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.

Only 1 Week until Go Live of EU-Wide Clinical Trials Information System

Remember the Clinical Trials Regulation? Much time has passed since its publication in 2014. No worries if your memory fails you: we have discussed the Clinical Trial Regulation at length in this article appeared on the Indian Law Journal of Law and Technology. If you prefer a shorter summary, you may read here what the European Medicines Agency has prepared for you.

The actual entry into force of the Clinical Trials Regulation depended on confirmation of full functionality of the Clinical Trials Information System (CTIS) through an independent audit, which occurred on April 21, 2021. Now, the go-live date for the CTIS will be on January 31, 2022. Information on the go live planning can be found here.

The Clinical Trials Regulation was born to address the prior directive’s shortcomings, and particularly to target the goals of harmonization and simplification in this field, also with a view of making Europe a competitive region in the global clinical trials market. Good luck to the CTIS: we hope the Clinical Trials Regulation keeps its promises!

Much HEALTH and happy holidays to you all!

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.

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.

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/).

You may read it here or here.

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

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 promisemore 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.