After the European Commission proposed a massive overhaul to the EU’s drug legislation, a group of 19 European countries is launching an effort to reduce the bloc's supply chain reliance on outside countries.
The position paper (PDF) urges the EU to “take more drastic steps” to improve the security of Europe's supply of medicines. Belgium is leading the charge, and 18 other countries such as France, Germany and Spain are on board.
In 2019, more than 40% of global active pharmaceutical ingredients came from China, the countries point out. That, coupled with other factors such as the fact that "almost all API producers depend on China for intermediate inputs," make Europe and the rest of the world dependent on “a few manufacturers for a large bulk of their medicines supply," according to the paper.
The proposed European Critical Medicine Act would follow in the footsteps of similar acts such as the Critical Raw Materials Act and support European “green, digital” manufacturing for essential meds and ingredients, the paper says. The act should be considered “a toolbox of different instruments” and seen as complementary to the proposed pharma legislation, the paper said.
Late last month, officials in Europe proposed major updates to the bloc's pharma regulations. The proposals cover issues such as length of market exclusivity, regulatory timelines, transparency around R&D funding and more.
Some of the proposals drew pushback from the European pharma industry.
Meanwhile, as Belgium and other countries noted in their position paper, reliance on external manufacturers can cause supply shortages.
The member states are pushing officials to develop a list of critical medicines and map out the entire global supply chain for those drugs. This would allow them to identify potential weaknesses and act quickly in case shortages do arise.
The member states also suggested a “solidarity mechanism” in which countries affected by shortages can seek temporary relief from other participating countries.