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22 March 1994
Doc. 7045
1403-18/3/94-2-E
REPORT
on the protection and patentability
of material of human origin
(Rapporteur: Mr MONFILS,
Belgium, Liberal, Democratic and Reformers Group)
Summary
Biotechnological research requires immense resources and raises issues of the use and commercialisation of the human body. Debate on the protection of innovations involving living material should not be confined within the framework of patent law.
Ethical considerations should be taken into account from the outset. The Council of Europe's project for a convention on bioethics (the draft text is now at an advanced stage) has already established principles for the reconciliation of accepted moral standards, scientific research and commercial exploitation.
The Assembly calls for the urgent completion of the bioethics convention and for the drafting of a protocol which sets limits to the application of genetic manipulation to human beings.
I. Draft recommendation
1. The Assembly insists that human beings are subjects — not objects — of law, that the human body is inviolable and inalienable by virtue of its relationship to a person endowed with rights, and that limits must therefore be set to how it is used.
2. The draft bioethics convention of the Council of Europe (draft convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine) establishes the principle that the human body and its parts as such — that is, as they are found in the human body — shall not give rise to any financial gain.
3. The Assembly is aware of the rapid development of genetics and the striking range of its present and potential applications. Clearly, the immense resources invested in biotechnological research entail the protection of equipment, methods and products; such protection is the only way of safeguarding the development of research.
4. Patent law — more specifically, the provisions of the 1973 European Patent Convention — plays a role to this effect. Its purpose is to confer on the patent-holder not a right of ownership but an exploitation monopoly for a given period of time.
5. The debate today on protection of innovations involving living material focuses on this purpose and the legitimate character of patent law. This is because (in particular) of the granting of patents for transgenic production techniques based on animals, and also because of current controversies surrounding the acceptance or refusal of patents for DNA fragments, the industrial application and functions of which are not yet known.
6. The Assembly takes the view that fundamental debate on biotechnology must not be entirely confined to patent law.
7. The provisions of the European Patent Convention — signed prior to the birth of the first test-tube baby — were drafted without any deep reflection on prohibitions on and limitations to the commercialisation of the human body, its parts and products, or genetic mutation processes.
8. The provisions of this convention are today inadequate, notwithstanding certain restrictions which it provides for on grounds of public policy or morality, which could lead to querying certain patent awards.
9. Moreover, the convention only addresses problems inherent in the relationship between biotechnology and human beings in terms of specific cases without theoretical perspective, and in an environment where patenting is the norm and commercial considerations are omnipresent; application of rules and their monitoring are the responsibility of civil servants and technicians.
10. A proposal for a directive of the European Union (legal protection of biotechnological inventions), though limited to the perspective of patents, has the merit of clearly specifying certain prohibitions in regard to the patentability of living material. However, the approach chosen is simplistic, as much because of the European Union's substantive competence as because its action is geared to the harmonisation of the single market and development of Europe's competitiveness and trade. There remains moreover the possibility of commercialisation without patents of innovations involving living material, and the proposed directive does not provide for banning the commercialisation of non-patentable inventions.
11. In accordance with its previous Recommendations 1046 (1986), 1100 (1989) and 1160 (1991), the Assembly considers that ethical principles regarding living material should be a pre-requisite for providing scientists with a legal framework to guide them in their work.
12. The task of deciding — in the light of social trends — on how to reconcile generally accepted moral standards, scientific research and commercial exploitation is fundamentally political; moreover, the appropriate principles are now set forth in the Council of Europe's draft bioethics convention.
13. In accordance with its Recommendations 1046 (1986), 1100 (1989) and 1160 (1991), the Assembly recommends that the Committee of Ministers:
i. adopt as soon as possible the final text of the bioethics convention and open it for signature without delay, thereby providing Europe with a reference to fundamental moral principles in the field of bioethics;
ii. initiate the immediate preparation of a protocol to the draft convention, setting limits to the application of genetic manipulation to human beings;
iii. assign the drafting of the protocol to its Steering Committee on Bioethics (CDBI) with instructions to lay down a number of prohibitions, some of which may already be referred to in patent law, on inter alia:
a. processes for modifying the genetic identity of the human body for any non-therapeutic purpose contrary to human dignity,
b. techniques for cloning and producing chimeras,
as well as on such manipulations as:
c. transfer of human embryos to a different species, and vice versa;
d. amalgamation of human gametes with those of a different species;
e. production of an individualised, autonomous human being in the laboratory;
f. creation of children from persons of the same sex;
g. sex selection for non-therapeutic purposes.
14. The Assembly also calls, in the interests of coherent development, for the European Patents Office to transmit to the Council of Europe an annual report on decisions on applications for patents relating to living material, and invites the Committee of Ministers to determine in consultation with the Office the forms and procedures to be followed.
II. Explanatory memorandum
by Mr MONFILS
The extent and limits of legal protection for biotechnological inventions prompt two types of reaction which are the mainstays of this debate.
Firstly, we have the finding that the human being is a subject — and not an object — of law, that the human body is inviolable and inalienable since it is linked to the natural person to whom it belongs de facto, and consequently that limits should be placed on its utilisation.
Secondly, we have the obvious fact that the enormous resources invested in biotechnological research must give rise to protection of material, methods and products, since such protection is the only way of safeguarding the development of such research.
Even these two principles are not absolute, which does not help to simplify matters.
The draft European convention states, "The dignity of the human body shall be respected. The human body and its parts shall not, as such, give rise to financial gain". Nor has organ transplantation as yet been covered by a general prohibition of commercialisation; nor does the draft protocol on organ transplantation appended to the European Bioethics Convention lay down any such prohibition.
Conversely, the Convention on the Grant of European Patents has put up barriers to protection, reflected in specific action by the European Patent Office (see below).
The Convention on the Grant of European Patents (known as the European Patent Convention), signed in Munich on 5 October 1973, defines the scope of patents.
According to the convention, if an invention is to be patentable it must:
—be new;—
—in volve an inventive step;—
—be susceptible of industrial application (Article 52 [1]).Th
The convention lays down two categories of exclusion, both of which may concern, and have already concerned, living material, including the human being.
First of all, the following are excluded from patentability: "Methods for treatment of the human ... body by surgery or therapy and diagnostic methods practised on the human ... body ...".
This exclusion is grounded on the juris et de jure presumption that such inventions are not susceptible of industrial application (see Article 52 [4] of the convention).
However, there is also a general exception to patentability: patents must not be granted for "inventions the publication or exploitation of which would be contrary to ordre public or morality" (Article 53a).
Quite naturally, the partisans and opponents of legal recognition of protection for innovations concerning living material have focused on patent law, especially as controversy has, precisely, centred on matters of the acceptance or refusal of patents.
While the convention accepts the "lawfulness" of patents concerning biological innovations in general — that is innovations relating to life forms and processes — there are still problems.
For instance, whereas hitherto the European Patent Office has accepted the patentability of technical inventions dealing with human genes or DNA sequences which had definite industrial applications (production of useful substances such as serum, albumin and relaxin), the question of whether or not to recognise the patentability of DNA fragments, whose industrial application and functions are not yet known, is still outstanding.
Furthermore, patents have been granted for transgenic production techniques based on animals (see the Harvard oncogenic mouse, etc.).
We must therefore scrutinise the European Patent Convention and the actual activities of the Patent Office, since the whole debate on the protection of the human being centres on the field of patents.
Before considering whether patenting is the only area to examine, we should draw a number of distinctions within the patentability system itself.
In connection with the protection of innovations relating to living material, and in particular to the human being, expert opinion distinguishes between processes on the one hand and products on the other.
1. Processes
a. Treatment processes (therapeutic treatment processes, diagnostic processes and surgical processes).
These processes are in principle excluded from patentability (see Article 52 [4]), because they are assumed to have no industrial application.
However, difficulties arise, for example when a process is susceptible of uses other than therapeutic ones.
For example, Bernhard Bergmans quotes, in La protection des innovations biologiques (The protection of biological innovations — Brussels, Larcier, 1991), the case of a therapeutic treatment which is at the same time a process of utilisation of a patentable micro-organism.
Further problems arise in defining diagnostic methods which comprise "the execution for medical purposes of an examination regarding the condition of the human body". Consequently, according to the Patent Office, a process for correcting results measured during such an examination by means of X-rays is not a diagnostic process.
Despite these difficulties of application, it must be acknowledged that this is not the category where problems relating to the specific characteristics of the living human being arise.
The difficulty of deciding on patentability in this field is more technical than philosophical.
b. Processes for obtaining human cells
Such processes are not excluded by the convention. They are patentable.
However, the problems arising are much more serious and much more difficult to solve than in the case described in section a. For instance, is in vitro fertilisation a process for obtaining human cells or a treatment process? If it is the former, the process is patentable, but if it is the latter, it is not.
c. Processes utilising human cells or parts of the human body
These are also patentable under the terms of the convention, provided that they avoid the categories of treatment processes (for example cell or human gene therapy).
2. Products
a. The legal status of the human being leads one to consider that the human body as such, that is to say its entire genome, cannot be the subject of a patent.
b. On the other hand, the parts and elements of the body are patentable in so far as they have been lawfully separated from their source. Cells, cell lines, genes and DNA sequences are therefore patentable, provided that they fulfil the general conditions for patentability. (See the distinction which C. Byk draws, to quote one among a number of writers, in his report on patentability of living material of human origin (Council of Europe documents, 9 August 1993, AS/Soc (44) 44).
We can conclude from the foregoing summary that whereas living material is generally considered a possible source of patenting, the dividing line between what the specific features of the human being would lead us to accept or reject in terms of patentability cannot be easily deduced either from the definitions of patentability and the exceptions thereto or from the development of biotechnology, especially since there are many cases of overlapping processes, some of which are patentable and others not.
Moreover, further problems arise vis-à-vis the actual definition of a patentable invention.
For example, the National Institute of Health in the United States has submitted a patent application relating to over 2 000 fragments of human genes, without having ascertained the function of the corresponding genes, and consequently without being able to state a specific use for the fragments.
Another centre has submitted an identical application in the United Kingdom.
The Patent Office had hitherto accepted the patentability of genes in so far as the gene had been identified as being capable of coding a given useful protein, and therefore the invention concerned the technical utilisation of this discovery.
However in this case there is no information on any technical utilisation.
If these patents are accepted, it would mean that any research project could be stopped and even that any investment made with a view to achieving a specific goal might be rendered futile if the "invention" comes after registration of the patent, which has been taken out more as a "catch-all" than in the light of technical and scientific considerations.
Two attitudes have emerged to these new problems arising out of recent technology.
a. Some people consider that the advantages of the patent are vital to research, economic development and medical progress, and they trust the officials and Patent Office Board of Appeal to show sagacity in declaring non-patentable particularly obvious cases (embryo cloning, the production of chimeras, etc.).
Drawing on case law which is generally favourable to patentability, they stress the restrictions which the Office can impose by citing the "infringement of ordre public and morality" clause.
b. Others consider either that patentability may, on the contrary, obstruct all progress and may even lead to the patent holder having the power of life or death over human beings (for instance by deciding not to apply, or not to allow the application of, a useful invention), or that the development of biotechnology runs counter to moral or religious principles, and these people wish to call the very system of patents into question in all cases where it is applied to living material.
The advocates of patentability put forward arguments, the soundness and number of which they consider should lead us only to accept restrictive exclusions, since any non-patentable material would be extremely likely to be excluded from
economic and scientific progress.
An analysis of the arguments and the manner in which their scope should be qualified has been accurately described by B. Bergmans (op. cit., pp. 360-372). I shall confine myself here to summarising the main points.
1. Patentability encourages research and the conversion of its results into marketable products. Investment is encouraged and the state could not supply equivalent financing.
However, especially in the biotechnology sector, research has reached an advanced stage before there is any talk of patenting it. Moreover, a monopoly situation can curb research. People can also engage in "defensive" research with a view to obtaining patents as a precaution. Lastly, economic logic and the academic world are not necessarily compatible. In any case there are no reliable statistics on this field. After all, a patent per se does not attract investment, and in some cases it may even render pointless the financial input of firms pursuing similar objectives but finishing second in the race.
2. Applicants for patents are required to disclose their invention, so identical research is avoided. Moreover, a patent means that scientific work can be published, whereas secrecy means the opposite.
However, firms also resort to secrecy (for example, processes which are unknown, even though the product is well-known, and commercialisation for such a brief period that a patent is unnecessary).
The opponents of patents also present arguments of which certain parts are disputable.
For example they state that the public interest is not taken into account, because the patent protects a private interest (preventing access to genetic resources, monopoly situation, etc.). Health, safety and the environment may also be cited. The race for patents in the biotechnology field may reduce safety requirements, and industrial financing inevitably tends towards research which is commercially exploitable and follows market laws.
However, patents do not prevent free access to resources. They stimulate invention and analysis, because they are applied at the development stage, and not to mere discoveries. We should not forget that these are not products to which anyone can have access, but products obtained by processes. As for general risks, it is not only patent law which should take account of them. With or without patents, research can be dangerous for health and the environment.
What is needed here is not patents, but possible regulations to prevent, cover and generally reduce or remove hazards and their effects.
This finally brings us to a purely ethical debate in which those in favour and those against exchange familiar arguments, in which one side holds that the immoral element is prohibition, that is the prevention of any progress for human beings, and the other maintains that technology cannot be allowed to change the biological destiny of each living being.
Two international instruments currently being drawn up deal directly or indirectly with industrial property as it relates to the living human being.
1. The European Bioethics Convention
This convention is based on the conception already enshrined in the European Convention on Human Rights, viz the freedom of the human being.
From the affirmation of the primacy of the human being it draws the following consequences:
a. In connection with the characteristics of the human body (Article 11), "The dignity of the human body shall be respected. The human body and its parts shall not, as such, give rise to financial gain";
b. In connection with scientific research (Article 14), "Scientific research in the field of biology and medicine shall be carried out freely with respect for the dignity, identity and integrity of the human being and in accordance with the legal provisions ensuring the protection of the human being";
c. In connection with the human genome (Article 16), "An intervention on the human genome shall only be undertaken for therapeutic or diagnostic purposes and as long as the aim is not to interfere with the germ cell line".
2. The European Community directive on the legal protection of biotechnological inventions
This directive does not draw on the philosophy of the Council of Europe convention, which is based on human dignity and, ultimately, on human rights. In fact its title, "the legal protection of biotechnological inventions", indicates as much.
Its preamble also clearly indicates this, stating that, in the field of genetic engineering, research and development necessitate very great investment, that the protection of inventions is insufficient or else varies from country to country, and that harmonisation is "seemly", since this is the only acceptable way of implementing the Single Market.
(The only concession to the actual "economic" view of the problem is that the directive incorporates two paragraphs, one recalling the need for a reference to public policy (ordre public) and morality and the other deeming it "important" to set out in the body of the directive a (non-exhaustive) list of inventions excluded from patentability in order to "provide national courts and patent offices with an essential guide to interpreting the reference to public policy or morality".
Drawing on the principle that biological material is patentable, the directive:
a. takes up certain terms used in the Patent Convention and in some cases specifies the scope of protection;
b. draws up a non-exhaustive list of non-patentable material;
c. amends the regulations on the deposit of patents;
d. introduces a system of compulsory licences for plant varieties.
Let us examine these four points in detail:
a. Apart from the reminder of the non-patentability of methods of treatment and therapeutic and diagnostic methods, the directive reacts to a problem mentioned in this report (see above) by not excluding from patentability a process comprising a succession of steps, one of which would be subject to exclusion, the others being patentable.
The directive also extends the protection conferred on a process that enables the production of a biological material possessing, as a result of the invention, specific characteristics, to any biological material derived from such biological material through multiplication or propagation and possessing the same characteristics.
b. The (non-exhaustive) list of non-patentable processes or products in the biotechnological field is as follows:
—th e human body or parts of the human body per se;—p
—pr ocesses for modifying the genetic identity of the human body for a non-therapeutic purpose which is contrary to the dignity of man;—
—pr ocesses for modifying the genetic identity of animals which are likely to inflict suffering or physical handicaps upon them without any benefit to man or animal.At
At the Second Council of Europe Symposium on Bioethics, held in Strasbourg from 30 November to 2 December 1993, Doctor Elizalde made some very interesting comments on this article of the directive, including the following points:
"In the light of the general principle that the ownership of human beings is prohibited, the human body or parts of the human body 'as such' must be excluded from patentability. Words and nuances become very important here; therefore a gene (or a cell) in the natural state in the human body is 'part of the human body as such', while sequences of nucleotides obtained by genetic engineering techniques having an industrial application are not excluded from patentability; in this case, the human genes behind such sequences of nucleotides are excluded from patentability.
A second exclusion from patentability concerns processes for modifying the genetic identity of the human body which are contrary to human dignity: the legitimacy of certain research on human beings is today contested by the researchers themselves in the present state of knowledge; for example: replacing a nucleus of a cell of an embryo or subsequent development of the embryo (human embryo 'cloning'); producing chimeras with human hereditary material; as well as germ-line gene therapy (the draft exclusion from patentability is therefore not addressed to procedures concerning somatic gene therapy, where genetic changes made to a patient are not hereditary)...".
c. In accordance with practice, the directive officialises the deposit of biological material in view of the impossibility of giving an accurate description or classification enabling micro-organisms to be identified and characterised.
Moreover, the directive extends the protection provided by a patent from the process to the products obtained by the process. It is for the person manufacturing an identical product to prove that it is obtained through a different process.
d. Lastly, the directive introduces a system of compulsory licences, for plant material only. If the patent holder refuses to allow the use of the invention in return for appropriate remuneration, a non-exclusive compulsory licence may be requested, and this has to be granted upon payment of an appropriate royalty if "this is in the public interest".
Those who objected to the freeze on inventions relating to plants to the detriment of developing countries are thus satisfied, at least where freedom of utilisation is concerned, although the problem of the financial conditions for the grant of a licence remains intact.
The concise analysis which we have presented of both patent law and the two international legislative instruments — the European Bioethics Convention and the European Community Directive on the legal protection of biotechnological inventions — prompts us to put forward the following observation:
The fundamental debate on biotechnology does not fall entirely within the scope of patent law.
The European Patent Convention is now twenty years old. It was signed before the birth of Louise Brown, the first test-tube baby, on 25 July 1978!
Thus the restrictions accepted by the convention in the matter of patentability for reasons of ordre public and morality were not included with a view to their perhaps being used to prevent or limit the commercialisation of the human body, its parts and products, or genetic mutation processes.
Thus the authors of both the motion for a recommendation on the protection of parts of the human body and "products" of human origin and the European Community directive are quite justified in their concern that the provisions of the European Patent Convention are out of date and therefore insufficient, where living material, and particularly the human being, are concerned.
Of course the open-ended nature of the reference to ordre public and morality may be conducive to a debate on the appropriateness of certain patents.
However — and here we are reaching the limitations of patent law — the organisation's internal debate is both insufficient and dangerous.
It is insufficient because it only addresses the problem of the relations between human beings and biotechnology in the light of actual cases, without a theoretical approach, and this in an environment where patents are the norm.
How can we define general exceptions based on open-ended principles when there is only a restrictive list of exclusions from patentability?
It is dangerous because the debate on ordre public or the dominant morality in society at a given time takes place between a few officials — whatever their merits — or in appeal bodies, with the intervention of the handful of lawyers and technicians who are members.
Even there the debate is distorted, because it is taking place in an environment where — as might be expected in the case of patents — commercial concerns are omnipresent.
Surely it is a fundamentally political task to decide, in the light of the development of society, which measures to take to reconcile generally accepted moral standards, scientific research and commercial exploitation?
To that extent the draft international instruments are taking the right direction, since it is the competent political authorities who will be called upon to decide on substantive issues.
We also have to note that, while the European directive comes down clearly in favour of prohibitions of patents in certain very specific cases, the method chosen is simplistic, as the European Community has competence in this sphere, and its motives for its action obviously relate to the achievement of harmony within the Single Market and the development of our competitiveness and of trade.
We have also noted this phenomenon on the occasion of discussions on the free movement of products derived from human blood, which are treated as equivalent to medicines and are therefore susceptible of freedom of movement, giving rise to no particular public health concern.
Moreover, in the directive the prohibitions apply only to patentability. We mentioned above that patents normally, but not necessarily, led to commercialisation, and that, for a variety of reasons, research could be conducted without a patent, subsequently leading to commercialisation in fields denied patentability under the European directive. This seems rather absurd!
The extent of the protection of the human being provided by the directive is thus linked to the prohibition affecting the conclusion of a technical agreement, the patent. It is not based on a comprehensive analysis, and not even on discussion of the commercial aspect, which would fall outside the narrow field of patents.
Therefore, where the form of a protective legal instrument is concerned, we consider:
a. that simply amending the European Patent Convention would not achieve the aim of protecting the human being, since the said convention covers only one aspect of a possibly commercial process, and that, furthermore, the decision to "interpret the position in terms of morality or ordre public" cannot be a matter, in this very open-ended and essential field of biotechnology, for persons outside the legislative authority, which is the only one empowered to define and legislate on human activities.
b. that the European Community directive, constrained by its focus on patents, is also unable to take account of the whole issue, but that it does have the merit of specifying prohibitions which it can actually impose in the field of patentability.
From that angle we are surprised that the directive did not lay down the same provisions on the human being as on plant material, that is a compulsory exploitation licence in the event of a refusal to allow use of an invention. We feel that such a measure would have the effect of satisfying those who feel that patents in the biotechnological field are liable to give the holders the power of life and death over other persons, for example in cases of products useful for the eradication of a disease.
An analysis of the basis and substance of the Bioethics Convention and the European directive leads us to believe that stress must be laid on the technique of laying down general rules, based on the moral principles set out in the European Bioethics Convention.
We could thus propose initiating a draft protocol defining limits for genetic manipulations applied to the human being.
The protocol would include the concepts currently set out in the European directive, although not as concepts giving rise to a prohibition of patentability, but simply as prohibited. For instance, this applies to processes for modifying the genetic identity of the human body for a non-therapeutic purpose contrary to human dignity, and more precisely to techniques for cloning and for producing chimeras.
We might add to this list an enumeration of prohibited manipulations, already included in several international texts, but systematised in none. The following are examples:
—tr ansfers of human embryos into different species, and vice versa;—
—fu sions of human gametes with those from a different species;—
—th e production of an individualised, autonomous human being in the laboratory;—
—th e creation of children from persons of the same sex;—
—se x selection through genetic manipulation for non-therapeutic purposes;—
—th e creation of embryos using sperm from different individuals;—
—et c.It
It seems to us relatively easy, on the basis of scientists' opinion, to distinguish between research on living beings, which must be allowed to continue — for it is the fount of human progress — and the pointless manipulations which are mere scientific exercises.
It should not be very difficult to obtain a political consensus about genetic manipulations of living beings, which are prohibited in the light of the present-day values of European society.
Were the limits of action on human beings thus laid down in an international text, patent law would no longer have to bear the burden — which it unable to do — of fundamental ethical controversies. Legislation would acquire a really meaningful regulatory role, and patent law would be applied within this framework.
Since, nevertheless, in spite of the general indications included in a protocol, new questions may arise in respect of specific cases, it would be essential for the Patents Office to present a full annual report covering the decisions reached on requests for patentability relating to living beings, so that the Council of Europe could obtain information, discuss the report and possibly consider amending the protocol.
The motion for a recommendation on the protection of parts of the human body and "products" of human origin is thus justified in its approach and extended in scope, in so far as the Rapporteur's suggestions are accepted.
Reporting committee: Social, Health and Family Affairs Committee.
Budgetary implications for the Assembly: none.
Reference to committee: Doc. 6661 and Reference No. 1804 of 30 September 1992.
Draft recommendation unanimously adopted by the committee on 15 March 1994.
Members of the committee: Mrs Håvik (Chairwoman), MM. Rathbone (Vice-Chairman) (Alternate: Cox), Marques (Vice-Chairman), Mrs Albrink, MM. Andriukaitis (Alternate: Mrs Burbiené), Banks, Benvenuti, Bloetzer, Bowden, Bugli, Buzatu (Alternate: Leonte), Curto, Mrs Fleetwood, MM. Foschi, Geoffroy, Gouteyron, Mrs Guourova, Mr Gusenbauer, Mrs Halonen, Mrs Høegh, MM. Jacquat, Jurgens, Kouckı, Laanoja, Liberatori, Mrs Lybacka, MM. van der Maelen (Alternate: Monfils), Maginas, Menzel, Meyer zu Bentrup, Mrs Moynihan-Cronin, MM. Mozetic, Ottenbourgh, Miss Özver, MM. Palacios, Paunescu, Pini, Psaila Savona, Mrs Ragnarsdottir, MM. Raska, Regenwetter, Reimann, Robles Orozco, Schwimmer, Sofoulis, Mrs Soutendijk-van Appeldoorn (Alternate: Mr Eisma), MM. Ternak, Vajda, Mrs Waniek, Mrs Wohlwend, Mr Yürür.
NB: The names of the members present at the meeting are printed in italics.
Secretaries to the committee: Mr Hartland and Ms Meunier.