Newsletter ABPI - Edition Special Congress 2023 - Day 3


Regulatory Data Protection Must Ensure Access to New Medicines

Data Protection in the Pharmaceutical Industry was the theme of Panel 10, featuring Caitlin Mulholland, Professor at the Pontifical Catholic University (PUC) of Rio de Janeiro, and Christian Jervelund, Partner at Copenhagen Economics, with moderation by Ana Cristina Müller.

Jervelund’s discussion revolved around Regulatory Data Protection (RDP) issues and the benefits of adopting such measures. A study presented by the expert indicated that countries with RDP have an average availability of 31.5% of medicines launched in the last five years, compared to a mere 11% availability for countries without RDP. “Brazil records an intermediate index of 23.1%. There is significant growth potential for Brazil through RDP adoption, with substantial possibilities for new investments in clinical trials and drug commercialization, fostering further development for the Brazilian industry in the sector.”

Professor and researcher Caitlin Mulholland addressed key aspects related to clinical research in her presentation, considering it as a precursor to the establishment of medical data linked to drug development and a vital element for the provision of medicines.

Caitlin also highlighted fundamental issues concerning personal data and clinical research, which connect the general law with health-related regulations: levels of anonymization, consent revocation, and data portability and deletion.