Guidance for the Governance of Public-Private Collaborations in Vaccine Post-Marketing Settings in Europe

"At the European level, collaborative vaccine post-marketing projects...are hampered by the current context of vaccine hesitancy and public distrust in institutions. In this light, ADVANCE has developed guidance for appropriate communication strategies for vaccine benefit/risk results..."

ADVANCE is a consortium of more than 47 public and private partners working to implement a framework of transparent governance rules for collecting post-marketing data on influenza pandemic vaccine exposure, safety, and effectiveness in Europe. Through the experience of ADVANCE, this article examines the creation of infrastructures to strengthen public-private collaborations (PPCs) with processes to improve stakeholder interactions and collection and analysis of vaccine safety and effectiveness data.

Established in 2013 through Innovative Medicines Initiative (IMI) funding, ADVANCE is composed of European public and private stakeholders, including national public health institute (PHIs), the European Centre for Disease Prevention and Control (ECDC), the European Medicines Agency (EMA), national regulatory authorities (RAs), research institutes, universities, contract research organisations (CROs), and vaccine marketing authorisation holder (MAHs). ADVANCE has developed 2 components of best practice guidance: a code of conduct for collaborative vaccine benefit-risk studies (published elsewhere) and governance guidance for transparent, ethical, and trustworthy PPCs. The overall methods used for the development of the governance guidance proposal are summarised in Figure 1 in the paper.

The process was initiated in March 2014, and the proposal for guidance was finalised in September 2017. Key steps included:

1. A landscape analysis through a survey of European stakeholders and a literature review to identify existing PPCs in the field of public health, and more specifically in the vaccine area;
2. Development of the following aspects of a governance framework, using information from the PPCs identified in the landscape analyses: identification of potential advantages and disadvantages of PPCs in the vaccine area; clarification of governance functions; and establishment of core principles at the project level.
3. Internal and external consultations, where a key point to emerge was that having trust between participating stakeholders within a PPC and between participating and non-participating stakeholders was key. "A fully transparent process, based on open communication, information-sharing and shared decision-making can increase support for PPCs. Consistent, timely and proactive communication is primordial to help build public trust."

This process highlighted potential advantages and disadvantages of PPCs as perceived by ADVANCE participants, which helped shape the governance proposals. Example advantage: "Multi-stakeholder collaborations that can create scientific, resource and communication synergies may have a greater impact for benefit-risk monitoring than a single stakeholder and could provide more robust results covering diverse populations and larger specific population groups than a single stakeholder. Established PPCs would be more rapidly able to respond to an emergency as the creation of such collaborations can take a considerable time." There are, however, disadvantages, such as that "Concerns about scientific integrity and independence due to potential or real conflicts of interest when public authorities and vaccine MAHs collaborate could...have a negative impact on public trust."

According to ADVANCE, core governance principles for a PPC include:

• The governance model should be as simple as possible, transparent, acceptable to all partners, and appropriately sized.
• The roles and responsibilities and decision-making rules should be agreed between the partner organisations and included in the project contract.
• The structure and processes of the governance model should reflect mutual respect and shared benefits.
• The governance structure should ensure that the perspectives of all partners will be taken into consideration during the collaboration.
• All decisions and key communication from governance committee meetings should be recorded to facilitate compliance monitoring. Relevant documents should be made publicly available on the project website. A communication plan should be developed and agreed between partners at project initiation.
• Procedures related to compliance with good practices should be shared between partners, and specific training to promote compliance with these should be provided.

ADVANCE identified 5 core governance functions for PPCs: the decision-making function; the scientific advice function; the quality control and audit function; the implementation and management function; and the financial management function. Based on this vision, ADVANCE proposes a generic governance model, with options, as an optimal and flexible solution that could take into consideration the wide range of project specificities that may be present in the vaccine post-marketing setting in Europe.

The article offers recommendations for the roles the various partners can play in PPCs. For example: "The active participation of patient associations and civil society organisations is strongly recommended because of their added-value for a productive vaccine post-marketing benefit-risk evaluation, as well as for their support for enhancing transparency and public trust. They could be involved as members of the steering committee (with voting rights or as observers), or as members of the scientific committee or quality control & audit committee for those with the relevant expertise. They could also be involved as independent external experts, e.g., for reviewing project information in external communication material for the lay public."

In conclusion: "The discussion about methods initiated in ADVANCE needs to be continued to address the specificities of vaccine-preventable diseases and to involve all stakeholders with the participation of the main European institutions, i.e., the ECDC and the EMA." ADVANCE suggests that the proposed framework can be adapted to other scientific settings or regions in the world. To that end, the proposals for governance guidance shared herein "now need to be applied in real-life collaborations...to assess what works and what does not work and what added-value can be obtained from these collaborations."