King Annette: Therapeutic Products and Medicines Bill — First Reading 
King Annette: Therapeutic Products and Medicines Bill — First Reading 
[Volume:636;Page:7067] 
Hon ANNETTE KING (Minister for Food Safety) 
: 
 I move  
That the Therapeutic Products and Medicines Bill be now read a first time. 
 At the appropriate time I intend to move that the bill be considered by the Government Administration Committee that the committee report finally to the House on or before 30 April 2007 and that the committee have the authority to meet at any time while the House is sitting except during oral questions during any evening on a day on which there has been a sitting of the House and on a Friday in a week in which there has been a sitting of the House despite Standing Orders 192 and 195(1)(b) and (c). 
The bill is an omnibus bill. Parts 1 to 5 establish a new joint trans-Tasman regulatory scheme for the regulation of therapeutic products. Parts 6 and 7 repeal the Medicines Act 1981 and regulations made under that Act and replace them with updated legislation for controls on medicines such as the scheduling of medicines licensing of pharmacies and prescribing rights that apply after medicines have been approved for the market and are in the domestic supply and distribution chain. My colleague the Hon Pete Hodgson will speak to the new domestic medicine provisions. 
In moving the first reading I would like to focus on the key aspects of the proposed joint regulatory scheme. This is clearly very detailed legislation but underpinning it are some very simple very clear and very significant principles. These principles include the protection of public safety; the creation of a world-class organisation of international standing effectiveness and credibility; and the protection of New Zealand sovereignty and norms of parliamentary accountability. 
I refer now to the agreement and joint scheme. On 10 December 2003 New Zealand and Australia signed an agreement committing the two countries to establishing a joint agency for the regulation of therapeutic products. This signing stemmed from work that began in the 1990s under the National Government. The primary objective in concluding the agreement was to safeguard public health and safety by establishing a world-class agency to regulate therapeutic products. The agreement also aims to reduce barriers to trans-Tasman trade and to enhance Australia’s and New Zealand’s profile and influence internationally. The bill I am bringing to the House today gives effect to that agreement. 
Early next year the Australian Government will release an exposure draft of its own implementing legislation. The preparation of the Australian bill has been undertaken in conjunction with the development of this New Zealand bill with the intention that both bills should ultimately be passed by the respective Parliaments at much the same time. This gives me an opportunity to acknowledge the commitment and assistance I have received from the Australian Parliamentary Secretary to the Minister for Health and Ageing the Hon Chris Pyne in this key initiative for both countries. 
This is not the first time this House has considered the agreement and the scheme it anticipates. There have been two Health Committee reports that have discussed the agreement an initial inquiry in late 2003 and a subsequent examination of the agreement following its referral to the Health Committee by the chairperson of the Foreign Affairs Defence and Trade Committee. The Health Committee recommended that the proposed therapeutic products bill cover a number of matters and I am pleased to record that the bill addresses the matters raised by the committee particularly in respect of governance and accountability. 
The joint regulatory scheme will cover the regulation of the manufacture supply import export and promotion of therapeutic products; the setting of standards in relation to the quality safety and efficacy or performance of therapeutic products; post-market monitoring of therapeutic products; and enforcement of the joint scheme’s requirements. Responsibility for regulating aspects of the therapeutic products covered by the joint scheme will be transferred from Medsafe to a new agency the Australia New Zealand Therapeutic Products Authority. A two-member ministerial council will be established comprising the New Zealand Minister of Health and the Australian Federal Minister of Health and it will be charged with the overall accountability of the performance of the authority. Each Minister will be accountable to his or her own Parliament just as the Minister would be if the body were a domestic body. Reporting to the council will be a five-member board appointed by the council and accountable to it. 
In terms of international and trans-Tasman significance in a broader context the establishment of the joint regulatory scheme and agency is a flagship in our relationship with Australia and the development of a single economic market. The new scheme will be a significant enhancement of closer economic relations with Australia and of trans-Tasman regulatory cooperation consistent with the CER Agreement of 1983 and the Trans-Tasman Mutual Recognition Arrangement agreed in 1996. The Australia New Zealand Therapeutic Products Authority will be the first example of a true trans-Tasman authority. Contrary to what I believe is deliberate misinformation peddled by Green MP Sue Kedgley on Radio New Zealand today the new authority will not be an offshore entity based in Australia; the new authority will be an agency based both in New Zealand and in Australia with head offices in Wellington and Canberra. The new authority will replace Medsafe in New Zealand and the Therapeutic Goods Administration in Australia. 
The establishment of the authority will see New Zealand’s profile amongst the international therapeutic community increase. This will facilitate the export of therapeutic products beyond Australia. It will offer more to other key regulators in terms of information sharing and will act as a potential partner in mutual recognition agreements with other key regulators such as those in the US Canada and Europe. Greater regional and global influence over the development of international regulatory standards and harmonisation initiatives will also be provided. The new authority will regulate therapeutic products consistent with international best practice which includes risk-based regulation of medical devices and complementary medicines. The joint approach aims to enable the two countries to combine their resources to ensure that the health and safety objectives are met while minimising cost to businesses and the Government. The joint scheme will also enable information sharing and an enhanced ability to retain and develop specialist technical expertise. 
In the negotiations on the detail of this scheme and in the drafting of this bill issues have obviously arisen that have required Australia and New Zealand to reach agreed positions that acknowledge and protect the interests of both countries. One example of the success of this has been in arriving at a governance and accountability model for the authority that successfully accommodates the core requirements of both the New Zealand Crown Entities Act and the Australian equivalent the Commonwealth Authorities and Companies Act 1997. 
Another central issue for both countries has been to recognise and preserve the sovereignty of each country. In establishing the new authority neither country wanted to repeat models that have been used in the past but found to be unsatisfactory in respect of sovereignty. This model is a clear and deliberate departure from the model of Food Standards Australia New Zealand whereby New Zealand has a voice equal to the individual Australian states—that is one voice in 10. This was a scheme put in place under a National Government. 
Drafting the therapeutic products provisions of this bill has required ongoing detailed negotiation with Australia. Key to this was the recognition that it is fundamental that both countries’ bills be drafted in such a way as to ensure as near as possible identical outcomes in a seamless scheme. The bill has been designed to accommodate as far as possible the two country’s criminal justice systems and bodies of law but where necessary New Zealand has taken a differential drafting approach. The bill accommodates some differences in the domestic settings of Australia and New Zealand in areas such as disallowance judicial review and merit reviews. However there are new features including tiered offences and so on. The bill introduces a tool kit of lower-key options that provide an opportunity to avoid being taken to court—such things as for example enforceable undertakings and non-compliance notices. 
There is too much detail in respect of complementary medicines to be able to cover today but I do want to touch specifically on the place of complementary medicines in the scheme. There has been a lot of uninformed and in some cases deliberately misleading rhetoric about the place of complementary medicines and medical devices in the scheme. With this bill now entering Parliament I look forward to seeing that debate move to the constructive environment of the select committee and this Chamber. The regulation of medical devices and complementary medicines in New Zealand is minimal. The lack of pre-market regulatory control on medical devices or adequate control both pre-market and post-market on complementary medicines has been a significant gap in the New Zealand regulatory framework. Internationally we are well out of step in both these areas. I recognise that complementary medicines are a popular choice for many consumers and are often perceived to be a safe and natural alternative to conventional medicines but they are not risk-free. It is important that consumers are protected from complementary medicines that are not safe and are able to make an informed choice about the type of medicine they wish to use. The scheme will enhance public confidence by subjecting medical devices and complementary medicines to a regulatory scheme that provides assurance about safety and quality. 
The main risks with the use of complementary medicines are well documented in literature. These can include harmful ingredients adulterated products poor quality control during manufacture interactions with other medicines—for example interactions between St John’s wort and several prescription medicines—and inadequate information to guide safe use. The joint scheme for the first time in New Zealand introduces risk-based regulation of complementary medicines as a subset of therapeutic products using an approach that will enable product sponsors to gain market authorisation by self-certification against the scheme’s requirements. This will enable minimum regulatory requirements to be applied to low-risk products such as complementary medicines and more stringent requirements to be applied to high-risk products such as new prescription medicines. 
This bill does not include rongoaMaori. There is no regulation on products prepared in a traditional way for a patient such as rakaurongoa. Commercialisation of rongoaMaori products for mass-market supply however would be regulated by the authority for obvious safety reasons. 
I commend this bill to the House. There is much in it. It now goes to a select committee. Can I just conclude with one remark: contrary to the remarks made by Sue Kedgley today the managing director does not have the power to make rules. That is one more piece of misinformation that has been peddled on this bill over many years.