Europe should reconsider a recent review of its pharmaceutical rules and drug prices, Washington said in a critical report on global trade practices.
In April, the US hit the EU 15% fee for branded pharmaceutical products after concluding that her addiction to block drugs was a matter of national security.
The United States has now put the EU in its yearbook Section 301 Report on global intellectual property practices, arguing that it is squandering the potential of drug manufacturers with the new general pharmaceutical legislation, which lawmakers agreed to it in December.
“Using all the enforcement tools we have to tackle unfair trade practices is a top priority,” said US Trade Representative Jamieson Greer.
In the report, the US argues that the EU’s pharmaceutical package “raises serious concerns”, particularly by shortening basic data protection periods for companies and tying key franchise extensions to conditions such as domestic clinical trials and fast-track EU registrations.
“Both of these criteria present conditions of market entry that are beyond the control of an innovative pharmaceutical company or are otherwise unreasonable,” the report states.
The US also marked the so-called ‘Bolar exemption’, which would allow cheaper generic manufacturers to enter the market more quickly.
The report comes as trade tensions in the sector are already intensifying, with innovative industry lobbies such as EFPIA calling for more flexible drug pricing rules under pressure from Washingtonmost favored nationpolicies.
EU diplomats and MEPs will meet this week to discuss the Turnberry deal, but President Donald Trump’s threat of new car tariffs could complicate talks.
The Trump administration could use the report as a tool to threaten new sectoral tariffs on the EU.
Meanwhile, the industry is focusing its efforts on the Biotechnology Act, a set of proposed EU rules that could provide one more year of patent protection to biotechnology-based pharmaceutical companies.
Stine Bosse, a Danish lawmaker for Renew, said Euractiv that the EU healthcare industry is in a “difficult position”, especially amid national healthcare budget reforms such as in Germanywhich the industry has strongly rejected.
The new patent protections are “one way” to signal better protection for European companies, Bosse added.
The US said it would “continue dialogue with trading partners” to discuss innovation and pricing in the pharmaceutical and medical device sectors, including pharmaceutical packaging.
(bms, aw)
