The MHRA has published a draft Patient Involvement Strategy describing how patients and the public should be involved in processes related to medical devices and other healthcare products.
It is important to mention that a similar policy was already published by the CDRH earlier this year. The MHRA has published the present document in order to commence public consultations and collect additional feedback and comments from the stakeholders. All interested parties are encouraged to submit their suggestions before June 28, 2021. The responses received will be taken into consideration by the authority when developing a final version of the policy.
According to the consultation paper, the Agency acknowledges the importance of wider engagement of patients and the public in the regulatory processes related to healthcare products intended to be marketed and used in the UK. The suggested strategy is based on previous consultations conducted by the MHRA on the same matter. The approach the Agency intends to implement is based on five strategic objectives described in the document.
Patient and Public Involvement
As the first objective, the MHRA intends to introduce an effective and understandable process involving patients and the public. The development of the aforementioned process should be finalized by June 2022. The Agency will determine the potential results of such cooperation and ensure equal rights in terms of participation for all groups of patients, especially those having specific needs. Additionally, the MHRA intends to cooperate actively with other regulating authorities in the sphere of healthcare products. According to the notice, the Agency will take into consideration the views of children and youth.
In particular, the MHRA intends to:
- Ensure the patients have sufficient information about the medical devices used in order to be able to make informed decisions,
- Increase public awareness on various risks,
- Find the way to engage patients in the decision-making process related to regulatory requirements for healthcare products,
- Improve the overall transparency of regulatory framework and processes associated thereto,
- Extend the engagement of patients in creating information addressed to the public, including official communications of the authority,
- Establish public meetings to be carried out on a regular basis,
- Identify other ways to increase the extent to which patients and the public, in general, are involved in regulatory processes related to medicines and medical devices intended to be marketed and used in the UK.
According to the new approach suggested by the MHRA, the services provided by the authority should meet the needs of stakeholders. For this purpose, the Agency intends to implement a regular review of its policies in order to be able to take into consideration feedback received.
To achieve this, the MHRA intends to develop the appropriate standards of service delivery based on the principles of confidence and trust. In particular, the Agency will:
- Create a protocol prescribing how requests from patients should be addressed by the authority,
- Implement additional improvements for the Yellow Card framework, and
- Create the Customer Service Centre responsible for communications with patients and the public.
The Agency also intends to improve the existing system of internal training for its staff in order to make the interaction between patients and MHRA more efficient. For instance, the Agency is going to:
- Develop new formats of interactions,
- Carry out consultations with patients dedicated to engagement and involvement – on a regular basis,
- Improve training programs for personnel,
- Implement the patient-oriented approach in all communication processes,
- Pay special attention to the engagement of patients in the context of all long-term goals and objectives.
The UK regulating authority intends to create a patient outcome evaluation framework to assess the actual effectiveness of patient and public engagement in regulatory processes. The aforementioned improvement is planned to be achieved by December 2021. The Agency also mentions that such an assessment will cover all the aspects related to the engagement of patients and involvement of the public and would not be limited to the ones directly prescribed in the present draft strategy. According to the notice, further development in this sphere is important to ensure public confidence concerning the MHRA as a regulating authority, the actions it takes, and medicines and medical devices allowed to be placed on the market.
To make such measurements more precise, the Agency intends to introduce special indexes for all groups of patients. In this context, the MHRA intends to:
- Increase the speed of involvement, especially in terms of information exchange related to adverse events and other issues associated with medicines and medical devices,
- Increase the number of protocols of clinical trials incorporating the patient-reported outcome measures,
- Ensure and demonstrate that feedback and suggestions provided by patients are actually considered by the regulating authority and used as a basis for further actions,
- Improve the way the Agency reacts to feedback from patients,
- Increase the number of focus groups and public consultations,
- Additional surveys covering those who have interacted with the Agency to be performed in order to obtain additional feedback on such interactions,
- Further use of the Government Service Standards in the course of the development of digital services,
- Regular interactions by means of the Patient Group Consultative Forum,
- Evaluation of the effectiveness of patient engagement by comparison to other regulating authorities, including foreign ones.
This objective also covers the internal culture change measures to evaluate how the patient-specific aspects are treated by the MHRA staff. For this purpose, the authority intends to measure the number of staff covered by additional training or activities related to patient involvement and public engagement.
The authority intends to establish partnerships with various parties engaged in operations with medicines and medical devices in order to ensure effective communications. In particular, the MHRA intends to focus on the following aspects:
- Insight Exchange. Active interactions with patients and the general public constitute a valuable source of information the authority may use to improve its regulatory approach and the services it provides. Additionally, the Agency intends to establish an efficient exchange with the patient-reported information with other stakeholders.
- Patient Engagement Mechanisms. The Agency will improve the Patient Group Consultative Forum in order to make it more efficient. Moreover, the MHRA intends to collaborate with other parties developing similar mechanisms.
In summary, the present consolation paper published by the MHRA describes the particular steps the regulating authority will take in order to increase the involvement of patients and the public in all processes related to medicines and medical devices. For instance, the Agency intends to improve existing ones and create new mechanisms of cooperation with all stakeholders in order to ensure the effective exchange of information that could be used to improve the regulatory framework and operating activity of the authority in general.
How Can RegDesk Help?
RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.