Regulating, Reporting & Validating ART – are guidelines , rules and laws of any use ? Dr Malpani www.drmalpani.com

ART is a success story ! 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.

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.

Human Fertilisation and Embryology Authority (HFEA) Act 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.

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.

Global picture 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! 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.

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!

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.

UK v/s US Interestingly, the US has not found it necessary to pass a federal law to govern the practice of assisted conception in the United States , 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) ! And they are doing fine – thank you very much !

Interestingly, the US has not found it necessary to pass a federal law to govern the practice of assisted conception in the United States , 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) !

And they are doing fine – thank you very much !

Doctors v/s politicians 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

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

The mess in Italy Italy provides a stunning example of how IVF laws designed to protect patients can actually end up harming them. Italy 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.

Italy provides a stunning example of how IVF laws designed to protect patients can actually end up harming them.

Italy 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.

Law of unintended consequences 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 There are currently 50,000 embryos sitting unused in frozen storage in Spain - some beyond the five-year storage limit. What a sad mockery it is, when the law which was designed to protect embryos on paper , ends up destroying them in practice !

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

There are currently 50,000 embryos sitting unused in frozen storage in Spain - some beyond the five-year storage limit.

What a sad mockery it is, when the law which was designed to protect embryos on paper , ends up destroying them in practice !

IVF laws and doctors 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

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

IVF laws and doctors 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. 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 ?

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.

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 ?

Playing God ? When does life begin? and what are the rights of an embryo? Should cloning be allowed ? Can human embryos be used for harvesting embryonic stem cell lines ? Debate has ended up in generating more heat rather than shedding light.

When does life begin? and what are the rights of an embryo?

Should cloning be allowed ?

Can human embryos be used for harvesting embryonic stem cell lines ?

Debate has ended up in generating more heat rather than shedding light.

Two views 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 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.

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

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.

Helpful regulations 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. 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 !

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.

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 !

Should embryo research be banned ? 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. 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. 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 !

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.

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.

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 !

Useful regulation 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 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.

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

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.

Theory v/s practise Bureaucrats only understand paperwork – but creating an avalanche of paperwork does not contribute to good patient care. Overburdened doctors 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 !

Bureaucrats only understand paperwork – but creating an avalanche of paperwork does not contribute to good patient care.

Overburdened doctors 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 !

Improving our image 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. 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.

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.

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.

Single women and IVF Knowledgeable decisions on reproducing and having children, can and should be made by the people and the families immediately affected by such decisions. 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 fertilisation to be examined first by a psychiatrist and a social worker. 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 !

Knowledgeable decisions on reproducing and having children, can and should be made by the people and the families immediately affected by such decisions.

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 fertilisation to be examined first by a psychiatrist and a social worker.

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 !

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 ?

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”

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”