The Danish regulator says the new stockpiling and reporting requirements will give stakeholders time to take steps to mitigate the impact of long-term supply issues, but the pharma industry body, LIF, fears the move could create more problems than it will solve.

After an initial funding rejection last year, CSL Behring’s gene therapy for hemophilia B is to be made available to English patients under the Innovative Medicines Fund via a “first-of-its-kind” agreement. Hemgenix is also the subject of a funding deal in Denmark.

The R&D-based pharma industry has welcomed the “more careful and considered approach” taken by EU ministers to the European Commission’s proposed compulsory licensing system, but says there is room for further improvement.

The Council of the EU says it has produced a “well balanced” text in response to the proposals on tackling medicine shortages in the pharma reform package, and has flagged up a number of areas where it wants more clarity.

EU policymakers have the chance to adopt legislation that establishes a strong and predictable framework of incentives for R&D into new medicines, particularly those that require riskier investments, says CSL Behring’s Lutz Bonacker.

As well as differences of opinion over the “incentives” part of the EU legislative overhaul, the latest meeting of health ministers revealed uncertainties about whether to use incentives or obligations to improve medicines access and how to define “unmet medical needs."