governments, and position both countries well on the international stage. It would also have resolved the issues with the Medicines Act and the temporary exemption for therapeutic products under the Trans-Tasman Mutual Recognition Arrangement (which has now become a permanent exemption). Until 2007 a large amount of work was done to bring the ANZTPA initiative to fruition. Legislation was introduced in New Zealand (and released as an exposure draft in Australia) but could not be passed as there was a lack of political support. The lack of support largely reflected concern about the inclusion of complementary medicines within the scope of the joint scheme. (New Zealand has now developed a separate regime for these products in the form of the Natural Health Products Bill.) As a consequence the two governments put ANZTPA on hold. In 2011 the Prime Ministers of New Zealand and Australia recommitted to ANZTPA and work recommenced. A few years later, however, following a comprehensive review of progress and assessment of the costs and benefits to each country of proceeding, the Prime Ministers of Australia and New Zealand announced in November 2014 to cease efforts on this major project. Government expectations On 17 November 2014 Cabinet noted that the Minister of Health would signal the next steps to upgrade New Zealand’s regulation of therapeutic products. This involves “a new and comprehensive regulatory regime … which will replace the Medicines Act 1981 and its Regulations” [CAB Min (14) 36/22 refers]. A Therapeutic Products Bill to repeal and replace the Medicines Act 1981 has priority 6 on the Government’s Legislation Programme [CAB Min (15) 5/7 refers]. Objectives The new regime is being designed to meet the needs of the health and disability support sector now and into the future, and to give effect to Government’s expectations for regulatory systems (including international alignment or conformity as appropriate). More specifically, the regime is being designed to: meet expectations of risk management and assurance of safety result in efficient and cost effective regulation be flexible, durable, up-to-date, and easy to use ensure high-quality, robust and accountable decision-making foster sustainable regulatory capacity support New Zealand and economic objectives be trusted and respected support consumer access and individual responsibility for care. These objectives will require: an enabling legislative framework that can be readily maintained and updated regulatory requirements that are consistent with cost-effective risk management and accepted international practice a regulator with capacity, independence, flexibility, and accountability.
In the future, classification may need to apply to other types of therapeutic product and this development should be enabled legislatively. Product approvals: options and impacts Options Description Impacts Status quo The approval process for therapeutic products would be set out in primary legislation. The limitations of this approach are that it will not enable the regulator to take a risk-appropriate approach, and will quickly become rigid and out of date. The key consequence is limited effectiveness in managing costs and in promoting access. Areas of possible change Alternative approaches (the second is preferred in each case) Reason for preferred approach (most reasons relate in some way to the benefits of flexibility in managing risk) Approval process Process pre-defined, or Regulatory flexibility to modify process if necessary Flexibility enables processes to be risk appropriate and cost appropriate. Product categories / risk sub-categories Set out in primary or secondary legislation, or Set out in a combination of primary, secondary, and tertiary instruments Flexibility enables categories to be kept up to date, or kept up to date more efficiently (legislation – when it can be changed - is costly to change), while ensuring appropriate accountability. of approval Regulator must conduct its own technical assessment, or Mixed model – full assessment, partial assessment, unilateral recognition Flexibility enables regulator to determine best approach based on all the circumstances (including capacity). Mixed model provides full spectrum of alternatives, with benefits for effective cost management. Approval conditions Conditions must conform with a pre-defined approach, or Conditions may be determined and imposed as the regulator sees fit Flexibility enables the regulator to align the conditions with the particular circumstances and risk assessment for a particular product or activity. Less certainty for industry (in of type of conditions), but more certainty that risks will be managed proportionately (which is not without some benefit to industry). Change in approval Approvals must conform with a pre-defined approach, or Approval may be modified, suspended or revoked as the regulator sees fit Flexibility enables the regulator to modify approach to better address or contain risks. Greater uncertainty for supplier, but changes would only be occasioned when risks justify change. Responsible person Status quo (mixed accountabilities), or Responsible person More effective risk management is possible when a responsible person is designated as a condition of an approval or licence. Increases compliance costs potentially, but more costs are proportionate.
The Act then provides for a of exemptions where, for example, unapproved medicines may be prescribed and supplied because of particular circumstances. Issues with current exemptions provisions include: a perceived excessive use of exemptions (eg, the volume of product supplied through the s29 exemption is higher than anticipated when the exemption was originally introduced) not all situations exemptions are justified are covered under the Act (eg, keeping stocks of unapproved medicines for future emergency use by unnamed patients) quality standards for large-scale local compounding of products by pharmacists (the question is whether this activity should be subject to licensing as for local manufacturing of approved products); supply quality assurance for unapproved medicines (ie, assurance that the medicine is what it claims to be, and has been manufactured to standard). The approach taken to exemptions is affected by views about the overall role and reach of regulation. For example, if the objective is to ensure as many products are approved as possible, and as few unapproved products are used as possible (eg, because the regulator does not have the resources to monitor them) then exemptions should be tightly controlled. If, however, the view is that there is often sufficient information available for unapproved products to be judged safe and effective by accountable health professionals, exemptions might simply represent another valid and helpful pathway to product use. The challenge is to: facilitate access to worthwhile (and sometimes essential) products that will never be submitted for approval in New Zealand given the small size of this market protect the integrity of the approval process (ie, contain the use of unapproved products, and encourage sponsors to submit products for approval). The pressure to use unapproved products, however, may be reduced if the costs (direct fees and compliance costs) of obtaining an approval are reduced as a result of the regulator having more options available in the approval process (see Product approvals section above). Further, it may be possible for intermediate approaches to be developed where, under certain circumstances, the regulator may specify the basis on which products may be used (but not marketed) without an approval. Exemptions: options and impacts Options Description Impacts Status quo Prescribing and use of unapproved products in a range of circumstances. Current problems continue without any amendment. For example, desirable exceptions not legally provided for (with consequential adverse effects for health and safety outcomes):
emergency use; use by veterinarians. Further, some undesirable use of the exemption provisions will continue, potentially undermining the approval process itself (ie, products that would otherwise be submitted for approval will not be submitted), with adverse implications for the overall effectiveness of the regime (access to safe products). Option 1 – Enhanced status quo via updated categories (preferred) Retain exemption provisions but strengthen. For example: Emergency use exemption. Specification of products not needing to be approved. Continue to permit small- scale compounding by pharmacies, but require large-scale compounding to be separately licensed. Require unapproved product to have appropriate supply certification, with attached responsibilities. Other prescribers included (eg, veterinarians). Would involve targeted changes to address known issues as identified in the status quo with consequential beneficial effects on health and safety outcomes. Makes for a more complicated scheme (defining and delimiting the circumstances with sufficient precision). Would move New Zealand approach on to a basis more consistent with international practice. Option 2 – Comprehensive exemption An exemption for health professionals acting within and accountable for their actions. Would be used where they judge an unapproved product to be the most appropriate all things considered. In principle, an effective low-cost regulatory approach. Very different from international practice. May excessive burden for evaluating technical risk issues, and staying on therapeutic good developments, on health professionals. Post-market 12: Monitoring (by the Regulator) Monitoring needs to cover all products and activities where compliance is required, or where there is the potential for risk in terms of safety, quality and efficacy. Information is critical to effective monitoring. The regulator needs to have access to all the necessary information in order to analyse developments and to inform judgments about the nature and level of risks. Current monitoring issues include, for example, whether the regulator: