Mitochondrial replacement techniques Welcoming the first babies expecting

Mitochondrial replacement techniques. Welcoming the first babies, expecting an appropriate legal framework Lina Oplinus, Ph. D Researcher, Leuven Institute for Healthcare Policy

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Research question Are the current international legal instruments regarding interventions in the human genome appropriate to monitor the use of mitochondrial replacement techniques in national legal orders? 3 Leuven Institute for Healthcare Policy

Methodology • Description of mitochondrial replacement techniques • Demonstrate the need for an international legal framework • Appropriateness − Binding? − Scope? − Balance? • Of three international instruments − Universal Declaration on the Human Genome and Human Rights − European Convention on Human Rights and Biomedicine − Clinical Trials Directive and Regulation 4 Leuven Institute for Healthcare Policy

Structure of the presentation 1. Introduction 2. Medical background 3. Need for an international legal framework a. b. c. National legal framework in the United Kingdom Scientific tourism in Mexico Lack of a national framework in Ukraine 4. Evaluation of the current international frameworks a. b. c. Universal Declaration on the Human Genome and Human Rights European Convention on Human Rights and Biomedicine The Clinical Trials Directive and Regulations 5. Conclusion 5 Leuven Institute for Healthcare Policy

Mitochondrial diseases, mitochondria and mt. DNA • No designer babies • Mitochondrial diseases • Serious, life-threatening, no cure • Mitochondria • • 6 Energy production Nuclear DNA Own DNA, mitochondrial DNA Only inherited matrilineal Leuven Institute for Healthcare Policy

Preventing mt. DNA caused mitochondrial diseases 3 1 2 3 L. GOMEZ-TATAY, J. HERNANDEZ-ANDREU and J. AZNAR, “Mitochondrial Modification Techniques and Ethical Issues”, Journal of Clinical Medicine 2017, 4. 7 Leuven Institute for Healthcare Policy

Germline or somatic intervention • Traditionally − Somatic gene interventions − Germline gene interventions, higher risks • Germline interventions − Affect future generations − Generally rejected • Mitochondrial replacement techniques − Conditionally inheritable − Fall between categories 8 Leuven Institute for Healthcare Policy

Structure of the presentation 1. Introduction 2. Medical background 3. Need for an international legal framework a. National legal framework in the United Kingdom b. c. Scientific tourism in Mexico Lack of a national framework in Ukraine 4. Evaluation of the current international frameworks a. b. c. Universal Declaration on the Human Genome and Human Rights European Convention on Human Rights and Biomedicine The Clinical Trials Directive and Regulations 5. Conclusion 9 Leuven Institute for Healthcare Policy

National legal framework in the UK • United Kingdom − Mitochondrial Donation Regulations − Legalisation MST and PNT − Very strict conditions − Other countries may follow • Appropriate international framework − Enough safeguards − No national prohibition on beneficial and safe techniques 10 Leuven Institute for Healthcare Policy

Structure of the presentation 1. Introduction 2. Medical background 3. Need for an international legal framework a. National legal framework in the United Kingdom b. Scientific tourism in Mexico c. Lack of a national framework in Ukraine 4. Evaluation of the current international frameworks a. b. c. Universal Declaration on the Human Genome and Human Rights European Convention on Human Rights and Biomedicine The Clinical Trials Directive and Regulations 5. Conclusion 11 Leuven Institute for Healthcare Policy

Scientific tourism in Mexico • Scientific tourism • Mexico − First birth after Maternal Spindle Transfer − Implantation in Mexico of an embryo created in the US − Zhang: “there are no rules” • Appropriate international framework − Worldwide ground rules − No need or use to emigrate 12 Leuven Institute for Healthcare Policy

Structure of the presentation 1. Introduction 2. Medical background 3. Need for an international legal framework a. b. National legal framework in the United Kingdom Scientific tourism in Mexico c. Lack of a national framework in Ukraine 4. Evaluation of the current international frameworks a. b. c. Universal Declaration on the Human Genome and Human Rights European Convention on Human Rights and Biomedicine The Clinical Trials Directive and Regulations 5. Conclusion 13 Leuven Institute for Healthcare Policy

Lack of a national framework in Ukraine • Ukraine − First birth after Pronuclear Transfer − No explicit national legal framework − “In Ukraine, the situation is very simple – It’s not forbidden. We have not any regulation concerning this”. • Appropriate international framework can counter gaps in national frameworks 14 Leuven Institute for Healthcare Policy

Structure of the presentation 1. Introduction 2. Medical background 3. Need for an international legal framework a. b. c. National legal framework in the United Kingdom Scientific tourism in Mexico Lack of a national framework in Ukraine 4. Evaluation of the current international frameworks a. Universal Declaration on the Human Genome and Human Rights b. c. European Convention on Human Rights and Biomedicine The Clinical Trials Directive and Regulations 5. Conclusion 15 Leuven Institute for Healthcare Policy

Universal Declaration on the Human Genome and Human Rights Appropriate? Criterion Explanation X/V Binding Guiding principles with a moral standing X Scope Interventions in the human genome (art. 5, a) V Balance Contrary to human dignity (art. 11, art. 24) V Potential risks need to be weighed against benefits (art. 5, a) Consent in a manner prescribed by law, guided by the best interest (art. 5, b) Not appropriate 16 Leuven Institute for Healthcare Policy

Structure of the presentation 1. Introduction 2. Medical background 3. Need for an international legal framework a. b. c. National legal framework in the United Kingdom Scientific tourism in Mexico Lack of a national framework in Ukraine 4. Evaluation of the current international frameworks a. Universal Declaration on the Human Genome and Human Rights b. European Convention on Human Rights and Biomedicine c. The Clinical Trials Directive and Regulations 5. Conclusion 17 Leuven Institute for Healthcare Policy

European Convention on Human Rights and Biomedicine Appropriate? Criterion Explanation X/V Binding Regional binding instrument BUT • Only for signatories ( art. 33 and 34) • No own monitoring body X/V Scope Human beings (art. 1) Interventions seeking to modify the human genome (art. 13) V Balance All interventions which aim to introduce any modification in the genome of any descendants are forbidden X Not appropriate 18 Leuven Institute for Healthcare Policy

Structure of the presentation 1. Introduction 2. Medical background 3. Need for an international legal framework a. b. c. National legal framework in the United Kingdom Scientific tourism in Mexico Lack of a national framework in Ukraine 4. Evaluation of the current international frameworks a. b. Universal Declaration on the Human Genome and Human Rights European Convention on Human Rights and Biomedicine c. The Clinical Trials Directive and Regulations 5. Conclusion 19 Leuven Institute for Healthcare Policy

The Clinical Trials Directive/Regulation Appropriate? Criterion Explanation X/V Binding for member states under the scrutiny of the ECJ (art. 288, second limb TFEU). X/V Scope Prohibition: gene therapy trials which result in modifications to the subject’s germline genetic identity (art. 90 Regulation) • Human germline is altered (sperm also possesses mitochondria) BUT • MRT’s do not alter the identity, but lead to a new individual • Embryos and gametes are not subjects • The pregnant woman is the subject, but her identity is also not changed Regulation (art. 2, (2)) • Clinical trials which involve medicinal products • Pronuclear Transfer and Mitochondrial Spindle Transfer are procedures X Balance Member states have complete freedom. Current prohibition is too strict to extend the use X Not appropriate 20 Leuven Institute for Healthcare Policy

Structure of the presentation 1. Introduction 2. Medical background 3. Need for an international legal framework a. b. c. National legal framework in the United Kingdom Scientific tourism in Mexico Lack of a national framework in Ukraine 4. Evaluation of the current international frameworks a. b. c. Universal Declaration on the Human Genome and Human Rights European Convention on Human Rights and Biomedicine The Clinical Trials Directive and Regulations 5. Conclusion 21 Leuven Institute for Healthcare Policy

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Thank you for your attention! For all your questions: Lina Oplinus Ph. D Researcher Leuven Institute for Healthcare Policy Kapucijnenvoer 35 blok D - bus 7001 – 3 th floor Room 05. 55 – 5 th floor 3000 Leuven Belgium Tel: 016/32. 29. 75 www. kuleuven. be/ligb 23 Leuven Institute for Healthcare Policy