Harmonized standards & right to access

A harmonized standard is a European standard adopted on the basis of a request made by the Commission for the application of EU harmonization legislation, providing technical specifications for products, services and processes. Recognized European Standards Organizations ("ESOs") are responsible for the development of the standards. Such standards play an increasingly important role in international trade and the opening-up of markets. In short, a manufacturer may benefit from a presumption that their product is in conformity with requirements set out in a specific EU regulation so long as they manufacture a given product in conformity with the relevant harmonized standard. The medical device regulation and the draft of the upcoming artificial intelligence Act are examples of regulations that refer to harmonized standards.^[1]

Even though the harmonized standards are made based on a request made by the Commission, they have usually not been available to the public free of charge, but instead subject to a fee. The ESOs have relied on their copyright in the standards to stop unauthorized access or improper use. Thus, it is likely that the CJEU's judgment may have a big impact on the funding model of the ESOs, since the Appellants received access to the standards free of charge under the regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents (the "Regulation").

A key rule of the Regulation is that any citizen of the European Union, and any natural or legal person residing or having its registered office in a Member State, has a right of access to documents of the Commission, subject to the principles, conditions and limits defined in the Regulation. The Commission may also, subject to the same principles, conditions and limits, grant access to documents to natural or legal persons outside of the European Union.^[2] Of course, there are several exceptions.

One exception is that access shall not be granted to anyone if the disclosure would undermine the protection of commercial interests of a natural or legal person, including intellectual property, unless there is an overriding public interest in disclosure.^[3] In this case, the stated commercial interests were deriving from ESOs copyright in the standards in question, while the specific issue reviewed by the CJEU was whether an overriding public interest in disclosure of the four harmonized standards was present.

When answering the question, the CJEU pointed out that the harmonized standards in question formed part of EU law.^[4] The CJEU emphasized that the use of the standards has a legal effect, conferred by EU legislation, in the form of a presumption of conformity with the requirements to the extent those standards cover those requirements. Although it is not generally mandatory to use harmonized standards, it may prove difficult, or even impossible, for economic operators to employ a different procedure. For example, the use of different procedures may result in additional costs or administrative difficulties.

Furthermore, the CJEU emphasized that the European Union is based on the principle of the rule of law, which requires free access to EU law for all natural or legal person of the European Union. Individuals must be able to ascertain unequivocally what their rights and obligations are.^[5] As a result of the legal effect conferred on it by EU legislation, a harmonized standard may specify the rights conferred on individuals as well as their obligations and those specifications may be necessary for them to verify whether a given product or service complies with the requirements of such legislation.^[6]

The CJEU therefore concluded that there is an overriding public interest in disclosure, even though commercial interests were at stake. The judgment and its conclusion are of interest for purchasers of products regulated by product safety regulations and manufacturers of such products since the judgment is a step in the direction of making standards freely available.

Our IP & Technology team has extensive experience with regulatory questions related to a wide range of product types. Please reach out if you have any questions regarding the judgment or any product safety regulations.

^{[1] Artificial Intelligence Act, Article 40 (1): "High-risk AI systems or general purpose AI which are in conformity with harmonized standards or parts thereof the references of which have been published in the Official Journal of the European Union in accordance with Regulation (EU) 1025/2012 shall be presumed to be in conformity with the requirements set out in Chapter 2 of this Title or, as applicable, with the requirements set out in [Chapter on GPAI], to the extent those standards cover those requirements."
[2] Regulation (EC) No 1049/2001, Article 2.
[3] Regulation (EC) No 1049/2001, Article 4 (1) (b).
[4] C-588/21 P, para. 70 and 80.
[5] Ibid., para. 81.
[6] Ibid., Para 82}