On 30 September 2020, Spanish Member of the European Parliament (MEP) Susana Solís Pérez of the Renew Europe Group posed a written parliamentary question to the European Commission:
“COVID-19 is testing the resilience of European health systems. At the same time, we are facing a new wave of medical innovation: for example, up to 40 gene therapies are expected to be approved in the EU by 2030. These one-time, potentially transformative therapies are expected to cause a peak in healthcare expenses in the short term, while their benefits will be fully realised in the long term and will still be uncertain at the time of administration. One potential solution identified in recent literature would be to explore innovative payment models such as annuity-based instalment payments and milestone-based agreements. Spreading payments across a number of years would help to address the high upfront cost of these therapies. However, EU accounting rules (2010 ESA Regulation) would reportedly prevent Member States from implementing instalment payments, especially if there are issues relating to compliance with EU macro-economic convergence criteria and the fiscal discipline principles.
1. Can the Commission confirm the above problem and clarify which Member States are currently prevented from implementing instalment payments for gene therapies?
2. How can the Commission address issues relating to the 2010 ESA Regulation, thus enabling the implementation of instalment payments and facilitating access to gene therapies for European patients?”
On 19 January 2021, Economy Commissioner Paolo Gentiloni responded on behalf of the European Commission stating: “1. Medical technology is a main driver of healthcare expenditure. The EU Pharmaceutical Strategy raises the key challenges and proposes actions at EU level that cover the full lifecycle of a medicine. Over the next three years, it will develop and promote cooperation of a group of competent authorities, based on mutual learning and best-practice exchange on pricing, procurement policies and new payment models, with the aim to improve the patients’ affordability and health system’s sustainability. Actions also cover the cost-effectiveness of promising advanced therapy medicinal products such as cell based and gene therapy products.
2. To ensure comparability of international statistics, the European system of accounts (ESA 2010) follows international national accounts standards — the System of National Accounts (SNA) and the two systems are fully compatible. Thus, ESA 2010 follows the SNA revision cycle and is updated infrequently, broadly every 15 years.
Eurostat, as the statistical authority of the EU, monitors that all Member States produce government finance statistics (based on ESA 2010) according to the legislation in force and in line with national accounts concepts and definitions.”
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