Statement | 1 February, 2018 | Download PDF

Following the release of the European Commission’s Proposal for a Regulation on
Health Technology Assessment on 31 January, 2018, Ancel·la Santos Quintano, Senior Policy
Advisor with Health Action International made the following statement:

Health Action International (HAI) values the role of health technology assessments (HTA). Most
new medicines do not demonstrate meaningful benefit to patients compared to medicines already
on the market. At the same time, high prices for new medicines threaten affordability of care.
HTA better informs patients, consumers and healthcare professionals about the added
therapeutic value of the medicines they use or prescribe. It also assists payers in their
reimbursement decisions.

While we welcome the European Commission’s acknowledgement of the increasingly important
role of HTA in the European Union (EU), we have a number of concerns about the proposed

First, making joint clinical assessments mandatory among EU Member States is a
counterproductive step if high evaluation standards are not upheld. There is need for further
reassurances in this regard.

Second, we are deeply concerned that the new HTA framework would soon end up being funded
through industry fees. HTA fulfills a public interest role; therefore it should be publicly financed
and protected against undue influence, or situations that could be perceived as such.

In addition, while we encourage collaboration between the European Medicines Agency (EMA)
and HTA bodies, this collaboration should occur in a way that protects their distinctive mandates.

Given current regulatory trends to accelerate medicines approval and accept less robust data—
for example, the EMA’s initiative on Adaptive Pathways—the independence of HTA bodies in
assessing medicines is more important than ever…

Read the full statement here