EGA Press Release

Thursday, 5 October 2000

Mr. Czeslaw Sobierajski to receive EGA-TEVA Award for “Bolar” in Poland

The European Generic medicines Association (EGA) will present this year its Annual Generic Medicines Award, sponsored by Teva Europe, to Mr. Czeslaw Sobierajski, Member of the Polish Parliament, for his personal contribution in introducing the entitlement of advanced generic experimentation and registration (“Bolar”) into Polish legislation. Mr. Sobierajski is currently the Chairman of the Extraordinary Committee for Intellectual Property Law in the Polish Parliament. He will receive the prestigious award at the EGA Annual Conference in Krakow, Poland from 4-6 October 2000.

The significance of the provision of advanced generic experimentation and registration is paramount by allowing generic manufacturers to perform clinical trials, test, and experiment to generate data while the original product is under patent protection. Early development and testing provisions, commonly known as “Bolar”, permit generic companies to market their product soon after patent expiry, thereby enhancing competition in the pharmaceutical environment. Currently European Union legislation is silent on whether generic manufacturers can develop and test products before patent expiry. However such legislation is explicitly authorised in several other industrialised nations, such as the United States, Japan, Canada, Israel, and Australia. Additionally, the World Health Organisation actively supports “Bolar” provisions in legislation, and the recent WTO Panel Case (WT/DS114/R) further clarifies that early development and testing is compatible with the TRIPS Agreement.

The EGA-TEVA Award honours those who contribute to the evaluation, improvement, and stimulation of the use of generic medicines. Generics are less expensive than their “originator” counterparts, as competitive forces influence price. Thus generics add value to healthcare systems, by simultaneously improving quality of life and saving funds to payers of healthcare services. “Bolar” provisions in a country like Poland, which is acceding to the European Union, is monumental for legislation on generic products. Mr. Sobierajski’s contribution should influence other nations to adopt similar measures, which stimulates competition and effective cost-control measures. The Polish law puts Poland alongside Hungary, which has express law in favour of “Bolar” provisions. At present EU member states vary on their interpretation of national law, with the Netherlands and the United Kingdom court interpretations permitting registration but not experimentation, Portugal consenting to both, while most other member states are silent on the matter.

Teva Pharmaceutical Industries, Ltd., which is the largest generic manufacturer in the world, sponsors this annual award. Mr. Sobierajski will receive 5000 euros for donation to a charity of his choice, as well as a sculpture symbolising, “the hidden mystery in matter, the discovery in bulk chemicals and the added value of generic medicines”, for his achievements.

It is hoped that G10 will have a document ready for publication in the spring. “Once the document has been finalised it is important that we can monitor to what extent national governments and the EU implement the findings of G10,” said Andrew Kay.

More on the EGA Award

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