EGA Press Release

Monday, 24 November 2003

Access to Affordable Generics Under Threat from EP Amendments

Sustainable healthcare in Europe requires a strong and growing availability of affordable generic medicines, but this is now under threat from a series of amendments put forward in the European Parliament’s Second Reading of the Review of EU Pharmaceutical legislation.

At present only 15% of the volume of medicines consumed in the European Union are offpatent generic equivalents. This compares drastically to the USA where the figure is 50-60%. By the end of 2004 some 35% of molecules’ patents are set to expire giving Europe as a whole its first major chance to promote generic competition and healthcare systems will benefit hugely from the massive savings that generics can bring. Even under current figures nearly €13 billion of savings is made each year in the EU by generic medicines. This figure could almost double over the next 5-10 years.

The opportunity for major savings and sustainable healthcare is now under threat from a series of amendments put forward in the Second Reading in the European Parliament of the Pharmaceutical Review Legislation. These amendments, which will be voted upon on 27th November in the Committee on the Environment, Public Health and Consumer Policy, include extending the periods that generic companies have to wait before they can begin registration procedures, changing the definitions of generic and biosimilar products and creating new restrictions on generic manufacturing.

At a press conference held today in Brussels Greg Perry, EGA Director General, stated:

“As the population gets older and the workforce gets smaller it will be impossible to maintain healthcare delivery to patients unless it is financed by lowered-priced generic medicines. Not only will generics bring savings, but also they will provide budget headroom for the purchase of newer, more expensive products. However, just as this opportunity becomes a major reality as a number of patents expire, major pharmaceutical companies are seeking to change the registration rules in the EU in order to prevent generic competition.”

In the case of the 10 New Member States, generics are already playing a vital role as they can make up to between 30% and 70% of the volume of medicines consumed. In view of the fact that healthcare spending is five times lower per capita in CEE countries than in the remaining EU 15, generics already play a fundamental role in healthcare delivery in this region. For this reason the EGA is fully supporting an amendment proposed by Ms Corbey (Dutch PSE) which would provide a derogation option to New Member States from introducing the new and longer periods of data exclusivity.

---

<< Back

---

For further information contact the EGA on
Tel: +32-2/ 736-84 11 or .