All posts by Paola Sangiovanni

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!

Are doctors ready to fight corruption?

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.

Merry holidays and happy 2017! We’re moving and merging!

Dear Clients and Friends,

We are very pleased to inform you that, as of January 1, 2017, Studio Legale Bernascone e Soci – Italy Legal Focus will join forces with the law firm Gitti and Partners (www.grplex.com).

Gitti and Partners brings together talented attorneys who provide excellent independent legal advice in connection with complex and sophisticated transactions, some of which made history in the Italian market. After the combination, the firm will be powered by over 50 professionals with specific expertise in the areas of M&A/PE, Real Estate, Capital Markets, Banking & Restructuring, Litigation, Regulatory, Tax, Labour and Life Sciences.

Our clients will surely benefit from an increased spectrum of practice areas and industries’ focus, while continuing to rely on the excellence of client service that has always been a common feature of both firms”, commented Gabriele Bernascone, founding partner of Studio Legale Bernascone e Soci – Italy Legal Focus, whose roots trace back to 35 years ago and with a reputation as “an experienced and reliable firm” (The Legal 500, 2016).

As from December 30, 2016,  we will relocate to Via Dante 9, 20123 Milan, while our telephone numbers will remain unchanged. We are very excited by this new chapter of our professional lives and look forward to your continued support. We will continue to collect our reflections on law and innovation in this blog: stay tuned in 2017!

Best wishes from the blog’s contributors,

Paola Sangiovanni, Flavio Monfrini, Marco Bertucci

 

Healthcare, Technology and Malpractice in 2030

The “Home-Spital” of 2030.

I have enjoyed reading this article on what healthcare may look like in 2030 (in wealthy countries, may I point out). The author of the article says goodbye to the hospital, while welcoming the “home-spital”. She imagines that technology (think driverless cars and robot workers) will help us live in a safer world. Technology will also help preventing certain diseases. Regenerative options will slow down ageing. “You will go to hospital to be patched up and put back on track. Some hospital practices might even go away completely, and the need for hospitalization will eventually disappear. Not by 2030, but soon after”, she predicts.

Healthcare and Technology will be Increasingly Intertwined.

Telemedicine may become so pervasive that hospitals may be empty of patients and filled with patients’ data, continuously fed through wearable patient-monitoring devices or all kinds of sensors. Hospitals may become bio-printing laboratories, where 3D printers will manufacture organs, tissues and bones on demand.

It is somewhat uplifting to imagine that medicine may become so technologically advanced, so personalized and so effective, and health so plentiful. Others, however, warn against the threat of a de-humanized medicine that will solely rely on machines and will be unable to offer a human side to suffering individuals.

Will Technology Render Doctors Error-Free?

While this new world will pose issues of privacy, data security and fraud, will it solve the problem of malpractice? What will be the role of doctors in 2030? Will technology eradicate human error?

Technology is already helping doctors in many ways: drugs, devices, diagnostic instruments are now less harmful, more precise and a lot more effective. Watson computer is assisting oncologists finding the appropriate cure. Simulators helps doctor in their training and in performing surgical procedures. Checklists, protocols and guidelines can be embedded in the doctors’ routine so as to limit, recognize or avoid repetition of human error. We can foresee a world of doctors who follow protocols embedded in devices, leaving less room for deviation from standard practice, but also from mistakes: a computerized doctor, almost. Will this make doctors error-free?

Of Course, Technology can be a Source of Error, too.

The idea of technological devices that are perfectly designed and always perfectly functioning is false, as any product liability lawyer knows. Even the best technology is subject to faulty design of a whole line of products, or faulty manufacturing of a single product.

Malpractice and Product Liability Litigation may Merge in 2030.

Litigation may simply become more complex. In fact, doctors will be sued by patients along with creators of health apps, health data centers, data carriers, device or drug manufacturers, subjects who feed data to 3D printers or who analyze and monitor data processed by devices. It will be increasingly harder to disentangle doctors’ negligence with liability of med-tech, diagnostic or pharma companies. Litigation will rely even more heavily on the opinion of court appointed experts, who will need to be a panel of specialists with bioengineering, medical and information technology skills.

Two classes of doctors will probably emerge, even more distinctively than before: doctors who follow protocols suggested by computers, whose tasks will become closer to those of paramedics, and doctors engaged in research who write protocols that will bind other doctors. The first class will probably see a reduction in its freedom to make medical choices, but may be increasingly shielded from medical malpractice litigation. The protocol-writing doctors will work even more closely with the industry that designs, tests and manufactures medical technology.

Watch Out for the Paradox of Automation!

As this very interesting article (based on an analysis of the 2009 crash of Air France Flight 447, which killed 228 people) suggests, the so called “Paradox of Automation” could come into play. Tim Harford, the author, explains it as follows: “First, automatic systems accommodate incompetence by being easy to operate and by automatically correcting mistakes. Because of this, an inexpert operator can function for a long time before his lack of skill becomes apparent – his incompetence is a hidden weakness that can persist almost indefinitely. Second, even if operators are expert, automatic systems erode their skills by removing the need for practice. Third, automatic systems tend to fail either in unusual situations or in ways that produce unusual situations, requiring a particularly skilful response. A more capable and reliable automatic system makes the situation worse.

Technology that babysits doctors may ultimately weaken their skills. While automated devices may limit small errors, they may “create the opportunities for large ones”.

Conclusions.

Technology surely helps, who could deny that? But a messianic hope that technology will propel us into a risk-free, error-free and… malpractice-free world is a simplistic approach that is plain wrong.

Is Privacy Really a Fundamental Right?

Privacy of individuals is framed as a fundamental right in the European Union. In fact, the new European Union Regulation no. 2016/679 reiterates this in the very first of its “whereas”.

Yet, it is clear to everyone that such “fundamental” nature is regularly questioned by various factors, and particularly:

  • Technological progress, coupled with people’s growing addiction to smartphones, allowing the collection of an amazing number of personally identifiable information and leading to big banks of intrusive data; and
  • Security threats that prompt governments to closely monitor citizens’ behavior.

Once upon a time courts were called to decide on how to balance conflicting rights. These days, the act of balancing privacy and other issues has become much more common and it is in the hands of a variety of subjects, such as data processors, who must carry out a data protection impact assessment according to Section 35 of the EU Regulation no. 2016/679, and data protection authorities, who provide both general guidelines and specific advice.

A couple of recent decisions by the Italian Data Protection Authority have led me to believe that the Authority is readier than before to accept that there are justified limits to the right to privacy:

  • On July 14, 2016, the Italian Data Protection Authority has decided that a bank is allowed to analyze behavioral/biometric information regarding its customers (such as mouse movements or pressure on the touch screen) as a measure to fight identity theft and internet banking fraud. Of course, a number of limitations have been set by the Authority, in addition to consent of the customer/data subject, such as specific safety measures, purpose and time limitations, and the segregation of the customer names from the bank’s IT provider.
  • On July 28, 2016, the same Authority has granted its favorable opinion to the use of a face recognition software at the Olimpico stadium during soccer games in order to check that the data on the ticket and the face of the person actually attending the event correspond. Provided that strong security measures are used and that the processing is carried out by police forces, the processing was deemed to be necessary.

A tougher stance, instead, is adopted by the Italian Data Protection Authority in cases of processing aimed at marketing purposes, as in this decision, for example. (I note, however, that the code of conduct applying to data processing for the purposes of commercial information that will enter into force on October 1, 2016, blessed by the Italian Data Protection Authority, continues to allow the dispatching of commercial communications to individuals whose personal data is included in public listings, even without the data subject’s express consent).

Balancing rights and interests is inherent to law and justice. It remains to be seen, considering the obvious (and absolutely reasonable) limitations to which the right to privacy is subject, if it will continue to make sense to frame it as “fundamental” right.

The New EU-US Privacy Shield

Yesterday the European Commission announced that the new agreement between the European Union and the United States on European data flowing into the United States has been approved. After months of negotiations, the deal was enthusiastically announced as “a robust new system to protect the personal data of Europeans and ensure legal certainty for businesses” that “brings stronger data protection standards that are better enforced, safeguards on government access, and easier redress for individuals in case of complaints” in the words of Věra Jourová, EU Commissioner for Justice, Consumers and Gender Equality.

Ever since the 2015 Court of Justice of the European Union (“CJEU”) landmark decision that put an end to the Safe Harbour system (i.e., the previous agreement regarding EU-US data flows), the US and the EU had negotiated for about 2 years in the attempt to create a system that aims at reassuring European citizens and creating clarity for United States businesses. An initial agreement on the Privacy Shield was already reached in February, and heavily criticized by the association of European data protection authorities named “Article 29 Working Party” (as we covered in our blog). Allegedly, the European Commission has taken note of such criticism and added additional clarifications and improvements to the draft.

Here are the main features of the Privacy Shield, as set forth in the Commission’s fact sheet:

  •  The U.S. Department of Commerce will register U.S. companies under the Privacy Shield if they commit to process personal data in accordance with certain compliance standards. It will also conduct regular updates and compliance reviews of participating companies, and companies who do not comply face sanctions and removal from the Privacy Shield list.
  • U.S. government’s access to personal data for law enforcement and national security is subject to clear limitations, safeguards and oversight mechanisms. There will be no indiscriminate mass surveillance on personal data transferred to the US under the EU-U.S. Privacy Shield arrangement.
  • EU data subjects will, also for the first time, benefit from redress mechanisms in the area of national intelligence for Europeans through an Ombudsperson mechanism within the Department of State independent from the US intelligence services.
  • In case of processing of personal data in breach of the Privacy Shield, EU data subjects will have access to several dispute resolution mechanisms: (i) redress by the data controller, (ii) free of charge alternative dispute resolution solutions, (iii) complaints submitted to their national Data Protection Authorities, who will work with the U.S. Federal Trade Commission to resolve complaints, (iv) arbitration mechanism.
  • The functioning of the Privacy Shield will be monitored and a public report to the European Parliament and the Council will be issued.

The one million dollar question is: will the Privacy Shield hold?

The CJEU may struck it down in the future and privacy groups will undoubtedly test the waters with new cases. If this happens, some predict that there will not be any further attempt to create another “Safe Harbor” or “Privacy Shield”. As Mark Scott of the New York Times puts it: “The European Commission, the executive arm of the European Union, and the United States Department of Commerce spent years negotiating the new deal. If it were eventually overturned in court, few companies or privacy experts would have faith that either side could do any better the next time around”.