Zamfirescu Racoti Vasile & Partners counsels healthcare clients in the areas of transactional, litigation and enforcement, regulatory and finance matters. Rapid convergence of the healthcare and technology sectors requires even more legal expertise given the additional data privacy and intellectual property concerns.
We provide our clients with a unique combination of leading transactional capabilities, as well as broad regulatory and litigation experience.
Our team offers a full range of legal advice to pharmaceutical and medical device companies, hospital and health care systems and other service providers.
- Assistance in research projects
- Claw-back litigation
- Clinical trials
- Contractual assistance
- Distribution of medicinal products and of medical devices
- Health Technology Assessment (“HTA”) procedure & Cost-volume/ cost-volume-result procedure;
- License and supply agreements
- Operational matters
- Patent infringement litigation
- Pricing of medicinal products
- Public procurement
- Regulatory counseling
- Tax assistance related to specific projects carried out by pharmaceutical companies
Examples of our recent work include assistance to:
- The largest public hospital in Romania on determining the impact of the specific EU and national regulatory requirements regarding permits and mandatory procedures for hospitals and clinics, implementation of national health programs, contracting clinical trials, assistance in conducting complex public procurement acquisitions referring to medicines, medical products and equipment;
- One of the most active Romanian medical services market players in complex business transfers or share deals in the medical field – acquisitions of clinics and laboratories; conducting extensive due diligence analysis, legal assistance on the regulatory steps, determining the structure of the transaction, drafting and negotiating sophisticated transfer contracts;
- Several medical services providers to identify specific vulnerabilities, determining particular procedures for mitigating potential risks and select the most suitable mechanisms for implementing and further developing solid anti-corruption policies;
- The third largest importer and distributor of nutritional supplements, pharmaceuticals, dermatological cosmetics and technical-medical products in Romania and the largest entrepreneurial company on the Romanian pharmaceutical market on determining the strategy and assisting the client in challenging in court a decision issued by the Romanian Competition Council for an alleged anti-competition understanding;
- One of the world’s premier biopharmaceutical companies in relation to obtaining the additional protection certificate for the prolongation of the effects of an invention patent.