Healthcare and pharmaceuticals

Responsive lawyers across the full spectrum of healthcare and pharmaceuticals expertise.

The healthcare and life sciences sector in Serbia and Montenegro is developing quickly. Not only are pharmaceuticals giants becoming increasingly interested in the region, but the domestic healthcare sector is rapidly evolving. And as Serbia progresses towards EU membership, the regulatory landscape continues to change, making it more important than ever to receive the most up-to-date advice.

Pharmaceuticals and biotech is a longstanding focus area for Stankovic & Partners (NSTLAW). Having worked with some of the largest, most renowned players in the market we are confident that we understand the business needs and commercial drivers, as well as the obstacles confronting pharmaceuticals and integrated healthcare companies at present, both in Serbia and across the wider region. We also support smaller domestic healthcare companies, international private equity houses and debt funders, public sector bodies and professional groups and associations, among others, giving us a clear grasp of the sector from all angles.

We have particular experience of advising clients on regulatory compliance, and drafting terms and conditions governing the sales and distribution of pharmaceuticals products. In addition, we assist with product registration and clinical trials, public procurement processes and challenges, and reimbursement matters. However our large and skilled team handles a wide range of issues, from patent protection and prosecution to labour and employment law, often working in tandem with other teams across the firm. And whatever the issue, you can trust us to work hard to understand your aims and concerns, think creatively, and tailor our advice to your needs.

We support a number of leading international and domestic companies in the healthcare, pharmaceuticals, medical devices and life sciences sector, with standout names including Novartis, Takeda and GlaxoSmithKline Export Ltd. UK.

Recent highlights:

  • advising a leading medical devices manufacturer based in Scandinavia on the terms for its participation in a public tender for the supply of medical devices to public hospitals in Bosnia, including in relation to public procurement issues and risk management;
  • acting for Takeda, the largest pharmaceutical company in Japan and Asia, on competition issues associated with its plan to introduce an exclusive distribution model in Serbia;
  • developing a new comprehensive compliance program for a pharmaceutical company;
  • advising the German arm of an international pharmaceutical group on an important commercial project involving the collection and processing of personal data for employees, as well as doctors and healthcare workers, in a centralised database, including assisting with international data transfer issues;
  • advising the Serbian subsidiary of a well-known international pharmaceutical company on the process of establishing operations in Serbia, including advice on commercial compliance issues relating to the sale of pharmaceutical products, and a distribution framework agreement with its parent company;
  • advising Takeda Pharmaceuticals on compliance issues, including assisting with procedures for the collection and processing of employee data across the region, and for registering its databases;
  • representing a Japanese pharmaceutical company in an arbitration with a local distributor.
  • acting for a global pharmaceuticals company on employment matters, including everything from redundancy and downsizing exercises to employment negotiations and disputes, including drafting employment policies and procedures;
  • advising on the sale of 100% of the shares in Serbia’s second biggest chemical food additives wholesaler to Azelis Group;
  • representing Uniqa and Wiener Stadtische in damages claims due to a breach of the public procurement regulations brought against the State Healthcare Fund of the Republic of Serbia.