Radical Shake-Up In Store For Entire EU Pharma Legislation
Commission Proposals Tackle Regulation, Pricing, Shortages, Innovation – And Much More
The EU pharmaceutical strategy published on 25 November will be the first step in a “complete overhaul” of the medicines legislative framework to be proposed in about two years’ time, says the European Commission.
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European payers are calling for changes to the EU’s orphan drug rules that would transform the incentives system and avoid the market distortions enabled by the current legislation.
European Commission plans for an overhaul of the pharmaceutical legislation would halve market protection for orphan drugs and risk the predictability of the regulatory system, warns industry expert.
A major initiative to reform the EU medicines legislation has hit a bump in the road because of changes required by an internal scrutiny body, but these are likely to be more procedural than policy-related.