Tag Archives: compliance

Happy GDPR-compliant Xmas and a prosperous new year!

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Winter recess is about to start. While we’ll all be resting, GDPR will not!

While we will all be recharging our batteries to tackle the challenges for the upcoming 2025, GDPR will not go on vacation, and will thus never be out-of-office!

Check out the following tips that the Italian Data Protection Authority has recently issued in order to avoid threats to your privacy rights during the upcoming vacations:

  • Are you receiving plenty of virtual greetings and commercial offers? Be careful about them, even if apparently sent by a friend or parent: they may contain viruses, obscure links or may hide tentative of phishing. Not all presents may be welcome.
  • Have you taken good family pictures that you wish to share on your social network? Don’t forget to ask consent of all depicted individuals. Is your grandpa going to provide his consent as well?
  • Have you filmed your children’s Christmas pageant? Keep it for yourself! You’d need consent from all depicted individuals for publishing (including from their parents in case of minors).
  • Are you wishing to download any specific Christmas-related app on your smartphone? Choose them carefully, check their issuer and the reviews. You may inadvertently be downloading the Grinch’s one!
  • Are you going away for a trip? Don’t share too much information and pictures on your social media about your time off, your house and your vehicles, as it may attract thieves. Only Santa Claus shall be allowed to break in without your consent!
  • Are you connecting with your hotel’s or restaurant’s Wi-Fi? Ask the staff about its security: they may not be protected enough.
  • Have you bought any “smart” presents for your little nephews? Check whether they may collect any personal data from their users. In the affirmative, make sure that they will not harm them in any way possible.

Our own additional tips: rest, enjoy good food, spend time with your loved ones, and get ready for 2025! We wish you happy holidays and a healthy and successful new year.

Gitti and Partners Life Sciences Team

Italy – At Last – Implemented the Registry of UBOs (Ultimate Beneficial Owners)

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All legal entities established in Italy are affected by the new regulation, which provides for a December 11, 2023 deadline.

The register of ultimate beneficial owners has been established and has become
operational also in Italy, after several extensions and delays. In fact, on October 9,
2023, the decree certifying the operation of the system for the communication of
data and information on beneficial ownership was published in the Official Gazette.

This last decree, which completes the implementation of anti-money laundering
legislation, triggers the obligation for all companies, private legal entities
(associations, foundations and other institutions of a private nature with legal
personality) and trusts to communicate data and information relating to their
beneficial ownership.

The communication on beneficial ownership must be made to the Companies’
Registry at the territorially competent Chamber of Commerce by and no later than
December 11, 2023, using exclusively electronic methods. With regard to
companies, the communication must be digitally signed by a director, without the
possibility to delegate such task. Therefore, directors who do not yet have a digital
signature device will need to obtain one.

Subsequently, legal entities shall notify any change in their beneficial ownership
within 30 days of the occurrence of the change. In addition, on an annual basis (and
in any case within 12 months from the first communication), the beneficial
ownership shall be confirmed: for companies this may take place on the occasion
of the annual filing of the financial statements.

For more information on the new requirements, check out our Client Alert here or reach out to us directly.

New Whistleblowing Legislation Adopted in Italy

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Italy has implemented today the EU whistleblowing directive (UE) 2019/1937. The new legislative decree no. 24/2003 has in fact been published on the official journal and is scheduled to enter into force on March 30, 2023.

The final published version of the decree, which had been previously leaked in an unofficial draft, can be found here: https://www.gazzettaufficiale.it/eli/id/2023/03/15/23G00032/sg.

The new legislation is certain to affect private companies and public entities alike when it comes to managing whistleblowing reports and new measures may need to be adopted to comply with the new requirements.

For additional information on this subject, materials from our February webinar can be freely accessed here: https://lawhealthtech.com/2023/02/09/our-whistleblowing-webinar/.

Weekend Reading Recommendations

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Ready for the weekend? I have these article on my reading list: perhaps you, too, may enjoy some food for thought on some of the hottest topics in the fields of law and innovation:

  • “A Layered Model for AI Governance”: https://cyber.harvard.edu/node/100108, on governance for artificial intelligence aimed at ensuring transparency and accountability and addressing massive information asymmetries between the developers of artificial intelligence systems and consumers and policymakers;

 

 

 

Whatever you will be reading, have a great weekend!

Are doctors ready to fight corruption?

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If you are reading this blog post, chances are that you are working for a pharma or med-tech company. If so, you are probably spending a sizeable portion of your time ensuring that such company does not get involved in corruption (even more so, if your role specifically entails the duty of complying with the United States Foreign Corrupt Practices Act (FCPA), the United Kingdom Anti Bribery Act (ABA), or Italian 231 legislation).

The fight against corruption can often feel lonely and unrewarding. While the mission of instilling ethical principles into the company’s money-making activities may be inspiring, the day-to-day reality of compliance can, at times, feel disheartening.

Sometimes “compliance” seems at odds with “business”. Compliance people need to emphasize pessimistic worst-case scenarios, which at times appear to be completely opposed to the bright optimistic viewpoint of business people. Often compliance is confined to saying “NO”, when the sales people repeat, over and over, “BUT OUR COMPETITORS ARE DOING IT!”

Here are a few reasons why you should never, ever!, give up.

  • You are doing this for your company.

While you may be, in fact, stopping or delaying certain sales of your company, you are truly protecting the company from the horrendous sanctions that it could suffer under the FCPA, the ABA or 231 legislation. Anybody within your company should be grateful since you are ultimately saving the company’s existence. As a result, you are saving the jobs of the company’s employees.

  • You are helping your fellow citizens.

Corruption has a cost. Many entities, like Transparency International and its Italian chapter, have attempted to measure it. Certain sources estimate that corruption costs 20% of the total health expenses of a country. Eradicating corruption would thus mean a more efficient national health system, which would turn into more health services… and less taxes.

  • You are not alone.

Bribes can be offered by companies, but can also be requested by doctors. For a long time life sciences’ companies were interacting with doctors (who are public officials, under Italian law) who seemed to have a low sensitivity to corruption risks, as well as very little sympathy for compliance procedures of such companies. While companies in Italy had seriously started their anti-corruption battles about a decade ago, it seemed that doctors lagged behind.

This may now be changing as doctors are taking an active role in fighting corruption. In Italy, for instance, entities like Transparency International Italia and AGENAS have been working to involve doctors, too. On February 22, 2017 the medical societies Associazione Italiana Medici (AIM), Segretariato Italiano Giovani Medici (SIGM) and Segretariato Italiano Studenti in Medicina (SISM) have publicly endorsed the initiative “Cure Corruption”. Diabetologists (Associazione Medici Diabetologi (AMD) have also recently pointed to the close connection between sustainability of the health system and ethical interactions among its players (see the remarks by Maria Franca Mulas).

This is a very welcome development, as synergies between public administration, companies and doctors could really step up the fight against corruption and prompt a cultural change that will help the health system as a whole.