Pharmaceutical groups say more slots needed for joint scientific consultations
EU pharmaceutical industry groups said the demand for joint scientific consultation (JSC) meetings is exceeding the number of meetings scheduled for next year. These meetings focus on discussing the design of clinical trials and plans for evidence generation regarding new medicines and are part of the joint clinical assessment (JCA) process under the health technology assessment (HTA) regulation.On 4 December, a joint announcement was made, supported by five major pharmaceutical industry groups in Europe. These groups include the Alliance for Regenerative Medicines, the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), EuropaBio, and Vaccines Europe.
Starting on 12 January 2025, Regulation (EU) 2021/2282 on health technology assessment will take effect. This regulation enables joint assessments of new medical treatments across the EU, with the goal of streamlining the evaluation process, reducing duplication among member states, and speeding up patient access to new treatments. The JCAs will initially focus on oncology and advanced therapy medicinal products (ATMPs) and will expand to include orphan drugs in 2028.
The groups expressed their support for the JCA framework, emphasizing the importance of a transparent and inclusive HTA framework, as well as the need to reduce duplication of reviews among national HTA authorities.
They state that the number of planned JSC meetings next year does not reflect the realities of product development, where there are more products in the development stage than those submitted for marketing authorization.
They said only a small number of companies submitting for a JCA will have the chance to discuss their clinical trial plans next year as the HTA Coordination Group has scheduled only 5 to 7 meetings.
Results from an earlier joint scientific consultations subgroup survey indicated a strong demand for JSCs, with companies identifying over 50 products for which they were likely to request advice.
“As the new procedure will be mandatory and the number of affected products significantly higher, the number of advice meetings offered should be scaled up,” the groups wrote.
The groups state that for small to mid-sized companies, “The ability to discuss their evidence generation plans with the assessors is particularly important as they often have less exposure to the European market due to smaller product pipelines.”
“If the EU HTA Regulation is to successfully deliver on its aims of reducing burdens for companies and speeding up access for patients, it is critical to offer more JSC slots, starting in 2025,” said the statement.
Joint statement
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