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Roberto Cursano

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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.

On 18 January 2024, the World Health Organization (WHO) published a New Guidance on the ethics and governance of large multi-modal models (LMMs) of Artificial Intelligence (AI), targeting governments, technology companies and healthcare providers to promote the appropriate use of AI and protect public health.

On 1 January 2024, the provisions of the new Public Contracts Code on the digitization of public procurement laid down in Article 22 ‘National Digital Procurement Ecosystem (e-procurement)’ will come into force. The aim is to ensure maximum transparency, speed and a high level of simplification in the award and management of these contracts, with the aim of increasing the efficiency of the system and ensuring greater effectiveness of administrative action. The main innovation as of 1 January 2024 concerns the management of public tenders, for which the use of ‘certified’ digital platforms becomes mandatory, not only for the awarding phase, but also for all the other phases of the contract lifecycle, and in particular execution

On 23 November 2023, the Ministry of Health urged medical device manufacturers to speed up the process of alignment with EU Regulation 2017/745 (MDR). The Ministry of Health pointed out that, although six years have passed since the new regulations came into force, the number of certificates issued under the MDR is small compared to the number of certificates issued under the previous Directives. In addition, the Ministry of Health recalled that EU Regulation 2023/607 extended the period of validity of certificates issued under the former Directives until 21 December 2028, provided that the manufacturer submits a formal application to one of the Notified Bodies by 26 May 2024, and signs a contract with them regarding conformity assessment procedures by 26 September 2024.

The Council of State, in its judgment No. 2905 of 24 October 2023, reaffirmed that the principle of separation of tenders into lots may be derogated only to the extent that an adequate and specific motivation is provided, taking into account the principles of proportionality and reasonableness. The principle of subdivision into lots is an instrument which guarantees access to the market for small and medium-sized enterprises (SMEs) and it aims at increasing the efficiency of public expenditure, in particular by facilitating the participation of SMEs in public procurement.

On 15 November, the Minister of Health, together with the National Agency for Regional Health Services (Agenas) and the Conference of Regions and Autonomous Provinces, presented the Italian National Health Technology Assessment Program for Medical Devices covering the years 2023-2025, that was published in the Italian Official Gazette on 15 September 2023.

In July 2023 the European Medicines Agency, together with the network of the Heads of Medicines Agencies and the European Commission, started to work to in order to enable the use of the electronic product information, so called package leaflet 2.0. The package leaflet 2.0 consists of an electronic card that provides access to the information contained therein to the various telemedicine platforms; within that, the mandatory information on medicinal products, including the description of the product characteristics and the label, adapted for the electronic management, will be available.

Law no. 137 of 9 October 2023 introduced the offences of Bid Rigging (Article 353 of the Criminal Code), Interference with the Tender Process (Article 353-bis of the Criminal Code) and Fraudulent Transfer of Values (Article 512-bis of the Criminal Code) in the list of predicate crimes pursuant to Legislative Decree no. 231/2001.

On 5 October 2023, the European Medicines Agency amended its transparency rules on the publication of information on clinical trials submitted through the Clinical Trials Information System. This adjustment was made at the end of the public consultation, launched between May and June, to record stakeholders’ impressions and opinions a few months after European Regulation no. 536/2014 on clinical trials came into effect.

On 17 August 2023, the Ministry of Health published the draft decree, and related technical regulations, on the “Transparent Healthcare” public register and launched a public consultation to gather comments and contributions from stakeholders, including manufacturers of health products, healthcare professionals and organizations.