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Variations in Regulations on Assisted Reproductive Technologies

Medically assisted reproduction—also known as Assisted Reproductive Technologies (ART)—is practiced throughout the world. The Reproductive Bioethics Committee at the Albert Einstein College of Medicine has had an ethics advisory committee for ART since 1987 when it first introduced an egg donation program.

Embryologist transferring egg to a special culture media (selective focus)As a member of that committee since its inception, I have become acquainted with a wide array of ethical challenges that clinicians face in treating infertile couples and individuals. At a conference I attended last week in Switzerland, it was fascinating to learn about the variations that exist in fertility programs in other countries.

The United States has no national laws or regulations governing assisted reproduction. However, many states have piecemeal legislation. Some aspects are regulated, while others are not; some states have strict laws or regulations whereas others are looser.

European countries have considerable variation in what is allowed. Germany, Austria, Italy, and Norway prohibit egg donation and surrogacy, even when women are not paid for these services. But Norway, a country known for its egalitarian gender practices, permits sperm donation.  The prohibitions in numerous European countries—payment to egg donors and surrogates, as well as restricting who may have access to ART—have contributed to reproductive tourism for residents of these countries. The most popular destination is Spain, which has a flourishing practice of ART.  The UK is generally progressive in what it permits, and as a pioneer in the field of ART it has had a regulatory agency, the Human Fertilisation and Embryo Authority, since 1991.

Myriad Ethical Challenges
The ethical challenges physicians, regulators, professional societies, and ethics committees confront include at least the following.  

  • Whether it is ethical to select the sex of an embryo created through in vitro fertilization (IVF) to transfer to a woman’s womb. This is prohibited altogether in some countries, permitted only for medical indications in many countries, with no laws in other countries.
  • Who should get the frozen embryos when a couple divorces
  • Where paid surrogacy is permitted, how much money is too much and how much is not enough
  • Whether to conduct post-morten sperm retrieval at the request of the widow
  • Whether to provide ART to unmarried women
  • Whether to provide ART to same sex couples
  • Whether to provide ART for HIV-positive individuals or couples
  • Whether to provide ART to post-menopausal women
  • What are acceptable reasons for fertility programs to deny ART
  • Whether gamete donors should be required to allow their identities revealed to children born of such arrangements when they reach maturity
  • What should happen in surrogacy arrangements when a surrogate wants to keep the baby

Laws and regulations throughout the world differ in whether they prohibit, explicitly allow, or are silent on these ethical matters. This wide variation prompts the question of how an ethical analysis should proceed. When I encounter people who defend the prohibition of particular practices, I respond with two questions: Is anyone harmed by the practice (including psychological or social harm)? Are anyone’s rights violated? It’s not uncommon to be met with a blank stare. People either cannot articulate good reasons or they make judgments based on prejudice, albeit unwitting.

Guidepost: Respect for Autonomy
At our Reproductive Bioethics Committee at Albert Einstein College of Medicine, after a case is presented by one of the clinicians an open discussion follows. Factual questions are asked and answered, doubts are often expressed and as we say in bioethics, “reasonable people can disagree.” The ethical analysis uses well-known principles in bioethics.  Our general presumption is to invoke the principle, respect for autonomy, and then see whether there are any good reasons to deny a patient’s or couple’s request for treatment or for a specific aspect of treatment. The general presumption in favor of respecting autonomy has led the committee over the years to a progressive stance on some controversial issues. For example, after thoughtful deliberation, the committee recommended treatment of infertile single women, unmarried partners, and same sex couples. This is in sharp contrast to many, if not most of the countries I learned about at the conference in Switzerland. Respect for autonomy has been the ruling principle, unless there is a likelihood of harm or someone’s rights would appear to be violated.

Should Autonomy Trump Beneficence
No ethical principle is absolute. The principle of beneficence calls on clinicians to maximize expected benefits and minimize risks. Cases have come before the committee in which the patient’s medical condition, apart from her infertility, would pose significant risks to maintaining a pregnancy or undergoing the birthing process. This situation poses a familiar dilemma: if the patient has been fully informed of the risks to her and the fetus, she understands and appreciates those risks but still insists on treatment, should the principle of autonomy trump the principle of beneficence? It’s entirely possible that different clinicians and different ethics committees would disagree in confronting the same cases.

This is exactly what I experienced at the conference last week, attended by leading reproductive endocrinologists from the UK, Ireland, and Egypt, an ethicist from Belgium, a feminist ethicist from Canada, a sociologist from Africa and one from Sweden, a bioethicist from Argentina, a human rights lawyer also from Argentina, and a reproductive medicine scientist from the World Health Organization. It’s important to note that it is never the case that the ethicists line up on one side of an ethical controversy and clinicians on the other side.  In the end, even with reasoned arguments, some ethical disagreements will always remain unresolved.

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