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
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.
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.