INTERNATIONAL INITIATIVE AGAINST THE PLANNED BIOETHIICS CONVENTION FOR EUROPE AND THE BIOETHICS NETWORK

Step into my parlour, said the spider to the fly!

Some remarks on the final draft version of the Bioethics Convention (6 June l996)

Introduction

The options of biomedicine and biotechnology will affect the very core of our existence and determine the future face of our civilization. What this face is going to be like, which risk we are willing to accept at what expense and in return for which advances bought at what economic and social costs, is for us, the European citizens and our elected parliaments to decide in a broad public debate. It is no business of concocted expert groups formed by the academic community, the science lobby and industry, assuming behind a smoke screen of `confidentiality' legislative powers for which they have no democratic mandate The citoyen and and his elected representatives are ethically compentent in their own right to evaluate and shape the future autonomously and according to the rules of democracy.

One of the leading German sociologist has put it this way: `The end of democracy will not be a big bang but an imperceptible transition to an autoritarian technocracy in which the citoyen - the citizen - may not even realize that the dicisions on the fundamental questions of survival have long been taken out of his hands.' The European Bioethics Convention bears witness to this this development and this paper will deal with some aspects of the democratic erosion.

Article 32 / Amendments to the Convention

The pick of the whole outrageous bunch is tucked away in the small print of the routine clauses of the Convention. Right from the outset , the Steering Committe on Bioethics (CDBI) had decided that the committee responsible for the monitoring of the Convention should be the CDBI itself or a sub-committe of the CDBI. But as a result of protests, the intention was dropped and sank without a trace. For two years the relevant Article simply read, `For the purposes of this Article .... a Committee is hereby set up' leaving it open, what type of committee it would be. But now Jack-in-the-Box has jumped out again!

The committee responsible for handling and examining proposals for an amendment to the Convention, or proposals for a Protocol or for an amendment to a Protocol `shall be the Steering Committee on Bioethics (CDBI) or ...any other committee designated to do so by the Committee of Ministers'. (Article 32, Sec. 1) In addition, CDBI may present own proposals for amendments or for protocols. The papers will be shoved back and forth between the Committee of Ministers, the CDBI and the Secretary General of the European Council and of course there is no mention of information of and control by parliament, democratic procedure or the public. It may not be unrealistic to assume, that most of the provisions which had to be dropped as a result of the uncalled-for public debate will be stealthily smuggled in again through the back door.

But that is not all.

The Convention, with its solemn recital of all that is good and great in terms of declarations, pacts and covenants on human dignity, human rights, fundamental freedoms and political rights of the individual prevents that very individual from appealing to the European Court of Human Rights if one of these rights is violated by the Convention. Moreover, the European Court cannot be appealed to in the case of a violation of rights, but only in respect to legal questions concerning the interpretation of provisions (Article 29, Sec. 1) and only by the Government of a Party after having informed the other Parties or by the socalled `Committee' i.e. the CDBI `by a decision adopted by a two-third majority of the votes cast.'

In plain words:

The Convention claims to protect the rights of the individual, but when these rights are violated, it does not protect him and even refuses him access to the European Court of Human Rights. The Steering Committee on Bioethics (CDBI) however, as the author of the Convention, who - as shown by previous drafts - has not taken human dignity guarantees awfully serious in the past (an opinion shared by many and last but not least by the expertise of the Wissenschaftliche Dienst des Deutschen Bundestages and the Parliamentary Assembly, which rejected the Convention on 5 October l995) is not only entitled to appeal to the Human Rights Court, but by obstructing the necessary two- third majority it can even prevent that its work, compiled without democratic mandate behind a smoke screen of secrecy is subjected to the scrutiny of a public court.

These provisions make it very plain, that the objectives of the Convention, as recited in the Preamble are merely a rhetorical trick to smokescreen the real intentions of the undertaking: maximum freedom for research and the industry behind it and access to funds, human material and data and limitation of the rights of the individual. The provision which prohibits the discrimination of persons but not of human beings, the provision which allows research on in-vitro embryos (by definiton always destructive research) and nevertheless claims the `adequate protection'of that embryo, the outrageous wording of the provisions designed to make incapactitated persons available for non-therapeutic research can unly be understood as the open derision of the public, their elected representatives in parliament and their constitution.

Article 13 / Interventions on the human genome

Contrary to all claims, interventions on the germ line are not prohibited only because the the term `germ line' has disappeared from the text. The doors to germ line `therapy' are still wide open. In substance, this Article is practically unchanged since l994, the alleged `improvements' are only of a lingustic nature: some terms have been replaced by other terms!

The Article permits interventions on `the human genome' for diagnostic, preventive or therapeutic purposes, i.e. to detect, to prevent or to treat a genetic disease. The genome is the complete genetic informatic information of a human being, and this includes, of course, the germ line. And whether or not a modification in the genome of any descendants was intend or not, will certainly give rise to many an animated discussion in the scientific community! It should be added, that somatic gene therapy has not lived up to the optimistic expectations in terms of medical and monetary yields (the risk capital market has reacted promptly on a worldwide scale) and as a result of this general disillusionment, the run on the germ line will be intensified. Moreover, by inviting preimplantation diagnostics in through the back door (and that's what Article 14 (Non-selection of sex)-adds up to) the scene is set for germ line interventions.

Communication of genetic test results / former Article 13

The communication of genetic test results is not forbidden, it is no longer mentioned at all, and as everybody knows, all that is not expressly forbidden, is allowed. In fact, this non-regulation takes the biggest beating of the Convention, especially in view of massive attempts of certain coutries ,(such as Switzerland) to have provisions included in the Convention that would `guarantee insurers the right of access to genetic information that existed before the conclusions of the (insurance) contract' (Association suisse d'assureurs privés maladies et accidents and Union suisse des assureurs privés Vie)

By dropping the provisions on the communication of genetic test result, the principle of data protection has vanished into thin air, too. The communication of test results will be regulated in a separate Protocol, which is also `confidential' and withheld from parliament and the public, and since the CDBI was none too trustworthy in handling of the Convention, the public may be pretty sure to expect some startling surprises. We therefore demand that national parliaments and the public be given access to each Protocol during all stages of negotiation.

The provisons on the use of genetic test results (former Article 12, Sec. 2) have also disappeared from the Convention. Again, we must assume, that non-regulation is to afford maximum freedom of action for research and a restriction of the rights of the individual.

Consent / Research involving human beings not able to consent

Articles 5/6 and 17

Preliminary remark: With a few exceptions the terms `human being' `and individual' have been replaced by the term `person'throughout the Convention.If one follows the bioethical doctrin of person - and this is advisable since the Convention was drawn up by confirmed bioethics hardliners from science and research - the use of the term `person' will have certain consequences and implications which are obviously intended.

In contrast to mere `human beings', `persons' in bioethical reasoning are defined by characteristics such as rationality, self-consciousness, the ability to reflect the past and think into the future, or the ability to have interests, to mention but a few. On account of these abilities, `persons' have an unrestricted right to life, while human beings not qualifying for`person' are denied this right by stages and may eventually end up as a disposable object.

The evaluation of individuals not able to consent as a lesser category of human beings is also expressed by the provisions relating to organ and tissue removal for transplantation purposes (Article 20). They can be used as donor if (and this is expressly ranked as the first condition among several others) `...there is no compatible donor available who has the capacity to consent'. (Article 20, Sec. 2, lit. i ) In other words: if nobody else can be found - tough luck for the vulnerable! Curtesy of the European efforts to protect human dignity, this class of human beings has managed the transition to the the spare parts department.

It is easy to see where this is heading for, taking into account the rapidly growing supply gap in organ procurement, the intensive `philosophical' deliberations on how to best get hold of the organs of living children, the outrageous discussions relating to PVS patients, and last but not not least the legal initiatives underway in other countries, such as England, were the Law Commission Report and the draft Mental Incapacity Act were hurriedly shelved by the British Government when a wave of protests swept through the country.

Consent /Articles 5 and 6

The provisions of Articles 5 and 6 leave no doubt that individuals unable to consent are regarded as fungible objects. While human beings, who are able to consent, may `freely withdraw consent' (to take part in medical experiments) `at any time' (Article 5, Sec. 3) human beings not able to consent, cannot. In this case, consent may only been withdrawn `at any time in the best interests of the person concerned.' i.g. it must be proved that it is not only in the interest, but in the best interest of the human guinea pig to take off and jump off the test bench.

Those who are familiar with the international bioethical debate focussing on the socalled `best interest' will know, that an additional obstacle was deliberately put up here to prevent precious research material from slipping away too easily. This is CLEARLY A VIOLATION of the Nuremberg Code.

The yardstick of mental capability determining the right of a human being to withdraw from a research programme ( those who are able to consent, may quit freely at any time , those who are are vulnerable may quit only after having jumped several additional hurdles) is also applied in Articles 16 and 17 (Research).

As a rule, several conditions must be met before a person may be involved in a research programme, one of them being the provision that `consent may be withdrawn freely at any time' (Article 16, lit. v). In the case of persons not able to consent, this provision was dropped (Article 17, Sec. 1, lit. iv) and the researcher may carry on, if `the person concerned does not object'. (Art. 17, Sec. 1, lit. v.) An impression of what this may mean in practice could be gained at a hearing organized by the Alzheimer Association in Bonn in November l995: at this conference, a neurologist of Essen University demanding the go ahead for research on stroke patients with severe communication impediments would only recognize an objection of the patient, Æif he strikes out".

The provisions or rather the linguistic gyrations designed to cheat vulnerable human beings into non-therapeutic research on the pretext of a direct benefit when there is none, are worthwhile looking at. Research `which has not the potential to produce a direct benefit ....is allowed if `it has the aim of contributing, through significant improvement of the scientific understanding of the individual's condition ...to the ultimate attainment of results capable of conferring benefit to the person concerned or on other persons in the same age category or afflicted by the same disease....'

The entire provision hinges on the `aim' of the research, which is not quantifiable, which is not provable, which is a mere declaration of intent of the researcher: the aim of improving understanding, which will only `contribute' to ( i.e. have no free-standing result) the `ultimate attainment' (not even a hint of a time perspective, it could as well be on the 12th of never) `which are able to (i.e. do not necessarily) `confer benefit to the person concerned or on other persons of the same age category or afflicted by the same disease...'This clearly denigrades the person undergoing research to a mere object for third party interests.

Equally contestable is the condition, that research risks must not be `disproportionate to the potential benefits of the research'. While Article 6 of the Nuremberg Code requires that the risk incurred in research is determined (and limited) by the humanitarian significance of the problem, for which a solution is sought, the yardstick used in the Bioethics Convention is not the person undergoing research, but the requirements of science, i.e. an unspecified `benefit of the research'. On the flimsiest of pretexts, this Article is designed to achieve one purpose only: to let research have its way.

And finally it should be noted, that there is no mention of doctors' liablity, no mention of liabilty for damages, no mention of liabilty for delayed reactions , but plenty of reference is made to the `importance ` of the research.

Article 24 / Compensation for undue damage.

In the final version too, compensation is restricted to `undue damage' resulting from an intervention. Apparently any other damage must be accepted by the victim as part of the bargain. What constitutes `undue damage' in contrast to damage not deemed `undue', remains the secret of the Steering Committe on Bioethics (CDBI) and may hold some interesting surprises in stock for us.

Article 23 / Infringement of the rights and principles

Judicial protection is only foreseen in the case of `unlawful infringement' of the rights set forth in the Convention. Apparently, the CDBI holds that certain infringements are lawful therefore do not require sanctions.

Article 26 / Restrictions on the exercise of rights

Article 26 provides the means to overturn the little protection there is in the Convention for the human being exposed to the machinations of biomedicine and biotechnology: on account of public safety, for the prevention of crime, for the protection of public health or the rights and freedoms of others. However, this master key to unlock virtually every door is not to be used in resprect of some Articles such as the Articles on non-discrimination, transplantation, interventions on the human genome, non-selection of sex, research: on the one hand the scanty protective provisions contained in these Articles cannot be touched, but neither can the freedom of action of research be restricted! (Article 26, Sec. 2)

To sum it up: the INTERNATIONAL INITIATIVE need not revise its analyses and statements published in the past. All crucial provisions of the Convention are unchanged or have even become worse. Claims, that the Convention has been `improved' belong to the realm of fairy tales and fables.

One would say: the politician's hour has arrived. One could ask: when will politicians finally stand up for the rights of the citizen so solemnly evoked in the Preamble of the Convention? Both would be naive and quite beside the point: One should rather ask: when will politicians remember again the mandate entrusted to them by their voters and finally resume control in vital areas such as biomedicine and biotechnology and take the shaping of our future out of the hands of concocted expert groups back to where it belongs:into parliament, back to democratic rules, back into the sphere of the citizen. IT IS FOR THIS REASON ONLY that voters elect their representatives and support parliaments.

Industry and research have long begun to create special rights and special ways tailored to meet their demands, parliamentary prodecures have long been misused as speudo-normative fassade by pressure groups ,and legislative processes no longer take place inside but outside democratic institutions.

Commented by Wilma Kobusch, Gelsenkirchen, 14 June l996

Sources:

U. Beck, Gegengifte,l988, p. 269

Council of Europe, Steering Committee on Bioethics, Doc. CDBI/INF (93)3 of 18 Novembert l993, p. 3

Wissenschaftliche Dienste des Deutschen Bundestages, Ausarbeitung ÆZur Vereinbarkeit des Entwurfs der Bioethik-Konvention des Europarates mit den Grundrechten" WFIII-206/94 of 24 Jan., l995, p. 8

Council of Europe, Steering Committee on Bioethics (CDBI) , Amendments proposed by the Parliamentary Assembly, States, the Commission of the European Communities, Observers to the CDBI, Steering Committees, NGOs, Doc. CDBI (95) 5 of 4 May 1995, p. 5

Written Answers WA 43, WA44, Tuesday 16th January l996 (The Lord Chancellor (Lord Mackay of Clashfern) to Lord Denham on Mental Incapcity: Law Commission Report)

I. Meichsner, Menschenversuche, in: DIE WOCHE of 8 December l995)