On October 3, the European Parliament plenary adopted in the first reading the file on the proposal for a regulation of the European Parliament and of the Council on health technology assessment (HTA) with a great majority (576 votes in favour, 56 against and 41 abstentions).
As a highlight, the European Parliament decided to support joint mandatory clinical assessment, although with certain exceptions for medical devices. The idea behind the “joint clinical assessments” is to assess the value of a new medicine or a new medical device and help EU member states to take appropriate decisions regarding pricing and reimbursement.
Sadly, patient involvement is lagging behind in this HTA proposal. Despite the unstinting calls of patient advocates to have a policy that involves patients at every level of decision-, patient representation has not been included in the voted text. In practice, the fact that patients’ representatives will not be full members of the Coordination Group assessing HTA means that a patient voice will not be assessing health technology. For EFA, only can full membership ensure mutual trust and create the necessary partnership, so have patient-centred HTA activities.
Despite being a highly technical process, Health Technology Assessment (HTA) is crucial to enable patients to receive the best care in their home country. It refers to the systematic evaluation of properties, effects, and/or impacts of health technology, taking into account the social, economic, organizational and ethical issues and national specificities.
In the text passed by the Parliament, there is some positive evolution. For example, the green light for joint European action in the areas of clinical testing, scientific consultation and evaluation of new technologies in the market. Not only joint European action will allow to have more efficient and faster validation processes, but also it will permit to conduct much rigorous testing procedures before a product is approved for commercialisation in the EU single market, preventing the duplication of studies for the same technology and therefore different standards.
The next step for this legislative dossier is the interinstitutional negotiation with expected backdrops. At Council level, the process might be slowed down, as the Austrian Presidency only scheduled a political debate on HTA on 7 December, which might end up pushing a decision on the file to the next Presidency starting in January.
The text adopted by the European Parliament on the proposal for a regulation on health technology assessment is available here.