Strasbourg, 30 September 2022                                                                    CDBIO(2022)9REV2

STEERING COMMITTEE FOR HUMAN RIGHTS IN THE FIELDS OF BIOMEDICINE AND HEALTH (CDBIO), Draft Recommendation on equitable access to medicinal products and medical equipmentin a situation of shortage, as revised at the Consultation meeting held on 20 September 2022

Preamble

The Committee of Ministers, under the terms of Article 15.b of the Statute of the Council of Europe;

Considering that the aim of the Council of Europe is the achievement of greater unity between its members and that one of the methods by which this aim is pursued is the maintenance and further realisation of human rights and fundamental freedoms;

Bearing in mind the Convention for the Protection of Human Rights and Fundamental Freedoms (ETS No. 5);

Bearing in mind the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (Convention on Human Rights and Biomedicine, ETS No. 164), which requires the Parties to take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality;

Underlining the other principles laid down in the Convention on Human Rights and Biomedicine, in particular the principle of free and informed consent, the protection of persons not able to consent, the respect for private life in relation to health information, and the obligation to carry out any interventions in accordance with relevant professional obligations and standards;

Bearingin mind the European Social Charter (ETS No. 35) and its Revised version (ETS No. 163), in particular their Article 11 (The right to protection of health), in the light of its interpretation by the European Committee of Social Rights;

Conscious that health care systems may be greatly affected by unpredictable events and developments, such as epidemiological outbreaks and armed conflicts, and by the negative health-related effects of climate change;

Considering that medicinal products and medical equipment are an essential part of health care, which significantly contribute to saving lives and improving living conditions health and well-being;

Recognising the importance to have in place policies and systems to prevent, prepare for, and mitigate shortages of medicinal products and medical equipment;

Noting that health inequities are likely to increase in a situation of shortage of medicinal products and medical equipment, and that options to reduce inequities during such situations may be limited;

Recognising that the principle of equitable access to health care remains valid during a situation of shortage of medicinal products and medical equipment, both in an emergency and during routine clinical practice, whatever the cause of the shortage;

Emphasising that a multi-criteria strategy may be required to ensure equitable access to medicinal products and medical equipment in a situation of shortage;

Acknowledging the fact that shortage of medicinal products and medical equipment can significantly harm individuals with serious or life-threatening health conditions;

Emphasising that decisions on prioritising access to medicinal products and medical equipment should not be based on individual opinions or best intentions but on the best scientific evidence in accordance with defined criteria and not on individual opinion or best intentions;

1.         Recommends to the governments of member States:

a.       to adapt their laws and practices to ensure the implementation and follow-up, of the guidelines contained in the Appendix to this Recommendation;

b.       to examine, within the relevant Steering Committee/Committee of Ministers, the implementation of this Recommendation five years after its adoption.

2.         Entrusts the Secretary General of the Council of Europe with transmitting this Recommendation to the governments of non-member States of the Council of Europe, which have been invited to sign the Convention on Human Rights and Biomedicine, as well as to the European Union and to other relevant governmental and non-governmental international organisations.

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Appendix

Guidelines

CHAPTER I - OBJECT, SCOPE, AND DEFINITIONS

Article 1 – Purpose Object

This Recommendation aims to promote equitable access to medicinal products and medical equipment in a situation of shortage.

Article 2 - Scope

1.       The Recommendation appliesto access to medicinal products and medical equipment certified through an appropriate regulatory process provided for by law, which are needed for patients with to treat/for medical care of serious or life-threatening health conditions, in a situation of shortage.

2.       The Recommendation does not apply to experimental medicinal products and experimental medical equipment.

3.       None of the provisions in this Recommendation should prevent member States from applying part or all the provisions of the Recommendation to other health resources in a situation of shortage.

Article 3 - Definitions

For the purpose of this Recommendation:

-      “Medicinal product” refers to a substance or combination of substances that is intended to treat, prevent, or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action in human beings;

-      “Medical equipment” refers to medical devices, such as diagnostics, to instruments, and to machines;

-      [“Health inequities” refer to systematic and unfair differences in the health status of individuals or groups, including those related to social determinants of health, disability, chronic disease, and age];

-      “Shortage” refers to an insufficient availability of medicinal products and medical equipment relative to health care needs.

CHAPTER II - GENERAL PRINCIPLES

In a situation of shortage of medicinal products and medical equipment, access to them should be based on [all] the following principles.

Article 4 - Non-discrimination

1.       No person in need of medicinal products and/or medical equipment should be a priori excluded from access to them.

2.       Any discrimination in the access to medicinal products and medical equipment should be prohibited.

Article 5 – Disadvantage in relation to health

Specific attention should be paid to individuals and groups who are systematically disadvantaged in relation to health, due to including as a result of economic and social conditions, disability, chronic disease, and or age.

Article 5 6 - Prioritisation based on medical criteria

1.         Decisions on aAccess to medicinal products and medical equipment should be based on an individual medical assessment, taking into account the following elements:

-      the severity of the health condition of the individual concerned and the health care needs to address it;

-      the expected effectiveness of the medicinal product and/or medical equipment considered;

-      the possible therapeutic alternatives;

-      the consequences of the lack of access to the medicinal product and/or medical equipment for the health of the individual concerned.

2.      When there is a need for immediate [/urgent] health care,priority should be to minimise the risk of mortality, as well as and, subsequently, morbidity.

3.       When there is no need for immediate urgent health care, priority should be given to the worst-off in terms of health.  

Article 6 7 -Appropriate support and removal of barriers

To reduce inequities Barriers in accessing medicinal products and medical equipment barriers should be removed and appropriate support given to those individuals or groups who may be disadvantaged or exposed to a higher risk of harm to their health.

Article 7 8 – Respect for dignity of individuals persons excluded from access

When a person cannot access life-saving medicinal products and/or medical equipment, that person should, where available and opportune appropriate, be provided with alternative health care support, or otherwise with compassionate and palliative care.

CHAPTER III - PROCEDURAL PRINCIPLES

The following procedural principles should be observed when defining and implementing priority-setting standards in accordance with the principles laid down in Chapter II.

Article 8 9 - Accountability

1.       Responsibilities in defining and implementing priority-setting standards should be clearly defined.

2.       Health care professionals and the public should be informed about which entities can be consulted to address concerns regarding decisions on the priority-setting in access to medicinal products and medical equipment.

Article 9 10 - Reasonableness and relevance

1.       Policies for prioritising access to medicinal products and medical equipment should be based on the best available evidence, relying on relevant, measurable, clear, objective, and consistent parameters.

2.       The evidence taken into account should be recognised as relevant and fair by all affected parties, including those who might later be disadvantaged by their implementation.

Article 10 11 - Inclusiveness

Healthcare professionals, civil society organisations, and the general public, including vulnerable groups, should be meaningfully engaged in:

-      developing, refining, and reviewing policies for prioritising access to medicinal products and medical equipment, with a view to identifying needs, barriers, and values at stake;

-      creating, and disseminating educational tools;

-      developing and implementing strategies for communication; and

-      public dialogue on issues relevant to equitable access to medicinal products and medical equipment.

Article 11 12 - Consistency

1.       Policies for prioritising access to medicinal products and medical equipment should be applied consistently, with minimal variability.

2.       Policies should be designed to prevent acts of corruption, arbitrary exceptions, access on the basis of financial capacity, manipulations such as lobbying, and political interference.

3.       Local flexibility in implementing guidelines should be applied with after careful deliberation.

Article 12 13 - Transparency and communication of decisions

1.       Objectives, criteria, and reasons for priority-setting should be publicly accessible.

2.       Underlying principles and values should be clearly articulated and adequately explained.

3.       Information regarding priority-setting should be clear, accurate, understandable, and tailored to the needs of the target audience. Communication materials should be suitable for audiences with different levels of education, language, and communication needs.

4.       Open and honest communication should be ensured about the realities of the shortage of medicinal products and medical equipment and its impact on the level of care.

Article 13 14 - Review

1.       Mechanisms should be available to provide feedback on decisions regarding the prioritisation of accessto medicinal products and medical equipment.

2.       Interim and retrospective review processes should be introduced to take into consideration new evidence and developments.

3.       Independent mMonitoring of measures taken to address situations of shortage should be ensured in order to evaluate compliance with the principles laid down in this Recommendation.

CHAPTER IV - SYSTEM FOR PREVENTION, PREPARATION, AND MITIGATION

Article 14 15 - System to prevent, prepare for, and mitigate situations of shortage

Member States should have take appropriate measures to ensure that a system is in place to prevent, prepare for, and mitigate situations of shortage of medicinal products and medical equipment.

Article 15 16 - Prevention

1.       Measures taken to prevent situations of shortage should include a predictor model designed for forecasting needs in different scenarios.  

2.       Information for the predictor model should not be limited to historical marketing and consumption data of products, but should also consider:

-                 data on disease epidemiology;

-                 data on clinical and public health practices;

-                 data on available health care infrastructure and their capacities;

-                 relevant sociological data; and

-                 data on health iniquities.

Article 16 17 - Preparation

When a situation of shortage can be expected, measures should immediately be taken to address possible adverse consequences for the health of the individuals concerned. This will involve a regular assessment of the health care system’s capacities and planning to control the identified risks.

Article 17 18 - Mitigation

When a situation of shortage emerges, strategies should be implemented to minimise its impact and duration, while maintaining the principle of equitable access to medicinal products and medical equipment. These strategies should include:

-                 monitoring the availability of the medicinal products and medical equipmentconcerned;

-                 conserving available medicinal products and medical equipment;

-                 substituting medicinal products and medical equipment with suitable alternatives; assessing the availability of suitable alternatives to the medicinal products and medical equipment concerned; and

-                 adapting equipment for alternative purposes;

-                 re-using materials; and

-                 re-allocating the medicinal products and medical equipment concerned in accordance with health care needs.

Article 18 19 - Information

1.       Timely information should be provided to health care professionals and to the public on shortage, possible therapeutic alternatives, as well as the risks of purchasing products from unofficial supply channels and of unauthorised use.

2.       Information should be clear, accurate, understandable, and tailored to the needs of the target audience.

3.       Communication materials should be suitable for audiences with different levels of education, language, and communication needs.

Article 19 20 - Responsibilities

Responsibilities for developing and implementing measures to prevent, prepare for and mitigate situations of shortage should be clearly defined.

Article 20 - Health inequities

1.       Measures should be taken to avoid that health inequities increase as a result of a shortage of medicinal products and/or medical equipment.

2.       Data on health inequities and their causes should be systematically collected, monitored, and analysed, in accordance with data protection principles.

Article 21 - International co-operation

International co-operation should be encouraged to facilitate the prevention, preparation for, and mitigation of shortages of medicinal products and medical equipment.