Search for:

In brief

On 28 September 2021, the European Commission launched a public consultation on the proposed revision of the current EU’s general legislation on medicines for human use referred to in Directive 2001/83/EC and Regulation (EC) 726/2004 in order to ensure a future-proof and crisis-resistant medicines regulatory system.

The purpose of the consultation, which will be open for replies until 21 December 2021, is to collect contributions from stakeholders and the general public in order to support the Commission’s impact assessment of revisions and to define the text of the legislative proposal, whose adoption is planned for the fourth quarter of 2022.

In particular, the consultation addresses the following issues: access to affordable medicines, promotion of innovation, including in areas of unmet medical need; improvement of security of supplies; adaptation to new scientific and technological developments, and reduction of red tape.


Roberto Cursano has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.


Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

Write A Comment