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European Union's Seven-Year EU4HealthProgramme Enters Into Force

  • 30/03/2021
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Regulation (EU) 2021/522, which establishes the EU’s action plan in the field of health for the period 2021-2027, entered into force on 26 March 2021 and has applied retroactively since 1 January 2021 (see, text of Regulation (EU) 2021/522 attached). The plan, known as the EU4HealthProgramme (EU4Health) and endowed with a budget of EUR 5.1 billion, is the EU’s response to the Covid-19 pandemic and tackles short-term needs such as the creation of reserves of health crisis relevant products, including essential medicines, vaccines, medical devices and personal protective equipment; disease prevention; and protection against serious cross-border health threats.
 
At the same time, EU4Health is also designed to have a lasting impact by funding the European Health Data Space and increasing intra-EU and international cooperation in health matters. Significantly, EU4Health will address long-term public health challenges, including cancer treatment; mental health; and the reduction of health inequalities.
 
While the European Commission (the Commission) had initially sought a budget of EUR 9.4 billion (see, Van Bael & Bellis Life Sciences News Alert of 29 May 2020), the funding that results from a political compromise between the European Parliament and the Council of Ministers (see, Van Bael & Bellis Life Sciences News Alert of 17 December 2020) will still allow for meaningful health action at the EU level, given its tenfold increase over similar previous EU health programmes.

EU4Health will rely on a complex institutional architecture involving the Commission, a dedicated agency called the Health and Digital Executive Agency, eligible legal entities from Member States and third countries, the European Medicines Agency and the European Centre for Disease Prevention and Control. Additionally, the consultative EU4Health Steering Group, which brings together the European Commission and the Member States, will prepare annual work programmes and monitor results.

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    • 02/04/2021
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    • 02/04/2021
    • Articles

    USTR - 2021 National Trade Estimate Report on Foreign Trade Barriers - Assessment of European Pharmaceutical Markets

    The United States Trade Representative published on Wednesday 31 March 2021 her National Trade Estimate Report for 2021 on Foreign Trade Barriers (the Report; see, attachment). The Report defines trade barriers as “government laws, regulations, policies, or practices that protect domestic goods and services from foreign competition, artificially stimulate exports of particular domestic goods and services, or fail to provide adequate and effective protection of intellectual property rights” (Report p. 1). The Report says to cover significant barriers, regardless of whether they are consistent or inconsistent with international trading rules. As in previous years, the Report focuses extensively on foreign trade and investment barriers for the pharmaceutical industry in Europe (Report, pages 178 and following; pages 185 and following of PDF file). In a familiar lament, the Report decries “several Member State policies affecting market access for pharmaceutical products, including non-transparent procedures and a lack of meaningful stakeholder input into policies related to pricing and reimbursement, such as therapeutic reference pricing and price controls” (Report, p. 178). According to the Report, the lack of transparency and of “due process” gives rise to uncertainty and unpredictability for investment in these markets and is liable to undermine innovation (Id.). The Report cites the “clawback system” as a particularly pernicious system from an investment perspective. It requires pharmaceutical firms to return to the government a specific percentage of the amount spent by Member States over budgetary limits. The report identifies and targets various clawback systems in Member States such as Belgium, Greece, Hungary, Italy, and Romania. The Report also takes issue with inconsistent and lengthy time limits for pricing and reimbursement decisions, even though these procedures are supposed to be limited as a result of the application of the long- standing “pricing and reimbursement transparency” Directive 89/105/EEC. Furthermore, the Report keeps a watchful eye on the patent systems of overseas countries, both in general terms and in their application to the pharmaceutical system. This is why the Report expresses concern over the apparent disregard for patent protection in certain pricing and reimbursement decisions in Italy (Report, p. 179) and maintains earlier criticism of the EU manufacturing and stockpiling waivers, in effect since 1 July 2019, which introduced exceptions to the Supplementary Protection Certificate, the extended patent protection for active substances of medicines (Report, p. 206; see, Van Bael & Bellis Life Sciences News Alert of 13 June 2019).

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