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Differences in Regulatory Frameworks Governing Genetic Laboratories in Four Countries

Published online by Cambridge University Press:  01 January 2021

Anne Marie Tassé ,
Élodie Petit  and
Béatrice Godard
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Extract

A recent Organisation for Economic Co-Operation and Development (OECD) survey demonstrated that an internationalization of genetic laboratory services currently emerged from the rarity of certain genetic abnormalities and from the small of laboratories performing specialized testing. When DNA samples cross national boundaries for genetic testing services to be performed in another country, the heterogeneity of national legal frameworks raises important questions regarding quality of genetic services available internationally.

Some aspects of the genetic laboratories’ services are abundantly discussed by the literature, among which most prominent are quality control standards and patients rights. Firstly, a 2003 study identified key distinctions between the different legal frameworks for genetic services. While some countries impose exhaustive regulatory requirements, others favor guidelines for good practices. Moreover, proficiency assessment, clinical validity, retention of laboratory records and test reports are not dealt with uniformly.

Type
Independent
Information
Journal of Law, Medicine & Ethics , Volume 37 , Issue 2 , Summer 2009 , pp. 351 - 357
Copyright
Copyright © American Society of Law, Medicine and Ethics 2009

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References

OECD Biotechnology Division, Quality Assurance and Proficiency Testing for Molecular Genetic Testing: Summary Results of a Survey of 18 OECD Member Countries (Paris: OECD, 2005).Google Scholar
Id., at 12.Google Scholar
Secretary's Advisory Committee on Genetics, Health, and Society, U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of Health and Human Services (Bethesda: Department of Health and Human Services, 2008): at 72.Google Scholar
Cox, S. M., Faucett, W. A. and Chen, B. et al., “International Genetic Testing,” Genetics in Medicine 5, no. 3 (2003): 176–182.CrossRefGoogle Scholar
Id.Google Scholar
Id.Google Scholar
International Organization for Standardization and International Electrotechnical Commission, General Requirements for the Competence of Testing and Calibration Laboratories (Geneva: ISO, 2005).Google Scholar
International Organization for Standardization and International Electrotechnical Commission, Medical Laboratories – Particular Requirements for Quality and Competence (Geneva: ISO, 2007).Google Scholar
OECD Biotechnology Division, OECD Guidelines for Quality Assurance in Molecular Genetic Testing (Paris: OECD, 2007).Google Scholar
Australian Government – Attorney-General's Department, COMLAW Commonwealth of Australia Law, available at <http://www.comlaw.gov.au> (last visited April 5, 2009). (last visited April 5, 2009).' href=https://scholar.google.com/scholar?q=Australian+Government+–+Attorney-General's+Department,+COMLAW+Commonwealth+of+Australia+Law,+available+at++(last+visited+April+5,+2009).>Google Scholar
République Française, Le Service Public de la Diffusion du Droit, available at <http://www.legifrance.gouv.fr> (last visited April 5, 2009).+(last+visited+April+5,+2009).>Google Scholar
National Archives, Office of Public Sector Information (OPSI), available at <http://www.opsi.gov.uk> (last visited April 5, 2009).+(last+visited+April+5,+2009).>Google Scholar
U.S. Government, USA.Gov – Government Made Easy, available at <http://www.usa.gov/Topics/Reference_Shelf/Laws.shtml> (last visited April 5, 2009).+(last+visited+April+5,+2009).>Google Scholar
NCBI: National Center for Biotechnology Information, available at <http://www.ncbi.nlm.nih.gov> (last visited April 5, 2009).+(last+visited+April+5,+2009).>Google Scholar
Constantinesco, L. J., Traité de Droit Comparé (Paris: Economica, 1983).Google Scholar
Health Insurance Act 1973, Act No. 42 of 1974, as amended.Google Scholar
Health Insurance (Accredited Pathology Laboratories – Approval) Principles (2002), HS/11/2002 made under subsection 23DNA(1) of Health Insurance Act 1973; Memorandum of Understanding between the Commonwealth of Australia and the National Association of Testing Authorities, Australia, ABN 59 004 379 748, February 14th 2003.Google Scholar
Australian Government, National Pathology Accreditation Advisory Council, Standards for Pathology Laboratory (Canberra: Publications Production Unit, 2002).Google Scholar
Australian Government, National Pathology Accreditation Advisory Council, Laboratory Accreditation Standards and Guidelines for Nucleic Acid Detection Techniques (Canberra: Publications Production Unit, 2000).Google Scholar
Australian Government, National Pathology Accreditation Advisory Council, Guidelines for Cytogenetics Laboratories (Canberra: Publications Production Unit, 2001).Google Scholar
Code civil, § 16–10; Code de la santé publique, § L.2131–1 to L.2131–5, L.6211–2, R.1131–2; Arrêté du 11 décembre 2000 fixant la liste des analyses de biologie médicale ayant pour object de détecter les anomalies génétiques impliquées dans l'apparition éventuelle de la maladie recherchée pour les personnes asymptomatiques, J. O. December 16, 2000, at 20028.Google Scholar
See Code de la santé publique, supra note 21, § R.1131–13.Google Scholar
Id., § R.1131–11.Google Scholar
Id., § R.1131–6.Google Scholar
Loi de bioéthique de 2004 (Loi n 2004–800 du 6 août 2004 relative à la bioéthique, J. O. August 7, 2004, at 14040).Google Scholar
See Code de la santé publique, supra note 21, § L.1131–3.Google Scholar
Circulaire DHOS/04/DGS/SD 2 B no 2005–33 du 13 janvier 2005 relative à l'application de l'article 38 de la loi no 2004–800 du 6 août 2004 relative à la bioéthique.Google Scholar
See Code de la santé publique, supra note 21, § R.1131–17.Google Scholar
Guide de bonne exécution des analyses de biologie médicale, arrêté du 26 novembre 1999 relatif à la bonne exécution des analyses de biologie médicale modifiée par l'arrêté du 26 avril 2002, J.O. 11 décembre 1999.CrossRefGoogle Scholar
Deschênes, M., Réflexion sur L'encadrement Normatif de la Mise en Marché des Tests Génétiques (Montréal: Thémis, 2005).Google Scholar
National Health Service, National Library for Health, Clinical Genetics Specialist Library, available at <http://www.library.nhs.uk/genepool> (last visited April 5, 2009).+(last+visited+April+5,+2009).>Google Scholar
Expert Working Group Chaired by Professor Martin Bobrow, Laboratory Services for Genetics: Report of an Expert Working Group to the NHS Executive and the Human Genetics Commission (London: Crown, 2000) available at <http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4118936> (last visited April 5, 2009).+(last+visited+April+5,+2009).>Google Scholar
Department of Health, Our Inheritance, Our Future: Realising the Potential of Genetics in the NHS (Norwich: The Stationary Office, 2003).Google Scholar
Clinical Pathology Accreditation (U.K.), The Conduct of CPA (U.K.) Ltd Medical Laboratory Assessments, 3rd ed. (Sheffield: Clinical Pathology Accreditation (UK) Ltd., 2005).Google Scholar
Id., at 4.Google Scholar
UK NEQA-S, Genetics, available at <http://www.ukneqas.org.uk/Directory/serv07.htm> (last visited January 10, 2007).+(last+visited+January+10,+2007).>Google Scholar
Public Health Service Act, 42 U.S.C., chapter 6A, subchapter II, Part F, subpart 2.Google Scholar
Clinical Laboratory Improvement Amendments of 1988 (CLIA), Pub. L. No. 100–578, 102 Stat. 2903; 42 U.S.C. § 263.Google Scholar
Id.: § 263, 263 (a)(d)(1)(B)(i)(ii).Google Scholar
Centers for Medicare & Medicaid Services, List of Accreditation Organization, available at <http://www.cms.hhs.gov/CLIA/downloads/AO.List.pdf> (last visited April 5, 2009).+(last+visited+April+5,+2009).>Google Scholar
Laboratory Requirements, 42 C.F.R. § 493.17.Google Scholar
Hudson, K. L., Murphy, J. A. and Kaufman, D. J. et al., “Oversight of US Genetic Testing Laboratories,” Nature Biotechnology 24, no. 9 (2006): 1083–1090.CrossRefGoogle Scholar
Centers for Medicare & Medicaid Services, List of Exempt States, available at <http://www.cms.hhs.gov/CLIA/downloads/Exempt.States.List.pdf> (last visited April 5, 2009).+(last+visited+April+5,+2009).>Google Scholar
See OECD Biotechnology Division, supra note 9, at 24.Google Scholar
Id., at 25.Google Scholar
See Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2002, supra note 17.Google Scholar
See Code de la santé publique, supra note 21, § L.6213–3; Guide de bonne exécution des analyses de biologie médicale, supra note 29.Google Scholar
See Department of Health, supra note 33.Google Scholar
See Clinical Laboratory Improvement Amendments of 1988 (CLIA), supra note 38; Laboratory Requirements, supra note 41.Google Scholar
See Australian Government, National Pathology Accreditation Advisory Council, supra note 19; Australian Government, National Pathology Accreditation Advisory Council, supra note 20.Google Scholar
See Guide de Bonne Exécution des Analyses de Biologie Médicale, supra note 29.Google Scholar
Agence Française de Sécurité Sanitaire des Produits de Santé: Calendrier et Programme des Opérations 2008, avaliable at <http://agmed.sante.gouv.fr/htm/10/cnq/data2008/cal2008.htm> (last visited April 5, 2009).+(last+visited+April+5,+2009).>Google Scholar
See Guide de Bonne Exécution des Analyses de Biologie Médicale, supra note 29, § V. 2.2.Google Scholar
See Clinical Pathology Accreditation (UK), supra note 34.Google Scholar
See NEQAS, U.K., supra note 36.Google Scholar
See Hudson, , Murphy, and Kaufman, et al., supra note 42.Google Scholar
Id.Google Scholar
See OECD Biotechnology Division, supra note 9, at 25.Google Scholar
National Health Act 1953, Act No. 95 of 1953 as amended, prepared by the Office of Legislative Drafting and Publishing, Attorney-General's Department, Canberra.Google Scholar
See Clinical Laboratory Improvement Amendments of 1988 (CLIA), supra note 38.Google Scholar
See Code de la Santé Publique, supra note 21.Google Scholar