Hungary protests planned extension of data exclusivity period for pharma products in EU

["Gérald Sédrati-Dinet (gibus)" <sedrati@bigfoot.com>]

http://www.interfax.com/com?item=search&pg=0&id=5669665&req=pharma

Hungary protests planned extension of data exclusivity period for pharma
products in EU

Budapest. (Interfax-Europe) - Hungary, along with other countries set to
join the European Union in May 2004, is petitioning planned EU
legislation to extend data exclusivity protection periods in the
pharmaceutical industry from six to ten years, the Budapest Business
Journal reported.

According to current rules, member states' registration authorities
cannot approve generic drugs whose application refers to original drugs
that were authorized less than six years ago. The planned modification,
under discussions in the European Parliament since June, would extend
this period to ten years, and would be applicable to new member states
as well once they enter the EU next May.

Imre Czinege, a member of the Hungarian parliament's health care
committee and also part of Hungary's observer delegation in the European
Parliament, told the BBJ that the change would raise health care costs
in Hungary by an annual HUF 15 billion due to the ensuing limited
availability of generic alternatives. Of this, HUF 12 billion would have
to be covered by the National Health Care Fund (OEP), which is already
under considerable budgetary constraints.

Czinege added that the change would also hurt local producers by
limiting the number of additional products they can copy. In addition,
the long period of protection would also take away incentives for
innovative producers, who are otherwise the main proponents of the
change, to create new molecules.

However, the Association of Innovative Pharmaceutical Manufacturers in
Hungary (AIPM) is arguing that the budgetary impact of the extension of
data protection periods for manufacturers of original products would be
considerably less, at around HUF 3 billion a year, as only a handful of
low-turnover products would be affected. This would be "a small price to
pay" for the social benefits of medical innovation, AIPM chairwoman
Krisztina Szekely said.

Extending the data exclusivity period could create better conditions for
innovation, Szekely said, adding that research and development of a new
product normally costs an innovative producer USD 600-800 million over a
typical period of 10-15 years. "Sooner or later, Hungarian producers
will also have original products; then, they will have the loudest voice
defending patents," Szekely noted.



_______________________________________________
Ip-health mailing list
Ip-health@lists.essential.org
http://lists.essential.org/mailman/listinfo/ip-health


--------------------------------------------------------------------------
Vous avez recu ce message car vous etes abonne a la liste
de diffusion Escape_l, consacree a la propriete intellectuelle,
au Libre et au numerique.


Pour ecrire a la liste:
escape_l@freescape.eu.org

Abonnement/Desabonnement:
http://listes.samizdat.net/wws/info/escape_l

Pour inciter une connaissance a s'inscrire:
http://listes.samizdat.net/wws/info/escape_l

Archives de la liste:
http://listes.samizdat.net/wws/arc/escape_l
---------------------------------------------------------------------------


--
    ~     Gérald Sédrati-Dinet (Gibus)
   'v'
  // \\   mailto:sedrati@bigfoot.com
 /(   )\  http://gibuskro.lautre.net/
  ^`~'^

Attachment: signature.asc
Description: OpenPGP digital signature