Nature-based research often involves a beneficial and consensual
relationship between the research institution and those who harbor proprietary
knowledge or natural and genetic resources, such as plants, fungi, and microbes.
But frequently the relationship is not that simple, with providers sometimes
preventing important research from taking place, and research and commercial
parties occasionally conducting research and/or obtaining materials or
knowledge without appropriate permission or compensation — and sometimes even
seeking patents on such traditional resources.
On October 4, 2012, the European Commission published a draft regulation to “facilitate
nature-based research” by increasing and easing researchers’ and companies’
access to genetic resources.1,2 The legislation also seeks to ensure
that indigenous communities receive fair recognition and compensation for their
contributions of genetic resources, which “play a significant and growing role”
in the industries of plant and animal breeding, cosmetics, and pharmaceuticals.1
This dynamic is called “access and benefit-sharing,” or ABS. The proposed
regulation represents the first time in the European Union that obligations for
users of genetic resources and traditional knowledge have been set out (J. Hennon, email, October 25, 2012).
“The absence of clear rules,” wrote the European Commission in a press release,
“has led some countries to claim that their sovereign rights have been flouted
by foreign researchers, a situation known as ‘biopiracy.’ That lack of trust
has occasionally led to restrictive conditions that hinder access to genetic
resources. Today’s proposals are designed to address those fears, while
maximizing opportunities for research, development, and innovation in nature-based
products and services.”1
“Given the importance of EU-based companies in biodiversity-based research and
development in a range of sectors, this is a significant and necessary step [to]
advance fair and equitable sharing of benefits, and therefore promote the
conservation and sustainable use of biodiversity,” said María
Julia Oliva, the senior ABS adviser for the Union for Ethical BioTrade (UEBT) (email,
October 30, 2012).
If passed, the draft legislation would implement the Nagoya Protocol on ABS,
which was adopted in 2010 in Nagoya, Japan, and signed by 90 and ratified by
eight parties of the Convention on Biological Diversity (CBD), an international
treaty that aims to conserve the world’s biological diversity, encourage
sustainable use of its components, and promote fair and equitable sharing of
benefits.3 The Protocol is expected to go into full effect in 2014. (All
but four countries are CBD parties, with the exception of the United States, South
Sudan, Andorra, and the Holy See. More information on the CBD and Nagoya
Protocol — which was unpopular among indigenous groups and some country
parties, such as Venezuela and Bolivia — is available in this
2010 HerbalGram article.4)
Proving
Due Diligence
The draft legislation proposes a provision on due diligence, which would direct
the users of genetic resources to make sure that they access resources with
proper permits, establish mutually agreed upon terms for access and details on
benefits sharing (documented in private law contracts), and act in accordance
with local and regional laws.2 The due diligence provision is the regulation’s
most important in that it seeks to achieve the overall goal of the legislation:
minimizing the chance that illegally acquired genetic resources are used within
the European Union, while also supporting the “fair and equitable sharing of
benefits.”2 Companies and other organizations that conduct
bio-research must have due diligence policies and procedures in place for each
step in the process of accessing and using genetic resources, including
“receiving of public research funds, when a market approval for a product
developed on the basis of genetic resources is requested, or at the time of
commercialisation where a market approval is not required.” "The draft
regulations could significantly increase legal certainty in relation to ABS,”
said UEBT’s Oliva. “Until recently, because of the evolving legal framework
around the world, engaging in ABS has sometimes been seen as more of a risk
than an opportunity. Of course, it will still be crucial for provider countries
to establish ABS frameworks that are clear, practical, and effective. Nevertheless,
the draft EU regulations — through the due diligence obligation and
complementary measures such as awareness raising, training, and support for
best practices — would facilitate and incentivize compliance with ABS.”
The
regulation envisages a variety of procedures, tools, and mechanisms for meeting
the due diligence requirement. The first is an online register of best
practices developed by the users for ensuring due diligence. These best
practice strategies and processes should meet all parties’ stipulations and
should also be inexpensive.2 Users and associations of users may
submit to the European Commission applications for best practice recognition. All
accepted best practices will be available to all interested parties on an
online database, and subsequent users who employ these processes should enjoy increased
likelihood of due diligence compliance.
Another tool for aiding the implementation of due diligence is a register of
EU-trusted collections, which can include botanic gardens and other
organizations that contain genetic resources. In order to be included in this
register, a collection would have to ensure to Member State authorities that it
supplies and exchanges genetic samples to users and other collections with
documentation that they are acting legally and within mutually agreed upon
terms.2 The collections must also “keep record of all samples and
genetic resources and related information supplied to third persons for their
use,” and “use appropriate tracking and monitoring tools for exchanging samples
of genetic resources and related information with other collections.”
According to the regulation draft, “Users that acquire a genetic resource from
a collection listed in the Union register should be considered to have
exercised due diligence... This should prove particularly beneficial for
academic researchers as well as small and medium sized enterprises.”
Michael Kiehn, PhD, chairman of the International Plant Exchange Network Task
Force — which facilitates CBD implementation among botanic gardens — said that
this standardization of procedures is in the best interest of smaller botanic
gardens with less staff, as it enables such institutions to remain involved in
international plant exchange.
“The proposed regulation clarifies the tasks and needs for botanic gardens much
better than the old situation, where the Member States had different views on
how to address such specific issues,” said Dr. Kiehn (email, November 7,
2012). “If
achieving the status of an ‘EU-trusted collection’ is not going to be too
difficult, then such collections (including botanic gardens) can benefit from
an increased trust in their status by provider countries.”
A controversial aspect of the due diligence requirement is that it applies only
to genetic resources that were physically acquired after the enforcement of the
Nagoya Protocol (expected to occur in 2014).2 In addition, the draft
regulation encompasses only traditional knowledge that is recognized as such in
the mutually agreed upon terms relating to the genetic resources. These points, said Oliva, have been criticized by
provider countries as being contrary to the Nagoya Protocol, which has strong
provisions on traditional knowledge, and links benefit-sharing requirements to
the utilization of (rather than access to) genetic resources. However, Oliva
explained, “The impact assessment conducted by the European Commission
identified the alternatives — extending the scope to genetic resources accessed
since the entry [into] force of the CBD, for instance — as raising legal and
economic risks difficult to reconcile with the principle of legal certainty.”
Implementation
of Proposed Regulation
The
authorities of individual EU Member States are responsible for ensuring that
users employ due diligence, as well as enacting “effective, proportionate, and
dissuasive penalties,” or sanctions against users who do not fulfill their due
diligence obligations. Penalties may include fines, suspension of activities,
or confiscation of genetic resources.
According to EU
spokesperson Joe Hennon, discussions on the text, including on sanctions, are
about to start in the Council and European Parliament. “Under the rules of our
legislative procedure,” said Hennon, “the draft regulation will be examined by
both the Council and the European Parliament. These procedures may take from 18
to 24 months. Approval of the Regulation and entry into force is expected in
the course of 2014.”
“In
terms of the content of the draft regulations,” said Oliva, “it is important to
note that these are only at the start of the EU legislative procedure. In fact,
the text that is eventually voted upon may be considerably different. Certainly, there is a
need to further clarify or address certain issues, but nevertheless, the draft
EU guidelines are an important step and a clear signal: companies working with
biodiversity need to be aware of ABS principles and take measures to put them
into practice. This is important for both providers and users of biodiversity.”
—Lindsay
Stafford Mader
References - Environment: Commission proposes measures to tackle 'biopiracy' and
facilitate nature-based research [press release]. Brussels, Belgium: European
Commission. October 4, 2012. Available here.
Accessed October 31, 2012.
- Proposal for a regulation of the European Parliament and of the Council on access
to genetic resources and the fair and equitable sharing of benefits arising
from their utilization in the Union. Text with EEA relevance. European
Commission. Brussels, Belgium. October 4, 2012. Available here. Accessed October 31, 2012.
- History of the Convention. Convention on Biological Diversity website.
Available here. Accessed November 20, 2012.
- Stafford L. Convention on Biological
Diversity’s 10th Conference of the Parties. HerbalGram. 2010;89: 22-25.
Available here.
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