TRA ESCLUSIVITÀ E CONDIVISIONE: UN APPROCCIO PER PROMUOVERE UN ACCESSO EQUO AI DATI CLINICI NEGLI STATI UNITI

The thesis aims to analyze the legal regime of clinical data within the framework of the United States legal system, where pharmaceutical companies are granted a time-limited period of exclusivity over test data relating to the safety and efficacy of the newly discovered and studied drugs.

Starting from the conviction that science is founded on the sharing of ideas, methods, results and that the disclosure of test data could provide further momentum to scientific progress, the present work adopts an approach directed at promoting fair access to clinical data in the United States. Scientific research is marked by a delicate balance between conflicting interests: on the one hand, the need for transparency advocated by academics, and on the other, the demand for protection in the form of intellectual property rights asserted by pharmaceutical manufacturers. Transparency in the scientific domain could be achieved through sharing. In the author’s view, fair access to test data would be capable of overcoming the conflict between exclusivity and sharing.

The initial part of the thesis aims to frame the context in which exclusivity over clinical data arises and consolidates within U.S. pharmaceutical law, through a comparison between the approval process for new drugs and that of generic drugs. The task of defining clinical data exclusivity may be particularly complex, also due to the disputed nature of this legal institution in academic discussion.

The investigation is further extended to consider how, towards the end of the last century, the United States sought to export its model of clinical data protection and impose it globally, both through the TRIPS Agreement, particularly Article 39.3, and through a range of bilateral and multilateral agreements. The analysis reveals that, within the TRIPS framework, this attempt did not succeed. Indeed, the final text of Article 39.3 makes no reference to the mandatory nature of exclusivity as a measure of test data protection. The provision’s often vague and occasionally ambiguous language reflects lengthy negotiations and compromises and has been widely discussed and critiqued in academic literature. While the article does call for protection of data against unfair commercial use, such protection cannot be derived solely from an exclusivity right and may be secured through alternative mechanisms.

The final section focuses on the prospects for transparency and the sharing of clinical data. In this context, attention is given to the types of documents generated during a clinical trial that should be disclosed, the principles guiding their dissemination and the relevant reference platforms. Like any human activity, providing access to clinical data is not free from critical issues, such as risks to participants’ privacy and the substantial costs linked to the logistical infrastructure required for data sharing. However, these issues can be overcome. Several pharmaceutical companies have already adopted data-sharing policies as a form of self-regulation. Still, a legislative intervention by the U.S. Congress would be desirable to provide a clear and binding framework for the disclosure of clinical data, to establish a harmonized regime regulating access procedures and reuse possibilities, with particular emphasis on the management of consent.