Latest updates

Legislative decree opens way to commercial use of data obtained by non-profit clinical trials
Hogan Lovells
  • Italy
  • 05 June 2019

The government recently approved a legislative decree on clinical trials that introduces changes to several provisions of the existing national regulation on clinical trials. At present, clinical data obtained in Italy from non-profit clinical trials cannot be used for commercial purposes. Moreover, pharmaceutical companies funding non-profit research cannot claim ownership of data and results obtained from such research, irrespective of any agreement with the non-profit entity. This may now change.

Health risks arising from mobile phone misuse: government ordered to launch information campaign
Hogan Lovells
  • Italy
  • 01 May 2019

The Lazio Regional Administrative Court recently ordered a number of ministries, including the Ministry of Health, to launch an information campaign to advise the public about the potential risks arising from the misuse of mobile and cordless phones. The decision received considerable media coverage and will most likely renew the debate about electromagnetic pollution and mobile phones.

Towards the adoption of national templates for CTAs
Hogan Lovells
  • Italy
  • 10 April 2019

The Italian Medicines Agency recently opened a public consultation on national templates for medicinal products and medical devices to be used in clinical trials carried out in Italy. The public consultation will hopefully help to clarify whether such templates should be considered mandatory and to what extent they may be replaced by sponsors' templates or be subject to negotiation and amendments.

New medical device regulations: what liability do notified bodies face?
Hogan Lovells
  • Italy
  • 13 February 2019

Under the EU Medical Device Regulation and the EU In Vitro Diagnostic Medical Device Regulation, organisations that want be recognised as notified bodies must obtain a new designation. According to Assobiomedica (the association of medical device suppliers), the number of notified bodies in Italy that have applied for said designation is low. This has led to questions around what will happen if notified bodies fail to obtain the new designation and what liability they will face regarding manufacturers and patients?

Parallel import of medicinal products – when a name change is a game changer
Hogan Lovells
  • Italy
  • 10 October 2018

The Lazio Administrative Court recently decided that, as a rule, parallel importers of medicinal products have no right to change the trademark affixed to products in their country of origin unless this change is strictly necessary due to safety grounds or national regulatory restrictions. The court found that the right to undertake the parallel import of medicinal products should not unduly take advantage of the national reputation and trust built by the marketing authorisation holder in the products' state of origin.

AGCM takes action against online sellers of dietary supplements
Hogan Lovells
  • Italy
  • 25 July 2018

The Italian Competition Authority (AGCM) recently launched an investigation into the online sale of dietary supplements in Italy based on claims of non-compliance with the relevant regulatory provisions, resulting in misleading actions. The AGCM's role in this context is to ensure that consumers obtain accurate information concerning dietary supplements so that they can make informed decisions concerning these products.

Supreme Court upholds first class action relating to medical devices
Hogan Lovells
  • Italy
  • 16 May 2018

After seven years, the Supreme Court finally ended the first product-related class action promoted in Italy relating to a medical device. The decision is noteworthy, despite the small sum awarded, because very few class actions have been declared admissible to date and even fewer cases have been upheld on the merits due to strict admissibility requirements.

New legislation surrounding medical malpractice
  • Italy
  • 21 February 2018

In addition to setting out the legal scope for the safety of medical treatments and patients, Law 24/2017 provides the scope for imposing an effective risk management policy on healthcare personnel and prescribes risk allocation standards in the case of damages arising from medical treatments. It also provides for situations of impunity when these events occur despite the guidelines being followed.

New healthcare risk law enacted
DLA Piper
  • Italy
  • 05 April 2017

Law 24/2017 on the management of healthcare risks and the liability of healthcare professionals was recently approved. The law focuses on the requirement that public and private hospitals establish structural, technological and organisational resources and implement risk management and internal audit functions that are typical of other regulated industries, such as banking and insurance.

E-health closer to reality with electronic health privacy rules
  • Italy
  • 13 August 2014

E-health is closer to becoming a reality in Italy with the Data Protection Authority's approval of a decree which sets out the requirements for electronic health records systems. The decree categorises electronic health records according to the reason for processing the collected data and establishes strict requirements regarding the information to be provided to patients and necessary consent and security measures.

Top five takeaways on telemedicine and e-health
  • Italy
  • 25 June 2014

The European Telecommunications Standards Institute recently held the E-health Workshop on Telemedicine. Telemedicine and e-health raise a variety of legal issues – for example, the reimbursement of telemedicine services, which was covered in the recent Italian guidelines on telemedicine.

Remote patient monitoring systems: potential regulatory hurdles
  • Italy
  • 12 March 2014

Medical devices and new technologies are becoming more closely connected in order to allow practitioners to monitor patients' health conditions continuously. These new technologies trigger privacy obligations because of the large amount of sensitive data on patients' health conditions that is collected, in addition to the obligations of the applicable medical device regulations.

Access to clinical trial data: the Italian perspective
  • Italy
  • 18 December 2013

There is an increasing trend towards full publication of data resulting from clinical trials sponsored by the Italian pharmaceutical industry. However, the industry has also highlighted the importance of protecting confidential and commercially sensitive information. The policy of the Italian Pharmaceutical Authority on this matter mirrors that of the European Medicines Agency.

Chiara Cimarelli
DLA Piper
  • Rome
  • Italy
Roberto Valenti
DLA Piper
  • Milan
  • Italy
Giulio Coraggio
DLA Piper
  • Milan
  • Italy
Francesca Rolla
Hogan Lovells
  • Milan
  • Italy
Marco Dimola
DLA Piper
  • Milan
  • Italy
David Maria Marino
DLA Piper
  • Milan
  • Italy
Vito Bisceglie
DLA Piper
  • Rome
  • Italy