Advances and uncertainties in compliance measures for users from the Nagoya Protocol in the European Union

• Date: 01 July 2020
• Author: Laura Movilla Pateiro
• DOI: http://doi.org/10.1111/reel.12320
• Published date: 01 July 2020

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  wileyonlinelibrary.com/journal/reel RECIEL. 2020;29:282–290.© 2020 John Wile y & Sons Ltd

1 | INTRODUCTION

The European Uni on (EU) has become the secon d major geographic

area in the global biotechnology market, ahead of Japan and behind

the United States.1 It also hos ts a considerable a mount of genetic

resources from a ll regions of the world th rough an extensive n et-

work of botanical gardens, collections and gene banks.2 As a result,

the EU has given impo rtant financial suppo rt in recent years to re-

search and development in this field.3 Worth noting in particular is

the promotion of s o-called ‘blue biote chnology’ – using living ma-

rine resources – w ithin the framewo rk of the EU Blue Growt h

strategy.4

The EU played an impo rtant role in the n egotiation of the

Nagoya Protocol.5 In the ab sence of the United State s, it was the

most relevant actor representing the interests of developed coun-

tries and the bi otechnology indu stry. The EU represe nts approxi-

mately half of the gl obal utilization, e xcluding that of the Unite d

States, of the gene tic resources that ha d to be regulated.6 Both in

the negotiations of t he Nagoya Protocol and in t he elaboration of it s

internal regulations in this field, the EU had the difficult task of rec-

onciling two maj or issues. On the one hand, it ha d to deal with the

pressure again st the Protocol by pharmaceu tical companies and in-

dustrial associations7 and to avoid hinder ing the development of

biotechnolog y in its territory, which cou ld move to other territories

with less stri ct access and benefit-sharing (AB S) requirements. On

the other hand, developing and developed countries had entered

1 S Oberthü r and F Rabitz, ‘O n the EU’s Perfo rmance and Lead ership in Glob al

Environmen tal Governanc e: The Case of the N agoya Protocol’ (2 014) 21 Journal of

European Pu blic Policy 39, 49–50.

2 B Coolsaet , ‘Conclusion: C omparing Acce ss and Benefit-sh aring in Europe’ i n B Coolsaet

et al (eds), Implementing the Nagoya Protocol. Comparing Access and Benefit-sharing

Regimes in Euro pe (Brill Nijh off 2015) 363, 36 4.

3 This has been d one within the f ramework of the fo rmer Seventh Fr amework Progr am

for Research ( 2007–2013) and currentl y it is being done th rough the Hori zon 2020

Program and M arie Sklodows ka-Curie Ac tions. A joint pub lic–private initi ative – the

Biobased In dustries Joi nt Undertak ing – that provide s funding oppo rtunities fo r

biotechnol ogy innovatio n has also been es tablished.

4 Commission ( EU), ‘Blue Grow th Opportu nities for Mari ne and Maritime S ustainabl e

Growth’ (Com munication) CO M(2012) 494 final , 13 September 2012 .

5 Nagoya Protoco l on Access to Gene tic Resources a nd the Fair and Equi table Sharin g of

Benefits A rising from th eir Utilizatio n (adopted 29 Oct ober 2010, entere d into force 12

October 2014)

(Nagoya Protocol).

6 S Oberthü r and F Rabitz, ‘ The Role of the Euro pean Union in th e Nagoya Protocol

Negotiation s: Self-interest B ridge Buildin g’ in S Oberth ür and GK Rosenda l (eds), Global

Governance of G enetic Resou rces: Access an d Benefit Shar ing after the Nag oya Protocol

(Routledge 2 014) 79, 79.

7 K Kariyawas am and M Tsai, ‘Access to Ge netic Resource s and Benefit Sh aring:

Implicati ons of Nagoya Proto col on Providers a nd Users’ (2018) 21 Jo urnal of World

Intellect ual Propert y 289, 300.

Received: 17 Septe mber 2019 

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  Revised: 7 Decemb er 2019 

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  Accepted: 15 Janua ry 2020

DOI: 10 .1111/reel .12320

ORIGINAL ARTICLE

Advances and uncertainties in compliance measures for users

from the Nagoya Protocol in the European Union

Laura Movilla Pateiro

Correspondence

Email: lauramovilla@uvigo.es Abstract

The Nagoya Protocol develop ed the legal regime for the access to genetic re sources

and the fair and equ itable sharing of benef its arising from their ut ilization that were

already enshr ined in the Convention on Biological Diversity, and introduced binding

rules on compliance. Wit h its Regulati on 511/2014 adopted in 2014, the European

Union (EU) – the second mos t important geographical are a in the global biotechnol-

ogy market – has develop ed and sought to harmonize the complia nce and monitoring

measures for users f rom the Nagoya Protocol in the EU territor y. This article presents

and assesses the pr ogress made in this recent EU legal field , including the challenges

in the form of several unce rtainties that still lie ahead .