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
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).