The Human Fertilisation and Embryology Authority (HFEA) regulates fertility treatment and embryology research in the United Kingdom.
It recently asked the public for their views on its major proposals for changing the nature of its work. It wants changes to the law on the regulation of fertility treatment as well as embryo research.
Here are the HFEA’s stated desires, along with our responses to the consultation.
HFEA asks for less strict inspection of fertility clinics
The HFEA wants to have greater freedom to decide how regularly fertility clinics are inspected and how this happens. This is what it said:
“This could be done via periodic licences (whether five years as now, or longer) or a more radical option granting all, or the most compliant, clinics an ongoing licence, subject to periodic and risk-based inspection. This would take away the artificial ‘cliff edge’ of a licence renewal. We would expect that the clinic will continue to meet the required standards unless their performance shows otherwise. Where the standards of care have fallen to unsafe levels, the HFEA should retain the power to shorten, suspend or revoke a licence.”
We strongly disagreed with this. Given the ethical controversies surrounding fertility treatment and embryo experimentation, we believe inspections should continue to be regular and not simply be based on an opinion about current risks. The HFEA’s assumption that clinics will maintain standards unless performance indicates a problem is overly optimistic. Problems need to be spotted early before they get worse.
The HFEA should be able to tackle unregulated fertility services
Question 17 of the consultation asked “To what extent do you agree or disagree that the HFEA should have a broader range of powers to tackle related fertility services not taking place in licensed clinics?”
We agreed with this. At present there are a lot of people engaging in private transactions trading gametes, and this is resulting in lack of publicly available information about children’s biological fathers.
Information about sperm donors should be more easily available
The HFEA proposed that:
“Clinics should be required by law to inform donors and recipients of the potential for donor identity to be discovered through DNA testing websites.
This would affect the ability of children conceived through donated sperm or eggs to find out who their biological parents are.
As part of the consent process, clinics would be legally required to inform donors and recipients about the possibility that any children born from donation could discover their donor’s identity before they are 18. This would change what is currently HFEA guidance into a legal requirement.”
We strongly agreed with this.
Following on from this the HFEA proposed that the law should be changed so that parents and donors can choose anonymity until the child turns 18 (as is the case now), or that information identifying them would become available on request after the birth of the child. The HFEA recommends the following course of action:
“Parents would need to decide at the point of treatment whether they would like to choose a donor who is identifiable before or after their future child turns 18.”
We strongly agreed with this.
HFEA wants donors to be informed of implications of their decisions
The HFEA wants the law to be changed to require all donors and recipients to be able to get information and counselling about the implications of their decision before embarking on fertility treatment. We strongly agreed with this, and made the following comment:
“Identifiable information about the donor should be provided after the birth of a child. Children have a right to know their biological parents, in line with the UN Convention on the Rights of the Child.
Donors and recipients should be made aware of the negative impacts of mass fathering, particularly mass anonymous fathering, namely the increased risk of incest, with all the emotional, social, health and legal implications this carries.”
The HFEA wants details of fertility treatment shared more widely
The HFEA proposes that details of fertility treatment undertaken by individuals should be easier to share with other healthcare settings:
“The Act should be updated to require automatic record-sharing between clinics and the NHS central records systems, to support more joined-up and safer patient care at hospitals and within primary care. Comparable provision would also need to be made for record-sharing with private providers where fertility patients are receiving other medical treatment. Emphasis would need to placed on the fact that the sharing of medical data would only take place within regulated medical care in line with the rules that govern the sharing of other medical data.”
We agreed with this.
The HFEA wants to link embryo donation to consent to research on those embryos
Fertility treatment and embryo research are two distinct practices. However the HFEA wants to bring them more closely together, and extend patients’ consent to donating embryos to donating embryos for scientific research. This is what it proposes:
“Allowing for broader generic consent to research would enable patients to donate to a research bank to store embryos, whether or not their clinic is currently linked to any research projects itself. The research embryo bank could then allocate the stored embryos to a suitable research project(s) when needed, in line with the patients’ consent given to the research embryo bank. This could improve the timely supply of available embryos for research projects and allow more patients who wish to do so to support research. It would make it easier for patients whose clinics do not have links with research projects to donate their embryos to research if they wish to do so.”
We strongly disagreed with this, commenting:
“We believe that human life is sacred from conception and should not be commodified or treated as disposable.
This proposed new consent clause would make fertility treatment a gateway to creation of embryos for eventual destruction. This is inconsistent with the absolute value of human life.”
Question 29 asked “To what extent do you agree or disagree that the Act should explicitly give the HFEA greater discretion to support innovation in treatment?”
We strongly disagreed with this.
We also strongly disagreed with question 30, which asked “To what extent do you agree or disagree that changes should be made to the Act to allow Regulations to be made (by secondary legislation or statutory instruments) to enable future amendments and extensions?”
This was the comment we made about how the HFEA proposes to handle regulation of scientific developments and experimentation on human embryos:
“We are concerned that HFEA has a long history of pushing for relaxation of regulation on experimentation on human embryos including rushing approval of ethically dubious practices before the law has been changed through democratic means:
Twenty years ago it permitted families to conceive ‘saviour siblings’ (children conceived through IVF to provide stem-cell transplantation for an existing child with a fatal condition), when this was not clearly lawful in the UK. The practice of conceiving ‘saviour siblings’ is inherently exploitative of the children who are conceived, as they are not desired for their own sake but for helping save another’s life.
The HFEA gave its approval for animal-human hybrid embryo research in 2008, when Parliament had not even made a decision on the matter.
Two years later the HFEA made it easier for doctors to destroy IVF embryos without asking for special permission, by publishing a list of 116 genetic conditions where this would be allowed. Included in this list were minor conditions that could be treated such as thalassemia.
The HFEA has promoted dubious research practices banned in most countries, such as genetic modification of unwanted IVF embryos in 2016.
We are concerned that the outcome of liberalising the current regime by removing the current ‘necessary or desirable’ threshold for permitting new research on embryos. No indication is given of the future proposed limitations to these changes, which in turn raises concerns about the potential abuse of human life and dignity, with the social, emotional and legal consequences.
We are concerned that what is happening here amounts to changing the law by regulation rather than before Parliament with all the proper checks and balances and democratic accountability. Ethical debates of this importance need to take place in public.
We note that the HFEA desires greater flexibility in regulation in those very areas that have proven most controversial and most undermining of human dignity and uniqueness, such as creation of artificial gametes and embryos, animal-human hybrid embryos and genetic modification. Animal-human hybrid embryos in particular are not supported by the public.
We are concerned that there is no acknowledgment here that it is adult stem cell research has produced successful treatments for many different conditions, whereas embryonic stem cell research has not.
We are disappointed that the HFEA does not take the absolute value of human life into sufficient consideration; we see this in the case of embryo research and testing, which necessarily involves choosing to destroy many human embryos.
Human embryos are the smallest and most vulnerable members of human society; this is particular true of embryos created through IVF. It is all too easy to treat them as expendable commodities that we can create and dispose of at will, because they are so tiny. In all these processes that the HFEA desires to promote further and make more easy, what goes on is the creation of human beings purely for the sake of experimentation, being used for the sake of others. The inherent value of each human life is sidelined completely.”