Dati clinici, diritti di esclusiva e accesso ai farmaci

This research presents an analysis of data exclusivity and its impact on access to medicines, one of the essential elements for the full realization of the fundamental right to health. Data exclusivity is an exclusive right, defined by some as an intellectual property right, which grants the holder of a marketing authorization for a new medicine a period of exclusivity over the results of preclinical and clinical trials conducted for the purpose of obtaining that authorization. This mechanism prevents competing manufacturers from achieving approval of generic versions of the drug in question through the abbreviated or simplified procedure, which requires only the demonstration of bioequivalence through appropriate bioavailability studies instead of the submission of a full dossier of studies proving the safety and efficacy of the product.

For several decades, legislators have identified data exclusivity as a mechanism that can reconcile the diverse needs of the pharmaceutical industry, as it is believed to ensure the original drug developer the ability to recoup the substantial resources invested in the research and development of the product.  The events that have marked the past few years – particularly the Covid-19 pandemic – have raised renewed interest among the public and legislators in issues such as pharmaceutical innovation, clinical trials and the approval of new drug products. At the same time, with the management of this health crisis, some problematic profiles of the current system have emerged, especially with reference to the delicate balance between the interests of the pharmaceutical industry and the protection of the right to health. From this point of view, data exclusivity represents a highly controversial exclusive right, especially in the context of economically less developed countries, which frequently face health emergencies but lack the resources to ensure access to the expensive treatments produced by large American and European pharmaceutical companies.