About

Amgen is a leading US-headquartered biotechnology company that operates in a highly innovative industry, where legal issues often arise before adequate and effective regulation is created. Given the multitude of product launches, the company’s legal departments always remain at the forefront by providing practical solutions to constantly evolving problems. In the Central and Eastern European region, Amgen’s senior legal counsel for North and East Europe Ernest Jędrzejewski is based in Austria, and is responsible for overall co-ordination of legal support in the region. Amongst his team members, Jędrzejewski highlighted Polish-based associate counsel Przemysław Bukowy’s foresight, explaining how he ‘always remains at the forefront of legal changes and market trends in Poland’. Jędrzejewski also explains how the team in the region works closely with its legal colleagues outside of the region: ‘[The] legal department in Central and Eastern Europe is part of the international legal group, consisting of 40 lawyers. There are two other lawyers responsible directly for legal support in the region, as well as 12 other specialist lawyers in the international legal group in Switzerland and Brussels who provide ongoing direct legal support for affiliates in the region. There are two members of support staff directly in the region, as well as three more in Switzerland that provide support for the region as well’. As the biotechnology industry requires constant innovation, Amgen’s Central and Eastern European legal department is deeply integrated in all innovation processes of the company through the nimble participation in the cross-functional regional innovation group. The team is also credited for having executed a number of recent projects and deals in the countries of the region including setting up an innovative manufacturing deal, creating an Innovation Hub for digital health projects, supporting multiple innovative product launches such as including Amgen Biosimilars and implementing an innovative IP agreement across the region. In addition the team is distinguished for creating a value based healthcare partnership, structuring a highly innovative research project involving a potential breakthrough in cancer treatment and providing legal support on a project involving the creation of a mobile application (software as medical device) for the management of certain adverse events of cancer treatment. Jędrzejewski was keen to add that ‘one of the key challenges [of the team] is to support the translation of the value of our products to the payers, to allow for the adequate access of cutting-edge products to patients in a region where the ability to pay still falls short of the actual unmet need’.