EU Competition law in the pharmaceutical sector

Produced in partnership with David Hull of Van Bael & Bellis , Samuel Hall of Van Bael & Bellis and Michael Clancy of Van Bael & Bellis
Practice notes

EU Competition law in the pharmaceutical sector

Produced in partnership with David Hull of Van Bael & Bellis , Samuel Hall of Van Bael & Bellis and Michael Clancy of Van Bael & Bellis

Practice notes
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This Practice Note covers the application of EU competition law to common practices that take place within the pharmaceutical sector.

The pharmaceutical sector is consistently the target of scrutiny from both the European Commission and national competition authorities, which is unsurprising given the importance of pharmaceuticals to the health of citizens, and the high financial burden that pharmaceuticals place on national healthcare systems. Anticompetitive practices which jeopardise patients’ access to innovative and affordable medicines are therefore quick to catch the attention of competition enforcers.

The pharmaceutical sector has certain characteristics which distinguish it from other sectors. This includes the significant investment involved in bringing a therapy to market and high level of risk, the multiple decision makers influencing the choice of therapy used (eg healthcare professionals (HCPs), pricing and reimbursement authorities, insurers and hospitals), the high level of price controls, the importance of intellectual property (IP) rights, the high degree of regulation and the

David Hull
David Hull

David Hull practises EU competition law.

David has a wide range of experience as an EU competition lawyer, having started practising in Brussels in 1984.

David specialises in representing clients in complex investigations before the European Commission and in litigation before the EU Courts. 

Notable cases include: Lundbeck (“reverse payment” patent settlements); Cathode Ray Tubes (appeal of cartel decision); Ryanair (appeal of Commission decision blocking takeover of Aer Lingus); Akzo (landmark case on legal privilege); Bitumen (appeal of cartel decision) and Microsoft (appeal of fine for alleged non-compliance with Commission decision).

David has in-depth experience in the life sciences sector. He has successfully represented leading life science companies in major EU investigations and regularly advises them on life cycle management issues, European parallel trade and distribution issues (including co-marketing and co-promotion agreements), discount | rebate schemes, collaboration arrangements, IP licensing and mergers.

Samuel Hall
Samuel Hall

Solicitor, England and Wales, Van Bael & Bellis


Samuel Hall is an associate in the competition law practice of Van Bael & Bellis. He advises on both EU and UK competition law and has particular experience advising on issues which arise in the life sciences sector.
 
Before joining Van Bael & Bellis, Samuel worked in the Brussels and London offices of a well-known international law firm.

Michael Clancy
Michael Clancy

Michael Clancy is a competition lawyer who focuses on providing clients with actionable, commercially-minded advice and solutions, allowing clients to manage complex internal and external challenges and achieve their objectives.
 
Michael works with clients in a range of industries and has extensive experience in the life sciences sector, where he advises clients on the competition law issues arising throughout the lifespan of a product, including:
 
Licensing & R&D Collaborations
Developing and implementing effective licensing and R&D collaboration arrangements that take into account the limits imposed by the competition laws on issues ranging from pricing control, trade management, information exchange, exclusive arrangements and any required approvals from competition authorities.

Pricing Strategies & Governance
Working closely with clients’ pricing and reimbursement teams to develop effective and compliant pricing strategies that address threats from competitors and allow successful agreements with payors and authorities. Michael also provides advice on internal and external pricing governance systems that allow clients to implement desired pricing strategies across different countries and regions.

Supply and Distribution
Working with clients to structure and implement compliant distribution systems intended to ensure the appropriate and adequate supply of products to patients in each country.

Compliance Tools
Developing effective compliance tools, tailored to the clients’ specific business, which allow in-house counsel to constructively advise and guide business teams on issues such as dawn raids, market definition, collection of market intelligence, industry associations and trade activities, competitive pricing, distribution and supply and late life cycle management.

Investigation Defense & Complaints
While the objective is always to help clients avoid legal issues and regulatory scrutiny, where legal challenges arise, Michael works with clients on proactive strategies intended to quickly resolve the issue or investigation. Michael also supports clients where necessary to take legal actions against competitors engaging in illegal activities.

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Jurisdiction(s):
European Union

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