Åsa Hellstadius

Project summary

Agreements concerning human biological material

The collection, handling and use of human biological material (HBM) are governed by an extensive system of laws, regulations, guidelines and codes based on ethical principles. Access to HBM is founded on the principle of voluntary giving, or donation, and most donations take place within the healthcare system. A central principle of both Swedish and international law is that the human body and its parts must not, as such, give rise to financial gain. This provision is intended to prevent practices such as organ trafficking. However, the scope of this prohibition on financial gain is unclear, particularly with regard to the possibility of compensating donors. The use of HBM in collaborations between healthcare providers and commercial actors requires agreements governing access to and use of the material.

 

The research project aims to clarify the scope of the prohibition on financial gain under Swedish law in the light of principles of contract law, taking into account both EU law and Sweden’s international obligations. What scope is there for entering into agreements concerning access to HBM? A related question concerns the extent to which a donor may secure compensation in connection with the future commercialisation of donated HBM, for example through a share of the revenue generated by a patent.