Addressing the International Legal Challenges of Genetic Engineering

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In keynote address, Gary Marchant discusses the transnational implications of genetic engineering.

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Thanks to rapid advances in genetic technology, scientists can give cells cancer-fighting capabilities and improve athletic performance with genes that help build muscle faster. But this new gene editing technology raises serious ethical concerns.

In a recent keynote at the University of Pennsylvania Law School, legal scholar Gary Marchant argued that the international community can respond to these ethical concerns by taking steps to unify the regulation of genetic engineering.

Marchant, a professor at the Sandra Day O’Connor College of Law at Arizona State University, explained that the government strictly regulates genetic engineering in the United States due to prevailing social norms. For instance, according to Marchant, federal policies constrain the use of government funds to support research that makes changes to human embryo DNA. Similarly, social norms discourage the use of gene therapy for physical enhancement, such as seeking to make basketball players taller.

Yet other countries do not conduct research under comparable restraints. Marchant noted that without some form of international harmonization on research regulation, genetic engineering may be used without heed to ethical concerns and potential side effects. For example, if a country engineers a baby resistant to HIV, this change could be introduced into the human genome and subsequently spread worldwide without the consent of other countries.

Marchant explained that there are three tools to achieve international regulatory convergence: multilateral treaties, soft law, and transnational dialogue.

Marchant stated that treaties have the benefit of being legally enforceable—at least to the extent any international law can be—but they are also difficult to create. The complexity of issues in genetic engineering can make reaching consensus on specific details particularly challenging for diverse countries.

Soft law provides an intermediate approach to regulatory convergence by relying on substantive, though not legally enforceable, obligations to shape how technology progresses, Marchant said. For example, academic journals can limit the type of research they will publish. Businesses and academic institutions can also set guidelines and standards that researchers must follow. Although these nonbinding policies are effective on the ground, government agencies can ultimately still convert the standards to hard law by enforcing them if needed.

Still, Marchant noted that the lack of legal enforceability and potential inconsistencies among standards from groups with soft law programs limit soft law’s potential as a harmonizing tool.

Given the limitations of treaties and soft law, Marchant stated that transnational communication and cooperation is likely the most effective way to coordinate international approaches to genetic engineering. In a 2015 paper he published with Marc Saner, Marchant found that networking and developing connections between regulators in different countries could help bring about international harmonization.

Marchant’s analysis of these methods for achieving international harmonization informed the development of a recent National Academy of Sciences (NAS) report on the ethics of human genome editing.

In the report, the NAS Committee on Human Gene Editing acknowledged that the fact that there will never be a universal consensus on the ethics of gene editing poses the biggest challenge for harmonization. Countries like Germany may never allow the use of genetic engineering for enhancement, for instance, whereas countries like China are open to moving forward in this area.

The Committee debated whether to include recommendations on reaching an international consensus in its report at all. Developing international standards would require a large investment of time and resources, and the standards would never be completely enforceable.

Ultimately, the cost of international harmonization must be balanced against the potential benefits, Marchant explained. Establishing standards, for one, would spread the risk of harm from research to different populations so that no single country disproportionately burdens its citizens.

Additionally, creating international standards would allow countries to share the workload of making ethical decisions, and economies of scale would help collective research projects progress more rapidly.

The Committee concluded that complete agreement on genetic editing standards is not a practical expectation because the global landscape is a checkerboard of regulations, and it likely will remain a checkerboard even after harmonization efforts.

Nonetheless, the Committee proposed a promising principle for transnational cooperation in its report: Countries should respect cultural differences and maintain a collaborative approach to research involving human gene editing.

Marchant concluded the keynote by reinforcing this theme of open communication. Embryo research aimed at producing gene editing technology that will make both physical enhancement and requested changes to offspring possible is progressing rapidly. Marchant stressed that answering the open ethical questions raised by these advances will require both international collaboration and public engagement from all citizens.

Marchant’s keynote opened the University of Pennsylvania Law School Journal of Law and Public Affairs’ symposium, “Regulation of Genetic Engineering,” held on February 10. Later panels further explored the ethics of human genome editing and existing domestic regulations.