Singapore, Oct 20, 2009: Due to the lack of consensus among the law makers, the Government of New Zealand failed to proceed with legislation that would have enabled the establishment of a joint agency with Australia to regulate therapeutic products. Now, New Zealand’s new government is keen to bring in the legislation in place that is helpful for the industry and to the public health safety, at large.
On July 16, 2007, the New Zealand State Services Minister, Ms Annette King announced that "The government is not proceeding at this stage with legislation that would have enabled the establishment of a joint agency with Australia to regulate therapeutic products. The government does not have the numbers in Parliament to put in place a sensible and acceptable compromise that would satisfy all parties at this time.
Placing the Therapeutics Products and Medicines Bill on hold, Ms King says, "It will remain on the Order Paper to be revisited when sufficient parliamentary support is available. Our vision has been for a world-class regulatory system that reflects the special nature of our relationship with Australia."
The negotiations between the two countries to establish Australia New Zealand Therapeutic Products Authority (ANZTPA) have been postponed. The agreement between the two governments for the establishment of a joint scheme for the Regulation of Therapeutic Products, however remain in place.
New Zealand needs this authority, as its current regulatory framework around therapeutic products is outdated and out-of-line with international best practice. Establishing a new authority with Australia has advantages for both the countries in terms of efficiency, making the most of scarce technical expertise, sharing resources and reducing overall costs.
A ray of hope
With the new government in power in New Zealand, and Mr John Key as the newly-elected Prime Minister of the life sciences industry expects ANZTPA to become a reality.
Ms Bronwyn Dilley, Chief Executive, NZBIO—New Zealand’s national life sciences industry organization that represents approximately 270 individual and corporate members from the New Zealand’s life sciences industry says, "NZBIO is pleased to see that science and business remain high on the national led government’s agenda." Since his appointment last November, Mr Key has publicly stated the government’s intention to streamline the regulatory environment for businesses operating on both sides of the Tasman.
Regulations related to therapeutic products in Australia and NZ
Currently, in New Zealand, therapeutic products are primarily regulated under the outdated Medicines Act 1981 and Medicines Regulations 1984. In Australia, therapeutic products are regulated under the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002. It is proposed that this legislation will be replaced by new legislation that will cover the regulation of therapeutic products in both the countries.
Parts of New Zealand’s existing medicines law will not form part of the joint scheme with Australia and will remain as New Zealand-specific medicines law. This legislation will cover aspects such as prescribing, dispensing and licensing of wholesalers.
Objectives of the proposed joint regulatory scheme
The primary objective of the proposed joint regulatory scheme is to safeguard the health and safety of Australians and New Zealanders, who use and consume therapeutic products, by setting standards for therapeutic products; pre-market assessment of therapeutic products to assure product safety, quality and effectiveness or performance; licensing of manufacturers to assure product quality; and post-market surveillance to check for compliance.
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