The Honourable Mr. Czeslaw Sobierajski

Report of the Jury

The Board of the EGA, acting as the Jury for the EGA Award 2000, considered that:

• generic medicines are the classic medicines available for therapeutic use after expiry of a patent protection;
• the end of patent protection creates the possibility of a competitive environment;
• a competitive environment has economically spoken two effects in general: lower prices and increased quality;
• the use of generic medicines creates therefore in closed healthcare budgets headroom for innovation of care, while at least keeping up if not increasing quality of care;
• for economic reasons as well as for quality-of-care reasons it is a great benefit to society to have generic medicines available as soon as possible;
• for safety reasons and consumer protection it is obvious that any medicine must obtain an official marketing authorization. However, obtaining such authorization requires necessary but time consuming testing and evaluation procedures by the competent agencies;
• time consumption causes a delay for society to benefit fully from the competitive market forces if the procedures for marketing approval could start but only after patent expiry;
• the reason why industrialized nations like the United States, Canada, Japan, Australia and Israel took an explicit provision in their respective laws for advanced generic medicines experimentation and registration; the so callled “Bolar-provisions”. Such nations thus benefit fully from the relief of health care cost burden and the possibility of an increase of quality of care from day one after patent expiry;
• current European Union legislation is silent on whether generic medicines manufacturers can develop and test products before patent expiry;
• EU Member States vary on their interpretation of national patent law, thus creating insecurity throughout the European Union;
• moreover, the World Health Organization actively supports “Bolar-provisions” in legislation;
• and the WTO Panel Case (WT/DS114/R) clarifies that early development and testing is compatible with the TRIPS Agreement.

To the opinion of the jury, the honourable Mr. Czeslaw Sobierajski, Member of the Polish Parliament, Chairman of the Extraordinary Committee for Intellectual Property Law in the Polish Parliament, has in particular been supportive and decisive to the above mentioned issues with regard to establishing a Bolar-provision in Polish legislation for the benefit of Polish healthcare and its budget. Employment and investment in the European generic pharmaceutical industry will be stimulated by this Bolar provision as will be the useful application of generic medicines in general.

Therefore, with reference to the above mentioned, the jury has agreed to award the Honourable Mr. Czeslaw Sobierajski with the EGA Annual Award 2000. As a mark of honour the jury would like to hand the award to him as a special token of their respect for all of his work which should serve as a model and stimulus for other politicians in the European Union and the Accession Countries.

Having read the decision of the jury 2000, the EGA as an association will deliver the prize and its symbols to the honourable Mr Czeslaw Sobierajski during its annual EGA Conference in Krakow, on the 5th of October 2000.

Signed:

Dr. Klaus Lichtenberger
President of the EGA

Greg Perry
Director fo the EGA