Regulating, Reporting & Validating ART
There are government guidelines and laws which regulate the clinical practice of Assisted Reproductive Technologies (ART) to ensure that these technologies are used safely and responsibly.
Regulating, Reporting & Validating ART are guidelines , rules and laws of any use ?
The assisted reproductive technologies ( ART) represent one of modern medicine's spectacular success stories , but these advances in technology have also come with innumerable government guidelines and laws which regulate the clinical practice of these procedures. The purpose of these guidelines is to ensure that these technologies are used safely and responsibly, but it's now time to ask how well these guidelines work and what purpose they really serve.
Since IVF was first developed in the UK, it's not surprising that the first country to regulate IVF technology was also the UK. The Human Fertilization and Embryology Act was passed in 1990 (1) in response to the report of the Committee of Inquiry into Human Fertilization and Embryology (the Warnock report), which examined three main public concerns.These were:
- Creation of human embryos outside the body and their use in treatment
- Use of human embryos in research
- Use of donated gametes and embryos
The act established the Human Fertilization and Embryology Authority (HFEA), and its licensing and inspection procedures, as the main mechanism for regulating these activities. Probably the most controversial part of the act was that it was laid down to protect the "welfare of the child " and required that "a woman shall not be provided with treatment services unless account has been taken of the welfare of any child who may be born as a result of the treatment (including the need of that child for a father) and of any other child who may be affected by the birth." While one would expect these words to mean that it should be the parent(s) of the child who would be empowered to make the best decisions for their child, in practice is has meant that an impersonal government body without a heart or a soul makes these decisions, claiming that they are acting in the interests of the child.
Interestingly, the US has not found it necessary to pass a federal law to govern the practice of assisted conception in the United States (2) , except for the requirement of the 1992 Fertility Clinic Success Rate and Certification Act for each IVF clinic to report annually its pregnancy success rates to the United States Centers for Disease Control and Prevention (CDC) .
In fact, when looked at from a global perspective, what is truly remarkable about the regulations which govern ART in each country is that they vary so widely (3,4) ! In countries where legislation is fairly liberal, usually both physicians and the public view legislation with favour; conversely, where a number of restrictions exist, many complain that legislation impairs their ability to offer proper services. This clearly shows that the guidelines are arbitrary and often designed to fulfill prevailing political pressures, rather than being based on scientific principles. Not only do rules vary from country to country, they also vary in an individual country from time to time. Thus, the UK HFEA now allows parents to select embryos ( using preimplantation genetic diagnosis for tissue typing) so that the baby created can become a tissue donor to an ill sibling ( saviour siblings, as dubbed by the lay press), something which they had banned in 2001.
A key argument is whether it is better to allow doctors to make medical decisions, as is done in the USA, or to have legal oversight, as is the practice in many European countries. Unfortunately, the laws governing new technology tend to lag so far behind the technology itself , that they are often in danger of being obsolete by the time the legislation is enacted. There is also the problem that laws may be unsuited to responding to the complex individual circumstances that often characterize this area.(5)
Italy recently provided a stunning example of how IVF laws designed to protect patients can actually end up harming them. Italy recently passed the new Medically Assisted Reproduction Law in March 2004, which prohibits the destruction of embryos created outside the body. This means that all embryos created during IVF (to a legal maximum of three) must be transferred to the woman's womb, thereby increasing the chance of a high order multiple pregnancy. A young woman ( who should have had only one single embryo transferred ideally), was forced to accept the transfer of 3 embyros, and has been forced to ask a court's permission to terminate one of the fetuses in her triplet pregnancy for the sake of her and the other babies' health. This means that just four months after this law came into force in Italy, Italian politicians are already coming under pressure to amend the legislation. In countries where there is no restriction upon the numbers of embryos created, doctors and embryologists are able to choose the number and quality of embryos most likely to result in a pregnancy for that particular patient. Italian IVF doctors, however, are obliged to replace all embryos, regardless of their patient's best interests. And with no embryo freezing permitted, the Italian law obliges women to undergo a fresh cycle of IVF treatment - with the ovarian stimulation drugs it entails - each time, instead of using spare embryos that could have been frozen after a previous cycle. Countries are entitled to prohibit whatever research or clinical practice that they see fit. But when such prohibitions leave patients with less safe and less effective techniques as their only options, these states are surely shirking their responsibilities to patients. As Juliet Tizzard points out (6) , the message from the Italian government seems to be that the survival of all human embryos is more important than the safety and wellbeing of its infertile citizens.
The assumption is that regulation will prevent unsafe or unethical practices and protect patients, but regulation is a two-edged sword, and it does not always safeguard the health and wellbeing of patients. Restrictive legislation and heavy-handed regulation can often do more to put patients and their babies at risk and to force them into situations not of their own choosing, than it does to protect them. For example, in Spain, it is legal to put embryos in frozen storage, but it is illegal to destroy embryos or to donate them to research, despite the fact that 74 per cent of Spanish patients with spare embryos in storage would like to donate them to research. Because most couples would prefer not to donate their embryos to other patients, there are currently 50,000 embryos sitting unused in frozen storage in Spain - some beyond the five-year storage limit. What a shame - and what a waste ! The tragedy is that we don't seem to learn - and the same mass destruction of frozen "orphaned embryos " which occurred in the UK (7) , is likely to be replayed in Spain again soon. What a sad mockery it is, when the law which was designed to protect embryos on paper , ends up destroying them in practice !
The foundation of most Western countries' ethical practice is generally the World Medical Association's Declaration of Helsinki (World Medical Association, 1997). 'In the treatment of the sick person, the doctor must be free to use a new diagnostic and therapeutic measure , if in his or her judgment it offers hope of saving life, re-establishing health or alleviating suffering.' However, the guidelines which regulate IVF in most countries these days no longer allow doctors any medical discretion in these matters (8). By forcing doctors to practice medicine as laid down in a mindless statue drafted by bureaucrats, rather than by applying their own judgment, we are ending up harming our patients. The Embryo Protection Act of 1990 in Germany states that no more than three eggs can be collected from a patient for fertilization in vitro. After that, all embryos created must be transferred to the patient in order to avoid any embryo freezing or destruction. According to Professor Felberbaum, chairman of the German IVF registry, the imperative of putting back all available embryos, rather than a smaller number of good quality embryos selected from a larger batch, is resulting in lower conception rates for German IVF patients overall, and yet higher multiple birth rates when pregnancies do occur. As doctors, we can see that these laws are harming our patients in practice , and yet we seem to be unable to do anything to prevent this. Why have doctors become so impotent ?
The new reproductive technologies have spawned new ethical concerns. These are controversial subjects, which have attracted wide media attention and public debate. However, the law and public opinion all over the world have lagged behind the advances in artificial conception which have created a "brave new world" of possibilities of giving birth, never before considered possible - using a mix and match combination of sperms, eggs and uteri.
Artificial conception raises the possibilities of myriad problems, including:
- The question of embryo research and the time limits to be placed on it. Basic questions such as - when does life begin? and what are the rights of an embryo? remain unanswered.
- The child's right to access to information about his/her genetic background and mode of conception.
- Should cloning be allowed ?
- Can human embryos be used for harvesting embryonic stem cell lines ?
Because this is such a touchy area which deals with the beginning of human life, debate has ended up in generating more heat rather than shedding light. There are many interested parties, and theologians the world over differ sharply on the subject. For example, to the Catholic Church, adoption is acceptable; as are the use of fertility drugs. GIFT procedures are allowed when the sperms and eggs of the couple are placed in the woman's own Fallopian tubes. However, surrogacy; artificial insemination by husband or donor; and IVF are not allowed, because procreation without sexual union is considered unnatural, and the church has been quite vocal about its criticism. In Judaism, donor insemination is forbidden and a child is considered to be the offspring of the biological father. Most individuals also have their personal beliefs regarding the "rightness" or otherwise of many of these techniques. Many people believe that embryos should not be used for research because they have the potential to become human beings and, in fact, embryo research is banned in Germany by law. Others feel that to restrict research is unfair to infertile couples, who should be allowed to make their own choices.
There will always be two views of looking at the technology of assisted conception. At one end of the spectrum, will be people who feel that this technology allows couples to manipulate Nature to produce children and will object to it. At the other end will be people who believe that this technology is a triumph of man's ingenuity which can be used to overcome Nature's constraints. It will never be possible to reconcile these viewpoints - since these are based on deeply held personal beliefs (and not facts) - and we will have to learn to live with this moral dichotomy. Since it may never be possible to have a consensus on this issue, this decision should not be left to moralists, or philosophers or the government, or the doctors. Instead, the decision should be left to each individual couple, who provide the reproductive apparatus to create the baby.
While over-regulation can be harmful for infertile patients, let's not overlook the fact that certain regulations can be helpful, which is why it's important that we learn to make use of this power for the sake of our patients. Thus, a major hurdle for many infertile couples is the financial burden of IVF treatment. Today, while most diseases and medical conditions are covered by insurance, the disease of infertility is often singled out for exclusion, and such discrimination is unfair ! Unfortunately, insurance companies in most parts of the world still do not provide health insurance coverage for infertility. Insurance companies have traditionally denied claims for infertility on one of the following flimsy pretexts.
- Infertility is not an illness.
- Treatment of infertility is not medically necessary.
- Treatment of infertility is experimental.
However, it has now been well established that infertility is an illness, which is caused by various medical causes which result in the abnormal functioning of the reproductive systems (such as blocked fallopian tubes or a low sperm count); and that these can be successfully treated in most cases. Medically necessary is usually defined by insurance policies as medically appropriate for treatment of an illness under professionally recognized standards of health care and treatments such as IVF and ICSI are now universally acknowledged to be standard medical treatments, which are no longer experimental. While certain infertility treatments can be costly, most are quite inexpensive, and only about 5% of all infertile couples will need expensive treatments like IVF. Moreover, if expensive medical procedures like bypass surgery can be covered, then why should treatment for an abnormally functioning reproductive system be excluded?
Fortunately, this discriminatory attitude is now being challenged by advocates for infertile couples - at least in the US! The pathbreaking Americans with Disabilities Act (ADA) provides protection against discrimination for Americans with a disability - a disability being defined as" a physical or mental impairment that substantially limits one or more major life activities." The US Supreme Court has clearly ruled that reproduction is a major life activity. Since infertility is a physical impairment that substantially limits the ability to reproduce, this means that if an individual experiences discrimination because of his or her infertility, a claim can be made that this is illegal under the ADA. Thus, a police woman employed by the city of Chicago sued the city because it did not provide infertility insurance coverage. The court ruled that infertility is a disability under the ADA, and today the city of Chicago covers the cost of infertility treatment incurred by all its employees!
No matter how wild the idea of designer babies sounds now, technology has a way of making believers out of sceptics. When IVF was first being developed in the 1970s, people thought the idea was "unnatural", but today it has become widely accepted and commonplace. Will the same be said one day of children with genetically enhanced intelligence and endurance ? Genetic germline engineering today offers us the profound power to sculpt our children-and the future of our species. As Nobel prize winner, Dr James Watson, who discovered the double helical structure of DNA, put it- " If we could make better human beings by knowing how to add genes, why shouldn't we do it ? " Today, this research is banned, but is this the best solution ? Banning research ends up stopping scientific progress, and may deprive us of making breakthrough advances in medical technology, which could be invaluable for our children and their children. It is important for doctors to contribute to this debate, and we need to polish our public presentation skills and become opinion leaders in shaping these policies. We are not mad scientists trying to play God - we are simply doctors trying to do the best for our patients, and if we don't ensure that we project this correctly to the outside world, our freedom to do what is best for our patients will be curtailed by bureaucrats , activists and politicians. The three pillars of medical ethics - autonomy, beneficence and non-maleficence are all being sacrificed at political altars, and we need to prevent this from happening. Lobbying and advocacy are skills doctors will need to learn, so they can take an active part is shaping policies which affect their patients' rights, and their freedom to practice. If we do not learn to police ourselves, we will be policed by someone else !
Most doctors would agree that there is a need to regulate the practice of IVF, so that all IVF clinics meet certain basic standards. This is important to protect infertile patients, most of whom are scientifically illiterate and emotionally very vulnerable, as a result of which they get cheated very easily by unscrupulous doctors (9). IVF has become a billion dollar industry, but we all know of bad clinics and the games they play to lure patients and exploit them. In order to ensure that patients are confident in the assisted conception treatments they are receiving, checking that clinics have the required equipment and expertise, and achieve acceptable pregnancy rates , is very reasonable. One way of doing this by requiring them to report their pregnancy rates, but in practice, however, creating an avalanche of paperwork does not contribute to good patient care.
Ironically, it was in the UK which has such a long-established system for regulating and supervising IVF clinics , and which seems so perfect on paper, that gross clinical errors such as the birth of mixed race twins have occurred. After this mixup which hit the front pages of all the newspapers, in typical bureaucratic fashion, the Department of Health commissioned an investigation led by Prof Toft. This commission criticised the government and the HFEA, and noted that the confidentiality requirements imposed by the HFEA had led to a "culture of secrecy" that had had a prejudicial effect on the authority's own ability to carry out its duties in an open and effective way ! Prof Toft then made more than 100 new recommendations to further tighten up procedures governing the provision of infertility services - adding a further burden to overburdened clinics, which may finally end up spending more time filling up forms rather than talking to patients ! Good doctors don't need to be monitored; and monitoring bad doctors does not help !
The collection of pregnancy statistics and their reporting by a central agency and the publication of "league tables" , in order to feed the appetite of patients, politicians, and insurance companies for information on IVF programs , actually make the problem worse. This is because despite all best intentions the data receive an imprimatur of authenticity, objectivity, and fairness that they, even theoretically, cannot have (10). The limitations of scientifically unsound, statistical comparisons have been widely recognized in other fields of medicine, and there are many in the community of infertility experts who also acknowledge that this applies to infertility treatment as well. It's easy to embroider ART success rates, by selecting the best patients and rejecting the poor responders, and IVF clinics will take advantage of this loophole to manipulate their statistics, so that they look good.
I feel IVF clinics should voluntarily audit and report their results, so that they can compare themselves with other IVF clinics, in order to improve their success rates and improve the quality of medical care they provide to their patients. This should be the major goal of all data collection, and the best way of doing this would be by using the many recent advances which have occurred in the field of Information Technology. Thus, it should be possible to develop an "open source" software program, which is available free of charge, and could be used by all IVF clinics. This would be used by each IVF clinic in their daily practice, to take care of their patients. The clinical and lab data collected by this program during each patient's IVF cycle could then be uploaded ( with all identifying information removed) to a central website, where it could be analysed by any interested person. Because our field advances so rapidly, we need to collaborate with each other, so that we can incorporate the best techniques in our own clinics. This is why informal electronic mailing lists such as IVFMail and EmbryoMail are so useful - they allow quick information exchange, on a one-to-one basis.
One of the reasons IVF has been over-regulated as compared to most other fields of medicine, is that the public still feel that IVF doctors are cowboys, who are willing to do anything to make a quick buck. They feel that IVF medicine is not scientific in its approach, because we are ready to experiment with human eggs, sperms and embryos; and use techniques in clinical practice without validating their safety or efficacy in animal research. This is a valid criticism, and we need to continually scrutinize our practice, so we can provide optimal medical care. We need to show that we are responsible physicians, with our patient's best interests at heart. If we are able to unlock the secrets of stem cells, there is no question that the future of regenerative medicine lies squarely in the IVF lab - let us live up to this promise (11) !
Knowledgeable decisions on reproducing and having children, can and should be made by the people and the families immediately affected by such decisions. For example, let's consider the case of whether single women should be allowed to have access to IVF. Even in a small homogenous country like Israel, this matter has become contentious, and Israel's High Court of Justice recently overturned health ministry rules that require unmarried women wanting sperm donation or in vitro fertilization to be examined first by a psychiatrist and a social worker. This is a sad reflection of the fact that government regulations are now starting to encroach on individual's reproductive rights, and that citizens are being forced to approach law courts to seek redressal !
Surrogacy is another example of how difficult regulation of assisted reproductive technology can be. While surrogacy is an accepted form of treatment worldwide, the legal status of the child and the enforceability of the surrogacy contract varies from country to country. For example, in the UK, even though the child is genetically derived from one or both parents , the birth mother and her partner are the legal parents of a child born as a result of a surrogacy arrangement until legal parentage is transferred to the commissioning couple by adoption. The rules are completely different in California, and an objective observer is forced to wonder why this is so ! Since infertile couples and their desire to have a child are the same all over the world, such stark differences in regulations just mean that couples are being forced to obey the rules which happen to prevail in their place of residence. This means that what a couple is allowed to do and not allowed to do depends to a large extent on which part of the world they happen to live in ! The very fact that rules vary so much from country to country emphases the fact that there really are no right answers. In such circumstances, is it a good idea to impose rules on infertile couples and their reproductive desires ? Might it not be better to allow doctors to decide what is best for each couple ? After all, doctors are medical professionals, who have their patient's best interests at heart. They know their patients, and their backgrounds, and surely they can be trusted to come up with a solution which provides maximal benefit to their patients. Rather than apply rules blindly, isn't it better to allow doctors the freedom to select what is best for their patients ? Unfortunately, we live in an age which is dominated by bureaucracy, which only understands paperwork. As long as the paperwork is perfect, what happens to the individual patient is of little concern or importance to bureaucrats. This is why ART regulations are so frequently challenged in courts of law - after all, this is an area where it's practically impossible to develop rules where "one size fits all"(12) . Even in these Courts, the judge's intellect is taxed to the maximum, and he often needs the wisdom of a King Solomon to resolve the matter fairly. Sadly, there aren't too many King Solomons around when the laws and guidelines which regulate IVF are being drafted !
- Peter Braude and Sadia Muhammed. Assisted conception and the law in the United Kingdom. BMJ, Oct 2003; 327: 978 - 981.
- Michael Feinman and Geoffrey Sher . Comparing the British and American approaches to regulating ART programmes . Hum. Reprod. 1996 11: 1366-1367.
- Jones Jr. HW, Cohen J. IFFS surveillance 01 . Fertility and Sterility - November 2001 (Vol. 76, Issue 5 (Supplement 1))
- Legislation and guidelines . Fertility and Sterility - May 2004 (Vol. 81, Issue (Supplement 4))
- J.E. Stern, C.P. Cramer, R.M. Green, A. Garrod, and K.O. DeVries . Determining access to assisted reproductive technology: reactions of clinic directors to ethically complex case scenarios. Hum. Reprod. 2003 18: 1343-1352.
- Tizzard J. http://www.bionews.org.uk/. Accessed on 1 August 2004.
- RG Edwards and HK Beard . Destruction of cryopreserved embryos. UK law dictated the destruction of 3000 cryopreserved human embryos. Hum. Reprod. 1997 12: 3-5.
- RP Jansen . Evidence-based ethics and the regulation of reproduction Hum. Reprod. 1997 12: 2068-2075.
- TC Anand Kumar. Reproductive BioMedicine Online 2002 Vol. 5, No. 3, 351Proposed legislation for assisted reproductive technology clinics in India.
- Schulman, J.D., "What's Your Success Rate? Dr. X Comes to America," Human Reprod, Vol. 11, 1996, pp. 697-699.
- Guido de Wert and Christine Mummery. Human embryonic stem cells: research, ethics and policy. Hum. Reprod. 2003 18: 672-682.
- MH Johnson. Should the use of assisted reproduction techniques be deregulated? The UK experience: options for change. Hum. Reprod. 1998 13: 1769-1776.