United States Trade Representative - 2023 National Trade Estimate Report on Foreign Trade Barriers - Assessment of European Life Sciences Markets

• 05/04/2023
• News

On 31 March 2023, the office of the United States Trade Representative (USTR) published its National Trade Estimate Report on Foreign Trade Barriers for 2023 (the NTE Report). Published annually since 1985, the NTE Report now discusses foreign trade barriers in 64 geographical markets with regard to a wide range of practices, including import policies, technical barriers to trade, government procurement, intellectual property, investment barriers, subsidies, state-owned enterprises, and labour.

As in previous years, when it comes to the European Union, the life sciences sector features prominently in the NTE Report:

• USTR is not different from other stakeholders in waiting anxiously for the publication by the European Commission of its “pharmaceutical package”, i.e., proposed legislation that will bring about changes in a range of areas affecting the accessibility, availability, and affordability of medicines (NTE Report, p. 147). The European Commission is now scheduled to unveil its proposals on 26 April 2023. 

• USTR generally takes issue with opaque and occasionally lengthy medicine pricing and reimbursement procedures that do not allow for meaningful stakeholder input (NTE Report, p. 147). According to USTR, these problems arise in Austria, the Czech Republic (despite notable procedural improvements), France, Greece, Hungary, Ireland, Poland, Slovakia (despite improvements) and Sweden (NTE Report, p. 148 and p. 149). 

• USTR also expresses concern over a lack of protection for confidential clinical trial data that form part of applications for marketing authorisations (NTE Report, p. 147). 

• USTR is furthermore critical of specific pricing and reimbursement issues in Belgium (“domestically manufactured medicines are permitted a price premium of up to 10 percent on the manufacturing cost component when calculating their manufacturer’s selling price, [while] [i]mported products are only eligible for up to a five percent price premium”), Italy (where the business environment is said to be “unpredictable”, showing a “highly variable implementation of complex pricing and reimbursement policies”), and Romania which shows significant medicine access problems because of a failure of innovative products to reach the market (NTE Report, p. 148 and p. 149). 

• Once again, USTR challenges the EU manufacturing and stockpiling waivers, in effect since 1 July 2019, which introduced exceptions to the Supplementary Protection Certificate (SPC), the extended patent protection for active substances of medicines (NTE Report, p.168 – see, Van Bael & Bellis Life Sciences News & Insights, 13 June 2019). The continued interest of USTR in the regulatory framework governing SPCs is not a coincidence, because these rules will undergo further changes when, at the end of April 2023, the Commission will submit intellectual property proposals in tandem with its “pharmaceutical package”. 

• USTR is also closely monitoring the implementation of Article 118 of Regulation 2019/6 on veterinary medicinal products. The Regulation tackles antimicrobial resistance by restricting the use of antimicrobial products in animal medicine while Article 118 expands these restrictions to parties based in third countries (NTE Report, p. 159). 

• Finally, USTR has kept an eye on the implementation timeline for the Medical Device Regulation and the In-Vitro Medical Device Regulation (NTE Report, p. 157) and will be pleased to see that the transition periods for medical devices under these Regulations have been further extended following the formal publication of an amending Regulation on 20 March 2023.