PHARMAC’s Decision Criteria Consultation Document

Download PHARMAC’s Decision Criteria Consultation Document (PDF 203kb)

4 September 2013

PHARMAC's Decision Criteria Consultation Document

Thank you for the opportunity to comment on PHARMAC's Decision Criteria Consultation Document. In addition to seeking feedback on the use and application of the decision criteria to pharmaceuticals, you are seeking feedback on how the decision criteria might apply to medical devices, in anticipation of PHARMAC taking on responsibility for the prioritisation of medical devices used in district health board hospitals from July 2015.  

My role and function

I am charged with promoting and protecting the rights of health and disability services consumers, as set out in the Code of Health and Disability Services Consumers' Rights (the HDC Code). One of my functions under the Health and Disability Commissioner Act 1994 is to make public statements in relation to any matter affecting the rights of health or disability services consumers. The comments I am making in this submission are made pursuant to that function.

Regulation of medical devices and pharmaceuticals

As noted in the Consultation Document, Medsafe is responsible for approving the use of pharmaceuticals in New Zealand and for ensuring the safety of such pharmaceuticals, while PHARMAC is responsible for deciding which pharmaceuticals should be subsidised for use in New Zealand.

In respect of medical devices, Medsafe has an oversight role through its managing of adverse event reports with respect to the safety and quality of medical devices, but there is no approval process equivalent to that for pharmaceuticals. PHARMAC's extended responsibility for the prioritisation of medical devices used in DHB hospitals does not include a responsibility for approving such devices as safe for use in New Zealand.

Decision criteria for medical devices

As noted in the Consultation Document, there is much less data available about the effectiveness and safety of medical devices than pharmaceuticals. While it is not the mandate of PHARMAC to approve or endorse the quality and safety of medical devices, I consider that there is a legitimate concern that the public may interpret a positive funding decision by PHARMAC in respect of a medical device as an endorsement of the quality and safety of that product.

For that reason, in my view, PHARMAC should carefully consider the quality and safety of a medical device before it makes any decision to fund that device in New Zealand. Patient safety and quality is not currently one of the nine decision criteria PHARMAC uses and I therefore recommend that the decision criteria are amended to ensure that patient safety and quality is at the forefront of any decision to fund a medical device in New Zealand.

Please do not hesitate to contact my Office if you have any questions about the comments made in this submission.