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.