Commentaries: Art. 64

The federal authorities responsible for the enforcement of this Act may disclose information which is not publicly accessible to the foreign authorities and institutions responsible for the enforcement of therapeutic product regulations and to international organisations, provided that it is ensured that:
1. the requesting body is bound by official secrecy and uses the information received exclusively in an administrative procedure in connection with the enforcement of therapeutic product regulations and does not pass it on to third parties;
2. only information required for the enforcement of therapeutic product regulations is transmitted;
3. no manufacturing or trade secrets are disclosed, unless the transmission of such information is required to avert an immediate and serious risk to human life or health.
They may disclose personal data, including data on health and on administrative or criminal proceedings or sanctions, if legislation in the state concerned guarantees adequate protection of the privacy of the data subject. In the absence of such legislation, the data may only be disclosed if:
1. sufficient safeguards, in particular contractual clauses, ensure an adequate level of protection;
2. the data subject has consented in the specific case;
3. serious risks to health can thereby be averted in the specific case;
4. disclosure is required in the specific case in order to protect the life or the physical integrity of the data subject; or
5. in the specific case, there is a possibility that illegal traffic or other serious violations of this Act may be revealed as a result.
In particular, the following data may be disclosed:
1. results of market surveillance;
2. inspection reports;
3. information on clinical trials;
4. information from vigilance;
5. information on authorisations;
6. information on conformity assessment bodies.
The Agency is entitled to disclose the following information to the World Health Organization via its Global Pharmacovigilance Database, in connection with notifications and registrations of adverse reactions to medicinal products:
1. information which is not publicly accessible and personal data relating to health, together with the data subject’s initials, sex and year of birth;
2. a report on the adverse reactions.