Case 7 - Personalised Genomic Information

Summary

A.1. BASE CASE

Marc has a unique gene that makes him immune to a specific, but widespread, influenza virus. The Pharmaceutical Company (PhC) screens his genome. As a result of this information, PhC develops a (patented) vaccine against this type of influenza.

Is Marc entitled to veto research on the gene? Does he have a maiore ad minus the right not to give consent to experiments that he considers unethical? Could he object to commercial research and restrict the use to ‘academic research’?

A.2. EDITORIAL NOTE ON THE GDPR

When the case was draft ed and answered, the EC Directive 95/46/EC on Personal Data Protection was still in place, which has since been repealed by the General Data Protection Regulation (EU) No. 2016/679. This Regulation has strengthened patients’ rights to medical data. This subsequent fundamental change has to be kept in mind. Reports could not be updated.

The case was conceptualised after the Oviedo Convention on Human Rights and Biomedicine (1997), negotiated by the Council of Europe, came into force under public international law (1999) after five ratifications (Denmark, Slovakia, Slovenia, San Marino and Greece), and prior to Directive 2004/23/EC, Directive 2006/17/EC, and Directive 2006/86/EC. Depending on when the reports were submitted, transposing national regulations are reported or not.

A.3. COUNTRY REPORTS

(1) BELGIUM

I. Operative Rules

Due to the requirement of a prior informed consent and due to the revocability of it, we believe Marc:

• 1. would be entitled to veto research on the gene;

• 2. has the right not to give consent to experiments that he considers unethical; and

• 3. could object to commercial research and restrict the use to academic research.