Sylvain Poitras

Practice Experience

Sylvain Poitras is an international health-sector lawyer with a 25-year record of achievements in life sciences and healthcare. He provides specialized strategic, legal, contractual, regulatory and compliance (anti-kickback) support to health-tech players worldwide.

Sylvain teams up with clients to take them to their next success stage, acting as a virtual in-house counsel and executing mandates with a COO-like approach. His clients include mature firms, start-ups, investors, non-profit organizations and regulators. Sylvain is an active member of Swiss Medtech, the Swiss medical device industry association, itself a member of Medtech Europe, the Brussels-based European medtech industry association.

Acting in various past international legal leadership roles with large US health sector leaders  (Medtronic, Cardinal Health, IBM), Sylvain has led support to international business lines with annual sales of hundreds of millions of US dollars. He has been active in commercial operations at multiple levels, including business development, product development, sourcing, fundraising, multi-country product launches, marketing and sales strategies, product recalls and large scale legal and commercial negotiations with private and public sector players. 

Sylvain previously worked for the Geneva-based World Health Organization (WHO), the UN health agency, leading legal and regulatory reforms. In this capacity, he worked with officials from Ministries of Health in Europe, the Middle-East, Asia, and Africa.

Starting in 2010, Sylvain developed a number of university courses and case studies on the European medical technology oversight system (CE-marking, innovation, contracting practices, and compliance), which he has taught annually at two universities: the Ecole Polytechnique Fédérale de Lausanne (EPFL), and the University of Neuchâtel, home to the Swiss Health Law Institute.  He has been a guest lecturer at the University of Geneva and the University of Montreal.

Education

Certificate of Achievement, HMX Fundamentals - Pharmacology, Harvard Medical School, 2021

M.P.H. (Master of Public Health), Harvard University, 1991

LL.B. (Bachelor of Laws in Common Law – J.D. equivalent, Dalhousie University, Halifax, Canada, 1989

LL.B. (Bachelor of Laws in Civil Law – J.D. equivalent), University of Montreal, Canada, 1988

Languages

English and French

Sylvain is licensed as an attorney-at-law in New York and Québec and provides all services on behalf of Swiss Peak Technologies SA, a company registered in Geneva.

Appleton Luff is a specialty law firm focusing on issues of international trade, arbitration, investment, intellectual property, international life sciences, and public international law.  The attorneys of Appleton Luff are separately registered or incorporated and operate independently through offices located in Brussels, Geneva, Istanbul, Seattle, Silicon Valley, Singapore, Warsaw, Washington, D.C. and Zurich.

Countries of Professional Experience

Europe: Switzerland, France, Germany, UK, Ireland, Belgium, The Netherlands, Italy, Spain, Sweden, Iceland, Romania, Hungary, Bosnia and Herzegovina, Turkey, Russia

Asia: China, Japan, India, Tajikistan, Uzbekistan.

Americas: USA, Canada.

Africa: Tanzania, Mauritius, Tunisia, Egypt.

Middle East: Israel, Kuwait, Iran.

Current Positions

Partner, Appleton Luff (2021-...)

Managing Director, Swiss Peak Technologies SA (2013-...)

Lecturer in health-tech law, Ecole Polytechnique Fédérale de Lausanne (2010-...)

Lecturer in health-tech law and innovation, University of Neuchâtel (2010-...)

Mentor and judge, MassChallenge Switzerland (incubator) (2017-...)

Mentor and judge, MassChallenge Israel (incubator) (2021-...)

Board member ALA ELP (Vice President 2014-2022) (2014-...)

Membership of Professional Bodies

New York Bar and Quebec Bar

Selected Representative Matters

• Advised multiple health-tech executives and boards on development opportunities, growth projects, negotiations, crisis management and dispute resolution.
• Advised foreign health-tech firms on the establishment of European and Swiss offices.

• Performed health-tech investment opportunity assessment for investors, reporting on the strategic, legal, regulatory, contractual and compliance (anti-kickback, including FCPA) dimensions.

• Negotiated and closed on multiple complex international health tech in-licensing and out-licensing deals with private sector and non-profit players (e.g., universities and foundations).

• Assessed, set up and reformed entire international compliance programmes for several large health-tech players, including major listed US medical device groups, leading international non-profits and several SMEs.

• Led compliance breach remediation initiatives with Europe players.

• Led complex negotiations with health authorities in various European countries.

• Negotiated and signed complex development, supply and distribution agreements for international health-tech companies.

• Reviewed and advised on health claims in product literature (websites, brochures, Instructions for Use (IFUs)) in anticipation of multi-country product launches.

• Led a post-acquisition integration initiative by a Swiss health-tech group after an acquisition of two production facilities from a foreign medical device group.

•  Medtech law briefing series on key legal topics including anti-bribery compliance, contractual compliance with MDR, GDPR and clinical investigations, with Kevin Moore, 2019-2020 (https://www.linkedin.com/pulse/medtech-anti-bribery-compliance-refresher-smes-context-poitras/)

• The Biotech Industry in Montreal: An Empirical Assessment of Regulatory and Ethical Needs, University of Montreal, Canada, Themis Editor, in Bio-ingénierie et responsabilité sociale, 2005
• In Vitro Testing and Regulation – Comparing the US, EU and Canada, with Mylene Deschenes, Clinica, July 2003
• Mental Health Legislation: International Trends, with J.M. Bertolote, in Contemporary Psychiatry, Springer, 2001

• Several reports and articles, International Digest of Health Legislation, World Health Organization, Geneva, Switzerland,1991-2000

• Several country health-sector law situation assessment reports, World Health Organization, Geneva, Switzerland, 1993-2000

• Mental Health Care Law: Ten Basic Principles, World Health Organization, principal contributor, Geneva, Switzerland, 1996

• Legal support to medtech execution and investment, China Council for the Promotion of International Trade (CCPIT), Beijing, 12 December 2023
• An introduction to the law governing medical device manufacturers in Europe, course to engineering students, Ecole Polytechnique Fédérale de Lausanne (EPFL), Switzerland, annual course, 2010 - . . . 

• "Ten Legal Tips for Life Science Startups", talk to life science entrepreneurs, MassChallenge Switzerland, Lausanne, annual course, September 2022 - . . .

• Final judging round for life science startups, judge/panelist, MassChallenge Switzerland, Lausanne, annual role, September 2019 -. . .
• An Introduction to the Law Governing Medical Device Manufacturers in Europe, Course to Law Students, University of Neuchâtel, Switzerland, 2010-2022
• Cases in Medical Device Law and Regulation, University of Neuchâtel, Switzerland, 2015-2020
• Legal determinants of Medical Innovation, Innovation Day, University of Neuchâtel, Switzerland, August 2019
• IP Protection and Medical Product Development, MAS Drug Discovery and Clinical Development, University of Geneva, August 2016

• Determinants of Life Science Innovation, University of Neuchâtel, Health Law Institute, Fall 2015

• Complaints handling procedure of Medtech Europe, contributor, Brussels, Belgium, 2010-2012

• Training to Regional Finance Heads on Customer Interactions and Compliance in the Medical Devices Industry, Geneva, Switzerland, Spring 2011

• Training on Compliance by International Distributors in the Medical Device Space, Antalya, Turkey, Fall 2011

• Panelist, The Third International Medical Device Compliance Congress, Eucomed/Advamed, Berlin, Germany, May 2010

• Discussing Distributors’ and Other Third Parties’ Compliance with the Foreign Corrupt Practices Act (FCPA) and Anti-Corruption Law, VIB, Barcelona, Spain, December 2009

• Training to French Salesforce on Customer Interactions and Compliance in the Medical Devices Industry, Paris, France, December 2008

• Panelist, The First International Medical Device Compliance Congress, Eucomed/Advamed, Paris, France, May 2008