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In brief

On 26 April, the European Commission presented its long-awaited proposal for the review of the pharmaceutical legislation.

Key takeaways

The main objectives of the proposal include the creation of a Single Market for medicines aimed at ensuring that all patients across the EU have timely and equitable access to safe, effective, and affordable medicines; the offering of an attractive and innovation-friendly framework for research, development, and production of medicines in Europe; the drastic reduction of the administrative burden by speeding up procedures significantly, reducing authorization times for medicines, so they reach patients faster; and the enhancement of the availability of medicines.

One of the most significant elements of the proposal is a two year reduction of the standard period of regulatory data protection. In exchange, there will be opportunities for additional periods of data protection when certain conditions are met, such as where the medicine addresses an unmet medical need, for medicines containing a new active substance, where comparative clinical trials are conducted and for a new therapeutic indication approved during the period of data protection if supported by data that shows a significant clinical benefit over existing therapies. The current two years of market protection will be preserved following the expiration of the data protection period.

The proposal is now to be submitted to the European Parliament and the Council.


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.


Francesca R. Baratta is an Associate in Baker McKenzie Rome office.


Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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