Generics Up-date
REGULATORY
Paediatric Medicines: Children's healthcare through affordable solutions.
|
EU
Paediatric Medicines Regulation
Children's healthcare or corporate welfare?
The EGA is concerned over proposals by the European Commission
to automatically grant six months additional patent protection
to pharmaceutical companies that run legally required trials
on their products in children.
Even accepting the Commission's highest cost estimate for these
trials at €4 million, an extra six months of market protection for a mid-range
product with sales of €100 million will gain companies a tremendous €50 million sales windfall. Blockbuster products stand to gain windfalls of up to €500 million.
The EGA feels this disproportionate reward for obligatory trials is unacceptable.
“The move will unnecessarily delay the introduction of
generics”, says EGA Director General, Greg Perry, “upsetting the balance
achieved between the two sectors of the industry during last year's Review
of EU Pharmaceutical legislation.”
This could have serious effects on companies
supplying low-cost generic medicines to Europe’s healthcare systems.
A more reasonable 3-month extension of SPC/patent protection would provide
more than ample rewards on the vast majority of products concerned...[ continued ]
Background documents:
EGA Briefs
1st South East Europe Pharmaceutical Symposium - Sofia, Bulgaria
Meeting the European Challenge for the National Drug Regulatory Agencies and the Generic Medicines Industry
In its on-going effort to help integrate the eastern European countries into the fabric the EU, the EGA co-organised with the Association of Bulgarian Pharmaceutical Manufacturers (ABPhM) the 1st South East Europe Pharmaceutical Symposium on 21 April in Sofia, Bulgaria.
The event was designed to bring medicines regulators from the region together
with representatives from industry to discuss the challenges facing the generics
industry upon accession to the EU in 2007. “The EGA has always believed
in the potential of countries beyond the confines of the EU. Joint
efforts such as the South East Europe Symposium are highly
effective instruments for preparing the affordable medicines industry
for the Europe of tomorrow.”
The EGA membership has boasted countries from Eastern Europe
since 1998. Perry went on to say that “We are proud of our work
within EGA to foster greater cooperation and harmonisation throughout Europe
in the lead up to accession.”
A follow-up event is planned for next year in Romania.
|
