Europe should reconsider the recent overhaul of its pharmaceutical rules and drug prices, Washington said in a critical report on global trade practices.
In April, the US hit the EU with 15% tariffs on branded pharmaceuticals after concluding that its dependence on the bloc’s medicines was a national security issue.
The US has now placed the EU in its annual ‘Section 301’ report on global intellectual property practices, arguing it is squandering drugmakers’ potential with its new general pharmaceutical legislation, which lawmakers agreed to in December.
“Using all the enforcement tools we have to address unfair trade practices is a top priority,” said US Trade Representative Jamieson Greer.
In the report, the US argues that the EU’s pharma package “raises serious concerns”, particularly by cutting baseline data protection periods for companies and tying key exclusivity extensions to conditions such as domestic clinical trials and rapid EU filings.
“Both of these criteria present market entry conditions that are beyond an innovative pharmaceutical company’s control or are otherwise unreasonable,” the report states.
The US also flagged the so-called ‘Bolar exemption’, which would allow cheaper generic manufacturers to enter the market faster.
The report lands as trade tensions in the sector are already intensifying, with innovative industry lobbies like EFPIA pushing for more flexible drug pricing rules under pressure from Washington’s ‘most-favoured-nation’ policies.
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 leverage to threaten new sectoral tariffs on the EU.
Meanwhile, the industry is focusing its efforts on the Biotech Act, a set of proposed EU rules which could offer another year of patent protection to biotech-based pharmaceutical companies.
Stine Bosse, a Danish Renew lawmaker, told Euractiv that the EU’s health industry is in a “difficult position,” particularly amid national healthcare budget reforms such as those in Germany, which the industry has fiercely rejected.
New patent protections are “one way” to signal better protections to European companies, Bosse added.
The US said it would “continue dialogues with trading partners” to discuss innovation and pricing in the pharmaceutical and medical device sectors, including the pharma package.
(bms, aw)
Source:
www.euractiv.com