Last month, the EU proposed a legislative initiative to provide standardization for the approximately fifty national and regional Health Technology Assessment (HTA) organizations that will encourage greater cooperation and organization. The pith of the proposal entails creating a new body of permanent full-time scientists, technologists and administrators who will be in charge of coordinating HTA activities past 2020; this is a significant change from the previous system, in which efforts were voluntary and temporary, indicative of a lack of organization in the EUnetHTA3 program.

The proposal also calls for a joint assessment of a drug, likely to begin when an application is submitted to the European Medicines Agency at the latest, which will be finalized by the time the medicine gets approved. The system will no longer be voluntary, which means that companies will no longer get to decide which products should go through the assessment process. They will, however, be able to coordinate with and participate in dialogues with the new EU HTA body, which will direct the companies to gathering the appropriate data that will be required for a joint clinical assessment in the future.

When the proposed system is put in place, all EU HTA organizations will be required to not only participate in the assessment, but also take the results of the assessment into account. Member countries will be legally required to report on their usage of the results of the joint clinical assessment reports to the European Commission.

Source: PharmExec