The EU executive outlines its strategy for the sector in a document due to be published on Tuesday, with the goal of making drugs more affordable and preventing the dramatic shortages seen in the first phase of the COVID-19 pandemic in the spring.
“The Commission will consider targeted policies that support greater generic and biosimilar competition,” the document says.
Generic versions of medicines are effectively cheaper copies of patented drugs and are based on the same active substances. They can only be marketed by manufacturers after intellectual property rights to the original drug expire.
The proposal says EU antitrust rules will be applied more strictly to stop patent-holding pharmaceutical companies that “hinder the entry or expansion of the more affordable medicines of their generic and biosimilar competitors”.
Among the EU’s possible actions, expected in 2022, are the removal of barriers that delay the entry of generics to market, increased uptake by health systems and clearer provisions for the conduct of trials on patented products to support generic marketing authorization applications.