Chadwick Steve: Therapeutic Products and Medicines Bill — First Reading 
Chadwick Steve: Therapeutic Products and Medicines Bill — First Reading 
[Volume:636;Page:7085] 
STEVE CHADWICK (Labour—Rotorua) 
: 
 Today I will be covering two issues of interest relating to the Therapeutic Products and Medicines Bill. I chaired the Health Committee that conducted the initial inquiry and reported back in 2003 and the subsequent examination of the agreement between Australia and New Zealand. In that capacity I will be speaking to two issues of concern. 
I mention first that the Green Party referred in the House today to a unanimous Health Committee report but failed to mention the rider to the committee’s position—that it did not become a party to an agreement between Australia and New Zealand for the establishment of a scheme unless the committee’s subsequent recommendations were met in any implementing legislation. I have heard about the disrespect for the Health Committee’s recommendations by the Minister and I refute that absolutely.  
We put forward 13 recommendations when we reviewed the treaty; 12 of those recommendations are in this report. I think that that is absolute acknowledgment that where the committee saw we could get better things through the agreement our recommendations have all been implemented in this bill today. That is not showing disregard for the efficacy of a select committee. Amongst those recommendations were issues we were concerned about—of rongoaMaori protection and of governance and accountability. I understand that only one recommendation—that is a partial disallowance of rules in each country—is not included in the bill. That is the only recommendation not implemented in this bill.  
I want to go quickly to the issue of rongoaMaori because my colleague Annette King mentioned it earlier. This authority I must stress is a new authority. The Australia New Zealand Therapeutic Products Authority is not the old Trans-Tasman therapeutic goods agency. Effectively rongoaMaori will be treated in this bill by the new authority in the same way as it is now under the Medicines Act of 1981. In respect of the arguments I heard from the Hon Tariana Turia I say that I do not think we want to confuse whatever findings will come up from the Waitangi claims; I think that they need to be considered at a later date and not get confused in the machinations of this bill.  
Products used in the practice of rongoa are currently exempt from the requirements of the Medicines Act and I think that is really important. They are not given under prescription they are not restricted and they are not pharmacy-only prescribed now so this same arrangement will remain in this same way under the scheme. We will not bother to define rongoa in this scheme because its products are exempt. So the products used in the practice of rongoa will not be regulated nor will the relationship between a rongoa practitioner and a patient. Likewise where rongoa practitioners prepare rakaurongoa they will be exempt from manufacturing licence requirements. I hope that as the select committee goes through this bill those issues will be covered and covered also by those who submit on the bill.  
The Australia New Zealand Therapeutic Products Authority will bring significant benefits to manufacturers opening up the Australian market for exports without the added regularity costs involved in the selling of products in Australia. Mutual recognition agreements between the authority and other national regulators will be likely to increase export opportunities further. So I just wanted to cover off what I had heard about rongoa in the House and members’ concerns with this bill.  
The next issue I want to cover quickly is that of accountability which is a crucial aspect in ensuring good governance and the legitimacy of public power. I have heard members across the House show concerns about that. A strong accountability regime ensures Parliament and the public that public resources are being used efficiently and effectively. The simple truth of this new arrangement and the new authority is that New Zealand could never have afforded to go it alone in order to continue to meet the needs of regulating this industry. During the select committee deliberation as others have said no one argued with the need for regulation. It would have been far too expensive for New Zealand and Medsafe alone to advance regulation of these products. We did not have that capacity alone in New Zealand so the joint agency offers that shared expertise and capacity.  
I will quickly cover off the accountabilities of the new agency. It has to provide an annual report and a statement of intent. It will be a Crown entity like any other Crown entity and its reports will be tabled in Parliament in New Zealand. Its representatives will appear before select committees for financial reviews and inquiries like any other Crown entity. It will be subject to scrutiny of its regulatory decisions by the courts through a merits review process and judicial review and it will be subject to other legislative requirements that stand in both countries. That includes the Official Information Act the Australian Freedom of Information Act the Privacy Act and the Ombudsmen Act in both countries and scrutiny by both Auditor-Generals. I find that to be very strong and robust accountability. The agency will be a Crown entity and subject to rules and orders.  
We have heard ridiculous assertions about the powers of the managing director but the accountability arrangements of that position have been set to ensure that the managing director is equally accountable to both the Australian and the New Zealand Ministers of Health which will happen through the joint ministerial council. The executive is not able unilaterally to alter the arrangements and we will cover that off in the scrutiny of the select committee process. There will be a complaints system and there will be a review tribunal. So I feel that the spurious concerns that have been tabled in the House about accountability are simply not true. 
I would like to say a lot more but in conclusion I just say that the Health Committee did agree that a risk-based regulation of medical devices and complementary medicines was needed to ensure public safety efficacy of therapeutic products and their claims and a new regulation model commensurate with risks. The model is not the Therapeutic Goods Administration or Food Standards Australia New Zealand; the model will protect sovereignty through its governance mechanisms. 
This bill is about CER. The assertion from the member of the Opposition that this has nothing to do with CER is ridiculous. He is clearly flying in the face of the Australian Prime Minister who supports this regulatory agency. I remind members that the beginning of this proposal was in National Party policy in 1999—and we have to sit here and hear a hysterical refusal to accept that the 3 years of work since we put the inquiry on the table shows we have developed a new authority altogether with very strong governance and accountability mechanisms.