In its judgment of 30 January 2020, the European Court of Justice (hereafter the ECJ) for the first time clarified whether an agreement to settle upside-down payments relating to a dispute between the holder of a pharmaceutical patent (hereafter the initiator) and a generic drug manufacturer (hereafter referred to as “generic”) is contrary to EU competition law. In particular, the Court has given further guidance on whether and when initiators and generics should be considered “potential competitors”, (ii) a patent… Assessing the strengths and weaknesses of managed accession agreements (MEA) in Belgium. Note: This taxonomy is based solely on the structure of the agreements. All types of agreements mentioned above may exist not only between companies and health organizations, but also between companies and other types of institutions that constitute a health system, including government agencies or national authorities responsible for making coverage or pricing decisions and/or evaluating health technologies (HTA), regional health authorities, health care providers, etc. In particular, for products used in hospitals, MEAs may be available between companies and hospitals. Source: authors of the study based on Carlson (2010), Ferrario and Kanavos (2013) and Gerkens et al. (2017). Confidential managed entry agreements managed Entry Agreements (MEAs) originate from agreements between companies and health care recipients that cover new drugs while facing uncertainty about their financial consequences or performance. Financial agreements are used in at least two-thirds of OECD and EU member states.
Many of these countries also use results-related agreements, which subordinate coverage, business payments or discounts paid by companies to product performance, but these MEAs are less common. With the help of the European Commission, the OECD has reviewed the experience of countries that have adopted performance measures to date to identify best practices and opportunities to use these agreements in the future. 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.