2 Setting the Stage

Before turning to the authors' analyses of particular controversies, it is important to briefly introduce a few critical objectives of the ABS regime relevant to the rest of this discussion.

2.1 Construction of access regimes

This section provides a basic summary of the components of an “access regime” – that is, of those elements of ABS legislation that are directed at ensuring that the country is aware of, and able to receive a share of benefits derived from, the use of genetic resources from that country. It is based primarily on work published by IUCN in an earlier interim publication in this series – Cabrera Medaglia, J., A Comparative Analysis of Legislation and Practices on Access to Genetic Resources and Benefit Sharing (ABS): Critical Aspects for Implementation and Interpretation. It will not restate this detailed analysis, but will briefly describe the components of national access legislation, as considered there.

Following the Convention's entry into effect, ABS very quickly became highly controversial,24 beginning with the promulgation of the Philippines Executive Order in 1995, the first specific legislation centered on the regulation of ABS. Later, the first regional framework, Decision 391 “The Common Regime for Access to Genetic Resources” of the Andean Community, too was intensively discussed. Numerous studies, seminars, publications and discussions have been generated on this subject. Nonetheless, in spite of the time elapsed and of the accumulated experience, difficulties still continue to arise in the negotiations at the core of the CBD, and, what is even more worrying, a series of obstacles persist which impede the effective enforcement and implementation of these initiatives and measures.25

To date, numerous different studies and researches, on the efforts of promulgating and implementing legal frameworks on access and benefit sharing at the national and international levels, have been completed.26 These studies can be characterized basically according to their approach to four main issues:

However, even more recent studies, which refer in some degree to aspects of implementation and interpretation of ABS regimes in general, lack any legal or institutional analysis that emphasizes the needs which the regulation on access to genetic resources imposes on legal systems. This last has become more imperative, in consideration of the fact that at least 15 countries have some legislation on ABS and more than forty are in some phase of design or are considering introducing new legal rules to regulate the access to genetic resources and benefit sharing.

2.1.1 Main objectives of ABS legislation

It is generally stated that ABS systems must encompass, in general terms, the following aspects, in the law and other relevant practices and systems of source countries:

As a practical matter, of course, most of these elements are relatively straightforward legislatively, and do not require significant guidance: most countries can designate focal points, apply and/or extend their standard public participation practices, apply their standard contract laws (PIC and mutually agreed terms), and draft sanctions without external aid. The problems for most countries arise because the basic international design of the ABS concept is not completed or expressed in a way that enables practical implementation. Consequently, this chapter will provide only a summary of most of the above “elements” – leaving for later chapters the discussion about the more difficult problems of the overall ABS structure.

2.1.2 Frequent criticisms of access legislation to date

Before proceeding to a discussion of the specific elements of national access legislation, however, it is useful to briefly canvass the primary criticisms that have been leveled at these laws, generally by the commercial and academic sectors. At some points in the various ABS negotiations, these factors have been cited as the “reasons that ABS is not working.” More recently, however, most writers and negotiators recognize that these points are less common than formerly stated, and that they represent only the perspective of users. Consequently, while interesting, they should be seen as a list of the concerns of only one side of the negotiations, recognizing that there are generally equal and opposite concerns expressed by other stakeholders with an interest in the ABS issue (governments, civil society, etc.).

[Note: The following comments were derived originally from a list based on the experience of the Philippines, under its Executive Order No 247 (EO), as implemented by the Department Administrative Order 96,28 two documents which have since been de facto amended by the newer Wildlife Act.]29 Extent of scope and coverage30

The scope of the access provisions are frequently too broad due mainly to a vague definition of the term “bioprospecting” – a newly coined term which is often informally used, and sometimes legislatively equated with “access.” Objectors noted that the term “prospecting” means “to explore” or “to look for,” but that the law (in this case the Philippine EO) covers more than just “looking for,” extending to almost all kinds of collection, research, and utilization of biological and genetic resources, including conservation research that many scientists, academic institutions, and NGOs undertake and which have nothing to do with prospecting. While this is entirely true, it is not legally or practically incorrect – all legislation defines some key terms, as shorthand ways of specifying the coverage of the act or particular provisions. Cumbersome application process

The period from filing of the application to final approval of the agreement is another point of concern. In the Philippines (one of the more expedited processes), it is estimated to require at least five months. For most local scientists and researchers, the process is cumbersome, costly, and considered a deterrent to research, growth and development. Difficulties involving prior informed consent

The PIC requirement is usually seen by applicants as administratively tedious, burdensome and a cause of much delay – for example, the EO specified a 60-day period before PIC could be certified as complete. However, it is the cost of securing the PIC certificate that is the source of most complaints from the bioprospectors' point of view. For example, in the Philippines (as in many other countries), PIC responsibilities are delegated to the individual communities. Hence, if the research required utilization or collection of resources from 12 regions of the Philippines, the collector would have to go to 12 sites to secure 12 PIC certificates. Each community could impose different demands, terms and conditions on that process. Indeed, even the identification of which community should give consent is often problematic, given the range of species and the fact that many species populations are pelagic or migratory. Complexity of institutional mechanisms

Many of the most well-developed systems involve the use of an inter-agency body consisting of representatives of various agencies of the government and other sectors. This approach is thought to be advantageous because of the multi-disciplinary nature of the issues relating to bioprospecting. However, an inter-agency approach has many inherent problems as well. It is difficult to get a quorum of the members; resolution or decision-making takes a long time because of irregular attendance of members; and coordination between member agencies is difficult.

The contrary approach of broadly disseminating ABS obligations among the various ministries and sectors has become a common alternative, but places users in a different situation, in which it is difficult or impossible to know which agencies govern a particular application. At some points, both approaches are used, multiplying the administrative complexity.

At the international level, these concerns have instigated the requirement that each country designate an “ABS Focal Point,” who could undertake the regular activities which would not really need the involvement of the inter-agency committee, and could serve as a purveyor of information about which agencies and requirements apply. Ultimately, however, while most countries have designated ABS focal points, few such designees have been able to effectively address the above-listed complaints. Contractual expectations and benefit sharing

One of the most common complaints relates to the level of demand imposed under benefit-sharing legislative requirements. Often particular percentages may be stated as “generally applicable” components of the “mutually agreed terms.” In some cases, other kinds of benefit-sharing provisions are often seen as too demanding, particularly when imposed on researchers, given the possibility that they will compromise the confidentiality of information developed by these researchers.

2.1.3 Definitions, scope and exclusions

As noted above, in the past there have been criticisms regarding the lack of clarity of the term “genetic resource,” and especially its implications in determining the scope of regulations for access to genetic resources.31 Particularly, the vagueness of the definition included in the Convention on Biological Diversity has been debated, which has been criticized for its lack of precision. In the same way it has not always been clear when access to genetic resources occurs, in opposition to the access to biological resources, nor when the utilization of genetic resources takes place and if this constitutes a different phase altogether. Predominantly, in most of the legislation about access to genetic resources, even though those terms are defined, in practice, it has not always been so simple to establish which activities constitute access to genetic resources and which access to biological resources. It is also difficult to know which mechanisms are available to the State to find out whether there is access and utilization. Definition issues

The Convention on Biological Diversity defines genetic resources as follows (Art. 2 Use of Terms): “Genetic material of actual or potential value.” Additionally the Convention defines biological resources and genetic material, but does not actually clarify what it means by “access to genetic resources,” or “utilization of genetic resources.” It further states:

“Genetic material” means any material of plant, animal or microbial or other origin containing functional units of heredity.
“Biological resources” includes genetic resources, organisms or parts thereof, populations or any other biotic component of ecosystems with actual or potential use or value for humanity.

The implications of this definitional uncertainty in national laws on access have been easily perceived in practical application. Some requests have been presented, either in exclusively taxonomic terms or for the commercial utilization of biological resources, without clarifying the status of genetic or biochemical properties contained in the samples.32 In other cases, especially in applications dealing with the use of medicinal plants, nutraceuticals and botanicals, legislation in many countries excludes these entire categories from the scope of access, even though they are important growth sectors at a worldwide level in the private sector,33 both as whole (biological) resources and as genetic and biochemical resources. Sometimes they are included, but only as to entities and practices at a higher level of industrialization – another term that is not defined properly.

In general, the available legislation on access nearly always bases the definition of genetic resources on the above language from the Convention, with some modifications that do not alter its essence, or enable it to be practically applied. Additionally, definitions such as “bioprospecting” are often used to clarify national intention regarding the scope of ABS legislation.

One of the most troubling problems for practical application is the difference between the normal acquisition of biological resources and “access to genetic resources.” In general, countries do not provide a clear indication of the difference between “purchase of biological resources” (the organic material) and “taking the genetic material (which is contained in the biological material).” The difference is typically thought to be based on intended or declared use: the search for genetic or biochemical material contained in the biological specimen, for different purposes (basic research, bioprospecting, etc). Supposedly, in some countries, the taking of biological resources must comply with certain requirements, including the information provided by the applicant before granting removal. This information should contain details on the intended use and therefore if the proposed use implies access to genetic resources, the competent authority must refer the applicant to the appropriate legal body in charge of granting access in order to initiate the legal procedures for access and benefit sharing.

A related question applies to terms such as “utilization of genetic resources” and “access to genetic resources.” These terms are of great importance practically, and are discussed in more detail in Chapter 3, and other books of this series.34 Precise scope

Questions of definition also affect the scope of access, of ABS and of the international system being developed (both informally and formally) for ABS. The Convention on Biological Diversity in its article 15 refers only to genetic resources, without specifically using the term biochemical resources. Nevertheless, since “genetic resources” has no precise definition, one cannot tell whether the unique biochemical properties of a specimen are included in that term. In addition, the scope of Article 15 does not impede a country from deciding to extend the scope of its procedures of access to biochemical resources.35 The latter, owing essentially to the importance which biochemical resources hold for research and development in pharmaceutical industry, would be a substantial extension to some observers.36

2.1.4 Ownership of genetic resources

One critical element of national law that is needed is to determine and legally acknowledge the difference between the owners of the land, from which the specimen is collected, the owner of the specimen, and the owner of the genetic resources. The current complexities of this issue are more completely discussed in Chapter 3, but the basic issues should be summarized here for completeness.

The Convention to Biological Diversity does not define a property right over genetic or biochemical resources. Its only input on ownership issues is to recognize the sovereignty of the States over their genetic resources. This recognition puts genetic resources on an equal footing with all other kinds of property (tangible and intangible) – specifically, that the rights of an individual “owner” of any property extend only to those matters that the national government says he may own – something that differs from country to country. Up to now, however, property systems and constitutions, with few exceptions, have not made reference to genetic resources. The fact that genetic resources are usually integrally included in biological resources (physical samples of a specimen or part) creates confusion. However, in the same manner, some legal systems differentiate between property rights in biological resources and the proprietary rights in genetic resources.37 Generally, the State is considered the owner of the genetic resources but the individual landowner or specimen owner who gives the biological resource containing the genetic resource, or authorizes the entrance to the land where the resource is located or to the ex-situ collection, is considered the provider of the biological resource.

The definition of the property rights is recognized as one of the most complex issues related to ABS.38 The sovereignty concept is different from patrimony and from property; the latter is not approached by the Convention itself, giving each State the freedom to decide whether the genetic resources are private or public property. For instance, in Colombia, according to the sentence dictated by the C-977 State's Council, “the legal regime of property applicable to genetic resources with real or potential use is the one established for public domain goods, in generic terms in Decision 391 of the Commission of the Cartagena Agreement...” it means that genetic resources are the inalienable, unattachable and imprescriptible patrimony of the Nation.39

There are some sources of confusion even here, however. Decision 391, for example, specifically refers to the existence of different types of ownership. First there is a definition of “provider,” which acknowledges providers both of the biological resources and of the intangible component. As part of the application, an identification of the provider of the biological or genetic resources and intangible component is required (art. 26 b). This distinction is also envisaged in the different access contracts: the annex for the intangible component (art. 35) and the accessory contract for the provider of the biological resource, the owner of the biological resource, the land, and the ex-situ conservation centre (as owner or custodian of the biological resources) (art. 41). According to this article, accessory contracts are those that are signed in order to carry out activities connected with the genetic resource or its by-products, between the applicant and the owner, possessor or manager of the land where the biological resource is located, the ex-situ conservation centre or the owner, possessor or manager of the biological resource containing the genetic resource.

2.1.5 Mechanisms to control utilization

With regard to the mechanisms to enable a provider country to know when utilization takes place, there is much commonality among national systems, primarily because such mechanisms are illusory. In general, the country of origin only knows when utilization has occurred when there is a previous application for access wherein a mechanism has been established which informs about the future utilization of the resource. There is no system for monitoring the uses which imply access or utilization of the genetic resources. However, some countries are engaging in measures to attempt to address this, even if only in part. In the Philippines, for example, several references exist to training activities for controlling access to genetic and biological resources and attempting to ensure that their export is in compliance with the access legislation.

One country, Costa Rica, has attempted to unilaterally impose a requirement for a “certificate of legal provenance” stating that this certificate is a previous requirement for granting IPR protection to the innovations related to elements of biodiversity.40 Unfortunately, owing to primary jurisdiction issues, this provision only applies to those who seek IPR protection under Costa Rican law, unless Costa Rica is able to bring a claim, under another country's IPR law, that the IPR application is a breach of contract.

2.1.6 Restrictions on access for specific uses and third party transfer

One of the most relevant issues in ABS is related to the potential ability of the State or other provider of the genetic resource to impose limits on the further activities that can be developed by the user. These limits can (usually) consist of the following:

In essence, where one or more of these actions is restricted in the law or permit, the user can undertake that action only if he first returns to the provider country and obtains prior informed consent.

2.1.7 Legislative interpretation of access and benefit-sharing obligations and their relationship

There was a general view expressed by some legal authors in the early years following the adoption of the CBD that ABS is an exchange at the contract level, wherein access is the provision of genetic resources and benefit sharing is the payment for them. Increasingly a large number of experts share the opinion that this is legally incorrect.

Access refers to the ability to enter, bioprospect for, collect and/or remove genetic resources; while benefit sharing is an equitable construct – the obligation to fairly and equitably share the benefits arising from the utilization of genetic resources. This latter approach is based on the idea of utilization and means much more than just “payment” for access, as discussed in Chapter 3. However in most existing national ABS laws, including the ones analyzed in the Comprehensive Analysis, and from the point of view of the decision-makers, access and benefit sharing are considering two inextricable elements of the same process - or at least benefit sharing is always required in cases of access. Thus, access triggers the benefit sharing, but no law seems to specifically say that no benefit sharing will be required where the resources were obtained in other ways. This standard approach considers access as a first step for the utilization of the resources and does not separate – conceptually – access and the sharing of benefits, even if the latter occurs later.

2.1.8 Monitoring and legal remedies

Two of the most relevant aspects on ABS, that present larger difficulties, are related to the monitoring of access and benefit-sharing conditions, and the existing legal remedies against non-compliance with the contract or permit. ABS legislation will always be difficult to enforce, due to the nature of genetic resources, particularly their wide availability and the ease of dissemination or replication.43

At present, national ABS legislation does not include adequate monitoring systems. Monitoring and evaluation of the agreements is in most cases weak or absent.44 This seems to be one of the main difficulties of the ABS regimes. To this, the difficulties derived from the characteristic of genetic resources as information, are added.45 This characteristic has brought to evidence the inconvenience of applying the traditional monitoring instruments. Probably, as the Expert Panel on ABS recommended,46 monitoring could be more effective with the participation of an institution or local counterpart.47 This system has been considered by diverse countries (Bhutan, Bolivia, etc). Regardless of utility of in-country participation, it must be acknowledged that research and development in their most advanced phases will normally be carried out outside the borders of the country of origin. For this reason, additional mechanisms to warrant the tracking of the materials, for example identification systems, must be explored. In the same way, mechanisms to oblige the users to present periodical reports, including reports on the applications for patents, together with the possibility of making audits to verify the compliance, are some of the indicated solutions. In general, countries do not have systems that allow them to practice audits to verify the compliance with the clauses stipulated on the contract itself.

In the individual ABS contracts, however, most of the countries seem to have given a particular emphasis to establishing appropriate monitoring systems for compliance with the mutually agreed terms,48 although the effect of this work has not been to create clear and enforceable mechanisms. There are significant obstacles that generally prevent the effective exercise of legal remedies when contractual (MAT) or legal violations occur, particularly since most violations occur after the resources have moved from the provider country to another jurisdiction.

Here also, the question of penalties is very simple to insert in legislation,49 but the uncertainty about the meaning of key terms, as well as the inability to monitor or become aware of utilization, are a serious limitation preventing these measures from having any noticeable impact.

2.1.9 Restrictions imposed for environmental purposes

Another category of provisions that is easily drafted but nearly impossible to implement is the group of social and environmental-based restrictions on the uses to which genetic resources may be put. These restrictions are specifically authorized in the Convention, which limits the access requirement by calling on parties “to facilitate access to genetic resources for environmentally sound uses ... and not to impose restrictions that run counter to the objectives of this Convention” (Article 15.2). Thus, national laws include provisions calling for decisions that take into account the criteria of public interest and the precautionary principle and the objectives of conservation, sustainability, the avoidance of environmental harms, and human health.

2.1.10 Support for conservation

Connected to the previous section is the question of how ABS laws support conservation and sustainable use objectives. One of the main criticisms of the ABS laws is that only a tenuous link exists between access and the conservation of biological diversity. In many cases this link exists only indirectly in term of technology transfer, reporting and submission of ecological data, etc. The Bonn Guidelines are not categorical enough about this link, but consider as one of the main objectives: “to contribute to the conservation and sustainable use of biological resources.”50 At paragraph 22 (Overall strategy), it provides as well that the ABS system should be based on an overall access and benefit-sharing strategy at country or regional level. This access and benefit-sharing strategy should aim at the conservation and sustainable use of biological diversity and be part of a national biodiversity strategy and action plan to promote the equitable sharing of benefits.

One of the most significant factors in ABS-related debates at sectoral, national and global levels is the fact that they spend little or no time addressing environmental and social matters, especially questions of conservation, sustainable use and equity.

2.2 Different treatment for agricultural genetic resources and ex-situ collections

Another of the criticisms of the ABS regimes is based on the fact that they attempt to treat the different sectors equally.51 In all the cases, the current national laws do not seem to recognize the particularities of genetic resources for food and agriculture. This is expected, given that the Convention on Biological Diversity does not distinguish among different categories of genetic resources whose conservation and sustainable utilization vary (according to whether they are wild, domesticated, microbial, etc.).52 The exchange and appropriation practices of food/agriculture resources differ, however, in terms of their distribution and availability, the level of difficulty in reproducing them, and the existence or non-existence of market mechanisms for their exchange (among other factors).53 In the same way, these resources can be conserved either in-situ or ex-situ, with each option presenting technical, economical and juridical particularities. For example, regarding the ex-situ collections, processes have been developed like the Common Principles of Access to Genetic Resources and Benefit Sharing for Botanical Gardens and Micro-Organism Sustainable Use and Access Regulation International Code of Conduct (MOSAICC).

With some exceptions (e.g., Brazil and Bhutan), there has not been any legislation which differentiates between the treatment of genetic resources for food and agriculture and those of other genetic resources. Differentiated treatment is expected in future legislation, however, in connection with the implementation of the Treaty on Plant Genetic Resources for Food and Agriculture (PGRFA) of FAO in each member country. Broader extension of this Treaty's membership will probably increase the number of situations in which differentiated treatment is accorded for some agricultural species, held by some institutions.

In the same way, existing regulations do not always respond to all the particularities that ex-situ collections can present. The convention is very unclear about the status of genetic resources that are sampled from biological material collected before the entry into force of the Convention on Biological Diversity (December 29, 1993). This ambiguity coupled with the condition of the collections as users and providers of genetic resources; their nature as intermediary entities; the little information available about most of them; and the conditions on which the property or custody of the genetic resources can be transferred have created serious concerns regarding the manner in which those collections can be viewed in national and global ABS regimes.

2.3 Regulatory complexity: double permissions

As noted above, a common complaint among bioprospectors focuses on the complexity of ABS laws, particularly the need to apply for different permits to obtain access to the samples and to remove them from the country. For instance, in many cases, additional permits to obtain biological resources are required by other institutions without establishing adequate coordinating mechanisms among the governmental entities to facilitate access to genetic resources for sound uses. From a government perspective, this situation was probably not intentional, but is the unintended result of adopting new legislation that regulates a different component (the genetic) contained in biological resources traditionally regulated by other laws. In addition, it is not uncommon in other sectors, in most countries.54

The extent to which additional permits are needed (beyond the specific rules of “access to genetic resources”) in order to gain access to the biological resource that contains those resources, has become another important legislative inquiry. In the event of different permits being necessary it is important to determine if coordination mechanisms have been established to avoid duplication regarding the permits and to prevent obstacles to the access to the resources for environmentally sound uses. One important co-existing requirement may be the Environmental Impact Assessment (EIA) or related instrument.

2.4 IPR-related issues

Finally, the relation between the IPR and access to genetic resources has been the subject of various analyses and studies and it is still a contentious issue.55 It has been and continues to be the subject of enormous volumes of international academic and legal analysis, which will not be reproduced here. It is important to note that there are many other aspects to this issue. For example, as noted above, national legal regimes of provider countries sometimes seek to develop and apply mechanisms for securing and supporting the PIC and MAT by restricting the use of the IPR system, for example, by requiring the disclosure or certificate of origin of the genetic resources utilized in the claimed invention.56

2.5 Legal certainty

Legal certainty is a characteristic sought by the users of genetic resources.57 This concern, as expressed by the users of genetic resources, is based on the lack of clear regulations regarding ABS in the country of origin of these resources and associated traditional knowledge, e.g., developing countries. As a response to this difficulty, the Conference of the Parties to the CBD has requested an analysis of the theme.58

In response to this request, a comprehensive study on “legal certainty” was presented in the III meeting of the ABS Working Group in Granada, Spain.59

In accordance with the Report, “a party would have legal certainty regarding an instrument if he was fully aware of all relevant laws and certain that they were consistently and predictably in force and enforceable. A narrow definition of legal certainty for users focuses on three elements:

The relevance of legal certainty is evident in the position of some countries. For example, the government of Australia has indicated that one of the advantages of investing in bioprospecting in Australia is the existence of legal certainty under the Australian ABS legislation. This is reflected in the legal regime of that country, by the adoption of clear and transparent regulations for the granting of permits, based on a stable system of commercial transactions and property rights (intellectual and physical).61

2.6 Functionality and consistency in the ABS legal frameworks

This part briefly outlines some legal aspects that should be carefully established in national and international systems, with the purpose of ensuring that the regimes of access can function adequately.

2.6.1 General considerations

Certainly, legal impediments and obstacles exist that explain the limited implementation of ABS systems. Often, for example, countries may have assumed - incorrectly - that legal mechanisms and institutions currently functional for conventional contracts and/or property transactions would operate in the case of transactions involving genetic resources without the necessity for adjustments or modifications. At the same time, there are other reasons behind the low implementation of ABS measures, which are no less important. These include both legal gaps62 and other problems (e.g., lack of awareness and misunderstanding).63

For example, one critical factor is the lack of capacity, knowledge, and skills to negotiate the complex terms of the bioprospecting contracts. The author has had the opportunity to confirm that this is an element as relevant as the functional difficulties previously mentioned.64 These are related to the issue of the potential liability of the Governmental Officers in charge of granting permits or negotiating ABS agreements, if a mistake is made during the process of negotiation.

Another key problem arises from frustration in source countries, due to the limited economic and non-economic benefits (monetary and non-monetary) perceived to be derived from the different bioprospecting projects and, in general, from the application of ABS frameworks.65 Richness in biodiversity terms does not necessarily translate into commercial products such as new medicines, seeds, etc. In this sense, those who have asserted that bioprospecting would become a “green gold mine” have had to modify or moderate their observations. From this perspective, bioprospecting is a component of a more extensive strategy for the conservation and sustainable use of biodiversity, rather than the solution to immediate conservation needs.

Cases of illegal access, misappropriation or “biopiracy” that have occurred in countries and communities, especially in Latin America, Asia and Africa, have had frustrating, or even controversial results, suggesting a higher than expected level of difficulties in finding cost-effective legal solutions within the framework of national ABS legislation or in the context of industrial property law.66 Emblematic cases such as Maca in Peru or Neem in India, among many others, have frequently been mentioned as a rationale for undertaking modifications to the text or operation of intellectual property right systems (particularly patents, which are frequent causes of complaints being filed for misappropriation or biopiracy).

In addition, although the CBD requires the Parties to take measures to ensure fair and equitable benefit sharing (see particularly the provisions of article 15.7), it has mostly been developing countries that have issued regulations on ABS.67 Thus, the nations that are home to pharmaceutical, biotechnological and agricultural companies (mostly developed countries) have not effectuated the corresponding regulations to ensure benefit sharing - which are necessary if they are going to comply with their legally binding international obligations. The absence or limited presence of so-called “user country measures” has been criticized as one of the causes of high transaction costs and the highly controlling nature of current access laws. The need for “user country measures”68 has been stressed by those who have noted the transboundary nature of ABS in trade relations69 and the inadequacy of national regulations after the samples or information on the genetic resources leave the country that provided them. In this context, it can be stated that the ABS provisions in the countries of origin are incapable alone of creating an ABS system that is functional and consistent.

One of the common denominators of ABS is the lack of trust among the different actors involved or potentially involved in ABS transactions.70 This atmosphere is not appropriate to advancing negotiations, whether internationally, among countries, or in a more limited way, through contracts between providers and users of genetic resources.

2.6.2 Functionality and consistency of ABS systems

At the same time, some of the functionality difficulties mentioned by lead authors in this field are as follows:71

“Functionality is needed in any legal framework. It depends on the law maker's ability to weave laws, regulations, contracts, permits, institutions into a system satisfying five basic legal systematic requirements:

  • legal consistency,

  • clarity about what is forbidden, permitted, encouraged and or mandatory,

  • mechanisms that protect and give legal certainty to all parties,

  • practically implementable enforcement mechanisms, and

  • consistency related laws, frameworks, systems and tools.

  • Regarding ABS, the Convention itself has hindered the creation of sufficient clarity, consistency and replicability.”

    A recent paper on ABS functionality (developed under the ABS project) cites the following “elements to facilitate ABS implementation through consistency, legal certainty and clarity:”

    Following this line of argumentation it has been suggested that74 primary national implementation needs must be addressed if ABS and genetic resources systems are to function effectively. As such, the primary gaps in the framework above appear in the following categories:

    2.7 Brief reflections on the implementation of ABS laws

    Finally, it is convenient to present the status of implementation of access legislation.75 Although there is a lack of fact development and analytic studies on this question, the state of implementation has been considered low and incomplete.76 Normand77 offers the following description:

    ... countries are at different levels of implementation of access and benefit sharing and have adopted different approaches to regulating access and benefit sharing, reflecting their national administrative structures, priorities, cultural and social specificities. While certain Countries have only adopted one measure, generally legislation, others have adopted a package of measures, including for example, a national strategy, legislation or regulations or guidelines. A number of countries are still in the process of developing their national systems and therefore the package is often incomplete. In addition, the national procedures and structures are diverse. For example some Countries have different levels of government responsible for regulating ABS – at the national/ federal or at the state/provincial level.

    A majority of Countries, with national measures included on the CBD database can be divided into three categories: The first category includes Countries which refer to ABS in their national biodiversity strategy or their environmental or biodiversity legislation but have not yet regulated ABS in any detail. These measures generally provide for the developing of ABS regulations and include some general specifications regarding elements to be addressed. The second category includes Countries that have a biodiversity or environmental law with some general provisions on ABS or access to biological resources, which may include a provision for the establishment of a regulation on ABS. The third category is those which have addressed ABS in greater detail. They have established competent national authorities, procedures for prior informed consent, procedures for the development of mutually agreed terms, including benefit sharing and compliance measures. The issue of IPR is also generally addressed in various manners and in varying degrees of detail.

    With regard to the main features of their ABS regimes, the provisions vary from one national system to another, although some general underlying elements may be highlighted:

    She concludes: “Developments are currently taking place in a number of countries, through national initiatives and capacity building projects, however there is still a lack of relevant awareness and capacity to address access and benefit sharing among relevant actors, in both developed and developing Countries.” Ogolla adds to this description,79 noting that “Most measures require that a standard clause be incorporated in the contract. Some legislative measures appear to focus on non-monetary benefits such as the involvement of local institutions for research and development.”

    Table 1. Conventional legal mechanisms currently applicable to ABS systems

    Type of mechanism Specific application
    Contract law Provides the means by which the mutually agreed terms are established, and the possible use of contractual mechanisms to resolve disputes. Contracts with terms concerning tracking and monitoring of uses of genetic resources based on reporting obligations.
    Law of tangible and intangible property rights Direct application of property rights concepts, conventionally used for other types of property, to genetic resource transactions.
    Permit-based administrative law Systems for the granting of prior informed consent, requiring provision of information (to the competent authority) before an authorization is granted, and oversight of compliance (legal authority often limited to activities within the source country).

    ABS addresses IPR to varying degrees. A number of measures in the context of benefit sharing include specific requirements for disclosure of origin of genetic resources and traditional knowledge in IPR applications. Some countries have specific measures relating to consultations between national ABS authorities and national patent offices as well as the ex post facto review of IPR. Some developed countries have developed and revised their IPR law to accommodate a disclosure-of-origin provision, with some differences in scope (disclosure of origin only, or also evidence of prior informed consent). The issue of sanctions for non-compliance lies outside the patent law.

    In this regard, a study carried out in 2004 has found that80 relatively few cases exist in which a court or other official provided an interpretation/implementation of the regulations. In many cases, the interpretation/implementation can be deduced out of the omissions made by the authorities, for example, when considering whether an activity constitutes access or not. Nonetheless, leaving interpretation to be inferred from conduct can ultimately generate problems regarding the control and monitoring of those activities involving access to genetic resources.

    On occasion, in spite of the existence of applications for access and (sometimes) access contracts or permits, it is difficult to establish which systematic interpretation the authorities have utilized. It is a difficult and uncertain task, when starting from the few experiences available, to arrive at general conclusions. In some countries there are only one or two documented cases of access through the course of many years. Even in these cases, from the analysis of the permits granted, it is not possible to draw conclusions of interest due to the fact that these are limited to applying the legal framework without making any interpretations on important aspects.

    The available information on ABS applications or ABS contracts is not always public or readily accessible. There have been cases in which the access to the genetic resources is granted using general legislation enabling the grant of research or collection permits (under general laws on conservation of nature, forests, wildlife or the environment in general). In such circumstances, even if the bioprospecting agreements that are eventually adopted address access criteria and sharing of benefits, they generally have been negotiated and accomplished without considering a legal regime of access, suggesting that formal legal efforts to implement them may be difficult or impossible.81

    The different studies carried out on the implementation of national ABS laws82 confirm the difficulties that are faced by provider countries in seeking to obtain or verify adequate compliance with the current legislation of the provider countries. In practice, the level of enforcement of these laws is relatively low.83 There are many possible causes of this. For example, agencies may have limited negotiating power to deal with applications, particularly those involving transnational companies. Often there is also significant opposition from sectors of civil society that consider many kinds of bioprospecting initiatives to be per se biopiracy. Most important may be the absence of detailed regulations on procedures to facilitate decision-making by government officials (and give them confidence that they are meeting the responsibilities of their office). At the same time, it has been observed that existing ABS procedures are highly bureaucratic and based more on the premise of control84 than on promotion. This situation is probably caused, at least in part, by the need to control the flow of resources, due to the inadequacy of national regulations for monitoring the use of genetic resources, as well as to the lack of user country measures. This has generated a situation of legal uncertainty concerning access to genetic resources.

    Despite the foregoing, some countries have been able to apply the legislation - at least in a limited form. This is the case in Costa Rica,85 in the system being visualized and operationalized in countries such as Brazil86 and in others to a lesser extent.87

    In summary, as one commentator concludes:88

    Despite the apparent clarity of the objectives, the record of implementation is very poor. A growing, but still limited, number of Countries have passed legislation and those that have done so are finding it difficult to implement, only a limited number of contracts has been approved under new legislation. ...This situation is due to the lack of recognition of the need of an integrated regulatory approach in which both provider and users of genetic resources take action to enforce provisions of the CBD. This situation was in fact created by a limited recognition of the realities of biotechnological research and development as well as the lack of coordination mechanisms across jurisdiction. ...Some form of documentation of the genetic resources such as the certificate of origin, could play [a role] in fostering the CBD objectives in an economically and efficient manner.

    24 Caillaux and Ruiz, 2002.

    25 Caillaux and Ruiz, 2002.

    26 For example, even though the scope, methodology, objectives and geographic range of the studies vary, the following documents can be mentioned to guide the design of ABS legislation: Glowka et al., 1994; Glowka, 1998; Mugabe et al. (eds) 1997. From other perspectives it is also possible to mention: Seiler and Dutfield, 2001; Bass and Ruiz (eds), 2000; Swiderska, 2001; Columbia University, 1999; Crucible Group II, 2001; Secretariat of the Convention on Biological Diversity, “Case studies...”, 1998; UNEP-WIPO, 2000; and Svarstad, and Dhillion, 2000.

    27 These basic elements have been suggested by authors like Glowka, 1998; and Mugabe et al., 1997.

    28 Petit et al., 2001; Benavidez, in Carrizosa, 2002.

    29 2001 Wildlife Law, discussed in Benavidez, in Carrizosa, 2002.

    30 “Determining the coverage of the EO was from the start the most difficult issue” (Antonio La Viña, cited in Benavidez, in Carrizosa, 2002).

    31 CBD, First Report of the Expert Panel on ABS, 1999, reported in COP-5, Document UNEP/CBD/COP/5/8/; Ten Kate and Laird, 1999; Glowka, 1998.

    32 Cf. Ruiz, 2000; Osama, 2003; Barber et al., 2002. For instance, according to the amended regulations (2001), of the Sarawak Access, Collection and Research, collection means “the removal or taking away of biological resources from their natural habitat or any place where they are found, grown, propagated, kept or stored, but does not include (article 2): a) the inspection or study, but without removal, of any biological resources at the place where the same are found, grown, propagated, kept or stored; b) the making of any graphic or written description or representation of such biological resources; or; c) the taking of any photograph of any biological resources.” The amended regulations excludes a study, experiment, test or examination, carried out within Sarawak, of biological resources in connection with any educational course or syllabus conducted by an approved institution which does not or is not intended to lead to development and commercialization of the aforesaid properties, values and qualities.

    33 Ten Kate and Laird, 1999; Rosenthal, 2003.

    34 See especially Tvedt and Young, Beyond Access, 2007. 35

    35 This is specifically stated in the Costa Rican Law, for example, while the Philippine EO, Decision 391 of the Andean Community, and many other laws include both biological and genetic resources. See Cabrera Medaglia, 2002.

    36 Ten Kate and Laird, 1999.

    37 The United States may be an exception, based on the fact that some national delegates have claimed that the owner of the land is equally the owner of the genetic resources located on it. This claim is based on national parks however, which are indisputedly the property of the federal government. Consequently, it does not clarify the question of ownership of specimen vs. sovereignty over genetic resources. See the document submitted by the Delegation of the United States to the fourth session of the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore. The document is entitled “Access to Genetic Resources Regime of the United States National Parks.”

    38 Columbia University, 1999.

    39 See Hernández, 2000.

    40 Articles 71 and 80 of the Biosafety Law.

    41 See Ten Kate and Laird, 1999.

    42 See Ten Kate and Laird, 1999.

    43 This issue is examined in detail in Ruiz and Lapeña, (eds.) 2007.

    44 Columbia University, 1999. 45

    45 Ruiz, 2000; Cabrera Medaglia, 2003.

    46 First Report of the Expert Panel on ABS, par. 88. 47

    47 Cf. Bonn Guidelines, par. 56.

    48 Documented in Cabrera Medaglia, 2002. 49

    49 Ibid.

    50 Bonn Guidelines, para. 11.a.

    51 Correa, 2000.

    52 Correa, 2000.

    53 Correa, 2000.

    54 See Young, Options and processes... 2002, regarding other situations in which commercial entities must obtain multiple permits in order to be able to engage in a particular activity.

    55 See Dutfield, 2000; ICTSD, 2003; Report of the Commission on Intellectual Property Rights, 2002.

    56 As noted above, the possibility of a Global proposal for such a certificate is discussed in detail in Ruiz and Lapeña, expected 2007. See also the VI Conference of the Parties of the CBD (Decision VI/24) which contains several references to the use of these mechanisms and, in general, to the role of intellectual property rights in the implementation of access and benefit-sharing arrangements.

    57 See Oxley and Bowen, 2006.

    58 See CBD COPVII, Decision VII/19, part E. g.

    59 IUCN-Canada, 2005.

    60 The analysis covers: A. Process certainty: 1. Identification and empowerment of CNA. 2. Integration with other levels and processes. 3. Clear and transparent procedures. B. Scope and Nature of the Grant. 1. Nature of the Right Granted. 2. Clarity on the mutually agreed terms: the user obligations. 3. Restrictions on transfer and other rights. C. Legitimate expectations and vested rights. 1. Third Party impacts on the ABS agreements. 2. Claims of non-compliance. 3 Government alteration for other causes and the loss of a vested right.

    61 See Australian Government. Department of Environmental Heritage, Genetic Resources Management in the Commonwealth Areas. Sustainable Access and Benefit Sharing, Canberra, 2005.

    62 See those indicated by Carrizosa et al., 2004; and Nnadozie et al., 2003. See also SCBD, “An Analysis ... including identification of Gaps,” 2004.

    63 Another author identifies five often closely related problems for implementing ABS laws: (i) misunderstandings with regard to the definition of “genetic resources,” “sovereignty and benefit sharing,” and “IPR;” (ii) lack of awareness of objectives and purposes of the ABS; (iii) failure to distinguish between sectors and the adoption of the relatively homogenised approach provided by the CBD framework; (iv) lack of information creating protectionist reactions; (v) dispersed capacity and lack of coordination; see Lettington, 2004.

    64 The CBD has recognized this problem and has developed a Capacity Building Plan adopted by the VI Conferences of the Parties. For ongoing ABS capacity building projects see Gartforth et al., op. cit., and the CBD web site on capacity building initiatives.

    65 The implementation of ABS regulations, and even the existence of concrete initiatives on bioprospecting, has not generated the huge benefits some had expected for the provider countries and the communities or indigenous peoples. Cfr Cabrera Medaglia, 2004, A Comparative Analysis and Cabrera Medaglia, “Biodiversity Prospecting in Practice,” 2004. About the commercial value of biodiversity for the different industries and activities (not only using genetic resources but also biological resources) see Ten Kate and Laird, 1999. On the potential commercial value of genetic resources – especially from microorganisms – for the pharmaceutical industry, see Suzuki, 2005.

    66 It is difficult to quantify the level of these activities due to the lack of legal certainty on the definition of biopiracy. For some, it consists of the acquisition of genetic resources and traditional knowledge without the consent of the country or holder of the resource or knowledge; when rules for fair and equitable benefit sharing are not established; when IPR protects innovations that are copies or cosmetic modifications of the genetic resources; or when IPR protects biotechnological innovations based on the genetic resources, whether or not prior informed consent exists, etc. On the topic of biopiracy and the difficulties of judging whether certain activities constitute misappropriation. Cfr, Dutfield, 2004; and Young, 2006.

    67 Cfr, the study by Gartforth et al., who describe current ABS measures and legislation. According to this study, approximately 25 countries have some kind of specific legislation on ABS. In many cases, however, the ABS elements of the laws identified include only general statements whose effective application requires additional regulations or laws to further develop the general precepts.

    68 Cfr Barber et al., 2003. 69

    69 Young, 2005; Cfr Young, “Genetic Resources ...,” 2004.

    70 IISD, Stratos, and Cabrera, A Guide... , 2005.

    71 See Young, “Gaps and Obstacles...”, 2004.

    72 This issue is not addressed in this book. In this regard, however, Cabrera Medaglia mentions the complaints – from a bioprospector’s point of view – about the complexity of ABS laws related to the need to apply for different permits to obtain access to the samples. For instance, additional permits to obtain biological resources are required by other institutions without establishing adequate coordinating mechanisms among the governmental entities to facilitate access to genetic resources for sound uses. From a government perspective, this situation was likely not intentionally created, but it is the unintended result of adopting new legislation that regulates a different component (the genetic) contained in biological resources traditionally regulated by other laws. For that reason, a major difficulty for securing the legality of access is reflected in the existence of legal frameworks that regulate and control, from different perspectives, the access to or research on biological resources. That is, to which extent additionally to the rules of access to genetic resources, to access the biological resource (containing the genetic resources) additional permits are required. In the event of different permits being necessary it is important to determine if coordination mechanisms have been established to avoid duplicity regarding the permits and to prevent obstacles to the access to the resources for environmentally sound uses, Cabrera Medaglia, 2004, A Comparative Analysis... .

    73 See Young, 2004, “Gaps and Obstacles...”.

    74 Young, 2004, “Gaps and Obstacles...”.

    75 An overview on the implementation of ABS measures is found in Gartforth, 2004.

    76 Furthermore, experience of and documentation on such implementation is scarce. The information available indicates that the development of national measures has proven difficult for many countries due to a number of factors including a lack of technical expertise, budgetary constraints, weak government structures, and political support, local social conflict and conflict over ownership of genetic resources, see CBD, 2004.

    77 Normand, 2004.

    78 Normand, 2004.

    79 Ogolla, 2005.

    80 Cabrera Medaglia, 2004, A Comparative Analysis. 81

    81 A 2002 study carried out on the Pacific Rim Countries (42 countries) concluded that since 1992, 29 access projects have been approved in that region under ABS laws (Carrizosa, pers. comm.). Carrizosa concludes that “More than other natural resource policy, ABS has been the target of misconceptions, politics and negative publicity. Biopiracy claims, poorly defined ownership rights over genetic resources, the patenting of life, the protection of traditional knowledge and equity issues have thwarted access initiatives and have also contributed to the cancellation of bioprospecting projects.” Carrizosa, 2004.

    82 See, in particular, Cabrera Medaglia, A Comparative Analysis, 2004; Gartforth et al., 2004; Carrizosa, 2004.

    83 Nevertheless, some improvements are starting to be seen in the application of the legal ABS frameworks, such as in Brazil, for example, where the number of permits has grown steadily in the last few years, mostly having to do with non-commercial applications. For example, in 2005 there were almost 100 access applications for basic research and 20 for bioprospecting and technological development. See www.mma/port/cgen

    84 Cfr Barber et al., 2002. They suggest that there are only two approaches to be taken into account in building and applying the ABS regulatory frameworks: (i) controlling access through extremely restrictive legal provisions; and (ii) seeking to facilitate or promote access through flexible regulations that are more coherent with the user’s reality.

    85 See Cabrera Medaglia, 2004, “Costa Rica: legal framework and public policy.” 86

    86 See presentation of the Brazilian experience made at the COP VIII in Curitiba, “Implementación de la legislación de acceso y distribución de beneficios en Brasil,” Ministerio de Ambiente, March 2006.

    87 Some developments have taken place in Malaysia ( Sarawak) and in Venezuela. See Cabrera Medaglia, 2004, A Comparative Analysis...,; and Febres, 2003.

    88 Fernández, 2005.

    < previous section  < index >  next section >