Recent developments in Italy in response to the COVID-19 public health crisis: The Cura Italia Decree provides for public funds to support increased production of medical devices and personal protective equipment (PPE) and designates authority for clinical trial regulations and off-label use of drugs. More public funding to support medical device production and provide liquidity to life sciences companies is expected. Additionally, a consortium of Italian authorities and the World Health Organization are reaching out to industry and academic researchers to find the best available digital solutions and technologies for telemedicine, home care applications, and active monitoring of the risk of contagion.
Financial support scheme for the production and supply of PPE
Article 5 of the Cura Italia Decree proposed a € 50 million support scheme for the production and supply of medical devices and personal protective equipment (PPE) during the COVID-19 emergency period. In principle a form of state aid forbidden under art. 107(1) of the Treaty on the Functioning of the European Union (TFEU), the scheme was authorized after the European Commission adopted a Temporary Framework Agreement pursuant to art. 107(3)(b) of the TFEU on 19 March and, subsequently, expressly authorized the Italian Government’s proposal on 22 March. Under the scheme, financial support – in the form of direct grants or repayable advances – will be available to Italian companies wishing to expand or convert their production line for manufacturing medical devices and PPE. The support scheme is managed by the National Agency for Inward Investment and Economic Development (Invitalia) and applications for financial support can be made online to Invitalia.
The life sciences sector has been identified both by the European Commission and the Italian Government as one of the sectors most impacted by the Covid-19 crisis. More state aid schemes are expected in this space both to (i) support companies in the production of products needed to face the public health emergency, and (ii) provide liquidity to life science companies.
See more details on state aid here.
Authored by Sabrina Borocci
Update on off-label use of drugs to fight COVID-19
As provided by art. 17 of the Cura Italia Decree, the Italian Medicines Agency (AIFA) has been entrusted with the evaluation of clinical trials of drugs to be used in the treatment of COVID-19. AIFA has adopted a simplified procedure for clinical trials and continuously updates the information on their status.
AIFA also provides daily updates on the off-label use of drugs outside clinical trials in the treatment of COVID-19 patients. The agency has already provided information on the off-label use, among others, of the following drugs:
- Chloroquine and hydroxychloroquine;
- Umifenovir;
- Lopinavir/Ritonavir and, alternatively to the latter, Darunavir in combination with Cobicistat or Ritonavir;
- IF-β 1a.
In a 24 March 2020 communication, AIFA clarified that – to date – there are no reasons to exclude the combined use of Lopinavir and Ritonavir for the treatment of COVID-19 patients from reimbursement (i.e., the Italian National Health System continues to pay for treatment with these drugs), even though it acknowledges that a randomized clinical trial on COVID-19 patients showed no evidence that the use of such combination of drugs would help in the treatment of COVID-19 patients. This decision is based on the fact that the clinical trial does show a clear favorable trend with respect to death rates and a reduction of time spent in an Intensive Care Unit. Moreover, AIFA points out that the trial was carried out on patients in very serious condition, whereas the protocols and the Guidelines applicable in Italy provide for its use when patients are not so seriously affected by COVID-19.
In the 24 March communication, AIFA also withdrew IF-β 1a from the list of drugs reimbursed by the Italian National Health System as set forth by Law 648/1996, due to problems of incompatibility of the available formula with the proposed use.
Authored by Christian Di Mauro
Fast call – telemedicine and data analysis
The Italian Minister for Technological Innovation and Digitalization, the Italian Ministry of Health, the Italian Higher Institute for Health, the World Health Organization and an Interdisciplinary Scientific Committee jointly launched a three-day call (from 24 March 2020 to 26 March 2020) to business and research entities for technology to better monitor and assess the spread of COVID-19.
The new initiative (Innova per l’Italia) is aimed at finding the best available digital solutions and technologies for telemedicine, home care applications, and active monitoring of the risk of contagion. In particular:
- Apps and technical solutions for remote assistance of patients at home both for COVID-19 related diseases and for other pathologies of chronic nature, such as mobile phone apps and chatbots for health conditions self-monitoring and psychological support;
- Technologies for continuous tracking, alerting, and timely control of people’s exposure to the virus, and, simultaneously, of the epidemic itself. This area includes data analysis tools, hardware and software for health emergency management.
The deadline for submitting proposals (through a form available on the website of the Minister for Technological Innovation and Digitalization) has passed but the promoters of the Innova per l’Italia initiative have announced that more calls to action will follow.
If you think you have a solution that can make a difference, visit the Innova per l’Italia site and stay tuned.
Authored by Christian Di Mauro
[View source.]
