Abstract

Consumer genomics is an industry that is undergoing exponential growth. Although consumers in the United States (U.S.) currently purchase the bulk of online direct-to-consumer (DTC) genetic tests, the DTC industry’s business model depends on exploiting markets worldwide. DTC genetic testing companies increasingly seek to market and sell their services throughout the European Union (EU), which is one of the world’s largest economies and is home to a digital, educated, and wealthy consumer base. Since May 2018, the EU General Data Protection

Regulation (GDPR) provides EU consumers with enhanced data privacy protections and places stricter controls on genetic data. When EU consumers purchase online DTC genetic tests, they exercise two distinct fundamental rights—the right to data privacy and the right to informed medical consent. The article explores the intersection of these rights by examining relevant EU and other legislation, mainly the GDPR, the In Vitro Diagnostic Medical Devices Regulation, and the Council of Europe’s Oviedo Convention on Human Rights and Biomedicine. Additionally, the discussion highlights the challenges associated with protecting consumers’ autonomy and freedom to purchase online DTC genetic tests, while also safeguarding the bioethical standards of informed consent.

The analysis explains that the online purchase of a DTC genetic test involves two distinct consent processes—one for data processing and the other for informed consent. These two consent processes are highly dependent upon each other to protect consumers adequately. Yet, the status quo reveals that informed consent is severely lacking in the purchase of online DTC genetic tests. This results in consumers’ loss of control over health and medical decisions, as well as over personal data. Consequently, as the DTC genetic testing industry continues to grow, there is a critical need for more robust online informed consent procedures. The article concludes that current EU regulations fail to sufficiently address the issues specific to online DTC genetic tests. Furthermore, an EU regulation on informed consent, in general, is not feasible. Thus, the article considers opportunities for the EU and its Member States, consumers, and industry to work together to both empower and protect consumers who purchase online DTC genetic tests. Finally, the article discusses methods for industry to improve the online informed consent process.

Keywords

Genetic Testing, EU Consumers, informed Consent, GDPR