Article 21. Confidential information

553. Article 21 addresses the treatment of certain information provided under procedures established under the Protocol. In practice, most of this information is likely to be submitted in the context of the Protocol's AIA procedure (or consistent domestic procedures). However, Article 21 is not explicitly limited to such information. In principle, it could also be relevant, for example, to information provided on unintentional transboundary movements of LMOs under Article 17, or on LMO-FFPs under Article 11. Nonetheless the language used in certain provisions of Article 21, such as “Party of import” and “notifier”, suggest that the Article's primary relevance will be to information provided on a bilateral basis in the context of the AIA procedure.

554. A number of countries pressed for a provision on confidential information during the negotiations, on the basis that information provided to the Party of import during AIA, or other procedures, would be likely to include proprietary commercial information that required protection. Others argued that no such provision was necessary, since such requirements were already addressed in other international and national legal instruments (including intellectual property law), and that constraints on disclosure of information may hamper the ability of the Party of import to address emergency situations involving LMOs.

555. While Article 21 allows certain information to be treated as confidential, it does not require information concerning LMOs to be treated as confidential as a general rule. Rather, it is up to the provider of the information (the notifier) to specify the information which it considers should be treated as confidential and then to consult with the Party of import.

556. The provisions of Article 21:

557. Article 21(1) requires the Party of import to allow information provided by the notifier to be identified and treated as “confidential” upon request by the notifier. This may include, for example, certain information provided in accordance with Annex I, or subsequently upon request by the Party of import during the AIA procedure. Where the Party of import so requests, the notifier must provide reasons or justification as to why the information should be treated as confidential. The implication of Article 21(1) is that a Party of import would not be able to make available to others, for example to the public, the information provided. On the contrary, it would be under an obligation (see commentary on Article 21(3)) to take steps to ensure that the confidentiality of the information in question is protected.

558. Article 21(1) does not specify what may be required in terms of justification for confidentiality. This is a matter for the Party of import to determine (although consultation with the notifier is required – see commentary on Article 21(2)).

559. The language used in Article 21(1) is general, allowing the notifier, in the first instance, to identify as confidential any of the information which it provides to the Party of import. In contrast, Article 21(5), in common with a number of other global and regional agreements,103 refers to “confidentiality of commercial and industrial information”. It is not clear in what circumstances a notifier might claim confidential treatment for information other than commercial and industrial information.

560. Existing examples of national biosafety frameworks often make reference to confidential information, setting out the circumstances in which confidential treatment may be claimed, a requirement for justification of a claim for confidential treatment, and categories of information which may not be treated as confidential (see commentary on Article 21(6)). Some examples are given in Box 38.

Box 38. National provisions on confidential information: examples

561. Other international agreements such as the Stockholm Convention on Persistent Organic Pollutants also address the issue of confidentiality. Article 9(5) of that Convention, on “the exchange of information” establishes that information on health and safety of humans and the environment shall not be regarded as confidential. However, this Article provides that Parties that exchange “other” information pursuant to the CBD must protect any confidential information “as mutually agreed”. The 1998 Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade (Article 14(2)) also establishes that Parties that exchange information pursuant to that Convention must protect any confidential information “as mutually agreed”.

562. Where the notifier identifies information that should be treated as confidential, but the Party of import considers that the information in question does not qualify for such treatment, it must consult with the notifier. Thus the final decision on confidentiality rests with the Party of import. If the request by the notifier is considered unjustified, then the notifier must be informed before the information is disclosed. The decision refusing confidential treatment does not need to give reasons unless the notifier so requests.

563. Although the Party of import takes the final decision, it must allow for consultation with the notifier and also for internal review of its decisions refusing confidential treatment. Interestingly, this appears to be the only reference in the Protocol explicitly requiring the Party of import to provide for internal review of a decision (with the exception of Article 12).

564. The Party of import is not free immediately to disclose information which it has decided is not subject to confidentiality. The Party of import must notify its decision to the notifier before the information can be disclosed so that the notifier has an opportunity to consult and to have the decision reviewed ahead of any disclosure. If the consultation and review do not resolve the issue, the consequences of continued disagreement between the notifier and the Party of import as to whether particular information should be treated as confidential are addressed in Article 21(5).

565. Article 21(3) sets out a general obligation on Parties to protect confidential information received under the Protocol. Parties must protect confidential information in their national legislation. Adequate procedures must be set up to this effect to prevent disclosure or the commercial use of confidential information.

566. This paragraph also requires “non-discrimination” between imported and domestically produced LMOs in relation to confidentiality, i.e. the same level of protection must be accorded to each.

567. In the case of LMOs, confidential information is likely to be related to modern biotechnology techniques used in the production of the LMO and other relevant information of a commercially sensitive nature. While such information will need to be made available to the Party of import through the notification procedure (see commentary on Article 8, and Annex I), the Protocol forbids the commercial use of that information by the Party of import, unless written consent from the notifier has been obtained. It should be noted here that the notifier may not itself be the entity which has the legal right to permit commercial use of the information provided. As noted under Article 9, according to the Protocol's AIA procedure the notifier may be either the Party of export or the exporter. It may be that none of these is the entity which holds proprietary rights over the commercial use of information in question.

568. Article 21(5) addresses the situation where a notifier decides to withdraw a notification made to a Party of import. This may occur because the proposed transboundary movement is not going ahead for a variety of reasons, including the possibility that the notifier and the Party of import have been unable to agree on which information should be treated as confidential. In such circumstances, the Party of import is not free to use or disclose the disputed information. It must respect the confidentiality of the information, even if it is of the view that confidential treatment has not been justified by the notifier. It is noteworthy that paragraph 5 refers specifically to “commercial and industrial information, including research and development information”, as well as more generally to “information”.

569. Article 21(6) lists four categories of information which are not to be treated as confidential. Debate on this provision during the negotiation focused on the categories of information that should be included here, and also on whether such information should never be treated as confidential or whether a weaker formulation should be used. The provision adopted suggests that the four categories of information cannot be identified by the notifier as confidential, and shall not in any circumstances be treated as confidential. The categories identified mirror those set out in corresponding provisions of some existing national biosafety frameworks. National legislation may also identify additional categories of information which the Party of import will not treat as confidential. For example, EU Directive 2001/18 on the deliberate release of GMOs into the environment provides that the purpose of the release, its location and intended uses may “in no case” be kept confidential.104 Colombia's Resolution 3492 regulating and establishing a procedure for the introduction, production, release and commercialization of GMOs, South Africa's Genetically Modified Organisms Act and Swiss Ordinance 814.911 on the Release of Organisms into the Environment have similar provisions listing information that will not be considered as confidential in nature. These norms then exclude as confidential the description of the GMOs; the contact details of the applicant (South African GMO Act 1997) or of those responsible for the release for experimental purposes or the placing on the market (Swiss Ordinance 814.911) or responsible for the project (Colombia Resolution 3494); the methods and plans for their monitoring and emergency measures in case of accident; and the evaluation of foreseeable impacts (South African GMO Act 1997). Australia's Gene Technology Act states that the Regulator must refuse to declare commercial information as confidential if such information relates to field trial locations, unless the Regulator is satisfied that disclosure would involve significant risks to health and safety.

103 For example Aarhus Convention, Article 4(4)(d). See also paragraph 561 below.

104 Article 25(4), Directive 2001/18 EC, OJ L 106, 17 April 2001.

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