Life Science

Life Science

Key contacts

Václav Audes
Partner
vaclav.audes@havelpartners.cz

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.

Publications and newsletters

Legislative changes in the field of medical devices
Authors: František Neuwirth, Denisa Fuchsová In December 2022 and January 2023, new legislation … read more »

VAT and paybacks provided to health insurance companies
Authors: David Krch, Václav Audes, Vlaďka Laštůvková We would like to take this opportunity to i… read more »

New Health Technology Assessment Regulation – a step forward in promoting innovative health technologies in the EU?
Authors: Václav Audes, Kateřina Slavíková, Denisa Fuchsová In late 2021, the European Parliament… read more »

Biolegis – Research on vaccines liability compensation schemes
Overview of existing regulations or emergency measures governing liability for harm caused by COVID… read more »

Czech Republic to compensate for harm suffered as a result of Covid-19 vaccination
Authors: Václav Audes, František Neuwirth, Denisa Fuchsová In the Czech Republic, persons who un… read more »

Effective date of the European Regulation on Medical Devices to be deferred
Authors: Václav Audes, František Neuwirth, Denisa Fuchsová On 17 April 202… read more »

New price rules of the Ministry of Health in the field of medicinal products
Authors: Václav Audes, Tereza Brousilová A new price rule of the Ministry of Health on the regul… read more »

New Health Ministry Price Regulations for Medicinal Products
Authors: Václav Audes (Partner), František Neuwirth (Associate) On 1 January 2019 price regulat… read more »

New reimbursement regulation for consumer medical devices
Authors: Václav Audes (Partner), František Neuwirth (Associate) On 1 January 2019, the amendment… read more »

Significant Matters

HAVEL & PARTNERS provided comprehensive advice on the acquisition of Medema
Dentamed, a member of the Lifco group, has acquired 100 percent shares in Medema, Brno-based vendor… read more »

HAVEL & PARTNERS advised Genesis Capital Growth on the acquisition of Home Care Promedica
Several professional teams of the largest Czech and Slovak law firm HAVEL & PARTNERS headed by … read more »

Articles and Interviews

Telemedicine – 21st Century Healthcare
Authors: Václav Audes, Jan Diblík, Kateřina Slavíková The coronavirus pandemic has stirred up de… read more »

New reimbursement regulation for consumer medical devices
On 1 January 2019, the amendment to the Czech General Health Insurance Act1 came into effect, intro… read more »

New Health Ministry Price Regulations for Medicinal Products
On 1 January 2019 price regulation 1/2019/FAR1 of the Ministry of Health of the Czech Republic ente… read more »

Czech Republic: One Year after Adoption of the Amendment to the Act on Pharmaceuticals
1. Introduction On 1 December 2017, it will be one year after a fundamental amendment to the Act… read more »

The ePrescription System: Draft amending the Act on Medicines is under discussion in the Parliament of the Czech Republic
In response to the current regulation on mandatory electronic prescriptions, the Ministry of Health… read more »

Clinical trials and personal data protection: A new notice from SUKL
The protection of personal data under the General Data Protection Regulation (“GDPR”) in the field … read more »

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