Monthly Archives: February 2024

The Italian Government Fund for the Governance of Medical Devices

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With Ministerial Decree dated December 29, 2023, the Italian Ministry of Health has established criteria and methods for feeding the fund dedicated to the governance of medical devices, the so-called “Fondo per il governo dei dispositivi medici” (Fund for medical devices governance, “Fund”).

Key Features

  • Annual payment obligation.  Companies manufacturing or distributing medical devices, large medical equipment and in vitro diagnostic medical devices must pay a sum equal to 0.75% of the company’s previous year turnover from the sale of such devices to the National Health Service, net of VAT.
  • Annual Declaration Requirement.  Companies must submit an annual statement to the Ministry of Health regarding:
    • The estimated amount of 0.75% of the above-mentioned turnover.
    • The company’s previous year turnover to the National Health Service, net of VAT;
  • Use of the Fund. The Fund will be used for various activities related to Health Technology Assessment and governance of medical devices (including the management of the National Price Observatory, the vigilance system and the market surveillance system).
  • Deadlines and next steps. The first deadline for compliance with the fund regulations is set for December 31, 2024.

Companies are currently assessing whether the Fund can be challenged in court with arguments that may be similar to those raised in the so called “payback” litigation, which will see its day in Court (namely, the Italian Constitutional Court) on May 22, 2024.

Make Sure Employees’ E-Mail Metadata Are Deleted

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New guidelines have been issued by the Italian Data Protection Authority, or Garante, regarding processing of metadata relating to employees’ work emails. The Garante worries that, absent a specific agreement with trade unions, processing of such employees’ metadata may trigger risks of systematic monitoring, unlawful processing and excessive data retention. Therefore, they need to be deleted within a few hours/days and up to 7 days. Companies, who are acting as data controllers of such employees’ metadata, must ensure that their service providers carry out such deletions, making sure that default settings that prolong the processing are deactivated. They must also reflect in the information notice to employees the specific use of technologies that impact the processing of their data.

New Obligations for Companies Under the Proposed CS3D

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The proposed Corporate Sustainability Due Diligence Directive, so-called CS3D, may set new rules binding large EU or non-EU companies aimed at preventing adverse impacts on the environment and human rights resulting not only from their own operations, but also from those of their business partners.

CS3D has been criticized for its strong impact on the whole supply chain. While only large companies are in scope, vendors of such obligated entities will need to comply with such entities’ policies inspired by CS3D.

What Are the Proposed Obligations?

New due diligence requirements are supposed to be established by CS3D and may subsequently be implemented by each member state. According to the text under discussion, companies will have to identify, prevent, stop, mitigate and account for the adverse impacts on the environment and human rights caused by their activities. In addition, they will need to have a plan to ensure that their business strategy is compatible with limiting global warming to 1.5°C in line with the Paris Agreementand the climate neutrality goals set by Regulation (EU) 2021/1119.

Which Companies are In Scope of CS3D?

CS3D would apply to European companies that:

  • have, on average, more than 250 employees and a global net turnover of more than EUR 40 million in the last financial year for which the annual accounts were drawn up;
  • even if they do not meet the minimum thresholds, are the parent company of a group that had 500 employees and a global net turnover of more than EUR 150 million in the last financial year for which the annual accounts were drawn up.

It would also applty to third-country companies that:

  • generated a global net turnover of more than EUR 150 million, provided that at least EUR 40 million of that turnover was generated in the European Union in the financial year preceding the last financial year, including turnover generated by third-country companies with which the company and/or its subsidiaries have concluded a vertical agreement in the Union in exchange for licensing rights;
  • even if they do not meet the minimum thresholds mentioned in point (a), are the parent company of a group that had 500 employees and a global net turnover of more than EUR 150 million, of which at least EUR 40 million was generated in the European Union in the last financial year for which the annual accounts were drawn up, including turnover generated by third-country companies with which the company and/or its subsidiaries have concluded a vertical agreement in the Union in exchange for licensing rights.

When Will It Enter into Force?

CS3D is still under discussion. The proposal for the Directive was presented by the European Commission on February 23, 2022, and the Parliament adopted the amended text on December 14, 2023. The proposal must be formally approved by the Commission, the Parliament and the Council before it can officially enter into force.