Premium
STAKEHOLDER ENGAGEMENT IN PHARMACEUTICAL REGULATION: CONNECTING TECHNICAL EXPERTISE AND LAY KNOWLEDGE IN RISK MONITORING
Author(s) -
MEIJER ALBERT,
BOON WOUTER,
MOORS ELLEN
Publication year - 2013
Publication title -
public administration
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.313
H-Index - 93
eISSN - 1467-9299
pISSN - 0033-3298
DOI - 10.1111/padm.12027
Subject(s) - technocracy , stakeholder , democracy , process (computing) , ideal (ethics) , business , risk analysis (engineering) , public relations , political science , computer science , law , politics , operating system
The exclusive position of scientific expertise in pharmaceutical regulation is being increasingly challenged. Several authors suggest that lay knowledge could play a role in governing risks. We use the literature to develop ideal‐typical regulatory arrangements with low and high lay stakeholder involvement: a technocratic and a democratic arrangement. We propose that a more technocratic arrangement will yield a better process and output performance while a more democratic arrangement will result in more stakeholder satisfaction. These propositions are explored through two case studies of pharmaceutical regulation in the Netherlands: in pandemic influenza and in HIV . Our study shows equivalent process and output performances but we found indications that the democratic approach results in more stakeholder satisfaction. We conclude that in pharmaceutical regulation, there is no a priori reason to limit involvement to experts: in situations of fundamental uncertainty, democratic monitoring of pharmaceutical risks can contribute to the system's robustness.