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Legal Ambiguities Concerning Medical Genetics in Poland – Searching For a Common Ground

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Exploring Central and Eastern Europe’s Biotechnology Landscape

Part of the book series: The International Library of Ethics, Law and Technology ((ELTE,volume 9))

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Abstract

This paper constitutes an analysis of Polish regulation concerning genetic research and practice in the post-genomic era. The so-called post-genomic era is marked by the departure from genetic determinism and exceptionalism. Therefore, it seems increasingly difficult to treat genetic information as the essential determinant of human existence, and a particularly sensitive class of personal data. Still, in public opinion and mainstream medical jurisprudence, the genocentric dogma remains almost unquestioned. These difficulties translate into major conceptual quandaries about the regulation of the use of DNA and biological data at the national and European level. Despite EU enlargement and progressing unification, very little is known about the legal discourse surrounding life sciences in Poland, which in the last 20 years was preoccupied with the process of democratization with less attention given to regulating medical genetics. As a result Polish law in this area remains quite general. This paper examines the strengths and the weaknesses of the Polish regulatory framework in light of the recent paradigm shift in life sciences. It provides insight into how Polish regulators, reconcile liberal principles of free market economy, with the Catholic doctrine so prominent in Polish politics. Finally, it attempts to identify a common conceptual and normative ground for a much needed consensus among European states.

The final version of this chapter was submitted to the editors in December 2009.

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Notes

  1. 1.

    Genetics, defined broadly, is the science of heredity and variation in living organisms. See: Griffiths et al. (2009).

  2. 2.

    The Human Genome Project (HGP) refers to the international 13-year effort, formally begun in October 1990 and completed in 2003, to discover all the estimated 20,000–25,000 human genes and make them accessible for further biological study. Another project goal was to determine the complete sequence of the 3 billion DNA subunits (bases in the human genome). See: Human Genome Project Information, available at: http://www.ornl.gov/sci/techresources/Human_Genome/home.shtml. Retrieved on 3 May 2009.

  3. 3.

    The study of the proteome, the complete set of proteins expressed by a genome, cell, tissue or organism, using the technologies of large-scale protein separation and identification. The term proteomics was coined in 1994 by Marc Wilkins from the UNSW School of Biotechnology and Bimolecular Sciences. Retrieved June 30, 2008 http://www.babs.unsw.edu.au/staff_directory/wilkinsm.html.

  4. 4.

    Metabolomics is the global analysis of metabolites, small molecules generated in the process of metabolism. See also: Jenkins et al. (2004).

  5. 5.

    Postgenomic era, ‘in which genetic information will have to be examined in multiple health care situations throughout the lives of individuals’ (Peltonen and McKusick 2001).

  6. 6.

    The post-genomic paradigm emphasises the arbitrariness of taking genes as the most important casual factors in the development and functioning of organisms. Consequently, it highlights that the concept of the gene itself is a highly problematic conceptual and epistemological conundrum. I discuss this problem in legal terms in: Krajewska (2009a).

  7. 7.

    ‘Professor Steve Jones in: Alleyne and K. Devlin (2009).

  8. 8.

    I have analysed this problem in: Krajewska (2009b).

  9. 9.

    The former is usually defined as ‘a branch of biomedical science that studies the relationship between genes and health, and searches for an unknown gene that may be involved in a disease’, whereas the latter attempts to translate effectively genome-based knowledge for the benefit of health care. In: Connor and Ferguson-Smith (1997).

  10. 10.

    This term encompasses different methods used to achieve pregnancy by artificial or partially artificial means.

  11. 11.

    For further discussion see: Harris (2007) and Somsen (2008).

  12. 12.

    This problem has been thoroughly analysed by S. Jassanoff (2007).

  13. 13.

    M. Foucault analyses liberalism not ‘as a theory or an ideology – and even less, certainly, as a way for “society” to “represent itself…” – but, rather, as a practice (…) as a principle and a method of rationalizing the exercise of government, a rationalization that obeys – and this its specificity – the internal rule of maximum economy.’, Foucault (1997).

  14. 14.

    UN, UNESCO, WHO, HUGO, WMA, OECD and Council of Europe have issued many documents concerning, for instance human genome (UNESCO Declaration on Human Genome and Human Rights 1997), genetic data (UNESCO Declaration on Human Genetic Data 2003), genetic testing (Additional Protocol to the Convention on Human Rights and Biomedicine on Genetic Testing for Health Purposes 2008) and biobanks (OECD Guidelines for Human Biobanks and Genetic Research Databases 2009).

  15. 15.

    In Germany the Act on Genetic Diagnosis has been adopted by the German Bundestag on the 23 April 2009. See: ‘Gen-Diagnostik Gesetz verabshidet’ in: Focus, 24 April 2009, available at: http://www.focus.de/gesundheit/ticker/recht-gen-diagnostik-gesetz-verabschiedet_aid_393030.html. Retrieved 1 May 2009, In Switzerland the Federal Law on the Genetic Testing of Humans (Loi fédérale sur l’analyse génétique humaine (LAGH) FF 2004 5145), came into force in 2006. In the USA the famous Genetic Information Non-Discrimination Act (GINA Pub.L. 110–233, 122 Sta. 881) has been enacted on 21 May 2008. For regulation of biobanks in Iceland, Estonia, Hungary, and the UK see: Maschke (2005).

  16. 16.

    European Jewish Congress Website, available at: http://www.eurojewcong.org/ejc/news.php?id_article=159. Retrieved on 25 April 2009.

  17. 17.

    European Court of Human Rights (ECtHR), Tysiąc v. Poland, 20.03.2007 r., Application No 5410/03.

  18. 18.

    See e.g.: European Bank of Umbilical Cord Blood ‘Motherhood’, available at: http://www.macierzynstwo.pl/index.php. Retrieved on 20 May 2008; Stem Cell Bank ‘Progenis’ Ltd. Retrieved: http://www.progenis.pl/index.php/kontakt.html; Polish Stem Cell Bank S.A. (joint stock company), available at: http://www.pbkm.pl/. Retrieved on 20 May 2008.

  19. 19.

    All UNESCO documents on Bioethics are available at: http://portal.unesco.org/shs/en/ev.php-URL_ID=1372&URL_DO=DO_TOPIC&URL_SECTION=201.html. Retrieved on 29 April 2009.

  20. 20.

    World Medical Association, Helsinki Declaration 1964, last version adopted by the 59th WMA General Assembly, Seoul, October 2008, available at: http://www.wma.net/e/policy/b3.htm. Retrieved on 1 May 2009.

  21. 21.

    Council of Europe, Convention for the Protection of Human Rights and Fundamental Freedoms Rome, 4 November 1950, as amended by Protocol No. 11, available at: http://conventions.coe.int/treaty/en/Treaties/Html/005.htm. Retrieved on 30 October 2008.

  22. 22.

    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 at: http://conventions.coe.int/Treaty/EN/Treaties/Html/164.htm. Retrieved on 28 October 2008.

  23. 23.

    Art. 18 of the Vienna Convention on the Law of Treaties (1969) stipulates that: A State is obliged to refrain from acts which would defeat the object and purpose of a treaty when: (a) it has signed the treaty or has exchanged instruments constituting the treaty subject to ratification, acceptance or approval, until it shall have made its intention clear not to become a party to the treaty; or (b) it has expressed its consent to be bound by the treaty, pending the entry into force of the treaty and provided that such entry into force is not unduly delayed. See: United Nations, Treaty Series, vol. 1155, p.331.

  24. 24.

    The Committee is expected to announce the results of its work at the beginning of October 2008. It will propose necessary amendments to the existing law and new statutes on in vitro fertilisation and other biomedical issues. See: Interview with Jarosław Gowin, the Chair of the Bioethics Committee, Radio TOKFM, Retrieved September 18, 2008, http://serwisy.gazeta.pl/tokfm/1,53880,5707747,Gowin__Szykuje_sie_bardzo_pracowita_jesien.html.

  25. 25.

    Constitution of the Republic of Poland, 2 April 1997, Dz. U. Nr. 78 poz. 483.

  26. 26.

    The relationship between international and domestic law determines what prerequisites are required for the domestic validity of a treaty. In monist States, where international law and domestic law are part of one legal order, treaties are domestically valid as soon as they are duly ratified. Examples of monist States include Belgium, France, Japan, the Netherlands, Portugal, the Russian Federation, Spain, Switzerland, most Latin American countries. In dualist States, international law and domestic law are parts of separate legal orders. Thus, treaties have to be incorporated into domestic law in order to become domestically valid. There are two distinct kinds of dualist States. On the one hand are Germany, Italy, the US, and several Central and Eastern European countries (e.g. Poland). On the other hand there are the UK, a considerable number of countries which used to be part of the British Commonwealth, and the Scandinavian countries. In the first group of dualist States, formal parliamentary approval is sufficient to incorporate a treaty into domestic law. A treaty is treated as international law even after its incorporation into domestic law with the result that the treaty can be applied directly within the domestic legal system. In the second group of dualist States, parliamentary approval is not formal but takes the form of substantive implementing legislation. The treaty loses its international law character in this process and, therefore, cannot be applied directly. See: Kaiser (2009).

  27. 27.

    The competences of the EU are divided up into exclusive or shared competences, with other areas where the EU may take action only to support, coordinate or complement member states activities. Those areas that are not specifically mentioned in the Constitution remain the responsibility of the member states.

  28. 28.

    The acquis communautaire is the entire body of European legislation, including all the treaties, regulations and directives adopted by the European Union (EU) and the rulings of the European Court of Justice that each new country joining the EU is required to accept.

  29. 29.

    Constitution of the Republic of Poland, 2 April 1997, Dz. U. Nr. 78 poz. 483.

  30. 30.

    Act on the Professions of Physicians and Dentists 1996 (later also: Medical Professions Act or MPA) (Ustawa o zawodach lekarza i lekarza dentysty, Dz.U. 1997 Nr 28 poz. 152).

  31. 31.

    The Pharmaceutical Law Act, 6 September 2001 (Ustawa prawo farmaceutyczne, Dz.U. 2008 Nr 45 poz. 271).

  32. 32.

    Act on Medical Devices, 10 April 2004 (Ustawa o wyrobach medycznych, Dz.U. 2004 Nr 93 poz. 896).

  33. 33.

    Act on the procurement, storage and transplantation of cells, tissues and organs 2005 (also: Cells and Tissues Act or historically: Transplantation Act 2005) (Ustawa o pobieraniu, przechowywaniu i przeszczepianiu komórek, tkanek i narządów, Dz. U. 2005 Nr 169, poz. 1411).

  34. 34.

    Act on the Protection of Personal Data, 29 August 1997 (also: Personal Data Protection Act 1997) (Ustawa o ochronie danych osobowych, Dz. U. 1997 Nr 133 poz. 883 with later amendments).

  35. 35.

    Both established by the Act on the Agency for the Registration of Medicinal Products, Medical Devices and Germicidal Products, 27 July 2001 (ustawa o Urzędzie Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Dz.U. Nr 126, poz. 1397 oraz z 2002 r. Nr 152, poz. 1263).

  36. 36.

    Established by the Personal Data Protection Act.

  37. 37.

    Polish Chamber of Physicians and Dentists, Code of Medical Ethics, 2 January 2004. Polish version to be retrieved from http://www.nil.org.pl/xml/nil/wladze/str_zl/zjazd7/kel.

  38. 38.

    Articles 21 – 29 of the Medical Professions Act, supra note 32.

  39. 39.

    The Criminal Code, 6 June 1997 (Kodeks karny Dz. U. Nr 88 poz. 553).

  40. 40.

    Lex specialis, is a doctrine relating to the interpretation of laws in situations where norms collide. The doctrine states that a law governing a specific subject matter (lex specialis) overrides a law which only governs general matters (lex generalis). The situation ordinarily arises with regard to the construction of earlier-enacted specific legislation when more general legislation is later passed. This principle also applies to construction of a body of law or single piece of legislation that contains both specific and general provisions.

  41. 41.

    The Pharmaceutical Law (2001).

  42. 42.

    European Medicines Agency, Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories, November 2007, EMEA/CHMP/ICH/437986/2006. Retrieved on 30 August 2008: http://www.emea.europa.eu/pdfs/human/ich/43798606en.pdf.

  43. 43.

    § 2 Order of the Minister of Health on the Detailed Description for the Requirements of Good Clinical Practice, 11 March 2005, Dz.U. 2005 Nr 57 poz. 500.

  44. 44.

    Act on Medical Devices.

  45. 45.

    Act on Medical Devices.

  46. 46.

    Polish Constitutional Tribunal, 17 March 1993, W 16/93, Dz.U. Nr 23, poz. 103.

  47. 47.

    Family Code, 25 February 1964 (Kodeks rodzinny i opiekuńczy, Dz.U. 1964 Nr 9 poz. 59 with later changes).

  48. 48.

    ‘[I]ts raw material is derived from people; its “product” is often the genetic information derived from analysis of this raw material; there are conflicts over the legal status of both raw materials and the product; and the product has no ready substitutes’, in: Andrews (2005).

  49. 49.

    See also: C.Grand/K Atia-Off, Genmedizin und Datenschutz, w: S.F. Winter/ H. Fenger/ H-L. Schreiber (red.), Genmedizin und Recht, Monachium 2001, pp. 538–540, Brückl (2001), or Halasz (2003).

  50. 50.

    Act on the procurement, preservation and transplantation of cells, tissues and organs (Ustawa o pobieraniu, przechowywaniu i przeszczepianiu komórek, tkanek i narządów), 1 July 2005 (Dz.U. 2005 Nr 169 poz. 1411).

  51. 51.

    Laboratory Diagnostics Act 2001, supra note 11.

  52. 52.

    The Civil Code (Ustawa kodeks cywilny), 18 May 1964 (Dz.U 1964 Nr 16 poz. 93, last amendment Dz.U.07.82.557).

  53. 53.

    Art. 2 Cells and Tissues Act 2005.

  54. 54.

    Art. 51 of the Polish Constitution:

    1. 1.

      No one may be obliged, except on the basis of statute, to disclose information concerning his person.

    2. 2.

      Public authorities shall not acquire, collect nor make accessible information on citizens other than that which is necessary in a democratic state ruled by law.

    3. 3.

      Everyone shall have a right of access to official documents and data collections concerning himself. Limitations upon such rights may be established by statute.

    4. 4.

      Everyone shall have the right to demand the correction or deletion of untrue or incomplete information, or information acquired by means contrary to statute.

    5. 5.

      Principles and procedures for collection of and access to information shall be specified by statute.

  55. 55.

    Personal Data Protection Act 1996 (Ustawa o ochronie danych osobowych), 29 August 1996 (Dz.U. 1997 nr 133 poz. 883 z pózn. zm.).

  56. 56.

    J. Barta, R. Markiewicz, Ochrona danych osobowych. Komentarz, Kraków: 2001, p. 505.

  57. 57.

    Art. 27 para 1 Personal Data Protection Act, supra note 32.

  58. 58.

    S. and Marper v. U.K. – 4 December 2008, Application no. 30562/04, [2008] ECHR 1581, available at: URL: http://www.bailii.org/eu/cases/ECHR/2008/1581.html. Retrieved on 26 April 2009.

  59. 59.

    According to Art 27 para 2 consent is, however, not necessary for the erasure of data.

  60. 60.

    13.07.2006, I OSK 1083/05, LEX nr 275431.

  61. 61.

    15.11.2006, II SA/Wa 1612/06, LEX nr 301825.

  62. 62.

    Similarly administrative court in its verdicts given on 16.11.2005, II SA/Wa 139/05, LEX nr 213699 and 4.4.2003, II SA 2135/02, Wokanda 2004/6/30.

  63. 63.

    For the discussion regarding the Icelandic biobank see: Gertz (2004) and Chadwick (1999).

  64. 64.

    Recital 34 of the Preamble to the EU Directive 95/46.

  65. 65.

    For example The Federal Data Protection Act, 18 May 2001 (Deutsches Datenschutzgesetz), published in the Bundesgesetzblatt I Nr. 23/2001.

  66. 66.

    European Commission, CORDIS, EU project calls on Poland to pioneer new genetic testing guidelines, 21 September 2007, available at: http://cordis.europa.eu/fetch?CALLER=MSS_PL_NEWS_EN&ACTION=D&DOC=22&CAT=NEWS&QUERY=01204bc396f1:e508:045a3389&RCN=28383. Retrieved on 3 May 2009.

  67. 67.

    It is argued that this section cannot be interpreted as basis for disclosure to insurers. Jackowski M., Ochrona danych medycznych, 2002, 116, J. Barta, R. Markiewicz, Ochrona danych osobowych. Komentarz, 2001, p. 435.

  68. 68.

    In this respect Polish law seems to meet the criteria set by the Convention on Biomedicine and Human rights in Art. 3, which constitutes the right to equitable access to health care of appropriate quality depending on national resources. 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, ETS 164.

  69. 69.

    For more discussion on the right not to know see: Stumper (1996), Andorno (2004) Taupitz (1998), and Damm (1999).

  70. 70.

    Council of Europe, Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes, Strasbourg, 27 November 2008. Retrieved: http://conventions.coe.int/Treaty/EN/Treaties/Html/TestGen.htm.

  71. 71.

    Act on Health Services Funded by National Resources, 27.08.2004 r. (ustawa o świadczeniach opieki zdrowotnej finansowanych ze środków publicznych), (Dz. U. Nr 210, poz. 2135). The Bill has been issued to the Parliament on the 5.06.2008 and is currently revised. See: Rzeczpospolita, Jakie świadczenia znajdziemy w koszyku, 5.06.2008, Retrieved on 08.11.2008, http://www.rp.pl/artykul/22,144184_Jakie_swiadczenia_znajdziemy_w_koszyku.html.

  72. 72.

    In Germany guidelines are issued by the Federal Associations of Physicians (Bundesaertztekammer), German of Human Genetics (Deutsche Gesellschaft fuer Humangenetik), and in the UK the Human Genetic Commission, Clinical Genetics Society, or Nuffield Council.

  73. 73.

    Act on Family Planning, Prenatal Life Protection and the Conditions under which Pregnancy Termination is Permitted 1993 (Ustawa o Ustawa o planowaniu rodziny, ochronie płodu ludzkiego i warunkach dopuszczalności przerywania ciąży), 7.01.1993, (Dz.U. 1993 Nr 17 poz.78).

  74. 74.

    ECHR, Tysiąc v. Poland, 20.03.2007 r., Application No 5410/03.

  75. 75.

    Recently, a 14-year-old girl who had sought abortion was separated from her mother by a court decision (later revoked) and subjected to pressure from a priests and Catholic hospital manager. See: Bielesz (2008).

  76. 76.

    The Supreme Court has decided on the admissibility of the claim in 2005. See: Sąd Najwyższy, 13.10.2005, IV CK 161/05.

  77. 77.

    All available at: http://www.dh.gov.uk/en/Publichealth/Scientificdevelopmentgeneticsandbioethics/Tissue/Tissuegeneralinformation/DH_4136920. Retrieved on 3 May 2009.

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  1. University of Exeter, Exeter, UK

    Atina Krajewska

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  1. Atina Krajewska
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Correspondence to Atina Krajewska .

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  1. The Open University, Development Policy and Practice Group, ESRC Innogen Centre, Walton Hall, Milton Keynes, NW3 2JZ,, United Kingdom

    Peter T. Robbins

  2. , Development Policy and Practice, The Open University, Walton Hall, Milton Keynes, MK7 6AA, United Kingdom

    Farah Huzair

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Krajewska, A. (2012). Legal Ambiguities Concerning Medical Genetics in Poland – Searching For a Common Ground. In: Robbins, P., Huzair, F. (eds) Exploring Central and Eastern Europe’s Biotechnology Landscape. The International Library of Ethics, Law and Technology, vol 9. Springer, Dordrecht. https://doi.org/10.1007/978-90-481-9784-2_5

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