An Ethical and Legal Analysis of Ovascience – A Publicly Traded Fertility Company and its Lead Product AUGMENT

I. INTRODUCTION

In May 2015, the first baby created through an emerging ova technology called AUGMENT, was born in Canada.¹ Developed by OvaScience, AUGMENT essentially introduces mitochondria sourced from the genetic mother into her own ovum in order to revitalize the ovum.² This technology is controversial because OvaScience is a publicly traded company, and it is driven by short-term results, such as earnings;³ and (2) OvaScience did not complete adequate clinical trials before offering AUGMENT to the public.⁴ Moreover, in its 2014 annual report, OvaScience declared that it was intentionally offering its products in countries where clinical trials are not required.⁵ The lack of adequate clinical trials is the primary reason underlying the Food and Drug Administration's (“FDA”) prohibition of the technology in the United States.⁶ Finally, as of August 2018, OvaScience has shifted its research away from AUGMENT, and it only offers it through an “exclusive license to IVF Japan Group in Japan.”⁷

The purpose of this paper is to argue that while some individuals have used OvaScience's technology to give birth, greater regulation and federal oversight of assisted reproductive technologies is necessary, including rigorous clinical testing, especially with the use of private and public companies before the private use of new assisted reproductive technologies (“ART”). This paper proceeds as follows: Part I will outline what OvaScience is and the four proposed technologies they seek to develop; Part II will examine the history of mitochondrial manipulation; Part III will examine the laws in countries that currently permit the practice and why the FDA has prohibited OvaScience from using AUGMENT in the United States; Part IV will examine the ethical concerns of these technologies; and Part V will discuss the ethical issues surrounding OvaScience as a publicly traded company.

II. PART I: OVASCIENCE'S TECHNOLOGIES

OvaScience has four different fertility technologies in development. All of these technologies are derivative of OvaScience's “proprietary technology platform” of ova precursor cells.⁸ The four technologies are (1) Autologous Germline Mitochondrial Energy Transfer, (“AUGMENT”), (2) OvaPrime, (3) OvaTure, and (4) OvaXon.⁹ In 2014, several international fertility clinics began to use AUGMENT¹⁰, the furthest developed technology and the first technology to be offered to patients. The most prominently reported results are...