Introductory slides tothe webinar on EUPATI Guidance on Patient Involvement in Regulatory Processes

1. EUPATI Guidance for patient
involvement in regulatory processes
David Haerry, European AIDS Treatment Group, on behalf of the
EUPATI team

2. Contents
 Why have guidance?
 Process followed (review, workshops,
consultation)
 Content regulatory guidance
 Key points within each chapter (referencing online
guidance document)
 Questions welcome

3. EUPATI guidance for patient involvement
in regulatory processes – why?
 Patients & patient organisations to be involved more widely
• include early & post-approval stages,
not confined to clinical development
 Overarching guidance on meaningful and ethical interaction
is missing in many areas, especially in R&D, causing insecurity
• Existing codes/regulations hold mostly general legal & ethical
content, i.e. collaboration in general, communication, funding
• EMA framework of interaction with patient & consumer
organisations is an exception – mature document, covering all
areas & aspects in regulatory processes along product lifecycle
• EMA recommendations apply to EMA remit only. Aspects relevant
to national competent authorities are missing.

4. EUPATI Guidance documents to support
the systematic interaction in R&D
After extensive consultation, EUPATI has developed guidances for the
interaction of patient organisations with stakeholders
 in industry-led R&D
 in HTA
 in regulatory processes
 in ethics committees
Intensive public consultation
ended in Sept 2016,
publication in December 2016
Source: EUPATI Guidance documents on patient involvement in R&D (with regulatory processes, industry-led R&D, Ethics Committees
and HTA bodies), https://www.eupati.eu/guidance-patient-involvement/,  EUPATI.eu  Resources  Guidances

5. EUPATI Guidance for patient involvement
in regulatory processes
 Involvement of patients’ experience with regulators has a long history
 FDA
• 1988: Patient Representative Programme introduced after HIV activist lock down.
More than 200 people with part-time job on FDA pay-roll today
• 2016: FDA announced new working group with patient advocacy organisations
based on EMA PCWP model
 EMA
• Informal contacts with EATG from 1997
• 2000: Patients join Committee for Orphan Medicinal Products COMP as full
members
• 2003 Working group with patient organisations created
• 2005 Framework of interaction with patient and consumer organisations
• 2006: Patient & Consumers Working Party PCWP created
• 2014: Revision of framework for interaction
• 2017: Systematic inclusion in EMA regulatory outputs

6. EUPATI Guidance for patient involvement
in regulatory processes
 National competent authorities
 France
• 2006: AFSSAPS initiates structured interaction with patient groups
 Switzerland
• Trial phase ongoing since 2014
• No legal basis
 Other countries
• Austria, Canada, Germany, Italy, Netherlands, Sweden, United Kingdom (list not
comprehensive)

7. EMA Patient & consumer
involvement over years
167
213
307
423
525
551
633
743
770
0
100
200
300
400
500
600
700
800
900
2008 2009 2010 2011 2012 2013 2014 2015 2016
Slide courtesy EMA

8. Patient involvement at EMA

9. Categories of patient participation
Slide courtesy EMA

10. At national level: Swissmedic
• Pilot on Package Leaflet text review to start in
2017
• Focus on readability, understandability,
completeness in new product applications
• Complex undertaking involving companies on
voluntary basis due to missing legislation

11. Documentation
• European regulation (EC No 726/2004) article 78
• EMA Framework for interaction with patients, consumers
and their organisationsEMA “handling competing
interests” webpage
• Code of practice between patients organisations and the
healthcare industry (developed by PCWP members)
• EUPATI guidance on patient engagement with industry
• EUPATI guidance on patient engagement in regulatory
processes