The United Nations Bio-Diversity Convention
The United Nations Convention on Biological Diversity, known as the Biodiversity Convention or CBD, was enacted in Rio de Janeiro in June 1992. The Convention was originally signed by 157 governments. It came into force in December 1993. By December 2011 the Convention had been ratified by 193 states, including the European Community and its Member States, Canada, China, Japan, and the Russian Federation. The United States signed with reservations and has not yet ratified the Convention.
The three prime purposes of the Convention are set out in Article 1:
To conserve biological diversity.
To promote sustainable use of its components.
To share equitably with providers the benefits arising from such use. The Convention recognises that for poorer countries development is an overriding priority.
Before the CBD, plant genetic resources had been declared ‘a common heritage of mankind to be preserved, and to be freely available for use, for the benefit of present and future generations’ (United Nations Food and Agriculture Organisation (FAO) Conference, November 1989, see para 108). Under that regime, genetic resources could, in general, be exchanged and used freely, both for academic and commercial research and to develop new products. Now, in principle, they are under the control of the countries where they are situated.
Innovations flowing from research on genetic resources add to the stock of previous knowledge and practice in medicine, agriculture and food technology. They are new assets: they do not damage existing ones. They can be protected as intellectual property, e.g. by plant breeders' rights and patents.
Scope of genetic resources
The term ‘genetic resources’ is very broad. It covers all living matter (though the Convention has decided to exclude human materials from its remit) and certain constituents of such matter (for example, genes). There is a dispute as to whether it covers derivatives of such resources. The Convention makes no distinction between material in the public domain, e.g. in public germplasm banks, and material in private ownership. All is in principle covered by the convention.
Rights in genetic resources under the Biodiversity Convention
The Convention recognises the sovereign rights of states. These include powers over all entities within their boundaries, including their natural resources. Therefore national governments have the right to control access to these resources (Article 15 (1)). The Convention requires members to make their resources available to other members for ‘sustainable uses’. In return for providing such access, donor countries are to benefit in any of three ways:
participation in research, Article 15(6);
sharing in the results of research and proceeds of commercial exploitation, Article 15(7); and
access to and transfer of derived technology, Article 16(1).
According to Article 15(4), (5) and (7), access and sharing are to be dealt with ‘on mutually agreed terms’ and ‘subject to prior informed consent’ (PIC). Therefore, under the CBD, access to any genetic resources must be preceded by bilateral negotiation to decide how the donor country is to benefit, as well as other conditions of access.
The Convention is an arrangement between states, and is not self-executing. It requires enforcement by local legislation, which in many cases is still awaited.
An emerging problem is the extent to which the rights given by the Convention extend to materials that originated within national boundaries, but are now elsewhere. Under what circumstances can the 'country of origin' control these?
Benefit through technology transfer
According to Article 16(1) and (2) of the Convention, access to and transfer of technology among the Contracting States is necessary both to conserve biological diversity and to promote use of genetic resources. Article 16(3) requires Contracting Parties (National Governments) to ‘take legislative, administrative, or policy measures’ to achieve this objective, particularly where a developing country provides the genetic resources. Also, by Article 16(4), such measures must have the aim that the private sector facilitates joint development with, and technology transfer to, governmental institutions and the private sector of developing countries.
'Traditional knowledge' - Article 8j of the CBD
“Each Contracting Party shall, as far as possible and as appropriate: ....
(j) Subject to its national legislation, respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity and promote their wider application with the approval and involvement of the holders of such knowledge, innovations and practices and encourage the equitable sharing of the benefits arising from the utilization of such knowledge, innovations and practices; ...”
Such ‘knowledge, innovations and practices’ are often referred to as ‘traditional knowledge’ (or TK). This article is often interpreted generously. That is to say, as well as promoting wider use of TK with approval of the holders, it is held to require preventing use without such approval. In effect, the holders of the knowledge are given an exclusive right in its use. This causes difficulties, because the nature and scope of the right are inherently unclear. It may not be confined to knowledge obtained directly from the holders; it may not exclude knowledge already widely known.
Frequently, genetic resources of all kinds have TK associated with them. This may be clear and direct – as for example in the case of chinchona bark, the use of which in combatting malaria was learnt by Jesuit missionaries from South American tribes. It may be much more tenuous, as where a plant with medicinal properties is located in an area inhabited by indigenous peoples. Even where the plant has no history of local use, it may be said that the environment in which it is found is created or at least influenced by the local inhabitants, and the plant is a product of its environment. In such cases, investigators seeking access to such plants may need to negotiate both with the national government and with the local inhabitants. Typically, it will not be easy to ensure that the inhabitants understand the implications of giving access – but without this they cannot give the necessary 'prior informed consent'.
The mechanics of technology transfer
Technology transfer may take place in several ways. It will usually include the licensing of some form of proprietary right. This may be a statutory registered right, typically a patent: or it may be the right to secret know-how or proprietary biological material. In Article 16(3) and (5) the Convention recognises that the technology to be transferred may be the subject of patents and other intellectual property rights.
The role of intellectual property
Registered intellectual property rights can provide a basic framework for the structure of the licence. This may be supplemented by provisions for the supply of know-how and other factors, often less tangible and less easy to define. In biotechnology, patents are the most significant form of statutory protection. Patent law demands clear definition of the protected technology and thereby establishes the scope of the rights of the innovator, identifies what is transferred to a licensee, and allows for the corresponding freedoms of third parties to be assessed.
The existence of an adequate system of intellectual property rights in the donor country will not of itself ensure that technology transfer takes place. However, as it provides an orderly method of achieving such transfer and of controlling unlicensed and unfair competitive activity, it will offer a strong inducement to the whole process of investment in research and development of the genetic resource and in the subsequent exploitation of the derived technology.
Farmers’ Rights are not part of the Biodiversity Convention but are seen as a related concept in public debate on the broad issues covered by the Convention. These rights were first formulated in Resolution 5/89 of the FAO Conference mentioned above. In this resolution, ‘Farmers' Rights‘ means ‘rights arising from the past, present and future contributions of farmers in conserving, improving, and making available plant genetic resources, particularly those in the centres of origin/ diversity ...’
A more recent proposal defines Farmer's Rights more specifically as:
‘..the customary rights of farmers to save, use, exchange and sell farm-saved seed and propagating material, their rights to be recognized, rewarded and supported for their contribution to the global pool of genetic resources as well as to the development of commercial varieties of plants, and to participate in decision making on issues related to crop genetic resources.’ [See Farmers' Rights.]
However, such rights are not formally recognised in the laws of most countries.
Farmers' Rights are not to be confused with the so-called ‘Farmer's Privilege’ which stems from existing national laws on Plant Variety Rights. Plant variety rights primarily control commercial dealing in reproductive material (e.g. seed) of the protected variety, allowing material for consumption to be sold freely. The ‘Farmer's Privilege’ allows a farmer to save seed from a first crop for planting a second crop on the same farm (without further recompense to the owner of the variety right): it is sometimes limited to producing quantitities sufficient to replant the farmer's own land.
International Agreement on Plant Genetic Resources for Food and Agriculture
All countries are to varying degrees dependent on genetic resources originating outside their boundaries. This is particularly clear for food crops [See, for example Plant Genetic Resources for Food and Agriculture: A Common Heritage of Mankind by Radha Ranganathan]. The high-yielding strains of wheat and rice which sustained the Green Revolution were created from parent stock from dozens of countries. No country is self-sufficient in such material. It is vital to feeding the world that high-yielding crops continue to be improved, with the minimum of legal formality. Recognising that the bilateral negotiations required by the CBD could significantly interfere with crop development, the UN's Food and Agriculture Organisation has promoted a multilateral agreement to promote exchange of crop germplasm: the IAPGRFA. This provides for free exchange of germplasm of listed crops (including many but not all significant food crops: e.g., wheat, maize, rice but not soybean or tomatoes), with commercial breeders being encouraged to pay royalties on commercial materials developed using such germplasm, but not obliged to do so if the material they sell remains free for further research and development. The agreement refers to Farmer's Rights (see above). 119 countries (including the EU and the USA) have signed or ratified this agreement, which entered into force in June 2004.
Does the CBD conflict with TRIPs?
This is often alleged. However, the better view is that the two conventions deal with different subject-matters, and can and should be interpreted to be entirely consistent. The fact that a novel isolated gene may be patented, or a particular plant variety made the subject of plant variety rights, in no way diminishes the rights to control access to the germplasm that the CBD recognises.
What has the CBD achieved to date?
A major achievement of the Convention is to highlight the importance of biodiversity. Species are becoming extinct at an increasing rate: and the world is rapidly losing materials important to the stability of ecosystems and of potential value for a wide range of uses. The Convention has directed attention to this problem and inspired action to reduce it. Among its achievements has been the Cartagena Protocol on Biosafety, dealing with cross-boundary transfer of transgenic organisms.
What are its shortcomings?
The high aspirations of the Convention are difficult to implement. Much remains to be done – and some things, perhaps, need to be undone. The Cartagena Convention has been criticised as too conservative – imposing unjustified restrictions on transgenic organisms because of an over-pessimistic assessment of the balance of risk and benefit that these offer. The emphasis in the Convention is on the rights of ‘countries of origin’ of genetic resources: but there is ambiguity about how materials found outside the ‘country of origin’ are to be treated; and it is not always easy to determine, for any material, what its 'country of origin' is. The emphasis on the value of genetic resources has induced some countries to overestimate their immediate potential for profit – making them reluctant to share their resources. This has reduced access (and in consequence benefits) rather than promoting it. Developers still find it difficult to follow the prescriptions of the CBD. In many countries approval for access is slow and difficult: in some it is unclear which government department (if any) has authority to provide the consent the Convention requires. The need to deal with indigenous peoples complicates the situation even more.
The Nagoya Protocol
The Convention negotiated an International Regime (IR) on Access and Benefit Sharing (ABS) in October 2010: the resulting document is termed the Nagoya Protocol. It seeks to control research and development on genetic resources. It will enter into force 90 days after deposit of the 50th instrument of ratification. [As of January 2012, around 70 states have signed, but only two have ratified.] Countries who sign undertake to enforce the Protocol in their territories: for example, by having internal checkpoints to ensure that the obligations imposed by the Protocol are complied with. Such checkpoints might include organisations sponsoring research, or Patent Offices. Many have concerns as to whether the Protocol will prove useful and practicable. If not, it may impede the objectives of the Convention rather than promoting them.
The aims of the CBD are irreproachable, but the means by which it seeks to achieve these aims are not always optimal. Intellectual property rights need not conflict with the objects of the Convention. A failure to recognise intellectual property rights will, however, powerfully dissuade industry from investigating and developing many useful applications of genetic resources.