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France: Modification and simplification of the reimbursement evaluation procedure for certain medicinal products

Eveline Van Keymeulen

On 3 July 2019, a new Decree was published which modifies the evaluation procedure of generic and biosimilar medicines by the Transparency Commission of the High Health Authority (HAS). This Decree seeks to simplify the assessment procedures of such medicines in order to speed up their financing by French Social Security. The principle set out Read More

Germany Improves Patients’ Access to Medical Cannabis

Eda Zhuleku

The new Law for More Safety in the Supply of Pharmaceuticals in Germany (Gesetz für mehr Sicherheit in der Arzneimittelversorgung- GSAV) which has been in force since 16 August amends the law regarding the prescription and sale of medical cannabis in Germany. Since 10 March 2017, it has been possible for medical cannabis to be prescribed Read More

Belgian Minister of Health introduces new measures that will produce significant annual savings

Tine Carmeliet

In the beginning of March, the Belgian Public Health Committee approved five measures introduced by the Belgian Minister of Health that aim to reduce the price of medicines on the off-patent market. These measures, which will enter into force on 1 April 2019, will result in savings of EUR 10 million a year for the Read More

Coordination amongst member states on medicines’ prices supported by the European Commission

Nele De Backer

European Commissioner for Health and Food Safety, Vytenis Andriukaitis, said that the European Commission will support national competition authorities in their probes against excessive pricing practices in pharmaceutical markets. In addition, the European Commission will continue to monitor pharmaceutical markets itself, as part of its competition policy, and is ready to act against infringements of Read More

European Commission adopts revised definition of “similar medicinal product”

Eveline Van Keymeulen

Yesterday, the European Commission adopted Regulation 2018/781 amending Regulation (EC) No 847/2000 as regards the definition of the concept “similar medicinal product” in the context of the Orphan Medicines Regulation.  The Regulation extends the definition of “similar active substance”, by clarifying that “[i]f the principal molecular structural features cannot be fully established, the similarity between Read More