On 14 September 2009, the Decree of the Ministry of Labour, Health and Social Policy of 14 of July 2009 - (“Decree) was published in the Italian Official Journal (“Gazzetta Ufficiale”). The Decree, awaited for over six years, sets out a number of requirements for insurance policies relating to clinical trials to be conducted, wholly or in part in Italy. It also provides for severe sanctions in case of non compliance.
The Decree can essentially be summarised as follows.
Scope of the Decree
The Decree applies to interventional and non-profit clinical trials (“CTs”). Non-interventional (observational) clinical trials are expressly excluded (see article 4 of the Decree).
The certificate of insurance
Sponsors of CTs (“Sponsors”), in addition to the documents already required by law, should submit to the relevant competent ethics committee (“EC”) a specific insurance policy certificate (“Certificate”).
The Certificate, which should be based on the relevant insurance policy, should comply, in particular, with the following requirements: it should be drafted in Italian; signed by the relevant insurance company; include reference to the CT concerned; include the essential elements referred to in the template attached to the Decree (i.e. the maximum coverage, the duration, the franchise (none permitted), exclusions from coverage).
The insurance policy
The insurance policy concluded by Sponsors (hereinafter, the “Insurance Policy”) should comply with the following requirements:
Type of liability
The Insurance Policy should cover civil liability of both Sponsors and investigator for damages to clinical trials subjects (“Subjects”) arising out from CTs.
The Insurance Policy should be in force and effective for the entire duration of the CT. For this purpose, when necessary, it should be renewed by Sponsors, notified and treated by EC as a “non-essential amendment” under legislative decree 211/2003.
Maximum coverage (per Subjectand per Protocol)
The maximum coverage should not be less than EUR 1,000,000 for each Subject and not less than the amounts below for each clinical trial protocol (“Protocol”):
- EUR 5,000,000 for CTs concerning not more than 50 Subjects;
- EUR 7,500,000 for CTs concerning more than 50 but less than 200 Subjects;
- EUR 10,000,000 for CTs concerning more than 20 Subjects.
No franchise is permitted in the Insurance Policy.
Under the Insurance Policy, Subjects should be entitled to claim compensation for damages not later than 24 months from the termination of the CT and for which formal requests have been submitted not later than 36 months from the termination of the CT.
A CT should be considered terminated at the time of the last medical/surgical/diagnostic/therapeutic visit being performed in compliance with the Protocol, on the last Subject enrolled .
Extension of the terms above is possible in case of a CT potentially causing damage which may appear only after longer periods (see article 1, par. 4 of the Decree). A minimum of 10 years coverage should apply in cases of CTs concerning minors and/or gene and cell therapies and radiopharmaceuticals (see article 1, par. 4 and 5).
Type of damages
The Insurance Policy should cover physical damage such as death, health and bodily injury (permanent and transient) as well as direct economic loss (i.e. which are the direct and immediate consequence of the participation of the Subject to the CT).
Claims for unintentional damages caused accidentally and/or due to negligence, recklessness, unskilfulness, should not be excluded by the Insurance Policy provided that the relevant claims comply with the terms highlighted above.
The Decree also imposes upon the investigator the obligation to clearly inform Subjects (e.g. via informed consent) of the insurance coverage and the conditions applicable for claiming damages under the Insurance Policy. Subjects should also be made aware that beyond the applicable terms the Insurance Policy will be unenforceable.
The Decree introduces important and severe sanctions in case of non compliance such as the prohibition on using the results of the CT for applying for a marketing authorisation for a medicinal product. Any positive EC opinions/competent authority decisions on the CT should also be considered void.
The Decree, whilst introducing minimum common requirements for Insurance Policies for CTs, also raises some interpretation issues:
- It remains unclear which CTs should actually benefit from the extension for claiming damages under the Insurance Policy provided by article 1, par. 4, cited above, who should identify them and which criteria they should be based upon. In a country like Italy, where there are currently 269 ECs, a harmonised interpretation seems to be needed.
- Maximum coverage of the Insurance Policy risks being considerably undermined by circumstances such as the level of damages occurred during a
- Finally, it is also unclear whether and to what extent the compulsory reference to the relevant and specific CT in the Certificate will have an impact on existing practice. It should be noted that insurance policies covering risks arising from clinical trials in general, therefore non-Protocol specific, could no longer be considered in line with Italian legislation and no longer accepted by an EC.
Entry into force
The Decree will enter into force on 13 March 2010 and it will apply to applications submitted to ECs from this date (see article 6 of the Decree).