US threatens Australia over plan to block extensions to drug patents
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《英国医生杂志》
The US government has warned Australia that legislative provisions seeking to ensure generic drugs are not blocked by frivolous patent extensions to branded drugs could trigger a trade dispute between the two countries.
The warning comes as the Australian minister for trade, Mark Vaile, plans to push through what he describes as "minor changes" to legislation implementing the Australia-US Free Trade Agreement in the final parliamentary sitting for 2004.
In late August, the Australian government reluctantly accepted amendments insisted on by opposition parties in the Senate that seek to prevent "evergreening" of patents, in which companies get a new patent for minor changes to a drug coming off patent, thereby extending the patent抯 life and frustrating the entry of cheaper generics (BMJ 2004;329:420).
If patent drug holders succeed in slowing the entry of generics onto the market in Australia the costs of the subsidised public medicines programme, the Pharmaceutical Benefits Scheme (PBS), will escalate.
The agreement was certified with an exchange of letters between the two governments, which included specific references to the provisions relating to pharmaceuticals, on 18 November. However, unlike letters appended to the negotiated agreement, the final correspondence has not been publicly released.
After certification, the US trade representative, Robert Zoellick, noted in a statement that Australia has "committed to take steps, including legislative and regulatory changes" to tackle US concerns about amendments relating to intellectual property provisions. Commentators assume that the "minor changes" to legislation that Mr Vaile has said he will push through parliament will constitute these "steps" that Australia has promised to the Americans.
The US drug industry trade association, the Pharmaceutical Research and Manufacturers of America, has expressed its frustration that the Australian government "is not taking immediate action to repeal" the Senate initiated amendments.
In a similar vein, the US ambassador to Australia, Tom Schieffer, told ABC News that the United States could trigger the dispute resolution processes, if the "evergreening" provision "presents a problem in the future." One way of doing so would be through a complaint to the World Trade Organization
The convenor of the Australian Fair Trade and Investment Network, Patricia Ranald, argued that a complaint would be judged against the provisions in the agreement, which emphasise protecting patent rights of drug companies while remaining silent on consumers?rights to access essential medicines.
At the Australian general election in October, the government led by John Howard of the Liberal Party was comfortably returned. Also, from 1 July 2005, the Liberals gain control of the previously hostile Senate. Critics of the agreement believe that even if Mr Vaile抯 as yet unspecified amendments do not immediately repeal the evergreening provisions, repeal is more likely once the government controls the Senate.
Lecturer in health law at the Australian National University, Thomas Faunce, argued that it would be hypocritical of the US government to complain about Australia抯 anti-evergreening provisions but leave intact similar but politically popular provisions in its own Medicare Prescription Drug Improvement and Modernization Act of 2003.
As for Mr Vaile抯 planned amendments, Dr Faunce believes the government should be given the benefit of the doubt. "However, if they do undermine the protections to the PBS that were there before the election, then they are stepping outside what their mandate allows to them do," he said.(Canberra Bob Burton)
The warning comes as the Australian minister for trade, Mark Vaile, plans to push through what he describes as "minor changes" to legislation implementing the Australia-US Free Trade Agreement in the final parliamentary sitting for 2004.
In late August, the Australian government reluctantly accepted amendments insisted on by opposition parties in the Senate that seek to prevent "evergreening" of patents, in which companies get a new patent for minor changes to a drug coming off patent, thereby extending the patent抯 life and frustrating the entry of cheaper generics (BMJ 2004;329:420).
If patent drug holders succeed in slowing the entry of generics onto the market in Australia the costs of the subsidised public medicines programme, the Pharmaceutical Benefits Scheme (PBS), will escalate.
The agreement was certified with an exchange of letters between the two governments, which included specific references to the provisions relating to pharmaceuticals, on 18 November. However, unlike letters appended to the negotiated agreement, the final correspondence has not been publicly released.
After certification, the US trade representative, Robert Zoellick, noted in a statement that Australia has "committed to take steps, including legislative and regulatory changes" to tackle US concerns about amendments relating to intellectual property provisions. Commentators assume that the "minor changes" to legislation that Mr Vaile has said he will push through parliament will constitute these "steps" that Australia has promised to the Americans.
The US drug industry trade association, the Pharmaceutical Research and Manufacturers of America, has expressed its frustration that the Australian government "is not taking immediate action to repeal" the Senate initiated amendments.
In a similar vein, the US ambassador to Australia, Tom Schieffer, told ABC News that the United States could trigger the dispute resolution processes, if the "evergreening" provision "presents a problem in the future." One way of doing so would be through a complaint to the World Trade Organization
The convenor of the Australian Fair Trade and Investment Network, Patricia Ranald, argued that a complaint would be judged against the provisions in the agreement, which emphasise protecting patent rights of drug companies while remaining silent on consumers?rights to access essential medicines.
At the Australian general election in October, the government led by John Howard of the Liberal Party was comfortably returned. Also, from 1 July 2005, the Liberals gain control of the previously hostile Senate. Critics of the agreement believe that even if Mr Vaile抯 as yet unspecified amendments do not immediately repeal the evergreening provisions, repeal is more likely once the government controls the Senate.
Lecturer in health law at the Australian National University, Thomas Faunce, argued that it would be hypocritical of the US government to complain about Australia抯 anti-evergreening provisions but leave intact similar but politically popular provisions in its own Medicare Prescription Drug Improvement and Modernization Act of 2003.
As for Mr Vaile抯 planned amendments, Dr Faunce believes the government should be given the benefit of the doubt. "However, if they do undermine the protections to the PBS that were there before the election, then they are stepping outside what their mandate allows to them do," he said.(Canberra Bob Burton)