By Hannah Kerfoot
Following the Cumberlege review, published in 2020, the MHRA launched their Patient Involvement Strategy 2021-25. Now, in its final year, Pharmora is taking a look at what has been accomplished and what is still to come.
What is the Patient Involvement Strategy 2021-25?
The Patient Involvement Strategy is guidance developed through consultation with patients, where the patients discussed what was important to them in the regulatory process and product lifecycle.
- Patient and public involvement
- Response to patients and the public
- Internal culture, Building partnerships
- Measuring outcomes.
Patient and public involvement
The MHRA planned to increase transparency, increase the amount of material and information accessible to the public on GOV.UK; and involve patients and the public systematically in regulatory decisions.
The MHRA has been consulting patients and members of the public more during the decision-making process for approving new drugs or renewing drug licenses. This has led to reclassification of some medicines for ease of access, as well as some medicines being approved.
However, one criticism from patients, the public, as well as MHRA staff members, was that even when patient/public opinions have influenced agendas and decisions, this has not been fed back to the patients or the public. This has led to frustration, as observed in some of the quotes from the MHRA’s review of their strategy, which was published on the 7th of January this year:
“Listening was only as good as the follow up”
“They do listen and take it on board – but how far into the organization does it go?”
The MHRA has stated that patients welcomed communication from them but that in the future, more use should be made of the patient networks which they have set up.
Responding to patients and public
The MHRA established the Customer Experience Centre in March 2020, which allows the public to make a complaint about services provided by the MHRA. This could allow developments to be made based on what issues the public find with services.
The Yellow card scheme has been active for years, and in recent years an app has been developed for ease of access. This has been successful, however, some members of the public had not heard of the system, which can be found here.
Internal culture
The MHRA has developed internal online training courses, which had a 90% uptake from MHRA staff. In the future the MHRA is working on developing more training for staff. As well as this, tailored guidelines have been produced to support their staff with patient involvement. The MHRA also now casts its Board Meetings online to the public, which allows them to get involved and see what decisions are being made as well as the way the Board conduct their business. MHRA staff have been positive about the increase in patient focus, and have praised the MHRA Board as a key driver in promoting patient-centricity.
Building partnerships
The MHRA Patient and Public Community (managed by their Patient, Public and Stakeholder Engagement team) has been formed, which is an opportunity for patients to discuss problems with products with the MHRA, as well as for them to gain information. As well as this, multiple health and social care organisations have signed a commitment to improve public involvement in research. Read more about it and the other organisations who signed, here.
Measuring outcomes
On the 7th of January 2025, the MHRA published their Assessment of Progress for the Strategy. This has set the stage for the updates and refresh of the strategy from 2026 onwards. It also included some of the work the MHRA has conducted interviewing the general public, patients, and its internal workers to see what the general opinion is on the MHRA and patient-focus.
In addition to this, the MHRA has published the “MHRA Corporate Plan: 2023 to 2026”. This plan has included 4 priorities for the Agency for the next three years:
- Maintain public trust through transparency and proactive communication
- Enable healthcare access to safe and effective medical products
- Deliver scientific and regulatory excellence through strategic partnerships
- Become an agency where people flourish alongside a responsive customer service culture
The MHRA have plans which are due to be completed by March 2025: Pilot public hearings on major safety issues, Pilot the introduction of a single unified gateway to the MHRA, and Complete a Yellow Card biobank pilot. So, watch this space for more updates on this patient-centring strategy!
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