This article was co-authored by Rachel Westphal, Litigation Assistant, Cambridge.
On 1 February 2023, the Council of Europe (COE) Committee of Ministers adopted Recommendation CM/Rec(2023)1 “on equitable access to medicinal products and medical equipment in a situation of shortage”.
Here, we provide an overview of this Recommendation and its implications on the provision of healthcare in times of shortages in the United Kingdom.
The United Kingdom is a member state of the COE (a separate organisation from the Council of the European Union), which oversees the European Court of Human Rights and adopts policy, including Recommendations. This COE Recommendation provides a policy framework to be implemented into member states’ laws and practices and thus will impact the provision of healthcare within the UK. Shortages of medicinal products and medical equipment occurred globally as well as in the UK during the COVID-19 pandemic. Whilst there will be constraints on any publicly-funded health system, implementation of this Recommendation’s guidelines is intended to improve outcomes in future shortages.
In summary, the COE Recommendation proposes principles for determining and implementing access decisions in times of shortages as well as preparing to minimise shortages when they do arise.
This Recommendation centres on shortages of medicinal products and medical equipment utilised in treating life-threatening conditions. Developed by the COE’s Steering Committee for Human Rights in the fields of Biomedicine and Health and the former Committee on Bioethics, the aim is “to promote equitable access to medicinal products and medical equipment in a situation of shortage and safeguard the fundamental rights of individuals who need them for serious or life-threatening health conditions”. To achieve this, the guidelines for this COE Recommendation include principles for making access decisions, procedural principles for implementation, and a system to prevent, prepare for, and mitigate shortage.
Decisions regarding access to medicinal products and medical equipment should be based on a set of general principles (see Chapter II - Articles 4 to 8 in the Guidelines within the Appendix of the Recommendation).
Attention must be paid to non-discrimination and to “systematically disadvantaged individuals in relation to health”. The COE gives examples of individuals and groups that require protection from discrimination, including “persons with disabilities, with mental health problems, or learning disabilities, as well as those exposed to risks of discrimination or stigmatization”, including “individuals belonging to minorities”, experiencing homelessness or “living in poverty”. Further examples “include those individuals with addiction, geographically isolated, deprived of liberty, low-income migrant workers, and individuals without residence or with insecure legal status”.
There should also be prioritisation based on medical criteria, which requires undertaking an “individual medical assessment”. This assessment should consider the severity of the “individual’s health condition”, healthcare requirements and anticipated “effectiveness of the medicinal products or medical equipment for the healthcare of the individual concerned”, alternative healthcare, and the consequences of lacking access. In prioritising medical criteria, there should be a focus on minimising the risk of mortality and morbidity. Another principle to be taken into account is “Appropriate support and removal of barriers”. Further, there should be respect for the dignity of persons excluded from access; they should be offered other healthcare or palliative care.
Access decisions should be implemented in line with a set of procedural principles (see Chapter III - Articles 9 to 14 in the Guidelines within the Appendix of the Recommendation). These include accountability, which means ensuring that responsibilities for access decisions and avenues to provide feedback are clear. Reasonableness and relevance are also key; access decisions should be based on fair and objective evidence. Inclusiveness should be considered through dialogue, education, and revising policies. Consistency should be valued in order to prevent corruption whilst allowing for careful local flexibility. The transparency and communication of decisions means that there should be an understandable and accessible rationale for access decisions and that the reality of the situation should be shared. Further, review should be central, with feedback, new evidence, and monitoring refining access decisions.
Prevention, preparation, and mitigation
There should be a system for prevention, preparation, and mitigation (see Chapter IV - Articles 15 to 21 in the Guidelines within the Appendix of the Recommendation). Prevention includes utilising data to predict the likelihood of shortages. Preparation should be undertaken to minimise risks and limit the consequences of potential shortages. Mitigation should include monitoring shortages, conserving resources, seeking alternative healthcare options, and reallocating resources. Further, information should be promptly and clearly shared, responsibilities in dealing with shortages should be well defined, and international cooperation should be undertaken.
Anticipating and preparing for any future pandemics
The Recommendation does not cover access to vaccines, which is covered by a separate Recommendation. It does apply to medicinal products and medical equipment and these would include, we anticipate, in the context of the COVID-19 pandemic, ventilators as well as COVID-19 therapeutics approved by a regulatory agency, excluding those used “off-label” (i.e. outside authorisation).
The Recommendation should be of particular interest to the UK and further consideration might be given to adopting national triage guidelines in times of pandemic or similar to help guide the national network of clinical teams when resources are stretched. Such would presumably form part of a system in following the Recommendation to ensure equitable access to medicines and medical products.
Review of the response to the COVID-19 pandemic in the UK
The retrospective review of the response to the COVID-19 pandemic in the UK has aligned, in part, to the principles and the system of prevention, preparation, and mitigation in the COE Recommendation.
In the Technical Report on the COVID-19 pandemic in the UK, the Department of Health & Social Care discussed disparities and attempts to mitigate them, prioritisation efforts, and learnings.
The NHS Confederation briefing on supply chain resilience recognised causes of pandemic shortages included problems with demand as well as disruptions in manufacturing and transportation.
The Boardman Review of Government Procurement in the COVID-19 pandemic sets out a variety of recommendations to prepare for future events similar to the pandemic. These recommendations include better contingency planning, utilising ‘supply chain maps’, building resilience in the supply chain, designing scalability, training in crisis and risk management, and reviewing forecasting models. As set out in the NHS Confederation briefing, in response to the shortages that occurred during the pandemic, actions taken by NHS Supply Chain include increasing stock-holding, mapping the supply chain, and managing supply chain risk, among others.
In reviewing the COVID-19 pandemic and the shortages that occurred, better application of principles for access decisions and an improved system of prevention, preparation, and mitigation can be employed to minimise the harm of any potential future shortages. By retrospectively analysing the COVID-19 pandemic, the Government and the NHS have already begun implementing the principles and system proposed in the COE Recommendation. A more formal consideration and implementation of this Recommendation will further improve outcomes in the event of potential future shortages.
Rob Tobin sat on the UK National Emergency Critical Care Committee (NECCC) during the COVID-19 pandemic.