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Research Involving Human Embryos Act 2002—Report on the operation of the Act—1 September 2018 to 28 February 2019


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NHMRC Embryo Research Licensing Committee

Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

Publication Details

Publication title: NHMRC Embryo Research Licensing Committee:

Report to the Parliament of Australia for the period

1 September 2018 to 28 February 2019

Published: June 2019

Publisher: National Health and Medical Research Council

NHMRC Publication reference: HC55

ISSN Print: 2651-8554

ISSN Online: 2651-8562

Suggested citation: National Health and Medical Research Council

(2019) NHMRC Embryo Research Licensing Committee:

Report to the Parliament of Australia for the period

1 September 2018 to 28 February 2019. Canberra:

National Health and Medical Research Council

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The Hon Greg Hunt MP Minister for Health Parliament House Canberra ACT 2600

Dear Minister Hunt

I am pleased to present to you the thirty-third biannual report from the National Health and Medical Research Council (NHMRC) Embryo Research Licensing Committee (the NHMRC Licensing Committee), which, in accordance with section 19(3) of Research Involving Human Embryos Act 2002 (the Act), reports on the operation of the Act and the licences issued under it.

This report is for the period 1 September 2018 to 28 February 2019 and describes the activities the NHMRC Licensing Committee has undertaken during this reporting period, including associated monitoring and compliance activities.

The NHMRC Licensing Committee met once during this reporting period, and considered one licence application and fourteen applications seeking to vary previously issued licences for the use of excess assisted reproductive technology embryos and human eggs. In total twenty-one licences have been issued under the Act since the legislation commenced, of which eight were current at 28 February 2019.

Yours sincerely

Professor Dianne Nicol Chairperson NHMRC Embryo Research Licensing Committee May 2019

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NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

Table of contents Introduction 1

Legislative framework 1

Reporting to Parliament 1

Further information 2

Membership of the NHMRC Licensing Committee 3 Functions 3

Operation of the NHMRC Licensing Committee 4 Committee meetings 4

Consideration of licence applications 4

Variations to existing licences 5

Progress of licensed activities 6

Licence holder reports 6

Licensed use of excess ART embryos 8

Licensed use of human eggs or creation of other embryos 10

Monitoring compliance with the legislation 11 Monitoring activities 11

Outcomes of monitoring activities conducted 11

Communication and awareness 16

Information exchange visits 16

Appendix A: Membership of the NHMRC Licensing Committee 17

Appendix B: Variations to licences 18

Appendix C: Corresponding State and Territory legislation 19

Appendix D: Glossary of Common Terms 20

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NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

Introduction

Legislative framework The Commonwealth Prohibition of Human Cloning for Reproduction Act 2002 (PHCR Act) and Research Involving Human Embryos Act 2002 (RIHE Act) were developed to address community concerns, including ethical concerns, about scientific developments in relation to human reproduction and the utilisation of human embryos in research activities. The legislation prohibits human cloning for reproductive purposes and a range of other practices relating to reproductive technology. It also regulates research activities that involve the use of human embryos created by assisted reproductive technology (ART) or by other means. There are strong penalties for non-compliance with the legislation.

The RIHE Act established the Embryo Research Licensing Committee of the National Health and Medical Research Council (the NHMRC Licensing Committee) as a Principal Committee of the NHMRC. One of the functions of the NHMRC Licensing Committee is to consider applications for licences to conduct research involving human embryos. As required under section 29 of the RIHE Act, the NHMRC Licensing Committee maintains a publicly available database containing information about licences issued. This database can be accessed on the NHMRC website at www.nhmrc.gov.au.

In April 2002 and again in April 2007, the Council of Australian Governments agreed to introduce nationally consistent legislation to support the regulatory framework. Information about the implementation of complementary state and territory legislation is included at Appendix C to this report.

Reporting to Parliament Section 19(3) of the RIHE Act requires the NHMRC Licensing Committee to table six-monthly reports in either House of Parliament on or before 30 June and 31 December each year, and at any other time as required by either House of Parliament. The reports must include information about the operation of the RIHE Act and about licences issued under this Act.

This is the thirty-third Parliamentary Report of the NHMRC Licensing Committee, which covers the period 1 September 2018 to 28 February 2019.

Introduction

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NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

Further information Further information about this report and the issue of licences can be obtained by contacting:

Director, Strategic Projects and Support Research Quality and Priorities NHMRC GPO Box 1421 CANBERRA ACT 2601 Telephone: 02 6217 9000 Email: embryo.research@nhmrc.gov.au Website: www.nhmrc.gov.au

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NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

Membership of the NHMRC Licensing Committee The NHMRC Licensing Committee was established in May 2003 under the Research Involving Human Embryos Act 2002 (RIHE Act). The nine-member NHMRC Licensing Committee is responsible for making statutory decisions as outlined in the RIHE Act.

Members are appointed by the Minister for Health, according to the process prescribed in the RIHE Act. Appointments are on a part-time basis for a period not exceeding three years with members eligible for reappointment.

NHMRC Licensing Committee appointments for the 2018-2021 NHMRC triennium commenced on 26 September 2018.

The membership of the NHMRC Licensing Committee is detailed at Appendix A.

Functions Established as a Principal Committee of the NHMRC, the functions of the NHMRC Licensing Committee are to:

• consider applications for licences to conduct research involving human embryos

• issue (subject to conditions) or not issue such licences

• maintain a publicly available database containing information about licences issued

• monitor licensed activities and ensure compliance with the legislation through the appointment of inspectors and take necessary enforcement action, such as cancelling or suspending licences

• report to the Parliament of Australia on the operation of the RIHE Act and the licences issued under this Act

• perform such other functions as are conferred on it by the RIHE Act or any other relevant law.

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NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

Operation of the NHMRC Licensing Committee

Committee meetings During the reporting period the NHMRC Licensing Committee met on 7 December 2018.

Consideration of licence applications The NHMRC Licensing Committee agreed in principle to issue a licence which was under assessment in the previous reporting period, subject to HREC approval of all amendments to the application.

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NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

Variations to existing licences The RIHE Act empowers the NHMRC Licensing Committee to vary a licence issued under the Act. Variations to licences may either be requested by the licence holder or initiated by the Committee. Variations may be of an administrative nature (e.g. change to site address) or may relate to aspects of the authorised activities (e.g. number of embryos used).

During the reporting period the NHMRC Licensing Committee approved fourteen variations to licences, all initiated by licence holders, as follows:

• one variation related to the extension of a licence

• two variations related to the locations of authorised sites

• one variation involved updating the location of an authorised site in consent documents

• one variation involved changes to the reporting spreadsheet

• one variation increased the number of embryos permitted to be used

• one variation amended the skills required before a trainee is permitted to use excess ART embryos, and

• seven variations involved changes to the lists of persons authorised to supervise or conduct the licensed activities.

No variations were initiated by the NHMRC Licensing Committee.

Further information about variations to existing licences approved during the reporting period is at Appendix B.

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NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

Progress of licensed activities

Progress of licensed activities

Licence holder reports Licence holders are required to report every six months on the progress of their licensed activities. The following reports on the progress of licensed activities are provided here as received from the licence holders.

Current licences Licence number 309702B

Licence holder Genea Limited

Licence title Development of methods for pre-implantation genetic and metabolic evaluation of human embryos

Progress of licensed activity to date No work has been carried out in this reporting period.

Licence number 309703

Licence holder Genea Limited

Licence title Development of human embryonic stem (ES) cells

Progress of licensed activity to date Under this licence we have derived a total of thirty (30) cell lines, four of which are karyotypically abnormal.

Cell lines from this licence have been registered at the NIH registry and have been approved by the Steering Committee of the UK Stem Cell Bank for research use in the UK.

Cell lines are available to researchers worldwide for basic disease research and drug development projects. Various distribution services aid in this process.

Licence number 309710

Licence holder Genea Limited

Licence title Derivation of human embryonic stem cells from embryos identified through preimplantation genetic diagnosis to be affected by known serious monogenic conditions

Progress of licensed activity to date Under this licence, a total of forty six (46) affected stem cell lines have been derived, four of which are karyotypically abnormal.

Cell lines from this licence have been registered at the NIH registry and have been approved by the Steering Committee of the UK Stem Cell Bank for research use in the UK.

Cell lines are available to researchers worldwide for basic disease research and drug development projects. Various distribution services aid in this process.

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NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

Licence number 309718

Licence holder Genea Limited

Licence title Use of excess ART embryos and clinically unusable eggs for validation of an IVF device

Progress of licensed activity to date Over the lifetime of the project, clinically unsuitable abnormally fertilised eggs and excess-declared ART blastocysts have been used to develop an automated vitrification

instrument (Gavi) for freezing of oocytes, zygotes/cleavage stage and blastocyst stage embryos. After the product development process, the instrument and associated consumables are CE marked products and are commercially distributed across several regions. The Gavi system has approved protocols for freezing of oocytes, zygotes/cleavage stage and blastocyst stage embryos. Further optimisations for the different developmental stages may be required as post market surveillance data is monitored.

Licence number 309719

Licence holder Genea Limited

Licence title Use of excess ART embryos for the development of improved IVF culture media

Progress of licensed activity to date The current projects are centred around developing new products for inclusion within the Gems media suite. These projects, which vary widely depending on the product in question,

are ongoing; some having utilised excess ART embryos already and some progressing to a stage where they are likely to do so.

The use of excess ART embryos in product development is essential. Animal models play a large part in progressing new media, but as their response is not always a true representation of how human embryos will respond, it is important to have a stage between animal model experiments and clinical use, improving confidence in the new products before subjecting actual patients to them.

Licence number 309723

Licence holder Melbourne IVF Pty Ltd

Licence title Use of excess ART embryos for blastocyst-stage biopsy training

Progress of licensed activity to date Licence Number 309723 involves the use of excess ART embryos to train scientists in the technique of embryo biopsy at the blastocyst stage of development. This technique involves

removal of a small piece of tissue (trophectoderm) from the embryo and the processing of this tissue in a way that allows it to be subjected to genetic testing.

Licence number 309724

Licence holder IVFAustralia Pty Ltd

Licence title Use of excess ART embryos for blastocyst-stage biopsy training

Progress of licensed activity to date No activity has occurred using embryos covered by this licence in this reporting period.

Licence number 309725

Licence holder TasIVF Pty Ltd

Licence title Use of excess ART embryos for blastocyst-stage embryo biopsy training

Progress of licensed activity to date Twenty embryos were thawed in two lots on the 22/01/2019 and the 05/02/2019. This resulted in 13 blastocysts for biopsy. Trainee successfully biopsied all 13 blastocysts. Cell loading was

successful for 12 of the blastocyst with the biopsied piece being lost in one. Training has been completed.

A new trainee is to be added to the licence and [will commence] training once this has been approved.

Progress of licensed activities

Progress of licensed activities

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NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

Licensed use of excess ART embryos The following tables show the use of excess ART embryos under licence, as at 28 February 2019.

Current research licences Licence number Licence

holder

Licence title Embryos

authorised to be used under licence

Embryos used in licensed activity up to

28 February 2019

Embryos used during the reporting period

309702B Genea

Limited

Development of methods for pre-implantation genetic and metabolic evaluation of human embryos

220 58 0

309703 Genea

Limited

Development of human embryonic stem (ES) cells 300 (plus up to 20 inner

cell masses which may be transferred from 309702A or 309702B)

249

(plus 12 embryos first used in 309702A and then transferred to 309703)

0

309710 Genea

Limited

Derivation of human embryonic stem cells from embryos identified through preimplantation genetic diagnosis to be affected by known genetic conditions

500 304 0

309718 Genea

Limited

Use of excess ART embryos and clinically unusable eggs for validation of an IVF device

345 259 0

309719 Genea

Limited

Use of excess ART embryos for the development of improved IVF culture media

640 58 0

Total for current licences 2005 928 0

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NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

Current training licences Licence number Licence

holder

Licence title Embryos

per trainee authorised to be used under licence1

Number of active authorised trainees at 28 February 2019

Embryos used in licensed activity up to 28 February 2019 (total, all trainees)2

Embryos used during the reporting period (total, all trainees)

309723 Melbourne

IVF Pty Ltd Use of excess ART embryos for blastocyst-stage biopsy training

673 3 166 0

309724 IVF Australia

Pty Ltd

Use of excess ART embryos for blastocyst-stage biopsy training

24 4 13 0

309725 TasIVF Pty

Ltd

Use of excess ART embryos for blastocyst-stage embryo biopsy training

52 1 70 20

Total for current licences 249 20

1 The Special Conditions of each licence permit this number of embryos to be removed from cryostorage and thawed in order to obtain a smaller number of suitable embryos for the training activity.

2 Reflects the total number of embryos removed from cryostorage across the period of the licence, noting that the total number of embryos authorised for use under each licence is dependent on the total number of authorised trainees and fluctuates as authorised trainees are added or removed from the licence.

3 From 19 December 2014 to 11 December 2018 Melbourne IVF was permitted to thaw 50 embryos for each authorised trainee. From 11 December 2018, Melbourne IVF is permitted to thaw 67 embryos for each authorised trainee.

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NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

Licensed use of human eggs or creation of other embryos The following tables show the use of human eggs or creation of other embryos under licence, as at 28 February 2019. “Other embryos” is the term used in the RIHE Act to refer to human embryos created by processes other than fertilisation of a human egg by a human sperm.

Current licences Licence number Licence

holder

Licence title Eggs authorised

to be used under licence

Eggs used in licensed activity up to 28 February 2019

Eggs used during the reporting period

309718 Genea

Limited

Use of excess ART embryos and clinically unusable eggs for validation of an IVF device

1000 407 0

Total 1000 407 0

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NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

Monitoring compliance with the legislation The NHMRC is committed to ensuring that individuals and licence holder organisations comply with both the RIHE Act and the PHCR Act. The legislation establishes a Monitoring and Compliance Framework, which involves the appointment of inspectors and the conduct of a range of monitoring and compliance activities. Further information about the Embryo Research Monitoring and Compliance Framework can be found on the NHMRC website at https://www.nhmrc.gov.au/research-policy/embryo-research-licensing.

Monitoring activities During the reporting period, NHMRC inspectors conducted six inspections to assess compliance with licence conditions.

Licence Holder Licence Number Inspection Type Inspection Date

IVF Australia 309724 Monitoring 20 September 2018

Melbourne IVF 309723 Monitoring 17 October 2018

TasIVF Pty Ltd 309725 Monitoring 18 October 2018

Genea Ltd 309702B Monitoring 29 November 2018

Genea Ltd 309718 Monitoring 29 November 2018

Genea Ltd 309719 Monitoring 29 November 2018

Outcomes of monitoring activities conducted Monitoring Activity Monitoring Inspection Licence Number 309724

Licence Holder IVF Australia Pty Ltd

Monitoring Activity Date

20 September 2018

Licence Title Use of excess ART embryos for blastocyst-stage biopsy training Background • Licence 309724 was issued on 21 April 2017.

• This is the first inspection of IVF Australia conducted in relation to Licence 309724.

Monitoring compliance with the legislation

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NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

Monitoring Activity Monitoring Inspection Activities Conducted During Inspection • Reviewed licensed activity 309724.

• Examined documents and records to confirm the integrity of IVF Australia’s record keeping systems relevant to the licensed use of excess ART embryos in Licence 309724.

• Tracked seven embryos used under Licence 309724 from the responsible persons to the outcomes of the licensed use.

• Provided guidance to ensure continued compliance with licence conditions and legislation.

• Obtained information on the proposed activities under Licence 309724 to keep the NHMRC Licensing Committee updated on the progress of the licence.

Findings Related to Licence Conditions • The inspectors were satisfied with the licence holder’s processes. • The licence holder provided all the information requested by the NHMRC inspectors.

Findings related to compliance with Research Involving Human Embryos Act 2002

• No contraventions of the Research Involving Human Embryos Act 2002 were found.

Compliance Status Compliant

Monitoring Activity Monitoring Inspection Licence Number 309723

Licence Holder Melbourne IVF Pty Ltd

Monitoring Activity Date

17 October 2018

Licence Title Use of excess ART embryos for blastocyst-stage biopsy training Background • Licence 309723 was issued on 19 December 2014.

• This is the third inspection of Melbourne IVF conducted in relation to Licence 309723.

• The outcomes of previous inspections were reported in the 28th and 29th NHMRC Embryo Research Licensing Committee Reports to Parliament.

Activities Conducted During Inspection • Reviewed licensed activity 309723. • Examined documents and records to confirm the integrity of Melbourne IVF’s record keeping

systems relevant to the licensed use of excess ART embryos in Licence 309723.

• Tracked eight embryos used under Licence 309723 from the responsible persons to the outcomes of the licensed use.

• Provided guidance to ensure continued compliance with licence conditions and legislation.

• Obtained information on the proposed activities under Licence 309723 to keep the NHMRC Licensing Committee updated on the progress of the licence.

Findings Related to Licence Conditions • The inspectors were satisfied with the licence holder’s processes. • The licence holder provided all the information requested by the NHMRC inspectors.

Findings related to compliance with Research Involving Human Embryos Act 2002

• No contraventions of the Research Involving Human Embryos Act 2002 were found.

Compliance Status Compliant

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NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

Monitoring Activity Monitoring Inspection Licence Number 309725

Licence Holder TasIVF Pty Ltd

Monitoring Activity Date 18 October 2018

Licence Title Use of excess ART embryos for blastocyst-stage embryo biopsy training Background • Licence 309724 was issued on 1 September 2017.

• This is the first inspection of TasIVF conducted in relation to Licence 309725.

Activities Conducted During Inspection • Reviewed licensed activity 309725. • Examined documents and records to confirm the integrity of TasIVF’s record keeping systems

relevant to the licensed use of excess ART embryos in Licence 309725.

• Tracked nine embryos used under Licence 309725 from the responsible persons to the outcomes of the licensed use.

• Provided guidance to ensure continued compliance with licence conditions and legislation.

• Obtained information on the activities under Licence 309725 to keep the NHMRC Licensing Committee updated on the progress of the licence.

Findings Related to Licence Conditions • The inspectors were satisfied with the licence holder’s processes. • The licence holder provided all the information requested by the NHMRC inspectors.

Findings related to compliance with Research Involving Human Embryos Act 2002

• No contraventions of the Research Involving Human Embryos Act 2002 were found.

Compliance Status Compliant

Monitoring Activity Monitoring Inspection Licence Number 309702B

Licence Holder Genea Ltd

Monitoring Activity Date

29 November 2018

Licence Title Development of methods for preimplantation genetic and metabolic evaluation of human embryos

Background • Licence 309702B was issued on 16 April 2004.

• This is the seventh inspection of Genea Ltd conducted in relation to Licence 309702B. The outcomes of the previous inspections have been reported in the 4th, 6th, 9th, 11th, 14th and 16th NHMRC Embryo Research Licensing Committee Reports to Parliament.

Activities Conducted During Inspection • Reviewed licensed activity 309702B • Examined documents and records to confirm the integrity of Genea’s record keeping systems

relevant to the licensed use of excess ART embryos in Licence 309702B.

• Tracked five excess ART embryos used under Licence 309702B from the responsible persons to the outcomes of the licensed use.

• Provided guidance to ensure continued compliance with licence conditions and legislation.

• Obtained information on the licensed activities to keep the NHMRC Licensing Committee updated on the progress of the licence.

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NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

Monitoring Activity Monitoring Inspection Findings related to Licence Conditions • The inspectors were satisfied with the licence holder’s processes.

• The licence holder provided all the information requested by the NHMRC Inspectors.

Findings related to compliance with Research Involving Human Embryos Act 2002

• No contraventions of the Research Involving Human Embryos Act 2002 were found.

Compliance Status Compliant

Monitoring Activity Monitoring Inspection Licence Number 309718

Licence Holder Genea Ltd

Monitoring Activity Dates

29 November 2018

Licence Title Use of excess ART embryos and clinically unusable eggs for validation of an IVF device.

Background • Licence 309718 was issued on 11 December 2011.

• This is the fourth inspection of Genea Ltd conducted in relation to Licence 309718. The outcomes of the previous inspections were reported in the 19th, 25th and 28th NHMRC Embryo Research Licensing Committee Reports to Parliament.

Activities conducted during Inspection • Reviewed licensed activity 309718 • Examined documents and records to confirm the integrity of Genea’s record keeping

systems relevant to the licensed use of excess ART embryos and clinically unusable eggs in Licence 309718.

• Tracked four excess ART embryos and four clinically unusable eggs used under Licence 309718 from the responsible persons to the outcomes of the licensed use.

• Provided guidance to ensure continued compliance with licence conditions and legislation.

• Obtained information on the licensed activities to keep the NHMRC Licensing Committee updated on the progress of the licence.

Findings related to Licence Conditions • The inspectors were satisfied with the licence holder’s processes. • The licence holder provided all the information requested by the NHMRC Inspectors.

Findings related to compliance with Research Involving Human Embryos Act 2002

• No contraventions of the Research Involving Human Embryos Act 2002 were found.

Compliance Status Compliant

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NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

Monitoring Activity Monitoring Inspection Licence Number 309719

Licence Holder Genea Ltd

Monitoring Activity Dates

29 November 2018

Licence Title Use of excess ART embryo for the development of improved IVF culture media Background • Licence 309719 was issued on 28 March 2012.

• This is the first inspection of Genea Ltd conducted in relation to Licence 309719.

Activities conducted during Inspection • Reviewed licensed activity 309719. • Inspected and examined documents and records to confirm the integrity of Genea’s record

keeping systems relevant to the licensed use of excess ART embryos in Licence 309719.

• Tracked five embryos used under Licence 309719 from the responsible persons to the outcomes of the licensed use.

• Provided guidance to ensure continued compliance with licence conditions and legislation.

• Obtained information on the licensed activities to keep the NHMRC Licensing Committee updated on the progress of the licence.

Findings related to Licence Conditions • The inspectors were satisfied with the licence holder’s processes. • The licence holder provided all the information requested by the NHMRC inspectors.

Findings related to compliance with Research Involving Human Embryos Act 2002

• No contraventions of the Research Involving Human Embryos Act 2002 were found.

Compliance Status Compliant

During review of the licence holder reports received in March 2019 for the period 1 September 2018 to 28 February 2019, a minor breach of a licence condition was identified, in that a report required by Condition 3001 of Licence 309725 was provided shortly after the due date. A review found that a technical breach of the licence condition did occur. The breach did not meet the requirements for an offence under the RIHE Act. When alerted to the breach, the licence holder provided all information requested by the NHMRC Licensing Committee and undertook to improve internal processes to prevent a reoccurrence.

Communication and awareness

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NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

Communication and awareness The NHMRC Licensing Committee has published an information kit that can be accessed on the NHMRC website at: www.nhmrc.gov.au. Researchers and other interested people can contact the committee by e-mail or telephone. The committee responds to all queries received.

Information exchange visits No information exchange visits were conducted during this reporting period.

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NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

Appendix A: Membership of the NHMRC Licensing Committee Members of the NHMRC Licensing Committee for the 2018-2021 triennium are:

Professor Dianne Nicol, Tasmania (Chairperson) A person with expertise in a relevant area of law

Associate Professor Bernadette Richards, South Australia A member of the Australian Health Ethics Committee (AHEC)

Professor Sheryl de Lacey, South Australia A person with expertise in research ethics

Professor Justin St. John, Victoria A person with expertise in a relevant area of research

Professor Stephen Robson, Australian Capital Territory A person with expertise in assisted reproductive technology

Ms Dianne Petrie OAM, New South Wales A person with expertise in consumer issues relating to disability and disease

Ms Kay Oke OAM, Victoria A person with expertise in consumer issues relating to assisted reproductive technology

Ms Louise Johnson, Victoria A person with expertise in the regulation of assisted reproductive technology

Professor Patrick Tam, New South Wales A person with expertise in embryology

Appendix B: Variations to licences

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NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

Appendix B: Variations to licences During the reporting period, the NHMRC Licensing Committee approved the following variations to existing licences:

Licence No. Organisation Date of variation Brief description of variation 309724 IVF Australia 15 November 2018 Change of site of licensed activity, records storage and source of

excess ART embryos

309725 TasIVF 15 November 2018 Change of site of licensed activity, records storage and source of

excess ART embryos

309725 TasIVF 15 November 2018 Amendments to Plain Language Statement following site change

309702B Genea Limited 7 December 2018 Removal of authorised person from list of authorised persons

309702B Genea Limited 7 December 2018 Addition of authorised person

309718 Genea Limited 7 December 2018 Extension of licence

309718 Genea Limited 7 December 2018 Removal of authorised person from list of authorised persons

309718 Genea Limited 7 December 2018 Addition of authorised person

309719 Genea Limited 7 December 2018 Removal of authorised person from list of authorised persons

309719 Genea Limited 7 December 2018 Addition of authorised person

309723 Melbourne IVF 7 December 2018 Addition of three authorised persons

309723 Melbourne IVF 7 December 2018 Variation to number of embryos permitted to be used

309723 Melbourne IVF 7 December 2018 Variation to skills required before a trainee is permitted to use

excess ART embryos

309724 IVF Australia 7 December 2018 Changes to reporting spreadsheet

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NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

Appendix C: Corresponding State and Territory legislation Following the passage of the Prohibition of Human Cloning and the Regulation of Human Embryo Research Amendment Act 2006, embryo research in Australia must comply with both Commonwealth and corresponding state and territory legislation. At the 13 April 2007 Council of Australian Governments (COAG) meeting, all jurisdictions (except the Northern Territory) restated their commitment to introduce nationally consistent legislation.

Victoria, New South Wales, Tasmania, Queensland, the Australian Capital Territory and South Australia have all passed amending complementary legislation. The relevant legislation for each state and territory has been declared to be a corresponding law by the Minister responsible for the Research Involving Human Embryos Act 2002.

The relevant state and territory legislation is as follows:

Victoria Research Involving Human Embryos Act 2008

New South Wales Research Involving Human Embryos (New South Wales) Act 2003

Tasmania Human Embryonic Research Regulation Act 2003

Queensland Research Involving Human Embryos and Prohibition of Human Cloning for Reproduction Act 2003

South Australia Research Involving Human Embryos Act 2003

Australian Capital Territory Human Cloning and Embryo Research Act 2004

Appendix D: Glossary of Common Terms

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NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

Appendix D: Glossary of Common Terms Term Description

AHEC Australian Health Ethics Committee (a Principal Committee of the National Health and

Medical Research Council).

Application for a licence Application form for a licence to conduct research activities permitted under section 20(1) of the Research Involving Human Embryos Act 2002.

ART Assisted reproductive technology.

ART embryo A human embryo that was created by assisted reproductive technology for use in the

assisted reproductive technology treatment of a woman.

Blastocyst A 5 to 7 day-old embryo that has an outer layer of cells and a fluid filled cavity in which

there is a cluster of cells called the inner cell mass.

COAG The Council of Australian Governments is the peak intergovernmental forum in Australia.

The members of COAG are the Prime Minister, state and territory Premiers and Chief Ministers and the President of the Australian Local Government Association.

Compliance Ensuring that the requirements of the Research Involving Human Embryos Act 2002 and

the Prohibition of Human Cloning for Reproduction Act 2002 are met.

Embryonic Stem Cell An undifferentiated cell that is a precursor to many different cell types, obtained from a preimplantation embryo, usually at blastocyst stage.

Excess ART embryo An ART embryo that is excess to the needs of the woman for whom it was created and

her spouse (if any) at the time the embryo was created, as determined in writing by section 9 of the Research Involving Human Embryos Act 2002.

Gamete A human sperm or egg (ovum or oocyte).

HREC A human research ethics committee.

Human Embryo Clone A human embryo that is a genetic copy of another living or dead human.

Information Exchange Visit A pre-arranged visit by NHMRC inspectors to provide information about the legislation to interested stakeholders.

Inspection An inspection of records, documents and premises to ensure compliance with licence

conditions and the Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning for Reproduction Act 2002.

Investigation An inquiry into a suspected breach of the legislation with the aim of gathering evidence.

An investigation may be initiated as a consequence of monitoring by NHMRC inspectors, self-reporting or third party reporting.

IVF In vitro fertilisation.

Monitoring Activities conducted to assess the level of compliance with licence conditions,

the Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning for Reproduction Act 2002.

NHMRC National Health and Medical Research Council.

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NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia For the period 1 September 2018 to 28 February 2019

Term Description

NHMRC Licensing Committee The Embryo Research Licensing Committee of the National Health and Medical Research Council.

“Other embryos” “Other embryos” is the term used in the Research Involving Human Embryos Act 2002 to

refer to human embryos created by processes other than fertilisation of a human egg by a human sperm.

Parthenogenetic A process in which an unfertilised egg can be induced to develop like an embryo.

Preimplantation Genetic Diagnosis A procedure used prior to implantation to detect serious genetic conditions, diseases or abnormalities, to which the gamete providers are known to be at risk, to carry or to be predisposed.

Proper Consent Consent obtained in accordance with the Ethical Guidelines on the use of Assisted

Reproductive Technology in Clinical Practice and Research 2017, issued by the NHMRC.

Somatic Cell Nuclear Transfer (SCNT) A laboratory technique used to create a human embryo clone involving removing the nucleus of a human egg and replacing it with the genetic material from a somatic cell (such as a skin cell or fibroblast) or stem cell line.

SCNT Construct An entity created by the process of SCNT, which may or may not divide to become an

“other embryo”.

nhmrc.gov.au