Investigation of limited access to Ministry of Health influenza vaccine adverse reaction reports
The complainant, Mr Ron Law, requested information held by the New Zealand Medicines and Medical Devices Safety Authority (Medsafe), a Ministry of Health business unit, concerning adverse reactions to influenza vaccines in 2010 and 2011.
Health practitioners provide adverse reaction reports (ADR reports) on a voluntary and confidential basis to the Centre for Adverse Reactions Monitoring (CARM), University of Otago. The Ministry contracts CARM to collate and analyse the ADR reports.
Medsafe withheld information contained in the ADR reports and other information in reliance on sections 9(2)(a) (protection of privacy of natural persons), 9(2)(ba)(i) (protection of information subject to an obligation of confidence) and 18(f) (substantial collation required) of the Official Information Act 1982 (OIA). The information withheld included the patients’ doctors’ names, the places where the patients lived, the patients’ ages, the date of their doctors’ attendances, and details of the patients’ medical history.
Medsafe released ‘listings’ of some information in the ADR reports, including the following information: whether CARM considered the reaction described in the ADR reports was causally associated with the influenza vaccines, brief details of the adverse reactions, medicines prescribed to patients, the patients’ age group and gender, the outcomes of the reported reactions, and whether the reported reactions were within the World Health Organisation definition of ‘a serious reaction’.
There is a risk that disclosure of all of the requested information (even non-identifying information) would compromise the significant privacy interests of patients whose ADRs are reported. Full disclosure would risk undermining New Zealand’s pharmacovigilance regime, and would be contrary to protection of public health and inconsistent with the practice of comparable international medicines regulators. Publication of all the requested information would also be likely to damage voluntary reporting by medical practitioners, which underpins New Zealand’s system of pharmacovigilance. This would potentially be detrimental to public health.
In all the circumstances, Medsafe was entitled to withhold the information at issue.