The International Journal of Human Rights

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The convention of human rights and biomedicine

revisited: Critical assessment

Vera Lúcia Raposo

To cite this article: Vera Lúcia Raposo (2016) The convention of human rights and biomedicine
revisited: Critical assessment, The International Journal of Human Rights, 20:8, 1277-1294, DOI:
10.1080/13642987.2016.1207628

To link to this article: https://doi.org/10.1080/13642987.2016.1207628

Published online: 22 Jul 2016.

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The International Journal of Human Rights, 2016
Vol. 20, No. 8, 1277–1294, http://dx.doi.org/10.1080/13642987.2016.1207628

RESEARCH ARTICLE

The convention of human rights and biomedicine revisited: Critical

assessment
Vera Lúcia Raposo*

Faculty of Law, Macao University, Macao, China

The European Convention of Human Rights and Biomedicine is the first binding
international document that provides a general juridical and ethical framework on
medicine and scientific investigation. In this sense, it represents a major effort from
the Council of Europe member states, which has proved to be a daunting task to
achieve. Nevertheless, this convention leaves many empty spaces and gives rise to
some discrepancies. Probably it could not have been in any other way. After all,
medical law and bioethics configure an enormous vast domain and it is difficult to
create a broad and harmonised regulation for these fields, especially when facing so
many different legal orders and divergent ethical and juridical values. The aim of the
present study is to offer a critical perspective on the European Convention of Human
Rights and Biomedicine with the objectivity gained from having a 15-year gap after
its entry into force.
Keywords: bioethics; Europe; human dignity; human rights; European Convention of
Human Rights and Biomedicine

Introduction: juridical framework of the Oviedo Convention

The European Convention of Human Rights and Biomedicine1 – also known as the Oviedo
Convention, the designation that we will use in this text for simplification (or simply the
‘convention’) – is the first, and until now the only, juridical international binding document
in the specific field of biomedicine and bioethics, that covers a wide range of issues. In this
sense, and especially because of its pioneer position, it occupies the top spot on discussions
on bioethics and biomedicine on an international level.
Several factors explain the need for a document such as the Oviedo Convention. On the
one hand, European juridical instances, either at national level or supranational level, were
increasingly facing disputes related to medicine and connected issues, such as genetic
materials, patients’ rights2 and human experimentation. On the other hand, the growing
proximity of European countries made possible the increased movement of patients, phys-
icians, health enterprises and researches; but due to discrepancies between national legis-
lations, the danger of ‘medical paradises’ or ‘scientific paradises’ was quite real.3
Nonetheless, preoccupations regarding these themes were not a novelty, on the contrary,
they had begun many years before.4 Since the beginning of the 1980s the Council of Europe
has issued several resolutions and recommendations in genetic engineering and embryonic
research. Finally, in 1983 it created an advisory group in charge of combining efforts to

*Emails: vraposo@umac.mo; vera@fd.uc.pt

© 2016 Informa UK Limited, trading as Taylor & Francis Group

1278 V.L. Raposo

prepare a convention. Though in the beginning fear of losing sovereignty in such delicate
issues restrained member states’ enthusiasm,5 the advisory group developed into the later-
nominated Steering Committee in Bioethics and presented a first draft of the convention to
the public in 1994. However, it was only after several years and intense discussion that the
Oviedo Convention reached a consensual text and it was finally opened for signature in
1997. But, on the other hand, due to the care in its drafting it did not take long for the con-
vention to obtain the five ratifications needed to enter into force, which happened on 1
December 1997.
The Oviedo Convention intends to develop and deepen the framework set up by the
European Convention of Human Rights (ECHR) on the general domain of human
rights,6 this time specifically in the field of biomedicine and bioethics. Both of these docu-
ments were prepared by the Council or Europe; therefore, they follow the same general line
of thought. However, although the ECHR provides the juridical basis for some important
rights related to medicine and bioethics – right to life, right to physical integrity, right to
privacy – those rights were stated in very general terms, without consideration of their
specific application in biomedicine. Thus, the particularities of this domain demanded a
human rights document specifically aimed at those specificities.

The Oviedo Convention drafting difficulties

The lack of consensus
Europe is still much divided on these matters, with a huge clash between the north, tenden-
tiously laic, and the south, predominantly Catholic. For this reason the drafters of the
Oviedo Convention were well aware that they had to be extremely cautious. On the one
hand, the convention should merely impose general guidelines and a basic framework,
instead of regulating in detail the relevant matters. On the other hand, drastic or extreme
solutions should be avoided and, instead, compromises and even evasive norms should
be preferred, capable of multiple interpretations, thus, offering to national courts and
internal lawmakers some flexibility in dealing with the Oviedo Convention. In fact, the con-
vention usually only imposes minimum standards of protection that the states have to
comply with, but without forbidding national laws to implement stricter degrees of protec-
tion, according to the culture and the ethics and beliefs of each national community.7
If the Council of Europe was not careful enough, chances were that the Oviedo Conven-
tion would not gather a sufficient number of ratifications to enter into force.8 Consequently,
the final text of the convention was quite cautious in order not to offend sensibilities and to
promote ratification.
In addition, the convention’s drafters allowed some limitations to the rights therein pro-
claimed, in order to confer more flexibility to the dispositions of the convention. Because of
the strong relation between this document and the ECHR, the natural solution was to trans-
pose the limits therein accepted. So, Article 26 of the Oviedo Convention pretty much
repeats Article 8 of the ECHR, by accepting limitations grounded on public safety, crime
prevention, protection of public health and of rights and freedoms.9
Another mechanism aimed to promote ratification is the reservation proceeding. Once
again the convention followed the example of Article 64 of the ECHR, which allows reser-
vations on particular norms as long as those norms are contrary to the national laws of the
member state. This means that the reservation mechanism cannot act on every single pro-
vision of the convention, nor disregard some requisites. Despite these limitations, theoreti-
cally it could operate as a successful solution to gain approval from more member states
 The International Journal of Human Rights 1279

and, in fact, it was already used by some of them. Nonetheless, not even this proceeding
proved to be useful in allowing ratification from the more influential states.
Despite all the cautions taken around its drafting, the document was still received with
criticism. The strongest opposition came from Germany and the United Kingdom, though
for very different reasons and, in fact, opposing ones.10
Germany argued that the Oviedo Convention was too liberal, namely regarding embryo
experimentation, thus, contradicting the national law on embryo protection, the Embryo-
nenschutzgesetz (Embryo Protection Act, ESchG).11 Actually, Germany was the most critical
voice to the convention’s draft and all political forces found arguments to reduce its disposi-
tions.12 It seems that Germany had very strong ethical and juridical viewpoints in every single
issue. German fears are understandable if we have in consideration the firm intention of not
returning to the horrendous Nazi past of terrifying experimentations on human beings.
However, there are several juridical mechanisms aimed at controlling the misuse of scientific
developments instead of simply stating a general and indiscriminate prohibition. A good –
and wiser – solution is the qualification of many of those conducts as crimes against humanity
in the national criminal codes, in order to guarantee that the developments that seriously
violate human rights are forbidden, while less grievous conducts are mere relatively prohib-
ited. These last ones can be authorised as long as they fulfil various requisites and are able to
pass through the strict controls imposed. The roll of prohibitions foreseen on the ESchG is not
only excessive but also counterproductive for scientific development.
In contrast, the United Kingdom, one of the countries with more liberal laws in
Europe,13 allows some of the conducts banned on the Oviedo Convention, for instance,
the creation of embryos solely for experimentation. While allowed in English legislation,
this practice is prohibited by the Oviedo Convention. Actually, this is the main reason
why the United Kingdom has not yet ratified the convention until the present moment.
So, in order to surpass this difficulty, the drafters of the convention decided not to
include drastic innovations in the convention’s text, and instead repeated what was
already stated at the time in many national laws (except for Article 18/2, the only really
innovative norm and also the most controversial).14 Although this was the solution to
promote its ratification, the result turned out to be a quite redundant text.

The translation obstacle

The convention was originally written in English and French and both versions are sup-
posed to have exactly the same content. However, it is a well-known fact that some con-
cepts do not hold the exact same meaning in these two languages.15
For instance, Article 1 from the Oviedo Convention states in the English version:
‘Parties to this Convention shall protect the dignity and identity of all human beings and
guarantee everyone … ’, while the French version says that ‘Les Parties à la présente Con-
vention protègent l’être humain dans sa dignité et son identité et garantissent à toute per-
sonne … ’.
However, the term ‘everyone’ has a much broader scope than ‘person’, because it
includes human entities that are juridically considered as a person (that is, born human
beings), but also the ones that are not juridically considered as a person (that is, unborn
human beings).16 The first version of the Oviedo Convention used the expressions
‘person’, ‘individual’ and ‘human being’. However, on the final version the prevailing
term is ‘everyone’.17
In addition, though this is a more subtle difference, the English text passes the message
that it protects the dignity and identity of human beings (all human beings), but conversely
1280 V.L. Raposo

the French text seems to protect born human beings (and only those ones) because of their
dignity and identity.
The discrepancy between the available versions of a same document is not exclusive to
this convention. The same can be said about the ECHR, which also has an English and a
French version. Let us take again as an example the use of the expressions ‘everyone’
and ‘person’.18 Article 2 of the ECHR, proclaiming the right to life, states as follows in
the English text: ‘everyone’s right to life shall be protected by law’. But the French
version says: ‘Le droit de toute personne à la vie est protégé par la loi’. Thus, and for
the above-mentioned reasons, the English text seems to include within its scope of protec-
tion (actually, in the scope of protection of the right to life) unborn human beings, while the
French text only protects the life of born human beings. In its earlier versions, Article 2 of
the ECHR contained the expressions ‘each person’ and ‘all individuals’, but eventually
these terms were substituted by the more evasive concept of ‘everyone’. Nevertheless,
the norm does not include any clarification about the moment in which the protection pro-
vided by the right to life begins to operate, thus, leading to many doubts and even some
dangerous ambiguity from Strasbourg’s judicial organs. The aim that justified the choice
of such a neutral (but also ambiguous and unclear) term was ‘to attribute to contracting
States some carte blache, instead of trapping national legislators into a strict redaction
that easily would create violations and, therefore, international responsibility’.19
However, the final result was not as successful as expected, giving rise to dubious decisions
from the European Commission for Human Rights and the European Commission of
Human Rights (ECtHR) regarding Article 2 and huge discrepancies amongst national
courts while interpreting the ECHR.

Oviedo Convention: the achievements

One may say that the generic nature of the convention is a failure, making its norms pretty
much useless. However, we believe that this is actually an advantage and that it could not
have been written in any other way. In fact, because of its ambitious aims, the convention
cannot be anything other than generic. It provides a basic framework in the field of bioethics
and biomedicine, without advancing to controversial solutions for the many problems
arising, and leaving the more complex issues to additional protocols to be prepared later
on. The lack of homogeneity between European legal orders prevented more detailed sol-
utions and the only way to assure the convention’s ratification was to maintain its disposi-
tions as broad and generic. Afterwards, national laws are expected to implement and
develop the basic framework provided by the convention.
The same argumentation is valid regarding the low standards imposed by the conven-
tion. This is because the consensus needed to sustain the convention could only reach those
lower requirements, for the reasons stated above. However, the Convention does not
prevent national laws going further than those minimum levels. On the contrary, the impo-
sition of higher standards would probably lead to the convention’s non-entry into force.
Another successful feature of the Oviedo Convention is the relevant role played by
informed consent (Article 5),20 one of the cornerstones of the convention, present in thera-
peutic intervention, organ and tissue donation, human experimentation, clinical trials and
genetics interventions.21 The only exception to this right to be informed refers to cases
where the communication of the information may seriously injure the patient’s health
and jeopardises his recovery – the so-called therapeutic privilege.
The convention not only recognises the right to know but also the right not to know,
unless the information concerns matters of public safety, public health or the rights and
 The International Journal of Human Rights 1281

freedoms of others (Article 26/1).22 This right has special relevance in regard to the results
of genetic testing,23 also referred to in the Additional Protocol about Genetic Tests.
The prohibition of genetic discrimination is another note to applaud. Albeit this is not a
new acquisition of the juridical world – it can be found in other national and international
documents, namely in the UNESCO Declaration (Universal Declaration on the Human
Genome and Human Rights) – it does not hurt to repeat it again, as the Oviedo Convention
did, because of the underlying dangers surrounding genetic developments. The prohibition
is stated in Article 11,24 but the solution that forbids predictive tests, unless for health pur-
poses,25 also results from Article 12. The main aim of these norms is to exclude genetic tests
requested by insurance companies or by employers in order to base their decisions on the
genetic code of each person.
Finally – or maybe this is the first and main achievement – the primitive role granted to
human dignity should be underlined, especially because the principle of human dignity is
increasingly considered the nuclear stone of European bioethics.26 As stated in the Expla-
natory Report to the Convention, “[i]t is at the basis of most of the values emphasised in the
Convention”.27 It is a fact that human dignity already played a decisive role in the ECHR,28
if not directly, at least by means of its interpretation by the commission and the ECtHR.
Actually, the curious note is that even though there is no express reference to human
dignity in the text of the ECHR, nevertheless it is considered a nuclear implicit value of
that convention.29 But in the case of the Oviedo Convention we have an entire regulation
expressly grounded on the human dignity principle (which, as we shall see later, is also one
of its fragilities), in line with the reasoning that advocates that this is the key concept on the
regulation of science and technology.30

Oviedo Convention: the difficulties

The lack of effectiveness
The Oviedo Convention is, as the name indicates, a convention, not a declaration. More
than a mere terminological specification of international law, this designation has decisive
effects regarding the binding nature of the document. In international law, ‘declarations’
merely intend to express a wish or a will, without a proper commitment from the states,
whereas ‘conventions’ bind the states to act in a certain way, and therefore carry a penalty.
However, and despite its mandatory nature, the Oviedo Convention cannot be enforced
by the ECtHR, whose only task in this matter is to express opinions regarding the interpret-
ation of its norms (Article 29), without reference to any particular case pending in the court.
It is not even clear if those opinions should be deemed binding or not.31 Therefore, if a case
demands a juridical solution within the outline of bioethics and biomedicine, the document
used by the ECtHR will be the ECHR, not the Oviedo Convention. This last one will, never-
theless, intervene to help to interpret either the ECHR or other national legislations. So, vio-
lation of the Oviedo Convention can only have repercussions regarding the ECtHR
whenever there is also a violation of the ECHR. Curiously enough, the judges of the
ECtHR have been increasingly referring to the Oviedo Convention in court decisions or
in dissenting votes.32
The foregoing considerations mean that the control regarding the respect and implemen-
tation of the Oviedo Convention by the ratifying states is not due to the ECtHR, but to the
Council of Europe’s political organs. However, there are no actual sanctions provided for
the violation of its norms, which makes the document void of almost every effect regarding
the member states.
1282 V.L. Raposo

Actually, it is up to each state to anticipate in their respective internal laws adequate

sanctions concerning violation of the Oviedo Convention; obviously this is only applicable
to individuals and not to the state itself, as stated in the final part of the Article 133 and it is
afterwards reinforced by Articles 2334 and 25.35 The only exception regarding the impo-
sition of internal transposition are the convention’s norms that may be directly applicable,36
but there is no clear understanding of which of its norms are considered as self-executing
ones.

The European character of the convention

It is said that the convention has a very European nature,37 in the sense that it hosts prin-
ciples central to European culture and to its ethical and juridical identity, such as the absol-
ute prohibition of commodification of the human body and the concept of dignity as the
unconditional protection of the person, even against himself/herself.38
Nonetheless, this observation requires further clarification: though tendentiously the
Oviedo Convention expresses common European principles, the fact is that some of
them are received differently by member states. The major differences display the contrast
between the Nordic countries and the United Kingdom, on the one hand, and the rest of
Europe, on the other hand. This discrepancy within the European family was very
evident in the discussions surrounding the convention’s drafting, as already described.
But, disregarding this note for the time being, the fact is that some Oviedo Convention
rules are too attached to the European set of values (rectius, to a part of the European set
of values) and that may be an obstacle for the convention to achieve the universal scope
that some aspired to and originally envisaged.39 The initial universal aim, probably now
lost in confrontation with reality, justified the presence of other states (non-members of
the European Council and not even European: Australia, Canada, the Holy See, Japan,
Mexico and the United States) in the discussion surrounding the writing of the convention
and the concomitant possibility of their adherence to the convention (Article 34).
However, none of them has yet ratified, nor even signed, the convention. So, the
problem is that the European nature of the convention may make it inadequate for
other realities.
In particular, the Oviedo Convention seems strange to the north-American way of think-
ing (which, actually, is also very present in the Anglo-Saxon legal world, including in the
United Kingdom), more prompt to accept the respect for privacy and individual self-deter-
mination than the protection of the individual against himself/herself, typical of continental
Europe. Indeed, and though the Oviedo Convention proclaims self-determination, it is quite
evidently an omnipresent idea of collective values which limits individual autonomy. This
may be one of the reasons why the United States, which participated in the negotiations sur-
rounding the Oviedo Convention, is not party to the convention (the same reason is valid for
the United Kingdom).
Also, the aims and concerns of the Oviedo Convention seem very far away from African
and Asian countries, whose major goals in the field of bioethics and health care are still very
distant from the ones stated in the convention. Indeed, in countries still struggling with huge
deficiencies regarding access to health care and medicines and with an almost absolute lack
of patients’ rights, the discussions about gene therapy or stem cells seem extraordinary.
However, these concerns, apparently superfluous, may actually have some relevance for
those countries, namely, in order to avoid ‘bioethics paradises’ where pharmaceutical com-
panies and high-tech enterprises could, with impunity, make huge profits at the expense of
human rights violations and infringement of bioethical rules.
 The International Journal of Human Rights 1283

The omission of relevant topics

The Oviedo Convention is not the first international document dealing with bioethics, bio-
medicine and health. But, and unlike other international texts, it is not exclusively dedicated
to patients’ rights (European Charter of Patients’ Rights), nor to human experimentation
(Declaration of Helsinki), nor to the human genome (the already referred Universal
Declaration on the Human Genome and Human Rights).40
Its broad scope, covering many different issues, has revealed itself to be important for the
purpose of achieving some uniformity in the harmonisation of legal solutions for all the differ-
ent matters (though the convention sometimes fails in this regard, namely when we compare
the norms on informed consent with the ones on advance directives, as we shall see). Never-
theless, the Oviedo Convention left some of the most relevant topics in this domain outside its
regulations.41 For instance, the convention is totally silent regarding abortion, also nearly
silent about reproductive techniques and about euthanasia and end-of-life decisions.
This silence cannot be explained by the argument that these are already consensual
matters, with no need of further regulation and approximation. Quite the opposite, these
are some of the most controversial issues, even amongst European states (see, for instance,
the enormous difference between the regulation on abortion in the United Kingdom and in
Ireland).
Perhaps one could say that the convention drafters deliberately excluded those topics
because they were too controversial. In a sense, this could be considered a wise solution.
However, if it is so, then the convention cannot be considered a wide-ranging basic docu-
ment on medicine and bioethics. Instead, it is merely an almost wide-ranging document,
which falls short of its introducing note.

The indeterminacy of the basic value of human dignity

As with many other international documents (thus, the following critique is valid for many
other international texts) the Oviedo Convention stands all its force in the proclamation of
human dignity. Nevertheless, its text does not offer a definition of human dignity; therefore,
what we have is a collection of prohibitions grounded in an uncertain idea, susceptible to
multiple meanings.
The concept of human dignity is so immense and abstract that it has had many diverse
meanings throughout history. Nowadays, two main meanings of human dignity, contrary
to each other, have gained prevalence42: human dignity as a protection of the person
against every kind of attack, even if it is coming from the person himself/herself43; and
human dignity as the respect for self-determination, including the exercise of human rights
against the common standard accepted by the community.44 In fact, while European
dignity is mainly based on the idea of sanctity of life,45 north-American dignity is basically
equivalent to self-determination. Because the first concept of human dignity can easily fall
into paternalism and disrespects individual self-determination, we strongly prefer the
second understanding, as long as it does not violate the rights of others or relevant values
of the community. Nonetheless, the first understanding was, clearly, the one welcomed for
the Oviedo Convention, which frequently restricts personal autonomy grounded on human
dignity,46 as happens with the scarce relevance conferred to advance directives, the prohibi-
tion of germinal gene therapy47 or the ban on the use of the human body for profit.
This understanding of human dignity is not unexpected considering the way this prin-
ciple has been used in the ECHR’s rulings. Indeed, an analysis of the Strasbourg case law
leads to the conclusion that, in light of the ECHR, human dignity is basically the
1284 V.L. Raposo

maintenance of life and physical integrity, disregarding the person’s decisions and even lim-
iting some other basic values recognised in the ECHR. For instance, in the case X v. The
United Kingdom the commission ruled that every motorcyclist was required to wear a
helmet for his protection, even if for reasons of religion the person would rather wear a
turban.48 This reasoning also results from the cases Laskey, Jaggard and Brown v. The
United Kingdom49 and Pretty v. The United Kingdom.50 One of the most paradigmatic
decisions of the ECtHR in this regard was issued in the case De Wilde, Ooms e Versyp
v. Belgium, in which the court stated that when the person is entitled to some right it is
not always allowed to renounce that right.51 In this sense, the decision taken by the
ECtHR in the more recent Lambert case can be considered the first one to adopt a new
understanding about the relation between the right to life and human dignity.52
The problem of grounding an entire set of norms almost exclusively in the value of
human dignity, especially when understood in this protective sense, is that the concept of
human dignity it too vague to, solely by itself, justify legal solutions.53 As Ruth Macklin
puts it, dignity is a useless concept, as least as it is used in the Oviedo Convention.54
Namely, is it not sufficient to simply say that a certain practice should be forbidden
because it is contrary to the principle of human dignity. It is necessary to explain the
above-mentioned contradiction in order to justify the prohibition. Nowadays it is quite fre-
quent to ban a certain practice by simply stating that it is against human dignity, without any
further clarification. Actually, many of these prohibitions lack a proper juridical argument
and are only sustained in mere moral reasons. However, because moral arguments are not a
suitable base to endure juridical prohibitions, human dignity appears as the best argument to
justify what cannot be justified. After all, how can someone dare to refuse the utmost
respect to human dignity, whatever content it may have?

Informed consent regarding persons unable to consent

The Oviedo Convention intends to protect the ones unable to consent; however, probably its
intentions fall short in achieving this purpose.55
This was, in fact, one of the most discussed themes during the debates that surrounded
the convention’s drafting. The initial version of the text referred to ‘incapacitated persons’
(instead of ‘persons not able to consent’, as the actual version). When the text was translated
into German, the expression chosen, probably because there was no other available, was
‘physical and mental handicapped’, causing great consternation among German
society.56 In the end, racism accusations and old ghosts from the past imposed the modifi-
cation of the expression.
Besides the words used, there was also some concern regarding the content of some
norms.
A very controversial point was the disposition about scientific research performed on
those unable to consent, since under certain conditions it allows investigation without
‘results of direct benefit to the health of the person concerned’ (Article 17/2). In order to
justify this statement it was argued that, if this safeguard did not exist, purely scientific
investigation on minors or on incapacitated people would be forbidden, seriously damaging
the finding of new medical techniques or new drugs. Indeed, it is a well-known fact that
there is hardly any drug specifically tested on children or on people with physical or intel-
lectual disabilities, leading doctors to prescribe them off-label substances that might even-
tually endanger their health. A further justification for the broad permission of scientific
investigation in these subjects was based on the promotion of scientific development. It
is a fact that the Oviedo Convention, in its inaugural part, states the primacy of the
 The International Journal of Human Rights 1285

human being over science or society (Article 257). However, it is also true that the freedom
of scientific research, under some requirements, is proclaimed in Article 15.58 The final sol-
ution aims to establish the possible balance between these conflicting interests. So, pure
research on persons unable to consent depends on the fact that the predictable results can
substantially improve the conditions of the ones suffering from the same illness or disorder
and, in addition, involves a very low risk level for the person under the experiment. Even
with all these cautions the issue was so debatable that it required an additional protocol – the
Additional Protocol on Human Experimentation – where the question was the object of
further developments.
Another polemic topic regarding persons unable to consent concerns organ donation,
since the Oviedo Convention allows the retrieval of organs and genetic substances from
these individuals under certain circumstances, which were considered too flexible for the
German counterpart (Article 20). As a general rule, the organs of persons unable to
consent cannot be used for transplantation, but some exceptions are allowed, as long as
certain requisites are fulfilled: (i) the regenerative nature of the tissue; (ii) non-existence
of another compatible donor; (iii) the donor and the recipient are siblings; (iv) the donation
has a life-saving character; (v) there is written authorisation from the donor’s representative,
an authority or a person or body legally recognised; (vi) the donor does not present any
objection. Despite these safeguards, a protocol was once again necessary – the Additional
Protocol on Transplantation of Organ and Tissues of Human Origin – to calm fears.

The juridical status of embryos and foetuses

The juridical status of embryos and foetuses was already controversial under the ECHR and
solely the decision of the juridical bodies – the European Commission of Human Rights
first, and the ECtHR afterwards59 – managed to clarify the question, though only after
many pronouncements.
The question used to be discussed regarding abortion, and only in the last few years the
court was also confronted with decisions concerning in vitro fertilisation. Based on these
decisions, it is possible to conclude that embryos and foetuses cannot claim fundamental
rights, but still deserve some juridical protection.60 However, the position of the Strasburg
organs when it came to these matters was always very careful, especially because they did
not want to offend sensibilities. So they kept forwarding the decision to the (wide) national
states’ margin of appreciation, basically saying that almost any solution in this regard is
acceptable.
The Oviedo Convention does not include any disposition about abortion, but many of
its norms refer to embryos and foetuses.
The biggest contribution in this regard is the proclamation of human dignity in Article 1,
in opposition to the formula ‘dignity of the human person’, sometimes used in human rights
texts and also in the constitutions of Germany, Austria, Italy, Spain, Greece, Portugal and
Switzerland, though they also refer to the expression of human dignity.61
In fact, this later formulation excludes all entities not considered persons in juridical
terms, as happens with embryos and foetuses according to the majority of national and
international case law and legal doctrine in Europe.
We can also highlight Article 14, which forbids sex selection; and Article 18, which
allows embryonic experimentation under certain terms. However, both norms leave
space for doubts and criticism.62
Article 14 forbids sex selection, except when used to prevent a genetic disease linked to
a certain gender,63 a disposition very close to the national regulations of European
1286 V.L. Raposo

countries.64 But the norm uses a bizarre way of expressing this prohibition: ‘shall not be
allowed for the purpose of choosing a future child’s sex’. Does that mean that the prohibi-
tion is only valid if the unborn actually is born, but not if we are merely selecting the sex of
an embryo that happens not to be born, for instance, because it remains cryopreserved or
ends up being used in experimentation? Furthermore, the norm does allow sex selection
‘where serious hereditary sex-related disease is to be avoided’. This exception intends to
refer exclusively to the cases where the future person will be sick with the disease or
also to the ones where the person will be the gene carrier? Can this norm be considered
an authorisation for a saviour-sibling when the future person is going to be a donor for a
sibling suffering from a condition related to a certain gender?65
Article 18 is a complex norm and the product of a ferocious battle between ethical con-
victions and economic interests. In fact, policies regarding scientific investigation are pri-
marily designed considering financial concerns. Biotechnology became a very relevant
industry all around the world and Europe does not want to be left behind. In the advent
of the new century, even Germany realised that its strict regulation on the issue was trans-
ferring most of the research and development to other parts of the world.66
Article 18 allows embryonic experimentation, but only inasmuch as the national law
provides adequate protection to it, without any other clarification of this general and
vague expression.
Though dubious in many ways, the norm does state a very clear prohibition: the creation
of embryos solely for experimentation purposes is banned.
Nevertheless, this is not an absolute prohibition. According with Article 26/1 some
limitations can be opposed to the convention’s dispositions as long as they are ‘prescribed
by law and are necessary in a democratic society in the interest of public safety, for the pre-
vention of crime, for the protection of public health or for the protection of the rights and
freedoms of others’. Number 2 of this norm lists some articles that can never be restricted,
but Article 18 is not on that list, thus, national states can place limitations on this prohibi-
tion. But still, this prohibition discouraged British ratification.
This rigid differentiation between embryos created for reproductive aims and embryos
created for experimentation purposes became much criticised. Its opponents say experimen-
tation directed to develop medicine and save human lives is an aim as important (or even
more so) as reproduction.67 So, both finalities deserve juridical protection. ‘The difference
that can be identified between the two situations is that destruction is a more immediate
destiny in experimentation than in the technique of in vitro fertilization, because in the
former hypothesis other possibilities may be open to embryos (cryopreservation and later
uterine transference, embryo donation) thereby allow their survival.’68
Furthermore, this prohibition risks undermining the development of scientific research
in Europe, with severe losses for the purpose of alleviating the suffering of those attacked
by severe diseases,69 whose cure may eventually be grounded in the knowledge acquired
through embryonic experimentation.
As can be concluded from all these considerations, the Oviedo Convention can be cri-
ticised in many respects in what concerns the juridical status of embryos and foetuses and
practices involving them. But the first and major critic to the Oviedo Convention in this
regard relates to the omission regarding the concept ‘embryo’. This definition is lacking
both from the convention itself and from the additional protocols and explicative reports.
However, such a definition would be of the outmost importance because legal orders are
based on different concepts of what an embryo is. For instance, in the Spanish legal
order, the product of fertilisation only becomes an embryo after the 14th day of development
(until then it is considered a pre-embryo), as stated by Article 1/2 of Law n. 14/2006 from
 The International Journal of Human Rights 1287

16th May. Thus, the prohibition of experimentation does not apply before achieving the status
of embryo, that is, before the 14th day. Completely different is the definition of embryo in
force in Germany, where the ESchG defines the embryo as (Article 8 of ESchG) ‘the
human egg cell, fertilized and capable of developing, from the time of fusion of the nuclei,
and further any totipotent cell removed from an embryo that is assumed to be able to
divide and to develop into an individual under the appropriate conditions for that.’
This is a very broad definition, in the sense that it includes the product of fertilisation
from its very first moment, as well as any individual cell constitutive of it and capable of
developing into a human person. Actually, this definition is very close to the one sustained
in case C-34/10 of the European Court of Justice,70 first by the Advocat General Yves Bot
and afterwards by the court itself, which imposed a heavy obstacle on scientific research
that could be developed in Europe. However, in the recent case C-364/13,71 Advocate
General Cruz Villalón issued the following opinion (delivered on 17 July 2014):

Unfertilized human ova whose division and further development have been stimulated by
parthenogenesis are not included in the term ‘human embryos’ in Article 6(2)(c) of Directive
98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection
of biotechnological inventions as long as they are not capable of developing into a human being
and have not been genetically manipulated to acquire such a capacity.

Thus, organisms resulting from parthenogenesis, which do not have the inherent capacity of
developing into a human being, are not considered embryos in light of this opinion. This is a
slight retreat from the inflexibility of the previous definition, but weak and probably fugacious.
In sum, the proliferation of several definitions of ‘embryo’ would demand a clarification
from the Oviedo Convention, in order to identify which kind of entity is protected (or not)
by its norms, but we cannot find in its text – nor even in the additional protocols – such a
clarification.

The weak recognition of advance directives

Despite the strong recognition of the patient’s self-determination and his/her right to
informed consent, the Oviedo Convention fails in regard to advance directives, by
simply stating that they must be taken into consideration (Article 9). However, ‘to take
in consideration’ is a weak recognition, since it does not state an imposition of respect,
but solely the obligation of acknowledging its existence, without any obligation of comply-
ing with its content.
This legal solution goes against the general position of the convention on patient’s
autonomy, since the respect for the patient’s previous decisions is a core issue in the
domain of patients’ rights. It can probably be explained by the fear of using advance direc-
tives to request death, since the dominant conception of human dignity prevailing in con-
tinental Europe refuses the disposal of life, even in cases of acute suffering. But, if this is
indeed the reason, instead of providing advance directive with this weak strength, it would
be a logical and wiser solution to recognise their binding force, in conjunction with safe-
guards in order to allow their refusal in exceptional situations in which compliance could
lead to euthanasia, a practice still generally forbidden around Europe.72

The dubious juridical regime of human cloning

The Oviedo Convention says nothing about human cloning and not even adopting extensive
interpretations of the norms therein included makes it possible to find a legal answer to this
1288 V.L. Raposo

question.73 Though some have sustained that the mere proclamation of human dignity is
sufficient to prohibit cloning,74 the fact is that the relation between human cloning and
human dignity is not that evident.
The only clear position came from the Additional Protocol on Human Cloning, which
bans reproductive cloning.75 However, some problems remain.
Primarily, the dubious terms used by the protocol, which states: ‘any intervention
seeking to create a human being genetically identical to another human being, whether
living or dead’ (Article 1/1). The point is that human cloning does not always give rise
to genetically identical human beings. In fact, this only happens when the donor of the
nucleus coincides with the donor of the enucleated cell. On the contrary, whenever those
elements come from two different individuals the cloned human being will not be identical
to any other existing being. The new being will be the junction of two different genomes,
the one of the nucleus donor and the one of the mitochondrial DNA donor. Therefore, and
without any further clarification, the ban on human cloning would not apply in this second
situation. But the protocol adds an explanation in number 2 of Article 1: ‘For the purpose of
this article, the term human being “genetically identical” to another human being means a
human being sharing with another the same nuclear gene set’. In addition, the protocol elu-
cidates, in its point 7:

‘The term “nuclear” means that only genes of the nucleus – not the mitochondrial genes – are
looked at with respect to identity, which is why the prohibition of cloning human beings also
covers all nuclear transfer methods seeking to create identical human beings. The term “the
same nuclear gene set” takes into account the fact that during development some genes may
undergo somatic mutation. Thus monozygotic twins developed from a single fertilized egg
will share the same nuclear gene set, but may not be 100% identical with respect to all their
genes. It is important to note that the Protocol does not intend to discriminate in any fashion
against natural monozygotic twins.’

So, it is irrelevant that the cloned creature has or does not have a unique mitochondrial set of
genes, since the only genetic code able to determine if two individuals are or are not identical
is the one of the nucleus, which in every kind of cloning is always a repeated genetic code.
The second issue relates with therapeutic cloning, not referred in the convention or in
the protocol. Based on this silence, it must be considered admissible.76 The argument
advanced by some authors that therapeutic cloning is included on the prohibition of creating
embryos exclusively for experimentation cannot be accepted, by the simple fact that this
practice cannot be equated to experimentation.
In addition, it can also be stated that the product of cloning techniques is not a proper
embryo, but something different. The problem arises because the protocol (just as it
happens with the Oviedo Convention) does not provide a definition of ‘human being’,
leaving its clarification for each member state, according to their national laws. This is
the reason why the Permanent Representation of the Netherlands felt the need to add a
Verbal Note declaring that ‘in relation to Article 1 of the Protocol, the Government of
the Kingdom of The Netherlands declares that it interprets the term “human being” as refer-
ring exclusively to a human individual, i.e. a human being who has been born.’
Thus, in accordance with this statement, therapeutic cloning is not banned by the pro-
tocol, since in this modality of cloning the human being does not reach birth.
However, in our opinion this clarification is not compatible with the usual understand-
ing of the term ‘human being’ as every human living entity, including the ones that are
persons and the ones that are not persons but can develop into a person, in other words,
born persons and unborn ones.77 It is in this same sense that the expression ‘human
 The International Journal of Human Rights 1289

being’ seems to be used both in the ECHR and in the Oviedo Convention (while the term
‘person’ only refers to born human beings) and we see no reason to circumvent the meaning
of the concept in the additional protocol. In sum, or the protocol also intends to ban thera-
peutic cloning, which seems contradictory with the remaining dispositions, or the use of the
word ‘human being’ is incorrect and should be substituted by the term ‘person’.
The acceptance of therapeutic cloning is also reinforced by the Explanatory Report of
the Protocol, which adds that

cloning of cells and tissue is considered worldwide to be an ethically acceptable valuable bio-
medical technique ( … ) one has to distinguish between three situations: cloning of cells as a
technique, use of embryonic cells in cloning techniques, and cloning of human beings, for
example by utilizing the techniques of embryo splitting or nuclear transfer. Whereas the first
situation is fully acceptable ethically, the second should be examined in the protocol on
embryo protection. The consequences of the third situation, that is the prohibition of cloning
human beings, are within the scope of this Protocol.

The prohibition of germinal genetic interventions

The Oviedo Convention allows somatic genetic interventions, when directed to ‘preventive,
diagnostic or therapeutic purposes’; however, it forbids germinal interventions (Article 13).
The caution is understandable since those kinds of interventions are not so developed
that we can guarantee their safety and predict all their consequences. But if caution was
the only concern, then, there would not be any reason to sustain the banning of germinal
interventions once science provides us with the guarantee of a safe practice. Nevertheless,
the convention imposes an absolute prohibition. So, the motive justifying the total ban has
to be a different one. Probably the reason lies in the fear of genetic enhancements able to
jeopardise the prohibition of genetic discrimination (Article 11). Another reason may be
the risk of interfering in genetics and the possible consequent accusation of ‘playing
God’. Or even the risk that a development in the knowledge we have about genes could
turn them into a source of profit, thus, violating Article 21, which prohibits financial
gains from the body and its elements.
Nonetheless, by closing the door to germinal therapy absolutely, the convention may be
endangering the right to physical integrity and even the right to life of those that suffer from
severe diseases that could have been prevented or treated by means of genetic interventions
in their ancestors.78 As Mori and Neri note, ‘in what sense, if any, could an intervention
seeking to rid some individuals and probably their descendants from fatal diseases be inter-
preted as a “misuse of biology and medicine” that “may lead to acts endangering human
dignity” (preamble to the Convention)?’79 As these authors still underline, the safeguard
of an unmodified genetic code could make sense in what concerns future generations as
an abstract entity, but it is totally void of meaning when referred to concrete individuals tor-
mented with painful and severe diseases.80

Conclusion: a final evaluation of the Oviedo Convention

Due to the above-mentioned fragilities, the Oviedo Convention is not yet ratified by many
countries, including some of the most relevant ones in terms of their weight in bioethical
discussions in international forums, which (curiously) were also the most active players
during the redaction of the convention: Belgium, Germany, Ireland, Russia and the
United Kingdom. As Bellver Capella very interestingly notes, we have a very weird situ-
ation81: the states that prepared the norms are not bound by them, while the ones that
1290 V.L. Raposo

did not prepare the norms are obliged to them. For instance, the level of protection afforded
to unborn human life was one of the most disputed issues during the drafting of the conven-
tion. Countries such as the United Kingdom and Belgium sustained that the convention was
protecting too much, while others, such as Ireland and Italy, that it was protecting too little.
In the end, none of those countries have ratified the convention and only Italy has signed it.
Thus, the Oviedo Convention is not in force in any of them.
Because of all these difficulties, the final text of the convention actually does not say too
much, or at least much different, from the content of national laws. Probably it could not be
in any other way. But the fact is that the initial goal of delineating principles common to all
signing states, as a kind of European jus commune in what concerns bioethics (and probably
even aspiring to a universal ius commnune) failed. Instead, what we have is a very general
framework to be adopted and, more important than that, adapted, by every state. The adop-
tion of the convention is actually the recognition that we don't have a single bioethics law in
Europe, but several, as many as the signing states.82
Probably the only way to gather all these different perspectives on a single approach to
bioethical issues together will be by resorting to economic interests,83 taking as an example
the construction of the European Union and the European identity, in whose genesis were
purely economic interests. In fact, history shows that governments are much keener to
cooperate economically than in the matter of bioethics, because of its close connections
with religion, morality and other values that go far beyond mere juridical issues.
However, and despite all the fragilities, limitations and difficulties presented by the
Oviedo Convention, it should be recognised that, in the moment it was drafted – and
most probably still today – it was not possible to go any further. The fragile and extremely
general commitment achieved with the Oviedo Convention was, in the end, the only one
possible and even that is something to be proud of.

Disclosure statement
No potential conflict of interest was reported by the author.

Funding
This work was supported by the University of Macau [grant number MYRG2015-00007-FLL], [grant
number MYRG2015-00008-FLL].

Note on contributor
Vera Lúcia Raposo holds a law degree, a post-graduate degree in medical law, a master’s and a PhD
in juridical-political sciences, all obtained in the Faculty of Law of Coimbra University, Portugal. She
worked as an Auxiliary Professor at the Faculty of Law of Coimbra University and at the Faculty of
Law of Agostinho Neto University (Angola). In addition, she also acted as of counsel in some law
offices in Lisbon (Portugal), especially in the field of health law. Presently she is Assistant Professor
at the Faculty of Law of Macau University. She has authored several books and articles in Portuguese,
English and Spanish, in particular about health/medical law and human rights and she is a member of
several institutes and international organisations dedicated to this area of research. She is also a fre-
quent speaker at international events on these topics.

Notes
1. For a general analysis of the convention see Vera Lúcia Raposo and Eduardo Osuna, ‘European
Convention of Human Rights and Biomedicine’, in Legal and Forensics Medicine, ed. Roy
Beran (Berlin, Heidelberg: Springer-Verlag, 2013), 1405–23.
 The International Journal of Human Rights 1291

2. Herman Nys, Medical Law in Belgium (Alphenaanden Rijn: Kluwer Law International, 2010).
3. Maurice Wachter, ‘The European Convention on Bioethics’, Hastings Center Report 27, no. 1
(1997): 13–24.
4. See the history of the convention in Christian Byk, ‘The European Convention on Bioethics’,
Journal of Medical Ethics 19 (1993): 13–16; E.W. Dommel and D. Alexander, ‘The Convention
of Human Rights and Biomedicine’, Kennedy Institute for Ethics Journal 70, no. 3 (1997): 259–
76; Gabriella Scuderi, ‘Gli Indirizzi Dati da Alcuni Atti Internazionali alla Normativa Italiana
Relativa agli Aspetti Bioetici della Ricerca Scientifica’, Annali dell’ Istituto Superiore di
Sanità 37, no. 2, (2001): 195–206.
5. Referring to those difficulties, see Jessica de Alba Ulloa, ‘Dificultades del Proceso de Negocia-
ción de la Convención para la Protección de los Derechos Humanos y la Dignidad del Ser
Humano con Respecto a las Aplicaciones de la Biología y la Medicina (y un Llamado a su
Adhesión)’, Gaceta Médica de México 148 (2012): 307–20.
6. The intimate connection between both documents is also underlined in the Explanatory Report to
the ECHR (Council of Europe, Explanatory Report to the Convention for the Protection of Human
Rights and Dignity of the Human Being With Regard to the Application of Biology and Medicine:
Convention on Human Rights and Biomedicine, European Treaty Series – No. 164).
7. ‘The minimum rank of protection, required by the European Council, cannot be understood as
the defense of a liberal position on this matter, since it is expected that ratifying States go
beyond and above the level required by the ECRTHRBMed [the authors are referring to the
Oviedo Convention], by accommodating the generic guidelines imposed therein to their own
realities’ (Raposo and Osuna, ‘European Convention’, 1407).
8. Ibid., 1406.
9. All referred articles belong to the Oviedo Convention, unless another legal text is expressly
indicated.
10. Raposo and Osuna, ‘European Convention’, 1406–7.
11. Cf. Barbara Böckenförde-Wunderlich, Präimplantationsdiagnostik als Rechtsproblem (Tübin-
gen: Mohr Siebeck, 2002), 191–41; M. Frommel and Others, ‘Embryonenschutzgesetz
(ESchG) und die das VerfahrenregelndeRechtsverordnung (PIDV)?’, Journal für Reproduk-
tionsmedizin und Endokrinologie 10, no. 1 (2012): 6–17; Carol Muller, ‘The Status of the Extra-
corporeal Embryo in German Law (Part I)’, Revista de Derecho y Genoma Humano 22 (2005):
133–51; Carol Muller, ‘The Status of the Extracorporeal Embryo in German Law (Part II)’,
Revista de Derecho y Genoma Humano 22 (2005): 139–65; Ralf Müller-Terpitz, ‘Genetic
Testing of Embryos in Vitro – Legal Considerations with Regard to the Status of Early
Human Embryos in European Law’, German Yearbook of International Law 54 (2011): 489–
520; Vera Lúcia Raposo, O Direito à Imortalidade (O Exercício de Direitos Reprodutivos Med-
iante Técnicas de Reprodução Assistida e o Estatuto Jurídico do Embrião In Vitro) (Coimbra:
Almedina, 2014), 1103–7; Christian Starck, ‘Embryonic Stem Cell Research According to
German and European Law’, German Law Journal 7 (2005): 625–56.
12. Wachter, ‘The European Convention on Bioethics’, 16–18.
13. Cf. Austin Garwood-Gowers, ‘Contemporary Issues in the Regulation of Artificial Reproduc-
tion and Embryology in the UK’, Revista de Derecho y Genoma Humano 21 (2004): 67–
101; Thérèse Murphy and Geraóid Ó’Cuinn, ‘Taking Technology Seriously: STS as a
Human Rights Method’, in Law and New Health Technologies, ed. M.L. Flear and Others
(Oxford: Oxford University Press, 2013), 285–308; Raposo, O Direito à Imortalidade, 1119–
22; Peter Thompson, ‘Reproductive Therapy: HFEA Responds on Germline Therapy’,
Nature 500 (2013): 276.
14. Also sharing this opinion is Richard E. Ashcroft, ‘Could Human Rights Supersede Bioethics?’,
Human Rights Law Review 10, no. 4 (2010): 639–60, 657.
15. Pointing out some discrepancies in the translation of international human rights texts, see Vera
Lúcia Raposo, Catarina Prata, and Isabel Oliveira, ‘Human Rights in Today’s Ethics: Human
Rights of The Unborn (Embryos and Foetus)?’, Cuadernos Constitucionales de la Cátedra
Fadrique Furio Ceriol 62/63 (2010): 95–111.
16. Ibid., 101 ff.
17. Şule Toktaş, ‘Internationalization of Bioethics: The Search for Common Norms of Bioethics in
the EU and the Council of Europe’, Kocaeli Universitesi Sosyal Enstitusu Dergisi 12 (2006):
172–94.
18. Raposo, Prata, and Oliveira, ‘Human Rights in Today’s Ethics’, 95 ff.
1292 V.L. Raposo

19. Ibid., 95 ff.

20. Alain Garay, ‘El Consentimiento al Acto Medico a la Luz de la Convención Europea de los
Derechos Humanos’, Revista Latinoamericana de Derecho Medico e Medicina Legal 2, no.
2 and 3 (1997/1998), 4–6.
21. Raposo and Osuna, ‘European Convention’, 1412–16.
22. ‘No restrictions shall be placed on the exercise of the rights and protective provisions contained
in this Convention other than such as are prescribed by law and are necessary in a democratic
society in the interest of public safety, for the prevention of crime, for the protection of public
health or for the protection of the rights and freedoms of others.’ Criticising this norm, see
Gilbert Hottois, ‘A Philosophical and Critical Analysis of the European Convention of
Bioethics’, Journal of Medicine and Philosophy 25, no. 2 (2000): 133–46.
23. de Alba Ulloa, ‘Dificultades del Proceso de Negociación’, 310.
24. ‘Any form of discrimination against a person on grounds of his or her genetic heritage is
prohibited.’
25. ‘Tests which are predictive of genetic diseases or which serve either to identify the subject as a
carrier of a gene responsible for a disease or to detect a genetic predisposition or susceptibility to
a disease may be performed only for health purposes or for scientific research linked to health
purposes, and subject to appropriate genetic counselling.’
26. Roberto Andorno, ‘Human Dignity and Human Rights as a Common Ground for a Global
Bioethics’, Journal of Medicine and Philosophy 34, no. 3 (2009): 223–40.
27. Council of Europe, Explanatory Report, 3.
28. F. Seatzu, ‘The Experience of the European Court of Human Rights with the European Conven-
tion on Human Rights and Biomedicine’, Utrecht Journal of International and European Law
31, no. 81 (2015): 5–16.
29. Catherine Dupré, ‘Human Dignity in Europe: A Foundational Constitutional Principle’, Euro-
pean Public Law 19, no. 2 (2013): 319–39.
30. T. Caulfield and R. Brownsword, ‘Human Dignity: A Guide to Policy Making in the Biotech-
nology Era?’, Nature 7 (2006): 72–6.
31. Discussing this issue, see A. Gitti, ‘La Corte Europea dei Diritti dell’ Uomo e la Convenzione
sulla Biomedicina’, Rivista Internazionale dei Diritti dell’ Uomo 3 (1998): 719–35.
32. Also curious is the fact that sometimes those references appear in cases concerning member
states that have not so far ratified the Oviedo Convention. See ECtHR, Evans v. The United
Kingdom, Appl. No. 6339/05, judgment of 10 April 2007 or ECtHR, Ada Rossi v. Italy,
Appl. No. 55185/08, judgment of 16 December 2008, both referring to non-ratifying states.
Even more bizarre is the fact that some of the judicial references came from judges representing
those non-ratifying states, as for instance the vote of the Belgian Judge Marcus-Helmons (in
ECtHR, Cyprus v. Turkey, Appl. No. 25781/94, judgment of 10 May 2001, dissenting
opinion), despite the fact that Belgium is not yet bound by the convention.
33. ‘Each Party shall take in its internal law the necessary measures to give effect to the provisions
of this Convention.’
34. ‘The Parties shall provide appropriate judicial protection to prevent or to put a stop to an unlaw-
ful infringement of the rights and principles set forth in this Convention at short notice.’
35. ‘Parties shall provide for appropriate sanctions to be applied in the event of infringement of the
provisions contained in this Convention.’
36. CNE – Commission Consultative Nationale d’Ethique, Convention pour la Protection des Droits
de l’homme et de la Dignité de l’être Humain à l’égard des Applications de la Biologie et de la
Médecine: Convention sur les Droits de l’homme et la Biomédecine – Avis 1/1999 de la Commis-
sion Consultative Nationale d’Ethique pour les Sciences de la Vie et de la Santé (1999): 72–3.
37. Hottois, ‘A Philosophical and Critical Analysis’, 139.
38. For texts about the concept of dignity in international human rights documents, see Hector
G. Espiell, ‘La Dignidad Humana en los Instrumentos Internacionales sobre Derechos
Humanos’, Anuario de Derechos Humanos. Nueva Época 4 (2003): 193–223.
39. Cf. Louis Dubouis, ‘La Convention sur les Droits de l’ Homme et la Biomédecine’, Revue de
Droit Sanitaire et Social 2 (1998): 211–22; Maurizio Mori and Demetrio Neri, ‘Perils and
Deficiencies of the European Convention on Human Rights and Biomedicine’, Journal of Medi-
cine and Philosophy 26, no. 3 (2002): 323–33.
40. About the Universal Declaration on the Human Genome and Human Rights, see Noelle Lenoir,
‘Comment: Universal Declaration on the Human Genome and Human Rights: The First Legal
 The International Journal of Human Rights 1293

and Ethical Framework at the Global Level’, Columbia Human Rights Law Review 30 (1999):
537–87.
41. Underlying this omission, see Vicente Bellver Capella, ‘Los Diez Primeros Años del Convenio
Europeo sobre Derechos Humanos y Biomedicina: Reflexiones y Valoración’, Cuadernos de
Bioética XIX, no. 3 (2008): 401–21.
42. Raposo, O Direito à Imortalidade, 340–6.
43. Ruth Macklin, ‘Dignity is a Useless Concept’, British Medical Journal 327 (2003): 1419–20.
44. Describing these two meanings of human dignity, see Roberto Andorno, ‘The Oviedo Conven-
tion: A European Legal Framework at the Intersection of Human Rights and Health Law’,
Journal of International Biotechnology Law 2 (2005): 133–43; Roberto Andorno, ‘La Tutela
Della Dignità Umana: Fondamento e Scopo della Convenzione di Oviedo’, in Bioetica e
Dignità Umana. Interpretazioni a Confronto a Partire dalla Convenzione di Oviedo, ed. E.
Furlan (Milano: Angeli, 2009), 77–94; Roger Brownsword, ‘What the World Needs Now:
Techno-Regulation, Human Rights and Human Dignit’, in Human Rights, ed. Roger Brown-
sword (Oxford: Hart, 2004), 203–34, especially 206 ff.
45. European scholars keep trying to present a proper argument to justify the limits imposed on self-
determination, supposedly to protect human dignity. For instance, Meulders-Klein states that
dignity is the supreme value and self-determination merely one of its consequences, thus, it
can be restricted in order to protect dignity (M.T. Meulders-Klein, ‘Biomédecine, Famille et
Droits de l’Homme: Une Même Éthique pour Tous?’, Révue Trimestrielle des Droits de
l’Homme 43 (2000): 429–42, 451).
46. CNE, Convention pour la Protection des Droits, 12.
47. Unless we sustain that the prohibition is protecting the self-determination of future generations,
as Bellver Capella (‘Los Diez Primeros Años’, 409) states, but we cannot see how to justify this
statement when future generations do not have rights of their own. Regarding the juridical status
of future generations see Raposo, O Direito à Imortalidade, 995–7.
48. X v. The United Kingdom, Application No. 7992/77, judgment from 12 July 1978.
49. Laskey, Jaggard and Brown v. The United Kingdom, Application No. 21627/93; 21628/93;
21974/93, judgment from 19 February 1997.
50. Pretty v. The United Kingdom, Application No. 2346/02, judgment from 29 April 2002.
51. De Wilde, Ooms e Versyp (‘Vagrancy’) v. Belgium, Application No. 2832/66; 2835/66; 2899/66,
judgment from 18 June 1971.
52. Lambert and Others v. France, Application No. 46043/14, judgment from 5 June 2015.
53. Daniela-Ecaterina Cutas, ‘Looking for the Meaning of Dignity in the Bioethics Convention and
the Cloning Protocol’, Health Care Analysis 13, no. 4 (2005): 303–13.
54. Macklin, ‘Dignity is a Useless Concept’.
55. Cf. Alba Ulloa, ‘Dificultades del Proceso de Negociación’, 309–10.
56. On the German reaction see Wachter, ‘The European Convention on Bioethics’, 16–18.
57. ‘The interests and welfare of the human being shall prevail over the sole interest of society or
science.’
58. ‘Scientific research in the field of biology and medicine shall be carried out freely, subject to the
provisions of this Convention and the other legal provisions ensuring the protection of the
human being.’
59. About the unborn status in the ECHR, José Díaz de Valdés, ‘Análisis Crítico de la Jurispruden-
cia de la Corte Europea de Derechos Humanos sobre el Estatus del no Nacido en la Convención
Europea de Derechos Humanos’, Revista Actualidad Jurídica 18 (2008): 69–104.
60. Cf. Pieter van Dijk, Fried van Hoof, and Arjen Van Rijn, Theory and Practice of the European
Convention on Human Rights (The Hague: Kluwer, 1998), 300 ff.; Louis Favoreu, ‘Les
Juges Constitutionnels et la Vie’, Droits. Revue Française de Théorie Juridique 13 (1991):
1–75; Gregor Puppinck, ‘Abortion and the European Convention on Human Rights’,
Irish Journal of Legal Studies 3, no. 2 (2013): 142–193; Vera Lúcia Raposo, ‘O Tribunal
Europeu dos Direitos do Homem e o Direito à Vida’, Jurisprudência Constitucional 14
(2007): 59–87.
61. Cf. Patrick Fraisseix, ‘La Protection de la Dignité de la Personne et de L’Espèce Humaines dans
le Domaine de la Biomédecine: L’Exemple de la Convention d’Oviedo’, Revue Internationale
de Droit Comparé 52, no. 2 (2000): at 371–413; Raposo, O Direito à Imortalidade, 651–4.
62. Referring to the most relevant critics, see Raposo and Osuna, ‘European Convention’, 1416–19.
1294 V.L. Raposo

63. Cf. Aitziber Emaldi Cirion, ‘Las Intervenciones sobre el Genoma Humano y la Selección de Sexo’,
in El Convenio de Derechos Humanos y Biomedicina. Su Entrada en Vigor en el Ordenamiento Jur-
ídico Español, ed. Carlos Romeo Casabona (Bilbao-Granada: Editorial Comares, 2002), 205–31.
64. For a brief description of sex selection regulation see Raposo, O Direito à Imortalidade, 1037–
41; Heather Strange and Ruth Chadwick, ‘The Ethics of Nonmedical Sex Selection’, Health
Care Analysis 18 (2010): 252–66.
65. Discussing the saviour sibling, see M. Couverta and Others, ‘Le Double Diagnostic Pré-Implan-
tatoire et ses Conséquences : « Bébé-Médicament » ou « Bébé du Double Espoir » ?’ [Preim-
plantation Genetic Diagnosis With HLA-Matching and Consequences: “Designer Baby” or
“Double-Hope Baby?”], La Revue Sage-Femme 13, no. 4 (2014): 187–94; Raposo, O Direito
à Imortalidade, 941–50.
66. Toktaş, ‘Internationalization of Bioethics’, 187–8.
67. The argument is from John Harris, Clones, Genes and Immortality (Oxford: Oxford University
Press, 1998), 29.
68. Cf. Raposo and Osuna, ‘European Convention’, 1418.
69. Cf. Hottois, ‘A Philosophical and Critical Analysis’, 144.
70. Case C-34/10, Brüstle v. Greenpeace e V [2012] All E.R. (EC) ECJ 809 Grand Chamber,
decision commented on in Shawn Harmon, ‘Dignity, Plurality and Patentability: The Unfinished
Story of Brüstle v Greenpeace’, European Law Review 38, no. 2 (2013): 92–106; and Vera
Lúcia Raposo, ‘Juridical Status of Human Embryos and Fetus at the Oviedo Convention’,
Lex Medicinae 9, no. 17 (2012): 171–85.
71. International Stem Cell Corporation v. Comptroller General of Patents, Request for a prelimi-
nary ruling from the High Court of Justice of England and Wales, Chancery Division (Patents
Court), United Kingdom.
72. The exceptions are the Netherlands and Belgium.
73. An omission noted by Arthur Roger, ‘European Bioethics Treaty Finally Approved’, Lancet 348
(1996): 953; Danuel San José, ‘Nota Sobre la Ratificación por España del Protocolo Adicional al
Convenio para la Protección de los Derechos Humanos y la Dignidad del Ser Humano con Respecto
a las Aplicaciones de la Biología y la Medicina, por el que se Prohíbe la Clonación de Seres
Humanos, Hecho en Paris el 12 de Enero de 1998’, Anuario de Derecho Europeo 1 (2001):
221–9.
74. Carmel Shalev, ‘Human Cloning and Human Rights: A Commentary’, Health Human Rights 6,
no. 1 (2002): 137–51.
75. Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the
Human Being with regard to the Application of Biology and Medicine, on the Prohibition of
Cloning Human Beings. On this Protocol, see San José, ‘Nota Sobre la Ratificación’, 221–9.
76. Also sustaining this thesis, see Carlos Romeo Casabona, ‘Ethical, Legal and Social Issues
Related to Cell Therapy’, Revista Derecho y Genoma Humano 28 (2008): 141–58.
77. About those concepts, Íñigo Beriain, ‘Necesidad de Redefinir el Embrión Humano’, in Biotec-
nologia, Derecho y Dignidad Humana, ed. N. Martínez Morán (Bilbao-Granada: Editorial
Comares, 2003), 105–35; Pedro Femenia López, Status Jurídico del Embrión Humano, con
Especial Consideración al Concebido In Vitro (Madrid: McGraw-Hill, 1999); Silke Hetz,
Schutzwürdigkeit menschlicher Klone?: Eine interdisziplinãre Studie aus medizinrechtlicher
Sicht (Baden-Baden: Nomos, 2005); Cosimo Mazzoni, ‘Real Protection for the Embryo’,
Revista de Derecho y Genoma Humano 22 (2005): 115–32; Vera Lúcia Raposo, O Direito à
Imortalidade, 491; Mary Warnock, ‘In Vitro Fertilization: The Ethical Issues’, The Philosophi-
cal Quarterly 33, no. 132 (1983): 217–37.
78. Cf. Raposo, O Direito à Imortalidade, 965.
79. Mori and Neri, ‘O Direito à Imortalidade’, 328.
80. Ibid., 330.
81. Bellver Capella, ‘Los Diez Primeros Años’, 405.
82. Cinzia Piciocchi, ‘La Convenzione di Oviedo sui Diritti dell’ Uomo e la Biomedicine: Verso una
Bioetica Europea’, Diritto Pubblico Comparato ed Europeo III (2001): 1301–14.
83. Ibid.