The European Commission put forth a proposal on Wednesday to improve cooperation on health technology assessments (HTA) among European Union member states.
The draft bill proposes conducting joint clinical assessments and scientific consultations for new drugs and medical devices in order to determine their value for patients. The proposal also includes provisions for identifying emerging health technologies and increasing voluntary cooperation among EU countries.
The healthcare sector accounts for approximately 10% of the EU’s GDP. Currently, HTA processes and methodologies in the EU vary between nations and regions. This impedes and distorts market access for innovative technologies, and leads to duplication of work and inefficient use of resources, according to the Commission. Pharma companies and device manufacturers, for example, must submit evidence to multiple agencies across different countries in order to receive reimbursement for their products, even after their medicines are determined safe and effective by the European Medicines Agency.
The proposed bill would overhaul the existing process. If passed, the Commission says it will make innovative health technologies more available to patients, increase transparency, and use available resources more efficiently. National HTA authorities would remain responsible for determining pricing and reimbursement, but would use the joint assessments to do so.
The Commission said that patients, governments, and industry all stand to benefit from the new laws. Improved cooperation would especially benefit smaller member states. Many countries in Eastern Europe, for example, do not have the capabilities to do their own HTA, and often rely on the findings of bigger countries such as the UK or Germany, according to Science Business.
“Reinforcing [HTA] co-operation at EU level boosts innovation and improves competitiveness of the medical industry,” said European Commission Vice President Jyrki Katainen. “We are proposing a regulatory framework that will bring benefits to patients all over Europe, whilst encouraging innovation, helping the take-up of high-quality medtech innovations, and improving the sustainability of health systems across the EU.”
Commissioner for Health and Food Safety, Vytenis Andriukaitis, added that the plan would especially benefit patients “with unmet medical needs.” The Commissioner also noted the ways the plan would allow EU members to use resources more efficiently, saying, “the pooling of resources and exchanges of expertise” would avoid duplications in the assessment of the same products in different countries.
Health organizations, as well as consumer groups, welcomed the news. Nathalie Moll, director general of the European Federation of Pharmaceutical Industries and Associations, said the proposal’s 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.”
Similarly, Monique Goyens, director general of European consumer group BEUC, said, “It will save time and money to assess the same drug or surgery once at EU level rather than several times at national level.” Goyens added that the proposal “will put all consumers on an equal footing, as countries without such resources would benefit from EU-wide clinical assessments.”
If both the European Parliament and the Council approve the proposal, EU member states would have three years to prepare before the new rules take effect, followed by an additional three-year transitional period.
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