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  • EELS (Ethical Economic Legal and Social) Article
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EELS (Ethical, Economic, Legal & Social) Article

Pharmacogenetic research and data protection – challenges and solutions

The Pharmacogenomics Journal volume 6, pages 225–233 (2006)Cite this article

Pharmacogenetic research has been considered a special form of genetics and, therefore, many of the specific ethical, legal and social concerns have been applied to pharmacogenetics accordingly. Consequently, existing guideline documents and legislation on genetics – as well as for biobanking – are also meant to cover pharmacogenetics (e.g. on the international level UNESCO,1 CIOMS,2 European Data Protection Directive,3 CoE Explanatory Memorandum to Recommendation (97) 5,4 Working paper of the section 29 Data Protection Working Party 5 or on the national level ‘Biobanks for Research’ by the German National Ethics Council6). The broad and controversial spectrum of views is reflected in the following citations: The UNESCO paper states: ‘Human genetic data have a special status. Due consideration should be given and where appropriate special protection should be afforded to human genetic data and to biological samples’.1 In clear contrast to this position is the report of the Nuffield Council on Bioethics: ‘Given the similarities between genetic and other forms of personal information, it would be a mistake to assume that genetic information is qualitatively different in some way’.7

As pointed out by the Nuffield Council (see above) and in our view, a clear distinction between exploratory pharmacogenetics and genetic diagnostic tests can be drawn, however, once exploratory analyses led to a reliable and validated test for genetic markers for safety or efficacy of drug treatment, their diagnostic value and social and ethical implications may become comparably important to the patient. Therefore, the main question should possibly be if genetic data including pharmacogenetics deserve special consideration at all or whether the focus should be on the informational risk the data pose rather than on their source.

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References

  1. UNESCO International Bioethics Committee. DRAFT International Declaration on human genetic data, Addendum 2, 8.10. 2003.

  2. Council of International Organizations of Medical Sciences (CIOMS) in colloaboration with the World Health Organization (WHO). International Ethical Guidelines for Biomedical Research Involving Human Subjects, 2002.

  3. European Parliament and Council:. European Parliament and Council: Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data. Official Journal L281, 23/11/1995, 31–50.

  4. Explanatory Memorandum to Recommendation No. R (97) of the Committee of Ministers to Member States, Adopted by the Committee of Ministers on February 13, 1997. Available at: http://cm.coe.int/ta/rec/1997/ExpRec(97)18htm.

  5. Article 29 data protection working party, 1 August 2003 12168//02/EN WP 80 available under: http://www.statewatch.org/news/2004/feb/biometric-wp80_en.pdf.

  6. German National Ethics Council, Biobanks for Research, 2004; Available under http://www.ethikrat.org.

  7. Nuffield Council on Bioethics. Pharmacogenetics ethical issues 2003.

  8. EMEA. Position Paper on Terminology in Pharmacogenetics, 21.November, 2002 (EMEA/CPMP/3070/01).

  9. Unabhängiges Landeszentrum für Datenschutz Schleswig-Holstein: brief report on the data protection audit data processing infrastructure concept of the Schering corporation for the secure pseudonym storage and keeping of blood and tissue samples intended for genetic analyses. Available under: http://www.datenschutzzentrum.de/audit/kurzgutachten/a0303/a0303_engl.htm.

  10. ICH Topic E6. Guideline for Good Clinical Practice, CPMP/ICH/135/95 1997.

  11. FDA. Department of Health and Human Services, 21 CFR Part 11 1997.

  12. Luttenberger N Data protection concept for the ‘Sample and Save’ Part of the GENOMatch Project at Schering AG, Ver. 2.0 (available upon request).

  13. Renegar G, Webster CJ, Stürzebecher S, Harty L, Ide SE, Balkite B et al. Returning genetic research results to individuals: points-to-consider. Bioethics 2006; 20: 24–36.

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Acknowledgements

We thank Dr B Müller (Schering AG) and Professor Lutterbeck (TU Berlin) for his valuable advice and continuous support of the project.

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Authors and Affiliations

  1. Schering AG, Global Pharmacogenomics, Berlin, Germany

    J Reischl, R Ternes & S Stürzebecher

  2. TEMBIT Software GmbH, Berlin, Germany

    M Schröder & D Petrov

  3. Christian Albrecht Universität, Institut für Informatik, Kiel, Germany

    N Luttenberger & B Schümann

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  1. J Reischl
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  2. M Schröder
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Correspondence to S Stürzebecher.

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Reischl, J., Schröder, M., Luttenberger, N. et al. Pharmacogenetic research and data protection – challenges and solutions. Pharmacogenomics J 6, 225–233 (2006). https://doi.org/10.1038/sj.tpj.6500372

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