Danish proposal for bill regarding trial scheme for risk sharing in the drug reimbursement system

The Danish Minister of Health proposes a new bill L 64 Proposal for a law amending the Health Act (Danish language), which introduces a three year trial scheme for risk sharing in the drug reimbursement system.

The bill aims to strengthen patients' access to reimbursements for prescribed medicinal products, including quicker and easier access to new innovative products. The bill is expected to benefit the Life Science Sector by enabling general conditional reimbursements for products that do not currently meet the requirements.

During the trial, the Danish Medicines Agency can grant general conditional reimbursement to medicinal products, on condition of the pharmaceutical company sharing the risk. The National Health Service will cover the expenses for reimbursement of a number of patients that meet the reimbursement conditions and where the treatment value is proportional with costs. The manufacturer must cover the Regions' expenses for reimbursement of patients that exceed a target population.

The trial will include two medicinal products chosen among applications received by the Agency within an application period. The first reading of the bill will be on 9 October 2018. If passed, it is expected to come into force 1 January 2019.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, September 2018 Issue (Thomson Reuters).