ITALY: An Introduction to Life Sciences

Life Sciences in Italy: a Strategic Perspective 

The real challenge for the Life Sciences Industry in the Italian market is, first and foremost, to fully understand its characteristics and peculiarities, so as to be able to approach it in the best possible way and seize the opportunities it offers. In the process of knowledge, it is important to consider that the Italian public system is based on the National Health Service (NHS), an articulated and complex set of bodies, organs and functions established by Law No. 833/1978 and inspired by the principles of universality, equality and equity in access to care, which originate in Article 32 of the Italian Constitution, which also protects access to pharmaceutical assistance.

Homogeneous Access 

The system is universalistic, ie it guarantees all citizens homogeneous access to (health and pharmaceutical) care throughout the territory and, as for all universalistic models, one of the most delicate aspects is economic-financial sustainability, which requires a constant search for a “balance point” between universalistic vocation and resource constraints. It is important to mention the “governance” of the system, which involves the interaction of a plurality of decision-making centres for pharmaceutical policy: the NHS is, in fact, organised on two levels of government, State and Regional: the former with competence in identifying the fundamental principles of the sector and in determining the essential levels of care (LEA), which are guaranteed homogeneously throughout the national territory; the latter with competence in defining health policy lines, organisation and expenditure at the local level, without the possibility of limiting or conditioning the essential levels established at the State level.

Over the past decade, the acceleration of progress has been exceptionally intense, and the profound changes in the digital world, new technologies applied to science and research have irrevocably affected the economy and social relations in terms of increasing opportunities. Obviously part of this constantly evolving context, which is certainly fascinating but also challenging, is the personal care and assistance services, in which new therapeutic options have appeared, such as the potential of artificial intelligence (currently subject of the draft European regulation, the so-called “IA Act”), , telemedicine (which in Italy finds regulation in the National Guidelines of 2014 and 2020 and in some decrees of the Ministry of Health of 2022), advanced therapies (ATMPs, whose production and authorisation has been regulated in Italy by the decree of the Ministry of Health dated 16 January 2015), digital therapies (DTx, subject of a pending legislative proposal under consideration in Parliament), software as medical device (regulated by EU Reg. No. 2017/745), which are just some of the most interesting emerging market scenarios for the Life Sciences Industry Market which, let us remember, is highly regulated, reasoning that it is essential to have solid knowledge of it.

Digitally Oriented Progress 

Digitally oriented progress requires not only an adaptation of care models compared to traditional ones, but also different forms of relationship and collaboration between the stakeholders who are in a position to influence the processes of change in the NHS (industry, academia, institutions and patients and caregivers as well), so that the benefits that can be derived from these challenges will not be sacrificed to the demands of containing public health expenditure.

Inevitably, progress in medical research is producing a shift from the standardised “product” (the medicinal product or medical device, now of remote conception) to the customised “treatment process” for the individual patient, in which the therapy-patient interaction is only at the end of a series of complex activities and services involving multiple actors, both upstream (hospitals, pharmaceutical companies, manufacturing companies, providers) and downstream (physicians, patients and caregivers).

These new therapeutic solutions pose as many new fundamental issues from a legal point of view, starting with the consideration that the regulatory system into which they fit is the result of rules developed in the 20th century for traditional chemically synthesised medicinal products, which must therefore be adapted to the specifics of the case in order to reconcile innovation and sustainability.

Opportunities for Life Sciences Companies 

In this scenario, multiple opportunities arise for Life Sciences companies that will be able to respond to the needs of the new treatment pathways, also with the active involvement of the patient, who takes on a central role, contributing to greater effectiveness and sustainability of the system. The competitive company for the Italian market will be the one that offers advanced medicinal products, but also projects, focusing on the concept of “product plus service” to reconcile innovation and sustainability and move from the “cost” to the “value” of the solutions proposed. The diffusion of these new models can be a response to change and can enable all stakeholders to achieve the same goal: improving health outcomes in the most efficient way possible, all towards “value-based health”.

The dialogue between companies and NHS entities is and must be a way forward; the legal instruments are already available and the resources partly derive from the funds of Mission 6 of the plan financed by the European Union's “Next Generation Europe” programme (PNNR). In this sense, in addition to the public-private partnership (which in the new Public Contracts Code the Legislator presented not as a contract but as an “economic transaction”, cf. Art. 174 of Legislative Decree No. 36/2023), there are other forms of collaboration (“alliance”), which involve the company alongside the academy or other qualified private providers to support heterogeneous projects aimed at increasing the quality of care provided, improving the lives of patients, through the use of the right resources. Examples of this way of collaboration are the PTDAs (Percorsi terapeutici diagnostici assistenziali) or the PSPs (Patient Support Programmes), developed in practice and in the absence of a specific regulatory provision, as a result of the collaboration between the pharmaceutical companies and NHS entities.

Increased Interaction Between Public and Private Sectors 

With the increased interaction between the public and private sectors comes the need for a strengthening of the system of transparency of relationships, which Italy endowed with Law No. 62/2022 (“Sunshine Act”), still awaiting full implementation and enforcement.

Similarly, mention should be made of the reform of the Public Contracts Code introduced by Legislative Decree No. 36/2023 with a view to making the system more efficient. It will therefore be necessary to consider the ongoing evolution towards new models of the procurement process for medicinal products and medical devices, aimed at adequately enhancing the overall service offered by the new therapeutic solutions. In this respect, guidance is awaited from the Contracting Authorities on changes that could affect the criteria for awarding medicine supplies in public tenders with a gradual shift from "lowest price" to "most economically advantageous offer" evaluation criteria. It may therefore be necessary to understand how to dialogue effectively with NHS organisations to respond to the new design requirements.

Finally (but only for now considering the many regulatory areas in the making), as a corollary to a system that intends to embrace the new challenges, mention must be made of the reform of the Italian Medicines Agency (AIFA), launched in November 2022 (by Legislative Decree No. 169/2022) through a process of reorganisation of the Authority's governance, the aim of which is to encourage investment in pharmaceutical research and development and speed up drug approval processes by streamlining the regulatory framework, firstly, with the establishment, by Ministerial Decree No. 3 of 8 January 2024, of a Sole Scientific and Economic Commission for Medicinal products (CSE), which replaces the two advisory commissions, namely the Technical-Scientific Commission (CTS) and the Pricing and Reimbursement Committee (CPR). All that remains is to wait to see, then, how the new appointments and procedures will reverberate on the activities and proceedings conducted by the Agency and involving sector companies (for example, pricing and reimbursement process), which will, in turn, have to readjust to the new organizational models.

Conclusion 

In conclusion, we do not think we are wrong in saying that the challenge for individuals and companies entering or consolidating with investments in the Italian market will be to deal pragmatically with the new issues with the existing rules, in the knowledge that the Italian legal system, for those who know it thoroughly, already allows for adaptation to changes by filling alleged regulatory gaps through analogical interpretation of existing categories and on the basis of the general principles of Law. All of this without forgetting that, in the Life Sciences sector, an important role is also played by the ethical rules that the sector Associations have codified and that are periodically updated precisely to take into account the evolutions taking place and that, although not binding for non-member companies, constitute a rule of best practice for the hypotheses not expressly regulated by Law.