Australia and New Zealand have scrapped plans to create a joint therapeutics regulator, the trans-Tasman Australia New Zealand Therapeutic Products Authority (ANZTPA), after a review found it would not create sufficient cost benefits for either country.
IHS Life Sciences perspective | |
Significance | Australia and New Zealand have scrapped plans to create a joint therapeutics regulator, the trans-Tasman Australia New Zealand Therapeutic Products Authority (ANZTPA), after a review found it would not create sufficient cost benefits for either country. |
Implications | The scrapping of the ANZTPA comes after more than a decade of delays and controversies, including a disagreement over concerns that the joint body would have led to significant increases in the price of complimentary medicines, which led to New Zealand abandoning negotiations in 2007. |
Outlook | The scrapping of the ANZTPA is a setback for regional harmonisation, as well as a possible stumbling block for manufacturers of innovative drugs and the timely approval of innovative drugs. |
Australia and New Zealand have abandoned plans to create a joint medicines regulatory agency, following a review which found the trans-Tasman Australia New Zealand Therapeutic Products Authority (ANZTPA) would not create adequate cost benefits for either country.
The joint announcement by Australia's health minister Peter Dutton and New Zealand health minister Jonathan Coleman comes after more than a decade of delays under successive governments. The two countries agreed in 2003 to set up a joint regulator of therapeutic products, including medical devices, and prescription and over-the-counter (OTC) and complementary medicines. The statement can be read here.
The ANZTPA was originally conceived as a replacement for Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medicines and Medical Devices Safety Authority (Medsafe), with the prime ministers of both countries signing an agreement in 2011 to carry this out in the ensuing five years.
Despite the scrapping of ANZTPA, the statement said the two countries will continue to co-operate on therapeutics regulation where there are "mutual benefits for consumers, businesses, and regulators".
According to the statement, TGA and Medsafe will continue to explore "other trans-Tasman regulatory harmonisation activities that represent potential value to both countries, and that build in earlier business-to-business projects". This includes developing a new information-sharing agreement, and formalising mutual recognition of Good Manufacturing Practice (GMP) audits, with the aim of further aligning the two countries' regulations to reduce compliance costs.
In addition, Medsafe is expected to be modernised in its regulation of medicines, with New Zealand's minister Coleman stating, "There are benefits in bringing medicines, devices, cell and tissue therapies under a single cost-effective regulatory framework."
Outlook and implications
The scrapping of the ANZTPA is a setback for regional harmonisation and may prove to be a setback for the timely approval of innovative drugs and their manufacturers. It was hoped that the ANZTPA would make more efficient the lengthy drug approval processes in bringing innovative drugs to the Australian and New Zealand markets. ANZTPA was also expected to reduce the costs to drug makers of having to make regulatory filings to two separate markets rather than to a single body.
A related issue was New Zealand's relative lack of resources compared to its neighbour, leading to lower subsidies for costly treatments (see Australia - New Zealand: 17 July 2014: Report highlights lack of funding for new drugs in New Zealand compared to Australia). Although ANZTPA did not provide plans to harmonise funding, it was expected that New Zealand would have benefited from more streamlined and efficient regulatory processes.
The scrapping of the ANZTPA has received a mixed response. The New Zealand Self-Medication Industry Association (SMI) said it was disappointed by the announcement, saying in a statement that many of its members operate in both countries, so it made sense to have one regulatory system responsible for scheduling, labelling, and advertising in both markets, to minimise costs and delays in bringing products to market.
However, the industry group's chief executive Tim Roper also voiced concern "about the prevailing attitude that the Australian regulatory scheme is the "gold standard" to which New Zealand needs to harmonise".
On the other hand, the Medical Technology Association of New Zealand (MTANZ) welcomed the scrapping of the ANZTPA, calling it a "wise decision". In a statement, MTANZ chief executive Faye Sumner said, "New Zealand consumers and health boards could have seen increased healthcare costs and delayed access to innovative and life-saving medical devices if the ANZTPA had gone ahead as proposed."
ANZTPA was expected to start work in 2005 but came up against myriad problems, including concerns that bringing complimentary medicines under the joint regulator's remit – they were not covered by Medsafe – would lead to huge price increases and led to New Zealand pulling out of negotiations in 2007. At the time of the announcement, TGA and Medsafe had entered the later stages of harmonisation, including medicines (prescription and non-prescription), medicine ingredients, safety, medical devices, and biological and blood products, and the Joint Adverse Events Notification System, with joint rules on OTC drugs
Related articles:
- Australia - New Zealand: 17 July 2007: Plans for Joint Agency Between Australia and New Zealand Suspended
- Australia - New Zealand: 15 November 2013: Australia's TGA, New Zealand's MedSafe begin latest stage of harmonisation towards ANZTPA
- New Zealand - Australia: 18 April 2013: Australia and New Zealand roll out joint OTC rules as part of ANZTPA
- Australia - New Zealand: 11 March 2013: Australia, New Zealand release consultation paper on Trans-Tasman early-warning system.