As the second year of the pandemic draws to a close, it is easy to find reasons to complain: they sometimes come conveniently arranged in alphabetical order (Delta, Omicron…)!
But we also want to remember the many things we are grateful for: vaccines, for example, but especially your friendship and support in 2021.
May 2022 be a good year to you and your loved ones. May you face 2022 armed with hope, courage, empathy, resilience and joy.
The Gitti and Partners life sciences team.
I am happy to have been recognized in Who’s Who Legal Life Sciences in the TRANSACTIONAL and REGULATORY categories for 2021.
Thanks to clients and colleagues who make this possible!
Under Italian law a document saved through blockchain technologies can have legal effects.
According to Law Decree 135/2018 (“Decreto Semplificazioni”), which was recently confirmed into law by Law 12/2019, technologies based on distribuited records can have the same legal effects as electronic time stamps under section 41 of EU Regulation 910/2014. Such effects will be obtained if certain technical standards are met and the regulatory body Agenzia per l’Italia Digitale is entrusted with the task of setting forth such standards within 90 days.
Technologies based on distributed records are defined as “technologies and information protocols that use a shared register that is distributed, replicable, simultaneously accessible, architectural decentralized on cryptographic basis, such as to allow the recording, validation, updating and archiving of data both in accessible format and further protected by cryptography verified by each member, not alterable and not modifiable”. The scope of the definition is wide and intends to include blockchain technologies, which can be varied.
Similarly, technologies based on distributed records will also allow so called “smart contracts” to have legal effects. Smart contracts will be presumed to have legal effects when the contractual parties have been previously identified on the basis of technologies based on distributed records. Again, details will be up to the Agenzia per l’Italia Digitale.
Italy’s effort to pioneer the embrace of new technologies in the legal field is commendable, but there is a risk that standards set forth by the Agenzia will not be the same as other national or international standards that may be emerging in the near future.
Do you have a “Sunshine Act” in your jurisdiction? Any other piece of legislation that mandates that all interactions between the industry and health care professionals are made public?
Italy is about to enact one. You may find the proposed bill here.
In our seminar, which will be held on January 31 at 5 p.m. at our offices in via Dante 9, Milano (the full program can be found here) we will discuss how transparency and ethics interact. We will also ask ourselves how the behaviour of doctors, patients and life sciences’ companies may change following the introduction of the Sunshine Act, which promises disclosure of any exchange of value over €10. We will also ponder upon the use of the data rendered public by the media (see an interesting point of view here).
The topic of conflicts of interest seems especially “hot” these days, since Advamed just revised its code of ethics on interactions with US healthcare professionals and stories about conflicts of interest between doctors and industry continue to be in the media.
We look forward to this interesting opportunity of dialogue on a crucial aspect of healthcare.
Paola Sangiovanni will be speaking at the Paperless Lab Academy event (http://www.paperlesslabacademy.com/) on March 20, 2018 in Baveno (NO), Italy, on the topic of the impact of the new GDPR for science.
Sofie van der Meulen, Senior Supervision Officer at Dutch Data Protection Authority, will offer a special introduction titled “Why Privacy Matters”.
This promises to be an interesting event. See you there!
On February 8, 2017 Paola Sangiovanni will be speaking at this webinar organized by FAST on the new EU Regulation on medical devices:
http://www.fast.mi.it/webinar_fast.htm
If you are interested in learning about this topic, consider registering here:
http://iscrizioni.fast.mi.it/eventi-a-pagamento/Regolamento%20europeo%20sui%20dispositivi%20medici
See you there!
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
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:
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:
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.
By rejecting an appeal from Novartis, the Italian Administrative Supreme Court, with its decision n. 1306 of April 1st, 2016, focused on the notion of therapeutic equivalence under Italian law. Having underlined the difference with the concept of bioequivalence and having broadened its possible future application, the decision is likely to push forward the trend of public health care institutions to increase competition between pharmaceutical companies in the context of public tender offers, possibly for the benefit of taxpayers and patients.
The controversy arose from an opinion issued by the Italian Medicines Agency (“AIFA”) which, in a tender procedure held by Tuscany region, evaluated the drug Lucentis by Novartis (active ingredient ranibizumab) as a therapeutic equivalent to Eylea by Bayer (active ingredient aflibercept). This allowed the regional public administration to have the said drugs compete against each other in the same tender offer.
Debates as to whether Lucentis and Eylea are equivalent in terms of functions are not indeed new in the pharmaceutical scene and have caused many headaches to Novartis, let alone the critical issues raised in relation to Lucentis by the Italian Antitrust Authority. Not a surprise, then, that Novartis tried to defend its product, alleging the illegitimacy and erroneousness of AIFA’s evaluation, which stated that the cheaper option by Bayer (Euro 780) is equally safe and effective in the treatment of macular degeneration as it is its more expansive (Euro 902) drug.
Novartis, nevertheless, failed in its claims. The Italian Administrative Supreme Court confirmed the validity and correctness of AIFA’s evaluation, together with the decision of the lower court, affirming, inter alia, that:
Therapeutic equivalence, as it has recently emerged from Italian legislation and case law (in particular, from the decision discussed herein), is seen as a threat by pharmaceutical companies, unnerved by the increased competition effects.
Indeed, the debate has been escalated to a more general level by the Italian association of pharmaceutical companies, which challenged in many ways AIFA’s guidelines on therapeutic equivalence. As a consequence, a few days ago AIFA precautionary suspended for ninety days the said guidelines.
It looks like the match has just begun. Nevertheless, pharmaceutical companies should consider carefully on which side they should play. In fact, the expansion of the application of therapeutic equivalence, as a general trend, does not seem to be stoppable in a constant spending review context. Perhaps pharmaceutical companies should positively contribute to shape, rather than to stop, therapeutic equivalence and exploit its potential for the business in terms of new opportunities to access tender offer procedures.
This post features an interview with Diana Saraceni, founder and managing partner of PANAKÈS PARTNERS , a venture capital investor that finances medical companies, early stage startup and SMEs in Europe and Israel.
Why does Panakés Partners focus on Med-Tech?
Life sciences, especially Med-Tech, have always been an innovative and growing sector. Improving health conditions is one of the goal of developed countries, and new challenges will always face us. Considering this highly changing environment, start-ups and small companies appears to have the best structure to generate innovative solutions. In Europe there are several areas of excellence in technology and chemistry, the ideal environment where promising Med-Tech start-ups can develop. Moreover, European regulatory system has faster and easier protocols for companies to get CE mark and go to market, especially compared to the American system, where FDA approval requires more efforts, both in economic and clinical terms, to enter the market. Lastly, if we consider that western countries invest, on average, 10% of GDP every year on health services and that medical and pharmaceutical enterprises are the most active in acquiring start-ups, the great opportunity Med-Tech represent for us becomes evident.
What are the specific areas where you expect more growth in the future?
Considering the ageing of population and the need of hospitals to optimize their resources and reduce costs, we expect a great demand for technologies designed for home healthcare and chronic pathologies management. These new solutions will allow patients to receive their treatment directly at their own home, letting hospitals to focus their resources on acute pathologies treatment. Furthermore, we are confident that there will be a significant growth in all technologies aimed to a minimally invasive medicine. We are talking about in vitro diagnostics systems or robot-assisted surgery, which will substitute, or at least reduce, tissue biopsies and traditional surgery. Lastly, we expect a great increase in solutions for personalized therapies. These technologies, which combine genetic profiling to Big Data algorithms, will help physicians in the definition of therapies specifically tailored for every patients, increasing the probability of success.
Which countries appears to have the best factors (in terms of legislation, culture, access to funding and applied research) that helps fostering innovation?
By tradition, Anglo-Saxons countries are the ones with a more innovation-oriented policy. Everyone who has interesting ideas is encouraged in developing them, entrepreneurs never stop to look for new opportunities and skip from one project to another, as if they have not realized anything yet, legislation offers benefits to support the creation of new companies. These are the reasons why realities such as incubators and venture capital funds were born and are widespread in these countries. Regarding the specific case of Italy, we can state that the presence of top-class engineers and the excellence of Italy in clinical research in several areas, combined with lower costs than the other developed countries, are the main factors for the success of many Italian start-ups.
Which challenges lay ahead of you?
We received hundreds of requests of funding from companies all over Europe. Now, our main challenge will be to select the most promising ones, both in terms of proposed technology and feasibility of the project. Furthermore, we need to enlarge our network, in order to reach more companies and to find those ones whith the potentiality to change the status of medicine and build up more success stories out of Europe. We like to think of Panakés as a highly entrepreneurial start-up from a certain point of view, with great opportunities and successes just waiting for us!
Law, Health & Technology 
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