On 8 May 2019 the Italian government approved a legislative decree on clinical trials that introduces changes to several provisions of the existing national regulation on clinical trials (the Amending Act). The Amending Act will come into force 15 days as of its publication in the Official Journal.
Some of the changes will harmonise domestic legislation with the EU Regulation on Clinical Trials on Medicinal Products for Human Use (536/2014). Other amendments aim to improve specific aspects of the regulation (eg, the introduction of new provisions to allow the use of biologic materials from diagnostic or therapeutic activities in clinical research and the promotion of gender-specific medicine and paediatric trials). One of the most interesting changes concerns the regulation of non-profit clinical trials. This article focuses on the new provisions regarding non-profit 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 Amending Act stipulates that data and results obtained from non-profit clinical trials, including low-intervention clinical trials, may be assigned to third parties for authorisation purposes, provided that either the sponsor or the assignee refunds and reimburses any direct or indirect associated costs. The consideration paid in exchange for the ownership of the data and results will cover the costs of the clinical trial, including the reimbursement of any tax facilitation that the sponsor may have enjoyed as a consequence of the trial's non-profit initial qualification. In addition, when the price is calculated, due account will be taken of the royalty and revenues that the data and results may generate if they become subject of IP rights.
The Ministry of Health is expected to issue implementing regulation via a ministerial decree by 31 October 2019. The ministerial decree will introduce measures to promote and support non-profit clinical trials, including observational studies. Such measures should help to facilitate cooperation between sponsors in the public and private sectors with a view to acquiring post-authorisation clinical evidence.
In particular, the ministerial decree will specify:
- the criteria for non-profit clinical trials;
- the requirements that must be met;
- the conditions for the cooperation between the public and private sector; and
- the requirements for the transfer of data and its use for authorisation purposes.
The acknowledgement that data obtained from non-profit trials may be purchased and used for registration purposes is certainly good news. This is a sensible approach to avoid the unnecessary duplication of trials for commercial purposes if robust and reliable evidence has already been generated in a non-profit trial. The Amending Act also contains useful clarification regarding the price that must be paid, including the recovery of any tax discount or other facilitation. The ministerial decree (expected by the end of the year) may provide further guidance as to which parties should reimburse costs and the modalities thereof.
The Amending Act confirms the importance of cooperation between the public and private sector for the development of non-profit research. The funding by pharmaceutical companies of non-profit clinical trials, sponsored by Italian institutions or physicians, is essential considering the budgetary constraints that most of them currently face. External funding does not affect the qualification of the trial as non-profit, since the study design, objectives and any other scientific and technical aspects are independently decided. There are several grounds that may justify a pharmaceutical company funding an investigator-initiated trial; the ownership of data and results is not usually the main driver.
Nonetheless, if results or data that could be used for commercial purposes are obtained, ownership and the right to use such data for commercial development should consider the pharmaceutical company's actual financial contribution to the trial. In that regard, the right to purchase data does not provide a satisfactory solution to the extent that costs have already been covered by the funding companies and the parties have agreed on any additional reimbursement or payback for the transfer. Hopefully, the ministerial decree will take into account the importance of private funding for the sustainability of Italian non-profit research.
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