Table 3 ICH governance trajectory: Parallels to European regulator governance

1987–95

Transnational harmonization

Harmonization of pharmaceutical standards across EU, US and Japan through ICH

• Consensus-based governance: among regulators and industry trade associations in EU, US and Japan;

• Funded and housed by IFPMA;

• Industry members may chair standards Working Groups;

• Industry and regulators have equal votes in determining standards;

• Guidelines on safety, efficacy and quality reflect EMA standards

Transnational harmonization

Harmonization of standards pioneered in EMA; EC single market for pharmaceuticals demonstrates feasibility

• Consensus-based governance: among member state regulators;

• EU Centralized and decentralized process for authorizing medicines;

• Centralized concertation process for innovative products, GMP, labelling, advertising guidelines, rules for blood products and vaccines;

• UK and France: regulators use corporatist governance and negotiation with industry.

2000–1

Common technical document

• Harmonized product dossier for electronic submissions

Common technical document

• Used in EMA

• EU Clinical trial directive

2004–5

Risk Management Plan

Expands ICH role from harmonization to development of new standard

Risk Management Plan

UK House of Commons Health Committee criticizes MHRA relationship with industry and routine policy consultations; advises review of MHRA, post-market surveillance

2010–12

Conflict of Interest addressed

• Industry members can no longer chair an ICH Working Group developing an international standard

Conflict of Interest addressed

• Inquiry into France’s AFSSAPS concerning Mediator (benfluorex) highlights COI undermined regulatory decisions;

2012–5

Governance reforms:

• Negotiated governance: for decisions with no consensus, regulators vote;

• ICH is legal entity under Swiss law;

• Assembly; Management Committee;

• Membership fees fund ICH;

• Membership expands jurisdiction

Governance reforms:

• New French regulator (ANSM)

• EMA enables researcher access to clinical trial data

• EMA possibility of public pharmacovigilance hearings