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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 10 January 2024, the National Anti-Corruption Authority published some transitional indications on the application of the provisions of the New Public Procurement Code concerning the digitization of direct awarding for an amount of less than EUR 5,000.
This tool is a transitional and supplementary measure that can be adopted in case it is impossible or difficult to use the Certified Digital Procurement Platforms and does not exempt the contracting authority from the duty to transmit the relevant information to the National Public Contracts Database.

On 15 January 2024, the Decree of the Minister of Health No. 3 of 8 January 2024 on “Changes to the regulation on the organization and functioning of the Italian Medicines Agency” was published in the Official Gazette. The Decree will enter into force on 30 January 2024. The Decree provides, amongst other things, for the abolition of the role of General Director (while the position of the President as the body and legal representative of the Agency is maintained) and the creation of the management positions of the Administrative Director and the Technical-Scientific Director.

After the Conference on Emerging Biotechnology held on 14 November 2023, the Ministry of Foreign Affairs launched a round table for the internationalization of the biotechnology sector, which met for the first time on 9 January 2024. The round table was established in order to identify strategies and provide recommendations for those working in the field of biotechnology, with the aim of strengthening the national sector and stimulating the development of innovative supply chains and emerging technologies.

On 15 January 2024, Consip S.p.A. and Confindustria Dispositivi Medici (the Italian Association of Medical Device Companies) signed an institutional collaboration agreement aimed at identifying the best procurement opportunities for public administrations in the healthcare sector.

On 21 December 2023, the Italian Medicines Agency updated the operating instructions and forms that can be used for the submission to the Biological Medicinal Product Evaluation Office of the documentation regarding the import and the export of human blood and blood components.

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.