Published: 13 December 2018

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The Medsafe Files – Episode Eight: Section 29 Medicines

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Prescriber Update 39(4): 56–57
December 2018

Medicines Act 1981 provisions for supply of unapproved medicines

The Medicines Act 1981 permits a medical practitioner to administer or arrange for the administration of medicines for the treatment of a patient in his or her care¹ . Section 29 permits a New Zealand supplier to obtain and supply unapproved medicines to any medical practitioner, on the practitioner’s request, for the treatment of a particular patient currently under that medical practitioner’s care¹ .

These provisions in the Medicines Act 1981 allow access to medicines for which there is a clinical need, but where there is no approved product available in New Zealand. This is an exception process and should not be seen as an alternative to seeking approval to distribute these unapproved medicines.

Note that Section 29 specifies only medical practitioners. This means that other authorised prescribers may not procure medicines under the provisions of Section 29.

Medicines supplied under Section 29

Because these medicines have not been through the usual approval process (formally referred to as gaining ‘consent for distribution’), it is not possible to place the same reliance on their quality, safety and efficacy as it is for approved products. Medical practitioners should consider the need to use an unapproved medicine, and whether there is an acceptable benefit-risk balance for use of the medicine in the clinical situation. For instance, some unapproved products may have been approved overseas by a trusted regulator and supplied to New Zealand through the controlled supply chain, whereas others may not have been approved and they may not meet internationally agreed standards with respect to quality, safety and efficacy.

Responsibilities of the medical practitioner

The medical practitioner should be fully aware that medicines supplied under Section 29 have not been evaluated by Medsafe for quality, safety and efficacy. The prescriber, therefore, takes responsibility for quality, safety and efficacy in these instances. It is the prescriber’s responsibility to ensure that they are aware of any safety issues relating to the unapproved medicines that they prescribe. Knowing about the proposed product and the patient’s characteristics should allow the practitioner to weigh the risks and benefits and provide credible advice to the patient. Informed consent would be an appropriate way to signal acceptance of the advice.

The Code of Health and Disability Services Consumers’ Rights requires that patients have a right to treatment of an appropriate ethical and professional standard, and to be fully informed² . Where unapproved medicines are used, the patient should be fully informed of this fact and counselled accordingly. The patient should also be given information in writing if requested.

Further advice on unapproved medicines is available on the Medsafe website (www.medsafe.govt.nz/profs/RIss/unapp.asp).

Responsibilities of the supplier of the unapproved medicine

Suppliers of unapproved medicines under Section 29 must report this supply to Medsafe at the end of each month. The supplier is usually considered to be the importer or manufacturer of the medicine. The information supplied to Medsafe includes the product name, dose, and pack size, and the number of units supplied. The supplier must also hold information on the medical practitioners that they have supplied the unapproved medicines to, the names of each patient and the date and location of the supply. Medsafe may use this information to identify medicines affected by quality issues and to conduct recalls.

Prescribers should note that if they import a medicine into New Zealand for supply to other medical practitioners, they would be considered a wholesaler of that medicine, and required under Section 29 to report the supply to Medsafe.

References

1. Medicines Act 1981. URL: www.legislation.govt.nz/act/public/1981/0118/latest/DLM53790.html (accessed 24 October 2018).
2. Health and Disability Commissioner (Code of Health and Disability Services Consumers’ Rights) Regulations 1996. URL: www.hdc.org.nz/your-rights/about-the-code/code-of-health-and-disability-services-consumers-rights/ (accessed 24 October 2018).