AIFA – Standard template for clinical trial agreements On October 30, 2019, the AIFA published on its website the standard template for clinical trials on pharmaceutical products drafted by the National Coordination Centre of Territorial Ethics Committees for clinical trials on pharmaceutical products for human use and medical devices, in compliance with Law No. 3/2018.

The AIFA clarified that the standard template aims at enhancing uniformity and quality of agreements between sponsors and institutions and that, in the absence of special needs for integrations to its minimum contents, the template should be applied without amendments. The AIFA also specified that the publication of the standard template does not affect agreements already negotiated, which will not require any modifications. The template, which is available on the AIFA’s website at the page of the National Coordination Centre of Territorial Ethics Committees, governs the most important aspects of the trial, such as the relationship between the sponsor and the institution, the confidentiality of information during the trial, the ownership and use of the results, and the protection of personal data. 


New guideline for assessors of centralized applications on wording of therapeutic indications

On October 21, 2019, the EMA published a guideline on the appropriate wording of therapeutic indications to be used when assessing applications for centralized marketing authorizations (Guideline). The Guideline clarifies that therapeutic indications, to be included in applications for marketing authorizations, are the primary information on the use of a medicinal product and that they must clearly state the disease/condition and population that a medicine is intended to treat. The Guideline also provides a list of areas of common interest that assessors should take into account when evaluating the therapeutic indications' wording, such as the data submitted as part of the application, the therapeutic context and the proposed target population, the existence of a defined therapeutic pathway and the use of the medicinal product in combination therapy. As clarified by the EMA, the list is of a purely descriptive nature and includes those items generally relevant to the assessment of indications for the majority of therapeutic areas, without affecting the possibility for assessors to examine further aspects that, in a specific case, may influence the appropriate wording of therapeutic indications. 


Exclusion from a tender procedure if offer includes an accessory not bearing the CE mark

With Judgment No. 2202 dated October 22, 2019, the Administrative Court of the Lombardy Region annulled the award of a public contract for the supply of medical devices and other accessories, holding that an accessory to a medical device fully qualifies as medical device and, as such, must bear the CE mark. In light of the above, the administrative judge resolved that the offer of an accessory to a medical device without the CE marking is an aliud pro alio (i.e., the offer of something instead of something else), resulting in the automatic exclusion from the tender procedure — even in the absence of a specific exclusion provision — which cannot be remedied by subsequent regularization, as this is only permitted when the breach of the tender documentation is purely formal or clearly due to a clerical error. 


The precautionary principle in tender procedures for the supply of vaccines.

With Judgment No. 10535 of October 3, 2019, the Council of State ruled that two vaccines for a different number of serotypes could legitimately compete in tender procedures to be awarded on the basis of the lowest price criterion. In this regard, the court held that in choosing the appropriate prophylactic strategy to ensure the highest possible vaccination protection, the precautionary principle does not require the public administration to apply all risk containment measures at the highest intensity (so-called "zero risk"), but rather to identify a proportional response to the potential risk, in light of the epidemiological context. Having regard to the principle, according to which, in case of potential risks to public health, competent authorities may act preventively, even in a context of scientific uncertainty as to the existence and seriousness of such risks, the administrative court established that the choice of the most appropriate precautionary measure must, in any event, comply with the principle of proportionality. For these reasons, the Council of State ruled that the award of the contract to the vaccine with the lower coverage ensured an adequate level of protection since the epidemiological context, as resulting from the preliminary investigation, did not pose a level of risk such as to justify the use of the most intense risk containment measure (i.e., the vaccine with the higher coverage).