Portolano Cavallo

Life Sciences


Portolano Cavallo Life Sciences Blog
2 Feb
Transparency and responsibility regarding medical-scientific information on the web
On September 28, two international pharmaceutical industry associations, the IFPMA and the EFPIA, published a Joint Note for Guidance on social media and digital channels to guide the work of pharmaceutical companies that use the web to provide doctors and patients with information about their products and the illnesses they are intended to treat.
2 Feb
Register of Observational Studies: AIFA announces activation as of January 31, 2023
In a recent press release published on its website, the AIFA announced that as of January 31 the Register of Observational Studies (“RSO”) will be active and accessible through the AIFA online services portal — as is already the case for interventional pharmacological studies and the related OsSC portal.
2 Feb
The CJEU rules on the legality of a national law prohibiting medicinal product advertising to the general public that uses price to induce consumers to purchase
In the recent judgment of December 22, 2022 in Case C-530/20, the CJEU ruled that European law and in particular Directive 2001/83/EC are compatible with a national law that prohibits advertising even unidentified medicinal products if the advertising message encourages the purchase of the products by leveraging pricing, promotional offers, discounts, and combined sales with other products, medicinal or otherwise (including at discounted prices).
2 Feb
New decrees for the reorganization of ethics committees have been signed: The last fundamental steps for operation of the CTR in Italy
On January 30, the Ministry of Health finally signed four ministerial decrees that mark fundamental turning points in the construction of a regulatory framework for the European Clinical Trials Regulation (“CTR”) to become operations.
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
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Our highly-ranked team of professionals will provide news, insights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and venture capital transactions.

March 20, 2023
Today, Regulation (EU) 2023/607 extending the transitional provisions for the placing on the market and putting into service of certain medical devices and in vitro diagnostic medical device...
January 31, 2023
Clinical trials: Ministry of Health signed off on decrees that (i) reorganize ethics committees and coordinate their activities, (ii) determine the single tariff for the authorization proced...
December 19, 2022
On 13 December 2022, EMA, European Commission and HMA jointly adopted a recommendation paper on the introduction of decentralised elements in the conduct of Clinical Trials in the EU/EEA
September 21, 2022
Payback for medical devices: Decree quantifying the exceeding of the expenditure ceiling for medical devices at national and regional level for the years 2015, 2016, 2017 and 2018 published ...
September 1, 2022
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of p...
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