5. The difference between HTA bodies and Regulatory Authorities

Regulators and HTA bodies have a separation of roles in terms of a HTA, even though both play important roles. While regulatory authorities are responsible for the approval of health technologies HTA bodies give recommendations to regulators.

Regulatory authorities, like national or European agencies, focus on the safety, quality, and efficacy of medicines based on scientific data, primarily from clinical trials. Their job is to ensure that a product is safe for use but doesn't necessarily evaluate whether the product is meaningful or beneficial for patients in real-world conditions.

HTA bodies, on the other hand, look at the clinical effectiveness and safety of health technologies, and also consider ethical, legal, and social implications (often referred to as ELSI- Ethical, Legal and Social Implications) of their use. Their main role is to help make decisions about whether a medicine should be reimbursed by publicly funded health systems, based on its value, benefit-harm assessment, and cost-effectiveness. They provide recommendations to help policymakers prioritize limited healthcare resources. Learn more about the HTA bodies in the context of the EU HTA

While regulatory authorities make decisions based on scientific criteria, HTA bodies offer advice to support informed decision-making, often considering broader factors like patient needs and public values. Their recommendations are not mandatory but help ensure that health systems use resources wisely for the benefit of patients.