Eduardo Castillo and Ana Bayó explain the implications of amendments to Spain’s Medicines Act and the establishment that fixing the price of generic drugs does not constitute patent infringement.
Spain’s Medicine Act was amended in December 2009. The Ministry of Health and Consumer Affairs is responsible for deciding if a generic drug will be financed by the National Health System and, if so, for fixing the industrial price and public retail price at which the medicine can be sold.
Until the amendments took effect, the relevant laboratory was obliged to provide the Ministry of Health and Consumer Affairs with all the technical, economic and financial data requested. Now, the price will be directly fixed by the Interministerial Price Commission on the basis of certain general criteria that are yet to be established.
Until these criteria are established, the commission will not intervene if the maximum industrial price notified by the generic company is at least 30 percent lower than that of the reference medicine (innovator), or equal or lower than the reference price set by the corresponding ministerial order on reference prices.
Spain, Medicines Act, price, fixing, generic, drugs