Healthy Skepticism Library item: 2775

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Publication type: news

Kanter J.
Free-for-all over generic drugs in Europe
International Herald Trubine 2005 Nov 15
http://www.iht.com/articles/2005/11/15/business/phsell.php

Keywords:
generic Europe

Notes:

Ralph Faggotter’s Comments:

This article looks at the politics of patented versus generic drug use in Europe, and how drug companies influence doctors prescribing.

Full text:

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.

Elisabeth Rosenthal contributed reporting for this article.