Skip to main content
SpringerLink
Log in

Legal Aspects of Personalized Medicine

  • Chapter
  • First Online:
Personalized Medicine

Part of the book series: Europeanization and Globalization ((EAG,volume 2))

Abstract

Personalized medicine (PM) aims at improving the efficiency of medical measures by determining the health care measure on the basis of the patient’s biological information. It can be applied in the preventive field, as well as within the framework of medical therapies. A combination of diagnostics and therapies represents the main scope of PM in today’s health care systems, especially regarding cancer treatment. In this sense, PM allows to tailor the treatment according to the genetic information of the patient.

PM gives rise to a number of legal questions. First, personalized diagnostics and pharmaceuticals face difficulties in accessing the market and the health care systems under the current conditions, as these do not take into account the special features of the individualized health care approach. Second, the issue of data protection deserves particular attention, concerning the right to privacy of the patient and his or her relatives, as well as the collection and use of data for research purposes.

Professor Ulrich Becker, Ph.D. LL.M. Director of Max Planck Institute for Social Law and Social Policy, Munich, Germany.

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 84.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 109.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 109.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Notes

  1. 1.

    See the final report: Individualised Health Care: Ethical, Economic and Legal Implications for the German Health Care System, Subproject C “LAW.” Available at: http://opac.tib.uni-hannover.de/DB=1/LNG=DU/.

  2. 2.

    Schleidgen et al. (2013). The concept of Personalised Medicine varies broadly; see, for example, FDA, Paving the Way for Personalized Medicine, 2013. Available at: http://www.fda.gov/scienceresearch/specialtopics/personalizedmedicine/default.htm, p. 7.

  3. 3.

    See also for the term individualised medicine Fischer et al. (2014), Grabe et al. (2014), and Ma and Lu (2011).

  4. 4.

    Wöhlke et al. (2013), p. 25, Nekhlyudov et al. (2014), Ullrich et al. (2014), Alvarado et al. (2014), and Denford et al. (2014).

  5. 5.

    Although the US American FDA states that “the era of personalized medicine has clearly arrived”; see FDA, Paving the Way for Personalized Medicine (footnote 2), p. 54.

  6. 6.

    So Bernhard Stewart, one of the editors of the World Cancer Report 2014. Available at: http://www.iarc.fr/en/publications/books/wcr/wcr-order.php.

  7. 7.

    Published: August 5, 2009. Available at: http://www.nytimes.com/2009/08/06/opinion/06watson.html?pagewanted=all&_r=0.

  8. 8.

    Mehta et al. (2011), pp. 20–26.

  9. 9.

    Available at: http://ec.europa.eu/health/files/eudralex/vol-1/reg_1993_2309/reg_1993_2309_en.pdf.

  10. 10.

    Available at: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf.

  11. 11.

    Available at: http://ec.europa.eu/enterprise/sectors/healthcare/competitiveness/pricing-reimbursement/transparency/index_en.htm.

  12. 12.

    AMG of 12.12.2005 (BGBl. I, p. 3364).

  13. 13.

    §§ 21 et seq. of Pharmaceutical Act (Arzneimittelgesetz): the marketing authorization shall only be refused if documents provided by the applicant are not in accordance with § 25 par. 2 AMG; for the centralized procedure, see Regulation (EC) No. 726/2004. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2004R0726:20120702:EN:PDF.

  14. 14.

    § 31 par. 1 s. 1 of Social Code (Sozialgesetzbuch) V.

  15. 15.

    See for more details German Federal Social Court (Bundessozialgericht), Dec. of 28.2.2008, B 1 KR 16/07 R, and Dec. of 3.7.2012, B 1 KR 23/11 R (www.juris.de).

  16. 16.

    § 35a of Social Code (Sozialgesetzbuch) V.

  17. 17.

    Huster and Gottwald (2013), pp. 16 et seq.

  18. 18.

    FDA, Paving the Way for Personalized Medicine (footnote 2), pp. 32/33.

  19. 19.

    Sawyers and van’t Veer (2014), Waltz (2014), and Noweski et al. (2013). See also the nonbinding recommendations of the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, In Vitro Companion Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff of 6.8.2014. Available at: http://www.fda.gov/ScienceResearch/SpecialTopics/PersonalizedMedicine/ucm372544.htm.

  20. 20.

    COM(2012) 541 fin.

  21. 21.

    See Art. 2 (6) of the Draft: “companion diagnostic means a device specifically intended to select patients with a previously diagnosed condition or predisposition as eligible for a targeted therapy.”

  22. 22.

    Prasad (2013), Smith (2014), and Greenhalgh et al. (2014).

  23. 23.

    Hardenberg and Wilman (2013), p. 79.

  24. 24.

    Bericht des Ausschusses für Bildung, Forschung und Technikfolgenabschätzung v. 17.2.2009, BT-Drs. 16/12000, p. 153, Hardenberg (2014), p. 115.

  25. 25.

    See, e.g., for Switzerland the Human Genetic Testing Act (Bundesgesetz über genetische Untersuchungen beim Menschen—GUMG) of 8.10.2004 and the Regulation on Human Genetic Testing (Verordnung über genetische Untersuchungen beim Menschen—GUMV) of 14.2.2007; for Austria the Genetic Engineering Act (Gentechnikgesetz—GTG) of 1.1.1995.

  26. 26.

    See for Germany § 3 of Genetic Diagnostic Act (Gendiagnostikgesetz).

  27. 27.

    The case study is not yet published.

  28. 28.

    The answer is, presumably in all jurisdictions, clearly no, but it might come under discussion in the future (see §§ 8, 9 of Genetic Diagnostic Act for the current legal situation in Germany).

  29. 29.

    Again, under the existing rules in most countries, and especially in Germany, this possibility has to be denied; see §§ 10 par. 3 s. 4, 11 par. 3 of Genetic Diagnostic Act and for more details, e.g., Wollenschläger (2013), p. 161.

  30. 30.

    Chadwick et al. (2014), Juth, (2014), pp. 38–52.

  31. 31.

    Legally protected under Art. 13 ECHR.

  32. 32.

    Legally protected under Art. 8 ECHR; see for example CJEU, Case C-131/12 Google Spain, Judgment of 13.5.2014, ECLI:EU:C:2014:317; CJEU, Case C-291/12 Schwarz, Judgment of 17.10.2013, ECLI:EU:C:2013:670.

  33. 33.

    Revermann and Sauter (2006). Available at: https://www.tab-beim-bundestag.de/en/publications/reports/ab112.html.

References

  • Alvarado MD et al (2014) Patient preferences regarding intraoperative versus external beam radiotherapy following breast-conserving surgery. Breast Cancer Res Treat 143:135–140. doi:10.1007/s10549-013-2782-9

    Article  Google Scholar 

  • Chadwick R, Levitt M, Shickle D (2014) The right to know and the right not to know. Genetic privacy and responsibility, 2nd edn. Cambridge University Press, Cambridge

    Book  Google Scholar 

  • Denford S, Frost J, Dieppe P, Cooper C, Britten N (2014) Individualisation of drug treatments for patients with long-term conditions: a review of concepts. BMJ Open 2014:4. doi:10.1136/bmjopen-2013-004172

    Google Scholar 

  • Fischer T et al (2014) Individualized medicine – ethical, economical and historical perspectives. EPMA J 5(Suppl 1):A17

    Article  Google Scholar 

  • Grabe HJ et al (2014) Cohort profile: Greifswald approach to individualized medicine (GANI_MED). J Transl Med 12:144. doi:10.1186/1479-5876-12-144

    Article  Google Scholar 

  • Greenhalgh T, Howick J, Maskrey N (2014) Evidence based medicine: a movement in crisis? BMJ 348:g3725. doi:10.1136/bmj.g3725

    Article  Google Scholar 

  • Hardenberg S (2014) Genetische Gesundheitsdaten in der Individualisierten Medizin. ZD 2014(3):115–118

    Google Scholar 

  • Hardenberg S, Wilman N (2013) Individualisierte Medizin als Exklusiv-Medizin? MedR 31(2):77–81

    Article  Google Scholar 

  • Huster S, Gottwald S (2013) Die Vergütung genetischer Diagnostik in der Gesetzlichen Krankenversicherung. Nomos, Baden-Baden

    Book  Google Scholar 

  • Juth N (2014) The right not to know and the duty to tell: the case of relatives. J Law Med Ethics 42(1):38–52. doi:10.1111/jlme.12117

    Article  Google Scholar 

  • Ma Q, Lu AY (2011) Pharmacogenetics, pharmacogenomics, and individualized medicine. Pharmacol Rev 63(2):437–459. doi:10.1124/pr.110.003533

    Article  Google Scholar 

  • Mehta R, Jain RK, Badve S (2011) Personalized medicine: the road ahead. Clin Breast Cancer 11(1):20–26. doi:10.3816/CBC.2011.n.004

    Article  Google Scholar 

  • Nekhlyudov L, Levit L, Hurria A, Ganz PA (2014) Patient-centered, evidence-based and cost-conscious cancer care across the continuum: translating the institute of medicine report into clinical practice. CA Cancer J Clin 64(6):408–421. doi:10.3322/caac.21249

    Article  Google Scholar 

  • Noweski M et al (2013) Zulassung und Erstattung personalisierter Arzneimittel: Zwischenbilanz und Anpassungsprozess. Ethik Med 25:277–284. doi:10.1007/s00481-013-0270-8

    Article  Google Scholar 

  • Prasad K (2013) Fundamentals of evidence-based medicine, 2nd edn. Springer India

    Google Scholar 

  • Revermann C, Sauter A (2006) Biobanks for human medical research and application. TAB report no. 112. https://www.tab-beim-bundestag.de/en/publications/reports/ab112.html

  • Sawyers CL, van’t Veer LJ (2014) Reliable and effective diagnostics are keys to accelerating personalized cancer medicine and transforming cancer care: a policy statement from the American Association for Cancer Research. Clin Cancer Res 20:4978–81. doi:10.1158/1078-0432.CCR-14-2295

    Article  Google Scholar 

  • Schleidgen S, Klingler C, Bertram T, Rogowski WH, Marckmann G (2013) What is personalized medicine: sharpening a vague term based on a systematic literature review. BMC Med Ethics 14:55. doi:10.1186/1472-6939-14-55

    Article  Google Scholar 

  • Smith R (2014) Evidence-based-medicine – an oral history. JAMA 311(4):365–367. doi:10.1001/jama.2013.286182

    Article  Google Scholar 

  • Ullrich A, Hauer J, Farin E (2014) Communication preferences in patients with fibromyalgia syndrome: descriptive results and patient characteristics as predictors. Patient Prefer Adherence 2014(8):135–145

    Article  Google Scholar 

  • Waltz E (2014) FDA tows personalized line. Nat Biotechnol 32(10). doi:10.1038/nbt0114-10b

    Google Scholar 

  • Wöhlke S, Heßling A, Schicktanz S (2013) Wenn es persönlich wird in der “personalisierten Medizin”: Aufklärung und Kommunikation aus klinischer Forscher- und Patientenperspektive im empirisch-ethischen Vergleich. Ethik Med 25:215–222. doi:10.1007/s00481-013-0263-7

    Article  Google Scholar 

  • Wollenschläger F (2013) Der Drittbezug prädiktiver Gendiagnostik im Spannungsfeld der Grundrechte auf Wissen, Nichtwissen und Geheimhaltung. AöR 138:161–203

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Max Planck Institute for Social Law and Social Policy, Munich, Germany

    Ulrich Becker Ph.D.

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

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Ulrich Becker Ph.D. .

Editor information

Editors and Affiliations

  1. Jean Monnet Department of European Public Law, University of Rijeka, Rijeka, Croatia

    Nada Bodiroga-Vukobrat

  2. Croatian Academy of Sciences and Arts, Rijeka, Croatia

    Daniel Rukavina

  3. Department of Biotechnology, University of Rijeka , Rijeka, Croatia

    Krešimir Pavelić

  4. University of Applied Sciences, Hochschule für öffentliche Verwaltung und Finanzen Ludwigsburg, Ludwigsburg, Germany

    Gerald G. Sander

Rights and permissions

Reprints and permissions

Copyright information

© 2016 Springer International Publishing Switzerland

About this chapter

Cite this chapter

Becker, U. (2016). Legal Aspects of Personalized Medicine. 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_2

Download citation

  • DOI: https://doi.org/10.1007/978-3-319-39349-0_2

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-39347-6

  • Online ISBN: 978-3-319-39349-0

  • eBook Packages: Law and CriminologyLaw and Criminology (R0)

Publish with us

Policies and ethics

Search

Navigation