Category Archives: Legal news

GDPR: do’s and dont’s

Seminario GDPR 03052018

Paola Sangiovanni will be speaking at a seminar on GDPR on May 3, 2018 at Gitti and Partners’ office in Brescia.

The seminar, followed by a reception, will focus on DOs and DONTs for small and medium enterprises in the field of data protection.

While Italians are still awaiting the enactment of a national data protection law that will clarify the relationship between GDPR and the previous privacy legislation, GDPR compliance efforts must nonetheless continue.

Join us in this interesting seminar to find out what should be done and what should be avoided!

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Weekend Reading Recommendations

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!

New Rules on Continuing Medical Education

The rules on continuing medical education (“CME”) have changed since a new agreement between the Italian government, the Italian Regions and the autonomous provinces of Trento and Bolzano has come into force on February 2, 2018. You may find the new agreement here or here (only in Italian, sorry).

The agreement is an “upgraded version” of the previous principles, which remain largely unchanged, but are now better defined, stricter and hopefully more effective.

  • THE RIGHT TO CME. Health care professionals (“HCPs”) have the right to obtaining CME and regulators will need to remove impediments in order to allow the exercise of such right.
  • ACCREDITATION OF PROVIDERS. As before, providers of CME need to be accredited, but accreditation will be subject to stricter rules, which particularly focus on avoiding any conflicts of interest. Providers will also need to adopt an internal regulation setting forth how to prevent and exclude (even potential) conflicts of interest.
  • SPONSORSHIP OF EVENTS. Sponsorship of CME events will be possible by private companies, provided that the principles of transparency, objectivity, impartiality and independence are complied with. No advertisement of medicinal products or medical devices can be carried out during the CME event, but only before, after and outside the event. No direct payments or reimbursements are allowed to speakers or moderators of the CME events.
  • NO ACCESS TO PERSONAL DATA OF HCPs. On the data protection front, note that sponsors of CME cannot have access to lists and addresses of participants, speakers or moderators.
  • SPONSORSHIP OF HCPs. Lastly, HCPs may be sponsored by commercial firms operating in the health industry, but cannot fulfil more than one third of their CME requirement through such sponsorship. This is bound to change how CME has been handled before, forcing HCPs to bear the cost of at least two thirds of their CME requirements.

Have a great weekend!

Vaccines: the Italian Constitutional Court rules in favor of mandatory vaccination imposed by national law

The polarized debate over vaccines sees the Italian Constitutional Court taking an important step into the discussion, shortly before the last notable rebellion against compulsory vaccination in Italy. Only a few days ago, in fact, the Mayor of Rome, Ms. Raggi (together with the members her Council, unanimously), approved a motion contradicting the mandatory nature of the 10 (originally 12) vaccinations, made compulsory for school-age children by a recently enacted Italian law. Nevertheless, the “rebels” in Rome probably did not take into the appropriate account the decision of the Italian Constitutional Court, which ruled in favor of the vaccines imposition under Italian law.

The Court – in deciding a constitutional challenge brought by the Veneto Region against the imposition of vaccination by the State – explains its views in a straightforward way.

First of all, the Court makes it very clear that, when it comes to vaccines, fundamental health care rights are involved and, to such regard, no difference is constitutionally acceptable between different areas of the Italian territory. In other words, when a healthcare measure is imposed by a national law in the public interest, Regions and local authorities do not have a say about it.

Furthermore, and most importantly, the Court clarifies that – also taking into account the worrisome drop in vaccination rates in recent years – the choice of tightening up legislation to compel vaccinations is not unreasonable.

True, persuasive techniques – such as the ones that Veneto Region would like to implement – can, ideally, represent a better option, but only when the herd immunity result is somehow guaranteed. Conversely, when vaccination rates drop, obligations and sanctions by law – as the California example showed – are not only reasonable (and constitutional), but much more effective.

Well, when the going gets tough, the law gets going. And that’s reasonable, Italian Constitutional Court says.

Take our Quiz on the New MoH Guidelines on Medical Device Advertisement!

On December 20, 2017, the Italian Ministry of Health has issued interesting guidelines on medical device advertisement to the general public, which you can download here (scroll to the bottom of the page).

The new rules describe DOs and DONTs in advertisement on Instagram, YouTube and Facebook and offer interesting indications on the use of a celebrity in the ads.

The basic principle remains the same: advertisement of medical devices that are subject to medical prescription (or may be used only with the assistance of medical personnel) is prohibited by Italian law. When allowed, advertisement of medical devices to the public is subject to authorization by the Ministry of Health.

Take our medical device advertisement quiz to check if you know (or can guess!) what’s new in the guidelines!

  • Can a doctor recommend a medical device in an advertisement to the general public?

No, the Ministry of Health will not authorize such advertisement.

  • What about a celebrity appearing in an advertisement message?

While the mere presence of such individual may be tolerated, no express or implied endorsement of the medical device will be authorized.

  • Can authorized medical advertisement be shared through Instagram?

Yes, but only in the “Stories” section and if users’ comments are de-activated.

  • What about Facebook?

As comments cannot be de-activated, a special disclaimer must be used in order to clarify that the Ministry of Health authorization of advertisement solely covers advertisement, while any further comments are the responsibility of users.

  • Is a medical device company allowed to email advertisement to patients?

Yes, but only if the Ministry of Health has authorized the advertisement and if the patient has expressed his/her consent (always revocable).

Holiday Reading Selection

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.

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New Whistleblowing Legislation Approved in Italy

Whistleblowers will be granted a higher level of protection under new legislation passed earlier this week in Italy.

The new provisions apply to civil servants as well as employees in the private sector. Whistleblowing protection will shield individuals who submit a good faith report concerning unlawful conduct, provided that such report is based on a reasonable belief and factual elements.

The new legislation prohibits any retaliation or other discriminatory measures against good faith whistleblowers, including termination, demotion, transfer or other organizational action.

In the private sector, the new legislation has a significant impact on organizational models adopted to prevent corporate criminal liability pursuant to Legislative Decree 231 of 2001. In fact, all organizational models will need to set up appropriate channels for the confidential reporting of criminal conduct and violations of the organizational models themselves.  Measures aimed at protecting the identity of the whistleblowers and the confidentiality of the reports, as well as disciplinary sanctions against retaliatory or discriminatory measures against whistleblowers, will also need to be included in such organizational models.

The new legislation is expected to enter into force shortly, upon publication in the official gazette.

New crimes triggering criminal corporate liability introduced.

Starting from November 19, 2017 and following an amendment of the Anti-Mafia Code, additional criminal conducts will trigger corporate criminal liability pursuant to Legislative Decree no. 231 of 2001. (If you are not yet familiar with “231”, i.e., the Italian law setting forth criminal corporate liability, you may refer to our previous blog post for an overview of such legislation).

Section 25-duodecies of Legislative Decree no. 231 of 2001 has been amended by the introduction of three new paragraphs (1-bis, 1-ter and 1-quater) relating to the following crimes in the area of illegal immigration:

• Procured illegal entry into the State; and
• Favoring illegal permanence into the State.

The full list of crimes and sanctions can be found here.

The idea is to punish companies who take advantage of illegal immigration, as well as to provide an incentive to companies to organize their activities in order to prevent such corporate crimes (in fact, companies are exempt from liability if they set up and actively pursue organizational models aimed at preventing corporate crimes). It is, however, unclear if continuously increasing the list of crimes that companies must prevent is an efficient way to do that.

Clinical Trials in Italy: Changes Announced.

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.

Italy Liberalizes the Ownership of Retail Pharmacies.

Starting from August 29, 2017, restrictions regarding owners of retail pharmacies will fall.

Previously, ownership of pharmacies was solely reserved to licensed pharmacists and entities owned by licensed pharmacists.  Thanks to a law decree of August 2, 2017, converted into law no. 124 of August 4, 2017, corporations may now own a retail pharmacy.

While a licensed pharmacist must be in charge of the management of the pharmacy, the law repeals the requirement that a pharmacist must be a shareholder of the pharmacy.  The market of retail pharma distribution will open up to corporate investments and may lead to the creation of corporate-owned retail pharmacy chains.

Ownership of a retail pharmacy will continue to remain subject to the following requirements:

  • Manufacturers of pharmaceutical products, scientific informers, and health professionals will not be able to own a pharmacy, since the relating incompatibility provisions remain in force;
  • Each pharmacy owner (including corporate entities) will be allowed to, directly or indirectly, control no more than 20% of the pharmacies located within the same region or autonomous province.

The new law also sets forth that pharmacies may be open to the public beyond the current time limitation imposed by law, upon prior notice to the competent authorities and to customers.

While this field remains highly regulated (the retail distribution of medicines on the territory and the attribution of the relevant authorizations have remained untouched), the next months will show if investors intend to take advantage of this opportunity and if small owners of pharmacies will be able to create the networks that their association, FEDERFARMA, has been advocating.