Payers Set Out Radical Wishlist For Changes To EU Pharma Legislation
European payers have called for fast-track approval pathways and only limited use of conditional approvals in the upcoming reform of the EU’s pharmaceutical legislation. They also want to see data and market protection periods reduced to boost competition.
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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.
European payers and health technology appraisal organizations have warned that their decision making is being increasingly hampered by evidence gaps. Some solutions may lie in the better use of existing mechanisms, such as scientific advice and managed entry agreements, while others could be introduced through the overhaul of the EU pharmaceutical legislation.
At a recent webinar payers and health technology appraisal bodies gave further details on what they want included and left out of the European Commission’s overhaul of the EU pharmaceutical legislation. However, speakers voiced some concerns about whether their demands will be met.