[Sir Alan Meale in the Chair]
I beg to move,
That this House has considered the welfare of women undergoing IVF treatment.
I want to draw attention to the Human Fertilisation and Embryology Act 1990, which is also known as the HFE Act. It contains worrying failures that are endangering women’s lives and long-term health. As a result of the failures, it is time for Parliament to take action to protect the welfare of women undergoing IVF treatment. IVF is a huge industry, estimated to be worth some £500 million, with most treatment taking place in the private sector.
The Human Fertilisation and Embryology Authority code of practice, which follows from the 26-year-old HFE Act, rightly requires clinics to take into account the welfare of the child before providing IVF treatment, but the HFEA’s narrow interpretation means that women’s welfare is not considered. IVF treatment works by stimulating the ovaries of a woman to grow multiple follicles through the use of a drug identical to the natural stimulating hormone called follicle stimulating hormone or FSH. In turn, the growth of such follicles causes a rise in oestrogen in a woman’s bloodstream.
However, if levels become too high, there can be a profound and adverse effect on a woman’s health. Indeed, extensive research has shown that the high stimulation given to women during IVF can significantly compromise their health. The most common adverse effect following the use of such hormones during IVF is ovarian hyperstimulation syndrome or OHSS, which can be mild, moderate or severe. Mild OHSS can occur in up to 33% of IVF cycles, while 3% to 8% of IVF cycles are complicated by moderate to severe OHSS. Women with severe OHSS are hospitalised, some in intensive care, needing intravenous infusions and drugs to save their lives. In its most severe form, OHSS can be fatal and women have died in the UK as a result of the complication.
Given the serious health risks that can arise from women being treated with too much hormone medication during IVF, does my hon. Friend agree that the HFEA must collect and publish information on the type and amount of drugs given to women so that they can make a more informed choice about the treatment they may receive?
I thought I would get an intervention in while the hon. Lady was in the mood for taking them. I appreciate that she is talking about women who are going through IVF, but has she considered the health effects on women who want IVF but are prevented from doing so due to their age?
I have no comments in my speech that address the hon. Gentleman’s concerns about age and effectiveness. I mostly want to ask the Minister, and through her the Department of Health, to consider how figures are recorded, what the practice is and how we can improve on what is now a 26-year-old Act.
It goes without saying that OHSS has a huge emotional cost to women and a huge financial cost to the NHS, but it is preventable. It is widely known that there are modern OHSS-free protocols that can entirely prevent the syndrome from manifesting, but they are underused. In a 2011 article in The BMJ, authors Bewley and Braude reported on women’s deaths as a result of the complications around IVF treatment. The article states:
“The last Confidential Enquiry into Maternal Death recorded four deaths directly related to IVF via ovarian hyperstimulation syndrome and three deaths related to multiple pregnancy after IVF. Thus, more deaths were related to ovarian hyperstimulation syndrome than to abortion…despite many fewer procedures (for example, 48,829 IVF cycles v 198,500 abortions were performed in the UK in 2007). IVF associated maternal deaths may be underestimates, because record linkage is not allowed by the Human Fertilisation and Embryology Act”.
The article worryingly concludes that:
“infertility treatment now poses a higher risk for maternal death.”
Despite the potentially fatal risks to the health of women going through IVF, there is little accurate or complete information regarding the incidence of OHSS. Instead, the HFEA records it only via a flawed self-reporting system. In practice, that means that clinics must indicate when a patient has been admitted to hospital with severe OHSS when it is entirely induced by their IVF treatment, but that system of self-reporting is inadequate, for obvious reasons. The HFEA’s own data suggest that there is gross under-reporting of the condition.
We know that the number of eggs collected is a predictor of OHSS. The collection of more than fifteen eggs significantly increases the risk of OHSS, without improving the live birth rate. Bearing that in mind, over the first half of 2013, there were over 1,700 IVF cycles in which more than 20 eggs were collected—cycles that therefore posed an increased risk of OHSS. Yet, that same year, only 46 cases of severe OHSS were reported. Between 2010 and 2012, only 60 cases of severe OHSS and 150 cases of moderate OHSS were reported. During the same period, however, there were more than 3,000 IVF cycles in which more than 20 eggs were collected per cycle. Those examples demonstrate the worrying, and dangerous, trend of under-reporting. We also know that the stimulation dose given in IVF is negatively correlated to live birth. In other words, the higher the stimulation, the lower the rate of live births. Research has also shown that a high number of eggs collected increases rates of prematurity and low birth weight in babies. The risks are clear when considering how many cycles feature high stimulation and high numbers of eggs collected.
The HFEA database demonstrates that, between 2008 and 2013, more than 20 eggs were collected per egg collection procedure in more than 18,000 IVF cycles, more than 30 eggs were collected in 2,285 IVF cycles, and more than 40 eggs were collected in 313 IVF cycles. It cannot be stressed enough that those figures show a very worrying trend in IVF treatment in the UK, potentially placing women in real, and avoidable, danger. The evidence also demonstrates the pressing need for a change in legislation and for reliable data to be collected by an empowered regulator.
Furthermore, research from last year has observed an increased risk of ovarian cancer among women undergoing IVF in the UK compared with national averages. That was based on the HFEA database of more than a quarter of a million women who have received IVF treatment between 1991 and 2010. Similarly, a large Dutch study from 2011 of 20,000 women who had received IVF treatment concluded that ovarian stimulation for IVF may increase the risk of ovarian malignancies, especially borderline tumours. The link between ovarian cancer and IVF treatment, as well as the many health risks I have outlined, so obviously justifies the collection of reliable data by the HFEA.
As if the risks were not enough, several clinics are using a cocktail of drugs off-label in a manner for which they were not intended. It is most common in the use of drugs and intravenous infusions during IVF treatment and pregnancy that affect a woman’s immune system. However, they are often used without any supporting scientific evidence, posing significant risks to women. Both the Royal College of Obstetricians and Gynaecologists and the US Food and Drug Administration have issued warnings about the use of drugs off-label. The HFEA, while stating on its website that there is no evidence to support such practice, has admitted that it has no powers to stop it from happening despite being aware of the considerable potential harm posed to women. That clearly needs to change.
Despite the potential threat to women’s safety, the HFEA states that it does not have the statutory authority to take action in the so-called areas of clinical judgment and drug administration. Indeed, in relation to the HFEA’s limited response on the incidence of OHSS, the Minister stated the following:
“They have no express powers concerning the administration of drugs, which is a matter of clinical judgment. Although the HFEA does not collect data about the overall incidence of OHSS, clinics are asked to report when a cycle has been abandoned because of risk of OHSS. Severe OHSS is treated as an incident and depending on the nature of incident and the patient outcome, the HFEA will either expect an incident report or conduct an incident review itself”.
Given the severity of the risk to women that I have outlined, however, that response is clearly inadequate.
Considering the evidence, the absence of comprehensive data collection seems to be the result of a bizarre regulatory remit. That limited remit seems to see the safety of women as secondary. The McCracken review into the HFEA, the recommendations of which were entirely accepted by the Government, argued that the balance of HFEA activities was unacceptable. Recommendation 10 stated:
“The HFEA should conduct a review of the balance of its regulatory focus to ensure that it reflects the relative risks of the different activities that it oversees. Its approach should reflect the relative maturity of the sector it regulates…the need to ensure appropriate oversight of technical developments in the field of ART”—
assisted reproductive technology—
“the need to ensure that appropriate standards of practice are implemented consistently throughout the sector, and the continuing need for a high degree of public assurance regarding the sensitive activities that it oversees. This should not lead to any overall increase in regulatory activity or cost, but a rebalancing of activity.”
Further, as part of the preface to the recommendation, McCracken stated:
“Similarly where there are well known side effects of ART techniques, such as…OHSS…the HFEA should make sure that appropriate standards in managing them are being adopted across the sector...It is worth noting here that the work that the HFEA led in reducing multiple births, the ‘One at a Time’ project, is universally praised and may provide a model for addressing some of these other topics.”
To reiterate, the report states that reviewing the HFEA remit should not lead to an increase in regulatory activity or cost, but simply a rebalancing of its activity. However, the HFEA has not taken any specific action on OHSS or on the other interventions so desperately needed. That is why we need Parliament to act.
What can be done? I have a number of recommendations that I hope the Minister will be able to implement to address the risk to women’s health. First, an explicit commitment to the protection of the welfare of women urgently needs to be added to the Human Fertilisation and Embryology Act 1990 in order to give powers to the HFEA to regulate and monitor drug administration to safeguard the short and long-term health and welfare of women undergoing IVF.
Secondly, the HFEA must immediately start collecting information about all drugs, dosages—whether daily or cumulative—and off-label drugs administered to women during IVF treatment and pregnancy. The HFEA already collects extensive data about embryos, including the use of consumables or culture medium. In other words, what is administered to eggs, sperm and embryos is regarded as of primary importance, but what is administered to women is deemed to be of limited importance. We urgently need to redress that imbalance. Adequate information is desperately needed to gauge the adverse effects of the drugs on gametes and embryos, and to assess their threat to women’s health. Those data are already collected in the USA, Australia and across Europe. It is about time the UK followed suit.
Thirdly, the HFEA should introduce a campaign and licence condition expressly focused on reducing the incidence of OHSS, which can be fatal. That could be modelled on the HFEA’s successful multiple births minimisation strategy.
Finally, the HFE Act should be amended to link the HFEA registry with the hospital, cancer and death registries. That would allow accurate recording and publication of the links between IVF treatment and incidence of severe OHSS, cancer and mortality among women. The HFE Act has typically used patient confidentiality as a reason to have a hands-off approach to collecting important information. Links between IVF treatment and such incidences, however, have already been established in other developed nations by using such data. I am sure the Minister will agree that the more we understand such links, the more we can do to prevent unnecessary harm to women.
We urgently need a regulatory body that has the powers to monitor drug administration during IVF treatment, and to take action where needed to protect the welfare of women. We need to have adequate information to assess the safety of fertility treatments. Indeed, it seems absurd to have a regulator that is dedicated to licensing and monitoring clinics that carry out IVF, but that is unable to take action because it lacks statutory authority.
According to the McCracken report, such changes can be cost-neutral, and the HFEA has already achieved success in other areas. By including the welfare-of-women protection in the HFE Act, alongside the “welfare of any child”, we can finally act on the issue. By doing so, Government can oversee the collection of information about drugs administered to women during IVF treatment and pregnancy. What I am calling for is not unusual elsewhere in the world, and such systems of data collection are prevalent in so many developed countries. Changing the Act will also enable the HFEA to implement fully the recommendations of the McCracken report, in particular that
“appropriate standards in managing…are…adopted across the sector.”
That should include the use of modern OHSS-free protocols that prevent the incidence of potentially fatal OHSS.
Patients undergoing IVF treatment are often vulnerable, forced into paying for treatment themselves, and they desperately need someone to protect them. As more and more people use IVF treatment, the issue is no longer one for only a minority. It is time to give the safety of women the recognition that it desperately deserves in the Act. Let us not sit back and allow another woman to suffer or die unnecessarily during IVF treatment.
In the HFEA, we have a body dedicated to regulating IVF. Let us give it the tools to fulfil its duty. Twenty-six years since its creation, it is time to maintain what is good about the HFE Act and to reform what is inadequate. I hope the Minister will recognise the opportunity for the Government to pioneer a new chapter in the young history of IVF treatment.
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.
Sitting suspended for a Division in the House.
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.
Sitting suspended for Divisions in the House.