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The French Perspective The law

The French Perspective The law. 1994 Civil code: Art. 16-4. << No one may infringe upon the integrity of mankind << Any eugenic practice which aims at organizing the selection of persons is forbidden .

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The French Perspective The law

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  1. The French Perspective The law • 1994 • Civil code: Art. 16-4. • <<No one may infringe upon the integrity of mankind • << Any eugenic practice which aims at organizing the selection of persons is forbidden. • << Without prejudice to researches aiming at preventing and treating genetic diseases, there may be no alteration of the genetic characters with a view to changing the descent of a person. • 1997 Council of Europe Oviedo Convention, ratified by France in 2012 • Art. 13 • << An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants.

  2. The French Perspective • Ongoing discussions in academicsocieties << Inserm EthicsCommittee << French Society of Human Genetics (SFGH) and French Society of Cell and Gene Therapy (SFTCG) << AcadémieNationale de Médecine

  3. Humangermlineediting issues As discussed at the National Academy of Medicine • 1. Potentialclinical applications • - Avoiding the transmission of geneticdiseases to the child • - Reducing the risks of heritablediseasesthroughelimination or addition of geneticvariants • - Nonmedical indications? • In all cases whatwouldbe the risks and benefits of HGE compared to otheravailableachievment? • 2. Mode of action • - Level of efficiency and safetyrequested • - How to control safety and efficiency • - Whichgermcell or embryo stage could/wouldbeedited? • 3. Research • Shoulditbeprohibited or limited? • 4. Ethics • - Are the issues differentcompared to thoseconcerningtreatments in reproductive medicine • whichmay impact the genetic, epigenetic or cellular structure and functions in the offspring? • - Should the ethical issues be the same if HGE wasdonebefore or afterfertilization?

  4. Potentialclinicalapplications • Avoiding the transmission of geneticdiseases to the child • << PreimplantationGeneticDiagnostic (PGD) is not possible • Dominant homozygoty in one partner(Huntington’sdisease…) • Recessivehomozygoty in bothpartners(Cysticfibrosis…) • Mutations in mt DNA (Leber’shereditaryopticneuropathy…)

  5. Potentialclinicalapplications • Avoiding the transmission of genicdiseases to the child • << Preimplantationgenetic diagnostic (PGD) is not possible • Dominant homozygoty in one partner(Huntington’sdisease…) • Recessivehomozygoty in bothpartners(Cysticfibrosis…) • Mutations in mt DNA (Leber’shereditaryopticneuropathy…) • << PGD failure • PGD activity in Necker - A. Béclère centre; Jan1 2015 -Nov 15 2015 • 119 cycles for geneticdiseases; 22 withoutembryotransfer • 11 autosomal dominant • 8 autosomalrecessive • 2 X linked • 1 mt DNA

  6. Which germ cell or embryo stage could be edited? No PGD available Mouse Rat Mouse Rat Ferret Goat Sheep Cattle Cynomolgus Spermatogonial stem cell

  7. Which germ cell or embryo stage could be edited? No PGD available Mouse Rat Mouse Rat Ferret Goat Sheep Cattle Cynomolgus Spermatogonial stem cell PGD failure

  8. From experimental and somatic editing to clinical germline editing • A paradigm switch Mouse Rat Mouse Rat Ferret Goat Sheep Cattle Cynomolgus Spermatogonial stem cell

  9. From experimental and somatic editing to clinical germline editing • A paradigm switch Editingefficiency and safetyshouldbe controlledbeforeembryotransfer Mouse Rat Mouse Rat Ferret Goat Sheep Cattle Cynomolgus Spermatogonial stem cell Control ?

  10. From experimental and somatic editing to clinical germline editing • A paradigm switch Mouse Rat Mouse Rat Ferret Goat Sheep Cattle Cynomolgus Spermatogonial stem cell There is a long way to go for research beforeclinical application

  11. Research Should not beforbidden. Will includenecessaryresearch on humanembryos • Research on embryosisauthorized in France • Carryingout research is only allowed on embryosfertilizedin vitro as part of a medicallyassistedprocreationand onlyif thereis no more parental project • On Dec 31 2013, 19 335 frozenembryosdonated for researchwerestored in the french IVF laboratories(www.agence-biomedecine.fr)

  12. The French Perspective • Sinceclinicalapplication of humangermlinegenomeeditingseemsimpracticable in the short term, thereis no reason to change the law.Researchshouldbeallowed and supportedwhenneeded.Should the creation of embryos for researchbeauthorized? • The debateisongoing.

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