The nagoya protocol on access and benefit- sharing implementation progress and gaps

• Pages: 151-186

THE NAGOYA PROTOCOL ON ACCESS AND BENEFIT- SHARING

IMPLEMENTATION PROGRESS AND GAPS

Index: 1. Introduction; 2. Access and Benefit Sharing under international law; 3. The Convention

on Biological Diversity and genetic resources as State ‘property’; 4. The Nagoya Protocol; 4.1.

Overview; 4.2. The ABS mechanism; 5. Implementation Challenges; 5.1 Provider Pillar; 5.2.

Implementation case studies; 5.2.1. Brazil; 5.2.2. India; 5.2.3. South Africa; 5.3. User Compliance

Pillar: the EU ABS Regulation; 6. Concluding Remarks.

1. INTRODUCTION

Typically, pharmaceutical, cosmetic and industrial products are derived by genetic resources (GR)

associated to traditional knowledge (TK) of indigenous or local populations, as plant-based

treatments are often the basis of their medicine.

Over the past 40 years outstanding developments in medicine and biology associated with the

biotechnological revolution have enabled the transformation of natural resources to a source of

income through the commercialization of products derived from their use.1 Indeed, since 1970

through the spread of genetic engineering, TK has become a source of financial gain. At the same

time the decline of biodiversity (intended as genetic diversity between and within species) has

become a highly debated global issue (Stockholm Conference on Human Environment, 1972, Rio

Conference on Environment and Development 1992; Johannesburg Conference on Sustainable

Development, 2012, High-level Political Forum on Sustainable Development, 2013), and object of

specific programmes (the Aichi Biodiversity Targets, the 2030 Agenda for Sustainable

Development).

The main issue is that genetic resources on one hand, and the technology used for their exploitation

on the other hand, are not equally distributed. Indeed, the global scenario is characterized by a clear

divide or economic asymmetry: innovation, research and development (R&D), funds and

knowledge to carry out research are localized in the North, while biodiversity is located in the

tropical South in the s.c. ‘megadiverse countries’.

For this reason, the current situation requests a balance of interests between the different

stakeholders involved: the countries that own the resources and their indigenous and local

populations that are the ‘custodians’ of these resources (‘providers’), and the countries and their

private companies (or also universities or research bodies) that own the biotechnologies and the

funds to use them in order to obtain a financial gain or to carry out research (‘users’).

Access and Benefit Sharing (ABS) is the main solution provided by international law to avoid the

grabbing of these resources by industrialized countries. Indeed, the misappropriation and misuse

by foreign multinationals genetic resources and the associated traditional knowledge held by

1 Genetic resources, whether extracted from plant, animal or micro-organisms, can be utilized for several purposes

ranging from basic research to the creation of a new medicine and important for the commercial sector and in particular

the agricultural and pharmaceutical sector. See, Kerry ten Kate, Sarah A Laird, The Commercial Use of Biodiversity.

Access to Genetic Resources and Benefit Sharing (Earthscan, London, 1999) 3.

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indigenous populations without any prior authorization has given rise to the problem of biopiracy

(or biorace), that was labelled as “the plunder of nature and knowledge”.2

The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of

Benefits Arising from their Utilizations to the Convention on Biological Diversity (CBD)3 has

attempted to address the concerns of developing countries, implementing the third goal of the CBD:

“the fair and equitable sharing of benefits arising out of the utilization of genetic resources,

including by appropriate access to them”.

To achieve these purposes, the Nagoya Protocol has framed a legal mechanism to avoid cases of

biopiracy based on two layers of guarantees for the provider countries (Previous Informed Consent

– PIC, and Mutually Agreed Terms – MAT).

Despite the high number or ratifications,4 some issues have been raised, however, regarding its

implementation and the effectiveness of its compliance mechanism, due to the low rate of ABS

agreements signed to date.5 First, some of the megadiverse countries such as Malaysia and

Indonesia were and are still facing difficulties in adopting ABS legislations. Indeed, most of

developing countries and especially the least developed countries, small islands and States with

economies in transition do not possess the capacities requested to effectively implement the NP; it

has implicated an implementation gap.

Second, most countries that instead implemented the Nagoya Protocol opted for restrictive

legislations since they consider their GR as a domestic property and deem external intervention by

foreign companies as a form of modern exploitation. In addition, problems at a higher level can be

highlighted: the development of adequate policy frameworks and ABS legislations is not enough:

indeed, a further step (and here lies the main problem) requests to implement the conservation

policies and to follow the legislation in practice.

What follows is an analysis of the evolution of the concept of benefit sharing (BS), now ABS,

highlighting the conceptual shift from GR intended as common heritage of humankind to GR as

property of States. Then, implementation case studies by providers (Brazil as an example of

restrictive approach, India and South Africa as examples of b etter law-making) and users (EU ABS

Regulation) will be scrutinized.

In the conclusions, I will then argue that – in spite of cases of successful translation of the NP into

national law – there is yet an implementation gap which is particularly striking and hinders a full

enforcement of the ABS principle.

2 Pete Bsumek, Biopiracy: The Plunder of Nature and Knowledge, Social Epistemiology (1999) 239-240, at 239.

3 The Nagoya Protocol was adopted on 29 October 2010 and entered into force on 12 October 2014.

4 To date, the States Parties are 114, with the notable exception of Australia, Brazil, Canada, Russian Federation, USA

().

5 The number of ABS agreements signed can be calculated on the basis of the number of international certificates of

compliance released by the ABS-Clearing House, the official of web platform established under Art. 14 of the Nagoya

Protocol ().

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