The clinical trial plays a fundamental role in the pharmaceutical sector as it contributes to the development of knowledge and the fight against diseases, as well as being a central element of the regulatory process for marketing authorization. The notion of clinical despair was codified at community level by the Guide of the European Union to the norms of good clinical practice 1 and subsequently reiterated with Directive 2001/20 / EC 2 . In particular, clinical trials are those investigations carried out on a human being in order to verify the effects of a medicine on it and to identify and / or study its reaction and absorption 3 .
Usually, it stands out in experimentation carried out exclusively for scientific purposes, and therefore aimed purely at the progress of science, and in therapeutic experimentation, practiced for the purpose of saving patients' lives or improving the quality of existing therapies. In turn, therapeutic experimentation stands out in profit experimentation, ie promoted by the for-profit pharmaceutical industry 4 , and non-profit, that is promoted by public or research bodies 5 .
In recent years, clinical trials have increasingly benefited from advances in technology, while always maintaining a fixed point: the priority protection of those involved with respect to any other interest. Given the pace at which science and technology evolve, as well as the impact of the latter on the conduct of clinical tests, the need to harmonize certain principles of constitutional rank and relating to fundamental rights, such as the right, becomes increasingly pressing to health and privacy, with constant technological progress, in particular with regard to patient health data.
The subject was deeply marked by the introduction of Regulation (EU) n. 2016/679 regarding the protection of personal data (General Data Protection Regulation, GDPR) 6, which became mandatory in all Member States starting from 25 May 2018. According to the new legislation, the health data are those concerning physical health or mental health of a person, able to reveal information regarding his state of health 7 . As personal data, health data are included in the discipline referred to in Article 9 of the Regulation 8 .
Although not explicitly mentioned, health data could fall under the special discipline of the GDPR based on recital (35) 9 , and therefore qualified as sensitive data. The information on the use of sensitive health data must be drafted in a concise, transparent and clear and simple language, especially in the case of information intended for minors 10 .
Clinical trials are now regulated, at European level, by Regulation (EU) n. 536/201411. Since the subject of data processing falls within the scope of both regulations, coordination between the relevant disciplines is required, as established by recital (161) of the GDPR 12 . In this context, the European Data Protection Board (EDPB) 13 intervened on 23 January 2019 . While not exhaustively treating the topic, the Committee clarified how the provisions of Regulation 536/2014 concerning the processing of personal data in clinical trials with the GDPR discipline should be coordinated, establishing that it should not necessarily be based on the consent of the interested parties14.
In Italy, the Supreme Court has 15 identified health data as "super sensitive" data, that is liable to affect the most intimate aspects of a person's life as his health was, in fact confirming the European practice. As regards their treatment, on May 14, 2019 the Government approved Legislative Decree no. 52/2019 16 . The decree, which introduces some novelties in the health field by modifying the previous provisions concerning clinical trials, aims to harmonize the regulations in force with Regulation (EU) no. 536/2014.
Nello specifico, una delle modifiche più rilevanti riguarda l’utilizzo dei dati clinici derivanti da sperimentazioni cliniche no profit, che in Italia costituiscono circa il 25% del totale17. Prima dell’entrata in vigore del D. Lgs. n. 52/2019, i dati ottenuti a seguito di sperimentazioni cliniche senza scopo di lucro non potevano essere utilizzati per scopi commerciali. Le case farmaceutiche, inoltre, non potevano reclamare la proprietà dei dati e dei risultati ottenuti da tali studi. Con il nuovo decreto, invece, i dati e i risultati ottenuti potrebbero essere
affidati a terze parti a fini registrativi e regolatori, ed il corrispettivo versato dal promotore o dal cessionario per il possesso dei dati e dei risultati potrà coprire i costi connessi alla sperimentazione. Inoltre, è fatto obbligo al promotore di corrispondere le tariffe precedentemente non versate ai sensi della legislazione vigente per l'iniziale qualificazione dello studio quale studio senza scopo di lucro18. Infine, è stato inserito il nuovo articolo 21bis relativo ai sistemi informativi di supporto alle sperimentazioni cliniche che, oltre a richiedere il coinvolgimento di figure professionali specifiche, conferma che i dati devono essere raccolti conformemente alle disposizioni del GDPR19.
The use of data obtained from non-profit clinical trials for commercial purposes could have very significant implications, not least the possibility of avoiding further tests for profit if the former have already provided reliable data. However, to have a first response at a concrete level, it will be necessary to wait until the Ministry of Health issues a further decree, by 31 October 2019, which specifies the criteria and requirements of the non-profit trials, will provide useful information to facilitate the conduct of studies non-profit clinics and establish the conditions for cooperation between the public and private sectors and for the transfer and use of data 20 .