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[e-drug] Time of pseudogenerics appearing on market (cont'd)

E-drug: Time of pseudogenerics appearing on market (cont'd)
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Dear Valeria,

1. About your question, I attach you a Website  where you can find
the short story telling what happened to adalat (nifedipine) in
Germany after patent expiry: following the patent expiry of Adalat in
1985, generic competition had captured 30% of total molecule
sales by 1986. By 1997, an astonishing 45 generic products had
been launched with a combined market shared of 68% by revenue.
Nevertheless, Adalat still held nearly a quarter of the market in
1997, despite facing some of the ferocious generic competition in
Germany.
http://www.ims-global.com/insight/report/generics/nifedipine.html

2. You also know that your question is also a topic in the ongoing
review of the european pharmaceutical legislation. Besides the
patent of a drug, there is also the so-called data protection: the
European Commission's proposal is a harmonisation of the period
of data protection to 10 years + 1 year for a new indication.
However, in the current situation, the data exclusivity period is only
6 years for half of the member states and 10 years
(Belg-Fr-Ger-UK-IT-NL) for the other half. If you compare the
current situation of Europe with the USA (which has 5 years of data
protection + 3 years for new indication), Canada (5 years) and
Japan (which has no data protection), you can note that Europe is
as well (and even more) protected as the other countries. What will
be the consequences of this proposal: it will delay the market
authorisation for the generic drugs and thus jeopardise even further
the health insurance systems and hence increase the health
spending of the individuals. It will be of course worse in any case
for all new accession countries, where there is no data exclusivity.
Unfortunately, the EC has not conducted any impact study on
these measures.

To have information on the Council's proposal of 2 June, see:
http://europe.eu.int/rapid/start/cgi/guesten.ksh?p_action.gettxt=gt&;
doc=IP/03/785|0|RAPID&lg=EN&display

With the European Medicines Forum, the struggle continues, as
the next steps will be a second reading at the European Parliament
level in. For more information, contact
europedumedicament@free.fr

Dr Philippe Swennen
Project Manager
AIM
Rue d'Arlon, 50
B-1000 Brussels Belgium
Phone: +322 234 57 04
Fax: +322 234 57 08
e-mail: philippe.swennen@aim-mutual.org
www.aim-mutual.org
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