Non-profit clinical studies have a new source of regulation: the Ministry of Health November 30, 2021 decree (“Non-Profit Decree”), repealing the December 17, 2004 decree.
The Non-Profit Decree applies to:
- low-intervention clinical trials;
- observational trials;
- non-profit clinical trials provided that the following conditions apply:
- The trial is not aimed at industrial or commercial developments of drugs;
- The sponsor is a non-profit entity (if non-profit and profit sponsors coexist, then the trial falls outside the scope of the Non-Profit Decree);
- The sponsor does not have title to the marketing authorization of the trial drug, nor has any economic relationships (cointeressenze) with the marketing authorization holder;
- Data and results of the trial, as well as decisions over their publication, are exclusively of the sponsor.
The main novelty of the Non-Profit Decree is the possibility that sponsors of non-profit trials transfer the relating data and results, both in the trial phase and once the trial is completed, for registration purposes. Such transfer must be governed by a contract between the promoter and the transferee, the consideration of which is identified by a patent consultant jointly identified by the parties.
In the event of a transfer:
- The transferee becomes the data controller of the trial data;
- Costs associated with the trial, as well as fees due to AIFA and the competent ethics committees, which were waived in light of the non-profit status of the trial, must be paid; and
- The proceeds of the transfer are allocated in favor of the sponsor (50%), a non-profit trial fund (25%) and a an AIFA fund (25%).
The transfer must be notified by the promoter to AIFA, the competent Ethics Committee and the trial centers involved.
The Non-Profit Decree also sets forth that observational studies require prior approval by the competent ethics committee and that AIFA will adopt new guidelines for the classification and conduct of observational studies on drugs.
In case of any non-profit trial on a study drug, the pharmaceutical company having title to the drug must share with the sponsor an updated copy of the drug dossier and any safety data on the trial drug must be shared between the pharmaceutical company and the sponsor.
The Non-Profit Decree opens new opportunities for non-profit sponsors: it remains to be seen if there will be an appetite to purchase data by private entities and if a price set forth by an independent expert will be an effective mechanism.
On January 16 our firm Gitti and Partners will be hosting a seminar on clinical trials legislation and its related opportunities and risks. The seminar will look at drug trials and medical devices investigations from various angles, including regulatory, data processing and criminal law perspectives.
Ms. Alice Cabrio and Ms. Giulia Corti, Corporate & Compliance Managers at Roche S.p.A., will focus on the challenges of reconciling GDPR and trials.
Dr. Eleonora Ferretti will bring the perspective of the trial unit of a large public hospital that is also a research center.
Ms. Elisa Tacconi and Ms. Elisa Corleto of Medtronic Italia S.p.A. will dive into real world evidence and will explore the limits of trials’ regulations.
Our Fabrizio Sardella and Ms. Castagno and Mr. Stigliano of Orrick will highlight criminal risks linked to clinical trials.
The seminar promises to be very interesting and you are welcome to join us.
The full program can be found here: http://grplex.com/en/conferences/download/765/clinical-trials–risks-and-opportunities-in-a-new-regulatory-environment
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.
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.