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Title page 1

Contents 2

Forewords 3

Executive Summary 9

1. Introduction 13

1.1. The UK fertility sector 13

1.2. Social value and patient impact 14

1.3. Economic value and strategic advantage 15

1.4. Government commitments and 'why now?' 16

2. IVG and the technology landscape 18

2.1. What IVG is and what it could enable 18

2.2. The broader regenerative medicine context: how IVG relates to other novel assisted reproductive technologies and related research tools 19

2.2.1. In vitro fertilisation (IVF) 19

2.2.2. In vitro growth and maturation of gametes 20

2.2.3. Preimplantation genetic testing (PGT) and genome editing 21

2.2.4. Stem-cell-based embryo models (SCBEMs) 21

2.2.5. The 14-day rule 22

2.2.6. Implications for regulation of emerging assisted reproductive technologies 23

2.3. Scientific readiness and safety assessments 23

2.3.1. Replicating human germ cell development in vitro 23

2.3.2. Genetic integrity 24

2.3.3. Epigenetic integrity and genomic imprinting 24

2.3.4. Functional competence and embryo quality 24

2.3.5. Reproducibility, standardisation, and scale 24

2.3.6. Linked challenges from adjacent technologies 25

2.4. What evidence would be needed before any first-in-human clinical step? 25

2.4.1. Evidence that the IVG process is controllable and reproducible 25

2.4.2. Evidence of genetic and epigenetic integrity 25

2.4.3. Evidence that embryos created using IVG behave like embryos created using conventional IVF 25

2.4.4. Evidence from suitable animal models that addresses intergenerational safety 26

2.4.5. Evidence that there is a regulatory governance system ready for a new way of assisting human reproduction 26

3. UK legal and regulatory position 28

3.1. What is permitted today and what is not 28

3.2. Why IVG cannot be used clinically under current law 29

3.3. Adjacent technologies where legal clarity is also needed 30

4. Broader international context and UK positioning 32

4.1. Where other countries sit today 32

4.1.1. United States: permissive research conditions, fragmented governance, uncertain translation route 32

4.1.2. Japan: strong research capability, guidance-led oversight, cautious sequencing 33

4.1.3. Europe: wide variation, with many jurisdictions structurally restrictive 33

4.1.4. Australia: licensed research within hard statutory limits 34

4.1.5. Middle East: selective clinical capacity under high constraints 35

4.1.6. China: a new regulatory pathway 35

4.2. What this means for investment, talent and influence 36

4.2.1. Investment follows scientific capability, but translational investment follows regulatory clarity 36

4.2.2. Talent moves towards ecosystems that combine research freedom with trusted oversight 36

4.2.3. Influence is shaped by who sets norms and who runs credible evaluation pathways 36

4.3. Risks of UK not creating a path for IVG 37

4.4. Why the UK is well placed if it chooses to move 37

5. Options for regulating IVG and other future ARTs 39

5.1. Framing the options: timing and legislative design 39

5.2. Timing and Posture Options 39

5.3. Legislative reform models 42

5.3.1. Model 1. Create a statutory, staged evaluation route for novel ARTs, including IVG 43

5.3.2. Model 2. Create an IVG-specific, staged evaluation route 46

5.3.3. Model 3. Expand the statutory definition of "permitted gametes" to include in vitro gametes 48

5.4. How these two sets of options interlink 49

5.5. Non-legislative options 49

5.5.1. Clarify what is lawful today and reduce legal uncertainty (high priority) 50

5.5.2. Use existing licensing, guidance, and inspection levers to strengthen safeguards for research 51

5.5.3. Create a standing oversight and horizon scanning function 51

5.5.4. Prepare the ethical and social foundations before any legislative decisions 51

5.5.5. Build readiness for future evidence assessment, without pre-committing to clinical use 52

5.5.6. Commission a practical scoping exercise for modernising the framework 52

5.6. Oversight, accountability and governance choices 52

6. The RHC's preferred approach 54

7. Appendices 55

7.1. Appendix 1. Introducing Mitochondrial Donation into the UK Clinic 55

7.1.1. Mitochondrial Donation and the Law 55

7.1.2. Understanding mitochondrial donation 56

7.2. Appendix 2. IVG: ethical considerations 58

7.2.1. Gametes, embryos and embryo models 58

7.2.2. Safety and risk 59

7.2.3. Proposed use cases/indications for IVG 60

7.2.4. IVG as a 'gateway technology' 61

7.2.5. Public engagement and trust 62

7.2.6. Other ethical issues and the role of regulation 63

8. Acknowledgements 64

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