Skip to main content
SpringerLink
Log in

Ethics and Law in Regenerative Medicine: A Legal and Ethical Outline on Regenerative Medicine in Research in France, Germany and Poland

  • Chapter
  • First Online:
Regenerative Medicine

  • 2200 Accesses

Abstract

Although France, Germany and Poland share common legal roots, the national laws of biomedicine distinguish themselves. Working out these differences in existing law the picture drawn shows how particular the law situation in each of the countries is and that these differences are caused by basic different ethical adjustments.

The specific relation between ethics and law in general and in particular in the three neighboring countries has finally led to different procedures to deal practically with research in the Regenerative Medicine, described and critically evaluated in the following.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 219.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Similar content being viewed by others

Notes

  1. 1.

    Council of Europe. 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. Oviedo, 4.IV.1997 Available for consultation on: http://conventions.coe.int/Treaty/en/Treaties/Html/164.htm

  2. 2.

    That which ‘would ensure the widest ethical consensus’ according to the French Council of State. Further reading: Study – “The revision of bioethical laws”, Study adopted by the General Plenary Session, Les études du Conseil d’Etat, 2008, p. 12.

    Available for consultation on: http://www.conseil-etat.fr/cde/media/document//etude-bioethique_ok.pdf (text in French)

    “The Council of State advises the Government on the preparation of bills, ordinances and certain decrees. It also answers the Government’s queries on legal affairs and conducts studies upon the request of the Government or through its own initiative regarding administrative or public policy issues.

    The Council of State is the highest administrative jurisdiction – it is the final arbiter of cases relating to executive power, local authorities, independent public authorities, public administration agencies or any other agency invested with public authority.

    In discharging the dual functions of judging as well as advising the Government, the Council of State ensures that the French administration operates in compliance with the law. It is therefore one of the principal guarantees of the rule of law in the country.

    The Council of State is also responsible for the day-to-day management of the administrative tribunals and courts of appeal.

    Every year, 110 bills, 900 drafts of decrees and 3,000 non-statutory texts are examined by the Council of State” (http://www.conseil-etat.fr/cde/en)

  3. 3.

    For further general reading on this point, see: Christian Starck, Embryonic Stem Cell Research according to German and European Law, 41 EUROPARECHT 1 (2006) Available for consultation on: http://www.germanlawjournal.com/pdf/Vol07No07/PDF_Vol_07_No_07_625-656_Articles_Starck.pdf

  4. 4.

    For a summary of the debates and issues of the revision of the StGZ, see: http://www.etatsgenerauxdelabioethique.fr/base_documentaire/international/allemagne_bioethique.pdf (text in French).

    For a complete study, see the opinion  “Should the Stem Cell Law be amended ?”  of the German National Ethics Council: http://www.ethikrat.org/_english/publications/Opinion_Should_the_Stem_Cell_Law_be_amended.pdf

  5. 5.

    The human embryo is further protected with regulations more far-reaching than the banning of research. Articles L.2151-1 to L.2151-4 in fact state other bans:

    • That of cloning, whether it be reproductive, for therapeutic purposes, for research purposes or for use in commercial or industrial purposes

    • The creation of embryos for research purposes as well as industrial or commercial purposes

    • The use of the embryo for commercial or industrial purposes

  6. 6.

    Just as OPECST sums up perfectly in its report “In the beginning, Article 37 of the 2004 Law gave ministers of Health and Research the power to authorise the importation of embryonic stem cells, provisionally, after a recommendation by an ad hoc committee (decree No. 2004-1024 of September 28th, 2004; finalised on September 28th, 2004). These measures were intended to allow French researchers to answer calls for projects launched by the European Commission. The law was then supplemented by the decree No. 2006-121 of February 6, 2006 relating to embryo and embryonic stem cell research and modifying the Public Health Code. This exceptional arrangement actually began on February 6, 2006 and is due to run until February 5, 2011.” Report on research into the functioning of human cells. Report No. 3498, AN, drafted by M. Alain CLAEYS. Available for consultation on: http://www.assemblee-nationale.fr/12/rap-off/i3498.asp (text in French).

  7. 7.

    Decree No. 2006-121 of February 6, 2006 relating to research on the embryo and embryonic cells and modifying the Public Health Code, JORF No. 32 of February 7, 2006 page 1974.

  8. 8.

    Following the creation voting of the French Bioethics Law of August 6th 2004, the Agence de la biomédecine is the only such public body in Europe to combine the four domains of organ procurement, procreation, human embryology and genetics. Its close links with medical teams and patients enable it to ensure respect for safety and quality, anticipation, ethics and transparency”. (http://www.agence-biomedecine.fr/agence/english.html)

  9. 9.

    Just as Article L. 2151-5 of the Public Health Code sets out in paragraph 5: “The decision to authorise is taken according to the scientific relevance of the research project, its terms of implementation from the point of view of ethical principles and its interest to public health. The agency’s decision, accompanied by advice from an advisory council, is communicated to ministers responsible for Health and Research who can, when the decision authorises a factual record of observations, ban or suspend it from being carried out when its scientific relevance has not been established or when respect for the ethical principles is uncertain.”

  10. 10.

    Ever since their first issues, France chose to review bioethics laws on a regular basis, so regulations remain consistent with fast scientific evolutions and improvements. This policy is also an effective way to address outdated measures. This revision is theorically intended to be set every 5 years. After a first late revision (only settled in 2004), the next revision should be conducted with, more or less, respect to the deadlines, since it is scheduled for 2010.

  11. 11.

    The advisory council of the Biomedicine Agency brings together experts in the fields of science, medicine and human sciences, representatives of associations and various institutions, and members of Parliament. It watches over the consistency of the Agency’s actions as well as the respect for statutory and ethical principles applicable to these activities.

  12. 12.

    Parliamentary Office for Scientific and Technological Options, “Report on the evaluation of the appliance of the bioethics law of August 6, 2004”. Report No. 1325 (Assemblée Nationale) and No. 107 (Sénat), drafted by M. Alain CLAEYS and M. Jean-Sébastien VIALATTE. Available for consultation on: http://www.senat.fr/rap/r08-107-1/r08-107-11.pdf (text in French).

  13. 13.

    See: http://www.etatsgenerauxdelabioethique.fr/uploads/rapport_final.pdf (text in French).

  14. 14.

    See above, note 1.

  15. 15.

    See: Study of the Council of State – “The revision of bioethical laws”, p. 18.

  16. 16.

    For further developments, see: Study of the Council of State – “The revision of bioethical laws”, pp. 12–27.

  17. 17.

    See: Parliamentary Office for Scientific and Technological Options, “Report on the evaluation of the appliance of the bioethics law of August 6, 2004”. Report No. 1325 (Assemblée Nationale) and No. 107 (Sénat), drafted by M. Alain CLAEYS and M. Jean-Sébastien VIALATTE, p. 193 Available for consultation on: http://www.senat.fr/rap/r08-107-1/r08-107-11.pdf (text in French).

  18. 18.

    See: Biomedicine Agency Report, Application Report – Bioethics Law of August 6, 2004, Report to the Minister of Health, Youth, Sports and Associative Life, October 2008, pp. 58–80 http://www.agence-biomedecine.fr/uploads/document/rapport-bilan-LB-oct2008.pdf (text in French).

  19. 19.

    See above, note 8.

  20. 20.

    For all these questions, see: Advisory Council, Contribution of the Agence de la Biomédecine Orientation Council pertaining to the bioethics law revision preparatory debates . Lessons of experience (2005–2008) and Questionings, pp. 30–41 http://www.agence-biomedecine.fr/uploads/document/bilanLB-partie3.pdf (text in French).

  21. 21.

    See: http://www.etatsgenerauxdelabioethique.fr/uploads/rapport_final.pdf (text in French).

  22. 22.

    For this expression of opinion and the issues debated on this occasion, see: opinion No.105 of the National Consultative Committee on Ethics. Available for consultation on: http://www.ccne-ethique.fr/docs/avis105anglais.pdf (text in English).

  23. 23.

    See: Final report of The General Estates on Bioethics, p. 29 Available for consultation on: http://www.etatsgenerauxdelabioethique.fr/uploads/rapport_final.pdf (text in French).

  24. 24.

    See: Final report of The General Estates on Bioethics, pp. 31–32 Available for consultation on: http://www.etatsgenerauxdelabioethique.fr/uploads/rapport_final.pdf (text in French).

  25. 25.

    This law was revised on July 17, 2009 to conform with the Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.

    Available for consultation on: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:102:0048:0058:EN:PDF

  26. 26.

    Council of Europe. 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. Oviedo, 4.IV.1997 Available for consultation on: http://conventions.coe.int/Treaty/en/Treaties/Html/164.htm

  27. 27.

    According to Article 10 of the Polish Civil Code, the age of majority is conferred to the minor subject either when the minor reaches the age of 18 or gets married before the age of 18.

  28. 28.

    Dz. U. 1996 r. nr 139, poz. 646.

  29. 29.

    See: Constitutional Tribunal See: Constitutional Tribunal, 27.05.1997, sygn. akt K 26/96 (OTK 1997, nr 2, poz. 19) (text in Polish).

  30. 30.

    See in particular: A. ZOLL ‘Can we talk about a legal statute on stem cells?’ Gazeta Lekarska, No. 2005-02, Debata Available for consultation on: http://www.gazetalekarska.pl/xml/nil/gazeta/numery/n2005/n200502/n20050221 (text in Polish).

  31. 31.

    On September 15th, 2009, date when the present text was written (author’s note).

  32. 32.

    Article 118 of the Constitution grants the right to legislative initiative to citizens, as long as the law proposal comes from a group of 100,000 citizens able to vote in legislative elections.

  33. 33.

    Deputy GOWIN was named as head of the Bioethics Commission in 2007, in charge of the legislative proposal concerning the issues relating to in vitro fertilisation and supporting the ratification of the Oviedo Convention. The text of the proposal was fixed on December 6th, 2008. It is available for consultation on: http://ekai.pl/wydarzenia/x17354/co-dokladnie-mowi-projekt-ustawy-gowina-caly-tekst-projektu/(text in Polish).

  34. 34.

    For the KIDAWA-BLONSKA proposal, see: http://www.platforma.org/pl/aktualnosci/newsy/art1488,kidawa-blonska-o-projekcie-ustawy-regulujacej-zasady-korzystania-z-metody-in-vitro.html (text in Polish).

    For the GOWIN proposal, see Article 6: http://ekai.pl/wydarzenia/x17354/co-dokladnie-mowi-projekt-ustawy-gowina-caly-tekst-projektu/(text in Polish).

  35. 35.

    Available for consultation on: http://www.federa.org.pl/Informacje/INF.pdf (text in Polish).

  36. 36.

    See Chapter XIX “Offences against life and health” of the Penal Code.

    Available for consultation on: http://prawo.money.pl/akty-prawne/ujednolicone-akty-prawne/kodeksy/kodeks;karny;z;dnia;6;czerwca;1997;r;,1997,88,553,DU,410.html (text in Polish).

  37. 37.

    This requirement of collecting the informed consent can however be qualified when the research is intended on samples already in existence. As the German National Ethics Council specifies, the absence of the collection of further consent may, in certain cases, not constitute an illegal attack on the general right of the individual. It is mainly to do with premises where samples have been made anonymous. See the opinion “Biobanks for research” of the German National Ethics council: http://www.ethikrat.net/_english/publications/Opinion_Biobanks-for-research.pdf (text in English).

  38. 38.

    See: http://www.legifrance.gouv.fr/affichCode.do?idArticle=LEGIARTI000006685827&idSectionTA=LEGISCTA000006170998&cidTexte=LEGITEXT000006072665&dateTexte=20090818

  39. 39.

    Law No. 88-1138 of December 20th, 1988, known as “the Huriet-Sérusclat law” relating to the protection of persons who participate in biomedical research, Official Journal of the French Republic (JORF), December 22, 1988.

  40. 40.

    The French Agency for the Security of Health Products is in charge of a general task of evaluating the risks and benefits of health products. See: www.afssaps.fr

  41. 41.

    The report is available for consultation on: http://www.agence-biomedecine.fr/uploads/document/rapport-bilan-LB-oct2008.pdf

  42. 42.

    See: Biomedicine Agency Report, Application Report – Bioethics Law of August 6, 2004, Report to the Minister of Health, Youth, Sports and Associative Life, October 2008, p. 77 http://www.agence-biomedecine.fr/uploads/document/rapport-bilan-LB-oct2008.pdf (text in French).

  43. 43.

    http://www.mp.pl/prawo/index.php?aid=40167 (text in Polish).

  44. 44.

    http://www.kb.mz.gov.pl/index_en.html (text in Polish).

  45. 45.

    http://www.mp.pl/prawo/index.php?aid=13358 (text in Polish).

  46. 46.

    http://bundesrecht.juris.de/bundesrecht/mpg/gesamt.pdf (text in German).

  47. 47.

    Just as Professor TAUPITZ mentions, a model of the professional code has been drawn up by the Federal Order of Doctors. It can therefore provide inspiration to the Lander in the drawing up of their own measures for professional codes. So, for example, Article 15 of the code model features the obligation to seek the opinion of an Ethics Committee before all research on a human subject. See: Jochen TAUPITZ, “Germany: current legislation” in Biomedical Research, Council of Europe publ., 2004, pp. 107–120

  48. 48.

    They are specifically excluded from the field of application of the Medicinal products Act, Chap. 1, §2, pt. 5. See: http://bundesrecht.juris.de/bundesrecht/mpg/gesamt.pdf (text in German).

  49. 49.

    On this point, see: SCHLENKE, TAPERNON et al., “The impact of the german tissue act on the manufacturing of autologous and allogeneic stem cell preparations”, Transfus Med Hermother 2008;35:446–452.

  50. 50.

    See the English version of the German Drug Law: http://www.bmg.bund.de/cln_110/nn_1200354/SharedDocs/Downloads/EN/health/AMG-pdf,templateId=raw,property=publicationFile.pdf/AMG-pdf.pdf

  51. 51.

    See: http://www.pei.de/cln_109/nn_162554/EN/home/node-en.html?__nnn=true

  52. 52.

    Krippner (2004), p. 239; translation from German to English by G. Becker.

  53. 53.

    The question of the political state of ethical guidelines in many European States is de facto decided: the National Ethics committees, established – by what legitimation in this regard ever – by politics “furnishes politics a fit ethical occasion” by the ethical guidelines they prepare. It keeps debatable for pluralistic societies to disregard completely federal ideas of concrete ethics models, as e.g. represented by the Polish group for bioethics in Life Sciences: this pluralistic model follows the idea that the current top-to-bottom- model shall be replaced by a bottom-up model, in which Scientific institutions develop their own guidelines AND action rules – covered only by established law.

  54. 54.

    In a way it is amazing that although bioethics has improved its importance in Europe over the last decade, “action rules” in form of “rules of conduct” in labs, sickrooms etc. have not been established. Bioethics has not reached (yet) the units where concrete work is done.

  55. 55.

    Possible reasons for that kind of ignorance can be found in archaic self-images, in which Science itself has got an ethics status so developed that a concrete formulation on the “dos and don’ts” simply appears not necessary; another reason is the disability of Science and its representatives to deal concretely with that meta-level of Science without counsel – and in Europe there are not too many bioethics consultants with the ability helping implementation of concrete bioethics rules within Science.

  56. 56.

    Finally, law makers in parliaments raise their hand pro or contra a law suggestion – what finally has moved them to vote in this or that way keeps their secret. However, hopefully they all have reflected ethically the law they vote on!

  57. 57.

    Certainly, this is the “perfect case”; however, legal, political and tactical-political aspects are usually involved, too.

  58. 58.

    In this context the motive of “eternal recurrence” is the question how to build up laws in a pluralistic society at all. The practical answer usually given is the hint to the formulas of basic rights fixed in the constitution. Such a “check-up” in practice can be extremely difficult when a problem touches from all possible sites different basic rights at the same time or when it touches ideas beyond law; the debates about the Stem Cell Act in Germany was such a case: apart from the right of “physical integrity” and “dignity of man”, also the question of the beginning of Human life was relevant.

  59. 59.

    The same is valid for example in German Medical Law. The circumlocution in this case is that a syringe given by a medic is an “assented personal injury” without criminal sanction or prosecution. This formulation has been necessary for the constitution includes the physical integrity (Grundgesetz Article 2), but syringing in the frame of medical treatment makes perfectly sense, too. So, the law-makers had to combine both circumstances in a formulation appearing slightly odd.

  60. 60.

    This way it may be understandable that we call it debatable to involve ethicists from Philosophy in Ethics leading to concrete rules, regulation and laws. The aims of Philosophy, delivering a purposeless general outline of ethics is only in restricted ways compatible with the concrete goals of establishing rules. The consideration of e.g. Hume’s and Moore’s rules is – without any doubts” a “must” on the philosophical level of ethics, but contra productive and quixotic when it comes to societal relevance of real existing ethics, as a grown and developing societal phenomenon.

  61. 61.

    Keller (2009) points out the debatable distinction of the distinctive terms “embryonic -” and “adult stem cells” against the background that these terms are not describing exactly “the source of withdrawal” in a biological and medical sense.

  62. 62.

    Furthermore, it has to be said that there are certain indications that on a societal level the question whether it is morally justified to destroy Human Life in early stage for the benefit of sick people has found a clear positive answer. If it comes to the point that Embryonic Stem Cell research leads to life-saving therapies – becoming describable fact – societies may decide clearly for them, representing the ethical evaluation that these life-saving therapies have higher moral value but Human early-stage-life. This way, in real life, facts determine ethical evaluations, whereas the author disagrees on a moral level in the described case!

  63. 63.

    The metaphysical argumentation of Theology might be incompatible in discussions of practical ethics. Furthermore, the point of secularisation is an open question in this context.

  64. 64.

    Deutsch (2006), p. 631.

  65. 65.

    How far it is justifiable that a government or a ministry and NOT the parliament establishes ethics commissions, as it is the case in Germany referring the Central Ethics Commission for Stem Cell Research has to be released for further discussions!

  66. 66.

    This is not a natural given fact. Over the years, inter alia the Polish Group for Bio-Ethics in Life Sciences has tried to convince Science to build up ethics unit as a “voluntary self-monitoring” to prevent a political takeover of bioethics as such; until now in vain…

  67. 67.

    See also Szwarski (2004); the impact and tasks of the Ad-hoc commissions keep unclear. Generally, the state of sources referring ethics commissions and/or Regenerative Medicine are not satisfying. Statements and publications on officially planned actions referring law and ethics of Regenerative Medicine confine themselves on generalities or press statements without official character.

  68. 68.

    See http://www.kprm.gov.pl/s.php?id = 1273, Accessed 2009-07-27.

  69. 69.

    Loco citato.

  70. 70.

    L.c.

  71. 71.

    L.c.

  72. 72.

    Szawarski (2004).

  73. 73.

    Just within the last few years, we have observed that members of the Scientific community have been daring advocating ethical positions in opposition to church positions. Too, it has to be mentioned that recently provocations, also in bioethical sense, of the politician Mr. Palikot, have brought in the sequel a more open discussion e.g. regarding in-vitro-fertilisation and other also bioethical topics. A new term in Poland for unusual and provoking statements is named after him: “palikotyzacja”, it keeps an open question whether “palikotyzacja” can help establishing an open discussion generally on ethical aspects of Regenerative Medicine – we do not wish to exclude this possibility here and now.

  74. 74.

    See also: http://www.ethikrat.org/de_der/ethikratgesetz.php

  75. 75.

    RKI (2009).

  76. 76.

    The fact that in this commission the Protestant and Catholic Church are represented by Professors of Theology does de facto not speak against their designation as “church representatives. In Germany Professors of Theology need permission by church, the “missio canonica”, respectively the “Vokation” for filling their academic positions. Therefore, it might make a political difference between direct involvement of the Christian churches and the involvement of academic Theologians, but not in the matter. Academic Theologians are obliged to represent the official church guidelines and principles.

  77. 77.

    Loco citato.

  78. 78.

    For any concrete impact of bioethics it is a fatal mistake if bioethics is evaluated a discipline of philosophy or theology! The competence of evaluating ethical dimensions of biomedical Science is given to scientists as well. Therefore, “ethics” is not an esoteric but exoteric discipline – not for specialist from Humanities only but –for all society, including scientists taking over responsibility by reflecting ethics of their own work! ZES is an excellent example how scientists “can be forced” dealing with ethics of their work; something that too rarely is still the case!

  79. 79.

    As mentioned before: although a research project can fulfil all legal requirements, in spite of that, by a commission like ZES it can be evaluated as unethical. This possibility makes the essential difference between a purely legal and an ethics commission; this way it builds a much “finer instrument” and therefore an “appropriate instrument” dealing ethically with issues from Biomedicine.

  80. 80.

    In an edition published on the occasion of the fifth anniversary Siep (2008a) deals critically with the German Stem Cell law and “The view of the German Central Ethics Committee for Stem Cell Research” (l.c.). He states that “according to the German Stem Cell Act the Central Ethics Committee for Stem Cell Research (ZES) advices the competent authority (Robert Koch Institute) as to whether an application to import human embryonic stem-cells for research is “ethically justifiable” (“ethisch vertretbar”). The law does indeed specify some conditions of this justification, but without precisely defining them.” (l.c.). Generally, the question of “broad” legal formulation and the possible leeway in interpretation from ethical side is quite a difficult one that requires another publication than the present one; however, from a legal point of view the question is “easy” to answer, regarding connected other laws and the spirit of basic rights formulated in the German Constitution (Grundgesetz).

  81. 81.

    Siep (2008b).

  82. 82.

    ZES (2008).

  83. 83.

    ZES (2008).

  84. 84.

    CCNE (2009a).

  85. 85.

    CCNE (2009b).

  86. 86.

    Sicard (2007).

  87. 87.

    Deutsch (2007).

  88. 88.

    Sintomer (2009).

  89. 89.

    Deutschlandradio (2006).

  90. 90.

    See also Sentimer (2009).

  91. 91.

    Sicard (2007).

  92. 92.

    Deutsch (2007).

References

Download references

Author information

Authors and Affiliations

  1. Group for Bio-Ethics in Life Sciences (GBLS), Faculty of Biochemistry, Biophysics and Biotechnology, Jagiellonian University, ul. Gronostajowa 7, Kraków, 30-387, Poland

    Gregor Becker Ph.D.

  2. Paris, France

    Anna Grabinski

Authors
  1. Gregor Becker Ph.D.
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Anna Grabinski
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Gregor Becker Ph.D. .

Editor information

Editors and Affiliations

  1. Klinik und Poliklinik für Herzchirurgie, Universitätsklinikum Rostock, Schillingallee 35, Rostock, 18057, Germany

    Gustav Steinhoff

Rights and permissions

Reprints and permissions

Copyright information

© 2013 Springer Science+Business Media Dordrecht

About this chapter

Cite this chapter

Becker, G., Grabinski, A. (2013). Ethics and Law in Regenerative Medicine: A Legal and Ethical Outline on Regenerative Medicine in Research in France, Germany and Poland. In: Steinhoff, G. (eds) Regenerative Medicine. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-5690-8_45

Download citation

Publish with us

Policies and ethics

Search

Navigation