New Belgian life sciences regulations on pricing and clinical trials published
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Two new Belgian regulations relevant to life sciences stakeholders were published in the Belgian Official Journal on 31 December 2018.
A Ministerial Decree adopted on 21 December 2018 has amended the Ministerial Decree of 17 June 2014, which sets the maximum prices for medical implants, refundable and non-refundable medicines, generic medicines and medicines that are imported into Belgium. The revisions change the calculation method for the maximum price that a retail pharmacist can charge for refundable medicines: retail pharmacists can now sell refundable medicines at a slightly higher price (an increase of 0.38% for medicines priced at or below EUR 60, and of 0.12% and an additional EUR 0.226 for medicines priced above EUR 60).
A Royal Decree adopted on 20 December 2018 has added a new chapter to the Royal Decree of 30 June 2004, implementing the Law of 7 May 2004 concerning clinical experiments involving medicines for human use. This new chapter sets out the funding of activities conducted by the Federal Agency for Medicines and Health Products (FAMHP) in the context of medicine-testing pilot projects. In these pilot projects, the FAMHP cooperates with all actors concerned (for example ethics committees) in order to test, evaluate and optimise clinical trials of medicines.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, January 2018 Issue (Thomson Reuters).