JJUA55156U Life Science Law

The Life science area is heavily regulated and have pervasive impact on Danish and European Economy and competitiveness. This course will give you tools to understand and navigate highly regulated industries, by diving deep into the regulation and governance of the pharmaceutical industry. This will cover the entire innovation pipeline from pre-clinical development and considerations of intellectual property (IP) protection and business models to market access and post authorization requirements on drug manufacturers.  

The course will touch upon more technical topics such as patent protection of biomedical inventions as well as more ethical issues such as patient access to medicine and inclusion of vulnerable populations in clinical trials. The course is therefore highly complementary to other MA courses such as intellectual property law (Immaterialret), Health law (Sundhedsret), Health and human rights and Bio law & Bioethics. However, it is not necessary to have had any of them before taking this course. 

The seminars will be highly interactive, with activities focusing on exercises and cases which is important to get a good understanding of the details that often make the difference, and to practice analyzing complex problems in a creative and critical manner including with AI from a legal/regulatory perspective. “Field trips” to companies and organizations relevant to different aspects of the innovation pipeline are an integral part of the course. Therefore, physical attendance in the seminars and field trips are highly recommended. Should there be exceptional circumstances such as handicaps, that makes you wonder whether you can participate, please feel free to contact the course responsible and we’ll see if we can find a good solution.    

In December 2025 an agreement om the EU pharma package was reached by EU member states and the final negotiation on the EU biotech act is planned for July 2026. At the same time new regulations such as the regulation of substances of human origin and the health technology assessment regulation are being implemented across member states in EU. All of this adds up to a booming buffet of master thesis topics if you find an interest in this domain. 

Thinking beyond this course, the knowledge, skills and competences you will develop in this course can be a pathway down many different career tracks, both in public and private setting: Public authorities such as The Danish Medicine Agency (Lægemiddelstyrelsen), Danish Health authority (Sundhedsstyrelsen) and AMGROS, private companies such as LEO pharma, Novo Nordisk and Lundbeck and top tier Danish law firms are all places where previous students of this course are employed.