Acceptance of stakeholder comments during EMA scientific guidelines
public consultations: legitimacy of the quadruple helix model of
innovation
Abstract
Aim: 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 EU, and by that, they have an impact on
the pipeline decisions taken by the research-based industry. This study
analyses the level of acceptance for changes suggested by stakeholders
within the authoring groups at the EMA. Methods: We looked at 87
guidelines from EMA Working Parties (WPs) launched for consultation
between 2013-2017. Acceptance of stakeholder proposals and the time
between the end of consultation and guideline adoption were studied as
well as the openness of different Working Parties to accept changes.
Results: Adoption of a guideline after the close of public consultation
took at least 4 months, with average 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 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. The EMA WPs working with emerging technologies were more
open to accept proposed changes. 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. Further integration and utilisation of
competences of each stakeholder is necessary for guideline development.