INTELLECTUAL PROPERTY AND THE RIGHT TO HEALTH
by
Silvia Salazar
Consultant, Central American Economic Integration Secretariat (SIECA)
(SanJosé, Costa Rica)
1.Introduction
This paper deals with the subject of the various relations existing between intellectual property and the right to health. Reference will be made, within the industrial property system, especially to patents, as a crucial instrument in the development of the pharmaceutical industry, which in turn has afforded the world’s population greater and better access to health systems. Clearly therefore, it is by no means frivolous to suggest that industrial property protection systems, by means of patents in this case, have managed to make a profound contribution to the development and improvement of the health of the general public throughout the world, by creating a situation in which the right to health, as a first-generation human right, namely one of those relating to the individual, becomes a reality.
Clear though the above premise is, it is also fair to say that the subject of the protection of pharmaceuticals and especially drugs by means of intellectual property rights has given rise to major discussions on the world stage. Those discussions have stirred up serious antagonism, above all between developed and developing countries, and have been the cause of intensive debate at international gatherings. It is perhaps in the field of health that the most questions have been asked about intellectual property and its role as a promoter of development, as health is a factor that is crucial to the survival and welfare of mankind.
It would appear however that the differences of opinion were overcome in the course of the discussions during the Uruguay Round of trade negotiations, which culminated in the signature, by almost every country in the world, of the Agreement on Trade-Related Aspects of Intellectual Property Rights, forming Annex 1C of the Agreement Establishing the World Trade Organization (the TRIPS Agreement). The Agreement obliges signatory countries to give patent protection to drugs, along with other inventions, for a period of 20 years. There is some controversy as to the grounds on which the developing countries agreed to the proposals of the more developed countries on this subject, but what is certain is that, when an international undertaking of such magnitude has been made, any discussion of the implications that it would have for the health systems of the least developed countries seems redundant, as the political decision has already been taken.
We therefore move on to deal with another subject that is closely related but still relevant and which has given rise to serious discussion in industrialized as well as in less developed countries, concerning access to biological resources. Access to genetic resources is a subject that has come under discussion relatively recently and has become important as the search for new drugs, new therapies and new cures in our planet’s biodiversity has intensified. The search for curative substances in nature is nothing new: plants especially have long been the source of miracle cures, but now, while pharmaceutical companies continue to develop drugs on the basis of sophisticated computer work, there is a resurgence of interest in medicinal plants and in natural substances with biological properties. The event that has brought new insight into the subject is the emergence of the new biotechnology, which shortens time-spans and promises great revelations in this area. For that reason, the more powerful pharmaceutical companies are turning their attention to the planet’s forests in search of plants, animals, fungi and also microorganisms that are a potentially rich source of active ingredients suitable for transformation into drugs.
This interest has at the same time aroused controversy regarding the possibility of intellectual property rights being improperly asserted in order to appropriate the products of biological diversity without corresponding compensation for the country, area, tribe or ethnic group that provides the biological resource or raw material for its development. The debate has thus focused on the need, assuming the possibility of patents being obtainable for natural products, with the exclusive rights that they bring, for there also to be the possibility of recognition and due economic compensation for the person or persons who provide the raw material. This debate has also borne fruit with the signature of an international undertaking to grant such rights in accordance with the United Nations Convention on Biological Diversity, 1992 (the CBD). The problem that has arisen has to do with the implementation of the CBD, which is presenting difficulties of a practical nature.
Another major subject that arises when the issue of the relations between intellectual property and the right to health is introduced is bioethics. It is a subject that has also been seriously debated worldwide in connection with the possibility of using intellectual property to secure exclusive rights in human body parts. The debate came into the open above all with the implementation of the Human Genome Project, whereby all human genes are to be sequenced with a view to treating a number of diseases by means of gene or genetic therapy. The legal, ethical, philosophical and religious implications of such a project, and of the idea of patenting parts of the human body, has aroused protest on the part of various groups, and it is still uncertain just what the repercussions will be for the development of society.
This paper therefore aims to take a broad, sweeping look at the patenting of pharmaceuticals, and the controversy that has arisen between developing and developed countries on the subject, and to show how that controversy was brought to an end in an international treaty; it will then consider the subject of access to biological resources as a source of raw material for the development of new drugs. The first part will thus deal with subjects like the patent system, the pros and cons of the patenting of pharmaceutical products, the relevant provisions of the TRIPS Agreement and the matter of parallel imports and the exhaustion of intellectual property rights, the latter two being still contentious at the world level.
The second part will deal with access to biological resources and the relevant provisions of the CBD, with one or two practical examples of solutions to some of the conflicts that have arisen out of its implementation.
Finally, a third part will deal with the subject of bioethics, with special reference to the Human Genome Project and the United Nations Educational, Scientific and Cultural Organization (UNESCO) Declaration on the Human Genome and Human Rights.
2.The Right to Health
The right to health is provided for in Article 25 of the Universal Declaration of Human Rights of December 10, 1948 (the UDHR). That Article provides that “Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control.”
As we see, the State cannot guarantee an individual’s right to health in the same way as the other rights could be implemented, such as the right to freedom for instance; health is therefore a product of the combined action of a series of variables, some of which are beyond human control. What the State does have to guarantee, however, is the combination of situations which, like food, nutrition, medical assistance, hygiene, etc., contribute to the improvement of health.
Within that set of variables, access to drugs and techniques for therapeutic diagnosis, and also access to sophisticated apparatus for the diagnosis, prevention and cure of disease, become essential factors guaranteeing the health of human beings.
3.The Patent System
Before dealing with the patent system, it seems appropriate to speak briefly of intellectual property in general. Intellectual property is the generic term used to designate the subjective rights that the various legal orders grant to the creators of immaterial assets of intellectual origin. Those immaterial assets may be of two kinds, namely either literary and artistic creations or distinctive signs and inventions. Intellectual property therefore establishes the protection of ideas and designs in art and technology, in industry and in trade.
It is precisely because there are differences between the protection of literary and artistic creations on one hand and distinctive signs and inventions on the other that legal literature has divided intellectual property, the overall generic term, and created two subfields called copyright and industrial property. Copyright serves to protect the manifestations of intelligence and art, and above all creations in the sphere of what is aesthetically pleasing. The important thing about this subfield is that copyright protects the conception or the form of expression of the ideas, but not the ideas themselves. That means that there may be paintings or books on one and the same subject, created by different persons; each of those persons will have his own very special way of dealing with the subject, and it is precisely the manner or form in which he does so that is protected by copyright.
Industrial property, on the other hand, relates to objects that can be used in technology and industry, meaning commercial signs like trade marks, trade names and so on, and inventions in their various forms, such as utility models and industrial designs. Industrial creations, unlike literary and artistic creations which contribute to an environment of intellectual or aesthetic enjoyment, are characterized by their usefulness and serve a particular economic purpose.
It is therefore important to focus on patents as the means of protection for inventions. An invention may be defined as an idea that purports to solve a technical problem. This accounts for the social function that has been attributed to inventions as factors promoting development and as essential components of any economic organization. Patents, for their part, are the titles conferred by the State that attest the grant of exclusive rights to the inventor for the exploitation of his invention.
The patent is the reward or inducement that the State grants the inventor for his contribution to the solution of a problem in technology or industry. It is an arrangement between the State and the inventor whereby the latter decides to disclose and publicize his invention to society, in exchange for which the State assures him that no one thereafter will be able to copy it without his consent. The patent thus performs a twofold function as an inducement to invent on the one hand and as an essential factor of scientific and technological progress on the other. Most of the research and development that is done at present takes place on the basis of very sound patent protection systems that guarantee the exclusive right to work the invention. The world is passing through an age of modernization on such a scale that a business’s most prized asset is its human resources as a fount of ideas which, with the support of a research infrastructure, has ensured that scientific progress does not come as a surprise. More important than their material stocks, in the opinion of businesses, are their stocks of immaterial products of the mind, which are what give them an edge over the competition.
Patents originated with the Venetian Decree of 1474 and the British Statute of Monopolies of 1623. While it is possible to find forerunners of patents that predate the Venetian Decree, such as the privileges granted by certain kings, doctrine has decided that the Venetian Decree is the world’s first true patent law.
What the Decree laid down was that any person who in the city of Venice made a new or ingenious device and registered it at the Office of the Provededori de Commun (municipal registrars) secured the privilege that consisted in all other persons being prohibited from making another device identical or similar to it for a period of ten years.
For its part, the Statute of Monopolies represents the culmination of the privileges granted by the British Crown, and, by eliminating all monopolies except those relating to licenses for the exploitation or making of new products, exalts the principle of novelty and practically establishes that only those monopolies that protect a novel activity are lawful. The exception written into the Statute allowed letters patent for a period of 14 years for the exclusive exploitation, for the benefit of the true and first inventor, of any type of new manufacture within the realm. Indeed the Statute actually went further in its definition of novelty, establishing that the manufactures in question were required not to have been used by others.
While it is true that the literature regards these two legislative texts as the predecessors of the modern patent system, it should perhaps be pointed out that the Industrial Revolution, and in the course of it the invention of the steam engine, was the real generating and driving force of the patent system. This was due to the fact that, with the possibility of using machines to produce goods, and the growing demand for those goods, came a change in the organization of manufacturing industry and in people’s customs. At that point another substitute for quality was introduced, namely novelty. It then became important to manufacture new goods and to devise novel ones and improve those already in existence, all of which accounted for the very real importance of inventiveness and the emerging need to provide adequate legal protection for the inventor as a means of encouraging him and promoting inventive activity.
Historically it is also important to say that the transformation of economic activity, from a limited and obstacle-ridden pursuit in the Middle Ages to the free enterprise that followed the Industrial Revolution, conjures up an economic scene in which the value of invention is exalted and which ultimately explains the universal recognition of the exclusive rights of inventors.
Now we could mention, among the precursors of modern industrial property law, the 1778 Constitution of the United States of America, which allowed Congress to grant authors and inventors exclusive rights in their works and inventions for a specific period, and from which in turn emerged the 1790 Patent Act; one could also mention the French Law of 1791, which recognizes inventors’ rights as sacred and inviolable property rights.
Now that we have established where our present patent systems come from, it is interesting to take a look at their particular characteristics. It has already been mentioned that patents are titles conferred by the State, so that the rights actually represent recognition by the State. They do not legally come into being until such time as the State has caused them to be recognized by means of a procedure laid down in its legislation. As a general rule the inventor applies to a public office, usually a registry, where he has to provide a clear and concise description of the invention by filing various documents accompanied, where possible, by the corresponding drawings.
The inventor has to describe the invention clearly and in detail. The description has to be sufficient for a technical person with average skill in the field to be able to carry out the invention by following the instructions given by the inventor. The fundamental part of the description is called the claims; these constitute a set of coordinates, as it were, that demarcate the scope of the invention. The claims thus serve to define the extent of the exclusive rights, as the protection is determined solely by the information that they provide.
For an invention to be eligible for patenting, it has to comply with three universally accepted requirements. They are novelty, inventive step and industrial applicability. An invention is novel if it was not known previously, in other words has not been anticipated. Two types of novelty stem from this basic concept, namely relative and universal novelty. Relative novelty has to do with the technical solution embodied in the invention not having been previously known in a particular territory or area, while universal novelty, as its name suggests, relates to non-preexistence or non-anticipation anywhere in the world. The latter type of novelty is the most widely recognized internationally.
Inventive step is a rather more subjective criterion, and it is also known as non-obviousness, or the fact of the invention not being obvious to a person with average skill in the field concerned. Apart from being novel the invention must, in order to qualify for protection, have required a certain degree of ingenuity; it must reflect an element of creativeness, and be more than just the result of daily experience or of knowledge per se.
As a practical solution to a problem in industry, the invention must be useful, must possess a certain usefulness or, as some legislation puts it, it must have industrial applicability. This requirement means that the invention has to have an essential aim, it has to serve a purpose in the outside world.