The Italian Supreme Court has recently published a judgment (no. 23401 of 2022, hereinafter the “Impregilo Case”) that sheds new light on certain elements of liability of Italian companies arising from legislative decree no. 231 of 2001.
Put it simply, legislative decree 231 has established quasi-criminal liability of companies when one of their employees commits a certain crime to its benefit or in its interest. The same law has established that the company is exempt from liability if (i) it has adopted an organizational and management model (“Model”) aimed at preventing such crimes, and (ii) it has appointed an independent compliance committee (“Committee”), which has diligently overseen the actual application of such Model. If a company has not adopted an adequate Model duly enforced by the Committee, then it is regarded as failing to diligently organize itself in order to prevent 231 crimes: having failed at its duty to prevent the crime, it is therefore at fault (so called “colpa in organizzazione”, or organizational fault) and liable. Additional information on 231 legislation can be found here.
In the Impregilo Case, which followed a tortuous path through courts of various instances, the Supreme Court has established very interesting principles:
The mere fact that a certain 231 crime has occurred is not sufficient to prove that the Model was inadequate: 231 liability of a company is not strict liability, rather is based on fault, i.e., depends on lack of diligence in preventing the crime.
Adequacy of the Model must be assessed with a focus on the specific crime occurred, and not with regard to the Model as a whole.
If the Model conforms to codes of conduct drafted by industry associations, a court has the duty to indicate which best practices would have effectively prevented the crime.
This judgement ultimately grants exemption from 231 liability and recognizes that, since the Model was based on best practices, it was adequately preventing the crime, even if the crime was in fact committed due to the choice of the company’s managers to circumvent the Model.
If this trend in case law continues, companies will have a stronger incentive to adopt, enforce and update Models diligently reflecting best practices in crime prevention.
Save the date for Friday 18 November from 15:30 to 17:00 CET for a unique webinar about implementation of the EU MDR and IVDR in various European member states and recognition of CE marked devices on the UK market, hosted by the Alliance of European Law Firms in which medical devices legal specialists from Spain, Italy, the UK, Germany, Greece, Belgium and the Netherlands will address:
A compare and contrast of how competent authorities in the respective countries deal with the concepts of placing on the market and making available under the MDR and IVDR, both crucial concepts for upcoming regulatory deadlines (and maybe some news on where we expect things to go with the MDR and IVDR);
A compare and contrast of national implementing measures for the MDR and IVDR, such as regarding sanctions for non-compliance, enforcement policy and specific subjects where the MDR and IVDR allow significant local discretion (e.g. reprocessing of single use devices and as regards in-house produced devices);
A compare and contrast of national exemption possibilities under articles 59 and 97 in view of expiring MDD/AIMDD/IVDD certificates and not timely obtain an MDR / IVDR certificate.
Do not miss out on this unique opportunity to have all your questions about medical devices and IVD regulation implementation in the UK and important EU member states addressed by our expert panel:
Francisco Aranega from AMyS Law (Barcelona, Spain)
Laure le Calve from LCH Avocats (Paris, France)
An Vijverman from Dewallens & Partners (Leuven/Brussels, Belgium)
Ioanna Michalopoulou from Michalopoulou & Associates (Athens, Greece)
Mathias Klümper and Claudia Lützeler from Lützeler Klümper (Hamburg/Düsseldorf, Germany)
Paola Sangiovanni and Flavio Monfrini from Gitti and Partners (Milan, Italy)
Alex Denoon and Xisca Borras from Bristows (London, UK)
Erik Vollebregt from Axon Lawyers (Amsterdam, The Netherlands)
If you would like to attend, please send us an email to email@example.com and we will provide you with a link and technical information on joining the seminar well in advance.
Please feel free to share this save the date with colleagues or other people that may find the seminar interesting. If they send us an email, we can send them their own link and information for joining the webinar.
Patients associations will be involved in consulting, setting the agenda of the Ministry, co-planning, supporting implementation, generating evidence, as well as providing patients’ experience in the monitoring, evaluation and re-examination of measures.
Patients associations have welcomed the possibility to have a more formal and active role in the decisional processes that have an impact on healthcare: this may be a first step towards an a-political public participation in healthcare decisions.
Interested in the recording of our event of yesterday on data of non-profit studies?
You may find it here:
We really enjoyed discussing the new Ministry of Health decree on non profit clinical trial data with our stellar panel of speakers yesterday. A great opportunity to reflect on legal norms from various points of view!
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.