Spain’s new HTA decree sets a common assessment route for medicines and other health technologies before national decisions on financing, pricing, use and disinvestment.
France’s medicines-spending debate is being reframed around efficiency, prescribing patterns and the composition of use, not only aggregate expenditure.
The Netherlands has used the sluis, its temporary exclusion and negotiation mechanism for selected high-cost hospital medicines, to block reimbursement where price talks failed and to continue access where financial safeguards were extended.
Senate amendments would give Italy’s pharmaceutical reform bill a more specific agenda on early access, payback, expenditure caps and value-based medicines management.
Norway has updated national HTA routines for medicines covered by the EU HTA Regulation, confirming that companies must still seek a Norwegian assessment before national adoption decisions.
MHRA proposes a route for selected rare disease therapies to reach patients under controlled conditions while further clinical and real-world evidence is generated.
The Bundestag has moved to preserve savings from multi-supplier biosimilar discounting, limiting exclusive sickness-fund tenders that could narrow supplier participation.
New Greek legislation applies a cross-country reimbursement test already criticised for delaying access to medicines supplied through the IFET early access process.
Sweden’s pricing and reimbursement body has responded to the EFPIA WAIT Indicator debate by setting out why access to effective medicines cannot be judged by national reimbursement status alone.
Denmark has granted the first general reimbursement decision under a pilot scheme that lets manufacturers take an Amgros-negotiated confidential price back to the Danish Medicines Agency for national reimbursement assessment.
EFPIA’s 2025 WAIT Indicator shows stable overall European reimbursement availability, longer average time to availability and a higher share of medicines listed with conditions or restrictions.
The updated ILAP guidance confirms that Innovation Passport applications are open under a more selective pathway, with clearer entry criteria, defined application rounds and stronger links to UK HTA evidence expectations.
EU health technology assessment authorities have clarified how joint clinical assessment reports and company dossiers will be published, how confidentiality requests will be handled and how complete initial evidence submissions must be.
Stefania Cuccagna will lead AIFA’s access and HTA area as the agency develops its integrated model for clinical assessment, economic evaluation and price negotiation.
The provisional deal moves the Critical Medicines Act from proposal to agreed legislative text, placing public procurement and strategic manufacturing support at the centre of EU medicines-availability policy.
MHRA proposes to widen and clarify the UK definition of gene therapy medicinal products so that synthetic nucleic acid technologies and sequence-specific genome editing are captured more consistently.
