On 29 March 2024, the United States Trade Representative (USTR) published the 2024 National Trade Estimate Report on Foreign Trade Barriers (the NTE Report) which, as in previous years, offers a review of significant foreign barriers to US exports of goods and services, US foreign direct investment, and US electronic commerce in important export markets (see, attachment). In the process, the NTE Report also tackles a range of supposed barriers that are relevant to the life sciences industry.

From a European perspective, the NTE Report makes the following noteworthy points:

• It expresses renewed concern regarding the implementation of the Medical Device Regulation and the In-vitro Medical Device Regulation, especially the shortage of notified bodies available to assess qualifying medical devices (NTE Report, at p. 137). The NTE Report also takes note of the entry into force of the extended transition period for the new rules until 2027 or 2028 but does not express satisfaction with the changed state of affairs.
• The NTE Report indicates that the US is “monitoring” the legislative trajectory of the pharmaceutical package (see, Van Bael & Bellis Life Sciences News and Insights of 3 May 2023) and the implementation of the European Commission’s plan to tackle medicine shortages in the EU (see, Van Bael & Bellis Life Sciences News and Insights of 2 November 2023). With respect to the pharmaceutical package, the NTE Report is critical of the conditions attached to the incentives earmarked for firms that manage to launch within a given timeframe across the EU (NTE Report, at p. 156). However, it remains to be seen whether that provision will survive the vote of the pharmaceutical package by the European Parliament (EP) in plenary session, which is scheduled for 10 and 11 April 2024. The language displeasing USTR was removed from the text which the EP’s Environment, Public Health and Food Safety Committee adopted on 19 March 2024.
• The NTE Report is also critical of the new policy of the European Medicines Agency regarding the disclosure of clinical trial data, including commercial confidential information, despite the legal requirement imposed on EMA and EMA’s own stated policy to protect such information (NTE Report at p. 157).
• In keeping with its traditional approach, the NTE Report is again highly critical of Member States’ market access policies for medicines (NTE Report, p. 157 and p. 158). Most of the issues identified involve the pricing and reimbursement of medicines. This is the case for Austria (lack of transparency and stakeholder involvement); Belgium (discriminatory pricing in favour of locally produced medicines; deficient market access procedures for innovative medicines); France (slow reimbursement approval procedures); Italy (lengthy and variable reimbursement procedures); Poland (lengthy delays in reimbursement procedures); Spain (lengthy reimbursement procedures and uneven market access across Spain’s autonomous regions); and Sweden (increasingly “challenging and non transparent” pricing and reimbursement environment). The NTE Report also finds fault with pricing and reimbursement in the Czech Republic (despite acknowledged improvements); Greece; Hungary; Ireland; Romania; and Slovakia.  The NTE Report thus echoes the complaints of other critics, including the industry association EFPIA which showed that, on average, a new medicine will reach European patients within 517 days following market authorisation, with considerable intra-European variations (between 128 days in Germany and 1351 days in Malta).