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.

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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.

G7 Health Summit Closed Today in Milan

On November 5 and 6 the G7 Ministerial Meeting on Health was held in Milan. The meeting had an ambitious agenda, ranging from the impact of climate change on people’s health to antibiotic resistance.

According to the Italian Ministry of Health, hosting the summit on the occasion of the 2017 Italian G7 presidency, the meeting innovated in the way matters have been examined and discussed, by using a so called Delphi method based on the opinions of the world’s leading experts.

A number of satellite events have also taken place across the city, including a conference organized by police forces to address the cross-border fight against “pharmaceutical crime” in all its forms, identifying the critical factors and common responses. The conference focused on the strategies and international collaborations needed to crack down on counterfeit pharmaceutical products, as well as the import and on-line sales of unauthorized products.

Another satellite event focused on the employment of new technologies in the healthcare sector, with particular emphasis on sustainability. Antibiotic resistance has also been a key item on the agenda. Italy is among the countries in the world where deaths linked to antibiotic resistance are higher.

Italian authorities did not conceal that one of the hidden goals of the summit was for them to lobby for the relocation of the European Medicines Agency- EMA headquarters to Milan. The political battle among candidate cities is about to get more intense, as a decision is expected to be adopted before the end of November.

More information on the agenda and materials of the summit can be found here: http://www.g7italy.it/en.

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.

The Italian Constitutional Court Reaffirms Freedom of Doctors in Choosing Appropriate Care

On December 9, 2015 the Italian Ministry of Health had issued a much debated decree (also known as Decreto Appropriatezza). The decree listed a number of health services, with a particular focus on diagnostic tests, and limited the ability of a doctor within the National Health Service to prescribe them.

The aim of the decree was to limit the so-called “defensive medicine”, which plagues many health systems (see our previous post on medical malpractice and defensive medicine) and has been defined as follows:

“Defensive medicine in simple words is departing from normal medical practice as a safeguard from litigation. It occurs when a medical practitioner performs treatment or procedure to avoid exposure to malpractice litigation. Defensive medicine is damaging for its potential to poses health risks to the patient. Furthermore, it increases the healthcare costs. Not the least, defensive medicine also paves way for degradation of physician and patient relationship.”

The Ministry of Health intended to limit the ability of doctors to prescribe diagnostic tests to predetermined cases and conditions when they were deemed to be appropriate. Many doctors disliked the constraints (as well as the possible sanctions, subsequently lifted) denoted in the decree, which implied strong limitations to the “divine profession” and a fundamental distrust of doctors’ own judgment.

In a recent decision (Judgement no. 169 of 2017), the Italian Constitutional Court provides an interpretation of the decree that strongly favors freedom of physicians in their prescription activities. The Constitutional Court states that the decree can be regarded as being consistent with the Constitution only if it is interpreted as a mere recommendation to doctors, who must remain bound only by their personal judgment based on science and on their conscience. The judgment touches upon many other interesting principles, and an analysis of it can be found here.

In conclusion, the Court found that constraining doctors’ decisions would result in a breach of the constitutional right to personalized and effective health care. It also stated that decisions on appropriateness of health services cannot be based on political or economic rationales, but must always be filtered through the autonomous and responsible judgment of doctors.

Vaccination: an Issue between Policy, Science, Justice and Evidence.

 

The issue of vaccination, once simply relegated to the realm of medical science, has become increasingly political in the past few years. All of a sudden, you must be either strongly pro or fiercely against vaccines, as if this were a religious or civil rights issue. (Welcome to our new, polarized world).

THE EUROPEAN UNION COURT OF JUSTICE ON EVIDENCE AND VACCINES.  An interesting decision on this subject matter was issued a few days ago by the European Court of Justice. The case involved a French citizen, “Mr. W”, who “was vaccinated against hepatitis B through three injections, administered on 26 December 1998, 29 January 1999 and 8 July 1999, of a vaccine produced by Sanofi Pasteur. From August 1999, Mr W began to present with various troubles, which led to a diagnosis of multiple sclerosis in November 2000”. The case of Mr. W has been decided many times in France, where in some instance a causal link was found, while it was denied in other decisions.

The EU Court was requested to provide guidance on two questions relating to the interpretation of EU law on product liability and based its decision on the assumption that “medical research neither establishes nor rules out the existence of a link between the administering of the vaccine and the occurrence of the victim’s disease”.

The EU Court concluded that:

  1. National evidentiary rules are not precluded by EU product liability law so long as the burden of proof remains on the plaintiff who must prove the damage, the defect and the causal relationship between the defect and the damage; and

 

  1. National evidentiary rules are precluded based on presumptions according to which the existence of a causal link between the defect attributed to the vaccine and the damage suffered by the victim will always be considered to be established when certain predetermined causation-related factual evidence is presented.

 

The decision was harshly criticized as possibly opening the floodgates of vaccines litigation without requiring the plaintiff to actually prove a causal link. In this New York Times article, Dr. Paul Offit of the University of Pennsylvania, commented the decision by pointing out that “Using those criteria, you could reasonably make the case that someone should be compensated for developing leukemia after eating a peanut butter sandwich“. Many scientists have roared against the decision, and some pointed out that “Courtrooms are generally not a good place to decide issues of science”.

In my view, the European Court of Justice did what it usually does: interpret EU law and define the boundary between EU mandatory principles and national law. Civil procedure evidence rules are not harmonized between Member States, so I am not overly surprised by the ruling.

ITALY ESTABLISHES MANDATORY VACCINATION.  Italy has recently taken sides on the vaccination debate when on June 7, 2017 the Ministry of Health issued a law decree (n. 73) which renders 12 different vaccines mandatory (for free) for children between 0 and 16 years old. The aim of the decree is to achieve the so called “herd immunity” after which such diseases pose no threat to the entire community, as recommended by the World Health Organization. As explained by the same WHO, “Herd protection of the unvaccinated occurs when a sufficient proportion of the group is immune”.

The fear that there may be a link between vaccines and autism originated from an article appeared on Lancet in 1998 by Dr. Andrew Wakefield and his colleagues (Lancet 1998;351[9103]:637–41), which later the same British medical journal retracted since based on data that “are incorrect, contrary to the findings of an earlier investigation.” Yet, many courts have awarded damages to plaintiffs claiming to be victims of vaccination and many parents have failed to vaccinate their children.

The Italian vaccination decree arises out of a worrisome drop in vaccination rates in recent years. Anti-vaccination sentiments have been strongly voiced by the 5 Star Movement, the main populist political party in Italy with approval rates around 30%, even though they predate the rise of such movement. In the United States, a similar opinion has been held by Mr. Trump (a 2014 tweet of his read: “Healthy young child goes to doctor, gets pumped with massive shot of many vaccines, doesn’t feel good and changes – AUTISM. Many such cases!”, although his position has somewhat evolved) and consistently disputed by the medical community. The populist opposition to “big pharma”, who are allegedly making more money from vaccines than from people getting sick, often results in an anti-vaccination stance.

As the Editorial Board of the New York Times puts it, “One of the tragedies of these post-truth times is that the lies, conspiracy theories and illusions spread by social media and populist politicians can be downright dangerous. The denial of human responsibility for climate change is one obvious example; another is opposition to vaccination.”

The 2017 Results of WHO’s WHO Legal – Life Sciences Have Been Published

It is that time of the year when WHO’s WHO LEGAL – LIFE SCIENCES publishes the results of its analysis aimed at identifying “which law firms and which lawyers are the most highly regarded practitioners both by region and by type of life sciences law“.

Our firm has been featured in WHO’s WHO since 2013 and this year, again, we are proud to find ourselves listed in the Transactional, Regulatory and Product Liability categories. Here is what they say:

Paola Sangiovanni of GITTI AND PARTNERS comes highly recommended in our transactional, regulatory and product liability chapters as “a rising star” who is “highly competent, gives timely feedback and has great experience in biomedical and life sciences”.

Recognitions like this one allow you to look back: you are reminded that creating a practice takes time and dedication, but eventually bears fruit. We will continue to serve our clients with the usual passion in the future!

 

“The Legal 500” Recognizes our Life Sciences Practice

We are happy to report about The Legal 500 rankings, which have just been released for the Health Care and Life Sciences Industry and confirm that “The practice has ‘smart, practical and responsive lawyers who are top-notch’. “

The full review follows:

“Gitti and Partners is the result of a recent merger of Italy Legal Focus – Studio Legale Bernascone & Soci with Gitti Raynaud and Partners Studio Legale. The practice has ‘smart, practical and responsive lawyers who are top-notch’. It regularly advises medical technology, biotechnology and pharmaceuticals companies; the client base also includes hospitals, scientific societies, contract research organisations and medical malpractice insurers. Paola Sangiovanni ‘gives very practical advice and delivers quickly’.”

In case you participated to the survey, thank you!

In all cases, have a relaxing Easter weekend!

Medical Malpractice in Italy: New Promises for Old Issues

On February 28, 2017, the Italian Parliament approved a long-awaited act, aimed at providing new tools to improve the quality of health care services and to fight the downsides of the so-called defensive medicine.

The act has been proposed and announced as a historical step for Italian health care legislation by Federico Gelli, head of the health care committee of the Italian Democratic Party.

The bill, in its 18 articles, offers a new comprehensive regulation of major aspects of medical malpractice and related issues, such as litigation management and insurance.

  • Article 2 and 3 introduce new administrative authorities: the health protection authority and the national observatory on health care good practices;
  • Article 5 formalizes and regulates the publication of guidelines and good practices for better visibility and increased certainty;
  • Articles 6 and 7 (re-)define the nature and limits of criminal, contractual and tortious liability of health care professionals and hospitals;
  • Article 8 introduces compulsory ADR mechanisms to reduce (discourage?) court litigation;
  • Article 10 establishes insurance obligations for public and private hospitals and health care professionals;
  • Article 12 allows direct compensation from insurance companies to victims of medical malpractice;
  • Article 14 creates a guarantee fund for medical malpractice victims.

Everything looks very promising, at first, but medical malpractice is a too delicate and too complicated subject to think that a simple act could really solve all the outstanding issues.

For example, Italian lawyers and health care professionals certainly remember the goofy attempt to limit health care professionals’ liability by the Italian legislator in 2012 that was not upheld by Italian courts’ decisions, thus nullifying the legislator’s intentions.

From another angle, compulsory ADR mechanisms and insurance obligations always carry the risk to become an obstacle to the effectiveness of the rights of individuals, if not a gift to insurance companies.

Lastly, it is worth noting that the ambitious goals set forth by the Italian legislator would have to be achieved without any additional public investment, as article 18 of the act expressly prohibits such spending. Indeed, it is hard to predict whether a true improvement of health care safety is achievable – automatically and free of costs – just because of a new bill.

In order to have a better understanding of the true potential of the new legislation, stay tuned for more reflections, which will appear on this blog.