Making sure consumers access treatments that work at a fair price

When consumers take medicines or use medical devices, they expect them to work. But today, many drugs and medical devices are inefficient and waste consumers’ money. Even worse, some treatments are unsafe and might put consumers’ health at risk. Health Technology Assessment (HTA) helps governments decide which treatments should be reimbursed and at what price. Therefore, HTA can ensure that consumers only access and pay for effective treatments.

In this paper, we outline our recommendations for a permanent EU HTA mechanism that truly benefits consumers. To ensure good governance of the cooperation and achieve results that match consumers’ needs we recommend that:

• Member States must lead the HTA process;

• The Regulation should make it mandatory for Member States to use joint clinical assessments, but introduce possibilities to adapt reports to the needs of their national health care systems;

• The Regulation must ensure that the system is independent from economic interests;

• The Regulation must guarantee transparency and public access to documents; 

• The Regulation must grant Member States sufficient time to adapt their national HTA procedures to a new EU-wide HTA system.

Furthermore, to secure relevant, high-quality outcomes we insist the Regulation ensures that:

• Manufacturers disclose all relevant data and conduct trials against the best available treatment;

• Orphan medicines, which treat rare diseases, are subject to the same standards as widely-used drugs;

• Medical devices are covered by the Regulation;

• Patients and consumers are involved in the process;

• There exists a clear separation between the decisions of EMA and a new HTA mechanism.