On October 25, 2017 the lower chamber of the Italian Parliament (Camera dei Deputati) has approved a bill, which – inter alia – promises to change how clinical trials of pharmaceuticals are regulated by national law. The bill requires that the changes follow these directions:
- Requirements for trial centers will be issued and monitored yearly;
- There will be greater involvement of patients’ associations in the protocol definition, especially in areas of rare diseases;
- The name of the authorized trial centers, as well as of names and curricula vitae of all subjects involved in clinical trials, of the relevant financing arrangements and the relating contracts, will be published;
- Measures aimed at protecting the independence of clinical trials and the absence of conflict of interests will be strengthened;
- Minimum contents of clinical trial agreements will be set forth;
- Formal requirements for the requests of opinions to the Ethical Committees will be simplified;
- The possibility to use biologic or clinical residual material from previous diagnostic or therapeutic activities, under whichever title possessed, for clinical research purposes (subject to the patient’s informed consent) will be made easier;
- Proceeds arising from clinical trials will be allocated between the trial center and research funds managed by the Ministry of Health;
- Sanctions for breaches of legislation will be rationalized (and will include suspension of Ethical Committees, who breach procedures or miss deadlines).
According to the bill, the following changes would instead affect independent or non-profit clinical research, which in Italy continues to be based on a Ministerial Decree of 2004:
- Revision of legislation in order to facilitate non-profit and observational clinical studies;
- Private companies, who support such studies, will be allowed to purchase the relating data and use them for registration purposes.
The road to an actual change of legislation is still tortuous, as it requires a favorable vote of the exact same bill by the Senate, as well as a governmental legislative decree that would set forth detailed regulations along the aforementioned directions. Surely it is too early to predict the results of any such change.
In any event, given the room that EU Regulation 536/2014 still leaves to Member States’ legislation and how generic, old and fraught with issues the current Italian legislative framework is, reforming Italian clinical trial legislation is definitely a good idea.