The European Council and the European
Parliament reached a political agreement on June 22 covering a legislative
proposal to work together on Health Technology Assessment (HTA). Patient access
to medicines and medical products is to be facilitated and the submission
procedure for manufacturers of such health technologies will be simplified.
Cooperation at all levels
The new rules provide for cooperation
between member states on joint clinical evaluations and joint scientific
consultations covering health technologies at EU level. This collaborative work
will provide valuable scientific information to national health authorities
when making decisions about the pricing and reimbursement of a health
In order to reduce the administrative
burden, especially for smaller companies, the agreed text foresees that health
technology developers will only have to submit information, data and other
proof needed for the joint clinical evaluation once at EU level.
A long way
The Commission adopted a proposal for a
regulation covering health technology assessment on January 31, 2018, see also News
09/2019. Following an agreement reached between the member states on March
24, 2021, the Presidency opened negotiations with the European Parliament with
a view to adopting a common position.
Key issues in the final talks between
Parliament and Council included:
- the scope
- the voting system
- the implementing period for the regulation
Health technology assessment is a
proof-based process that allows competent authorities to determine the relative
effectiveness of new or existing technologies. Health technology assessments
specifically focus on the added value of a health technology compared to other
new or existing health technologies. Health technology assessments enable
national health authorities to make informed decisions about the pricing or
reimbursement of health technologies.
Where do we go from here?
The Portuguese Council Presidency will
submit the results of the negotiations to the European Council's Committee of
Permanent Representatives (COREPER) for approval. This will be followed by
adoption by the European Council and then by the European Parliament. The new
rules will become directly applicable in a phased procedure three years after
the regulation comes into effect.