Ethics and Law of Intellectual Property

Current Problems in Politics, Science and Technology

Christian Lenk, Nils Hoppe

• Publisher: Routledge
• Year: 2016
• ISBN:
  9781317141365
• Edition: 1
• Topic: Droit
• Subtopic: Droit de la propriété intellectuelle

Divided into three parts, this edited volume gives an overview of current topics in law and ethics in relation to intellectual property. It addresses practical issues encountered in everyday situations in politics, research and innovation, as well as some of the underlying theoretical concepts. In addition, it provides an insight into the process of international policy-making, showing the current problems in the area of intellectual property in science and research. It also highlights changes in the fundamental understanding of common and private property and the possible implications and challenges for society and politics.

PART 1
Political Regulations and Institutions

Chapter 1
Biobank Governance: Property, Privacy and Consent

Roger Brownsword^*

Introduction

If “biobank”¹ governance is to be ethically clean, then – guided by the UNESCO International Declaration on Human Genetic Data² – its principal aim should be “to ensure [respect for] human dignity and protection of human rights and fundamental freedoms in the collection, processing, use and storage of human genetic data…and of the biological samples from which they are derived…”.³

Crucially, biobank governance must adopt the right approach with regard to property in the collection and associated privacy (including confidentiality) issues⁴ as well as attend in the right way to the consent of participants. In principle, there are three options:

• An across-the-board regime of strong provisions on property, privacy and consent.

• A mixed regime of provisions relating to property, privacy and consent, some weak, some strong.

• An across-the-board regime of weak provisions on property, privacy and consent.

In a culture committed to human rights, the third type of regime will not be an option; rather, the first type of regime will be the obvious choice. Yet, if the U.K. Biobank⁵ is a representative test-case, some form of mixed regime is likely to prevail.

Within the category of mixed regimes, a number of governance permutations are possible. However, a regime (the “compromise approach” as we may term it) that combines strong provisions for privacy and consent with weak provisions for property has particular appeal. First, it balances the interests of participants against those of the research community – biobank operators being shielded against the objection that consent is not taken sufficiently seriously (this being the standard bioethical criticism of the Icelandic scheme)⁶ while, at the same time, it cannot be complained that participants’ upstream proprietary rights are interfering with downstream research and intellectual property rights. Secondly, it connects with both the Convention on Human Rights and Biomedicine (which rejects property and commerce in human body parts)⁷ and the International Declaration on Human Genetic Data⁸ (which expresses strong consent requirements where human genetic data is banked).

Notwithstanding the superficial attractiveness of the compromise approach, it does not fit well with an ethic of human rights. While its requirements for consent are too strong relative to participants’ rights, its position on property is too weak. If, by contrast, we test out the compromise approach against a utilitarian ethical standard, we find that it fits rather well. Alas, this is no happy ending; the reason biobank governance regimes are now a matter for intense bioethical scrutiny is precisely because of a concern about the abuse of individual rights that utilitarian thinking is capable of licensing.

The chapter is in four sections. First, using the U.K. Biobank as an illustrative example, the salient features of the compromise approach are identified. Second, the general orientation of human rights to consent, property, and privacy is discussed. Third, the degree of fit between the compromise approach and a human rights ethic is considered. Fourth, the credentials of utilitarianism as the implicit ethic of the compromise approach are reviewed. The upshot of the discussion, as I have said, is the worrying thought that, instead of being responsive to concerns about human rights, biobank governance might already bear the imprint of utilitarian ethics.

The U.K. Biobank and the compromise approach

The aim of the U.K. Biobank is to develop a major health care resource that will throw light on the interaction between genetic make-up, environment and lifestyle, so that more effective measures for the prevention and treatment of disease might be developed.⁹ To this end, lifestyle and environmental information from some 500,000 volunteers (aged 45–69) will be collected, such information being linked to medical records and biological samples. The reason for selecting this particular age group is that these are the persons most likely to succumb to common serious illnesses such as heart disease and stroke. Typically, participants will stay active with the project until their death (in some cases, many years after they have been first enrolled); and, indeed, even after the death (or mental incapacitation) of participants they maintain a passive involvement because the Biobank will retain and continue to make use of their samples and data.¹⁰ Broadly speaking, so far as the Biobank’s relationship with participants is concerned, the compromise model has been adopted – in other words, the governance framework designs in strong consent, weak property and strong privacy.

Strong consent

The governance regime seeks to ensure that participants fully understand the purpose of the Biobank (that is, that no one will subsequently complain about having signed up on a false prospectus), that consent is free, and that the process of maintaining consent is ongoing. Crucially, participants should understand that the Biobank is not a health care program but a research resource, that there will be a link to the medical record, that commercial entities might apply to make use of the Biobank, and that the full assemblage of data will be maintained in a reversibly anonymized form.

With regard to the ongoing nature of the relationship, participants should be told that they have an unconditional right to withdraw at any time (without having to give a reason and without penalty) and that they might be re-contacted if fresh consent is required to cover new research purposes.

The right to withdraw is seen as “essential to preserve and demonstrate the voluntary nature of participation”.¹¹ While the recruitment and induction of participants will emphasize the desirability of long-term participation (until death do us part, and even beyond), there is neither an obligation to participate (the initial decision to participate is voluntary) nor an obligation to stay in the project for a minimum term. Participants, so to speak, opt-in and then opt to stay in. Where a participant elects to discontinue, this might signify:¹² (i) complete withdrawal (meaning that the participant’s samples and linkages are destroyed); (ii) discontinued participation (meaning that, although the link with the participant’s medical record is broken, materials in anonymized form remain available to researchers) and (iii) no further contact (meaning that the participant’s materials and data are maintained exactly as if the participant was continuing, but there would be no further contact with the participant). If the right to withdraw is to add anything over and above the voluntary nature of participation, it must be by virtue of either the first option (for destruction) or the second (for discontinuance). This is a matter to which we return later in the chapter.

As for the need to refresh a volunteer’s original consent “to participate in U.K. Biobank”, the governance framework gives no clear indication of how or when this might arise. Where the scope of each participant’s consent is drafted in a bespoke narrow fashion, it is easy to understand how the need for fresh authorization would arise.¹³ However, where broad consents are taken (as seems to be the intention) then the idea is to cover all anticipated purposes and minimize the occasions when fresh consent for secondary purposes is required. Nevertheless, the compromise approach, even if it employs broad consents (and, to this extent, is not as strong on consent as it might be), recognizes the need to return for further authorization if the terms of the original consent no longer apply.

Weak property

Participants enrolled to the U.K. Biobank are informed that:

the UK Biobank will be the legal owner of the database and the sample collection, and that participants have no property rights in the samples.¹⁴

This weak approach to property is underlined by emphasizing that participants will not be offered any significant financial or material inducement to participate;¹⁵ and, in the section dealing with the relationship with research users, it is reiterated that participants “will not have property rights in the samples”.¹⁶

Of course, if U.K. law provided that each person (pre-enrolment) has proprietary rights in his or her tissues or samples (including where such tissues or samples are removed), a bald declaration that participants have no such rights would be of no legal effect. However, the legal position is far from clear and settled: while proprietary rights over removed body parts, tissues and samples certainly may be recognized, seemingly this is limited to claims made by persons other than the source.¹⁷ On this basis, it is arguable that the governance framework merely rehearses the background legal position (not, it should be said, that this would preclude the Biobank operating in a way that, de facto, treated participants as having proprietary rights).

Strong privacy

Given the background provisions of human rights and data protection legislation,¹⁸ and given that the Biobank will collect inter alia medical and lifestyle information about the participants, it is no surprise to find its governance principles reflecting the importance of privacy and confidentiality:

UK Biobank will maintain strict measures to protect confidentiality of data and samples, and will ensure that samples are (reversibly) anonymized, linked and stored to very high standards. The same protection will be extended under contract for any handling or analysis of data or samples by third parties engaged to provide services necessary for developing the resource.¹⁹

The framework principles go on to provide further and better particulars about anonymization (including that “sensitive” data will be kept separate from identifying information and only linked using a code that has no external meaning), re-identification and security. Quite clearly, the intention is to instate a strong regime of privacy protection with regard to the information collected for and held by the Biobank.

Human rights, consent, property and privacy

Elsewhere, I have suggested that bioethics, particularly when applied to issues concerning reproductive and medical biotechnology, involves a trilateral debate between utilitarians, proponents of human rights, and a constituency that I have termed the “dignitarian alliance”.²⁰ However, in the case of biobank governance, the debate is more traditional, with utilitarians and human rights theorists lined up against one another, the former emphasizing the public health goods to be derived from biobank research and the latter insisting that public goods, however good, must be pursued in a way that fully respects individual rights. For present purposes, we can put the dignitarian view to one side and focus on the bilateral debate between utilitarians and proponents of human rights.

The general approach of utilitarian ethics is very easy to state: no matter what the particular issue, utilitarians consistently hold that governance regimes should seek to maximize utility and minimize disutility. Regulators should aim to optimize welfare (human health and happiness), making whatever provision for property, privacy and consent seems appropriate relative to overriding utilitarian objectives. The specific application of a utilitarian ethic is, however, a rather different matter. Utilitarians might disagree about which of various regulatory options will generate the best utilitarian consequences, judgments about particular regimes of biobank governance depending on the particular context. For example, if utilitarians were confident that biobank research would generate sufficiently large benefits, they might contemplate conscription of participants, processing of information that would violate every canon of data protection, and confiscation of property rights. On the other hand, in another context, they might advocate a strong across-the-board regime of protection for participants. It always depends on context, circumstance, contingency and the perceived consequences of a particular governance approach.

Against the utilitarians, the proponents of human rights insist that it is vital that the entitlements of individuals should not be neglected for the sake of the larger good – individuals ought to be taken seriously, their rights are “trumps”, and the person, property and privacy of each human is to be respected. However, if biobank governance is to be guided by respect for human rights, we need to be clear about the orientation of this ethic to questions of consent, property and privacy.

Consent

Viewed from a human rights perspective, consent by A (a rights-holder) might signal either a change of position or the creation of a new relationship. There is a tendency to focus more on the former than the latter, that is, on consent signaling A’s willingness to modify his or her position in relation to the background scheme of rights and duties that regulates his or her relationship with B (the recipient of the consent). As George Fletcher puts it:

When individuals consent to undergo medical operations, to engage in sexual intercourse, to open their homes to police searches, or to testify against themselves in court, they convert what otherwise would be an invasion of their person or their rights into a harmless or justified activity.²¹

In other words, where A consents, then (other things being equal) A is precluded (or stopped) from asserting that B may not justifiably rely on, or hold A to, the agreed change of position or the terms of the new relationship. There are many points of elaboration to make about the operation of consent within a framework of human rights and responsibilities; but, for present purposes, the essential point is that consent does not function at large but by reference to a particular right held by a particular right-holder.²²

Property (in biological samples)

Modern technologies have given rise to a clutch of issues concerning property. In the field of information technology, for example, there has been a heated debate about the “propertization” of the information highway;²³ and, in a parallel debate in biotechnology, the “propertization” of the human genome was a famously divisive issue as research teams raced to sequence the genome, some racing to get the results of their research into the public domain, others to get their inventive work protected by patent. Here, the key issue is whether, relative to a human rights perspective, property should be recognized in biological samples.

The question of whether, in principle, A can have property rights in his or her own body parts or samples is deeply contested in both legal and philosophical circles.²⁴ Some arguments badly miss the mark. For example, it is clearly a non-sequitur to hold that, because A has a claim-ri...

Table of contents

• Cover Page
• Title Page
• Copyright Page
• Contents
• Series Editor’s Preface
• Table and Figure
• Notes on Contributors
• Acknowledgements
• Introduction
• PART 1: POLITICAL REGULATIONS AND INSTITUTIONS
• PART 2: SCIENCE AND INTELLECTUAL PROPERTY
• PART 3: DISTRIBUTION, LICENSING AND PROTECTION OF INTELLECTUAL PROPERTY
• Index