EU report calls to minimize amount of data generated by sponsors

2016 十一月 29

The European Parliament’s policy department has published a report recommending regulators and health technology assessment (HTA) bodies take steps to minimize the amount of data demanded of drug developers.

Members of the Directorate for Economic and Scientific Policies made the proposal in a report on the links between pharmaceutical R&D models and access to affordable medicines.

Most of the more than 130-page report describes the current drug R&D and market access situation, plus the initiatives already in place to try to optimize the process. This information will support discussions at the Committee on Environment, Public Health and Food Safety (ENVI), the European Parliament group for which the report was written.

In the final few pages, the authors put forward some policy proposals for ENVI members and their peers. The suggestions include ideas that could affect regulators in Europe.

“Attention must be paid to commercially unattractive medicines with a valuable unmet medical need. However, regulators should avoid making any additional requirements for data collection for new medicines as this could result in a decline in productivity of new medicines,” the authors wrote. “This means that when [randomized controlled trials] aiming for more subgroups to demonstrate patient benefit are combined with increasing data requirements to demonstrate safety and efficacy, pharmaceutical companies have to collect more data on more patients.”

The authors are concerned this could both increase the cost of developing a drug and reduce the likelihood of it succeeding. These forces could make drug developers wary of advancing certain drugs, resulting in longer waits for effective treatments for some unmet medical needs.

Such concerns are underpinned by a belief that clinical data requirements are already weighing on sponsors. This belief stems from an analysis of the reimbursement landscape in Europe. The report’s authors are the latest observers to suggest HTAs and drug developers alike would benefit from the standardization of the clinical data requirements for reimbursement. Done correctly, the authors think standardization could save governments and drugmakers money while also shortening the path to market for new products. 

The suggestions feed into a debate about how best to ensure patients have access to new medicines at a time when national healthcare budgets are struggling to keep up with the rising cost of looking after aging populations. A separate report published by ENVI last month called for harmonization of pricing and reimbursement criteria. 

ENVI Report

Source: RAPS