The EU regulatory data protection in the agrochemical industry: Towards a data sharing model in favour of sustainable market play and a sustainable environment

• Published date: 01 November 2023
• Author: Żaneta Zemła‐Pacud,Gabriela Lenarczyk
• Date: 01 November 2023
• DOI: http://doi.org/10.1111/jwip.12280

Received: 26 July 2022

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Accepted: 6 April 2023

DOI: 10.1111/jwip.12280

ORIGINAL ARTICLE

The EU regulatory data protection in the

agrochemical industry: Towards a data sharing

model in favour of sustainable market play and

a sustainable environment

Żaneta Zemła‐Pacud

1

|Gabriela Lenarczyk

2

1

Department of Polish and European

Industrial Property Law, Institute of Law

Studies at the Polish Academy of Science,

Warsaw, Poland

2

Department of Private Law, Institute of Law

Studies at the Polish Academy of Science,

Warsaw, Poland

Correspondence

Żaneta Zemła‐Pacud, Department of Polish

and European Industrial Property Law,

Institute of Law Studies at the Polish

Academy of Science, Warsaw, Poland.

Email: z.pacud@inp.pan.pl

Funding information

National Science Center (NCN), Research

project Protection of Regulatory Data in

European Intellectual Property Law,

Grant/Award Number: UMO‐2019/33/B/

HS5/02198

Abstract

Regulatory data protection is mandated in the Agreement

on the Trade Related Aspects of Intellectual Property

Rights (TRIPS Agreement) for two kinds of goods: medicinal

products and plant protection products (PPP). In the

European Union (EU), the level of their protection has

been set far beyond the minimumTRIPS standards and the

adopted model of protection has been, for the most part,

based on temporary exclusivity. Innovative plant protection

products benefit from data exclusivity combined with a

compulsory data sharing regime. Data exclusivity refers to

products being authorised for the first time for the market

of the EU on the grounds of a complete authorisation

procedure, based on submission of a full data dossier.

Within the period of exclusivity, these data may not be

referred to in the authorisation procedure of a generic

product—an equivalent to the reference one. In this way,

data exclusivity creates a period of factual monopoly for

the innovative products and constitutes a sui generis

intellectual property right. This paper presents the regime

of regulatory data protection in the European Union law as

an instrument of legal protection for innovative products in

the agrochemical industry. It first analyzes the purpose and

functions of regulatory data protection in EU law and in the

TRIPS Agreement. Then, the rules of protection by means

J World Intellect Prop. 2023;26:458–476.wileyonlinelibrary.com/journal/jwip458

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© 2023 John Wiley & Sons Ltd.

of data exclusivity and compulsory data sharing are

examined. This allows for further considerations on the

role of regulatory data protection and compulsory sharing

of data in the overall legal protection for innovative

products in the agrochemical industry. In view of the

above, this chapter discusses both the instruments of

protection for PPP regulatory data and poses several

questions concerning their rules, practical meaning and

possible future modifications. In particular, it is considered

whether data exclusivity is the optimal regime of protection

for registration data and recommend that a data sharing

approach could be used instead of the data exclusivity rule,

as is the case with compulsory vertebrate data sharing, to

the benefit of the industry and public interest. This chapter

allows for evaluation and assessment of the economic and

social value of data exclusivity in said areas for fostering

primary and secondary innovation, while acknowledging

other vital interests such as protection of public interest

and safeguarding competition in the relevant markets.

Finally, this chapter maps challenges of the current model

of protection and indicates areas for further consideration

in both creating a coherent and balanced framework of PPP

data protection and the possible extrapolation of the data

sharing rules to systems of data protection for other life

science products.

KEYWORDS

commercial business information, compulsory data sharing, data

confidentiality, data exclusivity, plant protection products,

Regulatory data protection

1|INTRODUCTION

Pesticides are used to protect crops with the aim of optimising food production in conventional or organic

farming, to maintain food quality or to maintain certain areas in the condition needed for their proper

functioning. However, as they potentially can affect human and animals' health via direct or indirect

exposure, for example, as a result of residues in food or environmental contamination, the market of plant

protection products (PPP) is strictly regulated. In the European Union (EU), the key legal act for PPP is

Regulation (EC) 1107/2009 concerning the placing of plant protection products in the market (PPP

Regulation).

1

It establishes a two‐step authorisation system: in the first step, the active substance of a PPP

and, in principle, also its accompanyingnon‐active substances such as safeners or synergists, are approved at

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