Article by Julia Aube, Policy Trainee for Healthcare Delivery
The COVID-19 pandemic has jeopardised the access and availability of medicines in the EU, therefore, making the EU more resilient regarding the supply of pharmaceuticals is a key objective of the Pharmaceutical Strategy. In this sense, in June 2021, the European Commission held the Structured Dialogues on the security of medicines supply to build knowledge on the vulnerabilities of the supply chain and promote concrete policy proposals to secure access to medicines. The Dialogues were divided into four workstreams: (1) the robust supply chain, (2) the critical medical products, (3) vulnerabilities, and (4) innovation.
The Structured Dialogue facilitated the discussion between multiple stakeholders including actors in the pharmaceutical value chain, Member States, research community, health professionals and patient organisations. For my master thesis, I analysed the impact of COVID-19 on the EU regulation of the medicines shortages and interviewed several civil society representatives to understand their contribution to the agenda-setting. Several of them highlighted the organisational flaws that hindered the balanced representation of interests.
Considering the ongoing revision of the EU pharmaceutical legislation and future multi-stakeholder debates to ensure access, affordability and availability of medicines, there are key lessons that can be learned from the Structured Dialogue :
1. Ensure the parity between representatives of the public and private interests
For the Structured Dialogue, the participants were able to register to the workstream of their choice, regardless of parity. In most, if not all workstreams, civil society representatives were outnumbered by industry representatives. While civil society’s presence in the public policy was welcomed, their voices should also be heard. Ensuring parity through the upstream mapping of stakeholder’s interests and purposive sampling of stakeholders in each workstream, or weighted allocation of speaking time when numerical equality could not be reached, may have balanced the representation of interests in the problem analysis.
2. Allocate the rapporteurship to a neutral third-party
During the Structured Dialogue, the rapporteurship role was often attributed to representatives of the pharmaceutical industry which led to a biased representation of interests. Allocating the rapporteurship to a third-party, such as a consultancy group, may increase transparency but also accountability and inclusion of all actors in the process. Involving a third-party, that would be both knowledgeable of the supply chain and the impact of medicines in access and unaffordability on healthcare systems, can also capture all stakeholder’s views and policy recommendations to develop coherent and informed policies.
3. Strengthen the academia representativeness in the policy debate
Civil society representatives can testify the impact of medicines’ unavailability or unaffordability on patients’ continuity of care or physician’s practice. However, the understanding of the global supply chain and drivers of the potential vulnerabilities is complex. The strengthened representativeness of academia or independent experts on the supply chain, in the policy debate, can guarantee an impartial verification of facts and ensure the development of critically appraised and evidence-based policies.
4. Secure the public funding of civil society organisations
The limited financial and human resources constrain the civil society’s ability to act in full capacity and limit the scope and impact of their activities. Perennial public funding is key for a strong civil society that can build capacity, strategize and advocate for the public interest before and during the policy debates with the pharmaceutical industry. Public funding is a tool to overcome the structural imbalance and restore the fair representation of public and private interests regarding access to medicines.