The life sciences practice at Hogan Lovells International LLP has expertise spanning pharmaceuticals, medical devices, and healthcare regulatory issues, advising leading pharmaceutical clients on contentious and non-contentious matters. Fabien Roy acts as head of the practice, with particular knowledge of pharma, medical devices, and in vitro diagnostic devices. Cláudia Mendes Pinto is key to the team, frequently working on EU and global projects, focusing on advanced therapy medicinal products. Helene Boland and Gregoire Paquet are also noted.
EU regulatory: Pharma, medical devices and biotech in Belgium
Hogan Lovells International LLP
Praxisleiter:
Fabien Roy
Weitere Kernanwälte:
Claudia Mendes Pinto; Helene Boland; Gregoire Paquet
Referenzen
Adverum Biotechnologies
Balt USA, LLC
Celgene Corporation
Highlight-Mandate
- Advising Adverum, a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, on setting up a GDPR-compliant framework for their upcoming clinical trials in the EU and UK and on future clinical activities in the EU/UK.
- Advising Celgene on an ongoing basis with supply chain, manufacturing, and clinical trials regulatory aspects throughout Europe.
- Advising clients on the transition of their devices from the Medical Devices Directive to the Medical Devices Regulation.
HOYNG ROKH MONEGIER
HOYNG ROKH MONEGIER is the ‘go-to firm for EU regulatory matters in pharma, medical devices, and biotech’, advising across the life cycle of medical products and devices. The practice’s expertise extends to regulatory exclusives, market authorisation and access, and compliance issues, with members of the team also being skilled at handling domestic and cross-border litigation. Team head Liesbeth Weynants ‘stands out for her superb knowledge of pharma regulatory law combined with patent litigation expertise’. Tim Robrechts and Ine Letten are noted for their intellectual property expertise, with Letten also being highly knowledgeable of pharmaceutical regulatory law.
Praxisleiter:
Liesbeth Weynants
Weitere Kernanwälte:
Tim Robrechts; Ine Letten
Referenzen
‘They excel in their advice relating to pharmaceutical regulatory law and are very well connected locally to advise on national legislative changes and decisions.’
‘Liesbeth Weynants stands out for her superb knowledge of pharma regulatory law combined with patent litigation expertise.’
‘HOYNG ROKH MONEGIER is my go-to firm for EU regulatory matters in pharma, medical devices, and biotech. Their expertise is unmatched, and their advice is always spot-on and practical.’
Kernmandanten
BioNTech
Teva
Biocodex
Pfizer
Regeneron
Vertex
Sidley Austin LLP
The global life sciences practice at Sidley Austin LLP acts on high-profile litigation across the medical devices and biotech sectors, with vast knowledge of regulatory agencies. Maurits Lugard leads the practice, focusing on food and beverage, drugs, and medical devices. Maarten Meulenbelt specialises in EU regulatory matters, litigation, and competition law-related matters across the life sciences sector. Also of note is Michele Tagliaferri, who is leading the firm’s compliance work.
Praxisleiter:
Maurits Lugard
Weitere Kernanwälte:
Maarten Meulenbelt; Michele Tagliaferri
Referenzen
‘The team is very knowledgeable, creative, and commercially-minded. They are willing to come in as a partner to the business vs simply offering advice.’
‘This team has managed to achieve outcomes that had been entirely written off by other firms and turned matters around for us when we found ourselves in our worst-case scenario. They have been innovative and tireless in their approach.’
‘Reliable, timely with a clear political understanding.’
Kernmandanten
Les Laboratoires Servier
Highlight-Mandate
- Represented French pharmaceutical company Les Laboratoires Servier, as co-lead counsel, before the CJEU in appeals by Servier and the European Commission against a General Court judgment, successfully obtaining the annulment of the Commission’s findings of an infringement of Article 102 of the Treaty on the Functioning of the European Union (TFEU).
A&O Shearman
A&O Shearman yields a dedicated life sciences team, with experience representing global pharmaceutical and biotech companies in matters spanning regulatory and intellectual property work. Peter Van Dyck leads the practice, specialising in intellectual property disputes related to the life sciences sector. Van Dyck acts as head of the team alongside Tine Carmeliet is skilled at aiding clients dealing with EU regulations linked to the development of new medical products. Eline D’Joos is another key contact.
Praxisleiter:
Peter Van Dyck; Tine Carmeliet
Weitere Kernanwälte:
Eline D’Joos
Referenzen
‘As a global company pharmaceutical company operating in low and low middle income countries who rely on the European Medicines Agency for drug approvals, I need an outside counsel like A&O Shearman who is familiar with the procedures of the World Health Organization to approve drugs for LMICs.’
Crowell & Moring
With expertise across the full spectrum of contentious and non-contentious healthcare and life sciences matters, the ‘very professional, diligent and creative’ team at Crowell & Moring advises a range of clients including national and international pharmaceutical companies and government entities. Team head Kristof Roox has ‘outstanding knowledge of the pharmaceutical generic industry’, combining expertise in intellectual property litigation with knowledge of pharmaceuticals and medical devices.
Praxisleiter:
Kristof Roox
Weitere Kernanwälte:
Christopher Dumont; Jurgen Figys; Wietse Vanpoucke
Referenzen
‘Deep knowledge in EU regulatory law (pharma).’
‘Kristof Roox and Christopher Dumont for their skills in managing pan-European litigation.’
‘Working with Kristof Roox is very pleasant and collegial, with him swiftly answering any inquiries and trying to find the best solution in the interests of our joint clients.’
Kernmandanten
Birds Insemination and Fertilisation Station BV
PrOxi Biotech ApS
Ugani Prostethics
The State of Hungary
Pendulum Therapeutics
International Generic and Biosimilar Medicines Association
Sandoz
Viatris (formerly Mylan)
Synthon
Zentiva
Novartis
Medicines for Europe
Honeywell
Fresenius Medical Care
Polpharma
Neuraxpharm
Audax Management
Highlight-Mandate
- Represented Viatris, Polpharma, Neuraxpharm Zentiva, and Kern Pharm in the European-wide DMF (Tecfidera)-litigation with 22 filed actions before the General Court and Court of Justice of the European Union.
- Advised Sandoz on the framework for a partnership with an app developer promoting a home delivery service for pharmaceutical products
Jones Day
Described by clients as a ‘one-stop shop’, Jones Day acts on matters across the gamut of life sciences work, including pharmaceutical products, medical devices, and cosmetic products. Clients of the practice include leading pharmaceutical businesses, service providers, and medical technology manufacturers. Practice head Cristiana Spontoni is recommended for cross-border regulatory issues with focus areas such as clinical trials, pre-market authorisations, and compliance.
Praxisleiter:
Cristiana Spontoni
Weitere Kernanwälte:
Serge Clerckx; Kaarli Eichhorn; Mario Todino; Ursula Schliessner
Referenzen
‘Their breadth of knowledge is second-to-none which allows for a one-stop shop, making them invaluable and incredibly efficient from a business perspective. They are also not afraid of giving direct and practical strategic advice over and above legal advice.’
‘Cristiana Spontoni is a standout. She has excellent knowledge of multiple countries and topics and has a network of excellent contacts if there’s anything she doesn’t know, which is rare. Christina and the team are always available and engaged at both a legal and strategic level. They are a business partner rather than an external legal adviser. ’
Kernmandanten
Arsenal Capital
Astellas Pharma
BioMarin Pharmaceutical Inc.
Institut Pasteur
Lab Corp (Laboratory Corporation of America)
Lipton Teas and Infusions
Misonix, Inc.
Nanobiotix
Pharmaceutical Product Development (PPD)
Saint Luke’s Health System
Shiseido
Sumitomo Dainippon Pharma
Vésale Bioscience SRL
Simmons & Simmons
Simmons & Simmons has ‘strong experience and knowledge in healthcare compliance regulations’ with vast regulatory expertise linked to medical devices, biopharmaceutical products, and advanced therapy medicinal products. The team is adept at handling cross-border work, and collaborates closely with other teams of the firm. Olivier Mignolet leads the ‘professional and proactive’ practice alongside Annabelle Bruyndonckx. Dimitri Van Uytvanck is key to the team, bringing extensive employment expertise. Jérémie Doornaert is an ‘exceptional lawyer’, with experience on contentious and non-contentious matters across the pharmaceutical and medical device industries.
Praxisleiter:
Olivier Mignolet; Annabelle Bruyndonckx
Weitere Kernanwälte:
Dimitri Van Uytvanck; Jérémie Doornaert
Referenzen
‘Strong experience and knowledge in healthcare compliance regulations.’
‘They really understand our company and products and tailor their advice to suit these needs. The team is professional and proactive and it feels like they are part of the team rather than external advisors.’
‘Jérémie Doornaert is an exceptional lawyer. He easily pivots from data privacy to commercial topics – not a skill most data privacy lawyers have. He is extremely pragmatic and understands our business, stakeholders, and products very well. He is personable and I am confident in letting him also connect with my business.’
Kernmandanten
Align Technology
Air Liquide
BesinsHealthcare
Galderma
GlaxoSmithKline
Hartmann
Hospidex
Landauer (Fluke)
Noventure
Novo Nordisk
Octapharma
Oncoradiomics
Rhythm Pharmaceuticals
Samsung Bioepis
Shenzhen SiSensing Co. Ltd. (Sibionics)
Trasis
ALTIUS
The life sciences practice at ALTIUS is ‘always readily available and easily accessible’, representing companies in the pharmaceutical, medical devices, and biotech industries. The team that is ‘very hands on, to the point, communicates fast, and delivers within deadlines’ is led by the experienced litigator Christophe Ronse, Philippe de Jong, and Kirian Claeyé, who is adept at life cycle management and advice on clinical trials.
Praxisleiter:
Christophe Ronse; Philippe de Jong; Kirian Claeyé
Referenzen
‘Very fast, correct advice. Adapted to the real situation.’
‘The Altius team is always readily available and easily accessible. They accurately monitor projects and provide input based on sound, specific knowledge. ’
‘The individuals working at Altius have in-depth knowledge of the specific domains they advise in. They think along with the client also on strategic projects. ’
Kernmandanten
Merck Sharp & Dohme (MSD)
Novartis
Bayer Pharma
Ferring
Gilead
Equine America
Azelis
Beiersdorf
Organon
Midmark
Hipra
P3Lab
AbbVie
Highlight-Mandate
- Advised Beiersdorf on the EU Medical Devices Regulation.
- Representing Bayer in the enforcement of orphan drug market exclusivity.
- Advised Merck Sharp & Dohme on the implementation of various new EU Directives and upcoming EU pharma reforms.
Osborne Clarke
The ‘specialized, experienced, responsive’ practice at Osborne Clarke advises on regulatory issues related to medical devices, medicinal products, and digital health technology and is frequently sought out by clients entering the EU market. A ‘very good lawyer with great industry experience’, Vladimir Murovec is particularly experienced in the area of digital health technologies.
Praxisleiter:
Vladimir Murovec
Weitere Kernanwälte:
Benjamin Docquir
Referenzen
‘Specialized, experienced, responsive’
‘We worked very well with Vladimir Murovec. Very good lawyer with great industry experience and a practical approach. Always provided helpful guidance.’
‘The Brussels EU Life Sciences regulatory practice led by Vladimir Murovec is top-tier. ’
Kernmandanten
Afflelou Group
Alnylam Pharmaceuticals
Bepharbel Manufacturing
BioNTech
BioSenic
Chemviron
CooperVision
Epstein, Becker & Green
Grifols
Haema
Humble Brands
Intressa Vascular
Invisalign
Medi-Market
neuroClues
Novo Nordisk
Samsara Vision
Seegene
Steris
Terumo Corporation
Sunrise
UCB
Highlight-Mandate
- Advising a client on the EU regulatory due diligence for the potential multi-billion acquisition of a major listed medical device business, covering compliance with Medical Devices Regulations and related laws across several jurisdictions.
- Advised a healthcare company active in the EMEA region on interactions with healthcare professionals and organisations through a medical education services provider, interpreting various codes of conduct, ensuring compliance with donations and grants regulations, and assessing potential contract terminations under local laws.
- Assisting a listed Korean client in identifying and complying with the EU regulatory framework for reproducibility studies to assess various parameters of in-vitro diagnostic assays. Reviewing and advising on collaboration agreements, registration, and notification requirements under EU regulations, reporting and disclosure obligations, and addressing legal and regulatory issues for clinical studies.
Reed Smith
The ‘cross-functional’ practice at Reed Smith has extensive experience working with leading pharmaceutical companies, providing advice on complex regulatory issues. The team works closely with other offices of the firm, across the EU, and internationally. Team head Wim Vandenberghe‘s ‘advice is widely regarded as nothing short of brilliant’, and is ‘both technically correct, and practical’.
Praxisleiter:
Wim Vandenberghe
Referenzen
‘The Reed Smith team is cross-functional, covering both regulatory and trade aspects, which means that they’re looking around corners for us. We primarily work with the Brussels team, who has the ability to quickly pivot to local counsel support if and when needed.’
‘Wim Vandenberghe is exceptional. His advice is widely regarded as nothing short of brilliant. He asks the right questions, delivers on time, and it’s always spot on: both technically correct and practical.’
‘I have very positive experience working with Wim Vandenberghe. Very thorough approach, with a great European network of colleagues and extensive knowledge of the industry. Very responsive and focused on providing clients with exactly what they need.’
Stibbe
Ignace Vernimme and Philippe Campolini lead the life sciences practice at Stibbe, advising on complex compliance and regulatory issues. Vernimme’s experience covers IP, life science, and health products, while Campolini is well versed in advising Belgian and international clients in the medical devices and life sciences industry. The team is adept at handling related litigation, including disputes with Belgian pricing authorities. Louis Bidaine is also noted.
Praxisleiter:
Ignace Vernimme; Philippe Campolini
Weitere Kernanwälte:
Louis Bidaine
Referenzen
‘The high level of clients provide a network. The internal legal high level expertise.’
‘The individuals I have worked with at Stibbe consistently demonstrate professionalism, exceptional expertise, and a client-focused approach. Partners are highly engaged and readily available, offering invaluable strategic insights. Associates are diligent, detail-oriented, and proactive, often going above and beyond to ensure that all aspects of a matter are handled thoroughly.’
‘High level of clients providing a network. The internal legal high-level expertise.’
Highlight-Mandate
- Represented Mylan in proceedings before the Court of Justice of the EU against the European Commission regarding an exemption granted to one of its competitors on the market exclusivity of its product.
- Advised CSL Behring Blood on a government tender for the processing of Belgian blood in medicines whereby one pharmaceutical company is granted the exclusivity of this market.
- Advised CSL Behring on a new pricing model for advanced therapy medicinal products (ATMPs) whereby the payments for the products are spread out over several years to lighten the financial burden of the social security systems.