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10 April 2019
Scope of public consultation
On 11 March 2019 the Italian Medicines Agency (AIFA) opened a public consultation on national templates for medicinal products and medical devices to be used in clinical trials carried out in Italy. Stakeholders may participate in the consultation until 10 May 2019 using the forms available on the AIFA's website.
Law 3/2018 (the so-called 'Legge Lorenzin') established a National Centre for the Coordination of Territorial Ethics Committees (National Coordination Centre) for trials of medicinal products and medical devices. The Legge Lorenzin also enabled the government to issue legislative decrees establishing the content of clinical trial agreements (CTAs), which outline how clinical trials should be conducted.
At present, statutory provisions do not require the use of particular templates for CTAs nor the inclusion of mandatory clauses. Nonetheless, a number of regions (Italy's national healthcare service is structured regionally) and several hospitals have adopted clinical trial templates. In general, even if a clinical trial template has been adopted at a regional or local level, trial sites may use a sponsor's template or, in any event, are open to negotiation and amendments in that regard.
Unless CTA templates are enacted by law (which is not envisaged at present), their use will not be mandatory. However, stakeholders may want to take advantage of the public consultation. Irrespective of the legal instrument used, the availability of national CTA templates would likely encourage healthcare organisations to endorse their use.
In order to collect comments and suggestions for improvements, the AIFA launched a public consultation on the two draft CTA templates (one for medicinal products and the other for clinical investigations of medical devices) prepared by the National Coordination Centre.
While the initiative is certainly welcome, the definition of 'stakeholders' seems to be too narrow. The parties that can participate in the consultation (with a single contribution for each stakeholder) include:
Associations of sponsors should include industry associations (eg, Farmindustria and Assobiomedica), whose members may sponsor clinical trials of medicinal products or medical devices. However, the list does not mention the possibility of individual sponsors (eg, pharmaceutical companies) participating in the public consultation or consider other relevant stakeholders as service providers (eg, contract research organisations, consultants and other professionals who may assist sponsors or healthcare organisations with technical, clinical or legal aspects relating to the conduction of clinical trials).
The development of innovative medicinal products is essentially based on the cooperation between pharmaceutical companies and healthcare organisations. CTAs establish the terms and conditions of such cooperation in the interest of both parties. Although industry associations may participate in the public consultation, the Italian pharmaceutical landscape includes companies that are not members of these associations as well as service providers and professionals. It is important that their voices are heard.
The public consultation will hopefully help to clarify whether such templates should be considered mandatory (to the extent that this may be the case) and to what extent they may be replaced by sponsors' templates or be subject to negotiation and amendments. Although public discussion will lead to improvements, other aspects inevitably must be tailored on a case-by-case basis according to each trial (eg, taking into account the need to protect IP rights and confidential information, which in some instances may be an indispensable condition to conduct a trial).
For further information on this topic please contact Riccardo Fruscalzo or Carlotta Busani at Hogan Lovells Studio Legale by telephone (+39 02 7202 521) or email (firstname.lastname@example.org or email@example.com). The Hogan Lovells Studio Legale website can be accessed at www.hoganlovells.com.
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