Payer Wish List For EU Pharma Legislation – Is The European Commission Listening?
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.
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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.
The advanced therapies sector is undergoing something of an industrial revolution, but access issues for products coming to market remain, says Miguel Forte, CEO of Bone Therapeutics. However, there are opportunities to create a better environment for the sector, including regulatory change and more harmonization of HTA processes.
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.