Two of the most influential European pharmaceutical associations have issued a joint statement expressing concerns in the implementation of the upcoming EU HTA regulation. The statement, published on October 26th 2022 by the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and European Federation of Pharmaceutical Industries and Associations (EFPIA), highlights several major causes for concern.
The major issue expressed within the statement is that the comments from various key stakeholders (e.g. industry/HTA experts, patient organisations, healthcare professionals) on development documents of the HTA regulation appear not to have been taken into consideration
Additionally, there is concern that the process for Joint Clinical Assessment (JCA) seeks to crudely combine national HTA practices, rather than trying to align on common European methodologies. The result could create “an administratively complex and burdensome process”, which would damage, not strengthen, the attractiveness of Europe as a first-launch region. The lack of involvement of pharmaceutical manufacturers at the scoping stage of the JCA is also highlighted as a major missed opportunity.
The associations “call for a constructive dialogue with the European Commission and the newly established Coordination Group, to ensure Regulation (EU) 2021/2282 on health technology assessment meets its intended objective”, with both HTA agencies and pharmaceutical manufacturers having to adapt their approach to their ways of working. Given the looming timelines of the EU HTA, with JCAs expected to take place from 2025, this statement is likely to create significant unease amongst pharmaceutical manufacturers.
The statement, and the background information behind the statement, can be read in full on the EUCOPE website.