Life Sciences

Life Sciences is one of the most regulated and sensitive sectors of the economy. Attorneys from the Life Sciences practice understand this complexity very well. With our extensive experience gained over 20 years, we are able to respond to our clients’ challenges in a fast, efficient and creative way. In practice, our advisory services cover all stages of a product’s life cycle, from the concept stage to actual sales.

The Life Sciences team advises clients in the field of pharmaceutical law, including clinical trials, advertising and promotion, wholesale and retail distribution, labelling and manufacturing, and quality control. We specialise in:

• setting up distribution systems – with a particular focus on our clients’ business assumptions, the location of their production facilities and logistics networks, as well as national and European regulatory and technical requirements;
• reimbursement advice, including, inter alia, developing a reimbursement strategy, providing support in negotiations with the public payer and support in expanding availability of therapies for patients; and
• healthcare system support, including the establishment and restructuring of healthcare entities, telemedicine, medical data and health insurance.

Our expertise includes food law  – in particular in the areas of composition, support of production processes, marketing and distribution and sale of food; compliance and corruption prevention – with a particular emphasis on issues related to the transparency of internal and external processes, ethics, corporate governance, prevention of internal fraud, conflicts of interest and anti-corruption activities; and legislation – including drafting legislation, participation in the law-making process, development of industry positions, preparing, among others, opinions on the compliance of draft legislation with the constitution and international law regulations.

The Life Sciences team also advises clients on other regulated products, including, among others, medical devices, with a particular focus on ‘digital medical devices’, cosmetics, and biocides. We also offer our clients support in relation to tobacco and alcohol products.

The main challenges faced by companies and organisations in the Life Sciences sector today include technological developments and an increasing number of complex legal and regulatory issues. Our extensive knowledge together with a business-oriented approach allows us to provide support to our clients not only in the area of specific projects related to this sector, but also in adapting their business to the ever-changing regulatory environment. We are very proud of advising on a number of projects that involved the development and implementation of innovative solutions in the area of Life Sciences.