terça-feira, maio 23, 2006
OMS contra as licenças
A WHO report finds system fails the poor
By Elisabeth Rosenthal
International Herald Tribune
SUNDAY, MAY 21, 2006
World Health Organization delegates meeting in Geneva this week will be discussing a new report that will dramatically increase pressure on pharmaceutical companies, governments and even on the organization itself to do far more to develop and provide medicines for the world's poor countries.
Commissioned by the WHO General Assembly in 2003 and released quietly last month, the expert panel report offers a stinging condemnation of the current patent-based global system for new drug development, marketing and pricing.
The current system of "research and development has not yet produced the results hoped for, or even expected, for the people of developing countries," the report of the Commission on Intellectual Property Rights, Innovation and Public Health says. While in richer nations the system "broadly works to provide the health care required by their inhabitants, this is far from being the case in developing countries."
The pharmaceutical industry and many developed countries insist that the current system of granting lucrative patents for new drugs is crucial for encouraging and financing the invention of much-needed medicines, which are almost always produced in the private sector.
But the commission, led by former President Ruth Dreifuss of Switzerland, said that this path to innovation was inadequate, because people in the developing world often cannot afford to pay for high-priced new drugs, and because they sometimes need treatments that offer little profit for drug companies.
Governments should therefore develop and finance an alternate system for drug development and distribution in the developing world, the report concluded. More controversially, it suggested that drug companies should not seek patents in poor countries.
The report marks the first time the organization has positioned itself to become so directly involved in this contentious issue, which drug companies and global health charities have argued over increasingly in recent years.
"This is a very strong call for governments and the WHO to take leadership in an area where it has not shown a lot of leadership before," said Ellen't Hoen, director of advocacy at the Médecins Sans Frontières Campaign for Access to Essential Medicines. "It is the first time the WHO has dealt comprehensively with the link between access to medicines and intellectual property rights."
Delegates meeting at the World Health Assembly in Geneva this week will take up the report Thursday or Friday, said Daniella Bagozzi, a spokeswoman for the organization in Geneva, although she said it was too early to know if its recommendations would be adopted. "In the past, research and development of medicines wasn't seen as a primary part of access, but this report says we should be working on both," she said." If the member states say this is part of WHO's mandate, then we'll take it on," Bagozzi said.
The issue gained particular urgency a decade ago, with the advent of new lifesaving AIDS drugs costing $10,000 a year, far too expensive for residents of African nations being decimated by the condition.
But it is much broader than that.
Last week, for example, the U.S. Food and Drug Administration recommended approval of the first vaccine to prevent cervical cancer, the leading cause of death from cancer among women in poor countries, which harbor 80 percent of the world's cases. In the developed world, routine tests usually detect the disease in its treatable, precancerous stages.
With that announcement, Merck, the manufacturer, announced the price: $500 for the series of three shots - making it unaffordable where it is needed most.
In the past, such cost problems have been partly remedied by a number of mechanisms: Manufacturers cut deals with poorer countries, one at a time, for discounted rates. Manufacturers of generic drugs in countries like India invoke special provisions of trade law to produce low-cost versions of patented drugs - although drug companies condemn and sometimes block the practice. And foundations and international projects, like the Gates Foundation and the Global Fund to Fight AIDS, Tuberculosis and Malaria, have managed to purchase and distribute costly drugs in pilot projects.
But these initiatives fall far short of meeting the global need, treating only a small fraction of poor patients. Although the Clinton Foundation purchases drugs for children with AIDS in central China, for example, it provides hundreds of treatment courses - not the thousands that are needed. That means that where an older brother might get the lifesaving drugs, his younger siblings would have to suffer the disease.
"The response till now has been, we have private-public partnerships and then there is Bill Gates," said 't Hoen of Médecins Sans Frontières. "What the report says is that this should not be just a matter of charity - it is a global responsibility and that political action is needed.
"Some of the loopholes that have allowed cheaper generic drugs into the developing world have been closing in recent years. A thriving generic-drug industry in India has helped bring the cost of the standard three-drug treatment for HIV, the virus that causes AIDS, down to about $150 a year. That was possible because for many years India did not have pharmaceutical patents, and poor countries invoked World Trade Organization exceptions allowing them to bypass patent laws and import such generics in the event of a national emergency.
But since January of last year, India has begun enforcing medicine patents to be fully compliant with WTO rules. Pharmaceutical manufacturers are now applying for patents for newer AIDS drugs in India, which makes generic production impossible. Newer AIDS drugs that many patients require are unavailable or prohibitively expensive in the developing world.
The WHO report concludes, "Governments have the major responsibility to mobilize funds and promote new financing and incentive mechanisms to meet our shared goals." Brazil and Kenya, two countries with serious HIV problems, have proposed that the organization's General Assembly use the report as the basis for creating some sort of global program for developing essential drugs. Both countries have come under fire from drug manufacturers and the nations where they are based for violating patents, and have even been threatened with trade sanctions.
But many health advocates worry that the organization will not heed the recommendations in the report that it solicited on intellectual property, noting that the topic was not accorded prime position on the World Health Assembly agenda this week. Dreifuss, who heads the committee that produced the report, has not been invited to address the meeting, for example, although she has spoken at seminars organized by outside groups.
By Elisabeth Rosenthal
International Herald Tribune
SUNDAY, MAY 21, 2006
World Health Organization delegates meeting in Geneva this week will be discussing a new report that will dramatically increase pressure on pharmaceutical companies, governments and even on the organization itself to do far more to develop and provide medicines for the world's poor countries.
Commissioned by the WHO General Assembly in 2003 and released quietly last month, the expert panel report offers a stinging condemnation of the current patent-based global system for new drug development, marketing and pricing.
The current system of "research and development has not yet produced the results hoped for, or even expected, for the people of developing countries," the report of the Commission on Intellectual Property Rights, Innovation and Public Health says. While in richer nations the system "broadly works to provide the health care required by their inhabitants, this is far from being the case in developing countries."
The pharmaceutical industry and many developed countries insist that the current system of granting lucrative patents for new drugs is crucial for encouraging and financing the invention of much-needed medicines, which are almost always produced in the private sector.
But the commission, led by former President Ruth Dreifuss of Switzerland, said that this path to innovation was inadequate, because people in the developing world often cannot afford to pay for high-priced new drugs, and because they sometimes need treatments that offer little profit for drug companies.
Governments should therefore develop and finance an alternate system for drug development and distribution in the developing world, the report concluded. More controversially, it suggested that drug companies should not seek patents in poor countries.
The report marks the first time the organization has positioned itself to become so directly involved in this contentious issue, which drug companies and global health charities have argued over increasingly in recent years.
"This is a very strong call for governments and the WHO to take leadership in an area where it has not shown a lot of leadership before," said Ellen't Hoen, director of advocacy at the Médecins Sans Frontières Campaign for Access to Essential Medicines. "It is the first time the WHO has dealt comprehensively with the link between access to medicines and intellectual property rights."
Delegates meeting at the World Health Assembly in Geneva this week will take up the report Thursday or Friday, said Daniella Bagozzi, a spokeswoman for the organization in Geneva, although she said it was too early to know if its recommendations would be adopted. "In the past, research and development of medicines wasn't seen as a primary part of access, but this report says we should be working on both," she said." If the member states say this is part of WHO's mandate, then we'll take it on," Bagozzi said.
The issue gained particular urgency a decade ago, with the advent of new lifesaving AIDS drugs costing $10,000 a year, far too expensive for residents of African nations being decimated by the condition.
But it is much broader than that.
Last week, for example, the U.S. Food and Drug Administration recommended approval of the first vaccine to prevent cervical cancer, the leading cause of death from cancer among women in poor countries, which harbor 80 percent of the world's cases. In the developed world, routine tests usually detect the disease in its treatable, precancerous stages.
With that announcement, Merck, the manufacturer, announced the price: $500 for the series of three shots - making it unaffordable where it is needed most.
In the past, such cost problems have been partly remedied by a number of mechanisms: Manufacturers cut deals with poorer countries, one at a time, for discounted rates. Manufacturers of generic drugs in countries like India invoke special provisions of trade law to produce low-cost versions of patented drugs - although drug companies condemn and sometimes block the practice. And foundations and international projects, like the Gates Foundation and the Global Fund to Fight AIDS, Tuberculosis and Malaria, have managed to purchase and distribute costly drugs in pilot projects.
But these initiatives fall far short of meeting the global need, treating only a small fraction of poor patients. Although the Clinton Foundation purchases drugs for children with AIDS in central China, for example, it provides hundreds of treatment courses - not the thousands that are needed. That means that where an older brother might get the lifesaving drugs, his younger siblings would have to suffer the disease.
"The response till now has been, we have private-public partnerships and then there is Bill Gates," said 't Hoen of Médecins Sans Frontières. "What the report says is that this should not be just a matter of charity - it is a global responsibility and that political action is needed.
"Some of the loopholes that have allowed cheaper generic drugs into the developing world have been closing in recent years. A thriving generic-drug industry in India has helped bring the cost of the standard three-drug treatment for HIV, the virus that causes AIDS, down to about $150 a year. That was possible because for many years India did not have pharmaceutical patents, and poor countries invoked World Trade Organization exceptions allowing them to bypass patent laws and import such generics in the event of a national emergency.
But since January of last year, India has begun enforcing medicine patents to be fully compliant with WTO rules. Pharmaceutical manufacturers are now applying for patents for newer AIDS drugs in India, which makes generic production impossible. Newer AIDS drugs that many patients require are unavailable or prohibitively expensive in the developing world.
The WHO report concludes, "Governments have the major responsibility to mobilize funds and promote new financing and incentive mechanisms to meet our shared goals." Brazil and Kenya, two countries with serious HIV problems, have proposed that the organization's General Assembly use the report as the basis for creating some sort of global program for developing essential drugs. Both countries have come under fire from drug manufacturers and the nations where they are based for violating patents, and have even been threatened with trade sanctions.
But many health advocates worry that the organization will not heed the recommendations in the report that it solicited on intellectual property, noting that the topic was not accorded prime position on the World Health Assembly agenda this week. Dreifuss, who heads the committee that produced the report, has not been invited to address the meeting, for example, although she has spoken at seminars organized by outside groups.
