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Detailed guide: Opportunities for patients and the public to be involved in the work of the MHRA

Medicines Healthcare Products Regulatory Agency

June 15
16:00 2020

We are committed to delivering a step-change in the way we engage with patients and the public, putting their views and interests at the heart of our decision-making and culture.

We are taking steps to adopt a more transparent, responsive and systematic approach to listening to and involving patients and the public.

A fresh approach to patient and public engagement

In 2019 we ran a 12-week consultation on how we should engage and involve patients and the public in our work.

We published our findings and our response in June 2020.

Patient Group Consultative Forum

Our Patient Group Consultative Forum is open to people with an interest in medicines and medical devices, and to patient groups who can represent the views of their members and feed these into discussions. It acts as a means of bringing the patient/public voice into the Agency, to assist in our development of policy or our approach to a specific regulatory or scientific research area.

The Forum is managed by our Patient, Public and Stakeholder Engagement team and currently has over 100 participants, who are either representatives of patient groups/networks and research charities or individual patients.

We hold up to 4 meetings a year, and Forum participants can potentially also attend subject-specific workshops, provide comments (from the patient/carer perspective) on draft materials and participate in surveys that inform the development of our work.

Examples of topics covered in previous meetings:

  • patient attitudes to risk/benefit of medicines and the Accelerated Access Review
  • packaging of medicines patient views/experience/examples
  • medical device labelling and instructions patient views/experience/examples
  • regenerative medicine patient views on the pathways from innovation to clinical use
  • patient views on the regulatory implications of risk, customisation and data collection/ownership in relation to three bio-modifying technologies: gene editing, stem cell therapy, 3D printing
  • how patients could help to raise awareness of the Yellow Card scheme and the Early Access to Medicines Scheme

We expect participants in the Forum to be able to meet the following criteria:

  • a demonstrable interest in medicines and medical devices and the role they play in improving health and increasing quality of life
  • an interest in the regulation of medicines and devices
  • an interest in science and research
  • a commitment to the principles of patient and public engagement and involvement
  • an ability to draw on their experiences as a patient and as a consumer of medicines and medical devices and translate this into a population level perspective
  • an interest in championing patient safety
  • the commitment to participate in the work of the agency by attending patient group consultative forum meetings and participating in electronic methods of engagement
  • an ability to respect boundaries and confidentiality
  • an ability to contribute constructively to discussions
  • an ability to communicate effectively
  • a commitment to the agency values:
    • innovative
    • proactive
    • impartial
    • evidence-based
    • open
    • trustworthy

If you would like to get involved, either as a representative of a patient group or research charity, or as a patient or a carer, please email engagement@mhra.gov.uk.

Other examples of patients involvement in our regulatory processes

Reclassification of medicines

Patient and public representatives are part of expert panels established by the Commission on Human Medicines to advise us on issues which are important to them relating to how they access medicines, whether this be through obtaining a prescription from a doctor or being able to purchase a medicine from a pharmacy. More information can be found about these groups in the report of the UK Medicines Reclassification Platform

Licensing of medicines

In 2018 we changed the licence for tamoxifen to approve its use in the primary prevention of breast cancer in women at moderate or high risk. This was an important step to make tamoxifen available for breast cancer prevention. Patients taking tamoxifen and women at high risk of developing breast cancer participated in an expert group meeting that helped to inform the decision.

In 2019 we renewed the scientific opinion (which is an assessment of the risks and benefits of a medicine), issued under the Early Access to Medicines Scheme for Raxone to treat the decline of respiratory function in patients with Duchenne Muscular Dystrophy. The renewal decision was informed by a patient-focused meeting at which patients currently taking Raxone and their carers contributed views on how the medicine helps them to maintain quality of life.

Valproate Stakeholders Network

Valproate is a treatment for epilepsy and bipolar disorder and is prescribed to thousands of women. Since its introduction in 1974, the product information for doctors has included a warning about the possible risk of birth defects and developmental disorders in children born to women who take valproate during pregnancy. See our Valproate guidance page for more information about the risks and regulatory action taken to date.

In 2016 we established the Valproate Stakeholders Network (VSN), comprising representatives from over 40 different organisations including: healthcare professional bodies, health system delivery agencies and regulators, patient groups and research charities (for the indications of bipolar, epilepsy and migraine) plus campaign groups representing the families affected.

The VSNs purpose is to provide stakeholders with opportunities to contribute to the development of the materials to support implementation of the new 2018 regulatory measures and to help us communicate the information to healthcare professionals and patients.

Medicines in Pregnancy and Breastfeeding Consortium

To support the implementation of recommendations from a Report of the Commission on Human Medicines we established a consortium of the key providers of information to women and healthcare professionals regarding medicines taken during pregnancy and breastfeeding.

The consortium includes representatives from relevant NHS agencies, doctors professional organisations and information services, The British Pregnancy Advisory Service, The Breastfeeding Network and The National Childbirth Trust.

The consortiums aim is that all women will have access to accurate and accessible information to make informed decisions with their healthcare professional about taking medicines before or during pregnancy or breastfeeding.

Get involved

If you would like to be considered for participation in future opportunities for involvement in our work, please email engagement@mhra.gov.uk stating your areas of interest.

Public sessions of the Board

Each year we aim to hold six sessions of the Agency Board meetings in public. See further details of these public sessions, including how to register to attend. Details about the Agencys governance can be found on the relevant pages for the corporate executive team, advisory bodies and the

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