Due to the COVID-19 emergency and the consequent lockdown that is affecting most non-essential services in Italy, including some healthcare services, the Italian Medicines Agency recently issued guidance for sponsors, non-profit organisations and contract research organisations involved in clinical trials. The guidance tackles urgent needs that sponsors are experiencing in clinical trials due to restrictions on patients' access to trial sites.
Few Italian precedents have considered the plausibility of a second medical use invention as a potential requirement for patent validity. However, a recent decision has clearly stated for the first time and as a matter of principle that the plausibility of an invention does not need the support of experimental data; rather, credible information based on a sound scientific and technical rationale is sufficient.
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.
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.
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.
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?
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.
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.
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.
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.
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 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.
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.
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.
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.