Process
The development process of the Law of Biodiversity No. took about two years and revealed two opposing positions. Some regarded legislating access as a way of promoting bioprospecting and legitimizing biopiracy while others defended the law as a way to promote the sustainable use of genetic resources. In , the first draft of the law was developed by Luis Martínez, a former president of the Environment Commission of the Legislative Assembly with technical support provided by the regional office for Mesoamerica of the World Conservation Union. The draft law was widely distributed to the public by mail and it was also made available on the internet (J. Cabrera, pers. comm. April ). Many stakeholders considered this first version to be particularly restrictive and opposed both to the public good and scientific research.
The Environment Commission made the second draft available in January . Even though this draft addressed some of the objections made to the first draft, it also re- peated several of the contentious concepts stated in the ini- tial version of the document. Therefore, it received similar opposition. This situation led to the creation of a Special Commission in the Legislative Assembly. Its mandate was to create a new draft, taking into consideration the previous ones. The Assembly promised to respect the outcome.
The Commission, led by Jorge Mora, Rector of the National University, was established in April . It included the main political parties (National Liberation and Social Christian Unity), the Advisory Commission on Biodiversity, the National Small Farmers Forum, the National Indigenous Forum, the Union of Chambers of Private Business, the University of Costa Rica, the National University, the Costa Rican Federation for Environmental Conservation, and the National Biodiversity Institute. The Commission met until December when the new draft was sent to Congress. It received the favorable opinion of the Environment Commission, and after a few modifica- tions, the Legislative Assembly approved the draft law in April during the last days of the administration of President Figueres Olsen. The Law of Biodiversity entered into force as Law of the Republic No. on May (see Chapter ).
Concerns
Time constraints for completing the draft law prevented in-depth discussions of some of the most controversial
aspects such as ownership of genetic resources and s. In
addition, there were internal difficulties among the mem- bers of participating stakeholder groups. For example, representatives of the industry sector stated that since they were incapable of negotiating on behalf of all their associates, they would not vote for any of the proposals but would limit themselves to taking part in the debates of the Commission. Since the law covered multiple policy objectives, the possibility of dedicating sufficient time to issues was diminished due to the pressing need to finalize a comprehensive draft.
One of the most controversial issues was ownership of genetic resources. Stakeholders such as representatives of the farming sector criticized the fact that under the Law of Biodiversity these resources were considered to be in the public domain, independent of private ownership of the land. There were also concerns about integration between intellectual property and the procedures of the Law of Biodiversity, since diverse exclusions have been estab- lished. Compatibility of some of these exclusions with the Agreement on Trade-Related Aspects of Intellectual Property Rights () is an issue that needs careful con- sideration. In the end, some of the patentability exclusions were eliminated and others remained, in spite of warnings about their possible unconstitutionality (see Chapter ).
The development process for the Law of Biodiversity revealed a lack of technical expertise from certain sectors such as academic, indigenous, rural, political, and entre- preneurial groups. Many of them used the process to make political rather than technical statements. Therefore, some of the issues that may have needed a larger discussion fo- rum were addressed and defined by a few technocrats. For example, issues were debated by representatives from business and academic groups in a Special Subcommittee in charge of drafting the law. Concerns of indigenous peoples that opposed the use of s were disregarded.
In addition, discussions evolved around conceptual issues and ignored procedural, operative, or administra- tive issues that have impaired the full implementation of the law (see Chapter ). Several stakeholders argued that since the National System of Conservation Areas had a close relationship with the National Biodiversity Institute it should not be in charge of granting access permits and authorizations. Instead, this duty should have been given to a new commission able to represent the wider interest of society. Other provisions such as the creation of a National Commission for the Management of Biodiversity (- ) were accepted under different proposals. According to the Law of Biodiversity, ’s duties include the formulation of biodiversity and policies and the management of public funds. However, the Minister of the Environment and Energy considered these functions unconstitutional and asked the Attorney General’s Office to submit a constitutional challenge that is currently under review. The suit does not suspend the execution of the Law of Biodiversity. However, politically, it has definitely delayed ’s implementation of the law.
El Salvador
Process
issues were placed on El Salvador’s institutional agenda by the National Biodiversity Strategy. The strategy provided a participatory arena for the debate of issues among various sectors of society. In , with financial support from the Global Environment Facility (), the Environment Minister developed the follow- ing four reports: a) national assessment of genetic and biochemical resources; b) capacity-building strategy for access to genetic and biochemical resources associated with wildlife; c) administrative procedures for access to genetic and biochemical resources; and d) policy guide- lines on access to genetic and biochemical resources. These reports were developed by a variety of actors from gov- ernment, peasant, and academic institutions. Then, these reports were submitted to the Presidency for review, ap- proval, and adoption under a national policy on access to genetic and biochemical resources. The Presidency should be adopting the policy sometime in . Subsequently, government sectors in charge of administering biological resources (e.g., Agriculture Ministry) will develop rules and procedures that must be followed by bioprospectors in order to get access to these resources. The policy will also be consistent with and supported by the Central American Protocol on Access to Genetic and Biochemical Resources and their Associated Knowledge. The scope of the policy will exclude genetic resources covered by the ’s - that was already signed and ratified by El Salvador (J.E. Quezada-Díaz, pers. comm. January ). The Environment Law provides the legal framework for the new policy. Article of the law states that access, research, manipulation and use of genetic resources are allowed under permit, license, or concession granted by the government agency in charge of administering and managing the resource.
Concerns
Opportunities for stakeholders to participate in the de- velopment process are limited by their lack of expertise. Many sectors of society do not realize the implications of a policy that regulates access and benefit-sharing issues. There is lack of information and misinterpretation about concepts such as equitable sharing of benefits, protection of traditional knowledge, and issues. The country has yet to begin a process to address these issues properly and carefully. Biological resources are owned by the State. However, there is on-going debate about ownership is- sues related to genetic resources. Financial support for the development of the policy was provided by the and additional funding will be required to build local capacity to facilitate its implementation (J.E. Quezada-Díaz, pers. comm. January ).
Honduras
Process
and Environment Secretariat, the National Strategy on
Biodiversity was officially presented and one of its stra- tegic components was the issue. The strategy was the product of nine regional workshops that included the participation of indigenous communities, industry, peas- ants, and government organizations. The strategy created momentum for additional discussions on issues. But it is not clear how goals will be incorporated into national law. Some advocate for a comprehensive law similar to the Costa Rican Law of Biodiversity. However, there is also a possibility to develop a single law. This is one of the issues to be discussed in future meetings. An initial discussion of issues already begun at a government level and a preliminary draft has been developed. Next steps will include developing a final draft together with relevant stakeholders consulted at a national level (J.A. Fuentes, pers. comm. June ).
Concerns
The lack of technical capacity is one of the main obstacles that the development process will face in the future. The relationship between traditional property rights and indigenous knowledge was one of the main concerns ad- dressed during initial discussions of the draft policy. A great deal of debate went also into details about how to protect indigenous knowledge. Issues debated included: a) the number of years of protection provided by the system; b) the individual or collective nature of indigenous knowl- edge; c) strategies to protect indigenous knowledge; and d) the relationship between trade secrets and traditional knowledge. This discussion included also procedural is- sues such as identifying the characteristics of the govern- ment agency in charge of administering this system (J.A. Fuentes, pers. comm. June ).
Indonesia
Process
Indonesia is currently working on a draft law, the Act on Genetic Resource Management that includes a regulation on issues. This law will be comprehensive and the provisions will be consistent with existing laws on agri- culture, forestry, and biodiversity. The government is also conducting an assessment of existing legal instruments that regulate issues. Local officials estimate that legislation will be concluded in .
The act will have a national scope, but provincial or district level governments should develop their own regulations that must be formulated in line with the national law. The law will apply to the pharmaceutical, agricultural, botanical medicine, biotechnology, and other pertinent sectors. The Act will also be compatible with the ’s that Indonesia should be signing and ratifying soon.
As the focal point for the , the Ministry for the Environment established an inter-ministerial working group to formulate this law. This working group was or- ganized into smaller groups in charge of technical tasks
including the analysis of laws enacted by other coun- tries. The working group has also organized workshops to facilitate the debate and contribute to the identification of key issues. Participants include representatives from the Ministry of Agriculture, Ministry of Forestry, Ministry of Justice and Human Rights, Ministry of Environment, Ministry of Research and Technology, Indonesian Institute of Science, local universities, s, and national experts. There are no foreign consultants involved in the process, but the Bonn Guidelines on are being used to guide the process. Before the draft law is sent to Congress it should be available for public comment (B.S. Wardhana, pers. comm. March ).
Concerns
The main challenge is likely to be the resolution of controversial issues that include ownership of genetic resources, indigenous knowledge, and the relationship be- tween traditional systems and traditional knowledge. For example, the national constitution states that natural resources (including genetic resources) are owned by the State. However, since local communities have used these resources traditionally without major restrictions they be- lieve that they hold ownership over them (B.S. Wardhana, pers. comm. March ).
Malaysia
Process
The development of the draft law on Access to Genetic Resources has promoted an interesting cooperation among federal and state authorities. This process began in with the establishment of the National Committee on Biological Diversity, which supported by the Attorney- General, played a significant role in the development of the draft law (see Table of Chapter ). The process received ample input during a National Workshop on Access and Benefit Sharing of Genetic Resources held in (see Box of Chapter ). Two years later a task force, estab- lished by a National Technical Committee on Biological Diversity, completed the final text of the draft law.
Presently, the Ministry of Science, Technology, and the Environment (), in close collaboration with the Attorney-General’s Chambers, is handling the whole pro- cess from the final draft bill to the passing of the draft bill into law. This draft bill was scheduled to go through the national consultation process in and , then to the Cabinet for approval, and finally to the Parliament for the bill to be passed into law. However, the process has pro- gressed at a relatively slower pace particularly with regard to national consultation. Furthermore gave priority to enacting the Biosafety Bill into law. Consequently, the draft is not expected to be adopted by the government until or even later. Favorable comments from the states of Sabah and Sarawak6 among others, is crucial
to facilitate the completion and adoption of the draft law (see Chapter ).
Concerns
A major issue debated during the development process that needs to be clarified further is ownership of genetic resources. In Malaysia, there are biological resources found on public lands that belong to federal and state gov- ernments. In some states, ownership rights of biological resources found in indigenous or community-held land, belong to the community and ownership rights over tradi- tional knowledge and innovations still need to be clarified. systems for the protection of biological organisms and traditional knowledge were also major points of discussion. A sui generis system of community intellectual rights was proposed but it was not included in the draft bill because it turned out to be very controversial. In addition, stakehold- ers opposed the use of patents to protect genes, plants, and other organisms.
In addition, several procedural and conceptual issues discussed during the design of the draft law remain un- resolved. Tasks that remain to be tackled before the draft bill is passed into law include: a) determining the federal authority in charge of matters relevant to biological diver- sity; b) ensuring uniformity in relevant state laws; c) deter- mining the institutional structure for the implementation of the draft bill; d) determining the competent authorities and negotiating partners to identify and address the interests of the holders of indigenous knowledge; and e) ensuring adequate participation of indigenous representatives in the development of procedures and benefit-sharing requirements (see Chapter ).
Mexico
Process
The reform of the Ecological Equilibrium and Environment Protection General Act () introduced article that regulates access and benefit sharing for biotechnology purposes. This reform was carried out in months by the Commissions of Ecology and Environment of the Senate and House of Representatives and the Secretariat of Environment and Natural Resources (). The reform promoted by these organizations was the result of a small process of consultation that in- cluded few stakeholders. This process, nonetheless, facili- tated the approval of one provision and other measures that reformed the (J. Larson and C. López-Silva, pers. comm. January ).
Concerns
Issues such as ownership of genetic resources and the protection of traditional knowledge were not properly discussed and addressed by the reform of the . These legal gaps and the lack of a nation-wide participatory process of discussion of the reform may have provided im- petus for the public opposition that led to the cancellation of access granted under the law to several bioprospecting projects (see Chapter ).
Nicaragua
Process
The process of developing the draft Law of Biodiversity was initiated in by the national strategy for the con- servation of biodiversity and briefly supported in by a proposal from the Ministry for the Environment and Natural Resources (). In , reactivated the proposal with financial support from the World Conservation Union, the United Nations Development Programme, the Mesoamerican Biological Conservation Corridor, and the government of Nicaragua. Subsequently, an interdisciplinary team of national and international experts from Peru, Mexico, Argentina, Costa Rica, and Nicaragua developed the draft Law of Biodiversity. Representatives of more than % of Nicaraguan in- digenous communities participated in this process. They played a pivotal role in the development of one of the most controversial and novel provisions of the draft Law of Biodiversity that calls for the development of a sui generis system for the protection of the knowledge, practices and innovations of local communities. In , the draft was available for comment to a group of specialists from s and government organizations that suggested the inclusion of biosafety, wildlife, and environmental issues into the proposal. Most recently, indigenous communities, s, and industry representatives had the opportunity to provide additional input and contribute to the final draft. In late , Government officials completed a final draft that should be sent to Congress in (J. Hernandez, pers. comm. February ).
Concerns
Traditional knowledge, s, ownership of genetic re- sources, biosafety, and procedural issues have been the main topics of heated discussion during the development process of the law. The protection of traditional knowl- edge was so controversial that some government officials from the Ministry of Industry and Commerce opposed its inclusion into the draft law. In June , however, resolu- tions of the and guidelines of the World Intellectual Property Organization endorsing strategies to protect tra- ditional knowledge provided convincing arguments and this provision remained in the draft law.
While the draft law states that genetic resources are in the public domain, it provides indigenous communi- ties with ownership rights to genetic resources found in their lands. This property right distinction is likely to be controversial when the draft law reaches Congress. Policymakers are also uncertain about how to address the new commitments of the ’s that was acceded to by Nicaragua in November .
But perhaps the main problem is a current disagreement between the Environment Ministry and the Agriculture and Forestry Ministry about jurisdictional powers over access to genetic resources for agricultural purposes and biosafety issues. The Agriculture and Forestry Ministry argues that they handle biosafety issues and that a stand-alone law of
biosafety just like the Peruvian proposal should address
them. The Environment Ministry responds that biosafety is one of the main provisions of the and as such it should be included in the Law of Biodiversity. In addition, there is overlapping between the draft Law of Biodiversity and existing laws. The draft law includes provisions about inva- sive and domestic species, issues that are already regulated by the Law of Production and Commerce of Seeds and the Law of Animal and Plant Sanitation (J. Hernandez, pers. comm. February ).
Panama
Process
Currently, Panama does not have a clear and comprehen- sive law. However, in the last few years the National Authority for the Environment () has been using a contractual approach to facilitate access to bioprospecting projects. The Bonn Guidelines on have been employed in the negotiation of these projects and will be followed in the development of future national regulations.
The development process of laws and policies started with the General Law of the Environment No. () that designated as the competent authority for the regulation, management, and control of the access to and use of biogenetic resources. According