František Neuwirth

Email:
frantisek.neuwirth@havelpartners.cz

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František Neuwirth specializes in pharmaceutical and medical law, contract law, intellectual property law, unfair competition, advertising and regulatory matters.

In pharmaceutical and medical law, he focuses on medicinal products, medical devices, cosmetics and healthcare services, interactions with healthcare professionals and organizations (compliance agenda), distribution, clinical trials, pricing and reimbursement regulation, and advertising. František has also been seconded as in-house counsel to a leading multinational pharmaceutical firm.

Before joining our law firm in 2015, František worked as a member of the legal department for the EMEA region at a multinational manufacturer of medical devices for almost a year, focusing on contracts and interactions with healthcare professionals and organizations. Before that, he worked at another multinational manufacturer of medical devices for a year and a half, dealing with the implementation of French laws regulating the disclosure of data on payments to healthcare professionals. And before that, he worked as a paralegal at an international law firm for almost two years.

MEMBERSHIP IN PROFESSIONAL ASSOCIATIONS

Czech Bar Association

Languages
Czech, English, French, Italian

Education

Charles University in Prague, Faculty of Law (2013), Mgr. (Master of Laws)
Charles University in Prague, Faculty of Arts (2010), PhDr. (“Advanced” Master of Arts) Université de la Sorbonne Nouvelle (Paris III)

General legal advisory to leading multinational manufacturers of medicinal products and medical devices in everyday matters
Commercial contracts – manufacture, distribution, commercial agency, logistics and service agreements
Interactions with healthcare professionals and organizations – speaker, consultancy, grant, donation and sponsorship agreements, support for participation in training events, compliance assessment
Advertising and marketing – assessing advertising materials including TV spots, marketing services agreements, market research agreements, public awareness campaigns
Risk-sharing agreements with health insurance companies
Clinical trials and patient access programmes (compassionate use)
Agreements with patient organizations
Advisory to an Austrian manufacturer of medical devices, medicinal products and cosmetics with regard to the planned launch of its products on the Czech market
Representation before the regulator (State Institute for Drug Control) in borderline product proceedings
Advisory to an association of pharmaceutical companies in the area of parallel imports of medicinal products
Advisory to a US manufacturer of medical devices in the area of reimbursement regulation and notification of medical devices
Advisory to a manufacturer of medicinal products regarding market exclusivity of pharmaceuticals for rare diseases (orphan drugs)
Advisory to a manufacturer of medicinal products with regard to the provision of cross-border genetic testing
Advisory relating to cross-border prescription of medicinal products
Advisory to a manufacturer of innovative batteries on regulatory matters, development of a prototype (drafting contracts) and distribution
Advisory on regulatory aspects related to the acquisition of a manufacturer of a specific type of cars
Advising clients with regard to the implementation of the Contracts Register Act
Advisory to a biotechnological company developing a specific medicinal product during negotiations over a multilateral, supranational grant and consortium agreement on research and development, with a significant Swedish university being the major counterparty to the agreement
Advisory to a Swedish biopharmaceutical company on an agreement on supplies of an advanced therapy medicinal product

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