Insights & news

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

  • 02/04/2021
  • Articles

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
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).  


Key contacts

Related practice areas

Related insights

Sign up for updates
    • 09/04/2021
    • Articles

    Conclusion of Pharmaceutical Pricing Investigation in Austria

    On 2 April 2021, the Austrian competition authority accepted commitments and closed its case concerning pricing strategies alleged to unlawfully hinder entry by generic competitors. More specifically, the pricing strategies in question involved special offers to hospitals of below-cost prices or free products, with higher prices charged for supply to community pharmacies. The attached note provides a summary of the case.

    Read more
    • 02/04/2021
    • Articles

    European Commission Starts Revising Pharmaceutical Legislation and Publishes Evaluation Roadmap and Inception Impact Assessment

    Earlier this week, the European Commission (the Commission) started the process of revising the general pharmaceutical legislation – Directive 2001/83/EC and Regulation (EC) 726/2004 - which it labels as one of the flagships of the Pharmaceutical Strategy for Europe (PSE) (see, Van Bael Bellis Life Sciences News Alert of 26 November 2020). Both the general public and the stakeholders are invited to submit their views on the “Combined Evaluation Roadmap/Inception Impact Assessment” (see, attachment). The Commission is seeking contributions on the broad range of issues covered by the PSE such as (i) unmet medical needs in areas outside the scope of the rules governing rare diseases and paediatric medicines; (ii) unequal access to affordable medicines; (iii) new technologies, including genomic sequencing, genome editing, artificial intelligence and medication based on genetically modified organisms; (iv) simplification of applicable rules and procedures; (v) vulnerable supply chains, security of supply and shortages; (vi) competition issues, including the role played by generics and biosimilar products; (vii) incentives designed to stimulate innovation; and (viii) antimicrobials. This initial public assessment started on 30 March 2021 and will end on 27 April 2021. A more thorough public consultation featuring targeted questions will be held in the fourth quarter of 2021. The Commission plans to propose draft legislation one year later in the fourth quarter of 2022.

    Read more
    • 01/04/2021
    • Articles

    Court of Justice of European Union Dismisses Appeals By Lundbeck and Others Against Citalopram Pay-for-Delay Patent Settlement Agreements

    The Litigation Chamber of the Belgian Data Protection Authority prohibited a controller from passing on personal data obtained in breach of data protection rules to its legal counsel. The Litigation Chamber did not issue a fine, but the decision serves as a clear message that further processing of such unlawfully obtained personal data, even in the context of legal proceedings, is prohibited. Please click below for a Client Alert on this decision.

    Read more

Subscribe to our updates

Please select the practice areas you are interested in: *