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19 October 2006

ANZTPA second round consultation begins - 19 October 2006

The second round of consultation with stakeholders starts today about the proposed joint regulatory scheme for the Australia New Zealand Therapeutic Products Authority (ANZTPA). You have until 6 December 2006 to comment on the three draft documents which have been released.

View the three draft documents:

A Plain English Guide to the proposed medicines scheduling provisions of the draft Australia New Zealand Therapeutic Products Regulatory Scheme (Administration and Interpretation) Rule 2006 and a copy of a proposed ANZTPA Product Licence are also available.
Each of those documents is available at: http://www.anztpa.org/consult/consdocs2.htm

For assistance in preparing submissions or enquiries about the process, please contact us.

How might the proposed scheme impact on your business?

Under the proposed scheme, suppliers of therapeutic products will be required to apply for and obtain a full ANZTPA licence permitting the supply of each product in both countries.

The scheme includes a three year transition period for the supply of products. During that transition period, companies that already lawfully supply products in Australia or New Zealand will automatically be granted a three year interim licence. This permits them to continue to supply in the country or countries in which they already supply those products. Within the three year interim licence period companies must apply for a full ANZTPA licence. Companies must ensure they allow sufficient time to obtain a full licence as once the interim licence lapses they will not be able to lawfully supply the products until they have been granted a full licence.

While there are many issues which still need to be addressed, the regulators in each country appear committed to proceeding with the scheme. Consequently, participants in the industry should prepare themselves for the implementation of the scheme. Companies should carefully review their current product ranges and their registration portfolios. Now is the time to make decisions about rationalising registration portfolios to avoid unnecessary work and cost in transitioning obsolete registrations into the new scheme. Even more importantly, in entering into any new or renewed licence arrangements for Australia and/or New Zealand, companies should consider the possible implementation of the new scheme in the next 12 to 24 months and tailor their agreements to contemplate operation under the new scheme

Key issues for stakeholders

During the first round of discussions with stakeholders some key issues have emerged.

First, under the new scheme there will only be one licence per product. Currently, two different companies may supply the same product in the two different countries. Which company will apply for and hold the ANZTPA licence? The draft documents that were open for submission in round one did not contemplate this situation or provide a commercially acceptable solution to the issue.

Second, due to Australia’s obligations under the Australia United States Free Trade Agreement (AUSFTA), the Australian Therapeutic Goods Act currently has a patent certificate regime that must be complied with at the time of seeking to register new products. New Zealand is not a party to the AUSFTA and is not obliged to, and currently does not, have an equivalent regime in place. While the draft documents contemplate the regime continuing to exist under the proposed scheme, it is not clear how this will work in relation to New Zealand. Will companies seeking to register products be required to provide certificates in relation to New Zealand patents in addition to Australian patents? Will the obligations in relation to the conduct of patent proceedings extend to proceedings in New Zealand? Will companies be required to give a new certificate on applying for a full ANZTPA licence in circumstances where a certificate has previously been given to obtain registration in Australia?

Third, the new scheme appears to open the possibility of forum shopping as the separate judicial review mechanisms currently available in each country will remain in place. What measures will be taken to prevent forum shopping? How will an appropriate forum be determined in circumstances where the products are to be sold in each of the jurisdictions?