Politics
In this section you find information about the politics surrounding Biobanking. Questions about legal and regulatory aspects, on ownership and intellectual property rights are answered here.
1. Who is ownership of body samples?
2. Who has the Intellectual Property Rights?
3. Policies on data privacy.
1. Who is ownership of body samples?
This is a complex issue. Once body samples have been given to the biobank, both the biobank and the donor can legitimately claim the samples as their property. However, the European Union Database Protection Directive was devised in 1995 to act as a guideline for how personal data should be used.
The general practice in Europe is that DNA data belongs to the researcher or team that creates it. The individual who donated the DNA and who was the subject of that research has no legal entitlement to the research or the data it produces.
2. Who has the Intellectual Property Rights?
Where a drug or therapy is invented as a result of research carried out using donated DNA samples, the organisation that developed the treatment can claim ownership of the product they have created. In order to gain ownership of the product they will often apply for a patent of the treatment so that they have the rights to its production. Acquiring a patent for something is known as gaining 'intellectual property rights' to it.
3. Policies on data privacy.
While you may be concerned about large pharmaceutical organisations having access to your DNA data, they are obliged to follow strict international standards of privacy and confidentiality.
European union
If you are in the European Union and wish to find out information regarding data privacy in your own country, links to individual nation's Information Commissioners offices can be found here.
It is for you to discuss with your clinicians / researchers whether you wish to be involved with research studies that operate internationally across these countries.
Some people have concerns about submitting personal data that could be seen by a third party. However, in spite of this many thousands of people have been willing to donate samples to biobanks.
The Recommendation Rec (2006) 4 of the Council of Europe on research on biological materials of human origins can be found here.