Italy Issues Decree to Adapt to MDR

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.

Contractual Remedies for Supply Chain Disruptions

We hope you had a lovely summer and your batteries are fully recharged.

Businesses continue to face challenges due to soaring gas prices and supply chain disruptions. Depending on the agreement, there may or may not be a contractual remedy for such imbalances.

Find out what Italian law provides for contracts with private parties and public entities.

Have a nice summer!

Meanwhile you may check out our client alert , which illustrates the new rules for accreditation of medical centers in Italy:

https://www.grplex.com/it/newsletter/download/1057/client-alert-7-2022

authored by our administrative law partner Laura Sommaruga.

Enjoy your holidays (and do not forget that they are crucial for your well being and sustained productivity, as confirmed by the WHO!).

EU Policies for the Digital Age

Confused about the Digital Service Act, the Digital Markets Act, the Data Governance Act and the Data Act? My recent article tries to make sense of all of them:

https://www.mondaq.com/italy/data-protection/1195638/an-overview-of-the-european-union-laws-and-policies-for-the-digital-age

The article also explains that the European Union has a strong vision on principles and policies for the digital age and aspires to a worldwide leadership role in the governance of digital phenomena.

Google Analytics under Scrutiny by Italian Data Protection Authority

The second issue of our summer series focuses on the recent decision by the Italian Data Protection Authority, which affects all users of the Google Analytics services in Italy, as well as other similar services that entail the transfer of users’ personal data to the United States.

Read our slides to understand what actions are available to you.

3.5 Million Fine for Excessive Pricing Imposed on Pharma Company by Italian Anti-Trust Authority

On June 6, 2022 the decision of the Italian Anti-Trust Authority sanctioning Leadiant Biosciences was published. The investigation, which started in 2018, was concluded with an administrative sanction of over 3.5 million for abuse of dominant position.

The Italian Anti-Trust Authority held that the price negotiated with the Italian medicine agency (AIFA) was excessive and unfair on the basis of the following elements:

(i) Leadiant is a monopolist on the market and its orphan drug based on chenodeoxycholic acid (CDCA) is life saving;

(ii) Leadiant intentionally pursued a complex strategy aimed at increasing the price of CDCA;

(iii) Through an exclusive supply agreement with the only reliable supplier of CDCA, Leadiant blocked any galenic manufacturing of CDCA by hospitals;

(iv) Leadiant artificially differentiated CDCA from another drug (a cheaper medicine based on the same active substance as CDCA used off label since it had a difference therapeutic indication); and

(v) Leadiant intentionally delayed negotiations with AIFA, which ended up lasting 2.5 years.

The anti-trust investigation concluded that the drug price was (a) disproportionate compared to the aggregate costs incurred and (b) unfair given the nature of the product, the investments in research and development, the risk of registration and its added therapeutic value.

The above decision taken by AIFA is still subject to appeal by Leadiant. At the same time, anti-trust authorities in Belgium and Spain are investigating Leadiant’s conduct, while the Dutch authority has already issued a sanction.

The European Health Data Space

On May 3, 2022 a Proposal for a Regulation on the European Health Data Space has been published. The proposed European Health Data Space draws from the premise that access and sharing of health data within and across Member States is difficult due to the complexity and divergence of rues, structures and processes. The European Health Data Space aims at harnessing the power of health data for people, patients and innovation by pushing towards health data science that will transform public health and foster innovation, while empowering individuals to take control of their health data. This proposed legislation is also a product of the Covid-19 pandemic, where the role of up-to-date, reliable and FAIR health data (i.e., data that is based on principles of Findability, Accessibility, Interoperability and Reusability) have been key in responding to the crisis and developing cures and vaccines. The ultimate goal is to build a European Health Union[1] that would strengthen resiliency of health systems and deliver to each Union citizen.

The European Health Data Space Communication supports both primary and secondary use of health data. With regard to primary health data, patients will have their health data available through access points established by Member States, but connected through a cross-border digital infrastructure, will be able to control and share their health data and mandatory requirements on interoperability, security, safety and privacy will apply. Electronic health record systems are subject to mandatory self-certification schemes, which must comply with essential requirements related to interoperability and security. The European Health Data Space promises to “make continuity of care across EU a reality[2].

Secondary use of data (i.e., health data used for research, innovation and public health) will also be supported by a European framework. Permit to use the data will obtained by health data access bodies, designated by Member States, which will establish how the data will be used and for which purposes (charges may apply), but always requiring closed secure environments, anonymous or pseudonymised data and transparency in their use. The platform HealthData@EU will facilitate cross border studies.

Governance of the European Health Data Space will be up to a new body, named European Health Data Space Board, chaired by the Commission. The Communication does not forget that investments in digitalization are costly and has made available 810 million euros to support the European Health Data Space.

Benefits of the European Health Data Space are expected for citizens, health professionals, researchers, regulators and policy-makers and for the industry.


[1] Bucher, A. (2022) ‘Does Europe need a Health Union?’ Policy Contribution 02/2022, Bruegel

[2] See page 12 of https://ec.europa.eu/health/publications/communication-commission-european-health-data-space-harnessing-power-health-data-people-patients-and_en