December 6, 2022

IRCCS reform: Upcoming changes with regard to research

The Italian version of this article has been published on October 20, 2022 on AboutPharma.com, within our bi-monthly column about Clinical Trials Regulation EU 536/2014 and its implementation in Italy.

The regulation of Scientific Institutes for Research, Hospitalization, and Health Care (“Istituti di Ricovero e Cura a Carattere Scientifico,” “IRCCS” or “Institutes”) is undergoing a major transformation in Italy. On August 3, Law 129/2022 reforming the regulation of  IRCCS was published. It granted the government the authority to adopt one or more legislative decrees to revise and update the regulatory and legal frameworks of the Institutes within six months of taking effect. Those decrees will rewrite the text of Legislative Decree 288/2003, which currently regulates IRCCS.

IRCCS are structures of excellence for research conducted in Italy. This reform is part of the recovery measures in the National Recovery and Resilience Plan (“NRRP”), Mission No. 6, which also focuses on innovation and research. Its second component covers IRCCS reform with the aim of strengthening the relationship between research, innovation, and health care.

Key points of the act include strengthening the role of IRCCS as nationally and internationally important institutes of excellence, revising criteria for recognizing, revoking, or confirming the scientific character of the Institutes, streamlined processes for patient registration and product manufacture and marketing, and new regulations on protection of intellectual property and relations with companies involved in research.

The draft of the first implementing decree for the reform was recently approved after preliminary examination by the government at the Council of Ministers meeting on September 28. The text will now be examined by the Permanent Conference for Relations between the State, the Regions, and the Autonomous Provinces of Trento and Bolzano before its final approval, pursuant to Article 2 of the underlying act.

Criteria in the underlying act

The underlying act consists of a single article that identifies more than ten guiding principles and criteria for the government to use while preparing implementing legislative decrees.

Among the provisions most relevant to research carried out by Institutes are those delegating the following powers:

  • to provide and regulate methods and conditions for enhancing the role of IRCCS in order to promote, as a priority, excellence in research activities, as well as innovation and technology transfer within internationally recognized subject areas;
  • to proceed with revising criteria for the recognition, revocation, and confirmation of the scientific character of the Institutes, introducing strict evaluation criteria and high thresholds, as well as regulating participation in clinical research networks at the national and international level;
  • to regulate the establishment, governance, funding, and evaluation of IRCCS, in compliance, inter alia, with the principles of maximum knowledge sharing and the development of shared infrastructure and technology, open to cooperation both with other bodies of the National Health Service and with research networks or groups, including international ones, and with national and international scientific and industrial partners;
  • to regulate the performance of research activities by IRCCS in compliance with the criteria of transparency and research integrity in accordance with international standards, including compliance with codes of conduct;
  • to act in compliance with the provisions in effect on intellectual property to provide appropriate measures to ensure the protection of intellectual property of IRCCS, including with regard to transfer of research results, regulating any incompatibility of employees of public institutes in the technology transfer, spin-off, and startup stages, as well as relations with companies when choosing scientific and industrial partners for the development of patents held by IRCCS.

The draft implementing decree

As expected, the text of what should be the reform’s first implementing decree was preliminarily approved during the meeting of the Council of Ministers on September 28. The decree directly acts on Legislative Decree No. 288/2003, largely by supplementing the existing text.

While this is a draft and as such is still subject to change in the later stages of the approval process, we would like to highlight a few provisions of particular interest in the world of research.

New subject areas and national and international research networks

The new decree should identify “internationally recognizedsubject areas (amendments to Article 3 of Legislative Decree No. 288/2003) in which Institutes will carry out research and treatment and which will be the basis for the procedure for recognizing new Institutes. The subject areas will be identified in Annex 1, which is not yet available. Additionally, by March 31, 2023 each existing Institute will be required to notify the Ministry of Health and its respective region of its affiliation with one or more subject areas; a subsequent decree will validate the areas of activity, which will be subject to verification and confirmation every four years (under the amendment to Article 15 of Legislative Decree No. 288/2003).

Access by the Institutes to national and international research networks that aim to promote and facilitate the conduct of large-scale multi-center and multinational experiments[1] is also covered, in line with the European objectives for experimental research. Research networks are unrecognized associations pursuant to Article 36 of the Italian Civil Code, and their bylaws indicate their legal representatives, scientific coordinators, modalities for the functioning of the members’ assembly, and modalities for sharing scientific tools and expertise among members.

Without prejudice to the possibility for Institutes to participate in networks in their subject areas, access to research networks in subject areas other than those that are recognized is subject to documentation of meeting certain requirements, validated by the Ministry of Health.[2] In addition, upon accessing a network in a different subject area, an Institute will be able to access the funding provided in Article 10 of Legislative Decree 288/2003 if it can guarantee that for four years it will comply with certain parameters aimed at demonstrating experience in that additional subject area.[3] Compliance may be self-certified.

Spin-offs and innovative startups

The provisions for spin-offs and innovative startups in biomedical and biotechnological research conducted at the Institutes are also significant, and the legislature intends to encourage these as much as possible. Moreover, in line with the underlying act, the draft contains specific provisions on the incompatibility of potential appointment of Institute staff at spin-offs and startups, requiring each IRCCS to adopt internal regulations governing incompatibility and accumulation of employment and extra-institutional appointments. Reference is also made to the technology transfer phase of research results. In addition, only public-law institutes will be required to adopt further regulations governing the procedures for participation of their researchers in spin-offs and startups established within the institutes themselves.

Relations with industrial partners

Last but not least, we turn to the possible amendments to Article 8 of Legislative Decree No. 288/2003 on the subject of regulation of relations between public-law institutes and potential industrial partners in the context of institutional research activity conducted by the entities. Article 8 of current Legislative Decree No. 288/2003 already sets forth some rules with the aim of transferring research results to the industrial sphere. These include the possibility of entering into agreements, investing in companies that have already been established, and setting up investee companies in compliance with sector regulations.[4] However, specific rules are lacking. For example, guidance is needed on how to choose an industrial partner. Article 9 of Legislative Decree No. 288/2003 is limited to a sole and different scenario: conducting instrumental activities “other than institutional” research.

In this context, the draft implementing decree proposes adding paragraph 5-sexies to Article 8, which provides that in order to transfer research results to the industrial sphere, public-law IRCCS may enter into collaboration and licensing agreements and set up startups and spin-offs with third-party industrial partners in accordance with certain criteria and procedures. Specifically, (i) Institutes are to adopt specific regulations on the procedures and criteria for selecting partners with adequate technological and research skills, with a view to the subsequent adoption of a Register of Industrial Partners; (ii) the Register is to be kept and updated by means of public procedures that ensure transparency and that the information is made public; and (iii) the subsequent stipulation of agreements with parties already in the Register is to be carried out by means of a “special selective procedure.” Therefore, it seems the legislature will introduce a twofold transparent procedure, the first aimed at listing potential industrial partners in the register, and the second aimed at identifying the specific partners already listed in the register for the purpose of entering into a collaboration or licensing agreement.

Potential new aspects with great impact for research: A new burden?

There are many changes afoot, and many of them are particularly important for institutes and research. It remains to be seen whether the text approved by the Council of Ministers will remain the same once the Permanent Conference for Relations between the State, the Regions, and the Autonomous Provinces of Trento and Bolzano studies it. Passage is sure to require a delicate balancing act, since governmental powers must be exercised within the limits of the jurisdiction of the territorial authorities.[5]

Certainly, if the current wording of the text were confirmed, there would be a real risk that the mechanism for creating the list of partners and the subsequent choice of an IRCCS partner by means of a sort of “double public evidence” would be very burdensome in terms of time and costs—to the detriment of a streamlined technology transfer process. Balancing the need for transparency and the choice of the best possible contractor with the need to ensure streamlined and effective technology transfer is a great challenge, and it is to be hoped that this will not turn into an additional research burden that is too heavy to shoulder.

[1] On this point, see work plan 2022-2026 of the Accelerating Clinical Trials in the EU (ACT EU) initiative published on August 30.

[2] The following criteria are mentioned: (i) specific research activities carried out in the previous three years in the different subject area to an extent of no less than 5% of the indicators that will be identified in Appendix 3 of the implementing decree; (ii) provision of care activity in the different area to an extent of at least 10% of the total; and (iii) presence of instrumental resources, knowledge, and skills in the different area.

[3] These are the parameters: (i) nursing activity in the subject area equal to 20% of the total; (ii) research activity in the subject area equal to 20% of the total; and (iii) bibliometric indices for the impact of publications in the network’s subject area equal to the national average in the area.

[4] Legislative Decree No. 175/2017, known as the “Testo Unico delle società partecipate.”

[5] The areas of health protection and scientific and technological research are part of matters of concurrent legislation, where the state’s powers of intervention are limited to establishing fundamental principles of intervention only. In the past, some provisions of Legislative Decree No. 288/2003 were the subject of a declaration of constitutional unlawfulness precisely because of violation of the rules on the allocation of duties to the state and territorial authorities (Constitutional Court, 23 June–7 July 2005, No. 270).

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