1.3. Material and Intellectual Property Rights over Genetic Resources
The biotechnology sector emerged in the 1970s and, with it, the will to protect the new corresponding inventions [
1,
15]: From the first successes of each of these techniques, intellectual property rights (IPRs) on newly extracted, isolated, purified, modified, or artificially created GR have been claimed and, more or less rapidly depending on the case, granted [
16,
17,
18,
19]. If the material property over organisms (a herd of sheep, a plant nursery, etc.) is as old as the domestication of plants and animals, it has traditionally been assumed that no IPRs over living matter can be granted. Most IPR legislations require, for protection to be granted, that the IPR is claimed over an invention and not over the simple discovery of something already existing. Yet, biological matter, as a manifestation of Nature, cannot be invented, but only discovered. The living was thus considered to be part of a common heritage of humanity, which cannot be appropriated by IPRs [
1,
15,
20,
21]. However, the molecular biology techniques mentioned above started to challenge this doctrine. The direct manipulation of GR changed their status, from product of Nature to product of the ingenuity of the human mind and therefore qualified them as possible candidate for protection by IPRs. During the year 1980, a Supreme Court decision (The US Supreme Court decision in Diamond v. Chakrabarty’s case, which legalized the patentability of a genetically modified bacterium.) and the adoption of the Bayh-Dole Act (The Bayh-Dole Act is a patent law passed by US Congress, that allows publicly-funded research teams to patent their discoveries (including on living matter) and encourages them to build partnerships with the private sector) [
3], both in the United States, made the obtainment of IPRs over living beings possible. The general principle of this legal reversal is the following: once the natural GR has been genetically modified, it can be patented, provided that the modification in question is new, applicable within an industrial process, and can be considered as an invention [
16,
19]. Since then, patenting has become a widespread practice, first in the United States, then in Europe [
3,
16,
18,
19].
1.4. Global Regulation of Genetic Resources Utilization
Concerns about the appropriation of GR through IPRs met environmental ones in the 1980s, as discussions started on the necessity to adopt a global framework regulating biodiversity utilizations. At the time, the environment had already become a political issue and the erosion of biodiversity a public problem of global importance [
2]. Southern States, many of whom were newly independent at that time, contested the GR’s status as a common heritage of humanity. They considered it to be an insidious form of colonialism led by the northern agrochemicals and pharmaceuticals industries [
1,
13,
20,
21]. Rather paradoxically, the nationalist demands of GR suppliers were coupled with users countries’ will to support their biotechnology industry: the suppliers countries’ request of national sovereignty over GR located within their territories was perfectly acceptable to actors of the biotechnology field, as they saw it as an opportunity to extend the international IPR regime to living matter [
13]. In a nutshell, the deal was to exchange national sovereignty over GR for the possibility to claim IPRs on these resources.
Thus, an ad hoc Working Group of Technical and Legal Experts (who became the so called Intergovernmental Negotiating Committee) established by the United Nations Environment Program (UNEP) was able to submit a draft convention for an international regulatory regime on the uses of all living natural resources. The final text was accepted in 1992 during the Nairobi Conference for the Adoption of the Agreed Text of the Convention on Biological Diversity. The Convention on Biological Diversity (CBD) was adopted the same year at the United Nations Conference on Environment and Development (the Rio “Earth Summit”) and entered into force in December 1993.
The scope of the regime established by the Convention on Biological Diversity (CBD) extends to the genetic material of plants, animals and microorganisms, which means [
22] “(…) any material of plant, animal, microbial or other origin containing functional units of heredity”. The regime pursues a triple objective: to conserve genetic diversity, make its uses sustainable, and ensure an equitable sharing of the benefits flows derived from them. The legal concept of access and benefit sharing (ABS) refers to this last objective. With ABS, the request of Southern States on property rights over GR was integrated to the regime by granting to each State a sovereign right over the GR situated on its territory. Concretely, this means that the material ownership of GR belongs to the States and that they have sole competence to decide under what conditions access to ‘their’ GR can be granted and resulting benefits shared [
1,
21].
The regime is based on two categories of instruments to achieve its objectives. First, in order to conserve biodiversity and encourage sustainable utilization of biological and genetic resources, CBD States Parties are invited to develop and implement plans, strategies or programs. Second, regarding equitable sharing of the benefits, private law contracts are the core instrument. They formalize the arrangements concluded between a GR supplier state and a particular user by stipulating which GRs are used, for which purposes, and how any corresponding benefits could be shared. In this perspective, equity, conservation and sustainability are supposed to be linked by a “virtuous” cyclical process: monetary and non-monetary benefits shared by the users with the providers of the initial GR are (at least partially) used to support conservation and sustainability, through the funding of corresponding measures. Additionally, provider states and their local populations are encouraged to preserve their genetic capital, as the regime makes it a source of income.
Several alternative ABS regimes have been implemented. These regimes are distinguished by two main dimensions: the degree of cooperation between the actors and the nature of property rights on GR (which determines the conditions of access, use and exchange). Significant examples include the introduction of common pools of (free access to the resources and multilateral sharing of the benefits) seeds in order to ensure food security. The International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), adopted by the Food and Agriculture Organization of the United Nations (FAO) in 2001 and into force since 2004, established such a common pool of GR, called the Multilateral System (MLS). The MLS was elaborated in accordance with the CBD provisions but it differs from the Convention on several points. It is legally binding and aims at the conservation and sustainable use of food crops of extreme importance to global food security as well as the equitable sharing of benefits derived from these GR. It applies to 35 varieties of food crops and 29 forage varieties, which make up more than 80% of the caloric intake coming from plants in the human diet [
18]. These GRs are co-owned, improved, and traded almost everywhere in the world. States Parties must grant unrestricted access to these varieties. The monetary and non-monetary benefits are shared among all States Parties through a common fund and the corresponding knowledge and information are collected in a common database. The facilitating exchange system proposed by the MLS has been successful in terms of the volume of material exchanged [
18].
Originally, the ambition of the international community was the adoption of an “umbrella convention”. In other words, a treaty able to absorb and consolidate the numerous existing regional and global conventions dealing with the different aspects of biological diversity. The members of the Working Group of Technical and Legal Experts finally concluded that such an “umbrella convention” was both legally and technically impossible to set up [
23]. As a results, the CBD took the form of a “framework convention”, an intentionally loose and flexible treaty [
24] that features the founding principles of the cooperation between concerned States Parties in the specific field of biodiversity. The idea behind an instrument like the framework convention is to stagger the establishment of norms: first, the framework convention establishes the legal bases and principles; then, States Parties have the authority to implement them independently through national legislation [
25].
A framework conventions is equivalent to the convention-protocol approach: after agreeing on relatively vague core principles, States Parties continue to meet regularly in order to adopt more specific and binding collective rules on particular subjects related to the original convention. Their formal manifestation is often a protocol to this convention [
24].
This is typically the case with CBD: one year after the Convention entered into force, States Parties have begun to meet periodically within the context of the Conferences of the Parties (COP) for further negotiations. The implementation of the CBD through national ABS legislations in States Parties proved to be particularly difficult regarding its third objective of fair benefit sharing. The cooperation between Parties was not optimal as user countries had not assisted providers in this task [
11]. Concerns about the possible free use of GR despite the adoption of the Convention incited the States Parties to implement a set of binding rules dealing with the ABS elements of the CBD. In 2002, in Cancun (Mexico), several megadiverse countries set up the Group of Like-Minded Megadiverse Countries (GLMMC) (Bolivia, Brazil, China, Colombia, Costa Rica, Democratic Republic of the Congo, Ecuador, Ethiopia, Guatemala, India, Indonesia, Iran, Kenya, Madagascar, Malaysia, Mexico, Peru, Philippines, South Africa, and Venezuela). The origins of this group of countries go back to 1998, when Conservation International, a US non-profit environmental NGO established a list of the countries harboring the majority of Earth’s species, the 17 megadiverse countries (Australia, Brazil, China, Colombia, Democratic Republic of the Congo, Ecuador, India, Indonesia, Madagascar, Malaysia, Mexico, Papua New Guinea, Peru, Philippines South Africa, United States, and Venezuela). This group is the political expression of the interests of this minority of Southern States accounting for the majority of the existing GR. During the negotiations of the NP, the GLMMC has been a megaphone for the developing countries, defending strong views on the ABS related issues (like compliance measures from user States). It took 10 COPs to agree on a binding protocol to the Convention—the Nagoya Protocol (NP)—adopted in 2010 [
1].
States Parties to the NP are required to adopt a clear national ABS legislation. Provider countries have to put procedures into place to regulate access GR situated on their territory. Access to the resource is granted through an access permit whose deliverance is conditioned by the obtaining of the Prior Informed Consent (PIC) of the Competent National Authority (CNA, the official body entitled to regulate ABS according to the corresponding national legislation) or additional providers (local community, individual, etc.) if applicable. Basically, PIC embodies the consent of the provider on the basis of the information given by the user regarding the research he intends to conduct (description of the GR and the sampling sites, quantity of samples, duration of the access requested, etc.). Once a PIC is obtained, user and provider have to agree on the Mutually Agreed Terms (MAT). The MAT constitute a bilateral private law contract that establishes the conditions of access, uses of the resource and the sharing of benefits (commercial or non-commercial research purposes, amount of monetary benefits to be shared, payment terms, etc.). As a user country, a State Party has to ensure itself that GRs used through R&D programs on their territory were obtained in accordance with the provisions of the providers’ ABS legislation. If that is not the case, they must take compliance measures.
Regarding the scope of the NP, it is based on the same definition of GR as the CBD but clarifies however [
26] that: “‘Utilization of genetic resources’ means to conduct research and development on the genetic and/or biochemical composition of genetic resources”. This is considered to be an important improvement as it means that ABS rules also applies to derivatives, the variety of (bio)chemicals compounds extracted from GR (enzymes, flavonoids, alkaloids, etc.) [
11]. Therefore, by enlarging the scope of the regime to the biochemical compounds from GR but that do not themselves contain functional units of heredity, a wide range of R&D became concerned with ABS requirements. Only research and developments activities though fall within the scope of ABS, which means that for example the supply of a plant GR to extract an already known active compound will not be regulated by the NP, as such activities do not encompass research and development.
As of November 2016, the CBD has 198 States Parties. Since the adoption of the NP in 2010, 79 States Parties to the CBD signed and ratified it, thus becoming States Parties to the NP. Half of those 79 countries have a national ABS legislation in force. Regarding States Parties to the CBD only, 17 countries implemented a national ABS legislation. This latter group of countries includes the members of the Andean Community (Bolivia, Colombia, Ecuador, and Peru) who have implemented an alternative ABS regime based not on the NP but on the Decision No. 391 Establishing the Common Regime on Access to Genetic Resources adopted in 1996.
In short, there are four relevant groups of States Parties in regard to the CBD and the NP:
- (I)
States Parties to the NP: 79 countries
- (II)
States Parties to the NP with a ABS legislation in force: 22 countries
- (III)
States Parties to the CBD: 119 countries
- (IV)
States Parties to the CBD with a ABS legislation in force: 17 countries
The following figure details this typology of countries (I used the data published by the Access and benefit-sharing Clearing-house (ABSCH):
https://absch.cbd.int. ABSCH is the official platform for collecting information on ABS. I also used information collected through our survey and the following sources: [
27]; several documents found on The ABS Capacity Development Initiative’s website (
http://www.abs-initiative.info), a multi-donor initiative supporting stakeholders from Africa, Caribbean and the Pacific for the implementation of national ABS.):