Extra cooperation will avoid duplication of work and benefit EU countries that lack health technology assessment skills, Commission says
The European Commission has proposed joint health technology assessments (HTA) of new drugs and medical devices, to determine if they offer value for money and should be prescribed for patients.
A draft bill published this week would overhaul the current largely national approach to HTA that the Commission says duplicates work and impedes market access for innovation. Today, pharma companies and device manufacturers are required to submit evidence to different agencies in different countries to get their products reimbursed.
The Commission envisages 10 to 15 assessments in the first year of operation, rising to around 65 joint clinical assessments towards the end of a transitional period of three years.
“Healthcare companies will benefit from clearer rules and greater predictability,” said Commission vice-president Jyrki Katainen.
Extra cooperation should particularly benefit smaller countries. Many Eastern Europe states still do not have the capabilities to do their own HTA, and rely on the findings of bigger countries like Germany and the UK.
Health and consumer organisations welcomed the new plans.
Joint clinical assessments “will facilitate faster access, avoid duplication at national level and deliver greater consistency, clarity and predictability for everyone involved in the process,” said Nathalie Moll, director general of the European Federation of Pharmaceutical Industries and Associations.
“It will save time and money to assess the same drug or surgery once at EU level rather than several times at national level. Also, it will put all consumers on an equal footing, as countries without such resources would benefit from EU-wide clinical assessments,” said Monique Goyens, director general of European consumer group BEUC.
Governments would have three years to put the regulation into national law after approval by the European Parliament and European Council.