Constituciones

Obtaining access can be a long, confusing, and cumber- some process. Access permits may have to be obtained

  from several regional and local agencies that administer

the same resource. In addition, bioprospectors may have to negotiate with several providers of genetic resources and traditional knowledge. This bureaucracy and overlap- ping of functions can lead to high transaction costs and long processing times for required permits. This section discusses the main similarities and differences regarding access procedures of the selected countries and presents the access definitions proposed by some countries in their  laws and policies.

Australia: Draft EPBCAR

Access to biological resources is defined as the collection process and use of organisms, their parts, genetic material, and biochemical make-up for conservation, commercial, industrial, or taxonomic research purposes. According to the draft regulations bioprospectors (with commercial and noncommercial purposes) have to obtain a permit16

to access biological resources in Commonwealth areas and establish benefit-sharing agreements with the provid- ers17 _{of these resources. Permits are valid for a maximum}

of three years and the cost of a permit is the same for all applicants (national or international, commercial or non- commercial):   for access and no payment for a transfer of the permit or variation or revocation of a permit condition. Benefits are to be negotiated on a case-by-case basis and the benefit-sharing agreement takes effect only if a permit is issued. The regulations establish that biopros- pectors have to submit applications for access permits to the Secretary of the Department of the Environment and Heritage.

Once the Secretary has received the benefit-shar- ing agreement (including the  requirement) and the permit application, he or she must give a report to the Minister for the Environment and Heritage within  days of their receipt. This time can be extended if the authorities require the following information: a) whether the environmental impact assessment () (if required) was undertaken and completed; b) relevant information from the Commonwealth department or agency; c) ad- ditional information about the proposed benefit-sharing agreement; d) whether bioprospectors complied with the regulations requiring consultation with the providers of genetic resources; e) the views of any representative of the Aboriginal and Torres Strait Islander body within the meaning of the Native Title Act of ; and f) whether the access provider has received independent legal advice about the regulation. If the Minister decides not to grant the permit, the bioprospector can appeal through the courts under the  Administrative Decisions (Judicial Review) Act. Detailed administrative arrangements for the handling of access applications can be expected to be developed once the regulations are enacted

Under this regulation, the Minister may declare that the permit provisions do not apply to biological resources if: a) these resources are held in a collection by a Commonwealth department or agency and there are

reasonable grounds to believe that access to this collec- tion is administered consistently with the purpose of the regulations and b) there are reasonable grounds to be- lieve that access to the resources is controlled by another Commonwealth department or agency, self-governing territory, or state law, consistent with the purpose of the regulations. Due to ownership issues access procedures to

ex situ collections have not been defined yet. Holders of such collections and the Department will discuss potential solutions to this problem (see Chapter ).

Colombia, Ecuador, and Peru: Decision 391

Access is defined as obtaining and using ex situ and in

situ genetic resources, their derivatives, and associated knowledge with research, bioprospecting, conservation, industrial application, and commercial use, among others. Decision  proposes an access contract to be negotiated between the bioprospector and the Competent National Authority () in the member country where resources are sought. Prior to the negotiation of the contract the bio- prospector has to present an application for access to the relevant . The application must include: a) information about the applicant, including its legal capacity to enter into a contract; b) the identity of the supplier of genetic or biological resources and their derivatives and/or of the associated intangible component (or knowledge); c) the identity of the national support institution or individual; d) the identity and curriculum vitae of the project leader and team; e) the nature of the access activity being requested; and f) the area in which the access will be made including the geographic coordinates. The application must include a project proposal based on a model provided by the . Then, the  has  working days (extendable to ) to evaluate the application. If the  is satisfied with the application, it is placed on the official record and noncon- fidential information is available for public scrutiny in the national official gazette. Otherwise, the application may be returned to the applicant for more information or denied.

A successful application will lead to the negotiation of the “access contract”. The parties to the contract are the applicant and the . The  also needs to take into account the interests of other Andean countries and of the suppliers of the biological resources and intangible component (traditional knowledge) in the negotiation of the access contract. Therefore, the applicant must negotiate an annex contract with the supplier of the knowledge and an accessory contract with the supplier of the biological resource that contains the biochemical or genetic compo- nent. The provider of the biological resource can be the holder of the land or the ex situ conservation center where the biological resource is found. Accessory contracts can also be signed with national support institutions that are not included in the access contract. Annex and accessory contracts cannot authorize access to the resource by them- selves. Access is only granted through the access contract negotiated with the  (see Chapter ). Peru’s Law No.  endorses the use of an annex contract or license.

  Under this law, commercial bioprospectors have to identify

the community or communities that hold the collective knowledge and sign a license with them. Such a license has to be registered before the Peruvian National Institute for the Defense and Protection of Traditional Knowledge () (P C ).

Costa Rica: The Law of Biodiversity

Access to biochemical and genetic elements is defined as the action of obtaining samples from in situ or ex situ elements of indigenous or domestic biodiversity and their associated knowledge, for the purposes of basic research, economic benefit, or bioprospecting. Bioprospecting is de- fined as the systematic search, classification, and research (with commercial purposes) of new sources of chemical compounds, genes, proteins, microorganisms, and other products that have present or potential economic value with commercial purposes.

Under this law local and foreign bioprospectors are required to obtain access permits to obtain genetic or biochemical resources and their associated knowledge. These are valid for three years and can be renewed, but are not transferable. First, in conformity with the “General Access Procedure” ()18 _{interested parties must register}

with the Technical Office () of the National Commission for the Management of Biodiversity (). The application includes: a) identification of the interested party; b) identification of the responsible researcher; c) exact location of place where samples will be collected; d) the elements of biodiversity that will be the subject of the investigation; e) the owner and manager or holder of the premises; f) a list of activities, aims, and purposes; and g) an address for legal notifications. Later, the  must be negotiated between the applicant and the owner of the conservation area or indigenous land, resources, or

ex situ collections.

The permits will contain a certificate of origin, permis- sion or prohibition to extract samples, periodic reporting obligation, monitoring and control, conditions relative to resulting property, and any another applicable condition stated by the . Different requirements are established for those who request permits for noncommercial bioprospect- ing19 _{and for those who need access permits for occasional}

or continuing economic utilization.20 _{At this stage there is}

no information about the duration of these procedures. In any case, the current scheme empowers the owners of the lands where biological resources are found to negotiate contracts (by means of the ) with bioprospectors.

In case of ex situ collections, different rules will be proposed for framework agreements that authorize the transfer of multiple materials. In such cases material transfer agreements (s) will have to be standardized and approved by the . The Law of Biodiversity also requires all holders of ex situ genetic resources to register with the . Bioprospectors will have to obtain a permit in order to access ex situ genetic resources. However, no procedure has been defined yet because of the complexi-

ties associated with the holders of genetic resources and also because there are other national laws not necessarily related to access that regulate ex situ collections. The  provides  months for the drafting of an access procedure for ex situ genetic resources and establishes a moratorium on the access of ex situ genetic resources until such pro- cedure is adopted.

The Law of Biodiversity requires a determination of the administrative fee. The  states that this fee is a fifth of the minimum wage. After the  issues a certificate of origin, it publishes the requests and final resolutions on its website within eight calendar days. An  can be requested by the . Its evaluation is the responsibility of the National Technical Secretariat (see Chapter ).

Malaysia:

Draft federal bill on access to genetic resources

The draft bill defines access as all activities relating to bio- prospecting, collection, commercial utilization, research, and development of biological resources or the associated relevant community knowledge and innovations. If the draft bill is adopted, both foreign and local bioprospectors will have to follow the same basic access procedure in order to obtain access to genetic resources for commercial purposes. But international bioprospectors will have ad- ditional conditions for approval of the access application. For example, the application will require foreign biopros- pectors to have a local collaborating organization to both sponsor the collection and be responsible for actions of the collector. The local organization will also participate in the collection, research, and development of samples collected.

Both national and international bioprospectors will be required to sign an access agreement with the competent authority and the relevant resource provider. However, the relevant authority may decide that the restrictions relat- ing to access to resources shall not apply to Malaysian researchers conducting noncommercial bioprospecting activities. The procedure for foreign scientists who want to obtain access for noncommercial purposes is still not clear at this point. The financial costs of applying for ac- cess have not been determined yet, but it is not likely to deter bioprospectors from applying.

There shall be no access to biological resources or community knowledge and innovation without an access license granted by the competent authority. Information required in the application for the license includes: a) iden- tification of the collector; b) identification of material to be collected or knowledge to be accessed; c) identification of collection sites; d) quantity and intended use of the resource; e) time when the access activity is to be carried out; e) ; f)  certificate; g) benefit-sharing arrange- ments; and h) identification of the local collaborator or sponsor (a Malaysian institution). This information can be made available to the public. Once the application has been reviewed it can be approved, returned to the applicant if more information is required, or rejected. A decision can

  be appealed at any time within three months of the date of

receipt of the decision. Access procedures to ex situ collec- tions have not been defined yet (see Chapter ).

Mexico: EEEPGA, WGA, SFDGA, and draft LAUBGR

, , and  do not include an access defi- nition. But collection of biological resources under any of these laws requires a permit from the Secretariat of Environment and Natural Resources (). Under Article  and   of , local and foreign bio- prospectors have to apply to  in order to obtain access to genetic resources for scientific (noncommercial), economic (for reproduction and commercial activities) and biotechnology purposes. Under Article  of  and Article  of  access for scientific or noncommercial purposes requires a permit or a license for a researcher with a specific line of work. Both laws require the  of the landowner, report submissions, and deposit of at least one duplicate of the material collected in a local institution or scientific collection. Authorization under these laws cannot be extended to commercial purposes, and nonconfidential research results must be available to the public. However, Mexican legislation recognizes that scientific or academic collections can later be used for industrial or commercial applications. If this is the case norm --- mandates a new declaration stating a change of purpose, thus setting the stage for new  and  contracts. Chapter  suggests that this measure has a low transaction cost because the change in the  and the negotiation of the  contract would hap- pen only after a finding that the biological resource has a commercial application. However, an argument could be made that under controversial social and political circum- stances (see Chapter ) the costs of the delay that would be generated after a discovered commercial application could be very high.

Under Article  of  collectors and users of forest biological resources for scientific, economic, or biotechnological purposes have to apply for authoriza- tion to . This application must include the  of the owner of the land that provided the resources. It should be noted that under  and article   of  collectors must present the  in order to obtain government authorization. In contrast, under article  of  and , the  is not required to obtain this authorization but it is required before collecting activities are initiated (see Chapter ).

According to Article  of , commercial and noncommercial bioprospectors that use traditional knowledge must submit an agreement to  that includes the  of the indigenous community that provided the knowledge. This agreement must also acknowledge the property rights of indigenous communities to their knowledge.  evaluates the application and ensures that a benefit-sharing agreement is negotiated with the providers of genetic resources. The  Rural Sustainable Development Act () gives priority rights

to indigenous and local communities for obtaining permits and authorizations under either  or . Under , collections of forest biological resources carried out by public entities of the federal, state, or municipal governments or the owner of the land, need only to sub- mit a notification in accordance with the pertinent official Mexican norm and the consent of the owner of the land ( ).

On the other hand, the draft  defines access as the action of obtaining samples from in situ or ex situ elements of indigenous or domestic biodiversity and their associated knowledge with economic or bioprospecting purposes. The draft law would regulate only commercial activities, leaving noncommercial applications to the cur- rent regulatory framework. The access procedure includes the following steps: a) the applicant must obtain an autho- rization from a Federal Executive Authority (); b) an access contract must be signed with , the provider of the biological and genetic resource, and the provider of the traditional knowledge; c) if relevant, an authorization must be obtained either for collection done by an ex situ conservation body, transport to any area not specified in the access agreement, export of the material collected, or transfer of the rights and obligations given by the access authorization. The draft bill, however, does not define the procedure and requirements for authorization for

ex situ collections. Requirements for an  are not clearly regulated and the participation of Mexicans in research and development is required (G P ).

Nicaragua: Draft Law of Biodiversity

Access is defined as the action of obtaining samples from biological and genetic resources and their associated knowledge, practices, and innovations. Details about ac- cess procedures for genetic resources found in ex situ and

in situ conditions have not been defined yet. However, the draft Law of Biodiversity states that all domestic and foreign bioprospectors will have to obtain an authoriza- tion from the National Biodiversity Institute in order to obtain access to biological and genetic resources. Such authorization must include: a) the  of the provider of the biological and genetic resource as well as the traditional knowledge and b) a description about the intent to sign accessory contracts with local or foreign organizations or a description of accessory contracts signed with these parties before the law came into force. The authorization will also require a permit showing that an  was carried out (if required). Access to genetic resources may be denied if: a) the access application is determined to include false in- formation; b) the applicant has attempted to access genetic resources illegally in the country or overseas; c) access activities cause the endangerment or extinction of species; or d) access activities cause ecological, social, cultural, or economic impacts that cannot be mitigated. Bioprospectors will also have to deposit duplicates of specimens collected in local ex situ conservation centers. The draft law also

  states that “framework agreements” will be established

between the government and universities or other users of genetic resources for noncommercial purposes ( ). The draft law of biodiversity implements Article  of  which requires an authorization for studies on biotechnology ( ). This authorization has to be given by the national competent authority which in this case is the National Biodiversity Institute.

Philippines: EO 247 and Wildlife Act

  does not define the concept of access. However, it can be argued that this policy uses the concept “prospecting or bioprospecting” as a proxy for “access”. Bioprospecting is defined as the research, collection, and utilization of biological and genetic resources for purposes of applying the knowledge derived from these resources to scientific and commercial purposes. Under  , local and foreign bioprospectors must apply for access to genetic resources for commercial and noncommercial purposes. Applications for Academic Research Agreements () or Commercial Research Agreements () are submitted to the Technical Secretariat for an initial evaluation. Then, they are passed to the Inter-Agency Committee on Biological and Genetic Resources () and the  makes a recommen- dation to the pertinent agency. Foreign applicants must involve a local institution in the research process.   does not provide for a specific timeframe within which to process applications. However, it usually takes about five months or longer because the  is required to meet once every four months, although the chairman can call for special meetings. Also, the application process is often slow due to delays in obtaining the . Depending on whether it is an  or a  that is sought, certain distinctions are incorporated in the application process (see Table  of Chapter ).

The Wildlife Act, however, modified   substan- tially and excluded the collection and use of biological resources for academic or scientific purposes. Therefore, an  is no longer required. The Wildlife Act states that the collection and use of biological resources for academic or scientific purposes can be undertaken through a free permit. The Department of Environment and Natural Resources (), the Department of Agriculture (), and the Palawan Council for Sustainable Development () are in charge of implementing the Wildlife Act (P. Benavidez, pers. comm. February ).

Under the  draft Guidelines for Bioprospecting Activities (see endnote ) commercial bioprospectors must pay a fee of ,  for each Bioprospecting Undertaking (which replaces the  of  ) and such fee may be modified depending on whether the applicant