C Explanatory memorandum
by Ms Thorhildur Sunna Ævarsdóttir, rapporteur
1 Introduction
1. Following a motion for a resolution
entitled “Preventing vaccine discrimination”,
Note tabled on 10 September 2021 by Mr Ahmet
Yildiz (Türkiye, NR) and other members of the Parliamentary Assembly,
the Committee on Legal Affairs and Human Rights appointed me on
7 December 2021 as rapporteur on this subject. On 28 April 2022,
the committee considered my introductory memorandum and authorised
me to carry out a fact-finding visit to the headquarters of the
World Health Organisation (WHO) in Geneva, and to send out a questionnaire via
the European Centre for Parliamentary Research and Documentation
(ECPRD). On 23 May 2022, it held a hearing, which also covered the
follow-up to Assembly’s
Resolution
2383 (2021) “Covid passes or certificates: protection of fundamental
rights and legal implications”,
Note with the participation of
Ms Karine Lefeuvre, Vice-President, National Ethical Consultative
Committee for life sciences and health, Paris, and Mr Jan Rohde-Stadler,
Team Leader on COVID-19 Free Movement issues, Directorate-General
for Justice and Consumers, European Commission, Brussels. On 22 August
2022, I carried out a fact-finding visit to the headquarters of
WHO in Geneva, where I met Dr Rogério Gaspar, Director, Regulation
and Prequalification Department, Access to Medicines and Health
Products Division.
2. The motion for a resolution
focuses on the issue of discriminatory treatment stemming from the
use of different Covid-19 vaccines and recalls that some Council
of Europe member States have restricted freedoms of persons who
have not received vaccinations. Referring to the Assembly’s
Resolution 2383 (2021) and to Article 14 of the European Convention on Human
Rights (ETS No. 5), the movers of the motion stress that the “preferential
treatment” of persons who got vaccinated against Covid-19 should
not lead to “unlawful discrimination” among vaccines listed by WHO.
They deplore the fact that some Council of Europe member States
“(…) started to restrict the freedom of movement of people who received
WHO-approved vaccines” and consider that “imposing restrictions
on people vaccinated with vaccines approved by the WHO does not
have an objective and reasonable justification within the meaning
of Article 14 of the Convention”. Such restrictions “(…) fail at
striking a balance between protecting the interests of the community
and the rights and freedoms of the individuals, as the individuals
in question are vaccinated” and there is no ground for them, since “according
to the WHO, those who have been administered the WHO-approved vaccines
pose significantly less risk than those who have not been vaccinated.”
3. Referring to Assembly’s
Resolution
2338 (2020) “The impact of the Covid-19 pandemic on human rights and
the rule of law”,
Note the movers of the motion for
a resolution recall that although Council of Europe member States
have positive obligations to protect the health of their citizens,
the measures they take in this respect “(…) should not contravene
the Convention,
as well as the rights
and freedoms of citizens of other countries.” Therefore,
it is proposed that the Assembly should examine “the disproportionate
measures restricting the freedom of movement of people vaccinated
with the WHO-approved vaccines and suggest measures to ensure that
the rights of these people are not violated”, in line with the Convention
and other international legal instruments.
2 Issues at stake
4. Within the Assembly, a number
of reports, resolutions and recommendations on issues arising from
the handling of the Covid-19 health crisis have been adopted but
they do not focus specifically on the issue of discrimination based
on the different types of vaccines against Covid-19.
Note Most of them dealt with the general principles
that had to be observed while handling the pandemic. For example,
in
Resolution 2338 (2020), the Assembly called on member States of the Council
of Europe to “ensure that all measures restricting human rights
that may be taken in response to a public health emergency are lawful,
necessary, proportionate and non-discriminatory (…)”.
5. The motion for a resolution first mentions the issue of distinct
treatment of persons who have been vaccinated against Covid-19 and
those who have not. Then, it focuses on possible discrimination
between persons vaccinated with different WHO-listed vaccines, without
specifying the types of vaccines, and on restrictions in freedom
of movement of citizens of other countries. Both types of differential
treatment are closely related to the use of “Covid passes” or, more
precisely in this situation, to “vaccine passes”.
6. As regards the first issue – that of discrimination between
persons who have been vaccinated against Covid-19 and those who
have not – it has already been considered at length in particular
in Assembly’s
Resolution
2383 (2021).
Note The Assembly
has stressed that measures such as the introduction of a Covid pass or
certificate must be applied in compliance with the positive obligations
arising from the Convention and only when “clear and well-established
scientific evidence” exists that they lower the risk of transmission
of the SARS-CoV-2 virus “to an acceptable level from a public health
point of view”. While “certification of vaccination status has legitimate
and valuable medical uses”, the use of Covid passes “(…) is fraught
with legal and human rights complications (…)”. Moreover, “if Covid
passes are used as a basis for preferential treatment, they may have
an impact on protected rights and freedoms” and such preferential
treatment may constitute unlawful discrimination.
7. The issue of discrimination based on vaccination with different
types of vaccines against Covid-19, has not yet been addressed by
the Assembly. This problem is aggravated by the European Union (EU)
policies related to the handling of the Covid-19 pandemic and, in
particular, its EU Digital Covid Certificate (EUDCC), which is supposed
to facilitate freedom of movement within the European Union but
imposes on citizens of non-EU member States additional restrictions
on travelling and in the enjoyment of some fundamental rights and freedoms.
Since many EU countries (Germany, France, Italy and Latvia) introduced,
at least temporarily, vaccination/recovery passes (without the possibility
of submitting a negative Covid-19 test) and thus restricted access
to many public spaces (such as bars, restaurants or event venues)
or even to public transportation (like long-distance public transportations,
including TGV trains, in France), some persons travelling, staying
for some time or living in those countries could not have access
to such venues and/or means of transportation. This can raise several
issues under the European Convention on Human Rights, and in particular
as regards the enjoyment of the right to respect for private life
(Article 8 of the Convention), the right to freedom of assembly
(Article 11 of the Convention) or the right to freedom of movement
(Article 2 of Protocol No. 4 to the Convention, ETS No. 46).
8. The motion for a resolution raises several complex – legal
and scientific – issues. As some of these problems are new, I will
first focus on issues related to the WHO-listed vaccines and the
EU policies concerning vaccine approval. Then, I will look at the
vaccination coverage and the scope of the direct or indirect obligation to
get vaccinated against Covid 19, on the issue of mandatory vaccination
and the use of Covid/vaccination passes. In doing so, I will refer
to the previous work of the Assembly concerning the Covid-19 pandemic
and to the information provided by parliamentary delegations in
response to questionnaires sent through the ECPRD. Moreover, focus
will also be given to restrictions of freedom of movement within
the European Union and entering the European Union and the European
Union Digital Covid Certificate. I will then refer to the concept
of non-discrimination in international human rights law and the
case law of the European Court of Human Rights concerning compulsory
vaccination. Finally, I will have a look at the work of WHO concerning
a new international instrument on pandemic preparedness and response
(announced by its Director-General in his speech of 12 April 2022).
Note
3 EMA-conditionally-authorised
and WHO-listed vaccines against Covid-19
9. Issues related to developing
Covid-19 vaccines have already been examined in the report of the Committee
on Social Affairs, Health and Sustainable Development entitled “Covid-19
vaccines: ethical, legal and practical considerations” (which led
to the adoption of
Resolution
2361 (2021)).
Note As stressed in that report,
before being approved, any vaccine has to undergo rigorous testing
by its developer and then scientific evaluation by regulatory authorities.
In case of member States that are part of the European Union and
the European Economic Area, this may first include the European
Medicines Agency (EMA) and other European regulatory authorities
before the competent national authorities decide on introduction
of a newly approved vaccine in the national health care systems
and vaccine policies.
10. As regards Covid-19 vaccines being conditionally authorised
in the European Union, all of them have received from the European
Commission, upon the scientific assessment of the EMA, a
conditional marketing authorisation,
Note which is valid for one year and
is renewable. The companies that market the vaccines must apply
to have their authorisations renewed. The
renewal process can take up to six months, including up to 90 days
for EMA’s evaluation.
Note
11. The following six vaccines have been conditionally authorised
for use in the European Union: Comirnaty (developed by Pfizer and
BioNTech; BioNTech Manufacturing GmbH), Jcovden (previously Covid-19
Vaccine Janssen) (Janssen-Cilag International NV), Nuvaxovid (Novavax
CZ, a.s.), Spikevax (previously Covid-19 Vaccine Moderna) (Moderna
Biotech Spain S.L.), Vaxzevria (previously Covid-19 Vaccine AstraZeneca) (AstraZeneca
AB) and Covid-19 Vaccine (inactivated, adjuvanted) Valneva (Valneva
Austria GmbH) (which was conditionally authorised on 24 June 2022).
Note Vidprevtyn (Sanofi Pasteur) is currently
under evaluation.
12. Marketing authorisation by the EMA is different from the WHO
Emergency Use Listing (EUL) procedure, which is “a risk- based procedure
for assessing and listing unlicensed vaccines, therapeutics and
in vitro diagnostics, with the ultimate aim of expediting the availability
of these products to people affected by a public health emergency.”
Note It is a key tool for companies wishing
to submit their products for use during health emergencies. The
following criteria must be met (for vaccines): the disease for which
the product is intended is serious or immediately life threatening,
has the potential of causing an outbreak, epidemic or pandemic; existing
products have not been successful in eradicating the disease or
preventing outbreaks; the product is manufactured in compliance
with current Good Manufacturing Practices and the applicant company
must undertake to complete the development of the product and apply
for WHO prequalification once the product is licensed. An application
for an EUL should follow the common technical format of the International
Council for Harmonisation of Technical Requirements for Pharmaceuticals
for Human Use; the vaccine manufacturer has to submit to the WHO
a number of data (manufacturing quality, non-clinical and clinical
data, a plan to monitor quality, safety and efficacy and labelling
details). A decision to issue an EUL is accompanied by a series
of recommendations that must be addressed by the manufacturer. WHO
reserves the right to restrict or revoke the EUL of a vaccine product
if a quality/safety issue has not been or cannot be resolved to
its satisfaction.
Note An independent advisory group composed
of six members – the Technical Advisory Group for Emergency Use Listing
– assists WHO in the EUL process.
13. There are currently eleven Covid-19 vaccines recommended by
WHO under the EUL: Comirnaty (Pfizer-BioNTech), Vaxzevria (AstraZeneca),
Covishield (Serum Institute of India Pvt. Ltd), Ad26.COV2.S (Janssen-Cilag
International NV), mRNA-1273 (Moderna Biotech), SARS-CoV-2 Vaccine
(Vero Cell), Inactivated (InCoV) (Sinopharm/Beijing Institute of
Biological Products Co., Ltd), COVID-19 Vaccine (Vero Cell), Inactivated/CoronaVac
(Sinovac, Life Sciences Co., Ltd.), SARS-CoV-2 Vaccine Inactivated
(Vero Cell)/COVAXIN (Bharat Biotech, India) (however, its supply
has been suspended), NVX-CoV2373/Covovax (Serum Institute of India
Pvt. Ltd), NVX-CoV2373/Nuvaxovid (Novavax) and Ad5-nCoV (CanSinoBIO).
NoteFive of them have also been approved
by the EMA. The Russian vaccine Sputnik V, the Sanofi and Valneva
vaccines are still under assessment.
Note
14. The WHO recommendations made under the EUL are not marketing
authorisations but are designed to support temporary availability
and use of the product concerned in emergency situations. Each WHO
Member State can allow the emergency use of a product under an EUL
in their country.
Note An EU marketing authorisation offers
a robust post-authorisation regulatory framework based on legally
binding obligations, safeguards and controls. Nevertheless, there
is no objective justification for restricting within the European Union
the freedom of movement of people vaccinated with vaccines listed
only under the EUL. Both the EMA and the WHO processes are rigorous
and ensure that the approved vaccines comply with international standards
as regards their quality, safety and effectiveness.
4 Covid/vaccination
passes
15. On many occasions, Council
of Europe bodies and instances have expressed objections as to the
use of “vaccination certificates” or “passes”. In her Information
Document of 31 March 2021
Note the Council of Europe Secretary General
Marija Pejčinović Burić highlighted the relevant human rights standards
for addressing the issue of “vaccine certificates”, namely documents
that provide evidence of the administration of a vaccine to the
person for whom it is issued. She stressed that the use of such
certificates for medical and travelling purposes was not new and
supported the work undertaken in this context to harmonise these
certificates at European and international level. However, she added
that their use should be considered with “utmost caution” if they
served purposes other than strictly medical, for example to give
individuals exclusive access to rights, services or public places,
and that they raised numerous human rights issues (risk of discrimination
in relation to freedom of movement, right to respect for private
and family life, right to freedom of assembly or right to freedom
of religion). Their use for non-medical purposes also raises issues
with regard to the protection of personal data. Such concerns were
also raised by the Council of Europe Consultative Committee on the
Data Protection Convention 108 (T-PD) in its statement on “Covid-19
vaccination, attestations and data protection” of 3 May 2021
Note and the Council of Europe
Committee on Bioethics (DH-BIO) in its “Statement on human rights considerations
relevant to “vaccine pass” and similar documents” of 4 May 2021,
which was also endorsed by the Conference of INGOs of the Council
of Europe
Note.
16. In its
Resolution
2383 (2021), the Assembly considered that the use of Covid passes
may constitute “preferential treatment”, which “(…) may amount to
unlawful discrimination within the meaning of Article 14 of the
Convention if it does not have an objective and reasonable justification.
This requires that the relevant measure (i) pursues a legitimate
aim, and (ii) is proportionate. Proportionality requires a fair
balance between protecting the interests of the community (the legitimate
aim) and respect for the rights and freedoms of the individual.”
However, regardless the situation of others, restrictions on rights
and freedoms are no longer justified for the individual concerned,
if the risk of transmission of the SARS-CoV-2 virus is significantly
lower. The Assembly also stressed that “the extent to which a justification
for differential treatment is objective and reasonable depends on
the nature of the right or freedom in question and the severity
of the interference”. Therefore, it called on member States of the
Council of Europe to “(…) institute Covid pass regimes only when clear
and well-established scientific evidence exists that such regimes
lower the risk of transmission of the SARS-CoV-2 virus to an acceptable
level from a public health point of view” and to avoid discrimination,
in case such a regime has been instituted, in particular by taking
due account to the “relative effectiveness of different vaccines
and vaccination regimes” in preventing the transmission of the disease.
17. Similarly, in its
Resolution
2424 (2022) “Beating Covid-19 with public health measures”;
Note the Assembly called
on member States of the Council of Europe to use “vaccination certificates
only for their designated purpose of monitoring vaccine efficacy,
potential side effects and adverse effects (…)”. It also called
to avoid discrimination between and within countries with regard
to ensuring global equitable distribution of vaccines and, in particular,
to mutually recognise vaccination certificates issued by Council
of Europe member States, as well as vaccination certificates of
all WHO-listed vaccines.
18. As regards national practices, I have not addressed the issue
of Covid-19 passes in my questionnaire sent to the ECPRD, as this
issue had been previously covered by two similar requests lodged
by the Italian Parliament and the Knesset (Israel) submitted respectively
in July and September (ECPRD 4811 – Use of Green Pass to access
public spaces and ECPRD 4843 – Covid-19 Green Passes to access specific
venues). In reply to these two questionnaires, 11 out of 30 Council
of Europe member States who replied between July and September 2021
(Austria, Cyprus, France, Germany, Greece, Ireland, Latvia, Luxembourg,
Portugal and Slovenia)
Note indicated
that access to certain venues such as gyms and sport facilities,
restaurants and bars, indoor culture establishments, leisure facilities
and other public spaces was subject to the requirement of presenting
the EU Digital Covid Certificate. In Cyprus, this was also the case
with public transportation. Some countries also required the EUDCC
for tourism-related activities, such as hotels and other types of accommodation
(Austria, Czech Republic, Germany, Slovenia and the Canary Islands
in Spain) or transportation during excursions (Austria). 16 Council
of Europe member States indicated that they did not require the
EUDCC to access such venues (Albania, Belgium, Bulgaria, Croatia,
Estonia, Finland, Georgia, Montenegro, Netherlands, Norway, Poland,
Romania, Spain, the Slovak Republic, Sweden and the United Kingdom).
The restrictions related to the use of the Covid-19 passes were
subject to time limits and have been re-evaluated by national parliaments
on regular basis and on the basis of the epidemiological assessment
and vaccination uptake.
19. As stressed by Ms Lefeuvre at the May 2022 hearing of the
committee, the example of France is illustrative in the context
of the fight against the Covid-19 pandemic. The Law of 5 August
2021 on the management of the health crisis had made it compulsory
to have a health pass (pass sanitaire)
in order to carry out certain activities. The French Ombudsman pointed
out that this measure was discriminatory if there was no equality
in access to vaccination. Furthermore, the National Ethical Consultative
Committee had highlighted the need to ensure the proportionality
of this measure, referring to the question of the existence of scientific evidence
for the effectiveness of the pass, alternatives to vaccination and
the question of transmission of SARS-CoV-2; it had also emphasised
the gap in equality between those who had been vaccinated and those who
had not. If the health pass was to be introduced, there had to be
alternatives; otherwise, it would be a disguised form of mandatory
vaccination, especially when Covid-19 tests were no longer reimbursed.
The Conseil constitutionnel validated the health pass subject to
certain conditions. It also validated the Law of 22 January 2022
on vaccine passes, while rejecting two of its provisions, concerning
access to political meetings and measures taken by individuals checking
the vaccine pass. The Ombudsman had criticised the proportionality
of introducing vaccine passes as regards non-vaccinated children
and the possible violations of medical secrecy.
5 Mandatory
vaccination and the right to health
20. Ensuring good public health,
and therefore, high immunisation coverage by the use of vaccines,
falls in the scope of various international human rights instruments.
Article 12.1 of the
International
Covenant on Economic, Social and Cultural Rights recognises that everyone has the right to enjoy the
highest attainable standard of physical and mental health. More
precisely, States have a responsibility to take necessary steps to
achieve the full realisation of this right by the prevention, treatment
and control of epidemic, endemic, occupational and other diseases
(Article 12.2.c of the International Covenant). Similarly, Article
11 of the Revised European Social Charter (ETS No. 163) enshrines
the right to protection of health and calls on States Parties to
this convention to undertake, either directly or in cooperation
with public or private organisations, “to prevent as far as possible
epidemic, endemic and other diseases, (…)” (paragraph 3 of this
provision).
21. Moreover, the 1997 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, the “Oviedo Convention”),
Note the
only international legally binding instrument on the protection
of human rights in the biomedical field, enshrines the principle
of “equitable access to health care of appropriate quality” (Article
3), taking into account health needs and available resources. It
also clearly states that interventions in the health field may only
be carried out with the free and informed consent of the person concerned,
that “this person shall beforehand be given appropriate information
as to the purpose and nature of the intervention as well as on its
consequences and risks” and that he/she may freely withdraw consent
at any time (Article 5). Moreover, “everyone has the right to respect
for private life in relation to information about his or her health”
(Article 10.1) and “everyone is entitled to know any information
collected about his or her health” (Article 10.2). Nevertheless,
these rights can be subject to restrictions “prescribed by law”
and “necessary in a democratic society”, in particular “for the
protection of public health or for the protection of the rights
and freedoms of others” (Article 26.1).
22. Under the European Convention on Human Rights, States Parties
to the Convention have a positive obligation to take appropriate
measures to protect the life and health of those within their jurisdiction,
especially under Article 2 of the Convention, enshrining the right
to life, and its Article 8, enshrining the right to respect for private
life.
Note Mandatory vaccination
against Covid-19 poses a problem in terms of some human rights and fundamental
freedoms, and in particular the right to respect for private life
(Article 8 of the Convention).
23. The European Court of Human Rights has already examined cases
concerning compulsory vaccination, although not in context of the
Covid-19 pandemic. It has stressed that compulsory vaccination – as an involuntary
medical treatment – amounts to an interference with the right to
respect for one’s private life, which includes a person’s physical
and psychological integrity, as guaranteed by Article 8.1 of the Convention.
Note In
its 2021 Grand Chamber judgment in the case of Vavřička and Others
v. Czech Republic, the Court has confirmed that healthcare policy
matters, including compulsory child vaccination, come within the wide
margin of appreciation of national authorities. It has found that
the requirement that children be vaccinated against a range of diseases
in order to attend nursery school did not violate the Convention,
as it was not a disproportionate interference with the rights involved
– the children were only unable to attend pre-school, and the penalties
imposed on parents were not excessive. The Court agreed with the
argument of the Czech authorities that the aim of the legislation
at stake, i.e. protecting against diseases which might pose a serious risk
to health, was a “legitimate aim”, as the legislation referred not
only to those who received the vaccinations concerned but also those
could not be vaccinated and were thus in a state of vulnerability.
Furthermore, the Court pointed out the value of social solidarity,
by giving weight to the interests of those who could only rely on herd
immunity.
24. National vaccination schemes imposing mandatory vaccination
may also infringe upon other rights enshrined in the Convention,
such as the freedom of thought, conscience and religion (Article
9 of the Convention) – if the applicant has a critical opinion on
mandatory vaccination on grounds of religious or other beliefs;
the right to education (Article 2 of the Protocol to the Convention,
ETS No. 9) – if vaccination is required for children to access school
facilities; the right to property (Article 1 of the Protocol to
the Convention) – if it is required for workers to continue their
professional activities; or the right to respect for private life
(Article 8 of the Convention), when data protection issues are involved
Note
25. In its
Resolution
2361 (2021) the Assembly called on member States of the Council
of Europe to ensure a high vaccine uptake, it called on them to
“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”
and hence did not recommend a mandatory vaccination against Covid-19.
Note The Assembly also
called on member States to “ensure that no one is discriminated
against for not having been vaccinated, due to possible health risks
or not wanting to be vaccinated”. In its
Resolution 2383 (2021), the Assembly stressed that although vaccination would
be an essential public health measure for protecting the life and
health of populations, it would be insufficient by itself.
Note
26. More recently, in its
Resolution
2424 (2022), the Assembly called on States to “encourage vaccinations”, in
“a human rights-compliant way”. It also called for “legislating
for vaccination mandates for healthcare or social-care personnel”
in contact with “highly vulnerable persons” and for “starting a
public debate on possibly legislating for vaccination mandates for
specific groups or the general population”, however, without covering persons
who for medical reasons should not get vaccinated or, for the time
being, children. In its
Resolution 2455
(2022) “Fighting vaccine-preventable diseases through quality
services and anti-vaccine myth-busting”, the Assembly has stated
that “addressing suboptimal vaccination coverage is a matter of
human rights protection and should be a priority for Council of
Europe member States”. Council of Europe member States should develop
“comprehensive, forward-looking, pro-active and human-rights compliant
vaccination strategies”.
Note In
doing so, they should ensure that “mandatory vaccination is only
considered as a last resort, when this is necessary in order to
fulfil a legitimate aim, is provided for by law, and is proportionate;
its introduction is subject to public debate, parliamentary scrutiny
and judicial oversight; and less constraining measures are given
preference when feasible.”
27. As regards national practices, I have not addressed the issue
of mandatory vaccination against Covid-19 in my questionnaire sent
to the ECPRD, as this issue had been previously covered by a similar
request lodged by the Parliament of the Czech Republic in December
2021 (ECPRD 4929 – Mandatory vaccination).
Note Out
of the 24 Council of Europe member States whose parliaments replied
to that questionnaire between October and December 2021,
Note no member State had introduced
mandatory vaccination by legislation or decree. However, seven countries
(Austria, France, Germany, Greece, Hungary, Latvia and Poland) have engaged
in debates on this question generally (in particular Austria, which
had adopted a law – not enforceable yet in this respect) or for
certain professions (Poland). Five countries had already introduced
mandatory vaccination for some professions (France, Germany, Greece,
Hungary, and Latvia). Seventeen out of the twenty-four countries
did not pass any legislation or decrees for this purpose.
28. At the May hearing, Ms Lefeuvre stressed that, according to
comparative law studies, priority in vaccination against Covid-19
should be given to vulnerable people and that several member States
of the Council of Europe, including France, had based their strategies
in fighting against the pandemic on the very restrictive Italian
approach. In December 2021, the French National Ethical Consultative
Committee expressed its opposition to mandatory vaccination for
the entire population, taking the view that there were too many uncertainties
about its efficiency and the side effects of available vaccines.
It stressed that any mandatory vaccination infringed upon individual
freedoms and could only be imposed in very precise cases, taking
into account the gravity of the infection, the advantages of the
vaccination for the population and the risks related thereto. In
the context of the Covid-19 pandemic, it could only be a last resort
measure in a situation of uncontrolled pandemic and with the use
of vaccines with proven efficacy and whose side effects were well-known.
In March 2021, the National Ethical Consultative Committee had adopted
a position in favour of mandatory vaccination for healthcare and
medico-social staff, calling on them to show responsibility and solidarity
in the exercise of their profession and relying on the principle
of non-maleficence (namely, that they should not put in danger other
people). It stressed that such an obligation should be accompanied
by an equal access to vaccines and non-contradictory data concerning
their efficacy and side effects and that awareness-raising measures
were still needed in this respect. If healthcare and medico-social
staff showed a proactive approach, this could motivate the general
population to get vaccinated and increase herd immunity.
6 EU
Digital COVID Certificate
29. On 14 June 2021, the European
Union adopted Regulation 2021/953 establishing the EU Digital COVID Certificate
during the pandemic.
Note The EU Digital COVID Certificate
is issued free of charge by national authorities and is available
in either digital or paper format containing a QR code. It certifies
that a person has been vaccinated against Covid-19, has a recent
negative test result or has recovered from the infection.
30. Regulation 2021/953 sets out a common framework for the issuance,
verification and acceptance of interoperable certificates for Covid-19
vaccination, test or recovery certificates to facilitate free movement
of EU citizens and their family members during the Covid-19 pandemic
(Articles 3-6)
Note and has been aimed at gradually
lifting restrictions to free movement, in a coordinated manner.
Note At
the same time, the regulation does not require EU member States
to introduce limitations on the right to free movement.
NoteThe
regulation also states that it cannot be interpreted as establishing
a right or obligation to be vaccinated.
Note It is not a “vaccination passport”,
as it also covers test and recovery certificates. The regulation
permits interested non-EU countries to be connected to the EU Digital
COVID Certificate system, resulting in such certificates being treated
as equivalent.
Note So far, 48 non-EU
member States, including 17 member States of the Council of Europe
(Albania, Andorra, Armenia, Georgia, Iceland, Liechtenstein, the
Republic of Moldova, Monaco, Montenegro, North Macedonia, Norway,
San Marino, Serbia, Switzerland, Türkiye, Ukraine and the United
Kingdom and the Crown Dependencies), have done so.
Note
31. Where EU member States accept proof of vaccination in order
to waive restrictions to free movement put in place to limit the
spread of SARS-CoV-2, they are under an obligation to accept, under
the same conditions, vaccination certificates issued by other member
States for a vaccine centrally conditionally authorised at EU level
(pursuant to Article 5.5 of the regulation), given that the conditional
marketing authorisations for this vaccine, including the underlying
evaluation of the medicinal product concerned in terms of quality,
safety and efficacy, are valid in all EU member States.
Note
32. In addition, EU member States may, for the same purpose, accept
certificates for a Covid-19 vaccine that has completed the WHO EUL
procedure. As stressed in recital 34 of the regulation, EU member
States are “in particular encouraged” to accept vaccination certificates
issued for such vaccines, “in order to support the work of the WHO
and to strive for better global interoperability”. Moreover, if
a vaccination certificate has been issued in a third country for
such a WHO listed vaccine and the authorities of a member State
have received all the necessary information, those authorities may
upon request, issue a vaccination certificate, unless the vaccine
is not authorised for use on its territory (Article 8.1). Therefore,
the acceptability criteria for free movement purposes are broad
and can include the WHO listed vaccines that have not necessarily undergone
the stringent EMA process of conditional authorisation. Information
on which Covid-19 vaccines not authorised in the EU are accepted
by EU member States for this purpose is published online, showing
that many EU member States accept all or some WHO listed vaccines
(such as Covishield, the Sinopharm vaccine, CoronaVac, COVAXIN and
COVOVAX).
Note This is also
corroborated by the replies provided by some EU member States to
the questionnaire I had send through the ECPRD and which are summarised
in the Appendix to this report.
Note
33. EU member States also agreed to allow, as of 1 March 2022,
non-essential travel to the EU for persons vaccinated with vaccines
approved by the EU or having completed the WHO EUL procedure.
Note However,
such persons may be subject to additional requirements such as tests,
quarantine or the administration of an EU-conditionally authorised
vaccine.
34. It should also be stressed that Article 11.1 of the regulation
still recognises the EU member States’ competence to impose restrictions
on free movement on grounds of public health. It states that member
States can impose additional conditions on free movement (such as
additional testing for SARS-CoV-2, quarantine or self-isolation),
in addition to holding a valid Covid-19 certificate, if “they are
necessary and proportionate for the purpose of safeguarding public
health” in response to the pandemic, “also taking into account available scientific
evidence”. Such additional measures were taken, for example, in
response to the emergence of the ‘Omicron’ variant of concern and
included mainly pre-departure or post-arrival tests.
Note
35. The regulation covers the use of certificates for travel within
the EU during the Covid-19 pandemic. It neither prescribes nor prohibits
the use of Covid-19 certificates for domestic purposes, such as
to regulate the access to events, restaurants, sport venues, public
transport, or the workplace. If EU member States decide to use the
EU Digital COVID Certificate for other purposes, this must be provided
for in national law, which must comply in particular with data protection
requirements.
Note It should then also ensure that
the EUDCC can also be used.
Note Member States
are free to set their own rules and conditions of acceptance of
such certificates and there are divergences in their practices,
in particular as regards acceptance periods for domestic use.
Note
36. Regulation 2021/953 states that it: “respects the fundamental
rights and observes the principles recognised in particular by the
Charter of Fundamental Rights of the European Union, including the
right to respect for private and family life, the right to the protection
of personal data, the right to equality before the law and non-discrimination,
the freedom of movement and the right to an effective remedy”; when
implementing it, EU member States shall comply with the Charter.
Note
37. By 1 March 2022, EU member States issued more than 1.72 billion
EUDCC, made up of 1.15 billion vaccination certificates, 511 million
test certificates and 55 million certificates of recovery.
Note The EUDCC has been in
use since 1 July 2021 and has been recently prolonged till the end
of June 2023, following a decision taken jointly by the European
Parliament and the Council of the European Union; EU member States
should refrain from imposing additional restrictions to free movement
of EUDCC holders. As stressed in recital 58 of Regulation 2021/953,
such restrictions imposed in relation with the Covid-19 pandemic
should be lifted “as soon as the epidemiological situation allows”.
Moreover, the European Commission encourages EU member States to
lift the obligation to present the EUDCC in the same circumstances.
Note It
has also stressed that the EUDCC has had a “very positive impact
on free movement at a time where Member States continue[d] to restrict
travel on grounds of public health” and has helped to avoid a “fragmented
system of multiple national certificates”.
Note
7 Non-discrimination
in international human rights protection law
38. Article 26 of the International
Covenant on Civil and Political Rights stipulates that “all persons
[...] are entitled without any discrimination to the equal protection
of the law” and that “(…) the law shall prohibit any discrimination
and guarantee to all persons equal and effective protection against
discrimination on any ground,
such as race, colour, sex, language, religion, political or other
opinion, national or social origin, property, birth or other status.”
39. The European Convention on Human Rights also contains a non-discrimination
provision (Article 14)
Note but
only with regard to enjoyment of rights and freedoms laid down in
the Convention. The list of proscribed grounds of discrimination
is open-ended, as Article 14 prohibits discrimination based on any
“other status”
Note and may be developed further
on a case-by-case basis. Under the Convention, protection against discrimination
is offered to any person who is within the jurisdiction of a State
party (Article 1).
40. The European Court of Human Rights is therefore limited to
treating the right to non-discrimination only as an accessory right,
namely only in conjunction with other substantive rights enshrined
in the Convention (such as the right to life, the right to respect
for private and family life or freedom of thought, conscience and religion).
The Court is not competent to examine complaints concerning discrimination
which concern rights that do not fall within the ambit of those
protected by the Convention but it may find a violation of Article
14 of the Convention even when it does not find a violation of the
substantive right.
Note
41. According to the case law of the European Court of Human Rights,
the State may not, without any objective and reasonable justification,
treat in different way persons in substantially similar situations.
It enjoys a certain margin of appreciation in assessing whether
and to what extent the existing differences justify different treatment;
however, the inequality in treatment must pursue a legitimate aim
and respect the criterion of reasonable proportionality.
Note Moreover,
a failure, without an objective and reasonable justification, to
treat differently persons whose situations are significantly different
may also be contrary to the principle of non-discrimination.
Note The Court can also find a violation
of Article 14 in cases of indirect discrimination (namely when an
apparently neutral legislation or practice results in a disproportionate
disadvantage for a particular group without reasonable justification).
Note
42. Moreover, Article 1.1 of Protocol No. 12 to the Convention (ETS
No. 177) introduces a general prohibition on discrimination in the
enjoyment of “any right set forth by law” (and therefore not only
those enshrined in Article 14 of the Convention). It applies to
all acts of public authorities (paragraph 2). So far the application
of this Protocol has been limited, as it has only been ratified
by 20 States Parties to the Convention.
Note
8 Applications
pending before the European Court of Human Rights
43. The question of potential violations
of certain human rights and fundamental freedoms during the Covid-19
health crisis has already been raised before the Court, which has
communicated a number of cases to States Parties to the Convention
on this subject.
Note Nevertheless, the Court
has not yet pronounced itself on the issue of mandatory vaccination
against Covid-19, the use of Covid passes or discriminatory treatment related
to these two issues. An application by a French university lecturer
who complained about the “health passes” introduced in France in
2021 and incited other people to lodge similar applications to the
Court had been declared inadmissible by the Court, mainly for non-exhaustion
of domestic remedies and abuse of the right of individual application
(Article 35.1 and 35.3 of the Convention).
Note Therefore,
the Court did not pronounce itself on the merits of the application.
However, another application against France is pending and has been
communicated to the French authorities; it concerns the mandatory
Covid-19 vaccination imposed on firefighters.
Note The
applicant complains that he is subject to occupation-based mandatory
vaccination and also that his refusal to be vaccinated against Covid-19
has led, since 15 September 2021, to the suspension of his professional
activity and the total stoppage of his salary. The Court has communicated
this case to the French Government under Articles 8 (right to respect
for private life) and 14 (prohibition of discrimination) of the
Convention and under Article 1 (protection of property) of the Protocol
to the Convention.
9 Conclusions
44. The introduction of vaccine
passes or, to a certain extent, of Covid passes (in particular,
when access to Covid-19 tests is too costly) can be construed as
an indirect compulsion for vaccination. As explained above, international
legal instruments on the protection of human rights do not necessarily
prohibit mandatory vaccination, but the latter can be very problematic
in the context of the right to respect for one’s private life and the
right to free and informed consent on interventions in the field
of health. Furthermore, mandatory vaccinations are likely to erode
trust in the government and have the potential to further alienate
parts of society. Nevertheless, vaccinations should be widely encouraged
and accepted as a socially responsible thing to do for the benefit
of all.
45. The use of Covid-19 passes, and in particular vaccine passes
used for restricting travelling and access to certain public venues,
leads to different forms of discrimination in the enjoyment of the
human rights and fundamental freedoms enshrined in the European
Convention on Human Rights, especially as regards the right to respect
for private life, the right to freedom of assembly and the right
to freedom of movement. First of all, this may lead to discrimination
between persons who are vaccinated and therefore possess a vaccine
pass or another type of Covid pass, and non-vaccinated persons,
as already stressed by the Assembly and other Council of Europe
bodies. This type of discrimination may also occur between those
who have been vaccinated and those who cannot be vaccinated, either
for medical reasons (including those who recovered from Covid-19
and cannot be immediately vaccinated) or because they have no access
to vaccination for various reasons (including because of social
origin, age or nationality). Moreover, as children are usually not
required to be vaccinated, this circumstance may also raise an issue
in case there is an obligation to present a “green pass” to access
certain venues. In addition, the discrepancies as regards the maximum
age for such an exemption may also raise issues in case children
travel or stay in countries applying different restrictions. Another
group which may be subject to discrimination is that of cross-border
workers, who are required to undergo Covid-19 tests in case they
are not vaccinated. The requirement to undergo such tests at very
short intervals may also be considered as an indirect obligation
to be vaccinated.
46. In this context, the introduction of the EUDCC has been a
pragmatic and temporary solution, which facilitated to a great extent
freedom of movement within the European Union in the time of pandemic.
The EUDCC allows States to avoid further restrictions of fundamental
freedoms and does not, in an of itself amount to an indirect obligation
to be vaccinated, as it is also available to persons who present
a negative Covid-19 test result or proof of recovery. Therefore,
EU citizens and third-country nationals travelling to the European Union
from non-EU countries can enter the territory of the European Union
without being vaccinated. However, although the EUDCC has been a
practical tool used to alleviate travel and other restrictions,
it has also turned out to be a discriminatory measure in some situations,
especially vis-à-vis non-EU citizens travelling to the EU.
47. Another form of discrimination – which so far has been examined
to a lesser extent – is the one between persons vaccinated with
different vaccines (and therefore possessing a vaccine pass). The
vaccine in question may be conditionally authorised by the EMA or
listed by the WHO but not the EMA or by a national regulatory authority
but not the WHO, nor the EMA, such as Sputnik V. The fact of being
vaccinated with a non-EMA or non-WHO approved vaccine may also entail
indirect discrimination on the basis of nationality in some situations (for
example, in case of non-EU citizens travelling to an EU member State
and being prevented from accessing certain public venues or using
some means of transportation).
48. Although the EMA has granted conditional authorisation for
the marketing of only six vaccines, some EU member States administered
other vaccines, including those approved only by WHO or national
authorities. Moreover, although EU member States have been reluctant
to grant marketing authorisation to all WHO-listed vaccines, the
recognition of these vaccines is now more and more widely accepted
within the EU and individuals vaccinated with such vaccines may
enter the territory of EU member States. However, recognition remains
at the discretion of each EU member State. Moreover, both Regulation
2021/953 and Regulation 2021/954, on which the use of the EUCDD
is based, govern neither its use for domestic purposes nor the question of
entry of third-country nationals to the European Union. Therefore,
EU member States are free to limit access to public venues and to
impose additional restrictions on non-EU citizens access to their
territory, even though they accept Covid-passes issued on the basis
of vaccination with a non-EMA approved vaccine.
49. The use of the EU Digital Covid Certificate or other “green
passes” does therefore leave a door open for vaccine discrimination,
although some safeguards are included in the EU legal framework
establishing the EUDCC and there have been some positive developments
as regards the recognition of WHO-listed vaccines and the certificates
based on them as well as the inclusion of 48 non-EU member States
(including 17 Council of Europe member States) in the EU-Gateway
system for the EUDCC.
50. It is too early to fully assess the necessity and the proportionality
of the restrictive measures, such as the imposition of the Covid-19
passes, as one still lacks scientific data to assess their impact
on the transmission of the SARS-CoV-2 and the development of the
Covid-19. It should be noted that because of the lack of evidence
available to fully assess the necessity and proportionality of these
measures, the responsibility of States to use the least restrictive
measures possible must be even higher that when ample evidence supports their
implementation. Hopefully, the European Court of Human Rights will
soon provide some guidance on this issue following the applications
which have been lodged before it.
51. So far, vaccination against Covid-19 has made a major contribution
to overcoming the pandemic and people have reclaimed many of their
fundamental freedoms, as many Covid-19 restrictions have been lifted. However,
this does not mean that the pandemic is over and that new restrictions
will not be imposed. Several countries still carry out border controls
and require Covid-19 certificates such as the EU Digital COVID Certificate
or equivalent certificates to enter the national territory. Therefore,
the risks of discrimination and violations of human rights and fundamental
freedoms still persist.
52. To conclude, all people vaccinated by vaccines recognised
by the EMA or WHO should be treated equally and people should not
be prevented from exercising their fundamental rights and freedoms
because they have not been vaccinated or because they have been
vaccinated with a vaccine that is not authorised for marketing or
has not been recognised in a given country. The compulsory use of
Covid passes, and in particular of vaccine certificates, entails
risks of discrimination and risks of infringements of human rights
and fundamental freedoms. Those risks are further exacerbated when
inequalities persist in access to vaccination.
