The German pharmaceutical industry is calling for “directional correction” to the way implementation of the EU’s Health Technology Assessment Regulation is being developed.

Alnylam has opted to submit its orphan drug Amvuttra for a full benefit assessment in Germany, rather than an abbreviated process that requires no comparative data. In England, the drug was recommended following a pilot for designing a new and faster approach to health technology appraisals.

A Canadian court has dismissed an appeal brought by industry challenging new pricing rules that introduce a revised basket of reference countries as part of cost-containment measures.

The implementation of new pricing guidelines that are unpopular with the pharmaceutical has been put on hold, to the relief of the pharmaceutical industry.

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.

The UK government says that payments need to rise if the stability of the statutory and voluntary drug pricing schemes is to be ensured.