Malaysia is in the process of drafting Access and Benefit Sharing Law. The objective of this Bill to implement the objectives under the Convention on Biological Diversity specifically on access to biological resources and the sharing of benefits arising from their utilization.
For the purpose of this Bill, the author seeks to propose certain features to include in this Bill. These features are taken from the several countries which already enacted this law under their jurisdiction such as Australia, Costa Rica, Kenya, Bhutan and so on.
Title
This Act shall be
called the Access Benefit Sharing Act of Malaysia, 2012 and it shall apply throughout Malaysia
Purpose and objectives
This Act shall
have the following purposes and objectives: a) to ensure national sovereignty
of Malaysia over genetic resources in accordance with relevant National and
International Law; b) to ensure the conservation and sustainable use of the biological
and genetic resources; c) to promote the equitable sharing of benefits derived
from the use of genetic resources; d) to promote technology transfer and
capacity building at the national and local levels, including the building of
scientific and technological capacity relevant to the conservation and sustainable
use of biological diversity; e) to recognize and protect Traditional Knowledge,
innovation and practices of local communities associated with biodiversity; f) to
regulate and facilitate the process by which collectors may legally obtain
genetic resources; g) to prevent illegal access to genetic and biological
resources and associated Traditional Knowledge.
Justification:-
One of the purposes of this Act is to ensure national sovereignty
of Malaysia over genetic resources. This had been affirmed in the Articles 3
and Article 15 of the Convention on Biological Diversity which affirms
countries’ national sovereignty over their resources. For an example, the
Australian system is only applied to species naturally found in Australia.
Species from other countries are not covered. Australia does not seek to take
advantage of its possession, accidental or otherwise, of foreign species.
This accord with the spirit of Article 3 of the CBD.
Besides that, this
Act also promotes conservation and sustainable use of biological diversity. The
Australian law also promotes the three objectives of the Convention on
Biological Diversity as it states under Environment Protection Biodiversity
Conservation Regulations 2000 under regulation 8A.0.
In addition, there is an article which gives useful tips to make an ABS law
whereby in this article, it has encourages to promote conservation and sustainable
use in the ABS law.
The important
thing is this Act may seek to protect traditional knowledge. Traditional
knowledge has not been defined in the CBD and the Bonn Guidelines.
Nevertheless, the CBD speaks of “knowledge, innovations and practices of
indigenous and local communities embodying traditional lifestyles relevant for
the conservation and the sustainable use of biological diversity“ (Art. 8j).
The concept of TK is not limited to ancient wisdom, but also includes
innovative knowledge acquired because of traditional methods. Besides that, the
protection of traditional knowledge mentions under Article 7 of the Nagoya
Protocol whereby the scope states explicitly that the Protocol applies to traditional
knowledge associated to genetic resources within the scope of the CBD and to
benefits arising from the utilization of such knowledge.
Scope
This Act shall
apply to all the genetic and biological resources including wild, domesticated
and cultivated species of flora and fauna, both in-situ and ex-situ conditions
found within the territory of Malaysia. In addition, the procedure and
conditions provided by this Act shall apply even if the genetic resources for
which access is sought are located in protected areas or government reserved
forests. Next, the provision of this Act shall apply to the Traditional
Knowledge, innovation and practices associated with biodiversity.
Justification:-
We propose that
this Act shall apply to all genetic and biological resources in-situ and
ex-situ within the territory of Malaysia because it is consistent with both
Articles 8 and 9 of the CBD which promotes in-situ conservation and ex-situ
conservation.
Besides that, Costa Rica in their Biodiversity Law 1998 also applies to the
ex-situ and in-situ of all genetic and biological resources.
Moreover, this Act
shall apply to traditional knowledge because of Article 8(j) of the CBD focuses
on the relationship between biological diversity and indigenous and local
communities.
Further, parties providing the resource are obliged to take measures with the
aim that traditional knowledge associated with the resource is accessed with
the approval or involvement of indigenous and local communities as sets up
under Article 7 of the Nagoya Protocol.
For instance, traditional knowledge is a particularly important aspect for New
Zealand, due to the vital relationship between Maori and New Zealand’s
indigenous flora and fauna. ‘Matauranga
Maori’ is the term often used to refer to knowledge originating from Maori
communities - the relationship with their physical and spiritual environment. Thus,
it same goes to Malaysia because in all, the indigenous peoples of Malaysia
represent around 12% of the 28.6 million people in Malaysia.
Exemptions
This Act shall not
apply: a) where the biological material is used as a commodity for the purpose
of direct use or consumption as determined by the Competent Authority; b) to
access, use and exchange of biological and genetic resources among local
communities resulting from their traditional and customary practices; c) to access
of human genetic resources; d) to varieties for which patent protection is
available; e) To the prevention of the commercial exploitation, which is necessary
to protect public order or morality including prejudice to the environment, the
general interest or traditional rights of farmers.
Justification:-
Commodities and direct consumption are not within the ambit of Nagoya
Protocol and CBD. The Protocol only deals with acquisition for the purpose of
its 'utilization'. This has a special meaning under the Protocol which is to
conduct research and development on the genetic or biochemical composition of
genetic resources. Commodities for direct use as commodities including for consumption
or for non-breeding purposes are not accessed for research and development.
They clearly are not covered by the Protocol. It follows that if the resource
is accessed from wherever for research and development purpose, then the
Protocol would require that the PIC and MAT of the provider be obtained. Some
developing countries expressly provide for the exclusion of commodities from their
ABS law. Some others reserve the power to exclude biological resources
'normally traded as commodities', for instance, India Biological Diversity Act
2002, section 40.
Besides that,
according to Article 9(4) of the Nagoya Protocol states that parties shall not
restrict the customary use and exchange of genetic resources and associated
traditional knowledge within and amongst indigenous and local communities. It
means that Parties are required not to restrict the customary use and exchange
of genetic resources and associated TK within and amongst ILCs. This is ‘as far
as possible’ and in accordance with the objectives of the CBD.
Another thing is,
in this draft ABS law promotes patent protection. In the case of Hoodia
gordonii and the San People of Africa,
this case study illustrates how an indigenous plant (i.e., Hoodia gordonii) used
by an indigenous community (the San), was patented by a government research
body in South Africa and in turn licensed to a large pharmaceutical company,
without any consultation with the San community. Apparently, because they were
believed to be extinct. With the help of their lawyer, the San embarked on an
intensive campaign to be acknowledged as the legitimate holders of the
indigenous knowledge on which the patent was based. After months of
negotiation, they eventually successfully entered into a benefit-sharing
agreement with the research institute. The negotiations between the San and the
Council for Scientific and Industrial Research (CSIR) went on for seven months
(June 2001 to January 2002) before they signed a memorandum of understanding on
February 1, 2002. Thereafter, the parties negotiated for another year, March
2002 to March 2003, until they signed a benefit-sharing agreement on March 24,
2003.
The COP of CBD has
interpreted the ABS provision in such a way to exclude human genetic resources.
According to the Guideline 9 of the Bonn Guidelines states that All genetic
resources and associated traditional knowledge, innovations and practices
covered by the Convention on Biological Diversity and benefits arising from the
commercial and other utilization of such resources should be covered by the
guidelines with the exclusion of human genetic resources. During the COP 9, the
conference interprets the scope of the international regime extends to
biological resources, genetic resources and their derivatives and associated
traditional knowledge. It excludes, among others, human genetic resources.
It is important to
note that there are three basic sources for impetus to develop an ABS law or
policy. Typical cross-cutting conceptual elements to be considered when
defining the purpose of the legislation include promoting equity in natural
resources exploitation.
Requirements of access
Access covered by
this Act shall be subject to the prior informed consent and research agreement of
the Competent Authority of Malaysia. If the research and collection of
biological and genetic resources is intended, directly or indirectly, for
commercial purposes, the agreement must be a Commercial Research Agreement. If
the prospecting of biological and genetic materials is intended primarily for
academic purposes, the agreement shall be an Academic Research Agreement. In
cases where an academic research agreement detects the possibility of marketing
results of research, the applicant must apply for a commercial research
agreement. If the access is beyond or outside the agreed term in the PIC or
research agreement, the applicant shall make a fresh application.
Application for access permit
To enable the
Competent Authority to arrive at a decision to grant or refuse a permit, the
applicant shall include the following information, when submitting an
application for access to genetic and/or biological resources covered by this
Act:
a. Provide a description of the applicant including their legal
status, place of residence and a list of all entities and individuals, which will
be involved in the access activities and their respective responsibilities; b)Describe
the applicant’s technical and financial capability to conduct the access
activity and previous biological resource collection activities within Malaysia
and elsewhere; c) Identify the kind of genetic and biological resources it is
seeking.
Justification:-
Prior Informed
Consent is now also prescribed by the Convention on Biological Diversity for
the utilization and research of genetic resources which is states under Article
15(5) of the Convention on Biological Diversity: The competent national
authority of the providing country must be informed of the planned research as
part of the application process. The researcher seeking access needs to provide
all of the relevant information and ensure that the government or other
responsible authority obtains this information. The informed consent of the
competent agency is a prerequisite for access to biological resources.
Under national legislation, it may also be necessary to include stakeholders
involved on various intermediary levels in the Prior Informed Consent.
It is recommended
that stakeholders who are entitled to give their Prior Informed Consent to your
project or access be informed about the following elements (Bonn Guidelines 36)
such as legal entity and affiliation of the applicant and/or collector; contact
person if the applicant is an institute, project organization, possibly budget
and treatment of confidential information. For
example, all countries require that prior informed consent (PIC) is gained and
that mutually agreed terms (MAT) are reached before accessing the genetic or
biological resource.
In Costa Rica, Uganda, India and Brazil, PIC is required from the Competent
National Authority. The Competent National Authority is then responsible for consulting
with the access provider, be it local communities, private landowners, or government
departments.
In Australia, The Philippines, Norway, the USA, South Africa and Kenya, PIC is
required directly from the access provider. In the Bonn Guidelines 26 also
mention the basic principles of a prior informed consent system should include
a legal certainty and clarity, access to genetic resources should be
facilitated at minimum cost and etc.
The
Minimum terms of the Commercial Research Agreement and Academic Research
Agreement
The applicant must
fulfilled all the terms under the research agreement which are a) state the
potential use and anticipated benefits of the accessed material and how the
results will be shared; b) identify the nature of the legal rights the
applicant may seek over the collected resources, derivatives of the collected
resources, and innovations that are derived from those resources, including any
intellectual property rights; c) indicate agreement to abide by the conditions
set out by the Competent Authority for collection activities. This includes appropriate
arrangements with the Competent Authority to facilitate the collection mission,
including establishing provisional routes, estimated timing, types of material
collected and quantities and identification of methods of collection (sampling,
harvest and storage methods); d) the identification of the national institution
or institutions, which will participate in the research; i) indicate agreement
to bear all costs involved in collection; j) Provide information about existing
or proposed contracts between the applicant and any third party relating to the
use of any information and products resulting from the access activity; l) Provide
information on the arrangements made within Malaysia to facilitate the
collection mission; m) Indicate plans, if any, for cooperation with national
institutions, scholars, scientists, students, farmers and farmer groups in Malaysia
in the field mission and/or its follow-up activities; n) Demonstrate that the
collection/access activity will have no negative environmental impact; o) Provide
information on the prior informed consent of the relevant stakeholders when
necessary; p) The economic, social, technical, scientific, environmental or any
other benefits that are intended or may be likely to be accrued to the country
and an indication of the types of short, medium and long term benefits to be
shared with Malaysia and other relevant stakeholders as well as the proposed
mechanisms and arrangements for benefit sharing; q) An application shall be
affixed with an affidavit.
Justification:-
An academic research
agreement that deals with prospecting biological and genetic resources for
academic purposes and only duly recognized Malaysian universities and academic
institutions, domestic governmental and intergovernmental entities can apply
for this kind of agreement. On the other hand, commercial research agreement
deal with research and collection activities intended, whether directly or
indirectly for commercial purposes and thus encompass all agreements stipulated
with private persons, corporations and foreign or international entities.
Clearly, this law assumes that all agreements other than those undertaken with
domestic research institutions and domestic governmental entities have economic
ends.
According to
Article 15(4) of the CBD, the contracting parties need to negotiate and agree
on the terms of the access agreement, sometimes called the 'material transfer
agreement' or 'academic/commercial research agreement' that authorizes access
to genetic resources, controls subsequent use and establishes the type of
benefits to be returned.
If the provider country claims ownership over genetic resources, then it is up
to the state to negotiate the mutually agreed terms and enter into the
agreement.
Issuance of Permit
The Competent
Authority may, after considering the application issue or refuse to issue a
permit.The Competent
Authority shall refuse to issue a permit, if it satisfied that (a) a benefit
sharing agreement has not been established in accordance with Act; (b) in the
case of access to biological resource or traditional knowledge associated with
biological resource, as appropriate, the applicant has not obtained the prior
informed consent in accordance with this Act; (c) the access is likely to
result in adverse effects on the livelihood or cultural including religious,
ceremonial or other traditional or customary practices of indigenous and local
communities; (d) in the case of access to human genetic resource, its use is
for purposes contrary to ethical values; (e) the access may result in adverse
environmental impact which may be difficult to control and mitigate; (f) the
access may cause genetic erosion or affect the ecosystem function; (g) the use
of the biological resource is for purposes contrary to the national or State
interest; (h) the application does not comply with the requirements of this Act
or any other written law. Besides that, the
Competent Authority shall inform the applicant of its decision in writing.
Justification:-
An obligation to
issue a permit or equivalent at the time of the access. Such a permit or
equivalent is evidence of the decision of a country to grant PIC and of the
establishment of MAT (Article 6.3(e) and Article 14.2(c)).
The permit or equivalent also forms the basis of an internationally recognized
certificate of compliance. Once the permit is made available to the ABS
Clearing House, it automatically acquires the status of such an international
certificate (Article 17.2). As there is a mandatory requirement to notify the issuance
of the national permit to the Clearing House (Article 6.3(e)), all national
permits issued and notified would thus convert to the status of internationally
recognized certificates.
It is restated that such a certificate shall serve as evidence that the genetic
resource, which it covers, has been accessed in accordance with PIC and that
MAT has been established as required by the legal requirements of the Party
providing the resource (Article 17.3).
Comments
Post a Comment