Covid-19 vaccines: ethical, legal and practical considerations
Resolution 2361
(2021)
| Provisional version
Author(s):
Parliamentary Assembly
Origin
Assembly
debate on 27 January 2021 (5th Sitting) (see Doc. 15212, report
of the Committee on Social Affairs, Health and Sustainable Development,
rapporteur: Ms Jennifer De Temmerman). Text
adopted by the Assembly on 27 January 2021 (5th Sitting).
1 The pandemic
of Covid-19, an infectious disease caused by the novel coronavirus
SARS-CoV-2, has caused much suffering in 2020. By December, more
than 65 million cases had been recorded worldwide and more than
1.5 million lives had been lost. The disease burden of the pandemic
itself, as well as the public health measures required to combat
it, have devastated the global economy, laying bare pre-existing
fault-lines and inequalities (including in access to health care),
and causing unemployment, economic decline and poverty.
2 Rapid deployment worldwide of safe and efficient vaccines
against Covid-19 will be essential in order to contain the pandemic,
protect health-care systems, save lives and help restore global
economies. Although non-pharmaceutical interventions such as physical
distancing, the use of facemasks, frequent hand washing, as well
as shutdowns and lockdowns, have helped slow down the spread of
the virus, infection rates are now rising again across most of the
globe. Many Council of Europe member States are experiencing a second
wave which is worse than the first, while their populations are
increasingly experiencing “pandemic fatigue” and are feeling demotivated
about following recommended behaviours to protect themselves and
others from the virus.
3 Even rapidly deployed, safe and effective vaccines, however,
are not an immediate panacea. Following the festive season at the
end of the year 2020 and the beginning of 2021, with its traditional
indoor gatherings, infection rates will likely be very high in most
member States. In addition, a correlation has just been scientifically
established by French doctors between outdoor temperatures and the
disease incidence rate on hospitalisations and deaths. The vaccines
will no doubt not be sufficient to bring down infection rates significantly
this winter – in particular when taking into account that demand
far outstrips supply at this point. A semblance of “normal life”
will thus not be able to resume even in the best of circumstances
until mid to late 2021 at the earliest.
4 For the vaccines to be effective, their successful deployment
and sufficient uptake will be crucial. However, the speed at which
the vaccines are being developed may pose a difficult to combat
challenge to building up trust in them. An equitable deployment
of Covid-19 vaccines is also needed to ensure the efficacy of the
vaccine. If not widely enough distributed in a severely hit area
of a country, vaccines become ineffective at stemming the tide of
the pandemic. Furthermore, the virus knows no borders and it is
therefore in every country’s interest to co-operate on ensuring
global equity in access to Covid-19 vaccines. Vaccine hesitancy and
vaccine nationalism have the capacity to derail the so-far surprisingly
fast and successful Covid-19 vaccine effort, by allowing the SARS-CoV-2
virus to mutate and thus blunt the world’s most effective instrument
against the pandemic so far.
5 International co-operation is thus needed now more than ever
in order to speed up the development, manufacturing and fair and
equitable distribution of Covid-19 vaccines. The Covid-19 Vaccine
Allocation Plan, also known as COVAX, is the leading initiative
for global vaccine allocation. Co-led by the World Health Organization
(WHO), the Vaccine Alliance (Gavi) and the Coalition for Epidemic
Preparedness Innovations (CEPI), the initiative pulls funding from
subscribing countries to support the research, development and manufacturing
of a wide range of Covid-19 vaccines and negotiate their pricing.
Adequate vaccine management and supply chain logistics, which require
international co-operation and preparations by member States, will
also be needed in order to deliver the vaccines against the virus
in a safe and equitable way. In this regard, the Parliamentary Assembly
draws attention to guidance for countries on programme preparedness, implementation
and country-level decision-making developed by WHO.
6 Member States must already now prepare their immunisation
strategies to allocate doses in an ethical and equitable way, including
deciding on which population groups to prioritise in the initial
stages when supply is short, and how to expand vaccination as availability
of one or more Covid-19 vaccines improves. Bioethicists and economists
largely agree that persons over 65 years old and persons under 65
with underlying health conditions putting them at a higher risk
of severe illness and death, health-care workers (especially those
who work closely with persons who are in high-risk groups), and
people who work in essential critical infrastructure should be given
priority vaccination access. Children, pregnant women and nursing
mothers, for whom no vaccine has so far been authorised, should
not be forgotten.
7 Scientists have done a remarkable job in record time. It is
now for governments to act. The Assembly supports the vision of
the Secretary General of the United Nations that a Covid-19 vaccine
must be a global public good. Immunisation must be available to
everyone, everywhere. The Assembly thus urges member States and
the European Union to:
7.1 with
respect to the development of Covid-19 vaccines:
7.1.1 ensure high quality trials that
are sound and conducted in an ethical manner in accordance with
the relevant provisions of the Convention on human rights and biomedicine (ETS
No. 164, Oviedo Convention) and its Additional Protocol concerning
Biomedical Research (CETS No. 195), and which progressively include
children, pregnant women and nursing mothers;
7.1.2 ensure that regulatory bodies in charge of assessing and
authorising vaccines against Covid-19 are independent and protected
from political pressure;
7.1.3 ensure that relevant minimum standards of safety, efficacy
and quality of vaccines are upheld;
7.1.4 implement effective systems for monitoring the vaccines
and their safety following their roll-out to the general population,
also with a view to monitoring their long-term effects;
7.1.5 put in place independent vaccine compensation programmes
to ensure compensation for undue damage and harm resulting from
vaccination;
7.1.6 pay special attention to possible insider trading by pharmaceutical
executives, or pharmaceutical companies unduly enriching themselves
at public expense, by implementing the recommendations contained
in Resolution 2071 (2015) on Public health and the interests of the pharmaceutical
industry: how to guarantee the primacy of public health interests?
7.1.7 overcome the barriers and restrictions arising from patents
and intellectual property rights, in order to ensure the widespread
production and distribution of vaccines in all countries and to
all citizens;
7.2 with respect to the allocation of Covid-19 vaccines:
7.2.1 ensure respect for the principle
of equitable access to health care as laid down in Article 3 of
the Oviedo Convention in national vaccine allocation plans, guaranteeing
that Covid-19 vaccines are available to the population regardless
of gender, race, religion, legal or socio-economic status, ability
to pay, location and other factors that often contribute to inequities
within the population;
7.2.2 develop strategies for the equitable distribution of Covid-19
vaccines within member States, taking into account that the supply
will initially be low, and prepare for how to expand vaccination
programmes when the supply expands; follow the advice of independent
national, European and international bioethics committees and institutions,
as well as of WHO, in the development of these strategies;
7.2.3 ensure that persons within the same priority groups are
treated equally, with special attention to the most vulnerable people
such as older persons, those with underlying conditions and health
care workers, especially those who work closely with persons who
are in high-risk groups, as well as people who work in essential
infrastructure and in public services, in particular in social services,
public transport, law enforcement, and schools, as well as those
who work in retail;
7.2.4 promote equity in access to Covid-19 vaccines between
countries by supporting international efforts such as the Access
to Covid-19 Tools Accelerator (ACT Accelerator) and its COVAX Facility;
7.2.5 refrain from stockpiling Covid-19 vaccines which undermines
the ability of other countries to procure vaccines for their populations,
ensure stockpiling does not translate to escalating prices for vaccines
from those who stockpile to those who cannot, conduct auditing and
due diligence to ensure rapid deployment of vaccines at minimum
cost based on need not market power;
7.2.6 ensure that every country is able to vaccinate their health-care
workers and vulnerable groups before vaccination is rolled out to
non-risk groups, and thus consider donating vaccine doses or accept
that priority be given to countries which have not yet been able
to do so, bearing in mind that a fair and equitable global allocation
of vaccine doses is the most efficient way of beating the pandemic
and reducing the associated socio-economic burdens;
7.2.7 ensure that Covid-19 vaccines whose safety and effectiveness
has been established are accessible to all who require them in the
future, by having recourse, where necessary, to mandatory licences
in return for the payment of royalties;
7.3 with respect to ensuring high vaccine uptake:
7.3.1 ensure that citizens are informed
that the vaccination is NOT mandatory and that no one is politically,
socially, or otherwise pressured to get themselves vaccinated, if
they do not wish to do so themselves;
7.3.2 ensure that no one is discriminated against for not having
been vaccinated, due to possible health risks or not wanting to
be vaccinated;
7.3.3 take early effective measures to counter misinformation,
disinformation and hesitancy regarding Covid-19 vaccines;
7.3.4 distribute transparent information on the safety and possible
side effects of vaccines, working with and regulating social media
platforms to prevent the spread of misinformation;
7.3.5 communicate transparently the contents of contracts with
vaccine producers and make them publicly available for parliamentary
and public scrutiny;
7.3.6 collaborate with non-governmental organisations and/or
other local efforts to reach out to marginalised groups;
7.3.7 engage with local communities in developing and implementing
tailored strategies to support vaccine uptake;
7.4 with respect to Covid-19 vaccination for children:
7.4.1 ensure balance between the rapid
development of vaccination for children and duly addressing safety
and efficacy concerns and ensuring complete safety and efficacy
of all vaccines made available to children, with a focus on the
best interest of the child, in accordance with the United Nations
Convention on the Rights of the Child;
7.4.2 ensure high quality trials, with due care for relevant
safeguards, in accordance with international legal standards and
guidance, including a fair distribution of the benefits and risks in
the children who are studied;
7.4.3 ensure that the wishes of children are duly taken into
account, in accordance with their age and maturity; where a child’s
consent cannot be given, ensure that agreement is provided in other
forms and that it is based on reliable and age appropriate information;
7.4.4 support UNICEF in its efforts to deliver vaccines from
manufacturers that have agreements with the COVAX Facility to those
who need them most;
7.5 with respect to ensuring the monitoring of the long-term
effects of the COVID-19 vaccines and their safety:
7.5.1 ensure international co-operation
for timely detection and elucidation of any safety signals by means
of real-time global data exchange on adverse events following immunisation (AEFIs);
7.5.2 use vaccination certificates only for their designated
purpose of monitoring vaccine efficacy, potential side-effects and
adverse events;
7.5.3 eliminate any gaps in communication between local, regional
and international public health authorities handling AEFI data and
overcome weaknesses in existing health data networks;
7.5.4 bring pharmacovigilance closer to health-care systems;
7.5.5 support the emerging field of adversomics research which
studies inter-individual variations in vaccine responses based on
differences in innate immunity, microbiomes and immunogenetics.
8 With reference to Resolution
2337 (2020) on Democracies facing the Covid-19 pandemic, the Assembly reaffirms
that, as cornerstone institutions of democracy, parliaments must
continue to play their triple role of representation, legislation
and oversight in pandemic circumstances. The Assembly thus calls
on parliaments to exercise these powers, as appropriate, also in
respect of the development, allocation and distribution of Covid-19
vaccines.