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7 October 2015Asia-Pacific

TPP: Australia succeeds in limiting data exclusivity to five years

Australia’s government has said the period of data exclusivity available for biological drugs in the Trans-Pacific Partnership (TPP) will be five years, despite pressure from the US to extend it to 12.

Yesterday, October 6, Andrew Robb, minister for Trade and Investment in Australia, confirmed that the agreed TPP framework will not extend the period of data exclusivity in Australia.

Under Australian law the period of protection for data exclusivity currently stands at five years and it had lobbied to maintain this period.

Robb added that the agreement will not result in an increase of drug prices.

The 12 countries participating in the TPP—Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, US, and Vietnam—confirmed on Monday, October 5, that an agreement had been reached.

Among the key provisions is a chapter on improving harmonisation of intellectual property.

However, the details of the deal have not been communicated to the public and no date has been set for publication.

All participating countries must individually ratify the agreement through their national legislative bodies.

During the discussions, Australian and US representatives expressed different views on what the length of data exclusivity should be.

Australia had argued in favour of a five year period whereas the US had wanted the agreement to match its own domestic law, which offers a 12 year term of protection.

Australia, along with New Zealand, said a shorter period would mean biosimilar drugs would enter the market sooner and therefore reduce the price of drugs.

But the US argued that a five year limit would reduce incentives for biopharmaceutical companies to conduct research for drugs.

Despite the US reportedly offering a compromise of eight years, Australia prevailed in restricting the period of data exclusivity to a five year limit.

Ben McLaughlin, partner at Baker & McKenzie, and based in Sydney, said the five year period “is not in the best interests of innovators” and would be “tough on those innovative companies”.

McLaughlin’s disappointment was echoed by US trade association the Biotechnology Industry Organization (BIO).

Jim Greenwood, chief executive of BIO, said he “strongly believes that 12 years of data exclusivity is a prerequisite to attract the investment required to continue medical innovation and develop new biological cures and therapies.”

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