EU Parliament To Vote On Measure Against Biopiracy; Focus On UN Protocol

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European Union lawmakers will vote soon on a non-binding measure aimed at protecting genetic resources and fighting biopiracy, or misappropriation. Despite the critical importance of these issues, efforts to draw the European Parliament’s attention to the resolution have been difficult and its outcome is less than clear, its author says.

The motion for a European Parliament resolution is set out in a draft report on “development aspects of intellectual property rights on genetic resources: the impact on poverty deduction in developing countries,” written by Catherine Grèze, of France and the Greens/European Free Alliance.

The report, available here, will be voted on in the Development Committee on 6 December, and in plenary around 14 January, Grèze’s assistant said. It “may be accepted in committee but it is more complicated for the plenary,” she said.

As an ecologist and coordinator of Parliament’s Development Committee, she told Intellectual Property Watch, “I keep in mind that the protection and preservation of genetic diversity is a key component of the achievement of the [UN] Millennium Development Goals.” Genetic resources (GR) are particularly essential, she said. Despite its vital importance for human survival, genetic diversity “is being lost at an alarming increased rate. We need to preserve biodiversity, fundamental for humanity, while fighting against biopiracy.”

Biopiracy usually refers to a situation in which biological resources are taken from a local community or indigenous people and then patented, but whose resulting profits don’t benefit the community that originated the resources, disclosed their properties and used them, the draft report said.

The lack of balance between GR providers and users has brought the issue of access to and benefit-sharing from GR onto the international stage, it said. The UN Convention on Biological Diversity (CBD) plays a unique role here, it said. Although it is one of the key treaties regulating the conservation and use of biodiversity internationally, it differs from other global accords because it stresses fairness, equity and justice.

One of the main requirements of the access and benefit-sharing (ABS) framework established by the CBD and the Nagoya Protocol to the CBD (IPW, Biodiversity/Genetic Resources/Biotech, 29 October 2010) is that benefits must be granted in exchange for access to GR and traditional knowledge, and prior informed consent (PIC) must be obtained before access. In addition, mutually agreed terms (MAT) for benefit-sharing must be negotiated, the report said.

The CBD and Nagoya Protocol are the main international fora for discussions on the governance of ABS from genetic resources, Grèze said. But the fact that the question of governance related to intellectual property rights (IPRs), GR and poverty alleviation also concerns other bodies, such as the World Trade Organization (WTO), World Health Organization and World Intellectual Property Organisation (WIPO), raises “challenges in terms of ensuring coherence and ‘mutual supportiveness,’” she said.

Her report urged the EU and its member states to call for swift ratification of the Nagoya Protocol in order to combat biopiracy and restore fairness and equity in the exchange of GR, she said.

But quick ratification of the protocol requires that developing and developed countries take the steps needed to make it effective, the report said. Many developing nations have failed or been unable to put an adequate legal framework for ABS in place, while developed countries have not provided effective enforcement mechanisms that would ensure fair and equitable benefit-sharing.

To counter biopiracy, Grèze recommended that the right of farmers to rely on harvested seeds be safeguarded, and that IPR not hinder access to affordable medicines; and that traditional knowledge be granted the same level of protection as GR.

EC Pushes for Protocol Ratification

In October, the European Commission (EC) proposed a regulation [pdf] on access to GR and the fair and equitable sharing of benefits arising from their use in the EU which seeks to implement the Nagoya Protocol and enable its EU ratification. The EU and its 27 members are parties to the CBD, but that treaty provides little detail on how access and benefit-sharing for the use of genetic resources and associated traditional knowledge should be done in practice, the proposal’s explanatory memorandum said. The absence of clear rules means European researchers and companies have been accused of biopiracy by governments claiming a violation of their sovereign rights, it said.

The Nagoya Protocol, adopted on 29 October 2010 by consensus of the 193 parties to the CBD, is a treaty that significantly expands the CBD’s general ABS framework, the EC document said. The protocol is expected to become effective in 2014.

The protocol rests on two pillars: measures on access and on user-compliance. Signers have the discretion to decide whether to regulate access and require prior informed consent and benefit-sharing for the use of their GR, but if a party decides to do so, it must enact laws implementing the “international access standards” set out in the treaty. The user-compliance pillar mandates that all parties to the protocol take measures to ensure that only legally acquired GR and associated traditional knowledge are used within their jurisdiction.

The EU and most of its members have signed the protocol but EU law does not address access and user compliance implementation, the EC said. If approved by the European Parliament and Council of Ministers, the EC plan would require all users to exercise due diligence to determine that GR and associated traditional knowledge are accessed according to applicable laws and that, where relevant, benefits are fairly and equitably shared upon mutually agreed terms.

End to Incoherent Approach Sought

But the effectiveness of the Nagoya Protocol depends on a “real coherence between different legal regimes in force,” Grèze said. The protocol led several developing and emerging economies to propose that the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) be amended to add a new article on disclosure of origin of GR and/or associated traditional knowledge in accordance with Nagoya, she said. The EU should increase its support for mandatory disclosure, she said. In parallel, “special attention needs to be paid to the expansion of bilateral trade agreements” that could jeopardise developing countries’ interest through enactment of so-called “TRIPS plus” IPR standards, the report said.

In its draft opinion, the International Trade Committee urged Grèze to: (1) Stress the need to give resource providers, inventors and investors transparency and legal certainty on benefit-sharing. (2) Urge the EC to direct its negotiators to consider the Nagoya Protocol as their point of departure and to try to align the CBD and protocol with TRIPS, WIPO and other agreements. (3) Agree with industry that a rules-based international trade system requires preventing the wrongful grant of patents, which requires rules on source and origin disclosure. (4) Recognise the potential role of the IP and patent systems in spurring innovation, transfers and technology dissemination while protecting indigenous people and local communities from adverse effects of the IPR and patent systems.

“Long, Difficult Fight”

It has taken Grèze over two years to have her report accepted by Parliament’s political parties for action, a “long and difficult fight,” she said. Asked if she expects opposition, Grèze said that because the CBD, which constitutes the central, global framework for governance of ABS, requires a contract between the provider and the user of genetic resources, “of course industries are sceptical about that and would prefer a voluntary system instead of a binding one.”

Dugie Standeford may be reached at info@ip-watch.ch.

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