The UK Medicines and Healthcare products Regulatory Agency (MHRA) is a confident, transparent and risk-aware organisation which provides “outstanding leadership” in European negotiations, the Better Regulation Executive (BRE) has concluded in a review.
The Agency has a cadre of highly professional staff who understand the sector and its risks well, and it operates as a joined-up organisation, say the team members conducting the review, who were drawn not only from the BRE but also the National Audit Office (NAO), the Human Fertilisation and Embryology Authority (HFEA) and the National Consumer Council (NCC).
The extent of interaction across the MHRA is “impressive,” say the reviewers, adding that a good example of this is the way in which the Agency conducts European negotiations, bringing a strong grasp of implementation issues to its discussion of policy with European counterparts. Not only is it very effective at negotiating at this level, it is also a thought leader in European negotiations, they add.
Moreover, the Agency is highly focused on its objective of protecting public health and the reviewers say they found good evidence that it is a learning organisation. “We were impressed by the MHRA’s achievements, direction of travel and its plans for improving its regulatory performance still further,” they say.
However, they add, there is some room for improvement.
The Agency needs to improve its understanding of the economic impact of its activities and streamline processes for business, say the reviewers, who found some “relatively low-risk cases” where it could do more to take account of the sector’s practical business needs. It should strengthen the robustness of its impact assessments and look to ensure that the importance of cost-benefit analysis is embedded throughout the organisation, they add.
The reviewers also heard from some stakeholders of cases of “gold plating” – going beyond the minimum legal requirements when implementing European Union (EU) legislation. These claims had some substance, particularly in the regulations covering labelling and package leaflets, they found, noting that the MHRA had chosen to implement these early and with additional retrospective application.
“While we do not question the rationale behind the Agency’s decision in this case, we think it should be more aware of the impact that additional national legislative barriers can have over and above an agreed European approach. In these cases, it should consider the need for an enhanced level of communication, particularly in order to make the reasons for its approach clear to industry,” the team writes.
Moreover, they add that while the Agency generally consults extensively with external stakeholders, on some occasions it could consult and communicate more fully. They applaud the strong approaches which it is developing to simplifying medicines regulation in some areas, and note that the Better Regulation of Medicines Initiative (BROMI) has won an international award, but believe that this could go further.
There is also a need to improve the credibility and usage of Sentinel, the MHRA’s cross-Agency IT system, and to work with the industry to ensure that use of the system is increased; this should be a two-way process, they say.
Finally, while the reviewers are aware of the constraints on the Agency, they would “strongly encourage and support the development of a more risk-based approach to inspection.”
In a statement, the MHRA said it welcomed these “helpful suggestions” and that it was committed to implementing them.
– The MHRA review is one of a series undertaken at UK regulatory bodies following the 2005 review of regulatory inspection and enforcement carried out at the request of the Treasury by Sir Philip Hampton, chairman of J Sainsbury and, since January, of the Royal Bank of Scotland. The “Hampton Principles” outlined in his report constitute one of the cornerstones of the government’s “better regulation” agenda.
