Following the successful vote of the final report on the amendment of the Regulation 726/2004, POLITICo, one of Brussels most importnat news agency, reported on the hard work of ECPC and our champion MEPs to change the European legal framework related to the approval of cancer drugs.
If you want to read more about the amendments, and why the regualtion 726/2004 is fundamental to grant fast access to innovative medicines, click here.
Below you can find an extract from the article published by POLITICO.
Cancer groups win initial backing for binding HTA
In effect, the Parliament’s draft amendment aims to force national authorities into accepting joint drug assessments, by threatening to withhold their freedom to set their own prices if they fail to comply.
By PETER O’DONNELL 2/29/16, 12:43 PM CET
European cancer organizations are hoping a new European Parliament initiative will help trigger binding EU rules on common health technology assessment procedures, and result in faster patient access to innovative treatments.
When the Parliament’s health committee adopted a draft report on tougher controls on antibiotics in animals in late February, it quietly voted for a separate draft report to amend the 2004 regulation on the European Medicines Agency’s procedures for approving new drugs. A key amendment would introduce a novel limitation on the time-honored national sovereignty over drug pricing and reimbursement. It says those rights shall not be affected “provided that member states take in due consideration the reference comparative evaluation” of human medicines.
In effect, the Parliament’s draft amendment aims to force national authorities into accepting joint assessments, by threatening to withhold their freedom to set their own prices if they fail to comply. Another amendment insists on member countries “cooperating with the Health Technology Assessment Network, with health technology assessment bodies and other national authorities involved in market access, in particular to facilitate their assessment and reduce disparities in patients’ access to health technologies.” Building a more harmonized HTA system in the EU has repeatedly been urged by patients, policymakers and industry.
Two MEPs behind this initiative, center-right Elisabeth Gardini of Italy and Germany’s Socialist Matthias Groote, have been saying for more than a year that faster decision-making on reimbursement depends on some obligation for member countries to work together on drug evaluations. The Commission’s 2016 work program foresees an initiative on HTA, but so far no official indications have emerged of the nature, and the Commission is still testing the waters with member nations on what might be a feasible proposal.
If adopted, it will boost pressure for something binding (rather than voluntary) on relative effectiveness assessment at EU level, says Francesco Florindi of the European Cancer Patients’ Coalition. The hope is that parliamentary support will tilt the balance in favor of tougher action. “These amendments put the Council in the position to discuss and decide what to do to harmonize HTA using strong legal instruments, not anymore on the base of voluntary collaboration,” he said.