Challenges in Enforcing EU-wide Mechanism to Override IP Rights for Life-saving Medicines During Crises

EU-wide mechanism to override IP rights for life-saving medicines faces challenges

European lawmakers are facing hurdles in enforcing an EU-wide mechanism to override intellectual property rights for life-saving medicines during crises, as amendments proposed by MEPs could complicate the process, warn intellectual property rights experts.

The European Commission proposed new rules in April to establish a single instrument for compulsory licensing, allowing governments to grant licenses in exceptional circumstances to use protected inventions without the consent of patent owners. However, negotiations on the final legislative text will only begin once EU ministers finalize their own amendments to the proposal.

MEPs recently voted on a set of amendments to strengthen the rights of patent holders, granting the commission compulsory licensing powers only if companies fail to reach voluntary agreements to lift their patents. This delicate balance between innovation and access to essential goods in times of crisis was emphasized by parliament rapporteur Adrián Vázquez Lázara.

However, experts in the sector have expressed doubts about the proposed amendments. Olga Gurgula, a senior lecturer at Brunel University London, described some of the provisions as breakthrough but raised concerns about the unworkability of the new rules. Similarly, Ellen ‘t Hoen, an intellectual property lawyer and public health advocate, criticized the parliament’s position, stating that it would make the regulation nearly impossible to implement.

Criticism has also been directed at the parliament’s position on an export ban for products produced under the compulsory licensing scheme. Critics argue that this prohibition could have detrimental effects during emergencies, particularly for EU candidate countries like Ukraine, Moldova, and Georgia.

As discussions continue, stakeholders are hopeful that a balance can be struck between protecting intellectual property rights and ensuring access to life-saving medicines during crises.