Israeli pharmaceutical manufacturers have expressed concern that the Israeli government's new data exclusivity bill, scheduled to be included as a rider to the country's 2005 budget, will represent a surrender to US drug industry interests.
Member companies of the Manufacturers' Association Chemicals, Pharmaceuticals, and Environmental Society have complained that plans to concede key terms of five-year exclusivity on clinical trial data in the bill will damage the local industry, much of which is based on generics production.
Senior government officials have denied the charge, stating that if the US
does not issue an opinion before the bill is passed, it will be approved in
its present form. However, US negotiators are unlikely to accept an unamended
bill, as they may feel that its current provisions fall below international
standards. Such standards include those relating to the legal force of first
registrations in foreign countries, patent-term extensions, and the period in
which companies are entitled to develop a generic drug during the patent term
of its branded equivalent.