Managed Entry Agreements Belgium

Context of confidential access agreements administered In addition, biologic drugs are subject to a 20% price reduction if a biosimilar of a biologic drug is marketed and the biologic drug reaches the threshold of 1.5 million euros.57 It is important that the use of the biocliff is automatically responsible for the use of the old drug due to the entry into the market of a biosimilar, the original biologic drug is not yet reimbursed for a period of 12 years. In addition, the use of the old drug cliff also has the effect of ensuring the effectiveness of the biocliff, even though no biosimilar has been put on the market. It is important that the new law only applies to MEAs that were finalized after the legislation came into force. This will be done ten days after the publication in the Belgian Official Journal, which has not yet taken place at the time of the publication of this post. A second trend is that governments are beginning to cooperate at the international level to help each other assess the aforementioned cost-benefit ratio. This cooperation can be achieved through mutual recognition of evaluations, exchange of information and expertise (non-confidential), joint negotiation of market entry agreements and the development of joint evaluation reports. However, since the final decision is still taken by the competent national authority on the basis of its national system, decisions may vary from one participating country to another. In 2008, the European Commission launched a sectoral investigation to highlight the causes of low competition in the pharmaceutical sector in the Member States. As a result of this investigation, several pharmaceutical companies have been sanctioned by the European Commission for certain anti-competitive practices, including the conclusion of the so-called “pay for delay” agreements and the creation of clusters of patents50.

Since innovative pharmaceutical companies are often dominant companies, the granting of rebates and rebates can also lead to a breach of European competition law if these rebates and rebates lead to the exclusion of competitors. Belgium has set up a comprehensive social security system that includes compulsory health insurance from the Belgian National Institute of Health and Disability Insurance (“NIHDI”) (Rijksinstituut voor ziekte- in invaliditeitsverzekering (RIZIV) /National Institute of Health and Disability Insurance (INAMI).