The Life Sciences team provides legal services within the majority of the areas in the life sciences sector and has, unlike many other legal advisors, practical experience of the sector.
We have a profound understanding of your needs and the challenges you face within your business. Among our clients are Swedish and international companies and organizations, to whom we on a regular basis provide advice in relation to both Swedish and international matters.
Contracts for the research industry
We can assist you with contracts for research and development, clinical trials and non- interventional studies, manufacturing as well as other contracts necessary for the conducting of research projects.
Within the health care sector and especially with regard to pharmaceutical and medical device companies, most business activities are governed by complex regulations. We continuously work with the regulations that govern your business and are therefore well aware of the regulatory issues your company faces, both prior to initiating the work required to receive a Swedish marketing authorization for the product and until the day of patent expiry and beyond.
Marketing of pharmaceuticals is governed by law and, for many companies, by ethical rules which have been adopted by Läkemedelsindustriföreningen, the trade association for the research-based pharmaceutical industry in Sweden (LIF). After having served as secretary in the Information Practices Committee (NBL), the highest self-regulatory body that supervises compliance with the Ethical Rules for the Pharmaceutical Industry (LER), for several years and being the only law firm in Sweden having held such a position, we have a unique and extensive experience in marketing of pharmaceuticals. We are regularly engaged as speakers at educational seminars regarding marketing of pharmaceuticals.
Interactions with the health care sector and interest associations
Interactions between the industry and the health care sector are largely governed by ethical rules set by the industry associations in collaboration with the Swedish Association of Local Authorities and Regions (SALAR), implemented in the ethical rules LER. LER also contains provisions on interactions between the industry and interest associations. We have extensive knowledge of the ethical rules and how they are applied in practice both following several years as secretary in the Information Practices Committee (NBL), the highest self-regulatory body that supervises compliance with the ethical rules, and following practice as in-house lawyers at pharmaceutical companies.
Personal data, patient data and bio banks
We have extensive practical experience and knowledge regarding issues on processing of personal data with regard to clinical trials and non-interventional studies, processing of patient data, genetic testing, the keeping of bio banks, agreement structures and international flows of personal data.
Mergers and acquisitions
We assist with acquisitions and sales of research companies and other companies within the health care sector. We can help you with everything from initial strategic issues through presentation of offers, carrying out due diligence, negotiations and drafting of contracts.
Our clients include both Swedish and international companies and organizations, such as:
- Pharmaceutical companies
- Medical device companies
- Industry associations
- Other companies within the health care sector