Source: European Parliament
1. The Draghi report recognises the merits of the EU pharmaceutical reform[1] as it envisages a ‘modern and simplified regulatory framework with faster authorisation of new medicines’[2]. The report highlights elements such as simplification of the framework, speed of procedures, enabling the use of digitalisation and Artificial Intelligence, a conducive Research & Development (R&D) investment environment. The proposed reform will reduce administrative burden for medicine developers and authorities and make the framework simpler and future-proof. The reform also proposes increasing the speed and efficiency of the processes while maintaining high standards for quality and safety of medicines in the EU.
2. The Commission fully shares the Draghi report’s finding in relation to the intellectual property in the pharmaceutical sector. The report points out that ‘given the long development times of medicines, stability in the incentives offered by this framework is needed. At the same time, pharmaceutical markets are dynamic, driven by scientific developments. Their competitive functioning evolves in parallel, implying that future changes to this framework are likely.’ The Commission is following the discussions in the European Parliament and the Council, which will facilitate the agreement in this spirit. The future pharmaceutical legislation should support the creation of a new European health industry that is globally competitive and puts patients always in the centre.