The Case For Regulating ART

From time to time cases arise in ART that appear to cry out for regulation.   (You can read about some of them elsewhere on this blog, though I fear I have not been entirely consistent in using the appropriate tag.)   I’m not sure there’s really much of a debate about the need for some sort of regulation but, as is so often the case, the devil is in the details.  Who will regulate?  How will they regulate?  What interests will be protected?  Who will have a seat at the table?

There are several stories that cropped up (or at least came to my attention) recently that raise the regulation issue.   In the not-so-distant past there’s the number of offspring problem.   And this more recent story discussed the incidence of multiple births in IVF.    (Fairly obviously, transferring more than one embryo increases the risks of twins, triplets, etc.   There are many doctors who as a matter of practice will not transfer more than one embryo, but of course, plenty of others still do.)   And this story about the prospect of ever more extensive pre-implantation genetic testing and the spectre of designer babies could also encourage regulation in that direction.

As I said, I don’t think the idea that some regulation of ART is needed is a particularly controversial one.    The root problems posed are similar to those posed with regard to other medical care.    Some for-profit medical providers (no matter what field of medicine we are talking about) will place their financial interest ahead of the patient’s interests.   That might mean ordering unnecessary medical procedures or it might mean transferring multiple embryos.  Either behavior is problematic.  Someone has to set standards of care and perhaps has to actually enforce them.   (Of course, there is some enforcement of ART standards already–the doctor in the notorious octomom case lost his license.)

But what exactly should regulations say?   While it might typically be fine to only transfer one embryo, there are surely cases where prudent medical judgment would point towards transferring two.   And while some efforts at designing a baby may be deeply disturbing, using PGD to select a fetus with a high likelihood of successful transfer and development seems eminently practical.   And what should I make of proposed standards in Canada that would deny fertility treatment to obese women?

Then there’s the related question–who should make/enforce these regulations?   One possibility is obviously some government-centered entity.  I suppose that is rather like the UK model with the HFEA.   (I believe the HFEA is still slated for abolition as a part of the conservative government’s budget cuts.)    But thinking practically, enhanced government regulation isn’t terribly popular just now.    And it’s clear that some government regulation can be frankly political–essentialy a thinly veiled effort to accomplish some other end.   It’s just not a process that inspires competence.

Of course, one alternative is some form of self-regulation, which I think is what the ASRM tries to do.   But commenters here have been clear about the reasons to  mistrust self-regulation.  While it isn’t doomed to failure, there is certainly a whiff of the fox guarding the henhouse.

I’m afraid I cannot close here with some terrific proposal for some grand plan.  I think the most useful thing I can try to do here is to shift the discussion a little.  I don’t think many people will argue against all regulation in general.   What we need to talk about are those details.

12 responses to “The Case For Regulating ART

  1. Who should be at the table?
    *Adult Donor conceived
    *Ethicists including Bio-Ethicists
    *Department of Health and/or NIH and/or Childwelfare
    *ASRM with the caveat that they may be biased and provo to limit power?
    *Fertility Providers with same caveat as above

    What do they need to accomplish Ideas:
    *Rights for the donor conceived including access to records,
    *Donor registry so that max number of children can be assured across all providers,
    *Maximums for donors, numbers of gametes implanted.
    *Best practices for screening implemented and more than just STD’s screened for. Things like Cystic Fibrosis genes and other known screenings that are common or talked about with couples when planning pregnancy.
    *Education on updating of health history – when it is or isn’t needed.
    *Education for the intended parents – what are the best practices.
    *What screening should be done regarding the intended parents, minimums of mental and physical health.
    *Should all births be registered with the courts.

  2. I actually think they have a point when it comes to weight. As physicians they must first do no harm and the risks are real and multiple risks, and not to be taken lightly. Especially in light of the drugs they must use prior with IVF. It all comes down to risk factors and the level of risk a physician is willing to work with and what is deemed best practice.

    If I needed an elective surgery most likely I would be turned down due to my health and the high risk factors. That’s life and so be it.

  3. I’ve been thinking about this post for a few days. I don’t believe the government should interfere with citizen’s reproductive freedom by limiting the number of offspring.a person can have. What would the penalty be for exceeding the maximum? Would people be sterilized when they reach their limit? Would they throw them in jail? Fine them? Force them to abort?

    I surprised myself this week when I came to the conclusion that I am against government imposed limitations on the number of offspring one donor can produce. Donors are just men and women like the rest of us, exercising their right to reproduce themselves as much as they want with whomever they wish.

    I do feel that its the government’s job to enact laws that protect the public by requiring people to take responsibility for the results of their actions.Children are the result of a reproductive act and the law generally holds people responsible for taking care of the children they create, at least to the extent where they must relinquish the child in a court ordered adoption rather than abandoning the child.I think its important that people donating their genes know the outcome of each pregnancy because it should influence their future reproductive choices if their children are born with physical or mental disabilities for instance. In fact following the health of your own offspring is what responsible people do because reproducing with blinders on is reckless. Current laws put blinders on the people actually reproducing and place the owness on resellers when ultimately the responsibility lies with those that gave them the genes to market.

    • This is really interesting to me. Because I don’t think being a sperm provider makes a man a father, it is easy for me to say that the government could/should regulate the number of offspring. I don’t have to face the larger question of limiting freedom to have however many kids you want. But because for you, that sperm provider is a father (of some sort), you do have to face the larger question and so come to the conclusion that you cannot limit.

      I really didn’t see this particular consequence of our different views on the status of sperm providers coming. How fascinating.

      • ok lets just say every individual has the right to procreate – produce as many children as they can….it makes no difference whether that person meets your definition of a father – he is a person with procreative liberties, right?

        your correct this is more interesting than it seemed on the surface. I do want to make you think….tell me do men have a right to reproduce freely just like females?:

        • Excellent question that requires some thought. For starters, I’m opposed to forced sterilization, so I need to keep that in mind and consider what might be the equivilant of that.

          Here are some initial thoughts as to proper regulation on number of offpsring as a gamete provider. It seems to me the state could say “you cannot be paid for more than X times as a sperm provider.” That would take care of a portion of the problem of too many offpsring as I suspect many men who donate over and over are doing it for the money. You could also require disclosure–any man seeing to sell sperm has to tell each clinic all the other clinics he’s been to and how much he’s sold at each. Clinics themselves might refuse men who had donated too much because of my next thought. That is that the information then gets disclosed to potential buyers. And it has to be kept up-to-date so buyers know how many offspring the donor already has. My guess is that many buyers would not choose a provider who already had fifty offspring and so, to return to the earlier point, clinics might not accept them. (Many clinics would also self-regulate for other reasons, I think, if they had access to good information.)

          I know I haven’t answered the exact question you’ve asked–about the right of men to reproduce freely. It’s hard for me to answer in the abstract (and this is true for women, too, by the way.) I guess you would need to tell me more about what the right to reproduce freely means. I don’t mean to evade, but it’s a very broad statement as it is.

          • I think your approach is interesting, but honestly it seems complicated and cumbersome. I’ll return to it.

            I’m really not trying to be obtuse. Donors are just people like the rest of us. Healthy people of a certain age are capable of reproduction and the While having power to neither grant nor remove an individual right,”the Supreme Court has legally recognized some fundamental rights not specifically enumerated in the Constitution, including the right to procreation”.

            The supreme court currently treats reproduction as a human right for those capable of it. I’m not talking about the right to be a legal parent, just the right to reproduce without government interference or penalty.

            1. Should there be a federal law that limits each citizen to a certain number of offspring?

            2. If so, is it practical to give women higher limits than men? If a man and woman chose to reproduce only with one another he would max out before her

            3. Would we limit the number of offspring created with individual parters? Say no more than 3 offspring per reproductive partner?

            4. How would the government really ever hope to control the number of children an individual has if the identity of the individual and identity of their offspring are concealed by the clinic?

            • I’m not sure whether our topic here is what should the law be or, given constitutional contraints, what can the law be. It seems pretty clear to me that no state could enact a law that said “no more than X children genetically related to you.” But I suspect the Court would consider a law that said “you cannot provide more than Y donations to a sperm bank (or perhaps get paid for more) would be a different thing and It hink would probably be okay. I dearly doubt that women would be given a higher limit. I don’t actually see what the rationale for such a limit would be. I don’t think I understand the hypo in 2. (If they are reproducing together, don’t they have the same number of offspring?) I don’t see why we’d do three at all–again–what is the rationale? And as to 4–I think you are right to suggest that any control requires disclosure if it is to work–but you don’t have to know which kids match with which donor, just how many times the donor’s DNA has been passed along.

      • Regulation needs to start by shedding daylight and sunshine on where the eggs, sperm and embryos sold by doctors are coming from and that cannot happen as long as donation of those things is allowed to be anonymous. There needs to be written consent filed in court before any gametes are collected and it needs to include a statement of be providers intention including restrictions. Collection should be witnessed by third party inspectors just like in the building code it cuts down on graft. Inspectors can verify the dna matches that of the person who filed the statement of intention with the court and can certify the exact amount collected and that should be sent to the court as well. Third party inspectors should witness each procedure verifying the sample used matches the dna of the person who gave consent. Lastly children born should be dna tested at birth to verify the are the offspring of the person who gave consent and that should be sent to the provider to aknowledge the offspring is born and to relinquish any rights to that child if that is the intention and the whole thing should be filed with the court.

        I agree that performance of child raising does count so we don’t want people to go home and bond with children if the gametes to conceive them came from a person who did not consent.

        Women are being killed for their overies along the mexican border in record nymbers and nobody is doing anything about it. Semen and ovaries are harvested from healthy young people who died in accidents and patients who trust their gametes are in safe hands with their doctors find out they are being reproduced with other patients without their consent.

        Regulations need to start there

        • It seems to me that your points fall into different categories. One major thing that could change would be some sort of central tracking of those who provide gametes–essentially a national registry. I think this is what they have in the UK. It’s a big leap from what we are, but it would potentially address a lot of issues–men who go clinic to clinic, say. It might also facilitiate access to medical information for those who are concieved using gametes.

          But these things have nothing to do with another proposal you have in there–that consent needs to be filed in court before any gametes are collected. That’s a proposal I would be firmly opposed to. I assume it is there to accomplish a different end (because it doesn’t particularly serve the aims I mentioned in the previous paragraph.) You want to make provision of gametes more like giving a child up for adoption? Oh so many reasons I cannot agree to that. There’s no child. There’s no rights (in my view and the law is with me on this one in many states) to give up. There’s no simple court proceeding that this would be a part of.

          I think from here on out there’s a whole parade of things I don’t like or don’t quite understand. I don’t know what exactly is witnessed by third-parties is. You want someone in the room with the man while he produces sperm? Does that cut down on graft? How? And the consent includes a statement of some intention, but what?

          All these latter things do little (to my mind) but make the use of third-party gametes impractical. I understand that is the goal you seek, but I don’t like the idea of simply piling on obstacles in order to get there. Might just as well ban it. (The whole struggle over abortion comes to mind here–endless imposition of obstacles in place of outright bans.)

          It is incredibly rare that a man provides gametes for third-party reproduction without consent. I’m not really all that worried about it. Unless what you mean to suggest is that men don’t understand the ramifications of what they are doing and hence, are not competent to consent. That’s a different (and interesting) argument.

          • No you are missing my point entirely. Whatever people will buy people will steal. In this atmosphere of anonymity there is no assurance the semen or eggs actually comes from a people who donated it willingly. It might be harvested during autopsies or misappropriated from samples given by patients or people who said it was ok to use for research. Look at all the tragic mix ups, look at UC Irvine where it was not a mistake but intentional and doctors all fled to Mexico where interestingly hundreds of women’s bodies have been found dead with their ovaries and other organs cut out along the Mexican border because they command a high price and donor anonymity makes it impossible to trace. Nobody keeps track of which egg is genetically tied to which female and there is no court documented consent to relinquish their gametes or limitations as to their use. I’m not talking about the future children, I’m talking about the fact that that to protect humans from being reproduce without permission there needs to be government oversight of who willingly handed their gametes to a clinic, in what volume and for what purpose so that doctors don’t serve as the sperm provider for all their patients for instance. In helping people look for those providers its almost never a donor donor its their moms doctors. Stay with mw here I’m not starting with the existence of a child. Can we get to the point where children made this way can absolutely be traced to a male and female that agreed? Anonymity prevents that and there is a black market thriving on the idea that patient and donor privacy necessitates anonymity. I think the threat to public health should trump the right to privacy other people who reproduce have no right to privacy no right not to be named associated with their offspring-at least at first.

  4. I’m not sure I’m responding to what you are saying, but I’ll try. To the extent you need to have good systems and controls, ensuring that sample A is what it says it is, for instance, I agree. Even with the best of controls, it will never be error-free–nothing ever is. But you can certainly have safeguards in place that assure that A signs a consent form of some sort, that gametes are obtained, that they are properly labelled and tracked. I don’t think you need witnesses at every turn, but you do need a stringent procedure that is actually followed.

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