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Bipartisan PBS Safeguards a sensible move

AMA Vice-President, Dr Mukesh Haikerwal, said today the Government's decision to accept the Labor amendments to the Australia-US Free Trade Agreement (AUSFTA) provides stronger bipartisan safeguards for Australia's internationally-admired Pharmaceutical Benefits Scheme (PBS).

 

Dr Haikerwal reiterated the AMA's position that the PBS should never have been part of the AUSFTA, but any moves to strengthen protection for the PBS and to monitor developments are very welcome.

"At the outset, the AMA warned of the dangers of including the PBS in the free trade agreement with the US," Dr Haikerwal said.

"The Government responded earlier with guarantees and a monitoring process, and the Labor amendments now provide another layer of security and review.

"As the negotiations have unfolded about the PBS's inclusion, the AMA was outspoken in defending the integrity of the PBS.

"We championed the right of all citizens to access medicines, and called for greater protection of the taxpayer through the pricing mechanism.

"A viable and affordable PBS is vital to the good health of all Australians, especially the poorest and sickest.

"The right of generic pharmaceuticals to be marketed as soon as the originator patent expires must be guaranteed.

"Generics play a key role in keeping down drug prices.

"They provide consumers with the choice of a less expensive but equally effective product.

"They also set a lower benchmark reference price for all drugs in their therapeutic group, keeping down total PBS costs."

Dr Haikerwal said it was significant that at least four key products are coming off patent next year:

·        the lipid-lowering drug zimvastatin (Zocor and Lipex)

·        the anti-depressive sertraline hydrochloride (Zoloft)

·        the anti-fungal terbinafine hydrochloride (Lamisil)

·        and the anti-epileptic lamotrigine (Lamictal).

"The introduction of generic alternatives to these four products alone could make significant savings in PBS costs.

"What the debate of the past week has established is that evergreening does occur in Australia, regardless of the AUSFTA.

"The AMA supports practical measures to ensure that such patent extensions can only be granted where there is a genuine clinical improvement to the drug.

"However, we must be careful not to stymie research and development of new therapies.

"Our political leaders need to be careful not to diminish the R&D incentives for innovative medicines currently built into the PBS.

"At the same time, they must ensure that generic manufacturers can enter the market with lower priced bio-equivalents of the original patented product at the expiry of the 20-year patent.

"Greater public transparency of both the patenting and PBS-listing processes would help achieve this balance.

"The AMA urges the US Government and the US pharmaceutical industry to accept these amendments in the spirit of good faith and bipartisanship in which they are presented today.

"Australians love the PBS and the preservation and protection of the PBS is a big win for all Australians," Dr Haikerwal said.

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