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!
All posts by Paola Sangiovanni
U.S. vs Italy Healthcare Fraud Laws
I am happy to announce that the article that Marc Raspanti and Pamela Coyle Brecht of Pietragallo Gordon Alfano Bosick & Raspanti, LLP and I have authored has been published in Compliance Today: https://bit.ly/3Cs9HOI , a publication of the Health Care Compliance Association.
This is Part 1 of a three-part series discussing the similarities and differences between the U.S. and Italian healthcare fraud, waste, and abuse laws.
Keep an eye out for Part 2 and Part 3 of this series that will be published in the December and January issues of Compliance Today.
“Are Patents to Blame for Scarcity of Vaccines?”
Check out our article titled “Are Patents To Blame For Scarcity Of Vaccines?” just published on Mondaq.com.
Spoiler alert: the answer to the question in the title is “no”.
We hope you had a nice summer break and you are ready to face old and new challenges in the fall!
Our Article on Clinical Trial Legislation Is Out
We are happy to announce that our article on “Drug Clinical Trials Legislation in the European Union” has been published on the Indian Journal of Law and Technology (https://www.ijlt.in/).
The purpose of the article is to illustrate the basic tenets of European Union law on clinical trials. Such body of law has been progressively harmonized in the European Union over the years with the aim of subjecting interventional clinical trials conducted in any of the 27 European Union Member States to identical rules.
The article initially describes the reasons why clinical trials are important to measure the safety, efficacy and cost-effectiveness of innovative medical treatment. It then continues by illustrating the scope and basic principles of the current EU Regulation, as well as its main changes over the previous legislation. Further, the article explains the requirements of the scientific and the ethical approvals of a clinical trial application. Lastly, the authors focus
on the patients’ consent to the enrollment in a clinical trial, as well as to the patients’ separate consent to the processing of their personal data
“Excellent”!
Flavio Monfrini and I are very proud to be recognized as “excellent” counsels in the life sciences sector by Leaders League.
That’s what we strive for all day and every day, and it’s great when others notice!
Join us in (modest and distanced) celebrations of this achievement.
New Data Transfer Standard Contractual Clauses Approved by the EU Commission
On June 4, 2021 the EU Commission approved new standard contractual clauses (“SCC“), which are regarded to provide appropriate safeguards within the meaning of Article 46(1) and (2) (c) of the GDPR.
The new SCC are updated with GDPR, the opinions expressed during the course of the consultation phase (including those of the European Data Protection Board and the European Data Protection Supervisor), as well as take into account the recent Schrems II judgement of the Court of Justice.
There are two different sets of SCC: (i) for data transfers from controllers or processors in the EU/EEA (or otherwise subject to the GDPR) and (ii) to controllers or processors established outside the EU/EEA (and not subject to the GDPR).
The new SCC promise “more flexibility for complex processing chains, through a ‘modular approach’ and by offering the possibility for more than two parties to join and use the clauses“.
If you or your company are using the old SCC, you have a transition period of 18 months.
Patents on Covid Vaccines: the Plot Thickens
Last Friday I spoke at an interesting event, dedicated to lessons learned during the pandemic, sponsored by the association Women&Tech.
My plan was to illustrate the international aspects of intellectual property and, in particular, the possibilities afforded by article 31 of the TRIPS agreement to obtain a license to use vaccines’ patents without consent of the patent holder. There had also been a proposal by India and South Africa to waive IP rights on vaccines altogether, but it had been rejected. The discussion seemed largely theoretical.
Only a few hours before the event, the scenario completely changed when the US announced that it was backing the idea of a waiver of IP rights on Covid vaccines’ patents. Reactions by EU leaders were varied, and it is still unclear if the waiver proposal will receive the required three fourths of the votes at the WTO level.
You may find my slides (in Italian) below, but in my view the clearest explanation of the issues at stake is in the position paper by the Max Planck Institute for Innovation and Competition, which can be found here.
Entry into force of EU Regulation on Clinical Trials is Getting Closer
EU Regulations on Clinical Trials number 536/2014 will enter into force 6 months after the publication of a notice by the EU Commission confirming that the clinical trial portal and databases have achieved full functionality in accordance with the required specifications.
Such clinical trial portal and database, where all information submitted through the portal will be stored, supposedly one of the high points of the Regulation, is probably its worst enemy so far. In fact, due to technical difficulties with the development of the IT systems (aka “CTIS”), the portal’s go-live date had to be postponed for years. Therefore, so far, the Directive continues to apply, while some argue that the Regulation – that appeared cutting edge in 2014 – already shows the signs of age.
Now things are finally moving ahead.
On April 21, 2021 the European Medicines Agency’s Extraordinary Management Board confirmed that “CTIS is fully functional and meets the functional specifications, following an independent, successful audit“.
The ball is now in the European Commission’s court: once the Commission confirms the same conclusions on CTIS, a notice will be published in the Official Journal of the European Union. “Six months after this notice, the Regulation will start to apply and CTIS will go live. The aim is that CTIS goes live on 31 January 2022.” says the EMA.
Italian Laws on HCPs & Vaccination
With a law decree decided yesterday, the Italian Government enacted two interesting new rules aimed at health care professionals (“HCPs“):
- Criminal liability of HCPs administering vaccines for the crimes of manslaughter and personal injuries is excluded, provided that the vaccinations follow the indications of the authorization of the specific vaccine and the decisions of the Ministry of Health;
- The obligation of HCPs to be vaccinated is introduced: HCPs refusing to undergo vaccination may be assigned to different duties or her/his remuneration may be suspended. The constitutionality of this obligation has been often discussed, but most scholars believe that – on the basis of the Constitutional Court jurisprudence (especially decision no. 5 of 2018, drafted by Ms. Cartabia, who is now part of the government) – there is no doubt about compliance of this provision with the Italian Constitution. Vaccination is in fact aimed at not only preserving health for the individual who is vaccinated, but also other people’s health, and consequences of vaccination are tolerable.
Hopefully the above provisions will help the vaccination campaign move faster. I certainly cannot wait to roll up my sleeve!
Happy Easter!
EMA Committee Recommends Granting Conditional Marketing Authorization to Covid-19 Vaccine
Today the European Medicines Agency (specifically, its human medicines committee or CHMP) has recommended granting a conditional marketing authorisation to the vaccine developed by BioNTech and Pfizer to prevent COVID-19 in people from 16 years of age.
In the words of the EMA press release, “EMA’s scientific opinion paves the way for the first marketing authorisation of a COVID-19 vaccine in the EU by the European Commission, with all the safeguards, controls and obligations this entails.”
The CHMP has concluded that data on the quality, safety and efficacy of the vaccine are sufficient, given the results of a trial on 44,000 people so far. The process of data collection will in any case continue for at least 2 more years.
It is still unclear who, when and how we will have access to the vaccine, but certainly a vaccine is coming our way. After a 2020 filled with lives lost, fear, confinement and social deprivation, this is absolutely great news. What a few months back seemed wildly optimistic, is now happening.
We want to end 2020 on a high note and wish you relaxing holidays and a new happy, healthy and social year!
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