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TOPRA: European cooperation required for HTAs


The use of Health Technology Assessments (HTAs) is on the rise but more collaboration is required across Europe, according to experts speaking at The Organisation for Professionals in Regulatory Affairs (TOPRA) Symposium in Rome, Italy.

Aginus Kalis, Executive Director of the Dutch Medicines Evaluation Board, and Ad Schuurman from the Dutch Health Care Insurance Board called for more collaboration between EU regulatory agencies and HTA bodies.

Kalis and Schuurman outlined areas of progress, such as joint scientific advice and the EUnetHTA guidelines, but said there is still much work that needs to be done.

Welcoming the move to greater European collaboration, Mats Marfalt, the European RA, shared some of the practical issues facing pharmaceutical companies, such as a need both to develop new medicines and to ensure patients can access them.

Marfalt suggested that without agreement on the basics – such as disease classifications, intent to treat versus target population, maximum dose versus approved dosage levels, and the use of surrogate markers versus outcomes – it will be a long road to Europe-wide HTA cooperation.

Marfalt’s experiences with the multi-stakeholder consultation pilots of 2010 brought mixed success.

“There was a clear ambition from everyone to present his or her view and to contribute, which was welcome,” he said.

“To succeed, industry, regulators and HTA assessors must have a joint agreement on medical needs, priorities and the clinical development programme.

“To achieve this, there needs to be a willingness by all parties to contribute to assure effective patient access to innovative medicinal products with added value. The pilot stakeholder meetings in 2010 are just the start of this process.”

TOPRA 2011 Annual Symposium

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