Distribution, Parallel Trade and Security of Supply Considerations

Distribution, Parallel Trade and Security of Supply Considerations

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Michael ClancyMichael ClancyPartner at Van Bael & Bellis

Michael Clancy is a competition lawyer focused on the life sciences sector, with over 15 years of experience providing clients with actionable, commercially-minded advice and solutions on issues arising throughout the lifespan of products, including:

Collaborations / Licensing / M&A. Michael helps clients successfully plan, complete and implement complex transactions and long-term collaborations, and navigate required government approvals and issues ranging from pricing control/IRP management, trade, exclusivity and information exchange. IP / Regulatory / Promotional Strategies v. Competitors. While it is normal and allowable for companies to prepare for and compete with new entrants to the market and other competitors, certain IP / Regulatory / Promotional and other activities may violate the competition laws. Michael works closely with clients’ legal and business teams to develop proactive guidance allowing compliant and effective responses to competitive threats. Pricing Strategies. Michael routinely advises clients on the pricing of high-profile medicines and other products, working closely with clients’ legal and pricing teams to develop compliant pricing strategies that allow successful agreements with customers and payors, address threats from competitors, and minimize any implementation issues that might otherwise undermine commercial success. 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. Michael works with clients to develop effective compliance tools, tailored to the clients’ specific business, which allow in-house counsel to constructively advise and guide business teams on competition law issues that may impact commercial success or create legal compliance risks. Investigation Defense & Complaints. While the objective is always to help our clients avoid legal issues and regulatory scrutiny, where legal challenges arise, Michael works with clients on proactive steps intended to quickly resolve the issue or investigation, and has assisted clients to successfully resolve complaints and investigations by the EU and national competition authorities and before national courts. Michael also supports clients where necessary to take legal actions against competitors engaging in illegal activities.

Cristiane FerreiraCristiane FerreiraSenior Legal Director, Partner & Emerging Markets at Alnylam Pharmaceuticals

Cristiane is an experienced legal executive, with almost 20 years of experience, mainly in the pharmaceutical industry, supporting different regions and countries, including LATAM, Canada, Europe, Middle East and Asia.

Cristiane joined Alnylam in 2019, progressing from Legal and Compliance Director for LATAM & Canada to Sr. Legal Director for Partner & Emerging Markets, which is a region that covers 50+ countries. Before joining Alnylam, Cristiane worked at Aegerion Pharmaceuticals, Smith & Nephew and Abbott Laboratories.

During the course of her career, Cristiane has advised companies on a vast range of complex issues, including competition, compliance, privacy, regulatory, market access and commercial.

Cristiane holds a LLM in International and European Law from Vrije Universiteit Brussel (VU😎, Brussels, Belgium, and a MBA from Fundação Getulio Vargas, São Paulo Brazil.

Despoina SamaraDespoina SamaraLegal Director, , Greece at GSK

Despoina Samara is Legal Director for GSK Greece. She has been with the company for seven years. Prior to joining GSK as an inhouse lawyer, Despoina was working as a senior lawyer for a Greek law firm, for ten years, specializing in health care law, advising most of the Greek and multinational pharmaceutical companies operating in Greece. She has also represented pharmaceutical companies before the Greek civil and administrative courts, as well as the Hellenic Competition Commission. Despoina has worked as a research assistant for the Department of Health and Social Policy, London School of Economics and Political Sciences as well as did her stage with the European Commission General Directorate of the Internal Market – Industrial Property Unit. She holds a PhD in pharmaceutical law and a LLM in commercial and corporate law, both from King’s College (University of London).

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Description

Update on recent cases addressing parallel trade, including the impact of Mondelez decision Practical considerations for pharma distribution strategies Supply Security and Shortage Control

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