Abstract
We are living in an era of epic transformation and advancement of medical science and technology, which allows us to gather comprehensive information about a person’s health and predict and even prevent a disease. The focus on personalized or individualized medicine presents new challenges, not only in the fields of medical sciences, biotechnology, and nanotechnology but also in the fields of social law and economy, where the consequences of medical activities are manifested. The existence of technically available and possible methods of diagnostic and treatment raises the question whether there could be a constitutionally guaranteed fundamental right of access to them. What consequences would the introduction of personalized medicine in compulsory health insurance systems have? Is it possible, would it destruct or reconstruct the essential features of compulsory health insurance? These are just some of the issues this paper aims to address.
Professor Nada Bodiroga-Vukobrat Ph.D., Head of Department of EU Public Law, Faculty of Law, University of Rijeka, Rijeka, Croatia.
Professor Hana Horak, Ph.D., Head of Department of Law, University of Zagreb Faculty of Economics and Business, University of Zagren, Zagreb, Croatia.
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Notes
- 1.
- 2.
Radolović (2006), p. 133.
- 3.
Authors’ translation from German, see Damm (2009), pp. 303 and 312.
- 4.
- 5.
Niederlag et al. (2010), p. 776.
- 6.
Kroemer (2012), p. 12.
- 7.
The Royal Society and the Royal Academy of Engineering (2004).
- 8.
- 9.
Deutscher Bundestag (2009) (authors’ translation from German).
- 10.
German Academy of Sciences Leopoldina et al. (2010).
- 11.
German Academy of Sciences Leopoldina et al. (2010), p. 14.
- 12.
Constitution of the World Health Organisation (1946).
- 13.
United Nations, Millenium Development Goals (2000).
- 14.
Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (1997), Article 3.
- 15.
Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes (2008).
- 16.
Convention for the Protection of Human Rights and Fundamental Freedoms (1950).
- 17.
Charter of Fundamental Rights of the EU, Article 2.
- 18.
See, e.g., Directive 2006/54/EC of the European Parliament and of the Council of 5 July 2006 on the implementation of the principle of equal opportunities and equal treatment of men and women in matters of employment and occupation (recast); Council Directive 2000/43/EC of 29 June 2000 implementing the principle of equal treatment between persons irrespective of racial or ethnic origin.
- 19.
Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data.
- 20.
Article 8(3) of Data Protection Directive 95/46/EC.
- 21.
European Commission (2012a).
- 22.
Eecke et al. (2012), pp. 19–22.
- 23.
Gilbert (2012).
- 24.
Gilbert (2012), p. 21.
- 25.
Numerous cases of the European Court of Human Rights, e.g., S. and Marper v. the United Kingdom, ECHR App. No. 30562/04 and 30566/04, Judgement of 4.12.2008, point to the need for a clearer definition of the right of a person to seek deletion of his personal data from public registers, etc. See also a recent Judgment (13.5.2014) of the Court of Justice of the EU in the case C-131/12 Google Spain SL, Google Inc. v. Agencia Espanola de Proteccion de Datos, Mario Costeja Gonzales.
- 26.
Constitution of the Republic of Croatia, Article 59.
- 27.
Constitution of the Republic of Croatia, Article 70.
- 28.
Pavelić et al. (2015).
- 29.
Li (2011), p. 403.
- 30.
Li (2011), p. 403.
- 31.
Li (2011), p. 412.
- 32.
Li (2011), p. 412.
- 33.
See Kollek et al. (2004), p. 138: “Once obtained, they [i.e. data] stick to the individuals their entire life” (authors’ translation from German).
- 34.
Taupitz (2011), p. 225.
- 35.
Deutscher Bundestag (2009), pp. 14 and 148.
- 36.
- 37.
Martinović (2014), p. 56.
- 38.
Hatzopoulos (2009), p. 769.
- 39.
Kingreen (2003), p. 252.
- 40.
- 41.
See more in Martinović (2014).
- 42.
- 43.
Damm (2011), p. 12.
- 44.
- 45.
Deutscher Bundestag (2009), pp. 15 and 148.
- 46.
Bottinger (2007), p. 20.
- 47.
- 48.
Deutscher Bundestag (2009), pp. 18, 128, 154.
- 49.
Deutscher Bundestag (2009), p. 12 and 151.
- 50.
Deutscher Bundestag (2009), p. 151.
- 51.
Deutscher Bundestag (2009), p. 152.
- 52.
Deutscher Bundestag (2009), p. 145.
- 53.
Deutscher Bundestag (2009), p. 145.
- 54.
Feuerstein et al. (2002).
- 55.
Damm (2007).
- 56.
European Commission (2011), p. 12.
- 57.
European Commission (2013), p. 16.
- 58.
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. The pending Commission's Proposal for a revision of this Directive and adoption of a Regulation on in vitro medical devices of 2012 explicitly includes diagnostics used in the context of personalised medicine in the definition of an IVD. See European Commission (2012b).
- 59.
Directive 2001/83/EC on the Community code relating to medicinal products for human use.
- 60.
The new Regulation EU No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, entered into force on 16 June 2014 but will apply no earlier than 28 May 2016. In the transition period, all clinical trials in the EU are to be performed in accordance with Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations, and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. The new Clinical Trials Regulation is aimed at facilitating the conduct of clinical trials, particularly for personalised medicines, where diseases are increasingly narrowly defined. See more in European Commission (2013), p. 19.
- 61.
Data Protection Directive 95/46/EC.
- 62.
- 63.
Pavelić et al. (2015), p. 2.
- 64.
National Academy of Sciences (2009).
- 65.
Agency for Health Care Research and Quality (2001).
- 66.
Vogenberg et al. (2010a), p. 626.
- 67.
The Privacy Act of 1974, 5 U.S.C. §552a.
- 68.
The Electronic Communication Privacy Act of 1986, 18 U.S.C. §2510-2521, 2701–2710.
- 69.
The Americans with Disabilities Act, Pub.L. 101–336, 104 Stat. 327.
- 70.
The Health Insurance Portability and Accountability Act, Pub.L. 104–191; 110 Stat. 1936.
- 71.
The American Recovery and Reinvestment Act of 2009, Pub.L. 111–5; 123 Stat. 115.
- 72.
Vogenberg et al. (2010a), p. 629.
- 73.
Institute of Medicine of the National Academies (2009), p. 3.
- 74.
The Genetic Information Nondiscrimination Act of 2008, Pub.L. 110–233, 122 Stat. 881.
- 75.
U.S. Food and Drug Administration (2007a).
- 76.
U.S. Food and Drug Administration (2007b).
- 77.
A valuable overview of instruments and policy papers in relation to the federal oversight of genetic/genomic testing is provided on the Internet site of Duke Center for Personalized and Precision Medicine (2015). http://dukepersonalizedmedicine.org/policy/regulatorylegal. Accessed 20 Jan 2015.
- 78.
The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 244,000 laboratory entities. See more at https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia. Accessed 10 Jan 2015.
- 79.
- 80.
See more on this issue, e.g., Marchant et al. (2006).
- 81.
Personalized Medicine Coalition (2014).
References
Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes (2008), CETS No. 203
Agency for Health Care Research and Quality (AHRQ) (2001) Reducing and preventing adverse drug events to decrease hospital costs. Research in Action, Issue 1. http://archive.ahrq.gov/research/findings/factsheets/errors-safety/aderia/ade.html. Accessed 13 Jun 2014
Bottinger EP (2007) Foundations, promises and uncertainties of personalized medicine. Mount Sinai J Med 74:15–21
Centers for Medicare & Medicaid Services (CMS) (2015) https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia. Accessed 10 Jan 2015
Charter of Fundamental Rights of the EU, OJ C 83 of 30.03.2010
Constitution of the Republic of Croatia, Official Gazette of the Republic of Croatia Narodne novine nos. 56/90, 135/97, 8/98, 113/00, 124/00, 28/01, 41/01, 55/01, 76/10, 85/10 and 05/14
Constitution of the World Health Organisation (1946) Basic Documents, Supplement 2006, http://www.who.int/governance/eb/who_constitution_en.pdf. Accessed 10 Mar 2014
Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (1997) CETS No. 164
Convention for the Protection of Human Rights and Fundamental Freedoms (1950) CETS No. 005
Council Directive 2000/43/EC of 29 June 2000 implementing the principle of equal treatment between persons irrespective of racial or ethnic origin, OJ L 180 of 19.07.2000
Damm R (2007) Gendiagnostik als Gesetzgebungsprojekt. Regelungsinitiativen und Regelungsschwerpunkte. Bundesgesundheitsblatt – Gesundheitsforschung – Gesundhetisschutz 50(2):145–156
Damm R (2009) Prädiktive Gesundheitsinformationen, Persönlichkeitsrechte und Drittinteressen: Prinzipiendiskussion und Rechtspolitik. In: Ciacchi C et al (eds) Haftungsrecht im dritten Millenium. Liber Amicorum Gert Brüggemeier. Nomos, Baden-Baden, pp 303–330
Damm R (2011) Personalisierte Medizin und Patientenrechte – Medizinische Optionen und medizinrechtliche Bewertung. MedR 29:7–17
Damm R, König S (2008) Rechtliche Regulierung prädiktiver Gesundheitsinformationen und genetischer Exzeptionalismus. MedR 26(2):62–70
Deutscher Bundestag (2009) Bericht des Ausschusses für Bildung, Forschung und Technikfolgenabschätzung: Zukunftsreport Individualisierte Medizin und Gesundheitssystem. Drucksache 16/2000 of 17.02.2009
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, OJ L 121 of 01.05.2001
Directive 2001/83/EC on the Community code relating to medicinal products for human use, OJ L 311 of 28.11.2001
Directive 2006/54/EC of the European Parliament and of the Council of 5 July 2006 on the implementation of the principle of equal opportunities and equal treatment of men and women in matters of employment and occupation (recast), OJ L 204 of 26.07.2006
Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, OJ L 281/31 of 23.11.1995
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, OJ L 331 of 07.12.1998.
Duke Center for Personalized and Precision Medicine (2015) http://dukepersonalizedmedicine.org/policy/regulatorylegal. Accessed 20 Jan 2015
Dulčić K, Bodiroga-Vukobrat N (2008) Zaštita osobnih podataka pacijenata u europskom i hrvatskom pravu. Zb Prav fak Sveuč Rij 29(1):371–411
Eecke P, Craig C, Halpert J (2012) The first insight into the European Commission’s proposal to a new European Union data protection law. J Internet law 15(8):19–22, http://www.dlapiper.com/first-insight-into-the-ec-proposal-for-a-new-eu-data-protection-law/. Accessed 10 Jun 2013
European Commission (2010) Workshop report: Personalised Medicine: Opportunities and Challenges for European Healthcare, 13th European Health Forum Gastein
European Commission (2011) Conference Report: European Perspectives in Personalised Medicine, 12–13 May 2011. http://ec.europa.eu/research/health/pdf/personalised-medicine-conference-report_en.pdf. Accessed 12 Dec 2014
European Commission (2012a) Proposal for a regulation of the European Parliament and of the Council on the protection of individuals with regards to the processing of personal data and on the free movement of such data (General Data Protection Regulation) COM(2012) 11 of 25.01.2012
European Commission (2012b) Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices, COM(2012) 541 final, Brussels, 26.9.2012
European Commission (2013) Staff Working Document: Use of ‘-omics’ technologies in the development of personalised medicine, SWD(2013) 436 final, Brussels, 25.10.2013
Feuerstein G, Kollek R, Uhlemann T (2002) Gentechnik und Krankenversicherung: Neue Leistungsangebote im Gesundheitssystem. Nomos, Baden-Baden
German Academy of Sciences Leopoldina et al. (2010) Statement: predictive genetic diagnostics as an instrument of disease prevention. http://www.leopoldina.org/uploads/tx_leopublication/201011_natEmpf_praedikative-EN_01.pdf. Accessed 13 Nov 2014
Gilbert F (2012) Proposed EU data protection regulation: the good, the bad and the unknown. Internet Law J 15(1)
Hatzopoulos (2009) Financing national health care in a transnational environment: the impact of the European Community internal market. Wisconsin Int Law J 26(3):761–803
Institute of Medicine of the National Academies (2009) Report Brief, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research. https://www.iom.edu/~/media/Files/Report%20Files/2009/Beyond-the-HIPAA-Privacy-Rule-Enhancing-Privacy-Improving-Health-Through-Research/HIPAA%20report%20brief%20FINAL.pdf. Accessed 25 Nov 2014
Juengst ET (1995) “Prevention” and the goals of genetic medicine. Hum Gene Ther 6(12):1595–1605
Khoury MJ, Burke W, Thomson EJ (eds) (2000) Public health in the 21st century. Oxford University Press, Oxford
Kingreen T (2003) Das Sozialstaatsprinzip im europäischen Verfassungsverbund. Mohr Siebeck, Tübingen
Kollek R et al (2004) Pharmakogenetik: Implikationen für Patienten und Gesundheitswesen, Anspruch und Wirklichkeit der „individualisierten Medizin“. Nomos, Baden-Baden
Kroemer HK (2012) Personalisierte Medizin – zum Stand der Forschung. In: Personalisierte Medizin – der Patient als Nutznießer oder Opfer, Tagungsdokumentation, Jahrestagung des Deutschen Ethikrates, pp 11–21
Li C (2011) Personalized medicine-the promised land: are we there yet? Clin Genet 79:403–412
Marchant GE, Milligan RJ, Wilhelmi B (2006) Legal pressures and incentives for personalized medicine. Pers Med 3(4):391–397
Martinović A (2014) Europäisierung der nationalen Gesundheitssysteme: Zwischen Solidarität, Binnenmarkt und Wettbewerb – kroatische Erfahrungen, Erwartungen und Perspektiven. Dissertation, Karl-Franzens-Universität Graz.
Müller H (2012) Patientennutzen um jeden Preis? In: Personalisierte Medizin – der Patient als Nutznießer oder Opfer, Tagungsdokumentation, Jahrestagung des Deutschen Ethikrates, pp 39–57
National Academy of Sciences (2009) A new biology for the 21st century. http://www.nap.edu/download.php?record_id=12764#. Accessed 13 Jan 2015
Niederlag W, Lemke HU, Rienhoff O (2010) Personalisierte Medizin und individuelle Gesundheitsversorgung. Bundesgesundheitsbl 53:776–782
Nordgren A (2001) Responsible genetics. The moral responsibility of geneticists for the consequences of human genetic research. Kluwer, Dordrecht
Pavelić K, Martinović T, Kraljević-Pavelić S (2015) Do we understand the personalized medicine paradigm? EMBO Rep 16(2):133–136
Personalized Medicine Coalition (2014) The case for personalized medicine, 4th edn. http://www.personalizedmedicinecoalition.org/communications/theCaseforPersonalizedMedicine-11-13.pdf. Accessed 12 Feb 2015
Qattan M, Demonacos C, Krstic-Demonacos M (2012) Roadmap to personalized medicine. Croat Med J 53:294–297
Radder JE, Shapiro SD, Berndt A (2014) Personalized medicine for chronic, complex diseases: chronic obstructive pulmonary disease as an example. Pers Med 11(7):669–679
Radolović A (2006) Pravo osobnosti u novom Zakonu o obveznim odnosima. Zb Prav fak Sveuč Rij 27(1):129–170
Raspe H (2012) Personalisierte Medizin – Ende der Solidarität. In: Personalisierte Medizin – der Patient als Nutznießer oder Opfer, Tagungsdokumentation, Jahrestagung des Deutschen Ethikrates, pp 59–70
Regulation EU No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158 of 27.05.2014
Rugnetta M, Kramer W (2009) Paving the way for personalized medicine: facilitating inter-agency coordination for the integration science progress. www.scienceprogress.org/2009/09/personalized-medicine. Accessed 8 Nov 2014
Taupitz J (2011) Individualisierte Medizin: die internationalrechtliche Perspektive. In: Schumpelick V, Vogel B (eds) Medizin nach Maß. Individualisierte Medizin – Wunsch und Wirklichkeit. Herder, Freiburg, pp 219–238
The American Recovery and Reinvestment Act of 2009, Pub.L. 111–5; 123 Stat. 115
The Americans with Disabilities Act, Pub.L. 101–336, 104 Stat. 327
The Electronic Communication Privacy Act of 1986, 18 U.S.C. §2510-2521, 2701–2710
The Genetic Information Nondiscrimination Act of 2008, Pub.L. 110–233, 122 Stat. 881
The Health Insurance Portability and Accountability Act, Pub.L. 104–191; 110 Stat. 1936
The Privacy Act of 1974, 5 U.S.C. §552a
The Royal Society and the Royal Academy of Engineering (2004) Nanoscience and nanotechnologies: opportunities and uncertainties. https://royalsociety.org/~/media/Royal_Society_Content/policy/publications/2004/9693.pdf. Accessed 10 Nov 2014
U.S. Food and Drug Administration (2007a) Draft Guidance for Industry, Clinical Laboratories, and FDA Staff – In Vitro Diagnostic Multivariate Index Assays, http://www.fda.gov/RegulatoryInformation/Guidances/ucm079148.htm. Accessed 10 Dec 2014
U.S. Food and Drug Administration (2007b) Guidance for Industry and FDA Staff – Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions. http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm078423.htm. Accessed 10 Dec 2014
United Nations (2000) Millennium development goals. www.un.org/millenniumgoals/. Accessed 13 May 2014
Vogenberg FR, Isaacson Barash C, Pursel M (2010a) Personalized medicine. Part 2: Ethical, legal and regulatory issues. P T 35(11):624–642
Vogenberg FR, Isaacson Barash C, Pursel M (2010b) Personalized medicine. Part 3: Challenges facing health care plans in implementing coverage policies for pharmacogenomics and genetic testing. P T 35(12):670–675
Wiese G (2005) Zu einer gesetzlichen Regelung genetischer Untersuchungen im Arbeitsleben. Betriebs-Berater 2073–2083
Wiese G (2009) Gendiagnostikgesetz und Arbeitsleben. Betriebs-Berater 41:2198–2207
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Bodiroga-Vukobrat, N., Horak, H. (2016). Challenges of Personalized Medicine: Socio-Legal Disputes and Possible Solutions. In: Bodiroga-Vukobrat, N., Rukavina, D., Pavelić, K., Sander, G. (eds) Personalized Medicine. Europeanization and Globalization, vol 2. Springer, Cham. https://doi.org/10.1007/978-3-319-39349-0_3
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