The proposal to shorten the period for decisions on pricing and reimbursement of generic drugs from 180 days to 60 days was backed by 559 votes to 54.
Some member state governments are expected to resist the change, which could enable generic drug manufacturers to negotiate higher prices.
The deadline for new (branded) drugs would remain set at 180 days from regulatory approval, under rules that date back to 1989.
Bulgarian MEP Antonyia Parvanova, an architect of the new legislation, commented: “It is unacceptable that delays in the pricing and reimbursement of medicines can sometimes reach more than 700 days.”
The draft legislation would also require national health systems to publish an annual list of medicines available within each system and their prices, as well as the names and declarations of interest of the experts consulted.
While accepting that pricing and reimbursement are national responsibilities, the European Commission has stated the legislation will clarify these procedures and help to avoid unnecessary delays in access to generic drugs.
The proposed change may favour generic drug manufacturers in terms of pricing negotiations, as well as making the ‘patent cliff’ steeper for branded drugs.