František Neuwirth

Counsel
CV
Projects
Awards and media
E-mail
frantisek.neuwirth@havelpartners.cz
Practice Areas
Industry Sectors

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
We have summarized what we know about pharmaceutical law at HAVEL & PARTNERS in the life cycle of the imaginary medicine “HAVELEX”.
HAVEL & PARTNERS traditionally announces internal promotions at the beginning of the second half of the year. Ondřej Florián, the partner responsible for leading the firm’s corporate and private client services team, becomes an equity partner as of 1 July. Kateřina Slavíková, Jaroslav Baier, Ondrej Čurilla, Petr Opluštil and Miroslav Vozáb have been promoted to […]
Authors: František Neuwirth, Vlaďka Laštůvková On 14 June 2023, the Czech government approved an amendment to the Act on Medicines, which imposes new obligations on marketing authorisation holders (“MAH”), distributors and pharmacies in order to ensure the availability of medicinal products on the Czech market. The proposal will now be debated in the Chamber of […]
Authors: Václav Audes, František Neuwirth, Denisa Fuchsová In the Czech Republic, persons who undergo Covid-19 vaccination have been given the opportunity to claim financial compensation from the state if the vaccination (or, more precisely, the medicinal product containing a vaccine) causes harm. The Czech Parliament adopted Act No. 569/2020 Sb., on the Distribution of Medicinal […]
HAVEL & PARTNERS, the largest Czech and Slovak law firm, has promoted a total of 14 lawyers with the start of the New Year. Ondřej Majer and Jan Šturm have become equity partners with effect from 1 January 2021. Josef Adam has moved from the position of counsel to partner. In addition, another 11 lawyers […]
Authors: Václav Audes, František Neuwirth, Denisa Fuchsová On 17 April 2020, in response to the extraordinary circumstances triggered by the pandemic outbreak of COVID-19 caused by the SARS-CoV-2 virus, the European Parliament approved an amendment to Regulation (EU) 2017/745 on medical devices (MDR). The key aim of the proposed amendment is, in particular, to ensure the availability of […]
On 1 January 2019, the amendment to the Czech General Health Insurance Act1 came into effect, introducing a new system of reimbursements for medical devices used during outpatient care, i.e. consumer medical devices. The amendment covers consumer medical devices that are prescribed on a prescription and that patients pick up in pharmacies or at dispensing sites, […]
On 1 January 2019 price regulation 1/2019/FAR1 of the Ministry of Health of the Czech Republic entered into effect. The regulation introduces in particular the following changes:   The maximum mark-up will be reduced in the 7th band and in the 8th band to 4% and to 2% respectively; the surcharge in these bands will be increased. After the […]

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