Strong support for joint medicines agency and regulation of complementary medicines
Submission to the Government Administration Select Committee on the Therapeutic Products and Medicines Bill - March 2007
Major impacts of this Bill are proposals to set up a joint medicines regulation agency with Australia and to extend regulatory oversight to complementary medicines. These proposals have attracted some controversy but NZORD has worked over many years to discuss these issues in detail with a wide range of support group leaders in New Zealand. We believe both these major proposals are in the best interests of health consumers in New Zealand, and that there is widespread support for them among support groups representing the vast majority of patients. Here are the main points of the submission we made to the select committee:
Ensure efficacy, safety and supply. These three key themes are often used in medicine regulation worldwide and they are also matters of great interest to the patients, their families, and the support groups that advocate for them. Though the regulators’ approach to these issues may have a more technical aspect to it, the essential themes are the same for us. We want to know the medicines work, we want to know their safety (and risk) profiles, and we want to get reliable access to them. We are pleased to note that the Bill provides a good framework for addressing these issues.
Complexity of the regulatory task. It is clear from numerous comments in recent years, and from the introduction to the Bill, that the increasing complexities of the regulatory task, and the capacity of Medsafe as New Zealand’s medicines regulator, together pose risks to the efficient attainment of these three important goals for New Zealand patients. For this reason we strongly support the co-operative arrangement in the Bill which would establish a new joint regulatory agency for Australia and New Zealand. The proposed agency would give a much needed boost to the technical capacity available, and greatly enhance medicine regulation for New Zealand.
Avoiding delays. We note statistics provided from a number of sources which demonstrate a significant delay in getting new medicines onto the Pharmaceutical schedule in New Zealand. The new agency set up by this Bill will effectively deal with the regulatory function as one cause of those delays (the other delay being subsidy by Pharmac). This solution provided by a one-application two-country regulatory approval process is another reason that the Bill is good for efficient administration as well as good for New Zealand patient interests.
Access problems for New Zealand. NZORD is aware that in the past decade a number of pharmaceutical manufacturers have chosen not to seek regulatory approval for some medicines for rare “orphan” diseases in New Zealand. Again there are two clear hurdles at play here: regulatory process/costs and subsidy issues. Our assessment of the effects of the proposed joint agency is the complete removal of one of those significant barriers, and this is further grounds for our strong support for the Bill.
Sovereignty. We note concern expressed by some groups about sovereignty issues for New Zealand if we are potentially outnumbered in the decision-making processes within the new agency. We believe the amended provisions related to governance, and for disallowance by either Parliament, resolve any concerns in that area.
Extension of regulatory oversight. Other areas of concern noted by some groups, particularly those interested in non-prescription medicine or therapeutic product marketing, are the extension of regulatory oversight of these complementary medicines and therapeutic products. None of the discussions or feedback we have had from our networks gives any indication that extended regulation is a problem for them.
Support for regulation of complementary medicines and products. It is our experience, supported by frequent comments by group leaders, that many patients wish to have access to a variety of complementary medicines and therapeutic devices, but they are also firmly of the view that safety of those products is a very high priority. Reports of poor quality manufacturing and illegal addition of ingredients to some complementary medicines, plus strong marketing of products with dubious efficacy, are matters of considerable concern to patients and support groups. There has been comment that getting these complementary medicines and products under some form or regulation is well overdue. It is considered an essential step to protect the safety of New Zealand patients and health consumers. The Bill is strongly supported for the initiative to provide better oversight of complementary medicines and therapeutic devices.
Consistency across all medicines. We support the theme of consistency of approach in a number of areas addressed by the Bill. Advertising and risk analysis are among the major areas considered. Without commenting specifically on what the rules will be in regard to those matters, NZORD strongly supports the consistent approach taken across all types of medicines, whether prescription of complementary.