20 June 2007

Passage of ANZTPA Bill in New Zealand unlikely

A New Zealand Select Committee reported on 15 June 2007 that it could not recommend the passing of the Therapeutic Products and Medicines Bill.  The Bill represents the implementing legislation for the regulation of therapeutic products in New Zealand, and gives effect to the Agreement between the Australian and New Zealand Governments for the Establishment of a Joint Scheme for the Regulation of Therapeutic Products.
The Bill was considered by the Government Administration Committee, along with 895 written submissions from stakeholders.  More than three-quarters of the submissions received were from individuals, who were mainly consumers of dietary supplements and natural health products, and generally opposed the scheme.  The remaining submissions represented various interests, including:

• manufacturers and distributors of medicines, medical devices and cosmetics
  
• industry associations
  
• professional associations
  
• advertising industry groups
  
• employer and employee groups
  
• regulatory and legal specialists; and
  
• consumer groups.
  

Although there was general support for the overall intent of the Bill from a number of stakeholders, the majority of submissions from dietary supplement and natural healthcare stakeholders opposed the Bill.  The key criticism related to the perceived inappropriateness of imposing a pharmaceutical model of regulation on complementary medicines (such as herbal medicines, homoeopathic medicines, traditional medicines, aromatherapy products, vitamins, minerals and nutritional supplements) in New Zealand. 
The Therapeutic Goods Administration imposes regulatory requirements on the import and supply of complementary medicines in Australia.  In contrast, there is currently no requirement in New Zealand for independent scrutiny of quality and safety of complementary medicines before they are introduced to the market.  This is not in line with international best practice.
Notwithstanding this, the main opposition to the Bill was from small-to-medium sized businesses in New Zealand, which expressed concern that the higher compliance costs associated with tighter regulation will either force them to move parts of their businesses off-shore or may threaten the viability of their businesses altogether.  Consumers also expressed concern that the increased compliance costs incurred by businesses would be passed on to them in the form of higher prices.
Where to now?
Given that the main opposition to the Bill concerned the regulation of complementary medicines, there was discussion in the Select committee about whether to exempt complementary medicines from the trans-Tasman scheme.  National members, who generally opposed the Bill, noted that this would be the most sensible way of enhancing pharmaceutical regulation in New Zealand while allowing the requirements of small businesses and consumer demand to be met.  However, a proposal has also been put forward for an "opt-in" clause, which would require companies to meet the trans-Tasman regulatory requirements if they wished to also operate in Australia.  Companies that intended to trade solely within New Zealand would be regulated by the domestic regime.

The intention of the Australian and New Zealand Governments at the time the Agreement was signed was that the joint regulatory scheme would cover all therapeutic products, including complementary medicines.  Accordingly, if a decision is made to exempt complementary medicines from regulation under the joint scheme, a renegotiation of the Agreement would be required, that is, the process is not as simple as amending the Bill and resubmitting it to Parliament.  If there is a renegotiation of the Agreement to exempt complementary medicines from the joint scheme, then further time will be required to re-draft legislation in both countries and allow for passage of the legislation through Parliament.  Inevitably, the rejection of the Bill in New Zealand indicates that implementation of the joint scheme is unlikely within the next 12 months.