PATENT-RELATED BARRIERS TO MARKET ENTRY FOR GENERIC MEDICINES
IN
THE
EUROPEAN UNION: A review of weaknesses in the current European
patent system
and their impact on the market access of generic medicines
Patents
play an important role in modern society, encouraging the creation,
dissemination and efficient exploitation of new technology.
Generic medicines play an equally important role in promoting pharmaceutical
innovation, affordability and sustainability. Immediate market
access of generic medicines after patent expiry is crucial to society.
When patents—of sometimes questionable quality—are misused merely to prevent others from innovating and competing, they
can present a formidable barrier to entry onto the generic medicines market.
This report identifies some of the patent-related hurdles facing generic medicines
in the European Union.
Considering it a “positive step” toward simplifying and optimising the system of changes to Marketing Authorisations, the EGA welcomes the European Commission’s adoption of the EU Regulation on Variations to marketing authorisations...
The European Commission's forthcoming work programme for pharmaceuticals, including Variations | Information to Patients | Pharmacovigilance | Counterfeit Medicines | Inquiry into the Pharmaceutical Industry | and more...
• Georgette Lalis, Director
Directorate for Consumer Goods | European Commission
Some 40 representatives of governmental agencies from throughout SE Europe are taking part in the two-day event. Greg Perry, director general EGA told the gathering, “The fact that many of you are gathered here in Istanbul for the fourth such event speaks clearly of your genuine interest in pursuing broader levels of regional cooperation in the field of affordable generic medicines.”
The AFSSAPS—EGA Info Day is the
first of a series of encounters between the national medicines authorities
and the European generic medicines industry.
“The EGA is the official representative body of the European generic and biosimilar pharmaceutical industry, which is at the forefront of providing high-quality
affordable medicines to millions of Europeans and stimulating competitiveness and innovation in the pharmaceutical sector.”
