Ivfworld.com, the Independent Patients and Ratings' Organisation 

Ivfworld.com's Response (Part One)

To The Department of Health’s Consultation on The Review of the Human Fertilisation and Embryology Act

The Model and Scope of Regulation

There is definitely a place for regulating the development and use of human reproductive technologies. However, misunderstanding drives much of the regulation currently in place. Those best able to understand what assisted conception is truly about, both emotionally and physically, are the patients themselves. Patients’ organisations are the majority stakeholders in this industry, accounting for more than 92 per cent of the total, and have the type of in depth understanding that other stakeholders are crying out for. Which is why it makes sense for patients’ organisations to be the key group involved at every stage of decision-making, in order to help the world of assisted conception to become more transparent and to raise standards.

If regulation is to work effectively, the majority stakeholder (patients’ organisations) needs to be acknowledged with a significant stake in the overall structure through patients’ organisations including IVFWORLD.COM. Recognising the role of the majority stakeholder is the only way to create an effective and balanced regulatory environment.

The industry would benefit from viewing patients’ organisations as the answer. After all, patients know what takes places at the grass roots level on a daily basis at fertility clinics, as such their intimate knowledge and experience is invaluable and would be best reflected as a fundamental pillar of a new structure.

It is deeply disturbing that the Human Fertilisation and Embryology Authority, the body responsible for licensing and monitoring IVF clinics, appears to lack a grasp of some of the fundamental issues. The HFEA appears to have created an inner sanctum it can rely on for support and does not represent independent patient organisations such as IVFWORLD.COM. In our experience, the HFEA also does not appear to deal with complaints about its own organisation, which is worrying given that the HFEA is the watchdog for fertility clinics. Should not the HFEA be leading by example?

IVFWORLD.COM believes it is time for the HFEA to relinquish control, making way for the majority stakeholder (patient organisations) to step into a key role within a new structure,

with the contribution of ongoing advice from other stakeholders, so that regulation of the fertility industry can move into the twenty-first century.

We agree with the House of Commons Science and Technology Committee that the HFEA does not represent all the interested parties and we agree that it should be replaced. However, the Committee has sidelined the majority stakeholder – the patients themselves. IVFWORLD.COM proposes the focus be put on giving the majority stakeholder the key role in decision-making and professional organisations for doctors the role of advising the majority stakeholder.

The Way Forward: To Set Up A Patients’ Authority

IVFWORLD.COM proposes that legislation gives the majority stakeholder a formal role in the shape of a new Patients’ Authority, which would be integrated into the foundations of a new system, responsible for regulation, standards for assisted reproduction, clinic inspections, embryo research and the industry overall. The new Patients’ Authority would have patient organisations including IVFWORLD.COM on its Board.

The new Patients’ Authority would replace the Human Fertilisation and Embryology Authority.  It would take on all the responsibilities of the new body proposed by the Department of Health, the difference being that the emphasis would be on the majority stakeholder (patient organisations) leading the body. The chairperson would be someone who runs a patients’ organisation and preferably has experience of fertility treatment. The Board would consist of other genuine patients’ organisations run by current or former patients (60%), and the rest of the Board would include medical, scientific and ethical expertise.

The new Patients’ Authority would consider applications for licences, regular inspections of clinics issuing codes of practice. People working in fertility clinics are likely to treat patients with greater respect if they are involved in the regulation and licensing process. The Patients’ Authority would also provide advice to the Government where appropriate, given that the Authority embraces the views of the majority stakeholder (patients’ organisations) as well as other interested parties.

The chairperson of the Patients’ Authority would be appointed by independent patients’ organisations that are run by patients, including IVFWORLD.COM, and have a minimum of two thousand members[ie each patient organisation participating would have a minimum of two thousand members]. In this way, patients would be given a genuine voice in the regulation of the fertility industry which would not exist in the way it does without them. The NHS Appointments Commission would be available to advise these independent patients’ organisations.

The Patients’ Authority would have the power to withdraw or vary licences in response to breaches of regulation. It would also be able to impose licence conditions on licence holders. The goal would be to raise standards within the fertility industry, and where there are breaches the maximum penalty would be five years imprisonment in, for example, the following areas:

·         Giving a patient an aggressive drug regime when they have not consented to this, which results in the patient’s oestrogen level soaring above 15,000 before the Trigger Injection,

hyper stimulation, cysts or any other problems

·         If a patient asks and the doctor refuses to give patients information about their scans (on the day they take place), how many follicles they have in their ovaries with scan photographs if the patient want them.

·         If a patient asks and the doctor refuses to provide precise information on the day of the egg collection about how many follicles were aspirated from the left and how many follicles were aspirated from the right ovary on the day of Egg Collection.

·         If the clinic provides false figures about its live birth rates.

·         If the clinic does not tell the patient at the first appointment (and give them a sheet of costs) exactly how much the treatment will cost as a whole in varying circumstances, for example if they do or don’t have ICSI, and precisely what this treatment will

           include. Charges can mount up very quickly. Some doctors

           include blood tests in the fees for a treatment cycle, others

           charge patients as much as £80 for each one which can

           increase an already frighteningly high bill by a substantial

           amount.

·         Inform the patient a minimum of three weeks before the treatment what drugs they will be taking during a fertility cycle. This is particularly important with private treatment, as doctors tend to tell patients what drugs they will need at the last minute so they have to purchase them from that clinic, which may charge a great deal more than purchasing them elsewhere or prevent that patient from receiving an NHS prescription for those drugs so they are free-of-charge because there isn’t enough time to arrange it.

·         Putting the wrong embryo into a patient.

Ten years imprisonment would be maintained for: placing a non-human embryos or gametes into a woman, placing a human embryo in an animal or mixing animal and human gametes.

The Majority Stakeholder

IVFWORLD.COM, the association of IVF patients with members at clinics all over the UK, believes the only way for the system to work effectively is for the patients to be directly involved in laying down the standards and the regulation of clinics and the fertility industry in general. Sidelining the majority shareholder will not produce the type of structure that protects patients and their offspring effectively. It will simply fail to come to grips with what is happening at the grass roots level, fail to come to grips with some of the key issues and fail to represent the majority stakeholder.

A New Patients’ Authority would have a direct and pivotal role in the creation of standards, regulation, licensing and inspection of IVF clinics, patients and the fertility industry in general. This Patients’ Authority would be properly represented within the formal regulatory structure for assisted conception and would be an integral part of the system that regulates and sets standards for fertility clinics, patients and the industry overall.

IVFWORLD.COM has the type of experience, sensitivity, knowledge and understanding that we believe is necessary to genuinely take the patients point of view into account and to rid the industry of the low standard of treatment and some of the questionable occurrences patients have to put up with in some cases.

IVFWORLD.COM, which represents patients all over the UK, has an in depth and wide-ranging understanding of what is going on at IVF clinics at the grass roots level when no one else is watching. We have the type of knowledge about assisted conception that other people, including doctors, do not. For example, our members have direct experience of how the mixture and dose of drugs prescribed affects their bodies. They also have in depth knowledge of how clinics work on a daily basis as this impacts them directly, where improvements are needed and where doctors are breaking the standards and rules.

Transparency: Access to Information For Patients

The whole thrust of UK regulation is currently on regulating fertility patients, rather than ensuring patients who are undergoing stressful treatment receive precise details of what they want to know and that the whole process is made completely transparent. For example, some fertility doctors are withholding precise information about the number of eggs aspirated from each ovary during a patient’s egg collection and are failing to account for each of the follicles that the patient has produced.

If a doctor fails to account for all the follicles a patient has produced, how can the patient be sure that the doctor does not intend to use any of their follicles for research; that none of the follicles have been destroyed by errors the doctor has made; or that the doctor has simply not bothered to aspirate all the follicles and has only gone for four or five because it saves time (only one or two embryos can be transferred anyway and some doctors prefer not to freeze embryos as they can make more money by putting a patient through another treatment cycle), so the rest of the follicles are left to fester in the patient’s ovaries?

Remedy The Imbalance

It is crucial for IVFWORLD.COM to be represented on the Board of an independent Patients’ Authority in order to remedy the current imbalance. The focus has been on what role doctors, Parliament and everyone else in the minority should play, with little reference to giving patients who are in the great majority a concrete role in the regulation and licensing of themselves, doctors and the industry as a whole.

The latter is reflected, for example, in the way the questions are phrased in the consultation paper. It is clear that the questions are directed towards doctors, Parliament and the HFEA and it appears that informing patient organisations about the consultation was an afterthought (although this is definitely a step in the right direction). It is also reflected in the way the HFEA operates. At present, the HFEA wants the industry to believe it is taking the patients’ point of view into account, but in our experience it has been extremely resistant to giving IVFWORLD.COM a voice and does not represent our interests.

We believe it is crucial for IVFWORLD.COM and other patients’ organisations to have a major role in regulation and licensing. If IVFWORLD.COM had a direct role in the regulation and licensing of clinics, then doctors would become more accountable at a grass roots level and would be more careful about treating patients with the respect they deserve. With a Patients’ Authority overseeing the industry and standards, more decision-making could be devolved down to patients and doctors so that cases could be dealt with on an individual basis.

IVFWORLD.COM proposes that legislation gives the majority stakeholder – patients’ organisations – a formal role in the shape of a new Patients’ Authority, which would be integrated into the foundations of a new system which formulates regulation, standards for assisted reproduction, clinic inspections and embryo research. The Patients’ Authority would have patient organisations including IVFWORLD.COM on the Board.

Ageism and Sexism in the NHS

The NHS is offering free IVF treatment to women under 40, but is discriminating against women over this age and forcing them to pay for private treatment. IVFWORLD.COM members do not believe that the NHS should be allowed to discriminate against a generation of women who are trying to conceive later in life because they have pursued careers. Why should a 40-year-old woman be punished for her age by having to pay thousands of pounds for IVF treatment when women younger than her receive treatment free-of-charge? One cycle costs around £6,000 in a private clinic and given that it takes an average of three cycles to fall pregnant, the total cost could set her back by £18,000.

Men aren’t discriminated against if they decide to conceive at any age, MP David Blunkett, who became a father in his late fifties, is a prime example, so why discriminate against women especially if they have not yet had the menopause? The NHS needs to take on board the word equality in the area of assisted conception. We live in the modern world. Women work as well as men, and couples tend to settle down to have children later in life than they used to. The NHS needs to move into the twenty-first century and provide free IVF treatment to everyone up to the age of 55, which is a natural cut off point for the menopause.

The NHS should give everyone an equal opportunity. For example, if someone in the NHS refused to treat a person for breast cancer because they are over 60 and forced them to pay for private treatment instead, there would be uproar. IVF treatment is no different to any other treatment. Women of any age who have infertility problems should be treated equally.

Research overturns traditional beliefs about female reproduction

A number of fertility doctors are ignoring a radical research finding that reveals women are not in fact born with a lifetime supply of eggs, overturning one of the fundamental beliefs on which reproductive medicine has been based for over fifty years. The research carried out by Joshua Johnson of Harvard Medical School was published more than a year ago in Nature magazine, but fertility doctors are either not keeping up with the latest developments or are reluctant to embrace the findings of this research as it has such far-reaching implications for their work and how they explain the reproductive process to patients.

It has long been assumed that women are born with a fixed supply of follicles that can produce eggs in their ovaries, while men continuously generate new sperm cells throughout their adult lives. But, according to the research carried out by Johnson, female mammals have a reserve supply of cells that replenish the pool of follicles as follicles die.

The results revealed that a reserve of stem cells that form the building reproductive cells exist in females mammals as they do in male mammals. This is a radical departure from previous thinking and, in a study by Antonin Bukovsky in Reproductive Biology and Endocrinology; it has now been shown that if stem cells are removed from the ovaries and exposed to a growth-stimulating hormone, human eggs can be grown in a laboratory.

These developments have enormous implications for couples thinking of fertility treatment. When procedures have evolved to a stage that is considered safe, some patients may want to explore the possibility of growing eggs from stem cells in a laboratory rather than being pumped with huge doses of drugs in order to produce a larger than normal number of follicles in their ovaries for IVF treatment. Growing eggs in a laboratory would avoid the risk of Ovarian Hyperstimulation during an IVF cycle and the unknown impact of having large quantities of fertility drugs injected into the body during a series of IVF cycles that may or may not produce a positive outcome. Such an advance could also offer couples the possibility of growing an egg from their own DNA rather than opting for egg donation, solving the problem of a shortage of donors and making it easier for the child as the child would be of the DNA of both parents and there would no longer be an egg donor so the issue of a child contacting an egg donor at the age of eighteen would become redundant.

However, doctors at fertility clinics are still touting old beliefs when they interact with patients. “You’re how old?” said one fertility doctor to a new patient recently as she sat down in front of his desk for her first consultation. “I’ve just turned 37,” she answered. “That’s ancient in terms of reproduction,” he said coldly, as if talking to an inanimate object with no feelings. “But I’ve only just turned 37”, she said with tears starting to well in her eyes.”

The doctor continued unmoved. “Women have a fixed number of eggs from birth and they start to deteriorate rapidly as they get older,” he said in a clinical manner as if she were merely an experiment. “Sperm cells, on the other hand, are renewed continuously.” One could argue that this fundamental belief is borne out of sexism. It has been around for decades and even though it has been challenged by research carried out at one of the top medical schools in the world, many fertility doctors appear reluctant to accept the findings, as it would mean changing the way they think and do things in the field of reproduction.

The woman walked out of the consultation in a state of shock, not because of the regime the doctor had suggested for her IVF cycle but due to the way he had openly humiliated her by calling her “ancient”. He had no bedside manner to speak of and made it quite clear that if the treatment cycle did not work than it was her body that was to blame even though all the tests had concluded that everything was functioning as normal. The message was that her body was fully responsible for whether or not the treatment worked, which is a huge burden to carry. Another fertility doctor said to one of his patient’s: “We don’t make mistakes”.

It is convenient for doctors to stick to the traditional theory that women were born with a fixed number of eggs, because they can more easily pass on the blame to the patient if the treatment does not work rather than accepting responsibility for putting them on, for example, an unsuitable drug protocol. But, at some point, doctors will be forced to accept the reality and change the way they work and explain things, in order to take into account the latest ground-breaking research that challenges one of the fundamental views of reproductive biology and brings this field into the twenty-first century.
 

Embryo Transfers – Customising Treatment is Vital

There is currently little room for doctors to customise treatment to an individual’s specific situation. If a patient has had one failed IVF cycle and is over the age of 40, then the doctor should be allowed to transfer back more than two embryos at their discretion, with the decision of how many embryos to transfer back based on a clinical decision in consultation with the patient. The risk of the latter resulting in multiple births in these difficult cases is negligible.

If the world was a perfect place and technology had advanced further, then transferring back one embryo would not reduce the chances of success. However, the chances of an IVF cycle producing a live birth is already well below 30 per cent per cycle on average and less than ten per cent for those aged over 40 when two embryos are transferred back into the women during a treatment cycle. These low percentages would fall dramatically if the number of embryos that could be transferred were reduced to one. It does not make sense at this stage in the evolution of assisted conception to opt for such a blunt approach.

Reducing the number of embryos to one would mean patients having to go through an increased number of IVF cycles to achieve a pregnancy. The latter would cost the NHS more money and private patients would be even more crippled by the already fiendishly expensive costs of an IVF cycle. In addition, putting patients through an increased number of IVF cycles, because the chance of each cycle succeeding has been reduced, is a greater risk to the patient’s health. Each IVF cycle involves a patient injecting a large quantity of drugs into their body, which has unpleasant side effects. The fewer cycles a patient has to go through to achieve a pregnancy, the less risk there is of them developing cancer in the future as a result of the treatment. IVF treatment is also traumatic and can cause patients much stress. If there is a possibility of reducing the trauma, by increasing the success rate of each cycle then surely this is a sensible path to pursue. The aim should be to reduce the number of IVF cycles a patient needs to achieve a pregnancy in a responsible manner, not to increase this number by ruling that only one embryo can be transferred in all cases.

Reducing the number of embryos transferred to one would of course generate much more money for private clinics and increase the size of the fertility industry as many more cycles would have to be undertaken in order to achieve the same success rates as at present. But this is not an outcome that would benefit patients.

The regulation in this area seems to be driven by misunderstanding and fear. Doctors need the ability to customise treatment to an individual in consultation with that individual. For example, if a patient is 26 years old then it would make sense to transfer one embryo in the first cycle but two in subsequent cycles but if a patient is 40 years old and has had two failed cycles of IVF then it would make sense to take all the factors into account and base a decision on how many embryos to transfer on the facts. Blindly following a guideline for the general population does not take into account an individual’s specific circumstances. We propose that the current limit of transferring three embryos in women aged 40 and over is maintained, until a time when embryo selection has advanced to a stage where the percentage chance of success with one embryo is 50 per cent.

Natural IVF – Less Risk, Lower Cost, Better Chances

Given the discussion about moving towards the selection of one embryo, IVFWORLD.COM proposes that clinics are required to offer all patients natural IVF as an option if the women is ovulating normally on her own. We also propose that in cases where a doctor is likely to transfer one embryo only, for example, if a patient is 26, doing her first cycle and ovulating naturally on her own, then the doctor should be required to use natural IVF.

The latter is less of a risk to the patient than prescribing an aggressive concoction of drugs to stimulate her ovaries into producing more eggs than she would naturally each cycle, which increases her likelihood of contracting ovarian or breast cancer. It is more likely she will produce a mature egg and that her uterus will provide the optimal environment for implantation with Natural IVF. In contrast, pumping a woman with fertility drugs increases her chance of ovarian and breast cancer, gives her the symptoms of a menopausal woman but worse and can have other unpleasant side-effects such as hyperstimulation.

Natural IVF cycles have fewer risks attached and they are much cheaper than stimulated cycles. There has been an advance in embryo culture media which doctors should take full advantage of. If the single embryo is transferred at the morula or blastocyst stage, then it has a greater chance of success, then transferring it after 2 or 3 days. If an embryo fails to reach the morula or blastocyst stage in optimal conditions, then the evidence suggests it would not have grown to this stage in the uterus.

Natural IVF could also be used if a woman is ovulating and wants to try IVF with her own eggs, before pursuing the path of egg donation; if she has built up resistance to stimulation with fertility drug; or if she tends to hyperstimulate.

Doctors appear to be resisting Natural IVF because it involves closer monitoring and collecting the egg at just the right point in time before ovulation. Private doctors tend to be most vociferous in negating Natural IVF as they would earn far less money from this procedure, while having to give patients more individual attention. Natural IVF is not good for the private clinic’s bottom line, but it would dramatically reduce costs for the NHS. It is also a far safer way forward than stimulated IVF cycles, as it does not increase the risk of a woman contracting ovarian or breast cancer and put patients through unnecessary trauma. We believe Natural IVF is the path of the future, and once technology has advanced far enough it will become the norm everywhere.

Standardise cost of IVF treatment for patients

IVFWORLD.COM proposes that the cost of treatment should be the same everywhere, in other words private treatment should cost no more than NHS treatment. In addition, patients are often forced to buy expensive drugs from private clinics even if they could get them on the NHS or cheaper elsewhere. Private clinics often don’t tell patients until the last minute what drugs they have to take, making it virtually impossible for them to buy them anywhere else but at there clinic which they make a huge profit on. If a patient goes for private treatment, but their GP has said they will write an NHS prescription for the drugs, private clinics often make this very difficult to organise as it means the private clinics cannot sell expensive drugs to the patient. Private clinics make almost as much money on fertility drugs as they do on the treatments. We propose that clinics tell a patient a minimum of twenty days in advance what drugs they will need to take during their fertility treatment and provide them with a prescription for these drugs.

The use of so-called Artificial Gametes

Eggs grown from a person’s DNA in a laboratory promise a big breakthrough for infertile couples in the future, if used in a responsible and safe manner as with all other procedures related to assisted conception. If a woman is not producing eggs or they are defective in some way, then having the possibility of growing an egg from her DNA in a laboratory would mean there is no longer a need for egg donors.

It would mean the current shortage of egg donors, due to many of them being concerned about not being allowed to be anonymous, would no longer be an issue. This advance would also eliminate the worry about how the child could react to being told it is not created from a parent’s DNA; and the child wouldn’t have a burning desire to contact a donor when it reaches the age of consent, because there wouldn’t be a donor. In addition, the current issue some donors about whether a child created with donor egg might contact them in the future would no longer be relevant.

If there was still a need for a donor and the donor’s DNA was replaced with a parent’s DNA, this would also be a big step forward, assuming this development reaches a stage when it is considered to be safe. In this scenario, there would not be a shortage of donors, because they wouldn’t have to worry about a child contacting them at the age of 18, and the child and recipient mother would feel more comfortable as the original egg would have the recipient mother’s DNA.

There is some way to go before the latter can be proven to be a safe procedure, but we believe this will occur at some stage. This issue is about looking to the future and what is best for everyone involved directly in the process. There can be no doubt that it is preferable for the parents and for the child to be of the same DNA, as this eliminates many of the difficulties arising from an egg donor, recipient and their offspring relationship where the DNA is the DNA of the egg donor. If there is a way to achieve this responsibly, then we believe it should be embraced as a panacea that would solve a number of problems infertile couples face at present and be of benefit to the offspring. We believe regulation should embrace the possibility of future developments, as fertility research is moving at a swift pace.

Fresh Gametes and Regulation

The problem with applying regulation to a couple’s “fresh” gametes is where do you stop. It is not possible for regulators to license two people who come together for sexual intercourse where a couple are fertile, and it is important to take into consideration the need for an infertile couple who are having difficulties conceiving to have as much privacy as possible. Too much regulation could lead to criticism that the Government is attempting to control couples having sexual intercourse. Regulation in this area should be limited to safety and quality.

Internet Services and Regulation

If an Internet website is set up to deal solely with the supply and demand of human gametes, then it should have to follow guidelines to ensure the safety and quality of what is supplied. For example, if a website supplies sperm to people, then it should have to ensure certain tests are carried out on that sperm, there is criteria for how a sperm donor and recipient are matched; and that the recipient receives details about the characteristics of that sperm donor. However, there is a danger of trying to regulate “fresh” gametes, as it crosses over into the territory of any couple in the UK having sexual intercourse together. If too much regulation is applied, it might encourage some people to have sexual intercourse for the specific purpose of donating sperm and that would be both unpleasant and could not be regulated.

There is another danger here. People should have the freedom to discuss whatever they want to on issues related to assisted conception, and the Government should not attempt to control their freedom of speech. If the Government attempts to control Internet websites, then it could be accused of simply attempting to suppress what may be critical of the Government and favouring websites that openly support or are linked to or are funded by the Government. Freedom of speech is important in the world of infertility, as couples struggle long and hard to achieve their dream and it is crucial that they feel they can talk openly about it. The latter is becoming increasingly important with the number of infertile couples rising and the importance of doing what is possible to make them feel it is okay to be open about the difficulties they face. Open debate is far healthier than suppression.

Training and Regulation

The regulator should have the ability to licence the training of clinicians and researchers, ensuring that clinics do not employ cheap staff from abroad who do not have the appropriate qualifications or experience. The regulator should ensure that clinics are not elevating the position of doctors, clinicians or researchers from overseas who do not have the appropriate qualifications to take on the responsibilities they have been given.

Going abroad for Treatment

The HFEA Act should only apply to what takes place within the UK. Most couples who go abroad for treatment do so because it can be cheaper to have treatment abroad, the clinics can be more advanced, they may have higher success rates as do some US clinics or the waiting list for egg donors is much shorter. People looking to have treatment abroad tend to do a great deal of thinking before they take this route, often go and see a counsellor or talk to family and friends. They also tend to do a great deal of research first by contacting the clinics for information, talking to people who have been to those clinics and generally preparing themselves by going on a healthy diet and doing what they can to de-stress.

Going abroad for treatment is not an easy path to take, but then fertility treatment is not easy wherever it takes place. People need to have the freedom to make choices, and if they want to have treatment outside the UK they need to be able to do so.  UK clinics tend to abandon patients when they ask a clinic if they would help monitor their cycle before they go to the overseas clinic for treatment. If, for example, a patient cannot find an egg donor in the UK and they manage to find a clinic overseas that does not have a long waiting list, then they may decide to go there. The important step is for a patient to ask their doctor in the UK to communicate with that clinic overseas, so the patient is not alone in the process. The problem comes when UK staff at clinics do not properly monitor patients who go abroad, for example they give them a quick scan without writing a proper report about it so the patient can fax it to their overseas clinic rather than carrying out a full scan and writing a full report to be faxed to the overseas clinic.

IVFWORLD.COM proposes that the Government acknowledge that patients have the freedom to choose to go abroad for treatment and does what it can to help them to achieve their goal in the safest and best possible way. The Regulator should make it clear to UK clinics that they must help monitor the process if asked to and offer counselling to patients going abroad for treatment. There should also be a standard charge for carrying out scans and blood tests at a UK clinic if a person is doing treatment abroad. At present, UK clinics tend to charge over the top for helping to monitor a cycle for treatment overseas, while failing to do so in a thorough manner.

The welfare of the child is crucial. However, it is difficult for medical practitioners to make judgements on the future commitment of parents to raising children, or their future ability to provide a supportive environment. In general, people show that they have a strong commitment to raising a child by making the decision to have assisted conception treatment – it is not an easy path to pursue and takes a great deal of determination and focus.  The risks could be minimised within the constraints of available knowledge, but the danger is that judgements about the future may be wrong and there is a danger of discriminating against people with fertility problems. If people with infertility were subjected to the latter, then it would be sensible to apply the same rules to people who conceive naturally. However, the latter would be almost impossible to regulate in practise.

IVFWORLD.COM proposes that patients are treated as innocent before proven guilty in the case of the welfare of the child and that if there is a focus it should be placed on medical problems, otherwise there is a danger that this industry will become so bureaucratic that much of what is prescribed will fall by the way side in practise.

Storage of Gametes and Embryos

Written Consent & Withdrawal or Variation of Consent: The requirement for written consent must be maintained in order to protect patients and donors.  However, once consent has been given for the storage of an embryo, the HFE Act should be changed so that consent cannot be withdrawn in the case of the woman wanting to use the embryo for her own fertility treatment.

The law should also be changed to require the withdrawal of the consent of both parties whose gametes were used to create an embryo in order to allow a stored embryo to perish, otherwise it should be stored for statutory maximum storage period.

Statutory Storage Period: Storing gametes or embryos, whether or not it is from a donor, can save a woman having to put herself through all the risk and trauma of an IVF cycle. We propose that clinics optimise their storage facilities and use the highest tech equipment in order to store gametes and embryos successfully. The latter decrease the number of IVF cycles a woman has to go through, because clinics would be freezing their gametes or embryos more frequently and for longer periods of time. Fewer cycles means that the NHS would save money, but the private clinics would not make such a big profit, so are unlikely to favour this move.

We propose the limit on the storage of gametes or embryos is raised to twenty years, which would be crucial, for example, if a woman of 15 got ovarian cancer and decided to store her eggs for future use. She may only want to have children when she gets married and if that only happens in her thirties and the length of storage of her gametes was only ten years then she would could not have children unless she opted for egg donation.

Requirements to Provide Relevant Information

Clinics should be required to give every patient information about IVFWORLD.COM, which is a totally independent non-profit making patients’ organisation – so they can tap into the valuable resources we offer and that so many of our members consider to be a lifeline.

The shock of someone finding out they cannot conceive naturally can go right to the heart of who they are. IVFWORLD.COM aims to help them ease the pain and feel a genuine sense of relief, by welcoming them into its community where other people are going through similar experiences. We offer patients a safe place to meet and talk to each other to help relieve stress, make new friends at a difficult time in their lives, tap into mutual support, meet up with other people going through similar experiences in their area and more.

At the same time, clinics should also be required to offer counselling to fertility patients going through fertility treatment of any kind.

Section 4 (reference to public consultation document)

Requirements to offer counselling and provide relevant information

4.35: Yes, it should be a legal requirement for licensed centres to provide “such relevant information as is proper”

4.36: Yes, that requirement should be extended to require clinics to be specific about which treatments they provide are outside the National Institute for Clinical Excellence’s clinical guideline on infertility treatment.

4.40:Yes, it should remain a legal obligation for licensed centres to offer a suitable opportunity to receive counselling.

4.41: The legal requirement to offer a suitable opportunity to receive counselling should apply in all cases of treatment, not only in donated gametes and embryos.

Remuneration of donors

4.45: A new Patients’ Authority should set the appropriate level of compensation for donors (see part one of Ivfworld.com’s response for further information about the Patients Authority).

4.47: Donors should be given a set payment for providing gametes to a recipient, which is over and above their expenses and inconvenience. The latter would be one step towards helping to resolve the great shortage of egg donors.

Section Five
Screening and Selection

Sex selection should not be permitted in cases where a person who is able to conceive naturally wants to select a male or female embryo. However, choosing the characteristics of a child in general should be allowed to continue to be permitted where a couple use donor gametes to ensure the child bears similar physical characteristics.

Healthy human embryos left over from treatment should be used for “egg donation”, as one way of helping to deal with the severe shortage of egg donors.

If PGD can genuinely be used to screen out a wider ranger of diseases and disorders, it should be made available There must be checks and balances to ensure that doctors don’t use patients as human guinea pigs for their research. A new Patients Authority in unison with the professional bodies embracing doctors should decide what disorders can be screened for using PGD.

Pre-implantation Tissue Typing

5.19: This is a rapidly evolving science, which needs to be given the flexibility to allow the UK to maintain its position at the forefront of research and development. The danger of broad criteria is that they would soon become out-dated in this rapidly changing environment, although there may be parameters that are so broad as to embrace a very significant degree of flexibility. Doctors should have a legitimate reason to use PGD. They should not be permitted to use PGD simply because they want a chance to carry out more research in this area.

5.20: Yes, there should be a prohibition for screening in, or selecting for impairments and disabilities.  Only screening out, or selecting embryos free from impairments and disabilities should be permitted.

5.22-5.23: The uses of embryo screening and selection should be a matter for patients and clinicians, within the legal limits set by Parliament.

Screening and selection of gametes

5.24-5.27: The selection should be permitted to continue. If there are any unused embryos should be offered to patients who want donor embryos or eggs as a first priority.

Sex Selection

5.28- 5.32: Sex selection should not be permitted for anything other than medical reasons. Those who have healthy pregnancies should not be tampered with in any way. Strict rules need to be applied here so that doctors do not circumvent them. (See under the heading Screening and Selection for further details.)

Genetic modification of gametes and embryos in treatment

5.33-5.38: The modification of an embryo or gametes for the purpose of enhancement should be outlawed. The modification of an embryo for repair is not a possibility at the moment, but may become possible in the future. If at some point in the future it becomes possible to repair an embryo with, for example, spina bifida, then this would herald a big step forward. However, the latter is not currently a possibility and if it does become a possibility then the safety of these procedures would need to be established before given them the green light. Legislation should take into account that advances in this field could bring about a situation whereby it is safe to provide certain modifications to remedy disabilities and disease.

Section Six
A central register

A centrally based database should be maintained in respect of donor treatment and other treatment. However, if there is a central register of donor-conceived people and other treatment, it should be run by a new Patients’ Authority (see part one of Ivfworld.com’s report for details).

Information about donors

6.15-6.20: Parents should be given non-identifying information at the stage of treatment, so they have the option to provide this information to the child. At the stage of treatment, legislation should specify that parents be given non-identifying information, including at the very minimum: blood group, age, height, weight, hair colour, eye colour, education (eg 9 O levels, 3 A levels, BA Hons, MA, PhD) and hobbies.

6.23: Donors should not have the rights to any non-identifying information about children born as a result of donation. If a child is legally able to contact the donor at age 18 and decides to do so, that is up to the child. The danger is of a donor trying to contact the child born of the recipient. The child must be the key and protected from the latter.

Information about siblings

6.25: Donor-conceived people should not be given access to information about their donor-conceived siblings.

6.26: Natural children of donors should not be permitted to access any information about their donor-conceived siblings under any circumstances.

Singling out the donor-conceived should not be permitted

6.30: The birth register should definitely not “single out” people born as a result of donation. The latter could result in a new form of open discrimination. It should be left up to the parents to decide whether or not to tell their children they were conceived through embryo or gamete donation. Parents going through Egg Donation should be offered free counselling at the time of donation and at any time afterwards to discuss such issues with counsellors and then come to a decision they genuinely feel happy with.

6.31:Parents should not be forced to tell their children they were conceived through gamete or embryo donation.

Information for patients and follow-up research

6.39: A new Patients Authority should carry out the data register role. The HFEA’s data can be misleading. Some fertility doctors are so focused on being right at the top of the league tables, that they pick their patients carefully, turning away those they think may have a lower chance of success - for example, those with an FSH of higher than 9 or 10. Moreover, private clinics often have a large number of patients from overseas and the information and statistics provided on this group of people are questionable.

6.40: The data register is relatively meaningless. It is presented as a scientific guide which can mislead patients into blindly choosing a clinic because it is number one or number two in the league tables. The top clinics in the HFEA league tables are not necessarily the best clinics. Besides, the HFEA data is out-of-date by the time it is published. The HFEA’s approach is a bit like a salesperson trying to sell a supermarket product.

6.41: Data about the fertility clinics should continue to be registered.

Confidentiality

Information about assisted reproduction should remain strictly confidential, as provided under the HFEA Act, as patients find there is still great stigma association with infertility treatment. Just because this subject is in the press, doesn’t mean that there is no stigma attached to those associated with infertility treatment. Confidentiality is extremely important and must be maintained.

 
Section Seven
Surrogacy

The current laws should be maintained in terms of prohibiting the operation of commercial agencies. However, couples in need of surrogacy should be permitted to advertise, otherwise it can be extremely difficult for them to find a surrogate who is a match. We need to move into the twenty-first century when it comes to dealing with this and some of the other issues.

Section Eight 
Status and legal parenthood

In no circumstances, should the words “by donation” be added to the birth record of a child. The latter would be discrimination and lead to stigmatisation.

Section Nine
Research

If an embryo or gametes has been created in excess of what a couple want, then the excess embryos and gametes should first be offered to couples looking for an egg donor who are a match in terms of characteristics. If there are no couples who want the donor gametes or embryo, who match in terms of characteristics, only then should the embryo or gametes be permitted to be used in research.

To remain at the forefront of this field, the UK needs to be able to carry out research on embryos and gametes, otherwise it will lose its leading edge and some of its leading fertility doctors may decide to move to other countries. However, research should be subject to strict controls. In addition, couples who want donor gametes or embryos and are a match should be offered the donor gametes or embryos first. If no couples can be found and matched with the donor gametes and embryos, only then should they be permitted to be used for research.

The possibility of using a donor egg and placing the DNA of the recipient of that egg could be an answer to the donor egg shortage and make everything simpler for the offspring as they will be of the recipient’s heritage. So there would be no issue of a donor or donor-conceived wanting to contact each other, as the donor egg would simply be the shell provided and would ultimately have no relationship to the donor. The latter is not a possibility at present, but if this became a safe procedure in the future then it would provide an answer to the donor egg shortage and all the concerns about a child contacting the genetic parent, as the egg donor would not be the genetic parent. The child’s parent would be the genetic provider. (Please see part one of Ivfworld.com’s response under the heading ‘the use of so-called artificial gametes’, which is related to this subject.)

The current restriction should be removed on replacing a nucleus of a cell of an embryo with a nucleus taken from the cell of any person, another embryo or a subsequent development of an embryo for research purposes, subject to licensing. The latter should also be extended to include the possibility in the future that it may become safe to use this as a treatment for infertile couples. It would give the couple and child all the benefits of being the genetic parents and wipe out the key the issues that surround donor gametes and embryos. It would also go a long way towards resolving the shortage of egg donors.

There should be a prohibition on embryos created through the combination of human and animal material.

Payments for the supply of gametes for research should be restricted in order to prevent exploitation and the taking of inappropriate risks.

 
Section Ten

The subject of a new regulatory environment was discussed in Part One of Ivfworld.com’s report, including the proposal that legislation gives the majority stakeholder a formal role in the shape of a new Patients’ Authority, which would be integrated into the foundations of a new system responsible for regulation, standards for assisted reproduction, clinic inspections, embryo research and the industry overall. The new Patients’ Authority would have patient organisations including Ivfworld.com on its Board, and each patient organisation represented on the Board would have a minimum of two thousand members.

For more details on the proposal for a new Patients’ Authority, please refer to Part One of Ivfworld.com’s report.