European Commission Tables Health Technology Assessment Proposal
On 31 January 2018, the European Commission presented its highly anticipated but also controversial proposed Regulation on Health Technology Assessment (“HTA”) (the “Proposal” – see attached). HTA is a technique to evaluate the medical, social, economic, organisational and ethical issues of a health technology, including medicines, medical devices and medical interventions. The main purpose of conducting an assessment is to inform policy decision-making.
Cooperation on HTA among EU Member States has been in existence since the 1980s and over the years substantial EU funding has been made available under successive Joint Action programs. The last such program will run until 2020. The European Commission now wants to increase the existing cooperation between Member States to enhance efficiencies, reduce public sector costs and augment regulatory and administrative predictability for the life sciences sector. At the same time, the scope of the Proposal is limited to the clinical aspects of HTA and encompasses problem definition and the relative safety and clinical efficacy of a health technology when compared with those of existing technologies.
In practical terms, the Proposal envisages the following four avenues of cooperation:
- Joint clinical assessments;
- Joint scientific consultations in response to requests for advice from the life sciences sector;
- Identification of emerging technologies (known as “horizon scanning”); and
- Voluntary cooperation in areas outside the scope of mandatory cooperation.
The Proposal covers two types of health technologies: (i) medicines that are subject to the EU’s central marketing authorisation run by the European Medicines Agency; and (ii) specific medical devices that have received an expert opinion at the EU level pursuant to the new EU Medical Devices Regulations.
Initial reactions to the Proposal have been mixed, with Germany voicing the most explicit criticisms. The Proposal will expose the tensions that exist in Europe between advocates of enhanced cooperation between Member States in an area that is in the immediate proximity of Member State turf, namely pricing and reimbursement, and proponents of national sovereignty in the healthcare field that is funded mainly from national coffers.