Balance between new treatment opportunities and public health expenditure control: The Regulatory Agency role

Article type: Research Article

Authors: Tomino, Carlo

Affiliations: Italian Medicines Agency, Rome, Italy. E-mail: [email protected]

Abstract: A public debate is currently ongoing on the perception that the licensing regulations tend to give precedence to the interests of drug companies with programs, such as the "fast-track" program, aimed at shortening review times and allowing approval at much earlier stages of clinical development in order to allow early access to new drugs. The main concern is that lower standards may become acceptable, with serious consequences to public health. To this end, NICE developed a series of national clinical guidelines to secure consistent, high quality, evidence based assessment of clinical trial practice.

Keywords: AIFA, register, risk-sharing

DOI: 10.3233/PPL-2010-0286

Journal: Pharmaceuticals, Policy and Law, vol. 12, no. 1-2, pp. 137-138, 2010