Summary of the Opinion of the European Data Protection Supervisor on the Proposals for Regulations on supplementary protection certificates for plant protection products (The full text of this Opinion can be found in English, French and German on the EDPS website https://edps.europa.eu)
Date: 2023-11-14
Institutions: European Data Protection Supervisor
Subjects: European patent, market approval, plant health legislation, plant health product








C_202300714EN.000101.fmx.xml












Official Journal of the European Union


EN
Series C













C/2023/714


14.11.2023






Summary of the Opinion of the European Data Protection Supervisor on the Proposals for Regulations on supplementary protection certificates for plant protection products
(C/2023/714)


(The full text of this Opinion can be found in English, French and German on the EDPS website https://edps.europa.eu)



On 27 April 2023, the European Commission issued the Proposal for a Regulation of the European Parliament and of the Council on the supplementary protection certificate for plant protection products (recast) and the Proposal for a Regulation of the European Parliament and of the Council on the unitary supplementary protection certificate for plant protection products. The objective of the Proposals is to simplify the EU’s Supplementary Protection Certificates (SPCs) system as regards national SPCs for plant protection products, as well as improve its transparency and efficiency, and to create a unitary certificate for plant protection products, complementing the unitary patent system.
The Proposals provide for (a notification of) an application for a certificate, including personal data such as the applicant’s address, to be published in a Register. As the publication of personal data constitutes an interference with the right to data protection, the Proposal should clearly articulate the specific purposes for which personal data may be made available. In addition, the EDPS recommends to consider providing for a mechanism that would allow access not to the public, but only to parties capable of demonstrating a legitimate interest linked to the Proposal’s objectives.
The EDPS notes the Proposals provide for unlimited retention of all entries in the Register and in an administrative database. At the same time, the Proposals provide that the party concerned may request removal of personal data from the database 18 months after expiry of the certificate or the closure of an inter partes procedure. As personal data should not be kept for longer than is necessary to achieve the purposes of the processing, the EDPS considers that personal data in the Register and database should not be kept indefinitely. The EDPS invites the legislature to consider whether an 18-month retention period could be prescribed as a rule for personal data regardless of the submission of a request, both for the Register and the database, with the possibility to extend the retention period, where necessary, to safeguard the rights of individuals (e.g., in the context of possible exercise of legal claims).
1.   Introduction









1.


On 27 April 2023, the European Commission issued






—


the Proposal for a Regulation of the European Parliament and of the Council on the supplementary protection certificate for plant protection products (recast) (1) (‘the national SPC Proposal’) and










—


the Proposal for a Regulation of the European Parliament and of the Council on the unitary supplementary protection certificate for plant protection products (2) (‘the unitary SPC Proposal’)
(together ‘the Proposals’).
















2.


The Proposals are part of a larger package of new EU rules on patents. Four Proposals deal with Supplementary Protection Certificates (SPC), two of which are the subject of this Opinion.












3.


An SPC is an intellectual property right sui generis that extends the 20-year term of patents for medicinal or plant protection products by up to 5 years. However, SPC protection so far is only available at national level. As a result, according to the Commission, the current system suffers from fragmentation, which leads to complex and costly procedures, as well as legal uncertainty (3).












4.


The objective of the national SPC Proposal is to simplify the EU’s SPCs system as regards national SPCs for plant protection products, as well as improve its transparency and efficiency. The Proposal is a Recast of Regulation (EC) No 1610/96 of the European Parliament and of the Council (4), which provides for SPCs for plant protection products. The Proposal also aims to introduce a centralised procedure for granting SPCs for plant protection products. This would allow applicants to obtain SPCs in the respective designated Member States by filing a single ‘centralised SPC application’ that would undergo a single centralised examination procedure by the European Union Intellectual Property Office (‘the Office’), supported by national offices.












5.


The main objectives of the unitary SPC Proposal are to simplify the EU’s SPC system, as well as improve its transparency and efficiency, by creating a unitary certificate for plant protection products, and to complement the unitary patent system (‘European patent with unitary effect’). Under the Proposal, the unitary SPC can be requested by filing an application that would then be subjected to the same centralised examination procedure by the European Union Intellectual Property Office (‘the Office’) as applicable to ‘centralised SPC applications’ mentioned in the previous paragraph.












6.


The present Opinion of the EDPS is issued in response to a consultation by the European Commission of 27 April 2023, pursuant to Article 42(1) of EUDPR (5). The EDPS welcomes the reference to this consultation in Recitals 53 (6) and 43 (7) respectively of the two Proposals the introduction.




6.   Conclusions









18.


In light of the above, the EDPS makes the following recommendations:






(1)


to replace the references to Regulation (EC) No 45/2001 of the European Parliament and of the Council (8) with a references to Regulation (EU) 2018/1725;










(2)


to clearly articulate the specific purposes for which personal data may be made available and consider providing for a mechanism that would allow access not to the public, but only to parties capable of demonstrating a legitimate interest linked to the Proposal’s objectives










(3)


to designate EUIPO as controller within the meaning of the EUDPR for processing of personal data in the Register as well as in the additional electronic database;










(4)


to align the provisions on the deletion of personal data from the Register and the database with Article 4(1)(e) of the EUDPR by providing a maximum storage duration.










Brussels, 21 June 2023.

Wojciech Rafał WIEWIÓROWSKI
               





(1)  COM(2023) 223 final.

(2)  COM(2023) 221 final.

(3)  COM(2023) 223 final, Explanatory Memorandum, p. 1.

(4)  Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products (OJ L 198, 8.8.1996, p. 30).

(5)  Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).

(6)  COM(2023) 223 final.

(7)  COM(2023) 221 final.

(8)  Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1).


ELI: http://data.europa.eu/eli/C/2023/714/oj
ISSN 1977-091X (electronic edition)