How the first three-parent embryo potentially impacts health policy

In late September, it was reported that Dr. John Zhang, a U.S. doctor and fertility specialist based in New York City, had successfully created a three-parent embryo resulting in the birth of a baby boy in Mexico. When asked why he chose Mexico, Zhang said, “There are no rules.”

There are many valid reasons an individual would seek treatment abroad, including price, wait times, and availability. However, Zhang’s “no rules,” comment is one that should give us pause.

The creation of a three-parent embryo is controversial. For example, United States law effectively bans the creation of three-parent embryos. American bioethicists have argued that it may be justified in certain circumstances, for instance, when the woman suffers from severe mitochondrial disease and only if male embryos are gestated. The U.K. initially legalized three-parent embryo research in 2015, but in November 2016 the U.K. Human Fertilisation and Embryology Authority said that clinical trials were ready to begin. While there is much discussion in the medical community about whether such bans are appropriate, these circumstances raise interesting questions about physicians that deliberately circumvent American law by performing these procedures abroad.

Patients traveling for medical procedures in unregulated or under-regulated countries is not a new or rare phenomenon. However, medical tourism is primarily an activity conducted by patients, not practitioners. Typically, such procedures would be performed by local doctors on foreign patients. Zhang’s case is notable because he traveled to Mexico with his patients to conduct the procedure.

There should be a broader discussion about how we approach and deal with this type of medical tourism. The concerns with practitioners conducting experimental procedures abroad are:

• Undermining current regulatory mechanisms that act as safeguards (for example the legalization process in the U.K.)
• Concerns about remedies for relevant parties if there are adverse events
• The accuracy and reporting of relevant data
• Further exasperation of the medical tourism industry that is often rife with ethical concerns

In contrast, the most compelling argument in support of practitioners going abroad is the idea that overregulation stifles clinical research that can potentially offer cures and treatment for desperate patients, even as the FDA offers more ways to approve or provide access to investigational therapeutics more quickly.

Acknowledging these concerns suggests that there would be significant benefit with a formalized registry system for practitioners who seek to perform these treatments abroad. A registry would allow for data to be gathered both from a medical and sociological perspective. Questions about efficacy, demographics, medical benefits and consequences would provide useful information. This information could impact domestic policies, but in the very least it would educate both individuals interested in seeking these treatments, as well as practitioners who are advising their patients.

-By Katarina Lee, J.D., M.A., clinical ethics fellow in the Center for Medical Ethics and Health Policy at Baylor College of Medicine