Strasbourg, 6 October2022 CDBIO (2022) 22
STEERING COMMITTEE FOR HUMAN RIGHTS
IN THE FIELDS OF BIOMEDICINE AND HEALTH
in a situation of shortage
Prepared by the Secretariat and Prof. Kristof Van Assche, Consultant
This Explanatory Memorandum to the Recommendation on equitable access to medicinal products and medical equipment in a situation of shortage was drawn up under the responsibility of the Secretary General of the Council of Europe. It takes into account the discussions held in the Steering Committee for Human Rights in the fields of Biomedicine and Health (CDBIO) and in its predecessor, the Committee on Bioethics (DH-BIO), and it also takes into account the remarks and proposals made by Delegations. The explanatory memorandum is not an authoritative interpretation of the Recommendation. Nevertheless, it covers the main issues of the preparatory work and provides information to clarify the object and purpose of the Recommendation and to better understand the scope of its provisions.
i. Medicinal products and medical equipment are an essential part of health care and contribute significantly to saving lives and improving health. A shortage of medicinal products and medical equipment needed for severe or life-threatening health conditions can result in significant harm to health. The causes of shortage are multi-factorial, including the lack of raw materials, problems in manufacturing, quality control, and logistics, and changes in regulatory requirements. Unpredictable events, such as epidemiological outbreaks, armed conflicts, and emergencies caused by climate change, may significantly increase demand and reduce the capacity to guarantee availability.
ii. Considering the severe health consequences of a shortage of medicinal products and medical equipment, it is essential that appropriate measures are taken to as much as possible prevent these situations from occurring. Where a situation of shortage would occur, it is similarly important to take appropriate measures of preparation and mitigation.
iii. When confronted with a situation of shortage, prioritisation is required to decide who should have access to the medicinal products and medical equipment concerned. However, policies that define and implement priority-setting standards may raise questions concerning the principles on which they are based. Ensuring equitable access may be a challenge, but is essential to safeguard the fundamental rights of the individuals concerned and to recognise and strengthen the value of solidarity between individuals.
iv. The purpose of this Recommendation is to set out and safeguard the fundamental rights of individuals who need medicinal products and medical equipment for serious or life-threatening health conditions, in a situation of shortage. More specifically, the Recommendation addresses the general and procedural principles to be followed to ensure equitable access. It also addresses the system that member States should have in place to prevent, prepare for, and mitigate situations of shortage.
v. This Recommendation complements other relevant provisions applicable, contained, in particular, in the Convention for the Protection of Human Rights and Fundamental Freedoms (“European Convention on Human Rights”, ETS No. 5), in the Convention on Human Rights and Biomedicine (ETS No. 164), and in the European Social Charter (ETS No. 35) and the Revised version (ETS No. 163).
Drafting of the Recommendation
vi. In the framework of its Strategic Action Plan on Human Rights and Technologies in Biomedicine (2020-2025), the Committee on Bioethics (DH-BIO) agreed, at its 17th plenary meeting (3-6 November 2020), to develop guidelines to promote equitable access to vaccines and to treatment and equipment. This decision was taken in the light of the COVID-19 pandemic and the ethical considerations concerning access to vaccines as a scarce resource. It was emphasised that this work should be guided by the principle of equitable access to health care as enshrined in Article 3 of the Convention on Human Rights and Biomedicine, requiring Parties, “taking into account health needs and available resources” to “take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality”.
vii. Considering the evolutions in vaccine development, the DH-BIO agreed to first prepare a statement focusing on equity in access to COVID-19 vaccines. The “Statement on COVID-19 and vaccines: Ensuring equitable access to vaccination during the current and future pandemics” was issued on 21 January 2021.
viii. At its 18th plenary meeting (1-4 June 2021), the DH-BIO agreed to establish a drafting group on equitable access to treatment and equipment in a situation of shortage, focusing on critical products whose scarcity could cause serious harm to patients.
ix. In July 2021, a Drafting Group on equitable access to medicinal products and medical equipment in a situation of shortage was established, consisting of the following members: Tomas Dolezal (Czech Republic), Aime Keis (Estonia), Assunta Morresi (Italy), Verina Wild (Germany), Jorge Soares (Portugal), Lyalya Gabbasova and Olga Opanasenko (Russian Federation), Berenice Cruz (Mexico). Tomas Dolezal was designated Chair of the Drafting Group.
x. The Drafting Group met on 12 July (online meeting), 15 September 2021 (online meeting), informally on 28 March 2022 (online meeting) to follow-up, and on 9-10 May 2022 (Paris).
xi. From March to April 2022, the Drafting Group carried out a targeted stakeholder consultation to elicit comments and suggestions from international organisations and professional and patient organisations with expertise in the field of shortage of medicinal products and medical equipment.
xii. Preliminary draft guidelines, prepared by the Drafting Group, were discussed by the DH-BIO during its 19th meeting (2-4 November 2021).
xiii. In accordance with the Terms of Reference of the new Steering Committee for Human Rights in the fields of Biomedicine and Health (CDBIO), which took over the responsibilities of the DH-BIO, it was agreed to include the guidelines in a Recommendation on equitable access to medicinal products and medical equipment in a situation of shortage.
xiv. The draft Recommendation, prepared by the Drafting Group in the light of the comments received during the stakeholder consultation and taking into account the comments from delegations, was examined by the CDBIO during its 1st meeting (31 May-3 June 2022). To discuss in particular the wording of the scope of the draft Recommendation and its Chapter on general principles, a consultation meeting with delegations concerned was organised on 20 September 2022 in Paris.
xv. The draft Recommendation as revised during the consultation meeting was submitted to the CDBIO at its 2nd plenary meeting (2-4 November 2022) with a view to its approval. On …. the Committee of Ministers, at its XX meeting at Deputies’ level, adopted the Recommendation on equitable access to medicinal products and medical equipment in a situation of shortage.
1. The Preamble of this Recommendation reaffirms the aims of the Council of Europe and the principles embodied in the Convention on Human Rights and Biomedicine. It also reaffirms the relevant provisions of the European Social Charter (ETS No. 35) and its Revised version (ETS No. 163).
2. The Preamble recalls the principles on which the provisions of this Recommendation are based and in particular underlines the following aspects:
- medicinal products and medical equipment are an essential part of health care, and significantly contribute to saving lives and improving living conditions;
- policies and systems to prevent, prepare for, and mitigate shortages of medicinal products are of paramount importance to avoid and reduce harms to patients' health;
- health inequities are likely to increase in a situation of shortage of medicinal products and medical equipment, and options to reduce inequities during such situations may be limited;
- 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; and
- decisions on prioritising access to medicinal products and medical equipment should be based on the best scientific evidence in accordance with defined criteria.
Chapter I – Object, scope, and definitions
3. The objective of this Recommendation is to promote equitable access to medicinal products and medical equipment in a situation of shortage.
4. The term “equitable access” should be interpreted in accordance with the meaning provided in Article 3 of the Convention on Human Rights and Biomedicine and clarified in paragraph 25 of its Explanatory Report. In this context, “equitable” means first and foremost the absence of discrimination. Although not synonymous with absolute equality, equitable access implies effectively obtaining a satisfactory degree of care. The possibility to ensure equitable access depends on the medical needs and the available resources. In a situation of shortage of resources, as in the scenario that is covered in this Recommendation, this may mean that for some individuals in need of these resources access cannot be guaranteed.
5. The Recommendation applies to access to medicinal products and medical equipment certified through an appropriate regulatory process provided by law. This implies that the conditions and situations of use have been established and the risk-benefit balance is favourable and demonstrated (including for medicinal products authorised for emergency use).
6. The Recommendation only applies to access to medicinal products and medical equipment needed for serious or life-threatening health conditions; therefore, their shortage may significantly harm the health of individuals who are in need of them. The Recommendation applies irrespective of the cause of the shortage.
7. Not covered by the Recommendation are medicinal products and medical equipment where the shortage has no significant negative impact on health (e.g., medicinal products used to treat mild to moderate transitory pain).
8. Neither does the Recommendation apply to access to therapeutic products such as human organs, cell, tissues used in the context of transplantation, or human blood and its derivates used in the context of transfusion. In the contexts of transplantation and transfusion, access is guided by specific principles, as outlined in the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin (ETS No. 186), the legal instruments issued by the European Committee on Organ Transplantation (CD-P-TO) and the European Committee on Blood Transfusion (CD-P-TS), and guidelines and procedures adopted by national competent authorities and international organ exchange organisations.
9. The Recommendation does not apply to access to experimental medicinal products and medical equipment, such as those studied in clinical trials, or used under compassionate use schemes and off-label (i.e., indications not authorised in the marketing authorisation). For these products the exact conditions for use, and the indications and contraindications are not well-established and the expected risks and benefits are still uncertain.
10. The Recommendation does similarly not apply to vaccines, as these are not normally used to treat serious or life-threatening health conditions. Equitable access to vaccines is guided by specific principles as outlined namely in the“Statement on COVID-19 and vaccines: Ensuring equitable access to vaccination during the current and future pandemics”.
11. The Recommendation does also not apply to a situation of shortage of human resources, although the principles outlined here may be relevant to the extent that a shortage of human resources results in a lack of access to medicinal products and medical equipment.
12. Nevertheless, member States may wish to apply part or all of the provisions of this Recommendation to regulating access to other health resources in a situation of shortage when the principles outlined here may be relevant.
Article 3 – Definitions
13. The definition of “Medicinal product” is derived from Article 1 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.
14. The term “medical equipment” refers to products intended for a medical purpose such as medical devices, diagnostics, instruments, and machines. These products are subject to a conformity assessment to demonstrate compliance with legal requirements and safety and performance standards.
15. The term “shortage” refers to a situation where there is an insufficient availability of medicinal products and/or medical equipment relative to the health care needs, irrespective of the cause of the shortage.
Chapter II – General principles
16. This Chapter lays down the general principles that should guide priority-setting regarding access to medicinal products and medical equipment in a situation of shortage. The Chapter is addressed to all stakeholders entrusted with defining or implementing the priority-setting standards.
17. The principles outlined in this Chapter aim to guarantee equitable access to medicinal products and medical equipment in a situation of shortage. They implement the more general principle of “equitable access to healthcare” as enshrined in Article 3 of the Convention on Human Rights and Biomedicine. Acknowledging that the principle of equitable access to health care may as such already be difficult to implement, it may prove to be even more challenging in a situation of shortage.
Article 4 – Non-discrimination
18. Paragraph 1 states that no person in need of medicinal products and/or medical equipment in a situation of shortage should be a priori excluded from their access. Any model of allocation of these resources should be based on the principle that every individual has the right to have his/her health protected.
19. Paragraph 2 prohibits discrimination on any ground in the access to medicinal products and medical equipment in a situation of shortage. Non-discrimination is an individual right enshrined in Article 14 of the European Convention on Human Rights. Under this Article, the enjoyment of the rights and freedoms set forth in the Convention must be secured without discrimination on any ground such as “sex, race, colour, language, religion, political or other opinion, national or social origin, association with a national minority, property, birth or other status.” Other circumstances may negatively impact an individual’s access, such as socioeconomic position, geographical location, gender, ethnic background, and educational and literacy levels, as well as age, disability, chronic disease, and mental health problems. Priority-setting standards may hold a potential for discrimination if these grounds are used as a proxy for increased risk of mortality or morbidity, in this way deprioritising these individuals or groups.
20. Whereas the term “discrimination” has usually a negative connotation in French, this is not necessarily the case in English (where one must use the expression “unfair discrimination”). It has, however, been decided to keep the same term in both languages, as it is in the European Convention of Human Rights, in the case law of the European Court of Human Rights, and in the Convention on Human Rights and Biomedicine. Discrimination here should, therefore, in French as in English, be understood as unfair discrimination.
Article 5 – Disadvantage in relation to health
21. Individuals who already experience disparities in relation to health as well as in access to health care can be expected to have an even further decline in health when faced with a shortage of medicinal products and/or medical equipment. To ensure equitable access, specific attention should therefore be paid to individuals and groups who are disadvantaged in relation to health, including as a result of economic and social conditions, disability, chronic disease, or age. The aim is to avoid a situation where the application of priority-setting standards would reinforce existing health inequities. This principle can, for instance, be interpreted as requiring that difficult living conditions are considered as a factor in determining the consequences of the lack of access to a medicinal product or medical equipment, or that positive measures are implemented aimed at re-establishing a certain balance in favour of those at a disadvantage.
22. To ensure that specific attention is paid to individuals and groups who are disadvantaged in relation to health, they should be meaningfully engaged in developing, refining, and reviewing policies of priority-setting, as outlined in Article 11.
23. The first paragraph indicates that, before a decision can be taken as to whether an individual should have access to medicinal products and/or medical equipment in a situation of shortage, an individual medical assessment should first be made. The individual medical assessment is intended to determine the health care needs for which the use of the medicinal product and/or medical equipment concerned is essential.
24. In this medical assessment four elements should be taken into account. The first element is the severity of the individual’s health condition, taking into consideration medical urgency and the specific health care needed to address the health condition. The second element is the expected effectiveness of the medicinal products and/or medical equipment for the health care of the individual concerned. A careful medical evaluation should be performed of the clinical appropriateness, and proportionality of the use of these resources in relation to the health care needs of the individual concerned. The third element is the availability of possible therapeutic alternatives. In a situation of shortage, the concerned medicinal product and/or medical equipment should only be used if no suitable therapeutic alternative is available. The fourth and final element concerns the consequences for the health of the individual concerned if that individual lacks access to the medicinal product and/or medical equipment.
25. The second paragraph sets out the principle for defining and implementing standards of priority-setting for individuals who, on the basis of the individual medical assessment, are considered to be in urgent need of access to the medicinal product and/or medical equipment concerned. Priority-setting based on defined criteria helps to direct limited resources towards health care needs. In a situation of shortage, the term priority-setting is used as a synonym for rationing or allocation. Clear priority-setting standards are of particular importance for the health care professionals who are directly confronted with individuals in need of medicinal products and/or medical equipment.
26. This paragraph states that priority-setting should be guided by the principle of minimising the risk of mortality and, subsequently, the risk of morbidity. This implies that priority access to medicinal products and medical equipment should be provided to individuals for whom they will be more effective, in the light of this principle. This principle may be interpreted as focusing on the short-term likelihood that the individual concerned survives the acute medical episode. In that interpretation, only those underlying comorbidities that are prognostically relevant for surviving the acute medical episode in question should be considered.
27. The possibility to ensure a comprehensive individual assessment will depend on the time available to evaluate the situation of the individual concerned. Therefore, decisions may need to be taken under uncertainty, especially when the individual concerned requires immediate health care.
Article 7 – Appropriate support and removal of barriers
28. To ensure equitable access to medicinal products and medical equipment, this article underlines the importance of the removal of barriers and the provision of support to persons and groups who are disadvantaged or exposed to higher risk of harm to their health.
29. Examples of individuals and groups concerned include persons with disabilities, with mental health problems, or learning disabilities, as well as those exposed to risks of discrimination or stigmatization, such as individuals belonging to minorities, homeless or living in poverty. Other examples include those individuals with addiction, geographically isolated, deprived of liberty, low-income migrant workers, and individuals without residence or with insecure legal status.
30. Measures to ensure support and the removal of barriers include awareness-raising programmes for health care professionals, assistance for individuals with specific needs or who lack a social support network. Other measures include the removal of financial and administrative barriers, disseminating of adapted communication materials, implementation of novel or flexible delivery strategies, and, where possible, removal of other barriers, including for individuals without residence or with insecure legal status. In accordance with Article 11, these vulnerable groups should be meaningfully engaged in developing, refining, and reviewing policies, so as to take into account their needs, existing barriers, and possible solutions. The measures to ensure support and the removal of barriers should be defined through established protocols.
Article 8 – Respect for dignity of persons excluded from access
31. This Article focusses on the situation where, in light of the principles outlined in this Chapter, no access is provided to life-saving medicinal products and/or medical equipment. In this situation, other type of health care support should be provided, if this is available and appropriate.
32. As outlined in the Guide on the decision-making process regarding medical treatment in end-of-life situations, drawn up by the Committee on Bioethics in May 2014, the aim is to provide the best possible quality of life. The person concerned should be offered both active care designed to control pain and other symptoms and provided with the necessary support in coping with psychological or social problems and, where appropriate, spiritual support. Support should also be provided to their family members.
Chapter III – Procedural principles
33. This Chapter lays down the procedural principles that should guide the process of defining and implementing priority-setting standards in accordance with the general principles outlined in Chapter II. These procedural principles are essential to ensure that priority-setting standards are defined in a way that guarantees equitable access and are accepted as legitimate by all stakeholders. In this way, they are essential to build and maintain public trust in the fairness of decisions and to ensure their successful implementation.
34. The Chapter is addressed to all stakeholders that may be involved in the process of defining and implementing priority-setting standards, such as competent authorities, professional medical organisations, national ethics committees, hospital ethics committees, and interdisciplinary teams of professionals.
35. The possibility to ensure fulfilment of some of the procedural principles may depend on the time available to complete the process. Especially in cases of urgency, such as caused by unpredictable events and developments, some procedural principles may temporarily be difficult to observe. In that case, these principles should be observed as soon as the situation would allow it.
Article 9 – Accountability
36. This article emphasises the importance of the accountability as a central procedural principle. Accountability is crucial to ensure that considerations of equity remain at the centre of the decision-making process. Accountability implies that the entities which, at the different levels of the health care system, are involved in defining and implementing priority-setting standards should take responsibility for the consequences of their decisions.
37. Paragraph 1 states that the respective responsibilities of the entities which, at the different levels of the health care system, are involved in defining and implementing priority-setting standards should be clearly defined.
38. Paragraph 2 states that information about which entities are accountable at the different stages of priority-setting and implementation should be available to all parties who may be affected by their decisions, including health care professionals and the public. This should include information about where and how concerns can be addressed regarding decisions on priority-setting. The mechanisms that allow individuals to express possible concerns should be easily accessible and designed so as to guarantee that concerns will be adjudicated appropriately.
Article 10 – Reasonableness and relevance
39. This article emphasises that, in defining and implementing priority-setting standards, policies should be based on arguments that are reasonable. Paragraph 1 states that this will be the case when appeal is made to the best available evidence. Best available evidence refers to information that is relevant, measurable, clear, objective, and consistent. An evidence-based approach avoids those decisions are based on personal experience, speculation or biased sources. For treatment decisions, the best available evidence is provided by randomised controlled trials.
40. Paragraph 2 states that policies should be guided by the evidence that all affected parties can accept as relevant and as appropriate from the perspective of fairness. To the extent possible, this should include individuals who might later be disadvantaged by the implementation of these policies. In accordance with Article 11, deliberations on the relevance of the evidence used should take place as part of the meaningful engagement of the affected parties in developing, refining, and reviewing the policies for prioritising access to medicinal products and medical equipment.
Article 11 – Inclusiveness
41. This article states that the process of defining, implementing, and reviewing priority-settings standards should be inclusive so as to ensure that the views are represented from all parties who may be affected by the resulting decisions. An inclusive process does not only rely on the participation of professional stakeholders, including health care professionals, but also on input from the general public and civil society organisations representing groups that may be greatly affected, in particular groups that are disadvantaged or exposed to at a higher risk of harm to their health.
42. Meaningful engagement will guarantee that all parties have the opportunity to articulate the underlying values to be considered. This is especially important since disagreement may exist about the relative significance of certain values. In this way, meaningful engagement in the process of formulating policies is essential in order for these policies to be accepted as legitimate. In addition, the involvement of health care professionals, civil society organisations, and the general public will allow the identification of particular needs and barriers that might otherwise remain undetected. This will ensure that specific attention is paid to individuals and groups who are disadvantaged in relation to health in accordance with Article 5, and that appropriate support can be provided, and barriers can be removed in accordance with Article 7.
43. Health care professionals, civil society organisations, and the general public should also be meaningfully engaged in the development and dissemination of educational tools and in the development and implementation of strategies for communication. This will improve transparency of decisions and ensure that educational tools and communication materials are tailored to the needs of health care professionals and the public, in accordance with Article 13.
44. In the process of defining and implementing priority-settings standards health care professionals, civil society organisations, and the general public should also be meaningfully engaged in a dialogue on aspects relevant to equitable access, as outlined in this Recommendation. In combination with the other provisions set out in this Article, this will ensure that decisions are part of a broader deliberative democratic process involving all groups that may bear the consequences of these decisions. Steps to ensure an effective public dialogue on the conditions for access to health care are described in the Guide to public debate on human rights and biomedicine, drawn up by the Committee on Bioethics and published in December 2020.
Article 12 – Consistency
45. This article recommends that policies that define and implement priority-setting standards should be applied in a consistent way. Paragraph 1 explains that this implies that they should apply with minimal variability to all individuals and groups in accordance with explicit and predetermined criteria. Individuals and groups who should be treated similarly should therefore not receive different access. The consistent application of policies will also help avoid discrimination against certain groups and individuals, prohibited in accordance with Article 4. To avoid inconsistency, the need for individual interpretation of the guidance provided should be minimised.
46. Paragraph 2 raises attention to the risks of corruption, arbitrary exceptions, access on the basis of financial capacity, and manipulation such as lobbying and political interference. These ways to obtain priority access to medicinal products and medical equipment in a situation of shortage are contrary to the principle of equitable access, and should be prohibited. To that aim, policies should be designed so as to ensure that these interventions are impossible or unsuccessful, including by using terminology that avoids ambiguity and by relying on trustworthy, impartial, and neutral decision-making bodies.
47. Paragraph 3 acknowledges that some flexibility in implementing guidelines might be necessary, especially to account for changing circumstances and factors that may be unique to a local situation. In the light of the principle of consistency, any decision not to follow the guidelines provided should only be taken after careful deliberation and with due respect for the other principles set out in this Recommendation. Such a decision should be clearly documented.
Article 13 – Transparency and communication of decisions
48. This article emphasises the importance of transparency and communication in defining and implementing priority-setting standards. Paragraphs 1 and 2 underline the importance of making publicly accessible the objectives of priority-setting, the priority-setting standards, and the reasons why specific priority-setting standards have been chosen, as well as of clearly articulating and adequately explaining the underlying principles and values used. This is essential to allow all stakeholders to understand what and how decisions are taken.
49. In accordance with the provisions of Article 11 to meaningfully engage stakeholders, this information should, whenever possible, already be guaranteed before the priority-setting standards are decided. Similarly, in accordance with Article 9, professional stakeholders and the general public should be informed about where this information is available, and about where and how possible concerns can be expressed.
50. Paragraph 3 stipulates that information about which persons are prioritised, why they are prioritised, and on what basis priorities might change should be timely, clear, accurate, and understandable. Attention should be paid to adapting this information to persons with different educational and literacy levels or special language or communication needs. As far as practicable, communication materials should be produced in a variety of formats, translated into all the relevant languages at local and regional levels, and distributed on a variety of easily accessible platforms. Messages should be regularly repeated and provided by trusted voices operating in partnership with local communities.
51. Paragraph 4 states that communication should be ensured about the realities of the shortage of medicinal products and medical equipment. This communication should be open and honest, especially in acknowledging remaining uncertainties and the consequences that the shortages may have for the treatment options and the general level of care of persons in need of these resources. Communication plans should ideally be developed in advance, so as to ensure that information will be timely and effectively disseminated to all stakeholders once a situation of shortage arises.
Article 14 – Review
52. This article emphasises the need to provide for the possibility of feedback, regular review, and monitoring of measures. Paragraph 1 states that decisions regarding the prioritisation of access should be open to feedback. Responsiveness to concerns raised by stakeholders is essential to ensure equitable access and to promote public trust. To that aim, easily accessible and effective mechanisms should be in place to provide feedback to the entities that are accountable in accordance with Article 9.
53. Paragraph 2 states that, in addition, interim and retrospective review processes should be introduced to provide regular opportunities for improving policies. In the light of changing circumstances and new evidence it may be necessary to adapt priority-settings standards or their implementation. Regular review ensures that priority-setting remains up to date with the latest developments of the shortage situation, as well as consistent with best evidence.
54. Whether access to medicinal products and medical equipment is equitable may also depend on the measures taken to address the situations of shortage. Paragraph 3 therefore states that situations of shortage and the measures to address them should be closely monitored to evaluate whether equitable access is ensured, and the principles set out in this Recommendation are observed.
Chapter IV – Prevention, preparation, and mitigation
Article 15 – System to prevent, prepare for, and mitigate situations of shortage
55. This article states that it is essential that member States have a system in place to prevent, prepare for, and mitigate situations of shortage of medicinal products and medical equipment. It is essential that situations of shortage of medicinal products and medical equipment are as much as possible prevented. Member States should therefore take appropriate measures to prevent these situations from occurring. Where a shortage would occur, appropriate measures should be taken to prepare for and mitigate them. Member States should ensure that in their system of prevention, preparation, and mitigation all measures are defined and implemented in accordance with the principle of equitable access to health care of appropriate quality.
Article 16 – Prevention
56. Paragraph 1 states that measures in place for the prevention of situations of shortage of medicinal products and medical equipment should include a predictor model that is designed for predicting future needs in different scenarios.
57. Paragraph 2 provides clarification on the predictor model and the importance of using all sources of information that are relevant. These data should not be limited to historical marketing and consumption data of products, since predictions made on the basis of these data may reinforce health inequities. Therefore, data used in the predictor model should also include data on disease epidemiology, clinical and public health practices, and available health care infrastructure and their capacities, as well as data directly relevant from the perspective of inequity, such as relevant sociological data and data on health inequities.
Article 17 – Preparation
58. This article emphasises that, as soon as a situation of shortage of medicinal products and medical equipment can be expected, measures for the prevention of such situation should immediately be taken to address possible adverse consequences for the health of the individuals concerned. Strategies should be based on a regular assessment of the health care system’s capacities, including available infrastructure and resources, and planning to control the risk identified.
Article 18 – Mitigation
59. This article states that, when a situation of shortage emerges, the strategies prepared in accordance with Article 17 should be implemented to minimise the impact and duration of the shortage. These strategies of mitigation should include monitoring the availability of medicinal products and medical equipment, conserving available medicinal products and medical equipment, assessing the availability of suitable alternatives to the medicinal products and medical equipment concerned, and re-allocating medicinal products and medical equipment in accordance with health care needs.
60. This article stipulates that health care professionals and the public should be provided with timely information about shortages of medicinal products and medical equipment, the possible therapeutic alternatives, and the risks involved in purchasing products from unofficial supply channels and in unauthorised use.
61. This information should be clear, accurate, and understandable. Attention should be paid to adapting this information to persons with different educational and literacy levels or special language or communication needs. As far as practicable, communication materials should be produced in a variety of formats, translated in all the relevant languages at local and regional levels, and distributed on a variety of easily accessible platforms. Messages should be regularly repeated and provided by trusted voices operating in partnership with local communities.
Article 20 – Responsibilities
62. This article emphasises that the entities which are involved in defining and implementing measures of prevention, preparation, and mitigation should take responsibility for the consequences of their decisions, and that their respective responsibilities should be clearly defined. Information should be provided about which entities can be consulted to address concerns regarding measures of prevention, preparation, and mitigation of situations of shortage of medicinal products and medical equipment. The mechanisms that allow individuals to express possible concerns should be easily accessible and designed so as to guarantee that concerns will be adjudicated appropriately.
Article 21 – International co-operation
63. This article encourages member States to cooperate closely with a view to most efficiently preventing, preparing for, and mitigating situations of shortage of medicinal products and medical equipment. Faced with a complex and globalised production and distribution chain, coordinated action based on harmonised standards should be considered so as to guarantee timely measures to appropriately address situations of shortage.