All posts by Paola Sangiovanni

About Paola Sangiovanni

Partner of GITTI and Partners. Seasoned transactional and regulatory legal counsel with a thorough understanding of the life sciences industry.

Clinical Trials Seminar at Gitti and Partners

On January 16 our firm Gitti and Partners will be hosting a seminar on clinical trials legislation and its related opportunities and risks. The seminar will look at drug trials and medical devices investigations from various angles, including regulatory, data processing and criminal law perspectives.

Ms. Alice Cabrio and Ms. Giulia Corti, Corporate & Compliance Managers at Roche S.p.A., will focus on the challenges of reconciling GDPR and trials.

Dr. Eleonora Ferretti will bring the perspective of the trial unit of a large public hospital that is also a research center.

Ms. Elisa Tacconi and Ms. Elisa Corleto of Medtronic Italia S.p.A. will dive into real world evidence and will explore the limits of trials’ regulations.

Our Fabrizio Sardella and Ms. Castagno and Mr. Stigliano of Orrick will highlight criminal risks linked to clinical trials.

The seminar promises to be very interesting and you are welcome to join us.

The full program can be found here: http://grplex.com/en/conferences/download/765/clinical-trials–risks-and-opportunities-in-a-new-regulatory-environment

Don’t Forget to Close E-mail Accounts of Employees who Leave. And Happy Holidays!

The Italian Data Protection Authority has recently reiterated what to do when an employee leaves the company, i.e.:

  • Close down email accounts attributable to the former employee;
  • Adopt automatic response systems indicating alternative addresses to those who contact the mailbox; and
  • Introduce technical measures to prevent the display of incoming messages to unauthorized subjects.

The automatic forwarding of emails to colleagues of the former employee amounts to a breach of principles of data protection, which impose on the employer the protection of confidentiality even of the former worker.

In the case decided by the Authority the e-mail account had remained active for over a year and a half after the end of the employment relationship and before its elimination, which took place only after a formal complaint filed by the worker.

Our life sciences team at Gitti and Partners wishes you a relaxing Christmas break and a 2020 full of happy innovation, useful technology and interesting legal developments!

New 231 Crimes Introduced

New tax crimes that may trigger corporate liability have been introduced by the Italian budget law, namely by section 39 of law decree no. 124 of 2019 relating to fiscal measures (decreto fiscale).

The new section “25-quinquiesdecies” (sic!) applies to crimes of fraudulent tax statements through invoices or other inexistent transactions, invoicing inexistent transactions, fraudulent avoidance of tax payment and destruction of accounting documents.

As a result, companies that commit such fraudulent tax crimes are not only subject to tax liability, but also to “231” liability and punished with a monetary sanction up to 774,500 Euros. Such “231” liability may be in addition to the personal criminal liability of their directors. Additionally, in many cases the confiscation of money, goods or other benefits resulting from the tax crime also applies.

The new crimes will be in force starting from the publication on the Official Gazette of the law converting the above mentioned law decree, which must be converted by the Italian Parliament before Christmas Day.

Companies must therefore act in order to ensure that their 231 organizational models include sufficient provisions aimed at preventing such crimes, such as controls on the veracity of transactions, on the keeping of accounting documents and on the contractual counterparty indicated by the company’s tax documentation. Of course, we at Gitti and Partners can help!

Paola Sangiovanni to Speak on Artificial Intelligence

Our firm will be attending the EMEA Regional Meeting of Ally Law in Malta next week and on Friday November 15th I will be speaking at a panel discussion titled “Keeping an Eye on AI: Ethical and Regulatory Considerations.” 

Artificial intelligence is a hot topic, also in the med-tech field, and poses exciting legal, ethical and regulatory questions. I am sure this will be an interesting opportunity to discuss them with legal and technical experts. 

 

Is Your Cookie Policy Right?

In a recent decision by the Court of Justice of the European Union in case C-673/17 against Planet49 GmbH, the issue of consent was analyzed on the basis of the ePrivacy Directive and the GDPR.

The case regarded a preliminary question by the German Federal Court of Justice on the validity of consent given through a pre-ticked checkbox, which the user must deselect to refuse his or her consent.

The Court analyzed the features of consent under the ePrivacy Directive (“freely given specific and informed indication of his wishes by which the data subject signifies his agreement to personal data relating to him being processed” by reference to the Data Protection Directive) and in the GDPR (“any freely given, specific, informed and unambiguous indication of the data subject’s wishes”).

The Court concluded that the user is required to “give” consent and to provide an “indication”, which “points to active, rather than passive, behavior.” Therefore, an opt-out consent is not validly given.

You may want to check if your website has a passive mechanism to accept cookies (including a mechanism whereby “continuing to browse the website means acceptance of these cookies”): under the Court’s decision described above, it is possible that such a passive consent would be regarded invalid.

This conclusion would appear to contradict the previous guideline by the Italian Data Protection Authority providing that “if the user continues browsing by accessing any other section or selecting any item on the website (e.g. by clicking a picture or a link), he or she signifies his or her consent to the use of cookies.”

Further, the Court set forth that “the information that the service provider must give to a website user includes the duration of the operation of cookies and whether or not third parties may have access to those cookies.

Recent Data Protection Developments

There are a few interesting developments in the area of data protection that you may have missed and we can recap for you:

  • CONDITIONS TO PROCESS CERTAIN DATA ISSUED BY THE ITALIAN DATA PROTECTION AUTHORITY. According to section 9 paragraph 4 of the GDPR, Member States are entitled to introduce additional conditions for the processing of genetic, biometric or health data. On July 29, 2019 the final version of such conditions issued by the Italian Data Protection Authority has been published on the Official Journal. Such conditions apply to processing of data (i) in employment relationships, (ii) by associations, (iii) by private investigators, (iv) that are genetic or (v) for purposes of scientific research.
  • RIGHT TO BE FORGOTTEN. On September 24, 2019 the European Court of Justice has issued a judgment on the right to be forgotten in case C‑507/17 against Google Inc. The Court has ruled that “there is no obligation under EU law, for a search engine operator who grants a request for de-referencing made by a data subject, as the case may be, following an injunction from a supervisory or judicial authority of a Member State, to carry out such a de-referencing on all the versions of its search engine.” While the right to be forgotten must be enforced in all Member States, there is no obligation to do that in all national search engines. The Court, however, added that a supervisory or judicial authority, after balancing all rights concerned, would be able to order de-referencing on all search engines in the world since “EU law does not currently require that the de-referencing granted concern all versions of the search engine in question, it also does not prohibit such a practice.” Given the reaction to the judgment by the Chairperson of the Italian Garante (the data protection authority) Mr. Antonello Soro, it cannot be excluded that that the Garante may issue a universal, rather than EU-wide, dereferencing order.
  • PROCESSING FOR “OWN PURPOSES”. A med-tech company has been sanctioned for having used patient data (medical scans) in a public tender process and in a subsequent litigation in an anonymized form. The company had been appointed by the hospital as a data processor but, the Garante ruled, had further processed such patient data for an own purpose rather than for the purposes mandated by the data controller (i.e., maintenance of equipment generating scans for patients).
  • AGAIN ON THE RIGHT TO BE FORGOTTEN. In a decision by the Italian Garante dated July 24, 2019 Google LLC has been ordered to de-reference from its search engine news about criminal facts occurred in 2007 for which an individual, without any public role, had been condemned, but who had been fully rehabilitated.
  • CONSUMER CREDIT CODE OF CONDUCT. On September 19, 2019 the Italian Garante approved a new code of conduct for companies operating in the areas of consumer credit, credit worthiness analysis and payment punctuality.

 

EU Commission Factsheet on MDR and IVDR

Still confused about the regulatory changes affecting medical devices and in vitro devices? The EU Commission has published a useful factsheet, which you can find here.

Through the factsheet, the Commission warns health institutions and healthcare professionals that the upcoming changes may have consequences on the availability of medical devices because manufacturers may decide to stop their production or because products may not get their certificates on time.

Some notified bodies have also decided to drop off and only two notified bodies have been MDR designated so far, so this will create additional bottlenecks. A short grace period until 2025 is granted, but it does not apply to class I devices.

The path to an enhanced regulatory framework will be complicated and manufacturers, healthcare institutions and healthcare professionals need to know what to expect.

Clinical Trial Regulation: Another Piece of the Puzzle

Another piece of the puzzle that will become the Italian clinical trials regulatory framework has been completed last week through the publication of Legislative Decree no. 52 of 2019. We had already talked about changes to clinical trials legislation in this previous post and some of the current changes had already been foreseen in such bill.

Here are the major changes:

  • The Italian pharmaceutical agency (AIFA) will be called to issue requirements for trial centers and specific weight will be given to the involvement of patients’ associations by the center in the protocol definition;
  • Patients associations will be involved also in the process of evaluation and authorization of clinical trials;
  • AIFA will publish data on authorized trial centers, along with curricula vitae of individuals involved in the conduct of the study;
  • AIFA will also need to set forth rules to guarantee the independence of the clinical trials and the absence of conflicts of interest in furtherance of section 9 of EU Regulation 536/2014;
  • In case of breach of terms and procedures relating to clinical trials, or of rules on independence and transparency, an ethical committee may be suspended;
  • New rules aimed at facilitating non-profit trials and observational studies (also post-market) will be introduced, which will allow the assignment of study data and their use for registration purposes.
  • Research methodologies and clinical trials conduct will be the subject matter of specific training courses offered, also as continuing medical education.

In conclusion, we need to wait for further rules before the puzzle is complete.

New Rules on Public Procurement

On June 12, following a confidence vote, the lower chamber of the Italian Parliament has approved a law that will bring quite a few changes to the Public Procurement Code.

The new law, which has not been published in the Italian Official Gazette yet, has been enthusiastically announced as a way to accelerate governmental contracts, in line with the nickname of the act (“Sblocca Cantieri“, which could be translated as “Unlocking Building Sites”).

By way of example, the act allows subcontracting up to 40% (the previous threshold was 30%) and sets forth that only three competing offers will be required for contracts with a value between 40 and 150 thousand Euros. It also includes rather odd provisions, such as the increase in spending for close circuit tv cameras in public structures’ premises where small children and old people are cared for (see section 5 septies). 

The law has been bitterly criticized by the head of the Italian Anti-Corruption Authority, who pointed out that the aggregate value of public procurement contracts is at its highest (139.5 billions in 2018) and that criminal infiltration in companies bidding for public works is also very significant. Many fear that de-regulation of the sector will not bring positive results.

Others simply point out that this body of law has been subject to too many changes in the past years, which makes it difficult for helpful case law to develop and confuses operators.

Why the European Union Whistleblower Laws Are All Doomed To Failure – BY GUEST BLOGGERS MARC RASPANTI AND PAM BRECHT

Today we are hosting a blog post by the US attorneys Marc Stephen Raspanti and Pamela Coyle Brecht.

Marc is the name partner of the US law firm Pietragallo Gordon Alfano Bosick & Raspanti, LLP located in Philadelphia, Pennsylvania, the founder of the firm’s White Collar Criminal Defense Practice Group, as well as the firm’s global Qui Tam/False Claims Act Practice Group (msr@pietragallo.com).

Pam serves as the firm’s Practice Chair for the firm’s global Qui Tam/False Claims Act Practice Group (pcb@pietragallo.com). Their firm websites are:  http://www.pietragallo.com and http://www.falseclaimsact.com

Member States of the European Union, over the last several years, have passed a series of so-called “Whistleblower Laws.”  These laws are being implemented allegedly to bolster anti-corruption efforts throughout Europe.  While corruption is no stranger to either side of the Atlantic, the European Union would advance their fraud fighting efforts exponentially by taking a focused look at the highly successful American False Claims Act.

France, Ireland, Italy, Greece, Germany, Netherlands, Sweden, Hungary, Lithuania, Malta, Slovakia, the United Kingdom, as well as others, have passed or amended some type of a putative whistleblower law.  Here is the issue.  None of these whistleblower statutes, in our opinion, contain the basic tenents of a strong and effective whistleblower program.  The development of the whistleblower statutes within the United States of America illustrates the bedrock elements of an effective and successful whistleblower law.

In 1986, the U.S. Congress amended the existing whistleblower statute, the False Claims Act, which was passed during the American Civil War by President Abraham Lincoln.  The 1986 Amendments to the False Claims Act included provisions that finally gave the law real fraud combatting teeth. Examining these 1986 Amendments (and even more recent Amendments) illustrates the changes needed in the European Union member States’ whistleblowing statutes.  Without such robust amendments the European Union laws will never have a real and palpable impact on fraud, waste and abuse.

The American statute, known as federal False Claims Act, or the Qui Tam Law, has at its heart the following key provisions:

  • The United States has what is known as a “qui tam[4] or whistleblower provision.
  • A whistleblower who comes forward and meets the statutory requirements is authorized by the statute to bring an action on behalf of the government and is entitled to receive a set amount of any settlement or judgment the government receives from the defendant from 15% to 30%. This strong financial incentive has, singlehandedly, made the American statute the most successful fraud, waste and abuse statute in the world.  Of this fact there is no debate.
  • The United States’ Congress has provided strong protections against professional retaliation against whistleblowers. In contrast, the European statutes contain weak non-existent or watered down versions of this protection.  In fact, some of the European laws actually put the whistleblower at risk if he or she is incorrect in their allegations. 
  • The American whistleblower statute attracts skilled lawyers who take these cases on a contingent-fee basis, award legal fees and costs to whistleblowers and their counsel, if they prevail in their claims against a defendant.
  • The American statute provides government attorneys with muscular investigative powers. For example, while the case is under seal, the government can issue document requests, written interrogatories, take depositions of key individuals, etc.  These broad investigative tools are lacking in most of the current European statutes.
  • As a result of the key amendments in 1986, the American whistleblower statute has returned more than $62 billion to the U.S. Treasury. No other whistleblower law in Europe (or anywhere) has had such success.

The European legislative bodies still do appear to be committed (culturally or legally) to the type of whistleblowing legislation that will not make a real difference for their respective countries.  Here are some of the reasons why the statutes in Europe shall continue to be as ineffective as the pre-1986 American Whistleblower Law:

  • The European statutes do not truly embrace the concept that whistleblowers need to be encouraged to come forward to expose corruption inside large, well regarded institutions. The majority of the European laws do not contain any financial reward for successful whistleblowers.  Most importantly, none of the European statutes have a strong financial reward that would balance the risks against the rewards.  The European laws seem to go through the motions of supporting, yet not incentivizing, whistleblowers.
  • There is no clear and distinct prosecutorial entity in charge of effectively enforcing the individual European statutes.
  • Many of the European statutes lack strong protections for whistleblowers who come forward and risk their careers and livelihood. While there is a lot of “lip service,” there is no economic insurance that they will be protected.

While Americans and Europeans have shared and adopted approaches to governance over the centuries, their differences in efforts to curtail fraud, waste and abuse through whistleblower statutes is considerable.  Europe need look no further than its young sister state across the Atlantic for lessons that may be worth billions of dollars in recoveries.