domingo, março 12, 2006
Os genéricos na Europa
Free-for-all over generic drugs in Europe
By James Kanter International Herald Tribune
TUESDAY, NOVEMBER 15, 2005
PARIS
Generic drugs - or copycats, as big pharmaceutical companies prefer to call them - are far less widespread in much of Europe than in the United States. In an age of ever more complex medicine at higher prices, that has heightened the battle raging over access to affordable, effective drugs.
In Europe, it is a tussle that can involve government agencies, big pharmaceutical companies, doctors, patients and lobbying groups. In the end, everyone appears dissatisfied.
The companies that produce branded pharmaceuticals are rich and powerful. They have united with patients seeking access to their drugs and have helped finance groups that lobby for patients' rights. They have fought to slow down the introduction of generic drugs that could lower health care costs. They lavish spending on doctors who could prescribe their medicines and help finance studies that could favor their products.
The governments in Europe that regulate them are powerful, too. They help finance health care lobbying groups. They make decisions on approving drugs for sale or buying them for their citizens. They forbid the companies from advertising to consumers. They tell doctors and patients which drugs will be paid for by the state.
Patients and companies have sometimes united against cash-strapped governments anxious to lower drug costs and therefore reluctant to buy expensive new treatments.
Richard Horton, editor of The Lancet, the British medical journal, cites "an unholy alliance" between companies and desperate patients who hope that new medicines will help them.
Doctors feel torn. The government often will not fully pay for the newest treatments, so suggesting them could put a financial burden on their patients. At the same time, pharmaceutical companies make the doctors a prime target of their marketing.
According to Jon Hess of Cutting Edge Information, a research company, total ad spending by drug companies in Europe is only 13 percent lower than in the United States. On both sides of the Atlantic, drug companies spend about 50 percent more promoting product awareness than they do for research and development, according to Stewart Adkins of Lehman Brothers.
Companies also invite doctors to lavish conferences or finance research, a practice that raises questions about the findings. Top British cardiologists can collect more than £5,000, or $8,700, for an hour of lecturing to colleagues, and they also may be paid for articles that review drugs in medical journals, according to a report by members of the British House of Commons in April.
Jim Kennedy, a family doctor in London and a spokesman for the Royal College of General Practitioners, said drug companies often paid hospitals and clinics in Britain and elsewhere in Europe to conduct research geared more toward use of a specific drug than ascertaining its safety or medical value.
"Often the question being asked is stupid and the trial ridiculous," Kennedy said. "It's an area we need to tighten up on."
Big drug companies have sought to restrict generic versions of their medicines. Amgen is opening a new front, waging a fierce lobbying campaign that could impede copying of its next-generation medicines in Europe, arguing that their manufacture is complex and that the issue is the quality and safety of medicines for years to come.
Generic manufacturers agree that new technologies require new rules on copying, but they accuse patent owners like Amgen of seeking to impose extra testing to delay production of generics and protect profit as long as possible.
Drug companies frequently justify their most contentious behavior on grounds of quality. Amgen is "not trying to extend our patents," said Kevin Sharer, chief executive of the company. "All we're trying to do is participate in the dialogue at the public level and assure the patient's safety."
In the same vein, the Swiss drug maker Roche denies deliberately stalling wider production of its flu treatment, Tamiflu, to maximize profit ahead of a possible bird-flu pandemic. The company says ramping up production is hard because Tamiflu, the only drug that studies indicate may slow the symptoms of bird flu when it spreads to humans, requires a delicate, 10-step process.
The pharmaceutical companies have also helped finance events organized by the European Patients' Forum, a nongovernmental organization.
That poses a conflict of interest for the forum, according to Health Action International, an Amsterdam-based group partly financed by European governments.
The European Patients' Forum participated in workshops this year at the main EU regulator, the European Medicines Agency, on the kind of information patients should receive and how to warn them if safety problems arise.
Left out of the forum's promotional material was the fact that many of its activities were backed by some of the largest pharmaceutical companies and the public relations firms they employed. For a conference in June, Pfizer paid for travel and accommodations. Amgen financed a meeting in February about copying biological drugs.
The forum is "a model of secrecy and conflict of interest," said Jeremy Smith, a spokesman for Health Action International.
Günter Verheugen, vice president of the European Commission, said in a letter to Smith on Aug. 29 that he had asked the European Patients' Forum to "make the information on its funding public."
Anders Olauson, president of the forum, said campaigners had blown industry involvement out of proportion. He said companies should "remain an important source of funding for many patient organizations and their work" because governments often neglect members of groups like his who are fighting for better care for patients with rare diseases or, say, serious chronic conditions like AIDS or Alzheimer's. He added that a Web site with full details of the forum's financing would be ready by late November.
At the same time, European governments rival the big pharmaceutical companies in defending their interests, though often those interests vary depending on which ministry is involved, according to Greg Perry, director general of the European Generics Association, a Brussels-based lobbying group for the generic drug industry.
Perry said finance ministers seek "to protect their industry, in contrast to the efforts of health ministers, who struggle to keep pharmaceutical expenditures to sustainable levels."
In France, for instance, where there is strong backing for national champions like Sanofi-Aventis, fewer than 15 percent of medicines sold are generics. That is still an increase from three years ago, and as a result, France has lopped some 400 million, or $468 million, off its annual drug bill.
Perry said this pattern was commonplace in Europe, even if some countries like Britain and the Netherlands now are using generics at roughly the same rate as the United States, where half of medicines sold are generic.
Then there is always the big stick of European Union regulation to use against big drug companies.
In October, EU antitrust officials raided pharmaceutical companies in Denmark, Italy and Hungary suspected of colluding to shut out generic rivals.
And in June, the antitrust regulators fined AstraZeneca of Britain 60 million for misleading them about the timing surrounding its patents on Losec, a drug for stomach ulcers that became the best-selling drug in the world during the 1990s. It was the most aggressive action to date against a large pharmaceutical company for blocking low-cost competitors. AstraZeneca has appealed to an EU court.
An even fiercer fight pits pharmaceutical companies against traders who buy large quantities of patented drugs from wholesalers in countries like Spain and Greece, where governments set relatively low prices. These traders then repackage the medicines and sell them in higher-cost countries like Denmark and Germany, in a business worth about 5 billion annually.
For most of the past 20 years, EU authorities backed these parallel traders as a way of building a single market in goods and services.
The tide began to turn in drug makers' favor last year when senior European judges said that the German company Bayer could maintain some of its supply restrictions. But the traders are still fighting, and in October they filed a new complaint against Pfizer for offering rebates to Spanish wholesalers who agree not to sell drugs for re-export.
Blocking the traders is a serious matter for drug companies at a time when U.S. consumers and even some insurers are bypassing established distribution channels and scouting overseas for the best deals on medicines.
By James Kanter International Herald Tribune
TUESDAY, NOVEMBER 15, 2005
PARIS
Generic drugs - or copycats, as big pharmaceutical companies prefer to call them - are far less widespread in much of Europe than in the United States. In an age of ever more complex medicine at higher prices, that has heightened the battle raging over access to affordable, effective drugs.
In Europe, it is a tussle that can involve government agencies, big pharmaceutical companies, doctors, patients and lobbying groups. In the end, everyone appears dissatisfied.
The companies that produce branded pharmaceuticals are rich and powerful. They have united with patients seeking access to their drugs and have helped finance groups that lobby for patients' rights. They have fought to slow down the introduction of generic drugs that could lower health care costs. They lavish spending on doctors who could prescribe their medicines and help finance studies that could favor their products.
The governments in Europe that regulate them are powerful, too. They help finance health care lobbying groups. They make decisions on approving drugs for sale or buying them for their citizens. They forbid the companies from advertising to consumers. They tell doctors and patients which drugs will be paid for by the state.
Patients and companies have sometimes united against cash-strapped governments anxious to lower drug costs and therefore reluctant to buy expensive new treatments.
Richard Horton, editor of The Lancet, the British medical journal, cites "an unholy alliance" between companies and desperate patients who hope that new medicines will help them.
Doctors feel torn. The government often will not fully pay for the newest treatments, so suggesting them could put a financial burden on their patients. At the same time, pharmaceutical companies make the doctors a prime target of their marketing.
According to Jon Hess of Cutting Edge Information, a research company, total ad spending by drug companies in Europe is only 13 percent lower than in the United States. On both sides of the Atlantic, drug companies spend about 50 percent more promoting product awareness than they do for research and development, according to Stewart Adkins of Lehman Brothers.
Companies also invite doctors to lavish conferences or finance research, a practice that raises questions about the findings. Top British cardiologists can collect more than £5,000, or $8,700, for an hour of lecturing to colleagues, and they also may be paid for articles that review drugs in medical journals, according to a report by members of the British House of Commons in April.
Jim Kennedy, a family doctor in London and a spokesman for the Royal College of General Practitioners, said drug companies often paid hospitals and clinics in Britain and elsewhere in Europe to conduct research geared more toward use of a specific drug than ascertaining its safety or medical value.
"Often the question being asked is stupid and the trial ridiculous," Kennedy said. "It's an area we need to tighten up on."
Big drug companies have sought to restrict generic versions of their medicines. Amgen is opening a new front, waging a fierce lobbying campaign that could impede copying of its next-generation medicines in Europe, arguing that their manufacture is complex and that the issue is the quality and safety of medicines for years to come.
Generic manufacturers agree that new technologies require new rules on copying, but they accuse patent owners like Amgen of seeking to impose extra testing to delay production of generics and protect profit as long as possible.
Drug companies frequently justify their most contentious behavior on grounds of quality. Amgen is "not trying to extend our patents," said Kevin Sharer, chief executive of the company. "All we're trying to do is participate in the dialogue at the public level and assure the patient's safety."
In the same vein, the Swiss drug maker Roche denies deliberately stalling wider production of its flu treatment, Tamiflu, to maximize profit ahead of a possible bird-flu pandemic. The company says ramping up production is hard because Tamiflu, the only drug that studies indicate may slow the symptoms of bird flu when it spreads to humans, requires a delicate, 10-step process.
The pharmaceutical companies have also helped finance events organized by the European Patients' Forum, a nongovernmental organization.
That poses a conflict of interest for the forum, according to Health Action International, an Amsterdam-based group partly financed by European governments.
The European Patients' Forum participated in workshops this year at the main EU regulator, the European Medicines Agency, on the kind of information patients should receive and how to warn them if safety problems arise.
Left out of the forum's promotional material was the fact that many of its activities were backed by some of the largest pharmaceutical companies and the public relations firms they employed. For a conference in June, Pfizer paid for travel and accommodations. Amgen financed a meeting in February about copying biological drugs.
The forum is "a model of secrecy and conflict of interest," said Jeremy Smith, a spokesman for Health Action International.
Günter Verheugen, vice president of the European Commission, said in a letter to Smith on Aug. 29 that he had asked the European Patients' Forum to "make the information on its funding public."
Anders Olauson, president of the forum, said campaigners had blown industry involvement out of proportion. He said companies should "remain an important source of funding for many patient organizations and their work" because governments often neglect members of groups like his who are fighting for better care for patients with rare diseases or, say, serious chronic conditions like AIDS or Alzheimer's. He added that a Web site with full details of the forum's financing would be ready by late November.
At the same time, European governments rival the big pharmaceutical companies in defending their interests, though often those interests vary depending on which ministry is involved, according to Greg Perry, director general of the European Generics Association, a Brussels-based lobbying group for the generic drug industry.
Perry said finance ministers seek "to protect their industry, in contrast to the efforts of health ministers, who struggle to keep pharmaceutical expenditures to sustainable levels."
In France, for instance, where there is strong backing for national champions like Sanofi-Aventis, fewer than 15 percent of medicines sold are generics. That is still an increase from three years ago, and as a result, France has lopped some 400 million, or $468 million, off its annual drug bill.
Perry said this pattern was commonplace in Europe, even if some countries like Britain and the Netherlands now are using generics at roughly the same rate as the United States, where half of medicines sold are generic.
Then there is always the big stick of European Union regulation to use against big drug companies.
In October, EU antitrust officials raided pharmaceutical companies in Denmark, Italy and Hungary suspected of colluding to shut out generic rivals.
And in June, the antitrust regulators fined AstraZeneca of Britain 60 million for misleading them about the timing surrounding its patents on Losec, a drug for stomach ulcers that became the best-selling drug in the world during the 1990s. It was the most aggressive action to date against a large pharmaceutical company for blocking low-cost competitors. AstraZeneca has appealed to an EU court.
An even fiercer fight pits pharmaceutical companies against traders who buy large quantities of patented drugs from wholesalers in countries like Spain and Greece, where governments set relatively low prices. These traders then repackage the medicines and sell them in higher-cost countries like Denmark and Germany, in a business worth about 5 billion annually.
For most of the past 20 years, EU authorities backed these parallel traders as a way of building a single market in goods and services.
The tide began to turn in drug makers' favor last year when senior European judges said that the German company Bayer could maintain some of its supply restrictions. But the traders are still fighting, and in October they filed a new complaint against Pfizer for offering rebates to Spanish wholesalers who agree not to sell drugs for re-export.
Blocking the traders is a serious matter for drug companies at a time when U.S. consumers and even some insurers are bypassing established distribution channels and scouting overseas for the best deals on medicines.
