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Australia New Zealand Therapeutics Agency - possible challenges ahead?
JULY 7, 2011
Australia New Zealand Therapeutics Agency - possible challenges ahead?
Image sourced from the Therapeutic Goods Administration
One of the announcements coinciding with the Prime Minister of New Zealand’s visit to Australia was the establishment of the Australia New Zealand Therapeutic Products Agency. This will be a joint agency that regulates therapeutic goods, replacing the Therapeutic Goods Administration (TGA) in Australia and Medsafe in New Zealand (NZ). Implementation will be progressive with ‘information sharing’ to commence from July 2011. It is expected the new agency will be fully operational within five years. It will be accountable to both governments.
This proposal is not new. From 2003 to 2007 the Australian and NZ governments engaged in ongoing negotiations about the establishment of a joint agency. However, the NZ government did not have the support of the NZ Parliament in 2007 to pass the necessary legislation so that the agency could be established. There were concerns in the NZ Parliament about the proposed arrangements for complementary medicines and natural health products. It was argued that natural health products (such as kawa kawa, used in Maori medicine) would not be approved by the new regulator and become illegal. In response, proponents of the legislation considered the arrangements for complementary
medicines to be inadequate and a ‘public health risk’ (see question 5 of 'Questions for Oral Answer'). The failed passage of the legislation in the NZ parliament meant that consultation between the two governments on this issue ceased.
Throughout the negotiations with the NZ Government, the Australian Government undertook a series of consultations with stakeholders about the proposed regulatory arrangements. Much of what was agreed during that time formed part of the TGA’s regulatory reform program that commenced in 2008. This culminated in the passage of five Acts and amendments to regulations to update and streamline Australia’s regulatory environment. Stakeholders have been broadly supportive of these changes. The TGA has recently commenced a transparency review in response to community concerns about the lack of information it makes available.
The announcement to establish a joint therapeutic agency has elicited little comment in both the Australian and New Zealand press. In Australia, the Government has been urged to maintain Australian standards of regulation for therapeutic goods. Medicines Australia noted the ‘great opportunity’ but wanted to ensure that the current reform program was not ‘derailed’ as a result. The Complementary Healthcare Council viewed the joint agency as an opportunity for a separate regulatory framework for complementary medicines to be established.
In New Zealand, the NZ Prime Minister was reported as being very pleased by the proposed arrangements although they were attacked by the Greens as a threat to national sovereignty. The Labour Party of NZ have accused the Nationals of an ‘hypocrisy’ from their position of 2007 but it is nonetheless broadly supportive of the proposed agency. It is likely that any legislation will have the support of the NZ Parliament, as the National Party has the majority of members.
During the five year transition period, low risk complementary medicines in New Zealand will be exempt. A review will be undertaken after that time to determine if these products should remain separate or become part of the common regulatory framework. This has been supported by the Maori party of NZ which opposed the legislation in 2007. However, the Maori's Party position on the agency is unclear. Despite criticisms of the joint agency, the NZ Greens also support the exemption of NZ complementary medicines.
There is some information about how the proposed arrangements will work. A Transition Agency will be established to advise a select Ministerial Council (Australian and New Zealand Health Ministers and other relevant Ministers). The TGA and Medsafe are to commence working together immediately with a view to a single entry point for therapeutic products and a common regulatory framework. Until the regulatory framework is agreed, each country will maintain its existing arrangements and standards. Cost recovery arrangements for the TGA and Medsafe will continue to apply and it is envisaged that cost recovery will apply to the new agency.
Possible challenges ahead? It is not yet clear how much the processes of either regulator will change as a result of the joint therapeutic agency. During the transition period, products must meet the respective standards of each country. The NZ Greens and the National Government have recently
reached agreement that complementary medicines will be regulated by a separate natural products agency but this will not become law until the next term of Government. Complementary medicines in Australia will continue to be regulated as part of the medicines framework but the TGA does not evaluate each product in the same way it does for prescription pharmaceuticals. In both countries, complementary medicines are considered ‘low risk’ and largely unregulated. This has raised concerns about safety and the appropriate balance between risk and regulation.
One of the recent initiatives of the TGA is the publication of Australian Public Summary Report for prescription medicines (AusPARs). These are designed to provide information about what was considered by the TGA as part of the evaluation of a prescription medicine. They were modelled on a similar system in the European Union. It does not appear that Medsafe has an equivalent document, although it does publish Medicine Data Sheets (prepared by the pharmaceutical industry and approved by Medsafe).
Recent adverse events with approved products such Fluvax, Champix and Stillnox highlight the importance of post-marketing surveillance. Post-marketing surveillance (or pharmacovigilance) by the TGA is largely reliant on reporting by consumers, health professionals, State health departments and information sharing with other regulatory agencies and/or the pharmaceutical industry. While Medsafe also encourages the reporting of adverse events, pharmacovigilance is outsourced to the Centre for Adverse Reactions Monitoring at the University of Otago Medical School. A review of the recent recalls for TGA and Medsafe (see here and here respectively) and product alerts (see here and here respectively) from both agencies would suggest differences in approach.
These examples highlight some of the differences between the two agencies and the considerable challenges ahead. This was previously canvassed in the NZ National Interest Analysis (2004) which concluded that NZ’s system of regulation of therapeutic products was not sustainable due to the outdated nature of the legislation and the lack of sufficient technical expertise. It recommended that the joint agency proceed. These differences are likely to be even more apparent as the TGA has since implemented a raft of reforms that were based what was agreed in the context of the joint agency. How these divergent standards will be reconciled remains to be seen.
Questions remain about what level of transparency will apply to the new agency. Another issue to be resolved is how ‘commercial in confidence’ will be interpreted by the new agency, with obvious implications for all stakeholders. Disagreement exists among stakeholders exists about the TGA’s current interpretation. There are also differences in intellectual property (IP) standards and regulatory frameworks which may also influence the operation of the new agency. Governance and accountability mechanisms are yet to be determined. This may take some time as the agency will be accountable to both the Australian and New Zealand parliaments.
While the TGA has already undertaken a significant regulatory reform program, further change is likely as a result of the TGA transparency review. The volume of submissions to this review would suggest that there is strong stakeholder support for increased transparency of the TGA although there are divergent views (see here and here). The review was due to report to Government on 30 June 2011. It is not clear when this report will be
publicly available and to what extent the findings will influence the establishment of the new agency.
There are many outstanding issues and the establishment of the new joint therapeutic agency is likely to require significant work by both governments. To achieve the appropriate balance between risk and regulation of therapeutic products considerable negotiation with stakeholders (and between governments) is likely. The extent to which a ‘single regulatory framework’ between Australia and New Zealand can be established remains to be seen.
Posted by Rebecca de Boer at 12:50 PM
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Labels: regulation, therapeutic goods, Therapeutic Goods Administration