On Wednesday 25 November, the European Commission is due to present its pharmaceutical strategy, which aims to “ensure accessibility, sustainability and security of supply” in Europe (see EUROPE 12498/4). According to a draft text unveiled by Reuters, the communication could introduce several new measures by 2022.
“The Commission will consider targeted policies that support greater generic and biosimilar competition”, the news agency said. According to Reuters the proposal will suggest that EU competition 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”.
Possible EU actions expected in 2022 and identified by Reuters include 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 authorisation applications.
The Commission also argues that the incentives and obligations for pharma firms may be reviewed by 2022 to link them more closely to requirements for wider distribution and greater competition. It also announces new measures to strengthen the EU's “strategic autonomy”, including earlier notification of shortages and enhanced transparency of stocks. (Original version in French by Sophie Petitjean)