This book is intended to address the “Access” component of the Access and Benefit Sharing (ABS) legal analysis, in detail. Specifically, this book does not aim to provide a comprehensive listing of particular provisions by country,1 or engage in country-by-country analysis. Rather, it is focused on substantive issues of Access law, seeking to achieve three divergent objectives:
To identify the particular elements of “access” that must be addressed by each country that is or may be a source of genetic resources for use in another country (in the words of Article 15, that may be a “country providing genetic resources”);
To explain several primary legal concepts (enforceability, the problems of ambiguity and vagueness, etc.) in a way that is accessible to non-lawyers (international delegates, legislators, government officials, and involved civil society groups). Here the objective is to be very clear about why there are problems, why they have not been solved by existing national approaches, and (possibly) what might be the options for solving these problems;
To use these concepts:
to explain why earlier “assumptions” about the legal process of implementing ABS were incorrect; and
to enable understanding of the nature of the legal impediments that must be addressed and the kinds of issues and solutions that can function legally as tools of ABS implementation.
Although it cannot exist without its partner – the “benefit-sharing” component – the access element of the law of the source country, and the contents of any “ABS Agreement” negotiated in that country are the primary legal foundations on which the rest of the “international regime on ABS” will be built. Hence it is essential to create a systematic analysis of the requirements of that law, both the Convention on Biological Diversity (CBD) requirements and the basic requirements of enforceable legislation, which are often not considered in analysis of access legislative issues.
A number of issues are clear. For example, many of the most significant legal impediments to functional ABS legislation cannot be solved at the level of a single country. Some countries have tried to address key problems, but found that their solutions cannot be functional in the absence of generally agreed understanding regarding the legal principles underlying ABS. Other countries, although recognizing options that could make ABS law effective, have avoided those options, fearing that any decision to use language or concepts not found in the CBD could have the effect of narrowing their rights or legal protections.
A number of the standard statements about why ABS is not working appear to be false – for example, in the negotiations of the Bonn Guidelines, it was consistently stated that overly complex national legislation and institutional arrangements, and high transaction costs were the primary factors that prevented companies from involvement in ABS. There are certainly situations in which legal problems have gotten in the way of ABS negotiations. However, preliminary analysis of contracts and legislation suggests that a country with a very simple ABS law is no more likely to gain an ABS contract than one with very complex requirements. Companies' confidence in the individuals and agencies they are dealing with may be a much more significant factor.
Key legal issues that have a significant impact on enforceability of ABS Agreements are not addressed in many countries. One such issue relates to the definitions of “genetic resources,” “biological resources” and “utilization of genetic resources.” If the parties, the judge or other enforcing person/entity cannot objectively verify whether a particular transaction involves “genetic resources” or the “utilization of genetic resources” then the agreement may well be considered to be “vague” and the court will refuse to decide any legal issue relating to it. Many countries try to avoid this problem by writing their law so that ABS provisions apply to all “biological resources;” however this only compounds the problem, since under such a law, every market transaction involving agricultural products would be an “ABS transaction.”
Other key legal issues affecting implementation and enforcement include:
Application of (tangible and intangible) property law to genetic resources;
Clear understanding of the concept of “public domain” over genetic resources and its legal consequences on the rights transferred to the users;
Difficulties in drawing the line between commercial and non-commercial ABS projects;
Difficulties in obtaining Prior Informed Consent (PIC);
Reliance on unenforceable “assurances” regarding what will happen after the resource has left the country; and
Lack of incentives for users to affirmatively seek the relevant permits and agreements.
At least one question has so far not been seriously asked - the ability of the provider country to tie the access agreement to compliance by the user country. Specifically, it is clear that “access” provisions are only half of the required legislation. To be properly covered by law, each “access” arrangement can involve two types of legal instrument:
the “access” instruments (laws, agreement, license, etc.) in the source country, and
the “measure to secure benefit sharing and compliance with the terms and conditions under which access was granted.”2
Similarly, it is only possible to impose an access requirement where both provider country and user country adopt measures requiring it. User countries undermine the ability to apply ABS, wherever they fail to adopt legislation requiring the companies and institutions in their country to enter into access arrangements for every case in which they are using genetic resources from another country.3
In this regard it is equally important to address the legal ability of the source country to condition access on the use of resources only in (or under the jurisdiction of) countries that have adopted sufficient “user measures.”
This paper is intended to address the legal issues that can be appropriately applied in “source country” legislation - the need to, on one hand, properly protect national interests in genetic resources while, on the other hand, providing sufficient “user certainty” and other types of legal (market) confidence, to encourage users (research and commercial entities) to incur the time and expense of complying with the “access”4 component of ABS.
The legal systems for ABS were created without a clear and consistent understanding of certain critical themes necessary for the systems to be (legally) consistent and functional. Elements of existing legal frameworks (contracts law, property rights regimes, etc.) were utilized with the idea that they would be applicable without modification or explanation to transactions related to genetic resources.
Among the elements and mechanisms utilized for the construction of ABS systems are:
In the provisions discussing access, the terms “genetic resources” and “biological resources” are used as defined by the Convention without clarifying their scope. This has made it difficult to clearly determine a key aspect of the access systems, such as their scope, and the activities or resources covered by the ABS laws and regulations.5
Depending on how “genetic resources” is defined, the Convention on Biological Diversity can be considered as the starting point for the creation of a new property right (and consequently a right of commercialization) over these resources. Nevertheless, in contrast to other natural resources (wood, petroleum, minerals), the exercise of property rights (including control) over genetic resources presents difficulties that have not been adequately considered. The Convention intentionally leaves countries the freedom of determining their own systems of property rights over genetic resources, which is correct in terms of the overall convention (which consists predominantly of provisions which call for the development of national legislation), but at the same time, the lack of guidance from the CBD has been an impediment to the development of legal analysis of whether traditional systems of property rights could be applicable to genetic resources. For example, in Roman-Germanic systems, an essential aspect of the property right is the ability to exclude others. Regarding genetic resources, physical control over the property does not prevent others from the ability to extract, test or take other actions involving the genetic resource contained in other existing samples. Like the shared nature (even among countries) of the genetic resources themselves,6 this fact presents questions regarding ownership and dominion. Likewise, in some countries a distinction has been made between genetic resources (owned by the State) and biological resources (owned by private parties) which contain the genetic resources or components.
Related to the foregoing, the legal consequences of applying the regime of public domain to genetic resources, as occurs in some legal systems, especially with respect to the rights conferred to the user over the samples (extracts, fractions, etc.) needs to be addressed.
The application and the sufficiency of the contractual processes as a means of guaranteeing the conditions of access and the mutually agreed terms, including the benefit sharing, is still unresolved. In this sense, the principal instrument that the CBD has considered for the realization of its Third Objective has been the use of bilateral mechanisms (contracts).7 Not surprisingly, a body of literature dealing with “bioprospecting contracts” has been developed,8 but little formal or official legal interpretation (court decisions and other applications) has actually been generated. At minimum, the application of contract rights alone can be insufficient to protect provider countries or areas, especially due to the fundamentally transnational character of the relations of the ABS and the ease of reproducing genetic information contained in the samples.
The creation and application of national laws, and the established mechanisms of monitoring and control, have been considered to be sufficient to ensure compliance with the conditions of the permits and access contracts. Essentially, however, these laws and compliance mechanisms base their ability to determine compliance solely on the user's reports regarding his progress, including indirect reporting (under which the source country's awareness of these results is obtained by screening, patent applications, etc.).
The regulatory framework and policies of the ABS have not adequately considered the design of incentives to encourage the compliance of users (companies, universities, etc.) with the ABS regulations. The difficulties of applying traditional concepts of property, control, and monitoring to genetic resource uses have not promoted the establishment of incentives for compliance with access procedures, in a way that would make it “good business” for commercial and scientific users to follow the rules. As will be mentioned later, on occasion, the ABS systems have appeared to “penalize”9 those who want to follow the legal procedures.10
As conceived in this book, the development of national ABS regimes has over time displayed the following characteristics:
Legal/legislative development has occurred mostly in developing countries (that can be qualified as providers of these resources) considering the pioneering experience of the Philippines and the Andean Community.11
The existing regimes were designed without international guidelines or consensus on how to construct them.12
It was thought that the existing legal instruments (national laws, systems of property, and systems of contracts) were adequate without modification to establish operative ABS systems. The understanding of some concepts particular to access to genetic resources has impeded, in some degree, the realization of the objectives of the establishment of the ABS regimes. The legal instruments that the countries have utilized to construct ABS systems (such as contracts, procedures to grant permits for use of natural resources, etc.) are developed and regulated under the various national legal systems (i.e., not under a single unified international system). Nevertheless, some existing difficulties for the effective application of the ABS laws are due to the lack of understanding (or creating) of what can be called “legal concepts specific to access to genetic resources.”
For example, the ABS legislation to date has relatively easily encompassed, in general terms, the following aspects: objectives of the system; definitions (from the CBD); scope of application; competent authorities at different levels; procedure for obtaining prior informed consent; procedure for negotiating the mutually agreed terms (MAT) and the fair and equitable sharing of benefits (using contracts); and requirements that MAT must include mechanisms for monitoring and control and sanctions for non-compliance, including penal, civil, and administrative measures.13
As Young affirms,14 however, “After 12 years legislative draftsmen and agencies are still attempting to grapple with complex legal problems that hinder the effective ABS implementation. ABS is in some ways ‘unique,’ particularly in its merger of very new concepts of commercial law and science with the goals of conservation, sustainable use and equity. New legal concepts and tools are needed, as well as new uses of existing tools. Legal innovation, however, is not an easy process.”
Equally, it is not possible to address the issue of legal certainty (for provider entities as well as users) without considering the difficulties that users (nationals and foreigners, academics or companies) confront due to the difficulties of knowing how to obtain the prior informed consent and to have certainty with respect to the access procedure.15
Initially, it is important to note a critical point: Despite their importance, some of the questions that this study seeks to answer have not been addressed systematically by the specialized doctrine of theABS,16 by the national authorities, or by the decisions of the Conferences of the Parties, with significantexceptions.17 These difficulties have not been recognized as obstacles to the effective application of the access laws, except for some specific studies.18 For example, studies explaining how to formulate legal frameworks regulating access, although valuable, frequently do not identify the critical elements nor offer any actual assistance with them.19 There are studies of legislation that have addressed some of theseelements,20 but this book will not repeat them. Rather, it intends to explore conceptual aspects and to propose workable options. Nevertheless, when necessary, it may refer to provisions that illustrate the aforementioned concepts.21
This book seeks to address the most relevant legal issues to provide certainty for users of genetic resources and at the same time safeguarding the rights of the providers. Up to now, the efforts to develop an international regime of access to genetic resources and benefit sharing have not addressed this aspect in a systematic manner, despite its relevance in terms of satisfying the necessities behind the negotiations of the Regime.22
For this reason, the book has been structured in the following manner:
In Chapter 2, a basic overview of the primary approaches to “access legislation” at the national level is provided;
In Chapter 3, this book goes into more depth in consideration of several principal aspects that are considered essential for the construction of functional and operative ABS laws, also considering the concepts of legal certainty and functional consistency of the access system;
Chapter 4 addresses the efforts of provider countries to find ways of enforcing their ABS laws in the country where the users are located.23 This mechanism is perceived to be of paramount importance, and the difficulties of monitoring and compliance (and resulting lack of enforceability) is cited as the reason underlying the call for a “binding regime” on ABS.
1 Tables of then-current national ABS legislation were provided in an interim publication under this series – Cabrera Medaglia, 2004, A Comparative Analysis. That initial paper, and the tables within it, may be accessed on the IUCN Environmental Law Centre's website at www.iucn.org/themes/law
2 In this connection, it is important to remember that, in the CBD, ABS is entirely focused on cross-border situations. Domestic uses of the country's own genetic resources are not covered. This does not mean that the source country cannot regulate domestic uses, however, only that they are not directly part of the CBD's requirements.
3 These issues are discussed in Tvedt and Young, 2007.
4 It seems useful to divide the ABS process into “access” and “benefit-sharing.”
5 Cf Caillaux and Ruiz, 2002. In this paper, they affirmed that the access legal framework “must be thoroughly unambiguous with regard the definitions especially with respect to what is really meant by access. The legal regime that controls access must be also very clearly defined in terms of its scope and boundaries. (Does it apply to medicinal plants? Does it apply to taxonomic research? Do the same rules apply to nationals and foreigners?) The success of an access regime will largely depend on these variables.”
6 See regarding the transboundary nature of genetic resources, Aguilar, 2004.
7 A quick analysis of the ABS measures, like the 391 Decision of the Andean Community, the Biodiversity Law of Costa Rica and the Provisional Measure of Brazil, among others, shows how contracts are an essential instrument for the ABS systems. See Gartforth et al., 2004.
8 See for instance, Downes, 1994; Gollin, 2002; Cabrera Medaglia, 2004, “Elementos básicos ...”; Rosenthal, 2003; Sampath, 2005; CBD, 1998.
9 Young, 2006.
10 For instance the bioprospecting initiatives which became public in Mexico, see Larson et al., 2004.
11 On the legislative process in the Philippines, see Benavidez (in Carrizosa), 2004.
12 Later, the CBD adopted the Bonn Guidelines on Access and Benefit Sharing in 2002. See Decision VI/24. However, the Guidelines do not provide orientation on certain key issues (practical definition of genetic resources; what is utilization, etc.) but have focused on well known concepts like mutually agreed terms, examples of benefit sharing, etc. The Guidelines were based on the previous work of the Expert Panel created by Decision IV/8 para. 3. Before the Panel was created the CBD activities on ABS were limited to gathering information on national measures, good practices on ABS, etc.
13 These basic elements have been suggested by authors like Glowka, 1998; and Mugabe, 1997.
14 Young, 2004, “The International Regime from an implementation perspective...”.
15 This issue will be addressed later on. With regard to the private sector difficulties in obtaining prior informed consent, see Columbia University, 1999; Ten Kate and Laird, 1999.
16 However, Young has emphasized the importance of addressing these issues, see, among other articles of the author, 2005, “Gaps and Obstacles...”.
17 See for instance Decision V/26 para. 12 adopted at the V Conference of the Parties, which identified the need for more information on issues like: incentive measures, clarification of definitions, market for genetic resources, etc. Likewise, see Decision VII/19 adopted at the VII Conference of the Parties related to the Use of Terms or Definitions (Section A) and the “Measures in User Countries” (Section E). Lastly, Decision VIII/4 A adopted at the VIII Conference related to property rights on genetic resources.
18 Some limited analysis is presented in Cabrera Medaglia, 2004, A Comparative Analysis.
19 See Glowka, 1998; Mugabe et al., 1997; Seiler and Dutfield, 2001; Barber et al., 2002.
20 See Cabrera Medaglia, 2004, A Comparative Analysis. See also the study of the Pacific Rim Countries carried out for Carrizosa et al., 2004, which identifies as a problem for the ABS implementation, among others: “the broad scope of access and benefit sharing policies. Most of them cover genetic (DNA and RNA), biological (specimens or parts of specimens) and biochemical resources (molecules, combination of molecules and extracts) found in both in situ and ex situ collections. Monitoring of bioprospecting activities has proven to be a difficult, expensive and resource-consuming task and no Pacific Rim Country has established a monitoring system,” etc.
21 Among other sources, the author reviewed the following documents or studies: Cabrera Medaglia, 2004, A Comparative Analysis; Gartforth, 2004; Nnadozie et al., 2003; and the ABS measures data base of the CBD www.biodiv.org etc.
22 Some authors have suggested the relevance to include these aspects in the work of the ABS Working Group. See Young, 2004, “The International Regime...;” and Dross and Wolff, 2005.
23 See on the concept of User Measures Decision VII/19 Section E. See also Barber et al., 2003, and Tvedt, “Elements,” 2006. See also Loufi, 2006.
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