Xenotransplantation

An aid to ethical discernment

prepared by a working group on behalf of the Church Office of the Evangelical Church in Germany and the Secretariat of the German Bishops' Conference

Joint Texts No.13, 1998

Xenotransplantation

An aid to ethical discernment

5. Legal aspects

From a legal point of view, questions about protective rights and rights to benefits (the German concept of "Leistungsrechte") might arise in the context of xenotransplantation. In terms of protective rights, the following aspects have to be discussed: 

  • Problems related to patient safety could become legally relevant on two counts. In the first phase when xenotransplantations will still be of an experimental status, the try-out nature of therapeutic attempts might become problematic. The second legal problem that will persist beyond this first phase is the risk of infection that is widely debated.

    Taking into account that these operations are therapeutic attempts, stricter requirements as to the effectiveness of informing the patient have to be fulfilled. However, this problem has always occurred when breaking new ground in surgery. As far as it relates only to the individual patient, the danger of infection also becomes an issue of the patient's consent. Since knowledge about the type and degree of potential dangers is very limited at present, information on these risks can only be based on the current state of scientific development and learning. Again, general legal principles on the effectiveness of consenting to risks, in particular the risk of personal injury or even of one's own death, determine the effectiveness of the consent given on the basis of the information received.

    Therefore, as far as only the individual patient is concerned, no new legal issues arise. In accordance with the existing legislation, in particular the Federal Criminal Code with its stipulations regarding homicide and bodily injury as well as the federal legislation on contagious diseases and the Medicines Act would have to be taken into consideration.

  • When it comes to the protective rights of the general public, at the center of attention would be again the risk of retroviral infections. This would apply only in cases of transmitting retroviruses contained in the transplant. In addition to the above it should be pointed out that there is a risk of the organ recipient becoming a source of pathogen excretions that could affect the general public. Furthermore, the general regulations regarding physical injury and homicide resulting from negligence again become significant. In view of the virtually unlimited number of potential victims, strict requirements would have to be made regarding the duty of diligent care.

    In particular when considering the general public, the requirements of the Genetic Engineering Act have to be taken into account. This Act regulates, among other things, the release of genetically modified organisms. As xenotransplantation presently is conceivable only with transgenic animals, supplying animal organs would be subject to Article 2, para 2 of the Genetic Engineering Act, which would entail that a number of precautionary measures would have to be applied.

    In contrast to the protection of the patient, one would have to consider whether existing legislation is able to provide the general public with sufficient protection against the risks of xenotransplantation in the first place. Federal legislation on contagious diseases and the Genetic Engineering Act (as well as the Medicines Act) do not include any protective clauses that are chiefly geared at the specific threats emanating from xenotransplantation.

  • Regarding animal welfare, first a general question emerges, namely whether the production of transgenic animals is to be considered a violation of Article 1 of the Federal Animal Welfare Act, according to which the life and the well-being of animals as fellow creatures of humankind have to be protected. In accordance with the present state of the legal debate this question will have to be answered in the negative. At least there are no court decisions known that would indicate in this respect any reserves against the production of transgenic animals that is already being practiced. As a result, organ removal from animals is also not in contradiction to the Animal Welfare Act, even though Article 6 (1), 1 prohibits in principle the removal of organs from a vertebrate, but it explicitly allows organ removal for transplantation purposes in sentence 2, no. 4. Even if the animal dies in consequence of organ removal, this does not violate the Animal Welfare Act, as in Article 5 the only requirement stated is that for painful operations (and also lethal ones) on vertebrates anesthetics have to be used as a rule. 

 In the field of rights to benefits the following two aspects are of interest:

  • The principle of the social welfare state based on the rule of law in connection with the guaranteed respect for human dignity as enshrined in Article 1 of the German Basic Law, as well as the principle of equality stipulated in Article 3 of the Basic Law, which is a derivative participatory right, result in individual rights to benefits of the patient vis-à-vis the state, which are spelled out in greater detail in the Social Security Code. If the patient is subject to compulsory health insurance, the particular rights related to that field are defined in part five of the German Social Security Code (SGB V). According to Article 70 (1), 2 of the SGB V, treatment of insured persons under the compulsory scheme has to be sufficient and suitable, however, it must not exceed the limits of necessity and has to be provided on the basis of economic efficiency. Apart from that, it is necessary to effect a "humane treatment" (para 2). In its experimental stage, xenotransplantation will not be regarded suitable and necessary, with the effect that the benefit claim can rightly ignore the requirement of economic efficiency. However, should xenotransplantations one day become part of the medical lex artis, they will have to be qualified as suitable and necessary. Then, the aspect of economic efficiency will have to be included in the planning and the assessment of various possible approaches to a transplant, even though only on the basis of a fundamental entitlement. The requirement of a "humane treatment of patients" can definitely not lessen the rights of a potential organ recipient, not even on the basis of the idea that xenotransplantation in general might not be humane. It is merely a requirement that postulates to respect human dignity in medical therapy.

  • The issue of how to distribute organs harvested from transgenic animals also does not in principle raise any new legal concerns. Medical and social criteria for distribution could be determined similar to human-to-human transplant criteria, based on medical necessity, waiting time and other distribution categories. Naturally enough, essential questions as to whether the distribution factors should acknowledge the patient's previous life-style (Did he or she smoke or drink alcohol?) or observance of therapeutic suggestions ("compliance") come up in this situation, too, but in principle this is not different from human-to-human transplantations.




 


 

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