New free trade agreement sparks fight over drug pricing
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《英国医生杂志》
A push by the drug industry to raise the price of new drugs for hypertension looks set to become the battleground for the first major fight over the free trade agreement between Australia and the United States ( BMJ 2004;329: 420).
The controversial agreement, which came into force on 1 January, urges recognition of innovation and gives US drug companies new mechanisms to review the Australian government's internationally recognised system of pricing drugs on the basis of evidence of their effectiveness.
Critics of the agreement have urged other nations negotiating bilateral agreements with the United States to be cautious.
In a recent article Peter Drahos, professor of law at the Australian National University, and David Henry, professor of clinical pharmacology at the University of Newcastle, New South Wales, warned that the agreement might weaken Australia's rigorous analysis of the cost effectiveness of drugs, lead to higher drug prices, and lead to a loss of national sovereignty in policy making ( BMJ 2004;328: 1271-2). Supporters of the agreement argue that the new review mechanisms will not interfere with drug pricing decisions and will bring greater transparency.
The class of drugs at the centre of the current dispute is the angiotensin II receptor antagonists. Under Australia's pharmaceutical benefits scheme, these have been tied to the price of the older, cheaper angiotensin converting enzyme inhibitors, some of which have become off patent.
Given the low prices that the Australian government is prepared to pay for what the industry considered an innovative class of drugs, at least two companies, Merck and Novartis, decided not to release their angiotensin II receptor antagonists there. A confidential review for the Australian government, carried out by a government appointed academic, subsequently concluded that the drugs should be considered as a separate class. However, it made no ruling on whether a significant price differential with the older class was warranted.
In a secret submission currently before the Pharmaceutical Benefits Advisory Committee, a number of companies are understood to be arguing for higher prices for the angiotensin II receptor antagonists. If successful, it could cost the Australian government tens of millions of dollars. There remains, however, scientific uncertainty about the size of the benefits of these drugs over the older class. While the new class of drugs does not produce the same rates of side effects such as troublesome cough as the older class, it is unclear what kind of price premium this should translate into.
The advisory committee will make a decision on the submission and the pricing in the coming weeks. Under the new free trade agreement the industry could then try to trigger a series of appeal and review mechanisms, ultimately ending in trade sanctions.
Declining to comment on the specific details of this class, Jeff Trewhitt, a spokesman for the US Pharmaceutical Research and Manufacturers Association, said that, generally, "Industry prefers competitive private marketplace pricing, because that makes it easier to receive adequate return on investment." He added, "Government mandated price controls in other countries have clearly hurt the ability of companies... to create new medicines."
On the industry's gains from the Australian agreement, Mr Trewhitt, again speaking generally, said, "We are encouraged that the Bush administration has expressed concerns about price controls in other countries hurting innovation."(Ray Moynihan)
The controversial agreement, which came into force on 1 January, urges recognition of innovation and gives US drug companies new mechanisms to review the Australian government's internationally recognised system of pricing drugs on the basis of evidence of their effectiveness.
Critics of the agreement have urged other nations negotiating bilateral agreements with the United States to be cautious.
In a recent article Peter Drahos, professor of law at the Australian National University, and David Henry, professor of clinical pharmacology at the University of Newcastle, New South Wales, warned that the agreement might weaken Australia's rigorous analysis of the cost effectiveness of drugs, lead to higher drug prices, and lead to a loss of national sovereignty in policy making ( BMJ 2004;328: 1271-2). Supporters of the agreement argue that the new review mechanisms will not interfere with drug pricing decisions and will bring greater transparency.
The class of drugs at the centre of the current dispute is the angiotensin II receptor antagonists. Under Australia's pharmaceutical benefits scheme, these have been tied to the price of the older, cheaper angiotensin converting enzyme inhibitors, some of which have become off patent.
Given the low prices that the Australian government is prepared to pay for what the industry considered an innovative class of drugs, at least two companies, Merck and Novartis, decided not to release their angiotensin II receptor antagonists there. A confidential review for the Australian government, carried out by a government appointed academic, subsequently concluded that the drugs should be considered as a separate class. However, it made no ruling on whether a significant price differential with the older class was warranted.
In a secret submission currently before the Pharmaceutical Benefits Advisory Committee, a number of companies are understood to be arguing for higher prices for the angiotensin II receptor antagonists. If successful, it could cost the Australian government tens of millions of dollars. There remains, however, scientific uncertainty about the size of the benefits of these drugs over the older class. While the new class of drugs does not produce the same rates of side effects such as troublesome cough as the older class, it is unclear what kind of price premium this should translate into.
The advisory committee will make a decision on the submission and the pricing in the coming weeks. Under the new free trade agreement the industry could then try to trigger a series of appeal and review mechanisms, ultimately ending in trade sanctions.
Declining to comment on the specific details of this class, Jeff Trewhitt, a spokesman for the US Pharmaceutical Research and Manufacturers Association, said that, generally, "Industry prefers competitive private marketplace pricing, because that makes it easier to receive adequate return on investment." He added, "Government mandated price controls in other countries have clearly hurt the ability of companies... to create new medicines."
On the industry's gains from the Australian agreement, Mr Trewhitt, again speaking generally, said, "We are encouraged that the Bush administration has expressed concerns about price controls in other countries hurting innovation."(Ray Moynihan)