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.
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Notes
- 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.
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.
- 4.
- 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.
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.
Published: August 5, 2009. Available at: http://www.nytimes.com/2009/08/06/opinion/06watson.html?pagewanted=all&_r=0.
- 8.
Mehta et al. (2011), pp. 20–26.
- 9.
- 10.
- 11.
- 12.
AMG of 12.12.2005 (BGBl. I, p. 3364).
- 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.
§ 31 par. 1 s. 1 of Social Code (Sozialgesetzbuch) V.
- 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.
§ 35a of Social Code (Sozialgesetzbuch) V.
- 17.
Huster and Gottwald (2013), pp. 16 et seq.
- 18.
FDA, Paving the Way for Personalized Medicine (footnote 2), pp. 32/33.
- 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.
COM(2012) 541 fin.
- 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.
- 23.
Hardenberg and Wilman (2013), p. 79.
- 24.
Bericht des Ausschusses für Bildung, Forschung und Technikfolgenabschätzung v. 17.2.2009, BT-Drs. 16/12000, p. 153, Hardenberg (2014), p. 115.
- 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.
See for Germany § 3 of Genetic Diagnostic Act (Gendiagnostikgesetz).
- 27.
The case study is not yet published.
- 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.
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.
- 31.
Legally protected under Art. 13 ECHR.
- 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.
Revermann and Sauter (2006). Available at: https://www.tab-beim-bundestag.de/en/publications/reports/ab112.html.
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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
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