2.1 Introduction

The DTC industry is centred around the online sale of genetic tests. The industry has emerged and has been able to develop because of rapid advances made in two technological areas: genetic and genomic science; and computing. The rate of technological advances in genetics and genomics is continuing on an almost unprecedented scale. This chapter provides a brief introduction to the scientific advances that have enabled the DTC industry to develop and an overview of the types of service currently available.

2.2 The Nature of Genetic Information and Genetic Exceptionalism

(a) What is Genetic Information?

Genetic information can be defined as ‘the information carried in a sequence of nucleotides in a molecule of DNA or RNA’. For present purposes, genomic sequence data can be understood as the data generated by sequencing technology. It has recently been suggested by Raymond McAuley that the cost of sequencing a genome will be less than the cost of flushing a toilet by 2020. ‘As of January 2014, sequencing a human genome cost just under $1,000 – less than the cost of a chest X-ray’ and ‘genome scanning is dropping in cost faster than computers can keep up. Moore's Law observes that computing power doubles every two years, but the cost of sequencing a genome drops by 5 or 10 times per year.’

DTC services normally only sequence a portion of an individual's genome, rather than the entire genome sequence. However, this may change, as more companies begin to offer whole genome sequencing.

The original work upon which this book is based began almost a decade ago and as with many other new technologies, the personal genomics industry is still developing at a rapid pace. This is also a period of change for the law and so this book captures the industry and the state of the law at a particular moment. I intend to be able to update this volume in the future, but as this manuscript was submitted in late 2018 and will be published in mid-2019, some things may change in the interim and I will only be able account for these changes in the future. I ask readers to bear this in mind and to please note that this book is intended to provide an introduction to a complex area and provide some suggestions for reform, which it is hoped will contribute to stimulating a wider discussion of regulation of personal genomics and of technology more generally and the ways in which we all interact with contracts and privacy policies online.

The Table of Abbreviations for DTC Contracts provides links to the Wayback Machine wherever possible. Efforts have also been made to provide archived links throughout.

5.1 Introduction

This chapter sets out the findings of a review of the wrap contracts used by DTC companies that provide testing for health purposes.1 This takes the form of a descriptive comparative document analysis of these contracts. It provides an outline of the typical terms likely to be included in a DTC contract and a discussion of terms which are likely to be deemed unfair and unenforceable under UK law. In this chapter it will be argued that several terms commonly included in DTC contracts are likely to be deemed to be unfair terms under UK law and consequently unenforceable. Given the frequency of use of these terms it is suggested that the best means of enhancing protection for consumers in this context in the short-term is for the Competition & Markets Authority (CMA) to begin to take pre-emptive action and work with the industry to discontinue the use of such terms. Specifically, the following terms are likely to be deemed to be unfair or fail to meet transparency requirements:

• 1. clauses allowing for unilateral variation of the contract

• 2. clauses disclaiming liability for fitness for purpose or for personal injury caused by the company's negligence 3. clauses limiting scope of purpose

• 4. clauses purporting to bind the consumer to resolve any disputes in another jurisdiction

• 5. consent clauses

This chapter will also provide a brief overview of contract and consumer protection law, as it relates to DTC contracts. In so doing it will make reference to the applicable UK legislation, namely the Consumer Rights Act 2015 (CRA) and the work of the CMA. As it will always be difficult for an individual consumer to pursue litigation against a large company, if certain terms currently included in these contracts seem likely to be deemed as unfair, it is desirable that the CMA works with the industry to prevent the use of such terms.

4.1 Introduction

The nature of the DTC industry as providers of genetic tests means that privacy and data protection law have relevance to industry governance. As with many other digital service providers, security is also a significant issue here. At present, the European Union is undergoing a time of transition with the implementation of the General Data Protection Regulation (GDPR).1 Although the UK is also undergoing a broader period of transition with Brexit, the Data Protection Act 2018 (DPA18) transposes the GDPR into the UK's national law. As DTC companies collect genetic data, as well as other types of personal data, which they often use in ongoing research, companies should be complying with the GDPR and applicable data protection law in EU Member States and also other countries that have similar law.

This chapter provides a broad overview of privacy, data protection and security issues raised by DTC services. The aim here is to provide an introduction to a complex area and provide some suggestions for how industry practices and governance could be improved. In the context of privacy policies and notices, it is important to recognise that these documents are often linked with wrap contracts on DTC websites. This is often done through incorporation of terms by reference and for an individual to understand their legal rights in this context, they should really be reading all of these documents. This is problematic, as a number of studies have demonstrated in relation to privacy policies and contracts more generally that consumers are not reading these.