Spanish generics firms warn of Euro 3.6bn cost of patent extension
Spanish generic medicines manufacturers are warning that a proposal by the pharma industry to extend patent protection for medicines could cost the government and patients some Euro 3.6bn over the next decade.
Spanish generic medicines manufacturers are warning that a proposal by the pharma industry to extend patent protection for medicines could cost the government and patients some Euro 3.6bn over the next decade.
A report by the Spanish Association of Generic Manufacturers (AESEG) said the 20-year patent protection period for 27 drugs on the domestic market had already run out or would expire over the next few years. "Many of these are blockbusters for the pharmaceutical companies and some are among those medicines most prescribed by Spain's national health service," said the report, prepared by a consultancy firm.
Patents on 10 of the 27 medicines have expired but pharma companies operating in Spain have mounted legal challenges in the local courts which are responsible for keeping generic versions of those drugs off the market.
Under Spanish law, some generic versions of medicines can be introduced into the market years before the rest of Europe. Farmaindustria, the industry association for the originator pharma companies, is asking the government for extended patent protection as part of an integrated pharmaceutical plan that the industry is negotiating with the health ministry.
But Spanish health officials have taken an ambiguous stand on the issue. On the one hand, they say they support the proposed patent extensions so the pharma industry can maintain production of its biggest selling drugs and reinvest earnings into r&d where Spain lags behind much of the rest of Europe.
On the other hand, the government promotes the use of the cheaper generics as a way to curb national health system spending. Since generics were introduced in Spain 10 years ago, they have saved the government b7.8m, according to AESEG.
Generic medicines account for 7% of pharma sales in Spain, compared with a European Union average of 30-35%.
The European Commission is due to release imminently preliminary results of a probe into whether originator companies have attempted to curtail new generic launches through anti-competition measures such as the legal challenges and other methods.