Australia's free trade deal with US hangs in balance on drugs
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The fate of a proposed free trade deal between Australia and the United States, signed in May 2004 and due to come into force in 2005, is hanging in the balance because of the impact it could have on Australia’s drugs bill.
The deal brokered between the two countries would give Australia increased access to US markets for its exports, particularly agricultural products. But the fear has been that the deal could also force Australia to pay higher prices for drugs similar to those that the companies charge in the United States, thus jeopardising Australia’s public healthcare system.
Under the “reference pricing?system that currently operates in Australia, drugs proposed for the pharmaceutical benefits scheme (the government subsidised medicines programme) are benchmarked against the cost of generic agents. As a result, drugs approved by the scheme are three to four times lower than in the United States.
Various academics have warned that the cost of drugs in Australia would increase by $A1.5bn (?.6bn; $1bn; €0.9bn) as a result of the deal. “That is a very conservative estimate,?Dr Thomas Faunce, senior lecturer at the Australian National University Medical School and lecturer in the university’s law faculty.
“What they are trying to do by stealth is slow the introduction of generics to prop up the high profits on their ‘blockbuster?drugs and institute an appeals process to increase the chances of listing their new expensive drugs. As a backstop they want a trade dispute resolution mechanism, which can impose massive fines, with its stated goal as rewarding innovation not access to essential medicines,?Dr Faunce said.
The Australian government has consistently denied these assertions. However, it has already conceded to drug company demands following lobbying, because the companies were concerned they had no redress if the government decided to reject a new drug for the pharmaceutical benefits scheme.
As a result, the government has agreed that companies could appeal against such a decision.
The minister for health, Tony Abbott, announced last week that when a drug company objected to such a decision a single reviewer would assess that objection.
Under the proposal, the drug company will be able to resubmit only those data that were included in its original application. Further evidence by the company or other experts whose advice is sought will be closed to public scrutiny. The government proposes, however, that the final review report will be publicly available.
“No credible supporter of the PBS now has any justification for opposing the free trade agreement,?Mr Abbott said. “Cost effectiveness will remain the criterion for listing,?he added in a bid to calm public concern that the cost of drugs included in the benefits scheme would rise as a result of the agreement.
Dr Ken Harvey, senior lecturer at the School of Public Health at La Trobe University and a critic of the agreement, said the process is reasonable “if there has to be a review, but it still allows companies to bring pressure to bear on the pharmaceutical benefits scheme.?
In mid July the US Congress voted overwhelmingly in favour of the agreement and the Australian House of Representatives backed the agreement in June. But the Senate, which is dominated by the Opposition Labor Party and minor parties, delayed voting on the implementing legislation until a select committee inquiry report was tabled earlier this week (2 August).
While the Labor Party was split over whether to support the agreement or not, its members on the select committee argued that it should be supported. However, they have proposed several minor amendments to limit the impact on the Pharmaceutical Benefits Scheme and stated that if these are not accepted they will vote against the agreement.
However, at the time of going to press the government has rejected these amendments, leaving continuing uncertainty over the final outcome.(Canberra Bob Burton)
The deal brokered between the two countries would give Australia increased access to US markets for its exports, particularly agricultural products. But the fear has been that the deal could also force Australia to pay higher prices for drugs similar to those that the companies charge in the United States, thus jeopardising Australia’s public healthcare system.
Under the “reference pricing?system that currently operates in Australia, drugs proposed for the pharmaceutical benefits scheme (the government subsidised medicines programme) are benchmarked against the cost of generic agents. As a result, drugs approved by the scheme are three to four times lower than in the United States.
Various academics have warned that the cost of drugs in Australia would increase by $A1.5bn (?.6bn; $1bn; €0.9bn) as a result of the deal. “That is a very conservative estimate,?Dr Thomas Faunce, senior lecturer at the Australian National University Medical School and lecturer in the university’s law faculty.
“What they are trying to do by stealth is slow the introduction of generics to prop up the high profits on their ‘blockbuster?drugs and institute an appeals process to increase the chances of listing their new expensive drugs. As a backstop they want a trade dispute resolution mechanism, which can impose massive fines, with its stated goal as rewarding innovation not access to essential medicines,?Dr Faunce said.
The Australian government has consistently denied these assertions. However, it has already conceded to drug company demands following lobbying, because the companies were concerned they had no redress if the government decided to reject a new drug for the pharmaceutical benefits scheme.
As a result, the government has agreed that companies could appeal against such a decision.
The minister for health, Tony Abbott, announced last week that when a drug company objected to such a decision a single reviewer would assess that objection.
Under the proposal, the drug company will be able to resubmit only those data that were included in its original application. Further evidence by the company or other experts whose advice is sought will be closed to public scrutiny. The government proposes, however, that the final review report will be publicly available.
“No credible supporter of the PBS now has any justification for opposing the free trade agreement,?Mr Abbott said. “Cost effectiveness will remain the criterion for listing,?he added in a bid to calm public concern that the cost of drugs included in the benefits scheme would rise as a result of the agreement.
Dr Ken Harvey, senior lecturer at the School of Public Health at La Trobe University and a critic of the agreement, said the process is reasonable “if there has to be a review, but it still allows companies to bring pressure to bear on the pharmaceutical benefits scheme.?
In mid July the US Congress voted overwhelmingly in favour of the agreement and the Australian House of Representatives backed the agreement in June. But the Senate, which is dominated by the Opposition Labor Party and minor parties, delayed voting on the implementing legislation until a select committee inquiry report was tabled earlier this week (2 August).
While the Labor Party was split over whether to support the agreement or not, its members on the select committee argued that it should be supported. However, they have proposed several minor amendments to limit the impact on the Pharmaceutical Benefits Scheme and stated that if these are not accepted they will vote against the agreement.
However, at the time of going to press the government has rejected these amendments, leaving continuing uncertainty over the final outcome.(Canberra Bob Burton)