EGA

EUROPEAN GENERIC MEDICINES ASSOCIATION

Making Medicines Affordable

 
 

EGA REPORT on BARRIERS TO GENERIC MEDICINES

EGA Report on Patent-related Barriers to Generic Medicines

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.

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11th Annual IGPA Conference

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PRESS RELEASE: 8 July 2008 EGA WELCOMES THE ADOPTION OF THE REVISED VARIATIONS REGULATION

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...

OPENING ADDRESS | 14th EGA Annual Conference To Get the Framework Right—EU Initiatives in Pharmaceuticals

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

PRESS RELEASE: 19 June 20084th EGA SOUTH EAST EUROPEAN SYMPOSIUM: “Meeting the European Challenge for the National Drug Regulatory Agencies and the Generic Medicines Industry”

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.”

PRESS RELEASE: 5 June 2008 AFSSAPS—EGA INFO DAY: ONGOING JOINT
COOPERATION TO MEET GROWING EXPECTIONS

The AFSSAPS—EGA Info Day is the first of a series of encounters between the national medicines authorities and the European generic medicines industry.

Section Spotlight

About Generic Medicines

Basic Notions | The Science| The Economics | IP... Fact Sheets on Generic Medicines

Biosimilar Medicines

Basic Concepts | Scientific Articles | Legal Texts...

About the EGA

The EGA's History, Mission, Structure, Activities...

EGA Events

EMEA2nd EMEA—EGA Info Day
London | 3 Oct 2008

Paris2nd EGA—CMD(h) Symposium on Bioequivalence
Paris | 7-8 Oct 2008

Geneva 11th IGPA
Annual Conference

Geneva | 8-10 Dec 2008

Amsterdam 2nd EGA
Pharmacovigilance Discussion Forum

Amsterdam | 28 Jan 2009

Amsterdam 8th EGA
Regulatory and Scientific Affairs Conference

Amsterdam | 28 Jan 2009


 

“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.”