Italy updates

Healthcare & Life Sciences

Contributed by Hogan Lovells
AIFA guidance on management of clinical trials during COVID-19 emergency
  • Italy
  • 25 March 2020

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.

Milan court sets precedent on second medical use invention plausibility
  • Italy
  • 16 October 2019

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.

Legislative decree opens way to commercial use of data obtained by non-profit clinical trials
  • 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
  • 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
  • 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.


Product Regulation & Liability

Mobile phones may cause brain tumours: Turin Court of Appeals revives debate
  • Italy
  • 13 February 2020

After a two-year dispute, the Turin Court of Appeals has dismissed the appeal filed by the National Insurance Provider (INAIL) and upheld the first-instance decision issued by the Court of Ivrea in 2017, which established causation between extensive work-related use of mobile phones and brain tumours and ordered INAIL to compensate the claimant with a lifelong payment.

Hemp food – Ministry of Health sets acceptable levels of THC
Hogan Lovells
  • Italy
  • 06 February 2020

The Ministry of Health recently published the THC Decree, which sets the maximum tetrahydrocannabinol content permitted in food products, together with guidance on the appropriate method of analysis. Some commentators have welcomed the new regulation as a liberalisation of the use of hemp in food products; however, on closer inspection, this conclusion proves to be unjustified.

Regulation of cannabis use in food and cosmetics
Hogan Lovells
  • Italy
  • 15 August 2019

The cultivation and industrial use of hemp in Italy has a long tradition and recent changes to the law have led to a revival in this regard. While a law enacted in 2016 promotes hemp cultivation as a means to preserve biodiversity and reduce the environmental impact of agriculture, hemp-derived products for human consumption are still subject to restrictions. A recent Supreme Court judgment has had the last word on the legality of cannabis.


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