Life sciences & healthcare

COVID-19 ALERT:  IMPACT ON CONTRACTS 

Read CEELM COVID-19 Comparative Legal Guide to know more about the COVID-19 impact on contracts in Croatian market: CEELM-Covid-19-Comparative-Legal-Guide_-Contracts-in-Croatia.pdf

Full guide for 24 CEE countries is available here: https://ceelegalmatters.com/covid-19-and-contracts

We acted for various clients in the healthcare and life sciences sector, including laboratories, pharmaceutical companies, hospitals and health systems, medical centers, retail pharmacies and wholesale distributors, physician groups and health insurers. We  also advise a range of innovative pharmaceutical, medical device and biotechnology companies as well as investors in the sector.

Our service is based on:

  • Professional legal and scientific knowledge;
  • Deep industry knowledge and practical understanding of the sector;
  • Experience in supporting at all stages of the product lifecycle from innovation to funding, product development, exploitation, surveillance and enforcement;
  • clear guidance on the regulatory and legal framework in the sector;
  • Capability to advise clients on antitrust and competition issues;
  • Experience in corporate and commercial transactions acting for pharmaceutical companies, biotechs and VCs, including on  Capital Markets, M&A, licensing transactions, technology transfers, regulatory and privacy issues, R&D collaborations, clinical trials, marketing arrangements, trade mark and patent disputes and product liability.

In addition to advising on headline matters, we are also there for the day-to-day issues and we offer assistance with:

  • Clinical trial agreements
  • Distribution and marketing agreements
  • Medical advertising and competitor’s complaints
  • Pharmaceutical trade marks
  • Pricing and re-imbursement
  • Employment law matters
  • IT and outsourcing
  • Environmental issues

RECENT EXPERIENCE

  • Advising European Molecular Biology Laboratory on regulatory requirements issues concerning a research, donation and transfer of human embryonic stem cells (hESCs) and human embryos (2020);
  • Advising European Molecular Biology Laboratory on legal and regulatory requirements for establishing a research facility/ health institution in Croatia (2020);
  • Advising Vifor Pharma on various regulatory and marketing issues concerning a breach of marketing regulations by the competitor (2020);
  • Advising Vifor Pharma in relation to the filing and handling a competitor’s complaint (2020);
  • Legal review of SmPC for an international pharma business in relation to several medicines in Croatia (2020);
  • Advising a leading international pharma business in relation to various issues arising from the transfer of business unit as part of wider pan-European joint venture structuring process (2020);
  • Advising a leading international pharma business on licence and distribution agreement relevant to Croatian market (2019);
  • Advising international  corporate group investing in the field of medical cannabis in relation to Croatian  regulatory issues and licensing requirements (2019);
  • Advising international  corporate group investing in the field of medical cannabis in relation to Croatian  regulatory issues and licensing requirements (2019);
  • Advising  Attends GmbH (Domtar Personal Care company) on various regulatory issues in relation to the Croatian reimbursement system for particular medical products distributed in Croatia (2019);
  • Advising McKesson Corporation in relation to the distribution agreement and relevant commercial issues.