Life Sciences

Service description
Awards and Media
Team

We have been focusing on the business and legal regulation of the pharmaceutical and health sectors (Life Sciences) for a long time now. Our specialised team comprising more than 10 lawyers is equipped with unique know-how, practical experience and detailed knowledge of market standards.

Our clients are leading global manufacturers of pharmaceuticals, medical devices, cosmetic products and food supplements, distributors, hospitals, clinics, private physicians, research institutes, laboratories, pharmacies, biotechnological companies, and other entities doing business in these fields or exercising state authority.

We advise our clients in individual pharmaceutical and health sector regulation areas and in other specialised areas closely related to them, particularly the area of personal data protection, public procurement, M&A, competition and IP/IT. When advising in these particular specialised areas, we draw on our extensive practical experience. Our services take into account all specifics of the pharmaceutical and health sectors.

We specifically focus on the following areas:

PHARMACEUTICAL AND MEDICAL PRODUCT SECTOR

  • Pharmaceuticals, medical devices, cosmetic prducts, food supplements
  • Market access agenda
    - Reimbursements from the public health insurance; price regulation
    - Agreements with health insurance companies (risk sharing)
    - Assessment and set-up of various distribution models (standard distribution, direct-to-hospital model, commission model, consignment warehouses)
  • Compliance agenda – interaction with health professionals and health service providers
    - Providing grants, sponsoring, cooperation with experts, patient organisations and professional organisations, educational events for professionals
    - Drafting contractual documentation
    - Assessments in terms of legal regulations and codes of ethics (AIFP, EFPIA, MedTech, etc.)
    - Transparency & disclosure
  • Business agreements
    - Distribution and logistics agreements
    - Bonus arrangements and related advisory
    - Market research agreements
    - Data purchase agreements
    - Register of contracts, trade secrets and related advisory
    - Electronic signatures
  • Regulatory matters
    - Regulation of production, import, distribution, provision and sale
    - Registration, notification and reporting with competent administrative authorities
    - Digitisation (mail order, home delivery, etc.)
    - Product labelling requirements
    - Withdrawal of products from the market
  • Advertising
    - Assessment of promotional materials, incl. TV spots
    - Educational campaigns
  • Clinical trials and medical affairs agenda
  • Clinical trial agreements
    - Patient’s informed consent
    - Ensuring treatment after termination of a clinical trial (post-trial access)
    - Specific treatment programmes (compassionate use)
    - Patient support programmes
  • Manufacturers’ liability and claims for the compensation of damage caused by medicine or other products
  • Representation in administrative and judicial proceedings (particularly before the State Institute for Drug Control, the Ministry of Health)
  • Drafting bills (e.g., in the area of medicines price policy)
  • Relationships with the non-profit sector

HEALTH SECTOR

  • Establishment and transformation of health service providers
  • Health service provision regulation – hospitals and clinics
  • Reimbursement from the public health insurance
  • Negotiating agreements with health insurers
  • Compliance programmes
  • Professional accountability and insurance
  • Rights and duties of patients, physicians and educational institutions
  • Telemedicine
  • Keeping health documentation, GDPR compliance

ADDICTIVE SUBSTANCES

  • Permission to handle addictive substances
  • Advice in the fields of production, distribution and sale of cannabis and cannabis products
  • Regulatory obligations related to the handling of addictive substances
  • Audits and comprehensive set-up of registers and handling of addictive substances at health service providers
  • Using cannabinoids and other substances in foodstuffs and other products

We also address all of the above topics in our professional publications, lectures and on our blog.

We are very proud to have been in the legal team lead by Willkie Farr & Gallagher LLP Germany that advised PAI Partners ("PAI") on the acquisition of the majority stake in VAMED Group's rehabilitation business ("VAMED") from Fresenius SE & Co. KGaA. On HAVEL & PARTNERS side, the professionals involved in the transaction were […]
Authors: Kateřina Slavíková, Tomáš Hric, Alžběta Pospíšilová Like many other public health insurance systems worldwide, the Czech public health insurance system also faces challenges concerning sustainable funding and rising healthcare costs, particularly in connection with chronic and rare diseases. This April the Ministry of Health of the Czech Republic therefore introduced a draft amendment 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: František Neuwirth, Denisa Fuchsová In December 2022 and January 2023, new legislation on medical devices and in vitro diagnostic medical devices (jointly “medical devices”) came into force: We provide an overview of the most important changes in this post. AMENDMENT TO THE Act on Advertising Regulation Amendment to Act No. 40/1995 Sb. on Advertising […]
Authors: David Krch, Václav Audes, Vlaďka Laštůvková We would like to take this opportunity to inform you about conclusions made by the Coordination Committee[1] regarding tax implications of paybacks provided to health insurance companies based on risk sharing. At the end of last year, the Coordination Committee addressed adjustments of the VAT assessment base (and […]
Authors: Václav Audes, Kateřina Slavíková, Denisa Fuchsová In late 2021, the European Parliament adopted Regulation (EU) 2021/2282 of the European Parliament and of the Council on health technology assessment (the “Regulation”), which had been under discussion for several years. The European Union hopes that the adoption of the Regulation will establish a joint instrument that […]
Overview of existing regulations or emergency measures governing liability for harm caused by COVID 19 vaccine (liability for result of vaccine application, assuming there are no vaccine defects, i.e. general rules on liability for defective medicinal products excluded)
Dentamed, a member of the Lifco group, has acquired 100 percent shares in Medema, Brno-based vendor if consumables and equipment for dentists’ offices and dental laboratories in the Czech Republic. A dedicated HAVEL & PARTNERS team has provided comprehensive transactional advice to Dentamed on this acquisition. The advisory team comprised Jan Koval (Partner), Tomáš Navrátil […]
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 […]
Authors: Václav Audes, Jan Diblík, Kateřina Slavíková The coronavirus pandemic has stirred up debates about the need for healthcare in the Czech Republic to be modernised so that it can operate remotely without direct contact with the patient. Telemedicine, as the remote provision of healthcare is called, would reduce unnecessary travel to healthcare appointments or prolonged periods […]
Several professional teams of the largest Czech and Slovak law firm HAVEL & PARTNERS headed by Václav Audes, the firm’s partner, provided comprehensive legal advice to Genesis Capital Growth on the acquisition of a 100 per cent stake in Home Care Promedica, a provider of home healthcare and social services in the Czech Republic. Established […]
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 […]

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