Tag Archives: italy

Five Key Takeaways from Our Seminar on Clinical Trials

If you missed our seminar on clinical trials on January 16, here are five key takeaways to help you understand the changing regulatory environment in Europe and Italy.

  1. Be ready for a new regulatory landscape

The recent clinical trials regulatory overhaul within the EU aims at fostering research and facilitating the tasks of all actors involved in this area. However, delays in the implementation of such new legislation are posing an actual risk for the entire sector throughout the EU, while competition from emerging economies is getting stronger.

  1. Harmonized, but not enough

In several areas, such as observational studies or ethical committee’s assessments, a unified approach at European level is yet to be adopted. This leaves a lot of fragmentation among the various countries and a lot of work to be done at local level in order to ensure compliance with applicable regulations. Be prepared to deal with such inconveniences, in particular in the pharmaceutical sector.

  1. Changes in data protection laws offer new opportunities but challenges remain

GDPR brought new harmonized provisions to improve and support the use of data for the purpose of conducting research. However, guidance from national data protection and regulatory authorities in areas such as legal grounds for processing and secondary use is far from established. Moreover, different EU countries continue to adopt opposite approaches when it comes to consent and legitimate interest as valid legal grounds for data processing in the framework of clinical research. Data protection compliance will therefore continue to require local check-ups.

  1. New opportunities for independent research

Recent regulatory changes in Italy are being implemented to foster independent not-for-profit research in the clinical area. The new regulations, which are about to be adopted, envisage new opportunities for the participation of private actors in independent research and allow not-for-profit research institutions to better exploit the results of their research. The potential for conflicts remain and caution should be exercised within public-private relationships, but there is hope that new paradigms of collaboration will see the light.

  1. A new world of evidence is out there

More and more projects in the clinical research field involve real world data and real world evidence, gathered in a number of different ways outside the rigid protocols of a controlled study, whether through medical devices or other data collection instruments. Real world data are key to understanding how treatments work in reality and developing new healthcare paths. However, both clinicians and private actors are operating in uncharted territories and the line between studies and alternative research projects is thinner than you may expect. Be mindful of the regulatory and compliance ramifications of these new powerful tools.

Update: Italian Senate Steps Back on Light Cannabis

Optimism after last week’s news did not last very long.  The Italian Senate just approved its version of the Italian Budget Law for 2020 (still subject to the Italian House of Representatives’ vote) striking out the amendment clarifying that products with THC contents under 0.5% should not be considered as having a doping or psychotropic effect.

This quick turnaround was likely due to the highly political nature of the debate surrounding the whole industry, which may have influenced the Senate’s final decision on light cannabis business and, on a very different field, may as well still impact on the slow progress of the increase of the Italian production of therapeutic cannabis.

 

New Bill May Bring More Clarity for “Light Cannabis” Business

Italy has an uncertain scenario set forth for light cannabis (i.e. with THC levels below 0.2%) shops and businesses, after a recent decision of the Italian Supreme Court, last July.

The decision took a rather strict approach, specifying that, under current legislation (and especially, under Law 242/2016), only certain specific types of products may be considered legal, i.e.:

– food and cosmetics;

– certain semi-finished products, such as fiber (“fibra”), shives (“canapulo”), powders (“polveri”), wood chips (“cippato”), oils (“olii”) or fuels (“carburanti”), for supplies to businesses and artisanal businesses of different fields, including energy;

– material intended for the practice of green manure (“sovescio”);

– organic material intended for bioengineering works or products for bio-building;

– material intended for the phytoremediation to reclaim polluted sites;

– cultivations dedicated to educational and demonstration activities, as well as research carried out by public or private institutions;

– crops used for nursery gardening (“florovivaismo”).

Whatever falls outside the items listed above, even if the content of THC is below 0.2%, may be treated as an illegal drug with all relevant implications, especially under Italian criminal law – unless such products are proven to have no doping or psychotropic effect whatsoever.

It is not difficult to imagine the negative impact of such approach on business operators in Italy, which caused many of them to close, interrupt or suspend their activity, right after having experienced a quite impressive boom, leading to an estimated yearly turnover in 2018 of euro 150 million.

Just yesterday, nevertheless, the Budget Commission of the Italian Senate approved an amendment of the draft Budget Law for 2020 that, according to Senator Matteo Mantero, would clarify in express terms that products with a THC content under 0.5% cannot be considered as having a doping or psychotropic effect and, therefore, should be considered as legal. Of course, this measure will be linked to a specific taxation of all cannabinoid products (0.4 euro per gram of finished product), which is expected to bring benefits to Italy’s budget for 2020.

The specific amendment and the entire draft of the Budget Law for 2020 is still undergoing its approval process. We will keep an eye on it. Stay tuned for updates.

WHO Pushes towards Transparency of Prices of Health Products

Yesterday the World Health Organization announced a resolution encouraging Member States to “enhance public sharing of information on actual prices paid by governments and other buyers for health products, and greater transparency on pharmaceutical patents, clinical trial results and other determinants of pricing along the value chain from laboratory to patient.” The resolution also urged Member States to “work collaboratively to improve the reporting of information by suppliers on registered health products, such as reports on sales revenues, prices, units sold, marketing costs, and subsidies and incentives”.

The Italian Ministry of Health reported the adoption of this resolution with triumphant tones since the resolution was proposed by Italy and co-sponsored by Algeria, Andorra, Botswana, Brazil, Egypt, Eswatini, Greece, India, Indonesia, Kenya, Luxembourg, Malesia, Malta, Portugal, Russian Federation, Serbia, Slovenia, South Africa, Spain, Sri Lanka, Uganda and Uruguay.

Many hope that transparency of prices of health products will result in greater fairness in health systems and will ultimately drive prices down. On the other hand, representatives of the industry claim that the focus on price will not shed light on the complexities of costs linked to research and manufacturing of health products. Instead, Gaelle Krikorian of Medecins Sans Frontieres believes that the resolution marks only a first step and that more disclosure is necessary.

Therapeutic cannabis in Italy: business opportunities

Italy’s only authorized medical cannabis facility is currently controlled by the military. However, the production site, located in the Florence area, cannot keep up with the increasing demand, creating shortages for patients and barriers to its prescription by physicians (whose patients are unlikely to be able to obtain the quantities needed).

As Colonel Modica of the Italian Military recognizedThe health ministry and the defense ministry are trying to fix the shortfall because there’s been a huge increase in cannabis prescriptions and the number of patients who need them”.

Meanwhile, pressed by the patients’ associations, the Italian Health Care Ministry Giulia Grillo announced not only the increase of import of therapeutic cannabis products from the Netherlands (to cover the short-term shortages), but also the start of a longer-term project, eventually leading to the creation of a public-private partnership for the production of cannabis. “An invitation to present expressions of interest will be published in order to increase the production of therapeutic cannabis“, Ministry said. Although underlining that an appropriate time frame will be needed in order to implement the project, the Ministry confirmed that the cannabis production activity is “of great interest for both the Defense and the Public Health Care” and crucial in order to satisfy the increasing needs of both domestic and foreign markets.

The increase in the domestic production of therapeutic cannabis, along with the overall demand for it, appears to be inevitable.

On the other hand, the boom of “light cannabis” products in Italy (i.e., containing THC in a percentage lower than 0.2 and, therefore, expressly declared legal in Italy starting from January 2017) seems to have encountered some obstacles lately.

The Advisory Board of the Italian Health Care Ministry (Consiglio Superiore di Sanità) issued a report last spring, recommending the adoption of measures aimed at prohibiting the sale of light cannabis products.

In addition to that, an internal note of the Ministry of Home Affairs, recently made public, promoted a zero-tolerance approach and a strict application of the relevant laws and regulations. Such steps have caused great uncertainty and concerns amongst those who have invested in what came to the media’s attention in 2017 as a State-backed business.

Hence, the latest developments relating to therapeutic cannabis in Italy indicate that new business opportunities for both exporters and producers of cannabis-based prescriptions are likely to be offered in the Italian market. Conversely, serious questions can be raised in connection to the light-cannabis boom, in view of the inconsistent approach recently taken by Italian authorities.

Tax Crimes Will Trigger Criminal Liability of Corporate Entities

As a result of the so called “PIF Directive”, starting from July 2019 criminal corporate liability under Italian law 231 may be triggered by tax crimes, too.

(If you are not overly familiar with the principles of Italian 231 legislation on criminal liability of corporate entities, perhaps you may start here.)

Under Italian 231 law, corporations are subject to criminal (rather, quasi-criminal) liability when certain specific crimes are committed in their interest or to their advantage. So far, such crimes have never included tax crimes, although the issue had been widely debated and several court decisions had attempted to combine other types of crimes with tax crimes (the Supreme Court had always disagreed, though).

Now, the PIF Directive, which Member States must implement by July 6, 2019, “establishes minimum rules concerning the definition of criminal offences and sanctions with regard to combatting fraud and other illegal activities affecting the Union’s financial interests, with a view to strengthening protection against criminal offences which affect those financial interests.” Liability of legal entities must be foreseen by national legislation and serious offenses against the common VAT system must be punished.

The Italian legislator will thus need to introduce such serious VAT crimes (i.e., having a value in excess of 10 million euros) in the list of crimes triggering corporate liability. This, in fact, may open the door to other tax crimes as a basis of 231 liability of corporate entities.

Who’s Who Legal 2018: Our Life Sciences Practice in the Top Three!

Who’s Who Legal just published its 2018 rankings, highlighting the leading practitioners recognized “for their excellent work across the full spectrum of life sciences law”.

Our very own Paola Sangiovanni has been recognized among the top three most highly regarded practitioners in the life sciences legal industry in Italy. Here’s what Who’s Who Legal says about Paola:

«The “fantastic” Paola Sangiovanni at Gitti and Partners is “a truly dedicated life sciences expert”, who is considered “a great deal-maker”. Her transactional expertise in the life sciences space is in high demand, thanks to her “client-focused approach and excellent service”».

We are very proud to share such a terrific achievement with our clients and friends, and we would like to thank you all for your continued support!

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.

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.

Continuing Medical Education: New Rules under Italian Law (and How to Comply with Them)

A new regulation has been enacted in Italy, overhauling continuing medical education regulations. The new provisions will not only have an impact on healthcare professionals, who are subject to educational requirements, but also on pharmaceutical companies and medical devices manufacturers supporting educational events and congresses, as well as on third party providers and organizers. The new regulation has been adopted following consensus among regional authorities and the Ministry of Health on February 2, 2017.

The national commission for continuing medical education is entrusted with the task of determining the requirements and quality levels of educational events, as well as the minimum educational goals applicable nation-wide. The commission shall also adopt a manual for the certification of event organizers (so called CME providers). Regional authorities, on the other hand, must ensure a proper and adequate planning for medical education within their territories.

Furthermore, each professional shall develop and comply with an individualized educational plan (so called “dossier”), in order to ensure a coherent and complete education. Educational events attended abroad may also be recognized for purposes of medical education, in accordance with the criteria that will be established by the national commission.

As far as industry operators are concerned, the new regulation reiterates and strengthens the requirements of transparency and independence of educational providers from pharmaceutical/medical device companies. In particular:

  • CME providers must disclose any relationship between speakers/moderators and any private entity active in the healthcare industry;
  • CME providers must not have any direct or indirect interest in any pharmaceutical/medical device businesses or engage in any relationship with such businesses, other than the sponsorship pursuant to CME regulations;
  • CME providers must not organize any promotional events on specific products; a full segregation of activities between educational CME providers and other event organizers is therefore established;
  • The regulation further expands on the definition of conflict of interests and aims at better regulating all relationships and interests between the industry and educational providers;
  • More stringent provisions concerning advertisement and promotion during educational CME events are introduced, including restrictions for employees of the sponsor to attend educational classes and seminars.

While several provisions of the new regulation directly target CME providers, the industry should also be prepared to the new regulatory framework. Here is a list of what private operators should immediately think of:

  • Train your staff on the new regulations (both at your headquarters and on the field);
  • Check if internal company procedures needs to be updated;
  • Check if internal sponsorship documentation (including contracts) needs to be updated;
  • Review ECM providers with whom you usually work to ensure they comply with the new requirements and avoid conflicts of interests.