Harmonizing EU Health Legislation for New Genomic Techniques

Resumen

Este artículo examina la regulación y aplicación de las Nuevas Técnicas Genómicas (NTG) y las pruebas genéticas en la Unión Europea (UE). Analiza los aspectos detallados de las leyes de protección de datos de la UE, subrayando su importancia para salvaguardar la privacidad de los pacientes y facilitar el intercambio de datos en los sectores de la atención sanitaria y la investigación. El artículo profundiza en las dimensiones éticas y los avances tecnológicos de la ingeniería genética, centrándose específicamente en la edición de genes y las pruebas genéticas directas al consumidor, iluminando la compleja interacción entre la tecnología, la ética y los marcos jurídicos. El análisis se extiende a los diversos entornos normativos, tanto a escala nacional como de la UE, y pone de relieve la necesidad urgente de actualizar la legislación en respuesta a los rápidos avances de las tecnologías genómicas. Esta necesidad acentúa el reto permanente de encontrar un equilibrio entre el fomento de la innovación y el respeto de las normas éticas y jurídicas. Por otra parte, el
texto aborda los esfuerzos por armonizar la normativa sobre pruebas genéticas en todos los países europeos,
teniendo en cuenta las perspectivas de las múltiples partes interesadas. El discurso presentado subraya la complejidad y la importancia crítica de formular políticas que salvaguarden los intereses públicos e impulsen los avances científicos en este ámbito que está en rápida evolución. La UE debería mejorar la regulación y la normalización de los NTG en el ámbito de la salud humana y la medicina actualizando la legislación, aplicando protocolos de evaluación de riesgos y seguridad, estableciendo directrices éticas, implicando a las distintas partes interesadas, respetando las normas mundiales, fomentando la educación pública e integrando los NTG en los sistemas sanitarios, con el fin último de promover un desarrollo seguro y ético de estos y avanzar en los objetivos de salud pública.

Palabras clave:

NTG nuevas técnicas genómicas legislación Unión Europea

Citas

Akram, Fatima, Ikram ul Haq, Sania Sahreen, et al. “RETRACTED: CRISPR/Cas9: A Revolutionary Genome Editing Tool for Human Cancers Treatment.” Technology in Cancer Research & Treatment 21 (2022): 153303382211320. https://doi.org/10.1177/15330338221132078.

Amram, Denise. “Building up the ‘Accountable Ulysses’ Model. The Impact of GDPR and National Implementations, Ethics, and Health-Data Research: Comparative Remarks.” Computer Law and Security Review 37 (2020): 1054139. https://doi.org/10.1016/j.clsr.2020.105413.

Auffray, Charles, Rudi Balling, Inês Barroso, et al. “Making Sense of Big Data in Health Research: Towards an EU Action Plan.” Genome Medicine 8, no. 1 (2016). https://doi.org/10.1186/s13073-016-0323-y.

Barman, Antara, Bornali Deb, and Supriyo Chakraborty. “A Glance at Genome Editing with CRISPR–Cas9 Technology.” Current Genetics 66, no. 3 (2019): 447–462.

https://doi.org/10.1007/s00294-019-01040-3.

Bonomi, Luca, Yingxiang Huang, and Lucila Ohno-Machado. “Privacy Challenges and Research Opportunities for Genomic Data Sharing.” Nature Genetics 52, no. 7 (2020): 646–654. https://doi.org/10.1038/s41588-020-0651-0.

Borry, Pascal, Heidi Beate Bentzen, Isabelle Budin-Ljøsne, et al. “The Challenges of the Expanded Availability of Genomic Information: An Agenda-Setting Paper.” Journal of Community Genetics 20, no. 1 (2012): 103–116. https://doi.org/10.1007/s12687-017-0331-7

Borry, Pascal, Rachel E van Hellemondt, Dominique Sprumont, et al. “Legislation on Direct-to-Consumer Genetic Testing in Seven European Countries.” European Journal of Human Genetics 20, no. 7 (2012): 715–721. https://doi.org/10.1038/ejhg.2011.278.

Bradford, Laura, Mateo Aboy, and Kathleen Liddell. “International Transfers of Health Data between the EU and USA: A Sector-Specific Approach for the USA to Ensure an ‘Adequate’ Level of Protection.” Journal of Law and the Biosciences 7, no. 1 (2020). https://doi.org/10.1093/jlb/lsaa055.

Canedo, Juan R., Stephania T. Miller, Hector F. Myers, and Maureen Sanderson. “Racial and Ethnic Differences in Knowledge and Attitudes about Genetic Testing in the US: Systematic Review.” Journal of Genetic Counseling 28, no. 3 (2019): 587–601. https://doi.org/10.1002/jgc4.1078.

Cernat, Alexandra, Naazish S. Bashir, and Wendy J. Ungar. “Considerations for Developing Regulations for Direct-to-Consumer Genetic Testing: A Scoping Review Using the 3-I Framework.” Journal of Community Genetics 13, no. 2 (2022): 155–170. https://doi.org/10.1007/s12687-022-00582-3.

Chico, Victoria. “The Impact of the General Data Protection Regulation on Health Research.” British Medical Bulletin 128, no. 1 (2018): 109–118. https://doi.org/10.1093/bmb/ldy038.

Coller, Barry S. “Ethics of Human Genome Editing.” Annual Review of Medicine 70, no. 1 (2019): 289–305. https://doi.org/10.1146/annurev-med-112717-094629

Consumers, Health, Agriculture and Food Executive Agency. Assessment of the EU Member States’ Rules on Health Data in the Light of GDPR. LU: Publications Office, 2021. https://doi.org/10.2818/546193.

Consumers, Health, Agriculture and Food Executive Agency. Assessment of the EU Member States’ Rules on Health Data in the Light of GDPR: Country Fiches for All EU MS. LU: Publications Office, 2021. https://doi.org/10.2818/09448.

Council of Europe. Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data. 1981. https://rm.coe.int/1680078b37.

Cyranoski, David, and Heidi Ledford. “Genome-Edited Baby Claim Provokes International Outcry.” Nature 563, no. 7733 (2018): 607–608.

https://doi.org/10.1038/d41586-018-07545-0.

Demir, Esra. “The Protection of Human Biodata: Is There Any Role for Data Ownership?” Computer Law and Security Review 51 (2023): 105905. https://doi.org/10.1016/j.clsr.2023.105905.

Elangkovan, Nertiyan, and George Dickson. “Gene Therapy for Duchenne Muscular Dystrophy.” Journal of Neuromuscular Diseases 8, no. s2 (2021): 303–316. https://doi.org/10.3233/jnd-210678

ElZarrad, M. Khair, Aaron Y. Lee, Rose Purcell, and Scott J. Steele. “Advancing an Agile Regulatory Ecosystem to Respond to the Rapid Development of Innovative Technologies.” Clinical and Translational Science 15, no. 6 (2022): 1332–1339. https://doi.org/10.1111/cts.13267.

Erdoğan, İbrahim, Birsen Cevher-Keskin, Özlem Bilir, Yiguo Hong, and Mahmut Tör. “Recent Developments in CRISPR/Cas9 Genome-Editing Technology Related to Plant Disease Resistance and Abiotic Stress Tolerance.” Biology 12, no. 7 (2023): 1037. https://doi.org/10.3390/biology12071037.

Eriksson, Dennis, René Custers, Karin Edvardsson Björnberg, et al. “Options to Reform the European Union Legislation on GMOs: Post-Authorization and Beyond.” Trends in Biotechnology 38, no. 5 (2020): 465–647. https://doi.org/10.1016/j.tibtech.2019.12.015.

Eriksson, Dennis, René Custers, Karin Edvardsson Björnberg, et al. “Options to Reform the European Union Legislation on GMOs: Risk Governance.” Trends in Biotechnology 38, no. 4 (2020): 349–351. https://doi.org/10.1016/j.tibtech.2019.12.016.

Eriksson, Dennis, René Custers, Karin Edvardsson Björnberg, et al. “Options to Reform the European Union Legislation on GMOs: Scope and Definitions.” Trends in Biotechnology 38, no. 3 (2020): 231–234. https://doi.org/10.1016/j.tibtech.2019.12.002.

ESHG - European Society of Human Genetics. “Statement of the ESHG on Direct-to-Consumer Genetic Testing for Health-Related Purposes.” European Journal of Human Genetics 18, no. 2 (2010): 1271–1273. https://doi.org/10.1038/ejhg.2010.129

EURACTIVE. “New genomic techniques - what lies ahead?” https://events.euractiv.com/event/info/new-genomic-techniques-what-lies-ahead. Accessed October 25, 2023.

European Commission. “10. April 2018 EU countries will cooperate in linking genomic databases across borders.”

https://digital-strategy.ec.europa.eu/en/news/eu-countries-will-cooperate-linking-genomic-databases-across-borders. Accessed October 28, 2023.

European Commission. “EC study on new genomic techniques. Stakeholders’ consultation.” https://food.ec.europa.eu/plants/genetically-modified-organisms/new-techniques-biotechnology/ec-study-new-genomic-techniques/stakeholders-consultation_en. Accessed November 1, 2023.

European Commission. Commission staff working document. Study on the status of new genomic techniques under Union law and in light of the Court of Justice ruling in Case C-528/16. 2021. https://food.ec.europa.eu/system/files/2021-04/gmo_mod-bio_ngt_eu-study.pdf.

European Commission. Commission staff working document impact assessment report. Brussels, 5.7.2023. Proposal for a regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625. 2023. https://food.ec.europa.eu/system/files/2023-07/gmo_biotech_ngt_ia_report.pdf.

European Commission. Declaration of Cooperation. Towards access to at least 1 million sequenced genomes in the European Union by 2022. 2022. https://ec.europa.eu/newsroom/dae/document.cfm?doc_id=50964.

European Commission. Proposal for a Regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation). Document No.

PC0011, 2012. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A52012PC0011.

European Commission Directorate General for Research And Innovation. European Group on Ethics in Science and New Technologies Opinion on the Ethics of Genome Editing. LU: Publications Office, 2021. https://doi.org/10.2777/659034.

European Parliament. Regulating genome editing: Societal hopes and fears. Study of the Panel for the Future of Science and Technology. EPRS European Parliamentary Research Service, 2021. https://www.europarl.europa.eu/RegData/etudes/STUD/2021/697190/EPRS_STU(2021)697190_EN.pdf.

FDA. U.S. Food and Drug Administration. “Direct-to-Consumer Tests.” https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests. Accessed October 25, 2023.

Gostin, Lawrence O., and James G. Hodge, Jr. “Genetic privacy and the law: an end to genetics exceptionalism.” Jurimetrics 40, no. 1 (1999): 21–58.

Herd, Pamela, and Donald Moynihan. “Health Care Administrative Burdens: Centering Patient Experiences.” Health Services Research 56, no. 5 (2021): 751–754. https://doi.org/10.1111/1475-6773.13858.

HM Government. Genome UK. The future of healthcare. 2020. https://assets.publishing.service.gov.uk/media/5f6b06a9d3bf7f723ad68ccc/Genome_UK_-_the_future_of_healthcare.pdf.

Hock, Kathryn T., Kurt D. Christensen, Beverly M. Yashar, J. Scott Roberts, Sarah E. Gollust, and Wendy R. Uhlmann. “Direct-to-Consumer Genetic Testing: An Assessment of Genetic Counselors’ Knowledge and Beliefs.” Genetics in Medicine 13, no. 4 (2011):

–332. https://doi.org/10.1097/gim.0b013e3182011636.

Hoofnagle, Chris Jay, Bart van der Sloot, and Frederik Zuiderveen Borgesius. “The European Union General Data Protection Regulation: What It Is and What It Means.” Information and Communications Technology Law 28, no. 1 (2019): 65–98. https://doi.org/10.1080/13600834.2019.1573501.

Kalokairinou, Louiza, Heidi C. Howard, Santa Slokenberga, et al. “Legislation of Direct-toConsumer Genetic Testing in Europe: A Fragmented Regulatory Landscape.” Journal of Community Genetics 9, no. 2 (2017): 117–132. https://doi.org/10.1007/s12687-017-0344-2.

Kass, Leon R. “The Wisdom of Repugnance: Why We Should Ban the Cloning of Humans.”Valparaiso University Law Review 32, no. 2 (1998): 679. https://scholar.valpo.edu/vulr/vol32/iss2/12.

Kirpichnikov, Mikhail P., and Alexander M. Kudryavtsev. “Safe Use of Genetic Technologies.” Herald of the Russian Academy of Sciences 92, no. 3 (2022): 225–229. https://doi.org/10.1134/s1019331622030029.

Kjeldaas, Sigfrid, Tim Dassler, Trine Antonsen, Odd-Gunnar Wikmark, and Anne I. Myhr. “With Great Power Comes Great Responsibility: Why ‘Safe Enough’ Is Not Good Enough in Debates on New Gene Technologies.” Agriculture and Human Values 40,

no. 2 (2022): 533–545. https://doi.org/10.1007/s10460-022-10367-6.

Koller, Franziska, Meike Schulz, Matthias Juhas, Andreas Bauer-Panskus, and Christoph Then. “The Need for Assessment of Risks Arising from Interactions between NGT Organisms from an EU Perspective.” Environmental Sciences Europe 35, no. 1 (2023). https://doi.org/10.1186/s12302-023-00734-3.

Laaninen, Tarja. New genomic techniques. European Commission study and first reactions. 2021. https://www.europarl.europa.eu/RegData/etudes/BRIE/2021/698760/EPRS_BRI(2021)698760_EN.pdf.

Mahalatchimy, Aurélie, Pin Lean Lau, Phoebe Li, and Mark L. Flear. “Framing and Legitimating EU Legal Regulation of Human Gene-Editing Technologies: Key Facets and Functions of an Imaginary.” Journal of Law and the Biosciences 8, no. 2 (2021). https://doi.org/10.1093/jlb/lsaa080

Majumder, Mary A., Christi J. Guerrini, and Amy L. McGuire. “Direct-to-Consumer Genetic Testing: Value and Risk.” Annual Review of Medicine 72, no. 1 (2021): 151–166. https://doi.org/10.1146/annurev-med-070119-114727.

Marchant, Gary, E. “Global Governance of Human Genome Editing: What Are the Rules?” Annual Review of Genomics and Human Genetics 22, no. 1 (2021): 385–405. https://doi.org/10.1146/annurev-genom-111320-091930.

Mbaya, Hellen, Simon Lillico, Steve Kemp, Geoff Simm, and Alan Raybould. “Regulatory Frameworks Can Facilitate or Hinder the Potential for Genome Editing to Contribute to Sustainable Agricultural Development.” Frontiers in Bioengineering and Biotechnology

, (2022). https://doi.org/10.3389/fbioe.2022.959236.

McGuire, Amy L., and Wylie Burke. “An Unwelcome Side Effect of Direct-to-Consumer Personal Genome Testing.” JAMA 300, no. 22 (2008): 2669. https://doi.org/10.1001/jama.2008.803.

McGuire, Amy L., and Wylie Burke. “Health System Implications of Direct-to-Consumer Personal Genome Testing.” Public Health Genomics 14, no. 1 (2010): 53–58. https://doi.org/10.1159/000321962.

Molnár-Gábor, Fruzsina, Julian Sellner, Sophia Pagil, Santa Slokenberga, Olga Tzortzatou-Nanopoulou, and Katarina Nyström. “Harmonization after the GDPR? Divergences in the Rules for Genetic and Health Data Sharing in Four Member States and Ways

to Overcome Them by EU Measures: Insights from Germany, Greece, Latvia and Sweden.” Seminars in Cancer Biology 84, (2022): 271–283. https://doi.org/10.1016/j.semcancer.2021.12.001.

Munsie, Megan, and Christopher Gyngell. “Ethical Issues in Genetic Modification and Why Application Matters.” Current Opinion in Genetics and Development 52 (2018): 7–12. https://doi.org/10.1016/j.gde.2018.05.002.

Myskja, Bjørn K., and Kristin S. Steinsbekk. “Personalized Medicine, Digital Technology and Trust: A Kantian Account.” Medicine, Health Care and Philosophy 23, no. 4 (2020): 577–587. https://doi.org/10.1007/s11019-020-09974-z.

National Academy of Sciences (NAS) and National Academy of Medicine (NAM). Human Genome Editing: Science, Ethics, and Governance. National Academies Press, 2017. https://doi.org/10.17226/24623.

NIH National Human Genome Research Institute. “Direct-to-Consumer Genetic Testing

FAQ.”https://www.genome.gov/For-Health-Professionals/Provider-Genomics-Education-Resources/Healthcare-Provider-Direct-to-Consumer-Genetic-Testing-FAQ. Accessed November 16, 2023.

OECD. OECD Science, Technology and Industry Working Papers. OECD iLibrary, 2023. https://doi.org/10.1787/18151965

Oliveri, Serena, Federica Ferrari, Andrea Manfrinati, and Gabriella Pravettoni. “A Systematic Review of the Psychological Implications of Genetic Testing: A Comparative Analysis Among Cardiovascular, Neurodegenerative and Cancer Diseases.” Frontiers in Genetics

, (2018). https://doi.org/10.3389/fgene.2018.00624.

Oliveri, Serena, Giulia Marton, Laura Vergani, et al. “Genetic Testing Consumers in Italy: A Preliminary Investigation of the Socio-Demographic Profile, Health-Related Habits, and Decision Purposes.” Frontiers in Public Health 8, (2020). https://doi.org/10.3389/fpubh.2020.00511.

Orth, Matthias, Imma Rost, Georg F. Hoffmann, and Hanns-Georg Klein. “Praktische Umsetzung Des Gendiagnostikgesetzes (GenDG) in Der Laboratoriumsmedizin, Dem Humangenetischen Laboratorium Und Der Humangenetischen Beratung/Practical Implications of the German Genetic Diagnostics Act (GenDG) for Laboratory Medicine, the Human Genetics Laboratory and for Genetic Counseling.” Laboratoriums Medizin 35, no. 5 (2011): 243–253. https://doi.org/10.1515/jlm.2011.045.

Penticuff, Joy. “Ethical Issues in Genetic Therapy.” Journal of Obstetric, Gynecologic and Neonatal Nursing 23, no. 6 (1994): 498–501.

https://doi.org/10.1111/j.1552-6909.1994.tb01911.x.

Pormeister, Kärt. “Genetic Research and Applicable Law: The Intra-EU Conflict of Laws as a Regulatory Challenge to Cross-Border Genetic Research.” Journal of Law and the Biosciences 5, no. 3 (2018): 706–723. https://doi.org/10.1093/jlb/lsy023.

Rabaan, Ali A., Hajir AlSaihati, Rehab Bukhamsin, et al. “Application of CRISPR/Cas9 Technology in Cancer Treatment: A Future Direction.” Current Oncology 30, no. 2 (2023): 1954–1976. https://doi.org/10.3390/curroncol30020152.

Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General

Data Protection Regulation) OJ L 119, 4.5.2016, 1–88.

Roberts, J. Scott, and Jenny Ostergren. “Direct-to-Consumer Genetic Testing and Personal Genomics Services: A Review of Recent Empirical Studies.” Current Genetic Medicine Reports 1, no. 3 (2013): 182–200. https://doi.org/10.1007/s40142-013-0018-2.

Rössler, Franziska, and Johannes R. Lemke. “Legislation on Genetic Testing in Different Countries.” In Pediatric and Adolescent Medicine, edited by W. Kiess, C. G. Bornehar, and C. Gennings. S. Karger AG, 2017. https://doi.org/10.1159/000481321.

Rothschild, Jodie. “Ethical Considerations of Gene Editing and Genetic Selection.” Journal

of General and Family Medicine 21, no. 3 (2020): 37–47.https://doi.org/10.1002/jgf2.321.

Rumbold, John Mark Michael, and Barbara Pierscionek. “The Effect of the General Data Protection Regulation on Medical Research.” Journal of Medical Internet Research 19, no. 2 (2017): e47. https://doi.org/10.2196/jmir.7108.

Shinwari, Zabta Khan, Faouzia Tanveer, and Ali Talha Khalil. “Ethical Issues Regarding CRISPR Mediated Genome Editing.” Current Issues in Molecular Biology 26, (2018): 103–110. https://doi.org/10.21775/cimb.026.103.

SIENNA. D2.4: Ethical Analysis of Human Genetics and Genomics. Report of the SIENNA project – Stakeholder-informed ethics for new technologies with high socio-economic and human rights impact. European Commission, 2019. https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5c70bb81d&appId=PPGMS.

Tiller, Jane, Andrew Bakshi, Grace Dowling, et al. “Community Concerns about Genetic Discrimination in Life Insurance Persist in Australia: A Survey of Consumers Offered Genetic Testing.” European Journal of Human Genetics 32 (2024): 286–294. https://doi.org/10.1038/s41431-023-01373-1.

Unesco. Universal Declaration on the Human Genome and Human Rights. UNESDOC, 1997. https://unesdoc.unesco.org/ark:/48223/pf0000122990.

Varkey, Basil. “Principles of Clinical Ethics and Their Application to Practice.” Medical Principles and Practice 30, no. 1 (2020): 17–28. https://doi.org/10.1159/000509119.

Voigt, Paul, and Axel von dem Bussche. The EU General Data Protection Regulation (GDPR).Springer International Publishing, 2017. https://doi.org/10.1007/978-3-319-57959-7.

Wageningen Food Safety Research. Policy scenarios for new genomic techniques. University of Wageningen, 2022.

https://open.overheid.nl/documenten/ronl-f103e3ed5e8610825ee27a803983f786888361de/pdf.

World Health Organization (WHO). WHO expert advisory committee on developing global standards for governance and oversight of human genome editing. 2019. https://iris.who.int/bitstream/handle/10665/341018/WHO-SCI-RFH-2019.02-eng.

pdf?sequence=1.

Yuan, Bocong, and Jiannan Li. “The Policy Effect of the General Data Protection Regulation (GDPR) on the Digital Public Health Sector in the European Union: An Empirical Investigation.” International Journal of Environmental Research and Public Health 16, no. 6 (2019): 1070. https://doi.org/10.3390/ijerph16061070.

Zhou, Qi, Yan Zhang, Yujie Zou, Tailang Yin, and Jing Yang. “Human Embryo Gene Editing: God’s Scalpel or Pandora’s Box?” Briefings in Functional Genomics 19, no. 3 (2020): 154–163. https://doi.org/10.1093/bfgp/elz025.

Zimny, Tomasz. “New Genomic Techniques and Their European Union Reform. Potential Policy Changes and Their Implications.” Frontiers in Bioengineering and Biotechnology10, (2022). https://doi.org/10.3389/fbioe.2022.1019081.

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