EU regulatory: Pharma, medical devices and biotech in Belgium

Bird & Bird

Bird & Bird works with a wide range of major life sciences and healthcare clients on contentious and non-contentious issues, taking a multi-disciplinary approach to matters across the business cycle. Clients include pharma, medical devices, and biotech companies, universities and other research organisations, and investors. The team, led by specialist medicines and biotech advisor Marc Martens, has notable expertise in healthcare sector pricing and reimbursement, e-health, and public procurement matters, alongside playing a leading role in litigation before the European Commission relating to generics. Counsel Nicolas Carbonnelle has a focus on biological materials and biobanking, while senior associate Kevin Munungu handles market access and pricing issues.

Practice head(s):

Marc Martens

Other key lawyers:

Nicolas Carbonnelle; Kevin Munungu

Hogan Lovells International LLP

Hogan Lovells International LLP advises pharma, medical devices, and healthcare clients across a wide range of regulatory matters, with strong expertise across multijurisdictional projects. The practice leverages its global platform to handle cross-border work of significant scope, with expertise in areas such as gene therapies, healthcare apps, and Covid-related issues, alongside regulatory considerations from Brexit and the lapsing of the Swiss-EU regulatory agreement. The practice is led by Fabien Roy , an emerging leader within the space. Elisabethann Wright left the firm.

Practice head(s):

Fabien Roy

Key clients

Baxter AG, Baxter S.p.A and Baxalta S.p.A..

Nanobiotix SA

Zimmer Biomet

Ferring

Celgene

Recordati S.p.A

Celgene

Compass Pathways Ltd

Jazz Pharmaceuticals

Vifor (International) AG

Work highlights

  • Advising a global biopharma company on the development of supply agreements with clinics throughout the EU concerning Advanced Therapy Medicinal Products.
  • Advising a multinational healthcare company on regulatory compliance analysis of its mental wellbeing app.

HOYNG ROKH MONEGIER

HOYNG ROKH MONEGIER remains a strong choice for life sciences regulatory work, advising international pharmaceutical players on medical devices and medicines authorisations, pricing, distribution, and compliance matters at domestic and European level, as well as representing clients in high-level litigation and handling internal investigations and audits. The practice is led by Liesbeth Weynants, praised for her ‘user friendly‘ advice on complex regulatory issues, with senior associate Delphine Borgniet also playing a key role across the firm’s offering.

Practice head(s):

Liesbeth Weynants

Other key lawyers:

Delphine Borgniet

Testimonials

‘Very practical advice, on the cross-over between regulatory and IP law. Responsive and easy to work with. Really know their stuff.’

‘Liesbeth Weynants is very easy to work with and gives user friendly and practical advice.’

Key clients

Biocodex

Biogen

Boehringer Ingelheim

Ceva Santé Animale

Teva

Cooley LLP

Cooley LLP strengthened its Brussels-based EU regulatory offering with the arrival of Elisabethann Wright as practice co-head from Hogan Lovells International LLP in June 2021, a specialist in pharmaceutical and medical devices regulation. Wright joins a team that includes fellow co-head Patrick Van Eecke and offers support to life sciences and pharma clients across the full range of data protection, IP, and state aid issues, alongside advice on the lifecycle of products throughout regulatory and approvals processes, including clinical trials and data transfers. The team enjoys strong relationships with regulatory authorities and regularly represents clients before European courts in challenges to legislation and regulatory decisions.

Practice head(s):

Patrick van Eecke; Elisabethann Wright

Crowell & Moring

Crowell & Moring advises major pharmaceutical companies on regulatory issues alongside its standout litigation practice, which regularly secures favourable decisions in contentious regulatory, supply, and patent disputes. The team has been heavily involved in Covid-19 issues, including advising vaccine manufacturers on supply and regulatory considerations. Kristof Roox heads up the practice, offering significant industry expertise and a successful litigation record Counsel Jurgen Figys is noted for his work on patent litigation and strategic advice to pharma and biotech clients and Linh Truong is a key associate in the intellectual property team.

Practice head(s):

Kristof Roox

Other key lawyers:

Jurgen Figys; Linh Truong

Testimonials

‘Fantastic team, great knowledge, great professionalism and availability.’

‘The perfect knowledge of the dynamics within the industry and the history of the legislation/regulatory framework.’

‘The team is multidisciplinary so they can cover a broad range of expertise. They communicate very frequently with the clients’ needs in mind.

They are flexible in how they split up the bill for one client if there are several units of the client served.

Key clients

Viatris (formerly Mylan )

Sandoz

Novartis

Medicines for Europe

Gear Up Medical

Pharma Patent

Honeywell

Fresenius Medical Care

Apotex

Alcon

Synthon

Zentiva

Aurobindo

Jacoti

Novartis Gene Therapies (AveXis)

Stada

Work highlights

  • Representing Novartis in various parallel import cases relating to the medicinal products Femara®, Co-Diovane®, Exelon® and Ritalin®, through which PI Pharma is attempting to sell parallel imported generic Sandoz products as originator Novartis products.
  • Advising Zoetis on regulatory matters following its acquisition of Abaxis.
  • Advised a major pharmaceutical company on a variety of regulatory issues such as data exclusivity, patent linkage, skinny labelling and the regulatory aspects of parallel imports.

Jones Day

Led by the ‘exceptional’ Cristiana Spontoni, the team at Jones Day advises international pharmaceutical companies and research entities on pharmaceutical products, medical devices and diagnostics, with a growing focus on innovation in the care delivery space, advising on issues relating to AI, digital technologies, and Big Data. Alongside its regulatory and commercial advice, the team also handles IP litigation, competition law issues, and data protection.

Practice head(s):

Cristiana Spontoni

Testimonials

Very good knowledge about regulation and industry practice, very efficient and easy to work with.’

‘Criatiana Spontoni is an exceptional lawyer with very good knowledge about industry regulation and practice, very easy to work with and extremely efficient. One of the best.’

Key clients

AbbVie Inc.

Arsenal Capital

BioMarin Pharmaceutical Inc.

Institut Pasteur

Pharmaceutical Product Development (PPD)

Shiseido

Sumitomo Dainippon Pharma

Sidley Austin LLP

Sidley Austin LLP advises pharmaceutical, biotechnology, medical devices, and other life sciences clients on the full range of regulatory, trade, and enforcement issues, and maintains a strong record in litigation at EU level, including cases relating to e-commerce, IP rights, and drug pricing. Alongside multinational companies, the firm also regularly advises trade associations on advocacy, as well as innovative players in the medtech field. The team is led by Maurits Lugard, who has a strong record in advising clients on market access and regulatory compliance issues, and has strong relationships with regulatory authorities.

Practice head(s):

Maurits Lugard

Testimonials

Deep knowledge of the pharma market and industry.

Great knowledge of pharmaceutical field and great legal skill.

Key clients

Vereniging Innovatieve Geneesmiddelen

Vanda Pharmaceuticals Inc.

EFPIA

Vemedia

Laboratoires Théa

Work highlights

  • Represented Vermedia in proceedings against the Dutch Medicines Evaluation Board’s refusal to authorise melatonin as a medicinal product.
  • Representing Laboratoires Théa in a case against a generic medical product ‘free riding’ on the client’s clinical trials.

Simmons & Simmons

Simmons & Simmons advises life sciences manufacturers, distributors, investors, and industry organisations on a wide range of innovation and regulatory issues relating to digital health technologies, medicines, biopharmaceuticals, medical devices, and other regulated healthcare products. Areas of expertise for the firm include cross-border work, public procurement, and lobbying local authorities. The practice is led by healthcare and life sciences specialist Olivier Mignolet alongside Annabelle Bruyndonckx, who was promoted to the partnership in May 2021.

Other key lawyers:

Vladimir Murovee

Testimonials

‘The Simmons & Simmons team combines high quality, which I’d define as excellent analytical skills, knowledge of the market, understanding of the business and clarity, with a very easy-to-work with and informal style. They are truly capable to work with inhouse counsels as if they were members of the team.’

‘I am very satisfied with the work done by Vladimir Murovec, a young and very talented lawyer. Vladimir is knowledgeable and showed the agility and the business acumen required to work well in a fast paced and demanding environment like my company.’

‘The Brussels Life Sciences team has visibility over the European market and advises businesses of all sizes, from scale-ups and SMEs to listed MedTech or Pharma giants.’

‘The lawyers we work with leverage outstanding industry knowledge, with a focus on regulatory compliance and data protection. They are involved in early stage legislative developments and get to lobby for industry associations which in certain matters gives them unique insights to advise clients.’

‘Vladimir Murovec is our primary contact. He manages and coordinates healthtech contracts and regulatory work over multiple Member States. He has also become our go-to-person for all EU Life Sciences regulations, with a specific knowledge of artificial intelligence. These skills are in high need and of great value to both the pharma and medtech side of a global healthcare business.’

‘The S&S team I interact with is made by Mrs Annabelle Bruyndonckx and Mr Vladimir Murovec. They are extremely competent and professional; they carefully listen to all exigencies and clearly illustrate all possible strategies for client’s best result.’

‘They explain the real situation, they do not create false expectations’

‘The team of Annabelle Bruyndonckx is very competent. It is easy to schedule a call with them. The quality of the feedback is very good.’

Key clients

Align Technology

BeMedTech

Octapharma

Sanofi

GlaxoSmithKline