Acceptance of stakeholder comments during EMA scientific guideline public consultations: Legitimacy of the quadruple helix model of innovation.

Résumé

AIMS: Guidelines establish a framework for how therapeutics and vaccines are developed, assessed and approved. They influence which innovations are likely to be approved in the European Union (EU), and thus, they have an impact on the pipeline decisions taken by research-based industry. This study analyses the level of acceptance for changes suggested by stakeholders within the authoring groups at the European Medicines Agency (EMA).METHODS: We looked at 87 guidelines from EMA Working Parties (WPs) launched for consultation between 2013 and 2017. Acceptance of stakeholder proposals and the time between the end of consultation and guideline adoption were studied as well as the openness of different WPs to accept changes.RESULTS: Adoption of a guideline after the close of public consultation took at least 4 months, with an average of 12-16 months. The number of accepted and rejected comments were nearly equal across the stakeholders, with government having slightly higher chance for acceptance. Academia and nongovernmental organizations (NGOs) had generally higher chances to have their comments accepted for general and indication-level guidelines. Government and individual companies had highest acceptance for molecule-level guidelines and trade associations for indication-level guidelines. Only a third of the comments related to scientific content of the guideline.CONCLUSION: This pattern of progress in regulatory science at EMA demonstrates the essential and interrelated role of academia, industry, government and civil society-described as the quadruple helix model-to promote establishment of a strong innovation ecosystem in Europe.