[Random-bits] Michelle Childs: EC rules undermine curbs on excessive pricing or other abuses involving medicines

[James Love]

http://downontheriver.blogspot.com/

Michelle Childs
16 March 2006

EU Preparations for possible Bird Flu Pandemic (2)
We are currently in correspondence with the EU Commission to find out
whether they can issue a compulsory license to generic drug
manufacturers
to make generic versions of oseltamivir ( brand name Tamiflu,) in the
face
of predicted shortfalls in the recommended stockpiles in some Member
States. (Details here
http://downontheriver.blogspot.com/2006/03/is-europe-doing-everything-
it-can-to.html)

The European Generic Medicines Association ( a trade body for generic
manufacturers) have also written to the Commission asking whether other
legal rules, granting further protection to patent owners over test data
would be waived, in order to allow them to make the drugs quickly. The
answer? No, not even in an emergency.

A copy of the letter is here:.
http://www.cptech.org/IP/health/dataexcl/ec-de-tamiflu.pdf.

This view will have important consequences not only for generic Tamiflu
manufacturers but also for any European country that issues a compulsory
license for any drug, including high priced cancer or AIDS drugs, which
might be available for import from a domestic or foreign generic
supplier.
It essentially means that compulsory licenses become a nearly worthless
tool in Europe for a decade on any new drug.

Why? As a condition of selling drugs, the EU ( and Member States)
require
pharmaceutical sellers to submit information, ' registration data',
showing their drugs are safe and effective e.g clinical trials and other
studies. To gain regulatory approval to sell generic versions of drugs,
generic companies generally do not repeat these studies, which are
costly
and time consuming. Instead, they rely on the registration data
submitted
by the original applicant ( the patent owner) to establish the bio
equivalence (meaning it will work the same way in the body as the
brand-name drug) of their generic follow-on.

However EU law grants the patent owner a period of exclusivity for this
data . The rules are quite complex but in essence, these "data
exclusivity
rights" mean that the regulatory authority can't use the patent holders
data for 8 years to approve a generic drug, and the generic company must
wait another two years before it can actually market the product. In
other
words, a generic manufacturer can't place its drug on the market for 10
years from the date of the original approval, unless the patent owner
agrees they can use the data.

If the generic manufacturers are not able to rely on this data, in many
cases they simply will not enter the market, as the only option would be
to repeat the testing. In a health emergency it would not make sense
to do
so, for time reasons alone, as clinical trials ordinarily take 6-8 years
to complete.

Thus, the result of these rules is that generic manufacturers will
effectively be barred from entering the market, even if the
Commission or
Member States have issued compulsory licenses ( which lifts patent
protection) for 10 years , until the monopolies on data and marketing
end.

The Commission has confirmed in its letter that these rules would not be
lifted even in an emergency. Nor would it be lifted if there was abusive
behavior by the patent owner like excessive pricing.

So what does this mean for the stockpiling of Tamiflu? If the Commission
decided to issue a compulsory license, for example because Roche
could not
make an adequate supply of Tamiflu , a generic manufacturer would not be
able to rely on Roche' s registration data and would be unable to market
the drug until the 10 year period had ended. Unless of course, Roche
agreed. If Roche does not agree, or seeks to delay giving approval, the
Commission does not have the power to override these exclusive rights.

So, under current rules, the Commission appears happy to hand decisions
on, and control of, the production of alternative supplies of
oseltamivir
to the existing monopoly supplier, who can't meet demand and who has
little incentive to allow competitors to produce such alternatives.

Such is the state of emergency health planning in the EU today.

Read on:
explanation of the EU's Data Exclusivity Rules
: http://www.annamckay.com/article10.html

The European Generic Medicines Association
http://www.egagenerics.com

--
Michelle Childs -Head of European Affairs
Consumer Project on Technology in London
24, Highbury Crescent, London, N5 1RX,UK.
Tel:+44(0)207 226 6663 ex 252.
Mob:+44(0)790 386 4642. Fax: +44(0)207 354 0607
http://www.cptech.org

Consumer Project on Technology in Washington, DC
1621 Connecticut Ave, NW, Washington, DC 20009 USA .Tel.:
+1.202.332.2670,Fax: +1.202.332.2673

Consumer Project on Technology in Geneva
1 Route des  Morillons, CP 2100, 1211 Geneva 2, Switzerland
Tel: +41 22 791 6727