This comprehensive course is designed to equip professionals in the pharmaceutical sector with the knowledge and tools needed to navigate the complexities of competition law. It will cover the full spectrum of competition law from cooperation with competitors, to abusive life-cycle management, disparagement and the use of IP, to trends in public and private enforcement.
The expert speakers focus on the fundamental principles and key elements of competition law in the EU and UK that apply to the pharmaceutical industry. This is an interactive session that uses case studies and real-world examples from industry to address how compliance works in practice.
By addressing critical legal and operational challenges, participants will gain a clear and pragmatic understanding of how competition law impacts the pharmaceutical supply chain and how this translates to making commercial decisions in their day-to-day activities.
Benefits of attending
By attending this course you will:
- Understand the role of competition law in the entire pharmaceutical supply chain
- Update your knowledge on relevant competition law for the pharma industry
- Learn about horizontal and vertical co-operation
- Explore portfolio management and dealing with next generation products
- Get to grips with quota systems and export bans
- Gain insights into how to be prepared for public enforcement and dawn raids
- Familiarise yourself with key developments in damages directives, class actions and litigation funding
Certifications:
- CPD: 6 hours for your records
- Certificate of completion
Course Content
Introduction and legal landscape
- Pharmaceutical supply chain & role of competition law
- Competition law: relevant legislation for the pharmaceutical industry
- Anticompetitive agreements
- Abuse of dominance
- Mergers
- Where to find help
Horizontal and vertical cooperation in the pharmaceutical industry
- Commercial agreements
- Distribution agreements
- Co-promotion and co-commercialisation
- R&D
- IP related agreements and licensing
- Technology transfer
- Industry associations and working groups
Unilateral conduct
- Life-cycle/portfolio management - dealing with next generation products
- Quota systems and export bans
- Pricing: rebates, discounts and excessive pricing
- Parallel trade
- Disparagement - what can you say about your competitors?
- IP-related abusive conduct
Case studies
Enforcement of competition law
- Public enforcement
- Dawn raid preparedness
- Leniency
- Continued regulatory focus on the pharmaceutical industry
- Private enforcement
- Key developments: Damages Directive/Class Actions/Litigation Funding
- Damages claims against pharmaceutical companies
- Case studies
Course Provider
Mr Niels Ersbøll,
Partner ,
Arnold & Porter LLPNiels Ersbøll, Partner, Arnold & Porter LLP, advises clients on EU competition law in relation to cartels and restrictive practices, merger control, abuse of dominance, and State aid. He is currently involved in several pending EU cartel investigations. He advises on merger control investigations by the European Commission and competition authorities worldwide for clients such as General Electric, Boston Scientific, Pfizer, and Sanyo. Where investigations (mergers or cartels) are run by several authorities in parallel, he assists with overall strategy and coordination. Niels also has significant experience helping clients with designing and implementing compliance measures and conducting internal investigations and audits.
Zeno Frediani,
Arnold & Porter LLPZeno Frediani advises clients on UK and EU competition law in relation to merger control, cartels and restrictive practices, abuse of dominance, and private damages claims. He also advises clients on the UK’s investment screening powers for national security matters. He has extensive experience in providing commercial solutions to complex regulatory issues. Zeno advises world-leading organisations, particularly within the FMCG and pharmaceutical sectors. He has also assisted clients in CMA and European Commission investigations.
In relation to antitrust litigation, Zeno has experience handling competition damages litigation in various jurisdictions, including England & Wales and The Netherlands.
He maintains an active pro bono practice and regularly advises charities and NGOs on a wide range of legal and strategic matters.
Lazarinka Naydenova,
Arnold & Porter LLPLazarinka Naydenova, Senior Associate with Arnold Porter, focuses on all aspects of European (EU) competition law, with particular emphasis on merger control proceeding, abuse of dominance, cartel matters, and state aid.
Lazarinka joined the firm's Brussels team in 2016. Prior to joining the firm, Lazarinka worked in another leading international competition law firm in Brussels. She has worked as an in-house lawyer at the Bulgarian Ministry of Finance and has also undertaken a traineeship at the European Commission's Directorate General for Competition. Lazarinka worked the ex-U.S. processes for Monsanto in its US$66 billion acquisition by Bayer, a transaction that won the 2019 GCR Awards for "Global Antitrust Matter of the Year" and "Merger Control Matter of the Year - Europe" and for Fitbit in its acquisition by Google which won the 2021 edition of the same award. She also represented a client in a dawn raid conducted by the European Commission in relation to an alleged violation of the antitrust rules.
Who Should Attend
This course has been specially designed for:
- In-house lawyers
- Compliance managers and regulatory affairs specialists
- Commercial and contracts managers
- R&D managers
- Procurement and supply chain personnel
- Business development managers
- Heads of legal departments and legal advisers
- Patent, IP, trade mark and licensing counsel
