5. The difference between HTA bodies and Regulatory Authorities


The difference between HTA bodies and Regulatory Authorities

Some may question why HTA bodies are needed given the existence of regulatory authorities that approve medicinal products for sale (issue Marketing Authorisations), monitor their (safe) use (pharmacovigilance) and take appropriate measures if safety issues arise. However, regulatory authorities and HTA bodies have different mandates.

Typically, regulatory authorities  at national or European level base authorisation decisions on the objective scientific criteria of quality, safety and efficacy of the medicinal product concerned, and explicitly exclude  economic and other considerations (Recital 13 of Regulation (EC) 726/2004). Clinical data that form the basis for the decision about marketing authorisation, in most cases, originate from randomised controlled clinical trials where the medicinal product is tested against placebo or a comparator under tightly controlled conditions. Thus, obtaining marketing authorization does not require evidence that technologies provide benefit which is meaningful to patients in real world conditions, although increasingly patient input is sought during the Research and Development (R&D) process in order to address this.

HTA bodies, on the other hand, concentrate on evidence regarding clinical effectiveness, safety, and, when broadly applied, include Ethical, Legal and Social Implications (ELSI) of the use of health technologies.

A major application of HTA is to make recommendations about reimbursement eligibility and coverage in a publicly financed (statutory) health system, in which case HTAs should include benefit-harm assessment and economic evaluation, i e the concept of efficiency, or “value for money” as a criterion for prioritising health technologies for coverage. Such assessment is required because while patients should be able to access effective treatment and care, resources may be limited and must be allocated appropriately.

Since HTAs are embedded in various decision-making structures at national or regional level in different countries, their configuration varies.  However, a common characteristic – and the main difference from marketing authorization – is that their role is to provide recommendations and support informed decision-making. As such, their results are not necessarily mandatory in nature. And decisions should be balanced in light of public values and those of the patients served by the health system.