MHRA Urged to Lead International Approach to Device Fee Collections

The UK’s Medicines and Healthcare products Regulatory Agency should take the lead in developing a unified international approach for collecting fees related to the regulation of medical devices, a government review of the agency says.

That recommendation comes in the Triennial Review of the Medicine and Healthcare Products Regulatory Agency, released last week, the culmination of a Department of Health evaluation of the MHRA’s performance. The review took place between November 2014 and May 2015 and incorporated input from stakeholder interviews and workshops, meetings with sector experts, a public call for feedback and analysis of published material and in-house documents.

According to the report, stakeholders hold a generally positive impression of the MHRA. However, challenges remain, including increased competition from other EU regulators for licensing income. “Awareness of new developments with medicines and devices will better enable the agency to anticipate the need for changes to processes or the regulatory framework and to influence international partners,” according to the review.

One area in which MHRA may take the lead is developing an approach for applying fees for regulating medical devices. The agency expects to introduce a fee next year related to a medical device company’s turnover in the UK. This would provide a secure funding stream, increasing income to more than 90 percent of agency expenditures related to device regulation, the review says.

During the review, stakeholders expressed concern about the potential lack of international consistency in how the fees would be applied. A standardized approach across the EU could prove more effective, eliminating additional burdens, industry argued. With increased revenue from industry, the agency could provide a greater range of expertise when reviewing innovative devices.

The report also calls on the MHRA to continue its work on improving efficiency — something it has approached by cutting costs. It notes, for example, that the agency cut 21 device division staff positions over three years, leading to savings of about US $1.6 million a year by 2013-14. It also eliminated posts on the regulatory side, reflecting a decline in licensing activity.

While the review praises the MHRA’s flexibility in the face of changing demands, it also cautions the agency to ensure its employees have the right skills and expertise. This challenge is particularly acute with the complex new technologies and software being used by newer medical devices.

Another area for progress is the agency’s technology infrastructure. Currently, it employs a system known as Sentinel to collect information on license applications and adverse event reports for medicines and devices. However, this system has received criticism for not being robust enough. The MHRA is planning to phase in a new system over the next five years.

To review the report, visit www.fdanews.com/072715-MHRA-review.pdf. — Elizabeth Hollis