The Human Tissue Authority (HTA) has no plans to establish a single national protocol governing the handling or testing of miscarriage tissue, nor to establish a single national protocol for the communication of information regarding miscarriage tissue for parents beyond the current guidance.

However, the HTA guidance on the sensitive handling of pregnancy remains was updated following a recommendation of the Pregnancy Loss Review. It applies to any health service or organisation involved in managing pregnancy loss or termination of pregnancy, and should be used to inform policies and procedures governing the disposal of pregnancy remains resulting from pregnancy loss or termination of pregnancy. The HTA guidance is available at the following link:

https://www.hta.gov.uk/guidance-professionals/guidance-sector/post-mortem/guidance-disposal-pregnancy-remains-following

It includes information on developing a disposal policy, communicating information, staff training, and disposal options, including maintaining records of how and when the pregnancy remains were disposed of.

The Human Tissue Authority (HTA) has no plans to establish a single national protocol governing the handling or testing of miscarriage tissue, nor to establish a single national protocol for the communication of information regarding miscarriage tissue for parents beyond the current guidance.

However, the HTA guidance on the sensitive handling of pregnancy remains was updated following a recommendation of the Pregnancy Loss Review. It applies to any health service or organisation involved in managing pregnancy loss or termination of pregnancy, and should be used to inform policies and procedures governing the disposal of pregnancy remains resulting from pregnancy loss or termination of pregnancy. The HTA guidance is available at the following link:

https://www.hta.gov.uk/guidance-professionals/guidance-sector/post-mortem/guidance-disposal-pregnancy-remains-following

It includes information on developing a disposal policy, communicating information, staff training, and disposal options, including maintaining records of how and when the pregnancy remains were disposed of.

The Human Tissue Authority (HTA) has no plans to establish a single national protocol governing the handling or testing of miscarriage tissue, nor to establish a single national protocol for the communication of information regarding miscarriage tissue for parents beyond the current guidance.

However, the HTA guidance on the sensitive handling of pregnancy remains was updated following a recommendation of the Pregnancy Loss Review. It applies to any health service or organisation involved in managing pregnancy loss or termination of pregnancy, and should be used to inform policies and procedures governing the disposal of pregnancy remains resulting from pregnancy loss or termination of pregnancy. The HTA guidance is available at the following link:

https://www.hta.gov.uk/guidance-professionals/guidance-sector/post-mortem/guidance-disposal-pregnancy-remains-following

It includes information on developing a disposal policy, communicating information, staff training, and disposal options, including maintaining records of how and when the pregnancy remains were disposed of.

The Human Tissue Authority (HTA) has no plans to establish a single national protocol governing the handling or testing of miscarriage tissue, nor to establish a single national protocol for the communication of information regarding miscarriage tissue for parents beyond the current guidance.

However, the HTA guidance on the sensitive handling of pregnancy remains was updated following a recommendation of the Pregnancy Loss Review. It applies to any health service or organisation involved in managing pregnancy loss or termination of pregnancy, and should be used to inform policies and procedures governing the disposal of pregnancy remains resulting from pregnancy loss or termination of pregnancy. The HTA guidance is available at the following link:

https://www.hta.gov.uk/guidance-professionals/guidance-sector/post-mortem/guidance-disposal-pregnancy-remains-following

It includes information on developing a disposal policy, communicating information, staff training, and disposal options, including maintaining records of how and when the pregnancy remains were disposed of.

The Human Tissue Authority (HTA) has no plans to establish a single national protocol governing the handling or testing of miscarriage tissue, nor to establish a single national protocol for the communication of information regarding miscarriage tissue for parents beyond the current guidance.

However, the HTA guidance on the sensitive handling of pregnancy remains was updated following a recommendation of the Pregnancy Loss Review. It applies to any health service or organisation involved in managing pregnancy loss or termination of pregnancy, and should be used to inform policies and procedures governing the disposal of pregnancy remains resulting from pregnancy loss or termination of pregnancy. The HTA guidance is available at the following link:

https://www.hta.gov.uk/guidance-professionals/guidance-sector/post-mortem/guidance-disposal-pregnancy-remains-following

It includes information on developing a disposal policy, communicating information, staff training, and disposal options, including maintaining records of how and when the pregnancy remains were disposed of.

Pain relief, such as fentanyl, can be given to the fetus prior to or during procedures such as the insertion of a needle into the chest or abdomen. National Health Service units are adopting this practice in line with recent international guidance. For major fetal surgery, such as the in-utero repair of spina bifida, NHS England’s service specification provides guidance for the use of fetal analgesia, which is used in all cases.

Approved U.K. COVID-19 vaccines do not contain any human foetal tissue.

The Medicines and Healthcare products Regulatory Agency has confirmed that the Oxford/AstraZeneca, Moderna and Pfizer/BioNTech COVID-19 vaccines, which have all received regulatory approval, do not contain any components of animal origin and no foetal material is present in the final vaccines.

The Department’s Research and Development (R&D) settlement has increased to £11.1 billion for 2021/22. This settlement supports our commitments as set out in the R&D Roadmap and helps to consolidate our position as a science superpower. Specific funding is subject to our departmental allocations process, which is now underway and progressing at pace, including the allocation of this funding to UK Research and Innovation (UKRI).

Most of the research into vaccines for human use that is funded by the Department is carried out through the Medical Research Council (MRC), part of UKRI. The latest available data shows that in 2017/18, the MRC funded £25 million into research aimed at developing vaccines. This data does not record whether this work involved the use of aborted human foetal tissue.

Any use of such tissue would require an ethical review and must be in accordance with legal requirements. The MRC has produced guidance on the ethical and legal requirements for the use of human tissue in the research that it funds.

UKRI welcomes high quality applications for support into any aspect of human health and these are judged in open competition with other demands on funding. Awards are made according to their scientific quality and importance to human health. Where specific funding is allocated in advance for a strategic area of research, such as vaccines, such allocations would not normally specify the research methodology to be used.

The Department’s Research and Development (R&D) settlement has increased to £11.1 billion for 2021/22. This settlement supports our commitments as set out in the R&D Roadmap and helps to consolidate our position as a science superpower. Specific funding is subject to our departmental allocations process, which is now underway and progressing at pace, including the allocation of this funding to UK Research and Innovation (UKRI).

Most of the research into vaccines for human use that is funded by the Department is carried out through the Medical Research Council (MRC), part of UKRI. The latest available data shows that in 2017/18, the MRC funded £25 million into research aimed at developing vaccines. This data does not record whether this work involved the use of aborted human foetal tissue.

Any use of such tissue would require an ethical review and must be in accordance with legal requirements. The MRC has produced guidance on the ethical and legal requirements for the use of human tissue in the research that it funds.

UKRI welcomes high quality applications for support into any aspect of human health and these are judged in open competition with other demands on funding. Awards are made according to their scientific quality and importance to human health. Where specific funding is allocated in advance for a strategic area of research, such as vaccines, such allocations would not normally specify the research methodology to be used.

The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2020 amend the Human Tissue (Quality and Safety for Human Application) Regulations 2007 and regulate the quality and safety of activities concerning human tissues and cells intended for use in human application. These regulations apply to pregnancy remains to the extent they are used for human application. The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2020 do not make any changes to the consent requirements in this area. There will be some changes to the coding requirements, but there remains an underlying requirement to ensure traceability. Traceability of relevant material remains a key factor under the Human Tissue Act 2004, and any establishment working with human tissue under the purposes outlined in the legislation will need to be able to evidence this.

The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 amend the Human Fertilisation and Embryology Act 1990 and regulate the quality and safety of activities concerning gametes and embryos. The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 have not changed the safety and quality standards regarding transportation of human gametes under the Human Fertilisation and Embryology Act 1990 (as amended).

The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2020 amend the Human Tissue (Quality and Safety for Human Application) Regulations 2007 and regulate the quality and safety of activities concerning human tissues and cells intended for use in human application. These regulations apply to pregnancy remains to the extent they are used for human application. The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2020 do not make any changes to the consent requirements in this area. There will be some changes to the coding requirements, but there remains an underlying requirement to ensure traceability. Traceability of relevant material remains a key factor under the Human Tissue Act 2004, and any establishment working with human tissue under the purposes outlined in the legislation will need to be able to evidence this.

The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 amend the Human Fertilisation and Embryology Act 1990 and regulate the quality and safety of activities concerning gametes and embryos. The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 have not changed the safety and quality standards regarding transportation of human gametes under the Human Fertilisation and Embryology Act 1990 (as amended).

The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2020 amend the Human Tissue (Quality and Safety for Human Application) Regulations 2007 and regulate the quality and safety of activities concerning human tissues and cells intended for use in human application. These regulations apply to pregnancy remains to the extent they are used for human application. The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2020 do not make any changes to the consent requirements in this area. There will be some changes to the coding requirements, but there remains an underlying requirement to ensure traceability. Traceability of relevant material remains a key factor under the Human Tissue Act 2004, and any establishment working with human tissue under the purposes outlined in the legislation will need to be able to evidence this.

The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 amend the Human Fertilisation and Embryology Act 1990 and regulate the quality and safety of activities concerning gametes and embryos. The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 have not changed the safety and quality standards regarding transportation of human gametes under the Human Fertilisation and Embryology Act 1990 (as amended).

The Human Tissue Act 2004 makes no distinction between pregnancy remains and other tissue from a living person. Tissue for use in human application or for research is regulated by the Human Tissue Authority (HTA). HTA-licensed establishments maintain inventories of the material they hold and, by meeting expected standards on coding and records, are able to demonstrate full traceability for the human material for which they are responsible, from receipt to final disposal/disposition. Since 2018, the HTA has collected information from its licenced establishments on the import of fetal material intended for use in human application.

All imported human embryos and gametes and all those transported across UK borders are registered with the Human Fertilisation and Embryology Authority (HFEA), as required by the Human Fertilisation and Embryology Act 1990, as amended, and recently updated under the Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020. Further requirements, including traceability requirements, can be found in the General Directions issued by the HFEA and in the HFEA Code of Practice.

The Human Tissue Act 2004 makes no distinction between pregnancy remains and other tissue from a living person. Tissue for use in human application or for research is regulated by the Human Tissue Authority (HTA). HTA-licensed establishments maintain inventories of the material they hold and, by meeting expected standards on coding and records, are able to demonstrate full traceability for the human material for which they are responsible, from receipt to final disposal/disposition. Since 2018, the HTA has collected information from its licenced establishments on the import of fetal material intended for use in human application.

All imported human embryos and gametes and all those transported across UK borders are registered with the Human Fertilisation and Embryology Authority (HFEA), as required by the Human Fertilisation and Embryology Act 1990, as amended, and recently updated under the Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020. Further requirements, including traceability requirements, can be found in the General Directions issued by the HFEA and in the HFEA Code of Practice.

The Human Tissue Act 2004 makes no distinction between pregnancy remains and other tissue from a living person. Tissue for use in human application or for research is regulated by the Human Tissue Authority (HTA). HTA-licensed establishments maintain inventories of the material they hold and, by meeting expected standards on coding and records, are able to demonstrate full traceability for the human material for which they are responsible, from receipt to final disposal/disposition. Since 2018, the HTA has collected information from its licenced establishments on the import of fetal material intended for use in human application.

All imported human embryos and gametes and all those transported across UK borders are registered with the Human Fertilisation and Embryology Authority (HFEA), as required by the Human Fertilisation and Embryology Act 1990, as amended, and recently updated under the Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020. Further requirements, including traceability requirements, can be found in the General Directions issued by the HFEA and in the HFEA Code of Practice.

The Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2020 cover the quality and safety of activities relating to organs intended for donation and transplantation and do not cover pregnancy remains.

The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2020 amend the Human Tissue (Quality and Safety for Human Application) Regulations 2007 and regulate the quality and safety of activities concerning human tissues and cells, intended for use in human application. These regulations apply to pregnancy remains to the extent they are used for human application.

At the time of a marketing authorisation, the Summary of Product Characteristics (SmPC) will include a full list of the drug substances and excipients. There are statutory requirements for what is required in an SmPC document and we will follow those for Covid-19 vaccines. More information is available in the “Guideline on Quality Aspects Included in the Product Information for Vaccines for Human Use”.