Opportunities for patients and the public to be involved in the work of the MHRA
How we engage and involve patients and the public in our regulatory decision-making.
- From:
- Medicines and Healthcare products Regulatory Agency
- Published
- 15 June 2020
- Last updated
-
910OctoberJune20242026 — See all updates
We
Agency’s arecommitment committed to deliveringpatient, apublic step-changeinvolvement inand theengagement
The wayMHRA’s wecommitment engageto withpatient, patientspublic involvement and theengagement public,is puttingincluded theirin views and interests at the heartagency’s Corporate ofPlan our decision-making and culture.2023-26.
We are takinga stepssignatory toof adoptthe shared acommitment moreto transparent,public responsiveinvolvement andin systematicresearch. approachRead tomore listeningin toour andblog Reflections involvingon patientsthe andshared thecommitment public.to public involvement.
Our approach to patientpatient, and public involvement and engagement
Our first Patient Involvement Strategy published published in October 2021 set out how we willwould engage and involve the public and patients at every step of the regulatory journey. Our approach was informed at the very outset through consultation with patients on what was important to them. The Independent Medicines and Medical Devices Safety Review also provided us with clear direction on where we could improve our engagement with patients, and the resulting strategy was then approved by our Patient Safety and Engagement Committee and Agency Board.
If you would like to read about some of our activities within the first year of the strategy, please see our One Year On report for more information.
What the Public and Patient Involvement and PublicEngagement CommunityTeam do
The PatientPatient, Public Involvement and PublicEngagement CommunityTeam (previously(PPIE) knownacts as thea Patientcentre Groupof Consultativeexpertise Forum)within wasthe establishedMHRA, inadvising Octoberand 2024supporting followingMHRA theteams reviewto ofplan, ourdesign strategy and howdeliver wehigh‑quality couldpatient improveand public involvement of our Patient and Publicengagement community.activities.
ItSome isof openthe toprojects peoplewhere withthe anpublic interestand inpatient medicinesengagement andhas medicalassisted devices,us andinclude:
Rare toDiseases
The patientMHRA groupshas whoset canup representa theRare viewsDisease ofConsortium theirto memberswork andwith feeda theserange intoof discussions.stakeholders Itincluding actspatient asrepresentatives athat meanssupport the development of bringinga thepatient- ‘patient/publicfocused voice’regulatory intoframework. theThe agency,framework towill assistaddress inthe ourunique developmentchallenges of policyrare ordiseases ourand approachsupport tothe atimely specificaccess regulatoryto orinnovative scientific research areas.therapies.
WeIn expect2025 participantsworkshops inand themeetings Communitytook toplace bewith ablepatients toand meetpatient therepresentatives followingto criteria:
againdemonstrabletheirinterestviewsinonmedicinesaandrangemedicalofdevicesfundamentalandissues for theroledevelopmenttheyofplaytheinframework.improvingContinuedhealthpatientandinvolvementincreasingforqualitythisofworklifeanwillinterestbeincrucial as theregulationpatientofandmedicinesrareanddiseasemedicalcommunitydevicesanhaveinteresttheinlivedscienceexperience andresearchaexpertisecommitmentto enable theprinciplescreation ofpatientaandframeworkpublicthatengagementbest meets their needs.ILAP
The Innovative Licensing and
involvementanAccessabilityPathwayto(ILAP)drawis focused ontheirgettingexperiencestheasmostatransformativepatientnewandmedicinesastoapatientsconsumerinofthemedicinesUKandhealthmedicalsystemdevicesmoreandquickly.In
translate2025,thistheintoPPSE team recruited apopulationpoollevelofperspectivean20interestLayinMemberschampioning(memberspatientofsafety- the
commitmentpublic) toparticipateworkinwith theworkILAPofteam over theagencynextby2attendingyears.theTheyPatientbringandthePublicpublic,Communitypatientmeetingsperspective andparticipatingvoiceintoelectronicthemethodsassessment and selection ofengagement anILAPabilityapplications.To
toensurerespectthatboundariesLayandMembersconfidentialityanwereabilityable to contributeconstructivelyeffectively,totheydiscussionsanreceivedabilityatocomprehensivecommunicateinductioneffectivelyathatcommitmentexplainedtotheagencyILAPvalues:innovativeproactiveimpartialevidence-basedopentrustworthy
Theprocess, Communitytheir isrole managedwithin byin ourit Patient, Public and Stakeholderhow Engagementto teamassess andapplications comprisesfrom ofa representationnon-scientific fromperspective. patientLay groups/networksMembers andare charities/researcha charitieskey orpart individualof patientsthe orILAP carers.process.
What
Lay communityMember membersfeedback willhas do
Asprovided athe memberILAP ofteam thewith community,crucial youinsight can:
InfluenceinandhowinformtoourimproveworkthebyassessmentsharingofyourapplicationsinsightsforandfutureperspectivesHelprounds.usThistoprocessimproveofhowcontinualweimprovementinvolvewillpatients,continuecarersgoingandforward.National Commission into the
publicRegulation of AI inourHealthcareThe
workStayNationalinformedCommission into the Regulation ofourAIkeyindevelopmentsUseHealthcareyourislivedanexperience,expert,ornon‑statutorythatadvisoryofbodytheestablishedcommunitybyyoutherepresent,MHRA tohelpreviewothersexistingtoregulationsbeandengagedprovidewithrecommendationsourforwork
Wea willfuture hostregulatory eventsframework focusedfor onartificial aintelligence specificin areahealthcare.
The work of the agency’sCommission work.includes Thisa willcomprehensive provideresearch communityand membersengagement toprogramme. learnKey moreengagement aboutactivities ourhave activitiesincluded:
- A
andcallmeetforagencyevidencestaff.survey -
Three
CommunitydeliberativememberssessionswillheldalsoacrosshavetheopportunityUK,towithprovideparticipantscommentsselected(fromto reflect thepatient/carerdemographicsperspective)ofoneachdrafthostmaterialsregion. -
Three
andfocusparticipategroupsinwithsurveystargetedthatseldom‑heardinformcommunities: -theYoungdevelopmentpeople -ofUnpaidourcarers -work.People with learning difficulties
GetPublic involved
and Patient Community
WeThe continuePatient toand growPublic andCommunity evolve(PPC), andpreviously areknown keenas tothe gainPatient aGroup wideConsultative andForum, diversewas rangeestablished ofin patientsOctober and2024 conditionsfollowing fora thereview Patientof andour Publicstrategy Community.to Therestrengthen arehow twopatients typesand ofthe membershippublic –are individualinvolved orin voluntaryMHRA’s andwork.
The communityPPC sector.is Ifa youkey orMHRA yourtool organisationfor wouldpatient likeand topublic getinvolvement. involved,It eitherenables asthe aagency representativeto ofengage ameaningfully with patients and patient group,organisations orto charity/researchinform charity,regulatory orwork asand apolicy patientdevelopment, orhelping ato carer,shape signour updecision‑making.
Who usingcan join the relevantPPC?
The ‘ExpressionPPC ofis interest’open form.to Beforeindividuals youwith signan up,interest pleasein ensuremedicines thatand youmedical havedevices, readas andwell understoodas ourpatient Workinggroups Togetherand Agreement.
Expressionorganisations ofthat interestcan formrepresent –the Individual
Expressionviews of interesttheir formmembers. -The Organisation
PublicCommunity sessionshelps ofbring the Board
Eachpatient yearand wepublic aimvoice tointo holdMHRA sixpolicy sessionsdevelopment ofand theregulatory Agencyand Boardscientific meetingswork.
Members inare public.expected to:
See further
detailspart ofin thesePPC publicmeetings sessions,and includingonline howengagement
As ifa PPC member, you wouldwill likehelp to beshape keptMHRA’s updatedwork aboutby Agencysharing Boardyour meetingsinsights, insupporting publicbetter andinvolvement alsoof findpatients outand aboutthe whatpublic. isYou goingwill onbring inyour thelived MHRAexperience thatto mightsupport beMHRA ofengagement. interestYou towill you,have plusthe newsopportunity aboutto involvementgive activities feedback thaton aredraft happeningmaterials outsideand thetake MHRApart butin aresurveys linkedthat toinform our work.
Details
How aboutto theget agency’sinvolved
We governanceare cankeen beto foundbuild ona thediverse relevantand pagesinclusive forCommunity, ‘Ourrepresenting governance’a and ’Advisorywide bodies’ range includingof theirconditions, respectiveexperiences responsibilities and members.perspectives.
Agency’s
There commitmentare totwo patienttypes engagementof and involvementmembership:
Our
- Individual
commitmentmembersto(patientspatientor carers) - Voluntary and
publiccommunityengagementsectorisorganisations
If includedyou inwould thelike agency’s Corporateto Planjoin, 2023-26.
Weplease arecomplete athe signatoryrelevant Expression of the sharedInterest commitmentform toand publicread involvementour inWorking research.Together ReadAgreement morebefore inapplying.
Working ourTogether blog ReflectionsAgreement
Expression onof theinterest sharedform commitment– toIndividual
Expression publicof involvementinterest form - Organisation.
Updates to this page
Sign up for emails or print this page
Explore the topic
Update history
2026-08-26 16:37
Added section detailing the ‘MHRA Payment Policy for public participation’.
2026-06-10 12:26
Added – Agency’s commitment to patient, public involvement and engagementAdded – What the Public and Patient Involvement and Engagement Team doUpdated – Our approach to patient, public involvement and engagementUpdated – Public and Patient CommunityRemoved – Public sessions of the board
2024-10-09 14:25
Included ‘ways to get involved’ including the documents: -Working Together Agreement-Expression of interest form – Individual-Expression of interest form – Organisation