Intellectual Property, Medicine and Health

Johanna Gibson

• Editore: Routledge
• Anno: 2017
• ISBN:
  9781317114901
• Edizione: 2
• Argomento: Law
• Categoria: Law Theory & Practice

Intellectual Property, Medicine and Health examines critical issues and debates, including access to knowledge and medicinal products, human rights and development, innovations in life technologies and the possibility for ethical frameworks for intellectual property law and its application in public health.

The second edition accounts for recent and in some areas extensive developments in this dynamic and fast-moving field. This edition brings together new and updated examples and analysis in competition and regulation, gene-related inventions and biotechnology, as well as significant cases, including Novartis v Union of India.

Part 1
Health

1
The life of health

Valere, from which value derives, means to be in good health in Latin. Health is a way of tackling existence as one feels that one is not only possessor bearer but also, if necessary, creator of value, establisher of vital norms.¹

Introduction

[T]he fundamental substantive and methodological problem of economics is constituted by the question: how are the origins and persistence of the institutions of economic life to be explained, institutions which were not purposefully created by collective means, but which nevertheless – from our point of view – function purposefully? This is the basic problem of economics for the same reason that the problem of the explanation of the ‘purposefulness’ of organisms dominates biology. ²

During one of those inevitable moments in the writing process when the most banal television seems to be inexplicably compelling, a programme detailing the litany of disasters that may befall one while abroad caught the attention. A rather inane and irritating travel programme dressed up as informative, it included a bit on the Portuguese Man o’War. But the programme was less irrelevant than it might have first appeared. Indeed, what stood out was the way in which biological systems provide examples of colonies of individual organisms that are recognised and identified as one is immediately relevant in the context of current debates in the intellectual property system. The Portuguese Man o’War is of course not one organism but in fact a colony of organisms cooperating together and resembling and functioning as what appears to be to all intents and purposes a single jellyfish. Each member of the colony is an individual but with a specifically vital function in the ‘body’, so much so that each member cannot survive on its own. Such cooperation relies not only on the role of each contributing organism but also on trust and the assumption of risk. ³

This resonates with the organic nature of the knowledge economy and the critical role of all stakeholders in that economy. Furthermore, it provides some insight into the way the economic modelling of creative and innovative industries, the intellectual property system itself, sometimes masks the integral contribution of each of those actors. Instead, what is presented is a functioning, organic unity. As such, innovative and creative industry is seemingly fully accounted for within that unity. For example, patents are sometimes counted as indexical of a society’s innovative activity, not only for the purposes of demonstrating output in the university context, but also in terms of the annual indices of national patent filings. ⁴ With the publication of the 2008 Report, the WIPO Director-General was quoted as describing the increased filings as coterminous with ‘a major increase in innovative activity’ ⁵ and, more recently, the EU has suggested that ‘patents provide a valuable measure of the … inventiveness of countries, regions and firms’. ⁶ However, filings are not an indication of innovation in that filing activity is no indication of patents granted. Unfortunately, however, such statistics can be misused by various perspectives in the debate. For instance, patent filings are often taken to indicate not only the innovation of a society but also the ‘bad patents’ activity of a society. ⁷ The ‘organism’ of intellectual property has become perhaps quite misleading in that much innovation and improvement goes on despite what is presented in terms of the intellectual property system.

In the context of public health and access to medicines, it is necessary to identify the contributors to the colony of intellectual property. That is, while the knowledge economy is presented and experienced as a meaningful whole, it is nevertheless dynamic life and subject to intervention. Indeed, in the context of public health, it is vital to recognise the functioning individuals in order to maintain the health, the life of innovation. If one of the ‘organs’ of the body of ‘intellectual property’ over-develops its hypertrophy will obstruct the role of others. The expansion of rights can perhaps be seen as a kind of metastatic development at the expense of the users themselves and ultimately at the expense of the system. When looking at public health, it can be a matter of life or death.

The life of the system

The intellectual property system has often been taken to account for much more than what is proposed by a commercial law framework, including ethical oversight. However, this is necessarily beyond a commercial law system but not beyond the business models and healthcare systems which utilise the system to regulate the exchange and derive value from its products. In a sense, the present ‘crisis’ in access to medicines and health care demands the injection of the ‘life’ of the user back into the innovative and creative industries, in the face of the challenge of the scientific priority accorded to the intellectual property system and its protection of medicinal products. Indeed, ‘life’ is the very subject matter of all debates in intellectual property law and public health – whether in terms of access to medicines, sovereignty over living and genetic material, privacy and integrity in the individual body. It demands the recognition of the conflict between the intellectual property system and the problems that are facing all users of the system. Crisis, by definition within systems analysis, will ‘arise when the structure of a social system allows fewer possibilities for problem solving than are necessary to the continued existence of the system’. ⁸

The concept of ‘lifeworld’ comes from German sociology and phenomenology (Lebenswelt), and is relevant to the ‘crisis’ in intellectual property particularly in its more recent use by Jürgen Habermas. Importantly, it incorporates the individual and social resources of ordinary users of the system, including those cultural, linguistic and tools by which users maintain their individual and social coherence and integrity:

The everyday communicative practice in which the lifeworld is centered issues equiprimordially from the interplay of cultural reproduction, social integration, and socialisation. Culture, society, and personality mutually presuppose one another. ⁹

Indeed, it is the lifeworld in which a politicised civil society emerges. ¹⁰ Habermas uses the term to explain the crisis in the confrontation between the expertise and skills of ordinary people as distinct from the administered society. Indeed, Habermas interprets the concept of ‘crisis’ through the medical crisis in the body and the distinction between the objective disease state and the subject’s consciousness and lack of control:

[W]e would not speak of a crisis, when it is medically a question of life and death, if it were only a matter of an objective process viewed from the outside, if the patient were not also subjectively involved in the process. The crisis cannot be separated from the viewpoint of the one who is undergoing it – the patient experiences his powerlessness vis-à-vis the objectivity of the illness only because he is a subject condemned to passivity and temporarily deprived of the possibility of being a subject in full possession of his powers. ¹¹

Thus, the ‘crisis’ in intellectual property anatomises the confrontation between the subjective lifeworld of the user and the overriding objectivity of the commercial organism:

We therefore associate with crisis the idea of an objective force that deprives a subject of some part of his normal sovereignty. To conceive of a process as a crisis is tacitly to give it a normative meaning – the resolution of a crisis effects a liberation of the subject caught up in it. ¹²

Important opportunities for addressing crisis lie in this relationship between the lifeworld of users and the intellectual property system.

Indeed, the critical urgency with which inequities in access to medicines must be addressed necessarily includes not only a consideration of the system failures but also the subjectivity of individual users of the system. In particular, the distinction between the apparent objectivity of research agenda and the intellectual property system, as distinct from the subjectivity and lack of control of individuals over their social and developmental status is critical. Health becomes not a condition of biology but one of social status, ¹³ that is, the ‘life chances’ of the particular individual. Max Weber’s concept of Lebenschancen (‘life chances’) has been central to medical sociology and arguably is particularly significant in the context of access to medicines: ¹⁴

It is the most elemental economic fact that the way in which the disposition over material property is distributed among a plurality of people, meeting competitively in the market for the purpose of exchange, in itself creates specific life chances … the kind of chance in the market is the decisive moment which presents a common condition for the individual’s fate. ¹⁵

Representative of an economic and social class, life chances manifest in the opportunities for access to and possession of goods. ¹⁶ These life chances therefore administer not only the individual’s access to medicines but also the research agenda into diseases affecting certain populations and regions, in that the latter will be dominated by considerations of the profitability of markets. The once common-sense and automatic activities in the lifeworld of the ordinary user have thus become manifest by virtue of its confrontation by the intellectual property system. The ability to use creative material, to access medicines and to access educational material are all key issues demonstrating the conflict between the ordinary lives of citizens and the commercial system of intellectual property. The related concept of Lebensführung (commonly translated as conduct of life or life conduct) is the counter to ‘life chances’ in a person’s overall lifestyle (Lebensstil). In part, it indicates the circumstances in which the individual has control and autonomy over access to production. The critical articulating factor for lifestyle is therefore access.

Georges Canguilhem has explained, disease arises through the organism’s disequilibrium with its environment: ‘Nature (physis), within man as well as without, is harmony and equilibrium. The disturbance of this harmony, of this equilibrium, is called “disease”‘. ¹⁷ The ‘health’ of the knowledge economy is arguably compromised where the intellectual property organism becomes unbalanced and the user as ‘creator of value’ in the health system is undermined – a time of crisis. Without the proper balance in rights and access, all users of the system will be without the sufficient energy (knowledge) to function. But as Canguilhem explains, ‘Disease is a generalized reaction designed to bring about a cure; the organism develops a disease in order to get well’. ¹⁸ The crises in access to medicine must provoke a substantive therapy for the system and for the business models built upon that system. Civil society activity articulates the individual’s autonomy with respect to health, examined throughout this book, and current campaigns towards addressing the inequities in access to medicines and public health care are indeed part of this opportunity for the system to get well.

Health

The Constitution of the World Health Organisation (WHO) defines health broadly and recognises the right to enjoyment of the highest attainable standard of health as one of the fundamental human rights. ¹⁹ Of particular significance is the incorporation of social and mental well-being within the definition of health provided in Preamble to the Constitution. ²⁰ As well as the elimination of disease, the cultural and social unity of the individual is significant to a fulfilment of the right to health.

Furthermore, an individual’s health pertains not only to the individual, but also to the greater social organism. The health of the individual and that of society are mutually constitutive: ‘Dramatic differences in the health and life chances of peoples around the world reflect imbalance in the power and prosperity of nations. The undoubted benefits of globalisation remain profoundly unequa...