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Patient involvement in drug licensing: a case study.

Nicky Britten1, Sarah Denford1, Faith Harris-Golesworthy2

  • 1Institute of Health Research, University of Exeter Medical School, Veysey Building, Salmon Pool Lane, Exeter EX2 4SG, UK.

Social Science & Medicine (1982)
|December 3, 2014
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Summary

Patient groups can offer balanced drug licensing input by merging lived experience with scientific data. This approach helps regulate pharmaceuticalization and influences drug governance effectively.

Keywords:
Drug licensingHealth social movementsPatient groupsPharmaceuticalsPublic involvementUK

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Area of Science:

  • Health Services Research
  • Sociology of Health and Illness
  • Pharmaceutical Governance

Background:

  • Embodied health movements bridge lay and expert knowledge in healthcare.
  • Consumer groups can influence pharmaceuticalization based on their objectives.
  • Patient involvement groups in research collaborations can offer unique perspectives.

Purpose of the Study:

  • To explore if an institutionally funded, non-activist patient group can contribute balanced insights to drug licensing.
  • To assess the potential of such groups to mitigate the pro-pharmaceuticalization impact of other consumer groups.
  • To understand how patient groups evaluate licensing mechanisms and integrate lay knowledge.

Main Methods:

  • A small case study involving a patient involvement group evaluating a second-line type 2 diabetes treatment.
  • Qualitative interviews with five panel members before and after a panel discussion.
  • Analysis of how the group balanced scientific and embodied knowledge in decision-making.

Main Results:

  • Patient panel members were critical of existing drug licensing processes.
  • Embodied experiences of medicines were used to evaluate expert knowledge.
  • Decisions were based on balancing benefits and harms or trusting expert opinions.

Conclusions:

  • Institutionally funded patient groups can provide a balanced perspective in drug licensing.
  • These groups can potentially counterbalance the pharmaceuticalization effects of access-oriented groups.
  • Patient involvement can influence pharmaceutical governance by integrating lived experience with scientific evidence.