The legal research in the ELSAGEN project demonstrates that the governance structures for population genetic databases are not uniform or harmonious across Europe. The issues that have been raised by population genetic databases are not always addressed in the legal documents of each of the jurisdictions, and are often treated differently in the law of each jurisdiction. This is because countries have a ‘margin of appreciation’ in implementing European directives and conventions but also because there is currently no European instrument that specially relates to population genetic databases. As a result, new legislation has been written; the courts have been forced to develop the law; and existing governance structures have been used for population genetic databases. This section will highlight some of the common issues that have been raised in part III regarding the nature of the current governance structure for population genetic databases within Europe.

The lack of uniform implementation

An example of the lack of uniform implementation is the European Union Directive 95/46/EC on data protection which has been implemented into Icelandic, Swedish, Estonian and UK national law. The Directive requires that any use of health data must only be carried out with explicit consent, although there are a number of exceptions to this rule. The Directive allows data to be processed without consent ‘to protect the vital interests of the data subject or of another person’; or in cases where the ‘processing of the data is required for the purposes of preventive medicine, medical diagnosis, the provision of care or treatment or the management of health-care services’; in cases of ‘substantial public interest’ laid down in law; and in cases were research does not involve personally identifiable data.