3 Key Issues for Functional and Operative Certainty in Access Regimes

This chapter presents some of the most relevant legal concepts of access, whose proper interpretation/clarification/application is necessary for constructing functional and operative ABS systems.

The elements that have been considered particularly relevant are the following:

3.1 The conceptual aspects

This section seeks, by means of an integrated focus on the concepts “genetic resource,” “derivative” and “ utilization of genetic resources” to suggest some recommendations that would permit:

One of the main problems in the establishment of ABS regimes derives from the lack of clarification of three key aspects which can be referred to as “conceptual aspects of the ABS.” These conceptual elements cannot be analyzed separately because it is necessary to be clear on each one of them and on the manner in which they interact and complement each other to allow the operation of functional ABS systems.

Generally, the majority of countries with ABS legislation have focused on regulating access to genetic resources, based on the definitions contained in the CBD.89 Nevertheless, the direct use of this terminology from international instruments in national laws presents practical difficulties that impede legal certainty with respect to the scope of the ABS systems. In many cases, these definitions have been adopted without consideration of the implications of these concepts.

Additionally, as was mentioned earlier, there are practically no decisions of the COP90 that call for this clarification. Some recent studies of the implementation of access laws mention, as one of the problems with the efficiency of this legislation, the confusion with respect to the activities regulated. As examples, it has been pointed out:

The scope of most ABS policies covers non-human genetic, biological and biochemical resources found in ex situ and in situ conditions. This broad scope has caused confusion among users and providers of genetic resources about the type of activities that should be regulated by these policies.91

In the same sense, Dross and Wolff mention:92

It has been noted that a broad range of terms are either not defined in the Convention or even if defined in the Convention are not clear enough and can thus be interpreted differently by the Parties. One of the consequences is the invitation in the COP Decision VII/19 to submit information on existing national definitions on a number of terms including access to genetic resources, benefit sharing, commercialization and derivatives.

In general, the confusion with respect to activities that involve access remains. Such is the case with access requests in certain countries which supposedly deal with activities related to biological resources.

Box 1. Selected examples of access applications which involve conventional uses of biological resources.

3.1.1 Refining the concept of genetic resources

In the past there have been criticisms of the lack of clarity of the term “genetic resource,” and specially its implications in determining the scope of regulations for access to genetic resources.97

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 access to biological resources, nor when the utilization of genetic resources takes place and if this constitutes a different phase altogether. Predominantly, in most legislation addressing access to genetic resources, even though those terms are defined, they have continued to be unclear in practice. In particular, even with statutory adoption of these definitions, it is not simple to establish which activities constitute “access to genetic resources” and which are “access to biological resources.” Few States' ABS laws provide the mechanisms to determine whether their genetic resources have been accessed and/or utilized.

As noted in Chapter 2, neither the Convention nor national law have provided usable practical definitions of key terms. Even those terms which are defined in the Convention are not defined in a way that enables implementation. Thus concepts like “genetic resources,” “genetic material of actual or potential value,”98 utilization of genetic resources and other basic matters are not defined or not sufficiently clear.99 Little attention has been paid to the need to precisely define a number of terms, whose inclusion in the international ABS Regime100 would improve the effective application of national ABS systems.

These are concepts which the IR could help to clarify in order to create consistent and functional legal frameworks. There have been important incidences of legal difficulties arising due to a lack of understanding regarding the difference between biological resources and genetic resources.101 Young reports102 five uncertainties regarding the application of ABS principles to a particular claim of misappropriation, including the nature of genetic resources. “One area of uncertainty regarding the application of ABS principles related to whether the claim is in fact addressing ABS rather than some other kind of legal concerns....Unfortunately this is not a simple matter to determine whether a claim involves genetic resources or not because it is not possible to know with legal certainty what a genetic resource is.... More than half of the public cases [of misappropriation] examined involved direct uses of either natural products and essences or remedies using such products and essences and naturally or traditionally derived varieties already being used for conventional agricultural purposes....”.

This question goes to the heart of the CBD discussions. From the earliest CBD negotiations, it was clearly expected that ABS should not alter existing functional markets and market activities in biological resources. To create an ABS system without disrupting conventional markets in biological products, however, it was necessary to separate the concept of biological resources (traditional biological commodities) from genetic resources (the genetic and biochemical information which can become the basis for non-conventional uses).

The boundary between activities involving access to genetic resources and those that, to the contrary, make use of biological resources is not always clear.103 In effect, it has been noted that the CBD definitions of biological and genetic resources are, strictly speaking, functionally identical so it is not possible to clearly distinguish between the two.104 Cabrera, commenting on the implementation of ABS laws mentions:

“Neither does the Convention define what is to be understood as access and utilization. This has implicated that on the implementation and interpretation of the laws on access, requests have been presented to access biological resources with exclusively taxonomic purposes or for the commercial utilization of biological resources, without the existence of access to genetic or biochemical properties contained in the samples. In other cases, especially where dealing with the use of medicinal plants, nutraceuticals, botanicals, etc., the majority of legislation tends to exclude them from the scope of access, even though it is considered an important growth sector at a worldwide level and that there is an increased interest in botanicals from the private sector.105 Sometimes they are included, but only where there exists a larger level of industrialization – another term that is not defined properly.

In general, the studied legislation bases the definition of genetic resources on the one provided by the Convention, with some modifications that do not alter its essence. Additionally, the laws define access to genetic resources and eventually some of the activities that represent access, such as bioprospecting. ..... it is unclear to what extent the use of a whole medicinal plant, herbal plants, or nutraceutical food is an activity which involves access.”106

Typical approaches include:

The confusion increases because even in cases of conventional uses of biological resources, benefit-sharing provisions in line with the CBD have been developed. For example, the BioTrade Initiative of UNCTAD, which focuses only on extracts and natural ingredients, includes detailed provisions for compliance with national ABS requirements.112

Box 2. Benefit sharing and the BioTrade Initiative of UNCTAD113

The objective of the BioTrade Initiative of the UNCTAD is to contribute to the implementation of the three objectives of the CBD by means of the promotion of trade and investment in products and services of BioTrade. Based on the experience of the National BioTrade Programs, a set of principles of BioTrade have been developed, that are agreed upon between the Initiative and the Programs. One of them (principle 3) refers to the fair and equitable sharing of benefits derived from the use of biodiversity. Eventually these Principles and Criteria could be verified and certified with the aim of differentiating products derived from BioTrade.

Among the products selected by the Initiative or the National Programs and supported by the BioTrade Facilitation Program ( BTFP) are:

The natural ingredients include: colorants for the cosmetic and food industries; essential oils for the cosmetic and food industries; vegetable oils for these industries; powdered fruit pulp for the food industry (supplements and additives); vegetable extracts for the phyto-pharmaceutical and food industries. The market for natural products encompasses: fresh or dehydrated medicinal plants; fruits, pulps, fruit oils; herbal extracts; vegetable oils; essential oils; natural colorants and many ingredients of this nature for which demand has been increasing.

A variety of options have been developed114 that countries can consider as ways of clarifying the concept of genetic resources/biological resources for the purposes of their national legislative systems. These include:

Option 1: Determining whether the law will recognize any difference between biological and genetic resources, keeping in mind the intrinsic difficulties involved in controlling conventional uses of biological resources within the framework of ABS systems.

Option 2: Considering genetic resources to be a more specialized type of material, as compared with the general category of biological resources; for example, a genetic resource might be a particular type of material taken in a specific way, such as prepared dry materials.

Option 3: Setting the distinction based on the intended use on the part of the applicant at the time of access, for example, whether access to the materials is sought for conventional purposes or with the intention of utilizing them for their genetic or biochemical characteristics.

Option 4: Deciding that “genetic resource” refers to genetic information, independent of physical access to it.

Option 5: Deciding that genetic resources could be best understood as the “right to use genetic information.”115

No solution is simple. Considering the international and transboundary nature of ABS relations and the need for consistency and legal certainty,116 it is hoped that the International Regime should provide the countries with some guidance on this matter.

The following discussion section explores some approaches to applying the different options or criteria to clarify this critical issue. The utilitarian approach

According to some, the definition of genetic resources (in the CBD) is relatively clear. For them, the question is simply establishing an agreed distinction between genetic material and genetic resources. They do not recognize any physical distinction: “a genetic resource is a genetic resource rather than a genetic material because we perceive it as a resource, that is, we attach value to it.”

In essence, if one adopts a physical approach to defining these terms, genetic resources and biological resources are synonymous; if one adopts a utilization-based conceptual approach, then perhaps the terms can be distinguished. This suggests the CBD intends Parties to the Convention to adopt a conceptual or utilitarian rather than physical or natural view of genetic resources. However, the language of the CBD definitions and other articles does not indicate how a utilitarian approach should or could be constructed, and especially, how it can be applied.

Numerous examples can be cited to illustrate the legal importance of line-drawing - that is, of making it clear which resources are “biological resources” (not governed by ABS), and which are genetic (ABS applies). For instance, is the seed or tuber of an agricultural crop, a genetic resource or a biological resource?

Under the utilitarian approach, the purpose in collecting a particular seed or tuber of an agricultural crop would define whether it was considered to be either a genetic resource – and thus regulated under ABS law – or a biological resource – and thus unregulated. It is at this point that the construction of the utilitarian approach becomes important. The genetic resource does not lie in the properties of the species, (color, taste, etc.), per se, but in the possibility that they may be multiplied, propagated, transferred into other varieties or species or synthesized for use in some scientific or industrial purpose (although it is not clear if there should be a limit on its application for scientific purposes). Ensuring that this is reflected in a regulatory regime is purely a question of recognizing the problem and carefully drafting accordingly.

A problem that must be considered in the development of an utilitarian approach is the possibility of dishonesty on the part of the applicants for access to genetic resources. Once the resources are out of the jurisdiction of country of origin, it is not possible to control these resources and therefore not possible to know of and ensure a share in the associated benefits. Cabrera, after the analysis of most ABS laws in place, concludes that: “In general in most of the cases studied, there is no provision to differentiate the taking of biological resources (the organic material) from the taking of the genetic material contained in the biological material. The difference should be based on the 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....”

“It can be concluded that utilization of genetic resources is not defined. In general terms, the practice is based on the intended use of the biological resources, as a source of genetic information. For this reason, the only way to control the use of organic resources not as genetic information for different purposes (bioprospecting, scientific research, etc.) is looking at the information submitted by the applicant of the permit and whether it states that the access to the biological resource is for different purposes other than for its genetic composition. The intended use is the key aspect for knowing when a person is seeking access to genetic resources.”

In accordance with this line of thinking, the difference between access to genetic resources and biological ones is the “intended use,” that is, the declared purpose for which the applicant indicates that he desires access to a sample of a material. If this purpose is the search for new biochemical compounds for the creation of medicines or similar uses, the activity would involve access to genetic resources. If, for example, the purpose is to collect specimens only for taxonomic identification, this activity would not be considered access.117

However, the utilitarian approach faces some difficulties.118 “One theoretically clear understanding of ‘genetic resources’ is use of biological material for certain intentions or purposes. This defining criterion could link the scope of access legislation to the “purpose or intention” of the person or company having access to the biological material. This, however, implies a challenge for access legislation: As functional units of heredity are present in biological material also when sold for the purpose of commodities, the scope of access legislation would solely have been depending upon the purpose or intention of the one seeking to move biological resources across a border. The genetic resources could be said to cover certain intended uses of biological or genetic material.

“The primary intention of the use of biological material typically changes over time. The purpose of the use typically changes after the genetic material has left the country. When the original intention is altered, access legislation targeting the primary intention will not be robust enough to capture the value created later. This constitutes a major obstacle and perhaps implies that it is impossible to control and reserve all exports or “access” to genetic material by this criterion.

“The intention is not manifest in any objective manner at the point in time of access. It is hardly possible to overview the intention of each individual transfer of biological material containing functional units of heredity. To control the intention of each exporter of biological material is not at all easy for the provider country. To base a court case or enforcement mechanism upon a criterion as subjective as the intention that the exporter originally had is close to impossible. To prove that the original intention was another than using the biological material in bulk is not an easy task before a court.

“Choosing intention as criterion will also not create the predictable situation for research and industry: Such an understanding of the concept ‘genetic resources’ will not easily meet the call from industry for a clear and stable legal situation. Choosing intention as the defining criterion will not establish a clear and predictable situation for researchers or industry receiving biological material. Both researchers and industry need to be faced with a clear legal status for the genetic material that they bring to laboratory for research and developmen.”119

In synthesis, although the majority of legislation appears to have indirectly adopted the intentional criterion, this presents legislative and administrative problems relating to the determination of the existence of access, a legislative element that depends on the collector's intent at the time of collection, limiting the possibility of judging objectively whether the applicant truly intends to conduct activities of access. It makes it difficult for the administrative or judicial authorities to make an objective determination of compliance or of potential non-compliance with legislation regulating access to genetic resources, limiting the legal certainty of the provider, the user, and subsequent acquirers of the samples. Moreover, the intentional approach does not permit adequate control without the existence of measures that allows the source to know “utilization” of genetic resources has taken place. Genetic resources as the “utilization of genetic information”

With regard to this potential solution Tvedt affirms that:120

“To understand what is meant by ‘genetic resources,’ there is a need to look closer at the [phrase] ‘of actual or commercial value,’ in the definition of genetic material.” This qualifier establishes a distinction between genetic material and genetic resources, establishing the latter as a specific type of natural resource. The distinction focuses on certain types of value from biological/genetic material. The difficult question is which types of value that the CBD seeks to capture by the definition of genetic resources. The term ‘actual or potential value’ can be understood as the value of the biological material when it is used by taking advantage of the functional units of heredity. If this understanding of the legal concept is applied, the concept ‘genetic resources’ will be geared towards uses of biological material for certain purposes or categories of uses.

[It will then be clear that] Article 15 seeks to capture the value created from taking advantage of the genes (the functional units of heredity) in the biological material. Thus functional units of heredity (genetic material) - present in all biological material, even when used for bulk purposes - could potentially be used in breeding or replicating that specimen. Therefore, to control access by regulating export of genetic material is not at all possible or probably not even preferable. The vast majority of biological commodities contain genes and thus have potential to be used for their genetic material. Only small quanta of biological samples can be sufficient to capture the interesting genetic material. A necessary precondition for effective access legislation to create benefit-sharing, would require prevention of unauthorized access. As there are major obstacles related to controlling export of genetic material such exclusive control will not be possible. Therefore, the defining criteria for genetic resources need to be further explored.”

As a possible solution, it has been suggested that the term “actual or potential value” associated with genetic resources should be understood in the context of the CBD. In this way, the obligation of benefit sharing has its origin in “the benefits arising out of the utilization of genetic resources” and “the results of research and development and the benefits arising out of the commercial or other use of genetic resources” (art. 15.7). From this perspective, the term “genetic resource” should be understood to be all activities that result in capturing the real or potential value of genetic resources. Thus, it is suggested that instead of focusing on the intention of the party requiring access, the concept of genetic resources should be linked to specific uses. This would also lay the groundwork for user countries to issue measures in their territories, based on certain categories of utilization.121 (This approach is further discussed under the general heading of “the utilization issue,” at 3.1.3, below.) The permanent access criteria

A different approach uses a more objective consideration. If the sample is re-used (more or less directly – that is, as a whole specimen, direct extract, etc., without scientific/genetic alteration) as an ingredient in the production of commercial goods, it is not considered to be access to genetic resources, but the utilization of biological resources for conventional uses. Nevertheless, although this distinction can be used for the definition of genetic resources, without the establishment of measures that permit control over the utilization of the resources, it would present the same problems enumerated in the case of the utilitarian approach. However, it lends certainty to the moment of access and over legal procedures to follow, according to whether it is access to genetic resources or conventional uses of biological resources.

Box 3. Excerpts (Definitions) from the Seychelles Draft Law on Access to Genetic Resources122

Substantive scope/definitions:

“Biological resources” includes organisms or parts thereof, populations, or any other biotic component of ecosystems with actual or potential use or value for humanity;

“Genetic resources” means biological resources, including parts and components, with the exception of:

“Parts and components” includes functional units of heredity, DNA sequences, chemical compounds, secondary metabolites, biochemicals and other similar material and transcriptions of information describing any of the above in terms of structure or similar technical details;

Explaining the meaning of those definitions the authors point out:

First, the main element of the definition of parts and components to note is the word ‘include’, which is used to clearly state that the following list of examples is not exclusive. Equally, the items in this list are not necessarily mutually exclusive. For example, a DNA sequence might be considered a functional unit of heredity or a secondary metabolite might be considered a chemical compound. The key point to note is that the list is not trying to be scientifically precise: it is actually a political, rather than scientific, list and the aim is to ensure that it is understood that the definition clearly intends to include any possible element of a genetic resource.

Second, the reference to transcriptions of information is intended to ensure that rights are being claimed to any written source, or some other form of communication, describing the basic characteristics of a genetic resource. This is increasingly important as the details of materials' genetic or chemical structure can be unraveled and then sent by e-mail, fax etc. ever more rapidly. Finally, the term ‘parts and components’ could have been added to the definition of biological resources with equal effect, genetic resources being a subset of biological resources. However, the placing in the context of the definition of genetic resources is intentional, as a means to emphasize its role within the context of the legislation.

... the CBD definition of genetic resources only highlights the fact that countries should define the term in a utilitarian (as opposed to a natural or physical) manner, but does not actually provide a definition itself. This issue is, therefore, subject to national interpretation.... The approach taken in Seychelles is based on the same basic structure that can be found in the CBD, namely the identification of a general group and then of a subset of this group. The general group can be found in the definition of biological resources, which is intended to cover all biological material. This matches the CBD definition of the same term, with one exception, which is that the reference to genetic resources has been deleted because it was not felt that this added anything substantive to the broad scope of the definition and created a risk of confusion.

The development of the definition of genetic resources was one of the most thoroughly discussed aspects of the development of the legislation, due to its central role in determining which activities would fall within the scope of the legislation and which would remain outside.

The most obvious exclusion was one for commodities, such as fish for consumption and other foodstuffs. This exclusion operates at a range of levels from a need not to burden Seychelles' significant fish processing industry all the way down to the question of household shopping. In a more specific context a range of other activities, including taxonomic research, the production of essential oils and the collection of wild materials for household use, were considered and, to varying degrees, proved controversial. For the purpose of establishing a generally applicable principle... the basic line between what use of a biological resource should make it a genetic resource and what use shouldn't (i.e. the line between uses regulated by the legislation and those not provided for) could be drawn on the basis of whether the intended use focused on the commodity nature of a resource or on some other property. The main strength of this approach is that it automatically excludes the majority of foodstuffs and other directly extractive and consumptive activities.

The basic solution that was developed is the text of subsection (a) of the definition, which focuses regulation on activities that involve cultivation or reproduction, i.e. that mean that the recipient of material is not dependent on the source in Seychelles after the initial collection. Where the recipient of material will continue to be dependent on the source in Seychelles, i.e. commodity transactions, this is not regulated by the legislation on the understanding that such situations are most effectively regulated by traditional natural resource extraction systems. Such systems typically consist of a price set according to the volume of material and the known uses of that material. To avoid the regulation of generally accepted uses that might fall within this definition of genetic resources the concept of conventional uses, discussed below, is introduced as an exception. ..... To allow for situations that might not reasonably fall within the description of conventional uses, but that it might not be deemed appropriate to regulate as access to genetic resources, subsection (b) of the definition was introduced to provide the authorities with future flexibility to make exclusions as necessary. This follows the basic principle clearly established by stakeholders: an inclusive approach to regulation with exceptions to be established as necessary.

Supplementary scope definitions:

“Conventional uses”123 means widely practiced and accepted uses such as –

Explanation from the author:

The term “conventional uses” is different from “parts and components” in that, rather than clarifying the definition of genetic resources, it creates an essential exception to its scope. As mentioned earlier, the broad issue relates to what might be considered as generally accepted uses of biological resources that Seychelles deems it unnecessary or counter-productive to regulate through access to genetic resources.

Subsection (c) was probably the most controversial of the specific conventional use exceptions. Discussion covered distillation, both for alcohol and essential oils, and other similar activities as well as fermentation. As with subsection (b), the focus of the genetic resources definition on cultivation and reproduction might be seen to render this exception redundant. However, some activities, particularly fermentation, do involve the reproduction of biological resources. In addition, the fact that some stakeholders feel that the regulation, and taxation, of this kind of activity is currently inadequate suggests that access to genetic resources might be seen as a means to capture benefits. The conclusion, based on a majority opinion, was that fermentation, as an indicative example, should be excluded and that the other related forms of activity, particularly distillation, should also be excluded, as they are not really issues of access to genetic resources. If there are problems based on the perception that, in their commercial form, distillation or fermentation profit from the biological resources of Seychelles in a manner that is inequitable in terms of individual versus national benefit then this could be more effectively addressed through taxation or licensing.

As is suggested by the discussion of subsection (c), above, the list of specific examples of conventional uses is not intended to be exhaustive. It is primarily intended to provide an interpretative guide for use by the authorities.

3.1.2 An access-based (source country) view of the issue of derivatives

Another conceptual issue relevant to legal certainty is the concept of derivatives. Since the negotiations surrounding the Bonn Guidelines, and particularly in the COP 6 in The Hague, one of the most controversial topics has been that of derivatives and products and their relationship to access PIC and MAT. This discussion eventually resulted in the inclusion of “derivatives and products” in the Bonn Guidelines' discussion of benefit sharing. Thus, paragraph 44 of the Bonn Guidelines presents a list indicating the mutually agreed conditions included under point i: “provisions regarding the sharing of benefits arising from the commercial and other utilization of genetic resources and their derivatives and products.” Likewise, with regard to the procedures for obtaining prior informed consent, the Guidelines indicate in paragraph 36 (l) (in mentioning the information to be presented) the “kinds/types of benefits that could result from obtaining access to the resource, including benefits from derivatives and products arising from the commercial or other utilization of the genetic resource.”

According to their terms, the Bonn Guidelines are entirely “voluntary” (meaning in this case that countries have complete discretion as to whether to apply them); and in some cases, such as their provisions on the contents of PIC and MAT, and the lists of benefits and benefit sharing, they are doubly or triply voluntary, since these provisions are expressly made optional and expressed in non-mandatory language.124 While the topic of derivatives is also included in the International Regime negotiations125 (in fact, this discussion promises to be one of the most difficult due to the strong interest developing countries have shown in including derivatives and products in the International Regime),126 it is also a matter of national legislative concern for source countries.

In order to fully understand the issue, it is necessary to explain a few premises that may in some way contribute to advancing international negotiations on this subject. A number of national laws contain definitions of “genetic resources” that are much broader than the CBD's, applying access procedures equally to derivatives.127 In similar fashion, some national regulations extend the coverage of their access regimes by including “biochemicals” within the definition.128 Also, it may be possible to interpret the CBD language itself as including derivatives, if it is accepted that the object of ABS regulations is to share benefits from the use of “genetic information” rather than tying them only to the material in a physical sense.

On this basis, one might wonder if it is necessary to regulate access to derivatives per se or if, on the contrary, it is more appropriate to clarify that they are covered in regulations on access to the genetic resources from which they are derived. If the second option eases the concerns of developing countries, it is undoubtedly preferable, as long as it allows the derivatives to be subject to PIC and mutually agreed terms, including those related to benefit sharing (through access to genetic resources). In this way, the benefits arising from the genetic resources can be identified and monitored through mechanisms that should be incorporated in the international regime, such as the certificate of origin/source/legal provenance, the disclosure of origin in IPR applications, and contractual arrangements on which access is based, as well as their monitoring clauses.129

It is equally important to recognize that the term “derivative” itself is not entirely clear. Glowka already noted concerns in 1998 in mentioning that

There are two contexts in which the term derivative applies. In the first, derivatives may be described as non-modified chemical components other than DNA or RNA, but formed by the organisms' metabolic processes. As in the case of DNA or RNA, these components exist in samples of biological materials obtained under ex-situ or in-situ conditions. Derivatives in this context, for example, may constitute active biological components found in the collected plant material, but that have yet to be modified and used in technological applications. In the second context, derivatives can consist of chemical components that are modified and created or synthesized from materials originally obtained from in-situ or ex-situ sources. The resulting end products may be a hybrid seed, a traditional medicine or the synthetic version of a biochemical extract. Thus, they are products that are derived or synthesized from genetic or biochemical resources through human intervention. Access legislation may be extended to derivatives in the first context. However, it would be very difficult to extend it in the second context in that this would be a matter of regulating access to technologies.130

Casas coincides with this view when he states that The international regime should not only cover genetic resources, but also their derivatives, understood as natural molecules that do not contain genetic information, but have resulted from a genetic resource. That is to say, they are compounds, extracts or secretions that occur as a natural expression of the genetic material and are the result of a metabolic process.131

3.1.3 The utilization issue

On this basis, it seems obvious that there is a need for clarification on the issues of utilization. This suggests a problem for source-oriented legislation, since utilization typically happens in another country. While it is hoped that the International Regime negotiations might resolve the concept involved, it will almost certainly not substitute for national legislation, nor will it be finished and implemented quickly. The task of national implementation will also be eased if those negotiations should address relevant criteria or a catalogue of uses that would be relevant for confining the user obligation.

In the meantime, however, the need for national legislative and administrative approaches in source countries remains critical. There may be a need (or advantage) in this process for reformulation of source country (access) legislation, to coincide with a benefit-sharing approach based on the idea of the use or utilization of the GR. In this connection, it is notable that the concept of “access to genetic resources” has not been defined either. If “access” means the ability to collect samples, then benefit sharing and/or utilization of genetic resources may not necessarily be based on access to genetic resources.132 Both the CBD (article 1) and the Johannesburg Plan of Action refer to the need to share the benefits arising out of the utilization of genetic resources, but do not tie this to the fact that such resources have been “accessed.” The catalogue approach (listing activities that constitute genetic resources utilization) is primarily a tool of user-oriented legislation, but could be a useful tool for access legislation as well, if (after) user countries have adopted it. Particularly where the country defines “genetic resources” or “access” based on intended use of the resources, it will be necessary to determine which intended uses require ABS compliance. Such legislation must include a list of activities or intentions.

In any case, it should not be forgotten that the principal purpose of such a legislative reformulation would be to provide certainty – both for users and for the source country. With this in mind, independently of the criteria or lists to be used, the national laws – and international negotiations – should establish clearly the scope of the activities covered by the laws of access and which are excluded. At the same time, to give functionality to the system, it would be desirable that these criteria were harmonized by means of international decisions.133

3.2 Property rights in genetic resources

As noted above, the Convention on Biological Diversity has created a new system of property and commercial transactions for a specific material: genetic resources. This new property right was developed with the implicit understanding that the application of the property right to tangible property would be adequate and sufficient in the case of genetic resources, but that approach did not consider several circumstances.

For example, the assignment of exclusive rights to the physical property (rights to keep it, hold or change it, to exclude others, etc.), is based on the possibility of exercising physical control over the property. In the case of genetic information, its access and use cannot be controlled by means of the exercise of traditional (physical) property rights.

Another problem is the need to describe property, in order to exert rights to it. How it is possible to describe with sufficient clarity, the intangible component of genetic resources in order to permit the creation of property rights over genetic information?134 The notion of genetic resources as natural or inherent information has been suggested by diverse authors.135

Here also, there is some reason to hope that the international negotiations may provide assistance in these matters, however, the basic property law issues – development of new property systems or adaptation of traditional and conventional property systems to this new kind of property – will always be clearly matters of national governance, so that national legislative solutions, which are urgent now, will still be necessary and relevant, if any part of the international negotiation result provides critical agreements on supporting points.

3.2.1 Applying existing law of property to genetic resources

In general, the application of the traditional rights over tangible property to genetic resources can be difficult, raising, it has been affirmed, “Key questions of property ownership ... ABS created a new kind of commodity that is either intangible or possessed of a very complex legal status. No existing law is clear about who holds such rights.”136 In this connection, a study done in the Pacific Rim countries indicates the following:137

Evidently the information component of genetic resources is the most valuable for bioprospectors. However, no State has created a property rights system for this component. Therefore, Countries still rely on the physical component (e.g., organisms or their parts) to define the legal status of their genetic (and biochemical) resources.

In legal doctrine, a general classification of property as tangible, corporal, or intangible has been established. In the case of genetic resources, there may be a basis for distinction between the rights over the physical entity (physical property) and over the genetic information that the resources contain (intangible property). This last represents the real value of the resources, and where the judicial problems are particularly complex.138

The material and geographic aspects of genetic resources pose an extraordinary challenge because most living organisms reproduce and disperse naturally, irrespective of restrictive measures that policy makers wish to lay on them, carrying out into the world the very qualities (genetic resources) that bioprospectors and users are seeking rights in, and source countries are seeking to control. This biological fact is compounded by the elusive nature of information as valued added: information, even when derived from biological resources, is intangible and therefore requires a special property regime.

3.2.2 Property rights issues generally

The issue of property rights is very complex,139 raising questions and concerns relating to sovereignty, heritage and property – three very different legal issues. Of these, the latter is not addressed by the Convention, leaving each State free to decide if genetic resources are private or public property and under what circumstances. This issue is not fully clear in comparative law, because, in general, prior to 1992 (and indeed up to the present) most national property systems and constitutions, with few exceptions, have not made reference to genetic resources. National law on the property interest in genetic resources

There are, however, a few legal systems that do make a property-based distinction between biological resources and genetic resources. Generally, the State is considered the owner of genetic resources (and mobile biological resources), although the owner of the land must be contacted to gain permission to collect 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 which is considered the provider of the biological resource.

The issue of property rights over genetic resources is very important in the ABS legislative context for two reasons:

Table 2. Examples of different approaches to property rights on genetic resources in selected countries

Country Approach to property issues
Costa Rica, Nicaragua, Andean Community The legislation establishes specifically the property rights over genetic resources and establishes a system of public domain.
Philippines (not totally clear in the case of the ex-situ resources and domesticated ones); Nigeria, possibly the USA Wild flora or fauna and natural resources in general are considered the property of the state, but not expressly mentioned. In some countries (USA, Nigeria), the genetic resources located, for example, in national parks are considered property of the state, but this fact is not mentioned expressly in the national laws, and not clear in other situations.
India, Brazil, Bhutan, Uganda There are no specific regulations over property, but the state has the right to control or authorize the use of genetic resources.
Australia, (possibly the USA),140 Canada Countries in which there are private property rights over genetic resources, but the state preserves a limited power to control (species in danger of extinction, etc.).
Malaysia, Kenya Relationship between state property and the common and indigenous rights is not clear. Applying conventional property law to genetic resources

Tenure and ownership systems are not uniform across the countries nor are they clearly defined in any given country. Based on their own legislative heritage and legal cultural traditions, countries exhibit a mixture of ownership arrangements that range from traditional common tenure to state-enforced private rights to land and resources, including the broad diversity of biological material.141 Analysts have identified a few general categories among countries' legal systems, which are quite useful for purposes of discussion, but should not be considered to imply national similarity among countries within each category:

While most countries believe themselves within one of these categories, the practical reality is that a mixed approach applies in virtually all countries. Public domain

Many countries have specifically determined that a special status of ownership-related rights applies in the case of genetic resources. For example, in the case of Colombia, the Council of State determined in Decision C-977 that “the legal regime applicable to genetic resources of real or potential utility, is that which is established in general terms in the Political Constitution for public domain goods....”, that is, genetic resources are inalienable, unattachable and imprescriptible, and the Nation's heritage. This is generally how the concept of the public domain is characterized. Most countries' legislations define other resources possessing such attributes, such as water, minerals, wildlife, hydrocarbons, and the maritime land zone, in the same way. The example of Costa Rica

In a number of countries, national legislation declares (or treats) genetic and biochemical resources as goods of public domain. One example relevant to this discussion is the legal regime in the Costa Rican system.

The public domain goods (goods that may be considered as belonging to a public body) are linked to public utility purposes, therefore, they are subject to a special administrative regime of protection and use of goods. Thus, characteristics of the goods of public domain are three: (1) ownership to a public body; (2) public utility purposes; and (3) under a special administrative regime of protection and use of goods.

The public domain, in this case, reflects a grade of public purposes, which is so high that it excludes all other property relationships. Thus, when property or resources are in public domain a special administrative title “of intervention” (i.e., a title exercised only in order to prevent inappropriate use) applies, which must be considered as a res extra comercium. Property in the public domain is thus more than a special type of property - the State exercises a special protection based on powers (and competences) regulated by Public Law, whose mandatory focus is to guarantee the compliance and coherence with the purposes to which these goods are linked.

In this system the importance of linking public domain goods for public utility purposes is clear. This is reflected in the constitutional jurisprudence, which has specifically upheld the view that goods in the public domain are extra comercium goods, whose destination must be the public use and satisfy public interest. For this reason they are subjected to a special legal regime.

The classic paradigm for use of public domain goods is, without doubt, the assignment to a public use or utility. These are out of the trade, non-susceptible to private appropriation – the State's administrative title of intervention guarantees that the only uses of these resources will be for public purposes satisfying State scrutiny. There is, therefore, a special legal system of Administrative Law dedicated to identifying and applying standards for the legal characteristics of goods in the public domain such as non-assignability, non-applicability, immunity from seizure, etc. But, also, the application of this regime necessitates the use by the State of different means of guardianship and protection for public domain properties, as compared with the means available to a private owner when protecting private property. This has been pointed out by the Constitutional Chamber which noted that:

IV. (....) Characteristics of these goods, are non-assignability, non-applicability, immunity from seizure; they cannot be mortgaged neither can they be susceptible of obligation in Civil Law and other administrative action except for injunctions for recovering the domain. Since they are out of the trade, these goods cannot besubject to possession. Although a utilization right can be acquired, no property right may.143

However, the prohibition to alienate the public dominion of the State does not generally exclude its disposal by means of administrative law - through concession, lease, grant, authorization, and in general public or administrative contract. Once the resources have been delivered by an appropriate legal mechanism (concession or permit) the holder has a right of property, except where the authorizing title stipulates otherwise. For example, fauna is public domain, but the hunting and fishing permits allow the complete appropriation of individual specimens, including their destruction. Also, the concessions of water, minerals and hydrocarbons allow particular minerals, water and hydrocarbons to be sold, given, granted or destroyed.

The characteristics of non-assignability, non-applicability, and immunity from seizure, which apply to resources of public domain, cease to apply once resources such as petroleum, gold or water have been appropriated by individual users. Open questions

The consequences of this legal nature (public domain) for the content (rights and obligations) of ABS agreements still need to be studied. As noted above, this question of ownership of property is considered to be almost exclusively a matter of national law. Even in cases in which property of foreign citizens has been “nationalized,” international law has not generally contained the authority for other states or international bodies to intervene. Consequently, addressing the rights granted to those who are involved in prospecting of the materials is a crucial topic.

Given that users are acquiring these rights (or concluding that they have these rights) every day, the matter has a high degree of urgency. According to some, for example, the state concedes, upon permitting any type of physical access to biological resources, custody of the material for purposes of research and development.144

What rights would the receiver-user then have? And especially, what rights to transform it and protect it – for example, by means of rights of intellectual property – are taken away (i.e., the source country no longer has the right to dispense it)? Can it protect the improved material or an invention stemming from it if they contemplate the genetic dedicated component? Can one isolate and characterize a gene and its function and the invention be patented with corresponding future uses? From the point of view of the user, restrictions in the use of the genetic resource via intellectual property can determine whether a company decides to bioprospect or not.

What implications must be considered for the genetic resources of public domain, with regard to the work of preparing and delivering samples, extracts and fractions, etc.? Would it be possible (would a company accept) for a country to require that extracts and fractions are delivered to the user “in custody” (in other words, extracted and prepared by the source country, so that the entire genetic resource remains the property of the source country)? If so, is there any limit on future acquisition of these property rights (physical) by third parties, since they are only granted in custody? Would this approach alleviate the property law concern? And if so, would it simply transfer the problem to another branch of law (for example to criminal law, which would have to find a basis for action against those who take and use genetic resources without any permission)? The restrictions in the use of the materials must be specified. What is the degree of restriction on these extracts or fractions that may practically be imposed?

For example, Casas (speaking of the law of Colombia) indicates that the applicant for access should consider the utilization of the genetic resources as part of the rights that he is applying for, but that this right of utilization does not transfer a property interest in the resources, because they have an unalienable character. Eventually rights on the intellectual intangible property resulting from the investigation and development of the genetic resources are usually claimed by means of IPRs.145

3.2.3 Avoiding the property-definition problem

One way to address the difficult questions raised by the creation of this new kind of property right is to avoid addressing it. ABS issues are addressed contractually by many countries that have not described the right granted, but focused on the performances required. As has been indicated:146

One of the key requirements of user certainty is that user and the granting or source country share a mutual understanding of the exact nature of the rights granted by the ABS agreement. In this connection it is interesting to note that none of the [national legislative] measures examined describes or considers ABS rights from the perspective of the user, by stating in effect that the grant of ABS rights entitles the user to the following.... In general terms, the nature of the positive rights granted by the ABS decision is expressed in terms of limits. Apart from these, the nature of the grant is somewhat determinable by considering the activities that are strictly forbidden unless an ABS right is obtained.

Thus, for example, one possible solution would be to limit the permit-holder's or contract-holder's claim to the sample as delivered, or, in legislation simply to assure the free availability of the genetic material. Although it does not prevent any user from undertaking modification or from applying for IPRs on the modification of that resource, it at least provides a basis for holding that only new inventions and novel organisms (obviously including the genetic component of the organism) can legally be claimed in this way.

Table 3. Laws or regulations restricting uses of the genetic resources147

Type of control/ country/law Example
Restriction on patent or other IPR - India/Biodiversity Law No person shall apply for any form of IPR by whatever name called in or outside India for any invention based on research or information on a biological resource obtained from India without the previous approval of the National Biodiversity Authority.
Restriction on transfer of research results - India/Biodiversity Law A separate approval from the National Biodiversity Authority will be required for any transfer of the results of any research relating to biological resources occurring in or obtained from India.
Restriction on patent or other IPR - African Union/Model Law on [ABS and other issues] No person may apply for Intellectual Property Rights on life forms.
Restriction on research-related cultivation or multiplication – Malaysia/Access Agreement The Access Agreement prohibits the researcher to germinate, propagate, breed or cultivate any biological resources without prior approval of the Sarawak Council.
Restriction on patent or other IPR – Malaysia/Access Agreement The researcher shall not file any applications for patents, either inside or outside Sarawak, without the prior concurrence in writing of the Council.
Restriction on transfer of resources – Bhutan/Biodiversity Act Applicant shall not transfer the resources to any Third Party without the authorization of the Competent Authority.

In this sense, any attempt to control post-access activities relating to the genetic resources can be seen as a way of applying “property-like” rights to those resources, without (or in support of) creating new property rights. Table 3 provides a few examples of this type of provisions.

3.2.4 Recommendations

It appears that all countries have the need to address property rights issues in some way.148 While no external source can provide a model or complete guide to a country in this very individualized issue, a few clear recommendations arise:

3.3 Differentiating between basic and commercial research

One of the harshest criticisms of the legal systems of ABS comes from the sectors of basic research (universities and other research centers). From the earliest days of the CBD, these have considered that the regulations of ABS tend to impose requisites difficult to fulfill; they do not distinguish clearly between research done with commercial intentions and that without commercial purposes. They have complained that the Convention does not adequately recognize the intrinsic advantages of basic research and its contribution to the conservation and the sustainable use of biodiversity.149

A study undertaken by Columbia University,150 concludes that:

... hindrance to access to genetic resources is the use of same standards in commercial and non-commercial research.... access regulations have become increasingly restrictive and commercially-oriented. Hence a cumbersome, unnecessarily strict application process is imposed on what is considered basic, not for profit research. This basic scientific investigation is required to understand natural processes and almost invariably precedes commercial research ....

Several laws have sought to address these concerns, by establishing different regulations for research-related access, than for other types of use.151 For purposes of legal certainty, however, it is important to note several key concerns for countries seeking to make this distinction. First, the flexibility that some countries have established for basic research requires the designation of clear limits between the cases of access for commercial gain, and access for basic non-commercial purposes. Second, however, it is necessary to guarantee that the rights of the provider will be protected in the case that a commercially valuable result is obtained from an activity initially considered as basic research. Additionally, the user should have certainty that eventually it will be possible to seek commercial results.152

There is significant agreement in many countries and institutions that the process of access for basic research should be simpler, but subject to later negotiations in the case of the commercialization of the results of the research based on the genetic resources.153 This concept of subsequent negotiation is needed to balance past experience, where basic research has resulted in products on the market, without any ABS compliance or benefit sharing. This is especially so in the case of biotechnology research that requires a strong component of basic science. Both researchers and source countries share an important consensus with respect to the difficulties in establishing a clear frontier in this area.154

3.3.1 Legislative approaches

This flexibility of regulation for non-commercial activities has been considered in the legislation in draft laws of various countries,155 as presented in the following chart.156

Table 4. Select countries which differentiate commercial and basic ABS research

Country157 Provision
Philippines In accordance to the Wildlife Law, bioprospecting is limited to research with commercial purposes. Research with non-commercial purposes does not require the signature of a Commercial Research Agreement (CRADA). The authorization of scientific research is done by means of a gratuitous (no fee) permit. “Scientific research” is not defined but “bioprospecting” is defined as research, collection and utilization of biological and genetic resources for purpose of applying knowledge derived solely for commercial purposes.
Costa Rica Access for basic research is defined as “Activities directed at investigation, examination, classification or increase of existing knowledge over biological resources or their genetic or biochemical characteristics without immediate interest in commercializing its results.” Some (few) requisites do not apply for basic research (e.g., unlike in other ABS situations, in the case of basic research, it is not mandatory to share up to 10% of the research budget with the providers of the genetic resources).
Brazil The Council of Genetic Patrimony dispenses with some requirements (no contract for utilization of genetic resources is signed) and undergoes fast tracking, in which special authorizations are issued to domestic academic institutions that encompass a group of projects. Scientific Research is defined as using genetic resources with no economic purpose. Access for non-commercial purposes is considered to “contribute to the advance of knowledge of biodiversity of the country and not present previously identified potential for economic use as with the activities of bioprospecting or technological development.”
Australia The relevant law covers both commercial and non-commercial access. However, a benefit-sharing agreement is required for any applicant for a permit for access to biological resources for commercial purposes or potential commercial purposes.
Malaysia (Sarawak) According to the amended regulations of the Sarawak Access, Collection and Research, the regulations exclude 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.

Note: Other countries or regions have intentionally decided not to make any distinction between non-commercial and commercial research (e.g., Andean Countries, Venezuela, India).

A broader analysis of “research exceptions” provisions suggests a few common characteristics. For example, they define in a general manner, usually negatively (e.g., activities without commercial intent), the meaning they attach to basic research, and so far, they do not include criteria that would permit the user to know what actions, conditions or situations cause the (non-commercial) character of the investigation to change.

To facilitate access to genetic resources for basic research, it has been suggested158 that countries establish a “two track” application process, wherein any access applicant would be able to choose between either one of the two tracks. Under this system, the user/applicant would define his own intentions, avoiding the need to infer them from the project description or other criteria. Some criteria that can be utilized to differentiate between both types of research could include:159

In any case, the design of the legal framework will be functional if accompanied by mechanisms that allow the source country:

3.3.2 Recommendations

A few recommendations can be drawn from this analysis, to aid countries that have decided to include a research/non-commercial use distinction:

3.4 Prior informed consent (PIC): making it operative and certain

From the viewpoint of legal certainty, it is indispensable to address the issue of Prior Informed Consent (PIC). Despite its very simple description, PIC has been identified as one of the most complex and difficult aspects for the user seeking to obtain access to genetic resources. In fact, some of the strongest criticisms of the ABS systems have related to the difficulties of obtaining the PIC in practice.161 In its practical analysis of national implementation, the study on the Pacific Rim Countries identified the PIC procedures as one of the major shortcomings.162

As noted above, despite all of the attention, PIC is not a new concept. Not only does the concept of “informed consent” form the basis of all contract law, it is also specifically included in several international instruments. In contrast to other convention-based applications of PIC (medical treatment, transboundary movements of chemicals or toxic wastes), the prior informed consent within the context of the CBD is also intended to act as a guarantee of equitable benefit sharing and therefore plays a contractual as well as regulatory role.163 PIC difficulties, like most other issues in this book, find their basis in the basic functionality problems of the ABS concept, rather than in the national legislation itself.

3.4.1 National PIC measures

Administrative procedures relating to PIC in the ABS context vary from country to country. Based on analysis of these, several principal difficulties can be cited:164

A recent study166 indicates that “questions frequently exist about how to convey the information needed to make informed decisions and about how, when and from whom consent should be obtained. The answers to these critical questions often differ according to the precise ABS issue and community involved.”167 Problems relating to PIC have been identified across a wide range of parties and stakeholders whose concerns can probably best be satisfied by cooperation. The next section describes work by a user-oriented association, suggesting some issues which can be addressed, at least in part, by national legislation of the source country. Insight into PIC from user countries

Recently, the government of Japan, in the course of developing guidelines for its users of genetic resources,168 identified several practical issues of concern, which are usually not easily answered under the PIC laws and practices of source countries:

Some of these points may not be answerable or resolvable through source-country legislation at all, but many of them may be. Bonn Guidelines: recommendations for PIC implementation

Likewise, the Bonn Guidelines recognize PIC as an important element through which the ABS process can be catalyzed and legitimized.170 As noted by IUCN, it provides “a first step in promoting effectiveness and efficiency in the application of laws and regulations governing access and use of genetic resources in identifying and assigning clear functions, competences and roles to the National Competent Authority on access to genetic resources and benefit sharing;”171 however, choosing a focal point is a relatively simple action (unless it has political implications) and offers no expectation of a solution to the problems of national implementation or user certainty. In any case, PIC procedures must be clearly outlined in a way that reduces time and transaction costs for bioprospectors.

3.5 Conclusions: pathways to effective legislation in source countries

Obviously, the problem of source-country legislation is far from solved, even though source countries have been attempting to develop effective ABS regimes since 1992.

The case of the Philippines is quite illustrative of the issues being addressed in this paper. The Philippines has been a pioneer in ABS. In 1995, it was the first country after the entry into force of the CBD to regulate ABS in great detail with the development and implementation of Executive Order 247.172 At the same time, it has been one of the few countries to carry out a full review and modification of its legal framework. It adopted new legislation (the Wildlife Resources Conservation and Protection Act) in 2001, which contains a few general provisions on ABS and has developed new implementing guidelines on bioprospecting.173 This means that it has taken more than 10 years174 to revise a regulation that was widely considered as complex, bureaucratic and restrictive. This is not an isolated case; in the Mexican context (where the author has direct experience), consensus building in the Congress is very difficult to achieve. This means that once a problematic law is passed, it will be very difficult to change, especially if that change implies a full review or a whole change of direction.

89 Cf. Gartforth et al., 2004; Cabrera Medaglia, 2004, A Comparative Analysis....

90 Decision V/26 had indicated the need for gathering more information on definitions. The Executive Secretary convened an Expert Group on the Use of Terms, which limited its work to exchanging information about national practices. Decision VI/ 24 requests the ABS Working Group to study, among others, the use of Terms and Definitions. Finally, Decision VII/19 B invites Parties, organizations and stakeholders to submit information on the following terms: access to genetic resources, commercialization; derivatives, etc. It also requests the Working Group to continue working on the use of terms not defined by the CBD.

91 Cf. Carrizosa et al., 2004.

92 Dross and Wolff, 2005.

93 Ministry for Sustainable Development, 2004.

94 Febres, 2003.

95 Cfr Dross and Wolff, 2005. See of these authors other examples which might found under the category of biological resources in Cabrera Medaglia, 2004, A Comparative Analysis..., at Annex 4, Comparative Table of ABS Agreements.

96 Ruiz, 2000.

97 Ten Kate and Laird, 1999; Glowka, 1998.

98 CBD, Art. 2 Use of Terms.

99 The drafting history of the CBD does not present any particular help to clarify this issue and how some critical issues were not addressed at all or were addressed in a manner that does not provide enough guidance to policy makers and ABS practitioners. See Glowka, 1994.

100 Decision VII/19 had already mentioned the need to continue working on certain definitions. However, from the point of view of the international regime, more than being a matter of simple conceptual clarifications, this has to do with essential aspects that are needed to give the ABS systems legal consistency and functionality.

101 For example, the difficulties in analyzing cases of “misappropriation” or “biopiracy” of genetic resources and traditional knowledge, given the lack of clarity about which activities constitute access to genetic resources (and which would consequently be required to follow the respective rules) and which, on the other hand, constitute the use of biological resources. Cfr Young, 2006. As noted above, numerous claims have been based on direct utilization of oils, flours, grains or other extracts milled or taken in conventional ways using naturally occurring or traditionally derived subspecies or varieties. These actions use the variety in the same way that commercial trade in fruit juices used the property of the fruit, but do not require special genetic-based research or activities. Other claims focus on normal kinds of plant breeding (cross pollination, hybridization, etc.) or animal breeding. Many such claims are adequately regulated under other laws, suggesting that they do not need to be covered by ABS law. Likewise, a report on 36 cases of biopiracy in Africa, recently distributed during the Meeting of the Working Group in Granada, presents some examples in which there are at least well-founded doubts about whether a genetic or biological resource was involved. Cfr Edmond Institute (undated).

102 IUCN-Canada, 2005.

103 Cfr Dross and Wolff, 2005. Young notes that “Few concrete mechanisms have been suggested for determining which activities are normal com

104 Young, 2004, “Genetic Resources...”.

105 Ten Kate and Laird, 1999.

106 Regarding this issue, Glowka points out “For example if the blossoms of a plant were harvested as a bulk or biomass commodity for direct use in an herbal tea or a cosmetic and not for their genetic or biochemical informational value in a technological application, would harvesting and export trigger the prior informed consent and mutually agreed terms provisions under the legislation? The supplier of the blossom more than likely has or will negotiate a supply agreement with the users. This presumably reflects a mutually agreed price to supply a certain quantity of the blossom at a particular price... Benefits therefore will accrue without creating a new regulatory regime....However if for example, cells from the blossoms or seed from plants were used as the basis for a cell culture or farm cultivation to mass produce an active ingredient, then they are being used as a genetic resource.” Glowka, 1999.

107 In these cases, access or bioprospecting is sometimes also defined.

108 The Biodiversity Law of Venezuela is not clear. The scope of the access provisions refers in some cases to biodiversity resources and in others to genetic resources.

109 Environment Protection and Biodiversity Conservation Amendment Regulations, 2005.

110 These legislations also define access, bioprospecting or biodiscovery.

111 The Provisional Measure of Brazil defines Genetic Heritage as follows: “information of genetic origin contained in the samples of all or part of plant, fungal, microbial or animal species, in the form of molecules and substances originating in the metabolism of these living beings or from extracts obtained from in situ or ex situ conditions... ”. The Biodiversity Law of Costa Rica and the Access Norms (regulations) defines separately genetic resources and genetic elements, the genetic resources concept is based on the idea of some degree of human intervention.

112 It is noted that some important initiatives, especially the BioTRADE initiative of UNCTAD (see www.biotrade.org), are designing specialized programmes which apply the principles of ABS, in an abbreviated form, to the use of natural extracts (that is, of “biological resources”), especially in cosmetics and other consumer products. See the Informal Expert Workshop on Practical Guidelines for equitable sharing of benefits of biological resources in BioTrade Activities, Meeting Report, September 2006. BioTRADE joins a number of other actors who feel that the need for and importance of benefit sharing extends not only to genetic resources but to all components of biodiversity. The Addis Ababa Principles and Guidelines for the Sustainable Use of Biodiversity, for example, adopted by the Seventh Conference of the Parties of the CBD, include several references to this idea.

113 Cfr www.biotrade.org. See the Informal Expert Workshop on Practical Guidelines for equitable sharing of benefits of biological resources in BioTrade Activities, Meeting Report, September 2006 which indicates ”... equitable benefit sharing also arises in the context of the second objective of the CBD: the sustainable use of biodiversity. In this context, the need and importance of benefit sharing extends not only to genetic resources but to all components of biodiversity. The Addis Ababa Principles and Guidelines for the Sustainable Use of Biodiversity, for example, adopted by the Seventh Conference of the Parties of the CBD, include several references to this effect.”

114 Young, 2004, “An Implementation Perspective...”.

115 This definition makes it possible, at least theoretically, to deal with the issue of access to information that is available electronically, such as that deposited in data bases. The same information generated by genomic and proteonomic projects, for example, may gradually substitute physical access to samples, conceived as part of the normal or traditional collection process of ABS projects. Curiously, the international regime negotiators have not paid much attention to the impact of these technologies and the means of generating information on ABS proposals and systems, perhaps due to their technical complexity and the lack of analysis of their legal implications. Cf. on the topic, Oldam, 2005.

116 Cfr Young, 2004, “Genetic Resources...”.

117 For some, this is the most appropriate solution. Cfr Dross and Wolff, 2005. Others believe that this would involve considerable legal difficulties in determining the legality of access. The difficulties mentioned include problems in objectively determining the applicant’s intention; the possibility of his later being granted a different use of the collected materials by a third party - and possibly some time after the original collection was made, etc. Cfr Tvedt, 2006; and Young, 2004, “Genetic Resources...,”.

118 With regard to the intentional approach, Young criticizes: “There is no objective way to distinguish these actions from obtaining access to genetic resources. The only difference is the intention of the person taking the action. In ABS, it can be particularly complicated having so many different persons, actions, and intentions between the original collection of a biosample and the point when its genetic resources are utilized commercially. It is not objectively clear whether access to genetic resources occurs at the time the biological specimen is collected from the wild or the farm or at the time the genetic resources material is first intentionally studied, extracted or otherwise utilized in commercial or other development. Moreover there are many possible situations in which the relevant genetic and biochemical information can be transferred without collection of physical material. A gene sequence or a biochemical formula may be expressed on paper and sent to a researcher in another country by mail. In 2005, it is thought to be too difficult and costly to build genetic material into products solely from a gene sequence without a sample reference. That scientific capacity is expected to be developed substantially during the next decade.” Young, 2004, “Genetic Resources...,”.

119 Tvedt, 2006, and see detailed discussion of this issue in Tvedt and Young, 2007.

120 Tvedt, 2006.

121 Cfr Tvedt, 2006, who calls this the “catalog approach.”

122 Lettington and Dogley, 2006. NOTE: As of this writing, this bill has not been adopted.

123 In a similar approach, the Draft Biological Resources Bill of the Northern Territories in Australia lists activities that do not constitute “bioprospecting:” fishing for commerce, harvesting of wild flowers, taking wild animals or plants for food, collecting peat or firewood, taking essential oils from wild plants, collecting plant reproductive material for propagation, and commercial forestry.

124 See generally paragraph 7 of the Bonn Guidelines as well as the above cited sections.

125 In the discussions and negotiations, both within the ABS Working Group and in the VII and VIII Conferences of the Parties, there have been recurring disagreements regarding the inclusion or not of derivatives and products. See Annex to COP VIII, Decision VIII/4, UNEP/CBD/COP/8/4, for example, to note how the references to derivatives and products are bracketed in the paragraphs where they are mentioned.

126 From the commercial point of view, it must be accepted that derivatives or biochemicals – if they are accepted as equivalent – are very valuable for the pharmaceutical industry. Cfr Battig in this respect, cited by Wolff and Dross, 2005.

127 See Cabrera Medaglia, A Comparative Analysis, 2004.

128 See, for example, the Biodiversity Law of Costa Rica, articles 4, 6 and 7.

129 See in a similar sense, Tvedt, 2006.

130 Glowka, 1998. Likewise, according to Burton, the problem of derivatives is due to there being two interpretations or uses of the term derivatives. On the one hand, there are those who refer to derivatives as products or innovations originating from biological materials; their underlying concern is to control the commercialization or utilization of genetic resources in order to obtain a share of the benefits. Conversely, others address the topic from the perspective of the inadequacy of the CBD definition of genetic resources in not including the organisms’ components, the interaction of genes and the biochemical compounds they express. Cfr Burton, 2004.

131 Casas, 2004.

132 The Annex to Decision VIII/4 contains some references to the use of the financial mechanism in cases in which the countries of origin of the genetic resources and derivatives cannot be identified.

133 E.g., clearly regulate that bulk use of biological resources as ingredients in commercial products, herbal medicine, cosmetics, does not constitute access.

134 Cfr Glowka, 1998.

135 See Vogel, 1998.

136 Young, 2004, “An Implementation perspective...”.

137 Carrizosa et al.

138 Cfr Febres, 2002.

139 Concerning legal certainty, one of the most pertinent aspects to be studied regards the definition of physical property rights to genetic resources, as recognized by the COP 8 when it requested the Parties to provide information to the Secretariat. CBD COP VII, Decision VIII/4, UNEP/CBD/COP/8/4, part A.

140 See Note 36 above, the US information is based on a permit system that was adopted for collection of specimens in national parks. It is not clear that this limited statement embodies the USA's law on genetic resources, since it (i) was made by one agency (ii) applies to less than 4% of the country's land area and (iii) applies to only one property owner out of the millions of property owners.

141 Columbia University, 1999.

142 Cfr Pérez, 1997.

143 Constitutional Chamber of the Supreme Court of Justice. Award No 2306-91 of November 6, 1991.

144 Casas (2004) suggests that the system should recognize custody rights to the person in physical possession of the samples, which entitles them to provide PIC and receive benefits.

145 Cfr Casas, 2004.

146 IUCN-Canada, 2005.

147 It has been said that “a critical element of user certainty in the context of the nature of the rights granted relates to the question of whether additional permits or permissions will be necessary at later stages in the process of accessing and utilizing genetic resources,” IUCN-Canada, 2005.

148 This book does not consider the impact of variations among national decisions on this point. (See, Book 6 of this Series, Young et al., Covering Access.)

149 See Grajal, 1999.

150 Columbia University, op. cit.

151 Correa (2000) on a broader comment on ABS laws mentions: “The Convention applies to all types of genetic resources, including food and agriculture. No difference is made with respect to the treatment to be given to different sectors of biodiversity. The broad scope and the generality of the regulation on genetic resources is problematic. The conditions and use of animal, plant, microbial, aquatic or marine resources vary considerably. As a result, the practices of exchange and appropriation of such resources also differ, depending on the distribution and availability of the resources, the difficulty or ease to reproduce them, and the existence or not of markets for their exchange, among other factors.”

152 Rosenthal (unpublished) indicates: “It may also be useful to consider a two phase approach to preserve elements of both the freedom to academic research and the flexibility to pursue industrial development of potential discoveries, while offering security to providers.”

153 Fernández (2005) comments: “A basic implication of the valuation problem is that any effort to fully contract the terms and conditions of benefit sharing is likely to be faced with a wide variety of difficulties, from non-commercial projects that will unexpected turn commercial at an unknown point in the future to commercial ventures in which it will be extremely difficult to assess the value of the collection of species to be prospected. Therefore, there is a need for better information on the actual potential of genetic resources. If contracting is forced to take place fully at the outset, the value negotiated will be highly speculative and could end up being too low or the contract will not be signed.”

154 Cf. Carrizosa et al., (eds) 2004. Dross and Wolff (2005) indicate: “A more general question is whether scientific and commercial research should be differentiated. While this is desirable to foster scientific research, the differentiation is not always obvious. Often scientific research later leads to commercialisation.”

155 See Chile, ABS Draft Law which would be applicable only to commercial research.

156 See Carrizosa et al., 2004; Dross and Wolff, “New Elements,” op. cit; and Columbia University, 1999.

157 Names and citations of relevant laws are available in Cabrera Medaglia, 2004, A Comparative Analysis... .

158 Columbia University, 1999.

159 The principles for accessing genetic resources, the treatment of intellectual property and the sharing of benefits associated with International Cooperative Biodiversity Groups-sponsored research indicate: “Where national governments do not have clear regulations to guide informed consent procedures, activities should follow a two phase approach to distinguish basic and commercial research. Research intended primarily for publication including collecting and analyzing biodiversity, as well as bioassay and chemistry work, may be considered basic research. If at any time, researchers intend to file a patent application based on this work or send a sample for testing to an industrial partner, the research enters the commercial realm and must follow all the requisites,” available in www.fic.nih.gov

160 The Principles on Access to Genetic Resources of the Botanical Gardens, defines commercialization as “applying for, obtaining or transferring intellectual property rights or other tangible or intangible rights by the sale or licence or in any other manner commencement of product development, conducting market research, and seeking pre-market approval and/or the sale of any resulting product.”

161 See Lange, 2005; and Rosenthal, unpublished.

162 Carrizosa et al., 2004.

163 Cf. Hirakuri and Toben, 2005.

164 See cases studies on PIC in Perault, 2006.

165 For example, Decision 16/V of the V COP indicated that access to traditional knowledge should be subject to prior informed consent or prior approval from the holders of such knowledge.

166 See Perault, 2006.

167 In this connection, the IUCN-Canada study concludes that to “... enhance user certainty appears to be through clarity, including clarification of key elements of the application process such as: (i) the rights and duties of National Competent Authorities, (ii) the relationship between ABS applications and other approval processes, (iii) milestones and the timing of the various steps in the process, (iv) the extent to which the CND may request additional information and performances, (v) the bases on which the decision will be made, (vi) rights of appeal, and (vii) the objective factor that will determine whether an applicant is exempt from the need to obtain ABS permits. Perhaps the most important way to maximize certainty is to clarify the legal status of the rights granted whether it is a property right or vested interest. A user can determine what it can legitimately expect, whether it is worth his investment and what procedures and protections of law apply.” IUCN-Canada, 2005.

168 Ministry of Trade and Industry (METI), 2005. The Japanese Guidelines present principles set forth in the CBD for PIC; explanatory notes on the meaning of them; “points to note” including information on entities issuing PIC, procedures for obtaining PIC; etc.. Other Guideline documents have been put forward. See also Bioprospecting Guidelines for BIO members, developed by the Biotechnology Industry Association of the USA (see www.bio.org) and the approach found in the Access and Benefit Sharing. Good Practice for Academic Research on Genetic Resources, Swiss Academy of Sciences, Switzerland, 2006.

169 Similarly, Perault (2006) mentions five enabling conditions for PIC at the international, national, local and project levels, including: understanding and recognition of property rights, including community based property rights; community participation in decision making; building capacities for local communities to engage efficiently in PIC processes, including legal and technical capacities; effective mechanisms for resolving disputes and promoting compliance, etc.

170 See Bonn Guidelines, para. 24–40.

171 Cfr IUCN, position paper on Access to Genetic Resources and Benefit Sharing, submitted at the Seventh Meeting of the Conference of the Parties to the Convention on Biological Diversity, Curitiba, Brazil, 20–31 March 2006 (contact, Rojas, M.).

172 Executive Order 247 on Access to Genetic Resources is entitled “Prescribing Guidelines and Establishing a Regulatory Framework for the Prospecting of Biological and Genetic Resources, their By-products and Derivatives, for Scientific and Commercial Purposes and for Other Purposes.”

173 Benavidez, 2004, “The Challenges...”.

174 This figure should not be dramatically surprising. In a related documented case of capacity development in a developing country, it took more than 10 years for Mexico to fully understand its obligations and to play a full role in the workings of CITES. See Arroyo-Quiroz, 2005.

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