[Ip-health] EMEA: High cost could affect drug accessibility

[Judit Rius Sanjuan]

EU agency sees more drug cost-effective disputes
http://www.guardian.co.uk/business/feedarticle/7567946

LONDON, June 6 2008 (Reuters) - A growing number of new drugs for
cancer and other conditions are likely to be approved but not reach
patients because governments don't consider them cost effective, the
head of Europe's drugs watchdog said on Friday.
Thomas Lonngren, executive director of the European Medicines Agency
(EMEA), said consumers were often confused when treatments were
cleared by the EMEA but then rejected by national health authorities
as too expensive.
He predicted more such rows in the years ahead, given the large volume
of experimental cancer treatments now in development. Oncology drugs,
which typically cost tens of thousands of dollars per patient, form
the largest single component of new products submitted for review to
the EMEA.
"It could come to a situation where we are approving a product based
on efficacy, safety and quality ... but the patient can't get it
because the health technology institute says it is not cost-
effective," he told reporters.
"And that will be a different decision in each member state (of the
European Union) because this is not harmonised."
Britain's National Institute for Health and Clinical Excellence (NICE)
has, since 1999, been leading the world in evaluating drugs for their
cost-effectiveness.
The result has been a series of high-profile disputes in which new
drugs for conditions such as cancer and rheumatoid arthritis have been
turned down for use on the state health service. In some cases the
decision has later been reversed.
Other countries, including Germany, have recently set up their own
versions of NICE.
Lonngren said the emergence of such health technology institutes posed
a challenge for drug manufacturers since these bodies often required
additional research, and he suggested there might be scope for
cooperation with the EMEA in designing drug approval programmes in
future. (Reporting by Ben Hirschler, editing by Will Waterman)


Judit Rius Sanjuan
Attorney at Knowledge Ecology International
www.keionline.org / www.cptech.org
Phone: +1.202.332.2670, x18
Email: judit.rius@keionline.org