09/15 07:54 FOCUS-Pfizer's Viagra cleared for sale in EU
(Changes dateline, adds details about launch dates and social security
reimbursement)
By Suzanne Perry
BRUSSELS, Sept 15 (Reuters) - The European Union gave its blessing on
Tuesday to Viagra, Pfizer Inc's <PFE.N> popular drug for treating impotent
men, saying it could now be prescribed in its 15 member countries.
EU Industry Commissioner Martin Bangemann signed the decision in
Strasbourg, France, where he was attending a European Parliament session.
The decision, which rubber stamps earlier endorsements by EU scientific and
pharmaceutical experts, will bring to EU chemists' shelves the blue pills that
have been such a hit in the United States and around the world.
A Pfizer spokeswoman in Britain said Viagra should be available in a matter of
days, but industry and government officials said they expect sales in most
countries to begin in October or November.
National governments will decide individually whether to reimburse patients
through their social security systems, although several have already vetoed the
idea.
That question stirred controversy in Britain on Monday, when the government
announced it had banned doctors from prescribing the drug to National Health
Service patients, fearful that heavy demand and high prices would cripple the
publicly funded programme.
In France, where Viagra is so eagerly anticipated that news of its impending
approval drove President Bill Clinton off the front pages on Tuesday, the drug is
expected to go on sale in October, at a cost of 60 francs (about $10) a pill.
French health officials have decided that the state will not cover the cost of the
drug, prompting the daily France-Soir to muse that "at 60 francs apiece,
erections will be costly".
Germany, Italy and Denmark are among other EU countries that have decided
to let impotence sufferers bear the cost of reviving their sex lives. "It's a lifestyle
medicine, not a therapeutic one," a German official in Brussels explained.
Private medical plans in Germany are considering reimbursing their members,
however, in cases of medical necessity, while a spokesman for Austria's health
ministry said the government plans to allow the social security system to foot the
bill.
If the drug follows the pattern set in Switzerland, where it was approved for
sale in June, it could set some EU records.
A spokesman for Pfizer in Zurich said Viagra had been Switzerland's most
successful drug launch, with sales of two million Swiss francs in July.
The EU clearance is expected to lead shortly to marketing approval in other
European countries with close ties to the EU.
Tamas Pal, chief director of the National Pharmaceuticals Institute in EU
membership hopeful Hungary, said Viagra would appear there a couple of
months after the government received the EU registration documents.
According to restrictions agreed by the European Agency for the Evaluation of
Medicinal Products in London, the pills will be available by prescription only to
men over 18.
The agency said it should not be taken by men who are already taking nitrates,
have recently had a stroke or heart attack, or suffer from low blood pressure or
severe heart or liver problems.
It also warned of potential problems for patients with syndromes including
sickle cell anaemia, leukaemia, bone marrow cancer and bleeding disorders. An
EU advisory committee on pharmaceutical products agreed in August that
patients should be warned to contact their doctors if they experience prolonged
and painful erections.
While some men have been eagerly awaiting Viagra's EU launch, not everyone
is happy. Jean Dutourd, a member of the French Academy language watchdog,
told France-Soir the hoopla marked "a major decline" for French men, who
have traditionally enjoyed a reputation for not needing such products. |
