Request for bioequivalence studies and dissolution data

Confidentiality
Trade secrets
Legislation:
Official Information Act 1982
Section 9
Legislation display text:
Official Information Act 1982, ss 9(2)(b)(i), 9(2)(ba)(ii)
Agency:
Medsafe
Ombudsman:
Mel Smith
Case number(s):
165605
Issue date:
Language:
English

Not a trade secret but the data is subject to an obligation of confidence—risk of disclosure to competitors would make drug suppliers less likely to enter the New Zealand market—s 9(2)(ba)(ii) applies

A pharmaceutical company applied for consent to market certain generic medicines in New Zealand under section 21 of the Medicines Act 1981. One of their competitors requested bioequivalence studies[1] and dissolution data[2] provided in support of the application. Medsafe refused the request under sections 9(2)(b)(i) (trade secrets) and (ba) (confidentiality) of the OIA, and the requester complained to the Ombudsman.

The Chief Ombudsman rejected Medsafe’s argument that release of the information would disclose a trade secret. He noted that the products were readily available, and anyone could carry out the same tests, and arrive at the same information. He did not consider them to be trade secrets, which are usually more in the nature of ‘processes, patterns, and formulae’.

However, he did accept that the data was subject to an explicit obligation of confidence, and that disclosure would be likely to damage the public interest (section 9(2)(ba)(ii) of the OIA). The New Zealand market is small by international standards, and suppliers would be less inclined to seek approval to enter it if it meant their competitors could access information that might be used to their disadvantage in larger foreign markets. This would restrict the availability of affordable or efficacious drugs to consumers.

The requester argued that there was a public interest in ensuring that Medsafe carried out its function of reviewing the safety and efficacy of generic medicines properly, and that Medsafe’s performance could not be reviewed unless the information about bioequivalence and dissolution was released.

The Chief Ombudsman did not agree. He noted comments by Young J in Beecham v Minister of Health [2002] BCL 606 that ‘the public watchdog is Medsafe … not the plaintiffs who self-evidently have their own commercial interests to protect’. There was not sufficient public interest in the release of information in order to allow pharmaceutical companies to review the performance of Medsafe to outweigh the public interest in suppliers submitting applications to Medsafe and gaining registration in New Zealand.

This case note is published under the authority of the Ombudsmen Rules 1989. It sets out an Ombudsman’s view on the facts of a particular case. It should not be taken as establishing any legal precedent that would bind an Ombudsman in future.


[1]    Testing of two drugs with identical active ingredients, or the same drug at different dosages.

[2]    Testing of the batch-to-batch consistency of the same drug.

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