ABSTRACT

This chapter assesses the scope for exemptions for medical research, highlights problems of interpretation, and looks at the exemptions that partner countries have made in their laws. It presents an opinion about whether these are compatible with the aims and objectives of the Directive. Article 6 of the Directive contains five principles relating to data quality. Subject to the provision of suitable safeguards, Member States may, for reasons of substantial public interest, lay down exemptions in addition to those laid down in Article 8(2) either by national law or by decision of the Supervisory Authority. During Parliamentary discussion, Members of the Social Democratic Party have proposed to make a distinction between pure scientific research and commercially financed research. Article 16 prohibits the processing of personal data concerning inter alia a person's health. According to Article 7(7) exemptions may be laid down from prohibition to process health data where the processing of data takes place for reasons of substantial publ.