IVF: Welfare of Women

Jane Ellison Excerpts

Wednesday 20th January 2016 Westminster Hall

[The Parliamentary Under-Secretary of State for Health (Jane Ellison)]

It is a pleasure to serve under your chairmanship, Sir Alan.

I thank the hon. Member for Mitcham and Morden (Siobhain McDonagh) for raising this important subject for debate. I will take the opportunity to offer, I hope, some assurance to interested Members about what is being done to safeguard women’s health in the area.

IVF has been an amazing gift for millions of people throughout the world, bringing the joy of a child to those who would otherwise not have been able to have one. The treatment was a groundbreaking one that we can be proud to say was invented and developed in the United Kingdom.

Recognising the special ethical approach needed for the creation of human life, the Government introduced the Human Fertilisation and Embryology Act in 1990 to bring a strong legislative framework to the provision of fertility treatments, establishing the HFEA as the specialist regulator. That legislation was supplemented by a review and amendments in 2008, providing a legislative settlement agreed by Parliament, and it has served the United Kingdom well since then.

The hon. Lady eloquently outlined the effects of OHSS, which is a well recognised side effect of the use of ovarian stimulatory drugs. In its most severe form, it can be fatal for the patient if not treated, although thankfully that is rare. There are more than 60,000 cycles of IVF each year, with between 150 and 200 instances of what would be regarded as more serious incidents, known as grade A and grade B. That represents about 0.33% of all cycles.

--- Later in debate ---

[Sir Alan Meale (in the Chair)]

The debate may continue until 4.42 pm but could conclude before then if circumstances permit.

[Jane Ellison]

If the debate has to conclude early, which would be a great shame, I shall certainly undertake to write in detail to the hon. Member for Mitcham and Morden, to respond to the various points she made in her speech.

As I was saying, thankfully, very severe incidents for women undergoing IVF are very rare. There are more than 60,000 cycles of IVF each year, and around 150 to 200 instances of what would be regarded as more serious incidents. That represents 0.33% of all cycles. To put that in context, in 2013-14, there were four grade A incidents that involved a serious threat to health, while in 2012-13 there were none. It is helpful to explain that.

It would also be helpful for me to put on the record that ovarian stimulatory drugs are generally self-administered after being prescribed, and each patient is given instruction from the clinic with appropriate warnings about side effect symptoms to be aware of. Patients are monitored at the clinic through regular ultrasound scans and blood tests to check how the ovarian stimulation is progressing and to look out for any signs of OHSS.

I note the suggestion from the hon. Lady about amending the Human Fertilisation and Embryology Act 1990 to require the UK regulator to collect data on the dosage of drugs prescribed to women during fertility treatment and birth rates and information on any adverse outcomes for the patient. That proposal would also place a duty on all fertility clinics to consider the welfare of women proposing to undergo these treatments. It is important to put on the record that drug dosage levels do not determine the risk to individual women of OHSS. Patients react differently and individually to the same dosage levels, so it is not possible to identify those who may be at the highest risk of an adverse reaction.

In response to the suggestions made, I want to stress that all clinicians have a general duty to consider the welfare of patients when deciding whether it is appropriate to offer any treatment service. The 1990 Act also requires that same assessment to be made of any child born as a result of fertility treatment and any existing children who might be affected by it.

The prescription of stimulatory drugs is not an activity regulated by the HFE Act 1990, as amended, or by the HFEA. Prescribing is a matter for clinical judgment, taking account of professional guidance, of which there is a considerable amount, and the individual circumstances of the patient. All patients who undergo ovarian stimulation as part of their IVF treatment are given information on the symptoms to look out for and are advised to contact clinics immediately if they suspect they may be developing the condition. That includes being given contact details for out-of-hours arrangements, so that they can report immediately. In addition, it is a requirement under the 1990 Act that a woman shall not be provided with treatment services unless she has been provided with information relevant to the treatment, including the potential side effects, and a suitable opportunity to receive counselling about the implications.

Although the HFEA does not collect data about the overall incidence of OHSS, clinics are asked to report treatment cycles to the HFEA where a cycle has been abandoned due to there being a risk of the patient developing OHSS. All severe cases of OHSS must be reported to the HFEA as a serious adverse incident. Depending on the nature of the incident and the patient outcome, the HFEA will either expect an incident report from the clinic or will conduct an incident review itself. The HFEA publishes a detailed annual analysis of the data it receives, and information is also available on the HFEA’s website on outcome rates for each clinic, including information on live birth rates as a percentage of embryo transfers.

I reiterate that the administration of drugs is a matter for clinical judgment. The HFEA’s code of practice advises licensed fertility clinics to provide women seeking treatment with information on the likely outcomes of the proposed treatment and the nature and potential risks of that treatment. That includes the risk of children conceived having, for example, developmental defects, as well as the potential side effects and risks for the woman, including OHSS. That requirement is examined as part of the HFEA inspection regime. The HFEA also asks to see a clinic’s OHSS management protocols before a licensed renewal inspection, so it is part of the regulatory process for each clinic.

In its fertility guidelines, the National Institute for Health and Care Excellence advises clinics that they should inform patients about any potential long-term safety implications associated with IVF. That includes specific reference to limiting the use of ovulation induction or ovarian stimulation agents to the lowest effective dose and duration of use. In addition, the HFEA code of practice sets out the expectation that clinics should follow relevant and appropriate professional guidance in the care of patients, which obviously includes NICE guidance. Clinicians must have the clinical discretion to make decisions about the care of individual patients, taking account of their individual circumstances.

I want to give the hon. Lady assurance about some of the work the HFEA has in the pipeline. In its business plan, the HFEA sets out an intention to increase focus on learning from incidents and adverse events through, for example, publication of a report on clinical incidents between 2010 and 2012; dialogue with the sector about how best to learn from incidents and adverse events; and exploring, with professional groups, whether more data need to be collected better to understand factors contributing to ovarian hyperstimulation syndrome, in order to reduce its incidence. That is in the HFEA’s business plan, which is publicly available.

I would like again to thank the hon. Lady for raising this important and complex subject. I understand and appreciate the concerns she rightly has about the possible impact on women’s health of a reaction to stimulatory drugs during the process of fertility treatment and the consequences. However, I believe that the existing UK regulatory system is second to none in its approach to safeguarding women’s health. I am assured that, within its statutory and regulatory remit, the HFEA is taking proportionate action.

I know that the debate must end here, Sir Alan, so I will write to the hon. Lady with responses to additional points made in her speech.

Question put and agreed to.