Introduction
Scientific guidelines for medicines and vaccines are a part of the
complex governance framework for pharmaceutical innovation in Europe.
Scientific and technological advances are crucial to improve patients’
health, and support a more efficient, and cost effective, way of
discovering and using medicines [1]. Allowing patients in the
European Union (EU) to benefit from state-of-the art healthcare. As
recognized in the European Medicines Agency (EMA) Regulatory Science
Strategy to 2025, the EU network is responsible for providing a
regulatory environment that supports innovation and the development of
new and better medicines to meet human and animal health needs [2].
Regulatory guidelines aim to optimize and increase the predictability of
innovative developments by providing the standards of evidence that must
be met to determine the benefit/risk profile or quality to be achieved.
These guidelines should reflect and build on the most up-to-date
scientific knowledge [3] in providing a harmonized approach how
pharmaceutical industry develops and subsequently how regulatory bodies
perform their assessment of new marketing authorisation applications or
updates to marketing authorisations.
The EMA follows the principles and standards set by the European
Commission guideline on better regulation [4]. The four principles
set forth by the Commission are participation, openness and
accountability, effectiveness and coherence. The aim is to ensure as
representative and inclusive consultation process as possible but also
to give stakeholders a real opportunity to influence before the document
under development is finalised. The Commission guideline also highlights
the importance of prioritization of stakeholders on the basis of impact,
responsibility for implementation and interest in the topic [4].
When assessing stakeholders with an interest, it is also critical to
identify which competence and knowledge these different stakeholders can
bring to the creation process. Academia, government, industry and civil
society, are often referred to as “quadruple helix model”. Quadrable
helix model is a construct in which the four stakeholders are recognized
as contributors to the innovation system. Their engagement is supported
through partnerships, networks and relationships with the aim to have
the whole society involved in the co-creation process of innovations and
technological advancements [5]. The quadruple helix model can
enhance knowledge translation process which is necessary and valuable
for evidence-based policymaking [6].
A well-designed evidence collection and interpretation processes can
reduce the inherent risks of unintended consequences and negative
externalities associated with regulatory guidelines [7]. The World
Health Organization (WHO) Good Regulatory Practice
Guidance calls for conducting a regulatory impact assessment to
consider all the different perspectives and to allow for various
stakeholders to provide timely input [8]. This proposed consultation
will provide an indication to which extent there is an impact assessment
process which ensures a harmonized approach amongst all stakeholders
based on the the most up-to-date scientific knowledge and/or real-life
experiences. Additionally, the likelihood of compliance with regulations
is increased when affected parties understand the underlying policy
considerations and feel that their input has been seriously considered.