Rare Disease Body Wants EU Legislative Overhaul To Address Orphan Definitions & Incentives
Eurordis has welcomed some parts of the leaked proposals for overhauling the EU medicines legislation, but it has a number of concerns, including the future role of patient representatives if the European Medicines Agency’s committee structure is slimmed down as planned.
You may also be interested in...
Two members of the European Parliament claim the latest delay to publication of the long-awaited legislative revision is the result of pressure from the pharmaceutical industry.
The EU’s legislative revision proposals include stripping down the European Medicines Agency’s committee structure, abolishing the five-yearly marketing authorization renewal requirement, and doing away with the “sunset clause” that requires a product to be launched in at least one EU country within three years of approval.
With the proposals for an overhaul of the EU pharmaceutical legislation tentatively scheduled for publication on 29 March, the European industry federation EFPIA claims that the plans as currently drafted will drive investment away and damage the industry’s ability to compete at global scale. But the European Commission insists the revision will boost industry's global competitiveness and innovative power.