Another piece of the puzzle that will become the Italian clinical trials regulatory framework has been completed last week through the publication of Legislative Decree no. 52 of 2019. We had already talked about changes to clinical trials legislation in this previous post and some of the current changes had already been foreseen in such bill.
Here are the major changes:
- The Italian pharmaceutical agency (AIFA) will be called to issue requirements for trial centers and specific weight will be given to the involvement of patients’ associations by the center in the protocol definition;
- Patients associations will be involved also in the process of evaluation and authorization of clinical trials;
- AIFA will publish data on authorized trial centers, along with curricula vitae of individuals involved in the conduct of the study;
- AIFA will also need to set forth rules to guarantee the independence of the clinical trials and the absence of conflicts of interest in furtherance of section 9 of EU Regulation 536/2014;
- In case of breach of terms and procedures relating to clinical trials, or of rules on independence and transparency, an ethical committee may be suspended;
- New rules aimed at facilitating non-profit trials and observational studies (also post-market) will be introduced, which will allow the assignment of study data and their use for registration purposes.
- Research methodologies and clinical trials conduct will be the subject matter of specific training courses offered, also as continuing medical education.
In conclusion, we need to wait for further rules before the puzzle is complete.
Dear Readers and Friends,
With Christmas and Boxing days behind, you should have had your share of party time with your family and friends (if not, New Year’s is a good time to catch up).
If you are ready for some quiet time to read some interesting articles in the areas of innovation, health and the law, here is a selection of holiday reading that our life sciences group has prepared for you.
We wish you a 2018 filled with good health, great technology and interesting law!
Warm wishes from
Paola Sangiovanni, Flavio Monfrini, Marco Bertucci and Miriam Postiglione
a.k.a. the GITTI and Partners life sciences team.
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.