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Kce Managed Entry Agreements

It is difficult to know to what extent performance-based EREs have been successful to date. Few countries have formally assessed their experience. The confidentiality of agreements remains an obstacle to independent evaluation and little public evidence is availab evidence. However, information from expert interviews and previous studies shows that reports on the Evidence Development (EDC) agreements have so far had a poor record in reducing uncertainty about drug performance. Default payment agreements (PbRs) are still widespread, but they do not always provide evidence of product performance because the data used to trigger payments is not always aggregated and analyzed. The administrative burden of collecting and analyzing drug performance data can also make execution costly. 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. Confidentiality of performance-based MEA information versus interest in such informationNumbre from countries where information is not confidential and where there is interest in such information from other countries, based on interviews with experts from 12 OECD countries (1) using PERFORMANCE-based MEAs…

Managed Membership Treaty.- Published: Information is easily accessible in the public domain (z.B. on the Internet). – Unpublished: The information is not publicly available, but is not confidential and may be shared with third parties upon request.1. Australia, Belgium, the Czech Republic, Estonia, France, Hungary, Italy, Korea, Lithuania, the Netherlands, Sweden, the United Kingdom (England only) – information about Australia only relates to ad hoc agreements. Information for England relates only to access to employment agreements (31 agreements under the Cancer Prevention Fund and 4 for other OECD-controlled disease areas) that are publicly available; Not to other patient access systems. Source: Author of the study based on interviews with OECD experts. European competition law also applies to market authorisation holders, wholesalers and pharmacists. Article 101 of the Treaty on the Functioning of the European Union (TFUE) prohibits trade agreements, agreements or other agreements that prevent, restrict or distort competition in the internal market and affect trade between Member States.