Legislative Decree n. 137 of August 5, 2022 adapting Italian legislation to the MDR has been published on September 13; the decree will be in force starting from September 28, 2022. Legislative decree n. 138/2022 issues similar provisions in relation to the IVDR.
The main provisions of Legislative Decree n. 137 on medical devices are summarized here:
- Competent Authority: unsurprisingly, the Italian Ministry of Health has been designated as competent authority pursuant to Section 101 of the MDR and responsible authority for notified bodies. The Italian Ministry of Health will be in charge of:
- Resolving disputes arisen between manufacturers and notified bodies;
- Authorizing the sale of medical devices, which have not achieved full compliance, in cases of urgency and for public health or patients’ needs;
- Verifying the information rendered by manufacturers, agents and importers on Eudamed, and releasing the unique registration number;
- Surveillance activities on the implementation of the MDR;
- Receiving incident reports;
- Reporting of falsified devices.
- Custom-made medical devices: manufacturers of custom-made medical devices must notify the Ministry of Health their identifying information and the list of said devices.
- Clinical Investigations: no clinical investigation can be started without notification to the Ministry of Health. However, for Class III and invasive class IIa and IIb medical devices, clinical investigations may begin only after obtaining ministerial authorization.
- HTA: Health Technology Assessment is promoted.
- Remote selling of medical devices: in case a website is detected as a promoter of illegal practices, the Ministry of Health may issue measures in order to prevent access to the website.
- Advertisement: advertisement to the public of medical devices that (i) are custom-made, (ii) for which assistance by a healthcare professional is mandatory in accordance with applicable laws or with the manufacturer’s instructions, or (iii) require a prescription, is prohibited. Devices that are different from the foregoing may be advertised following authorization by the Ministry of Health. The Ministry of Health will issue specific decrees and guidelines on advertisement.
- Sanctions: several sanctions have been introduced (generally up to Euro 145,000).
- Medical Device Governance Fund: companies that manufacture or sell medical devices will have to disburse an annual fee equal to 0.75% of turnover, net of value-added tax, from the sale of medical devices and large equipment to the National Health Service to the fund. One third of the resources of the fund will be allocated to HTA activities.
While the decree helps aligning Italian law with the MDR, many more rules will need to be issued are delegated to the Ministry of Health and thus grey areas continue to exist.
We are happy to invite you to our event, which will take place both offline and online.
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.
We are happy to announce that our article on “Drug Clinical Trials Legislation in the European Union” has been published on the Indian Journal of Law and Technology (https://www.ijlt.in/).
You may read it here or here.
The purpose of the article is to illustrate the basic tenets of European Union law on clinical trials. Such body of law has been progressively harmonized in the European Union over the years with the aim of subjecting interventional clinical trials conducted in any of the 27 European Union Member States to identical rules.
The article initially describes the reasons why clinical trials are important to measure the safety, efficacy and cost-effectiveness of innovative medical treatment. It then continues by illustrating the scope and basic principles of the current EU Regulation, as well as its main changes over the previous legislation. Further, the article explains the requirements of the scientific and the ethical approvals of a clinical trial application. Lastly, the authors focus
on the patients’ consent to the enrollment in a clinical trial, as well as to the patients’ separate consent to the processing of their personal data
EU Regulations on Clinical Trials number 536/2014 will enter into force 6 months after the publication of a notice by the EU Commission confirming that the clinical trial portal and databases have achieved full functionality in accordance with the required specifications.
Such clinical trial portal and database, where all information submitted through the portal will be stored, supposedly one of the high points of the Regulation, is probably its worst enemy so far. In fact, due to technical difficulties with the development of the IT systems (aka “CTIS”), the portal’s go-live date had to be postponed for years. Therefore, so far, the Directive continues to apply, while some argue that the Regulation – that appeared cutting edge in 2014 – already shows the signs of age.
Now things are finally moving ahead.
On April 21, 2021 the European Medicines Agency’s Extraordinary Management Board confirmed that “CTIS is fully functional and meets the functional specifications, following an independent, successful audit“.
The ball is now in the European Commission’s court: once the Commission confirms the same conclusions on CTIS, a notice will be published in the Official Journal of the European Union. “Six months after this notice, the Regulation will start to apply and CTIS will go live. The aim is that CTIS goes live on 31 January 2022.” says the EMA.
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.
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.