Increasing patient involvement has been identified as an essential tool to improve patient outcomes and inform health and care service design. This extends to regulatory decision making and has led the Medicine and Healthcare Products Regulatory Agency (MHRA) to publish a patient involvement strategy for public consultation.
The draft strategy was based on a UK-wide consultation seeking patient and public views on their engagement and involvement in the MHRA’s work. The MHRA acknowledges the importance of patient and public input in regulatory decision making, and this has informed the five objectives set out in their strategy.
The first objective revolves around specific processes to ensure public engagement. For instance, the development of systematic programmes to ensure under-represented patient groups and those from diverse communities (such as minorities, older people, those with disabilities or those whose first language isn’t English) are involved in consultations. Another technique would be to incorporate patient and public engagement into existing processes such as the review of patient safety ‘signals’. Increasing transparency in regulatory systems, decision-making processes, committees and governance has also been identified as an important way to meet this objective.
The second objective is responsiveness. This entails designing and delivering services which are user-friendly and incorporate efficient systems that ensure those who have raised a concern are acknowledged and regularly updated regarding any ongoing work to resolve their issue.
Objective three is centred around the MHRA’s internal culture. The strategy outlines a commitment to introduce new systems, process and training for staff to foster a culture where all team members consider patient and public perspectives in their decisions.
Measuring outcomes is the focus of the fourth objective which states that a clear patient outcome evaluation framework that ensures all patients are considered and demonstrates the agency’s progress towards being a more patient focused regulator will be developed and delivered by December 2021. Specific discernible and measurable outcomes will be used to track whether patient engagement with the MHRA increases as planned and monitor the overall progress of the strategy.
The final objective outlines the key partnerships that will enable the MHRA to execute this strategy. This objective details the benefits of collaborating with partners across the health sector to improve the effectiveness of engaging with patients. To this end the MHRA also highlights a proposed overhaul of the Patient Group Consultative Forum to ensure it is more representative of the actual patient population.
The full draft strategy can be found here.