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Discussion Group 2

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Theme 6: Confidentiality [#3288]
Dear Forum Participant,

Welcome to Theme 6 on "Confidentiality".

We welcome you to answer the guiding questions listed below.

1. What laws and/or procedures are in place in your country to determine which biosafety information is to be considered confidential information?

2. What is/are the reason(s) for your country to have certain type of biosafety information confidential?

3. What are the major challenges with confidential information and how can they be addressed?

4. Is information available according to paragraph 6 of Article 21?

Best regards,

Ulrika Nilsson
(edited on 2012-06-11 18:48 UTC by Ulrika Nilsson)
posted on 2012-05-24 17:31 UTC by Ms. Ulrika Nilsson, UNEP/SCBD/Biosafety
RE: Theme 6: Confidentiality [#3531]
6. Confidentiality
The notifier can characterise certain provided information as confidential ones. In such a case the serious reason must be given.
Nevertheless, national legislation can define, which information cannot be denied.
According to the Czech legislation, to this group belong:
- general descriprion of genetically modified organism
- identity of  notifier
- location of  field trials
- risk assessment
- emergency response plan.
Nevertheless, even such information are accessible to certain authorized bodies, such as State Authorities referred in legislation, Governmental Commission acting in the given sphere, laboratories for detection of genetically modified organisms, relevant authorities of other EU Member States and European Commission.

Milena Roudna
posted on 2012-06-11 15:31 UTC by Ph.D. Milena Roudna, Ministry of the Environment of the Czech Republic
RE: Theme 6: Confidentiality [#3542]
Chapter III of the Specification of the procedure for the provision of information on the environment in the Republic of Lithuania to the public approved by Government Resolution No 1175 of 22 October 1999 (Official Gazette Valstybes Zinios, 1999, No 90-2660; 2005, No 26-831, 2010, No 19-864) provides a list of cases when authorities may not provide information on the environment.
Information may not be presented if: an applicant applies for information which the institution does not have and is not obliged by legal acts to have it; if an inquiry is very abstract or illogically formulated and the applicant fails to correct it upon a written request; an application is related to information and data that are still being accumulated, prepared or unprocessed, provided that this does not violate public interest.

In the announcement issued according to the regulation approved by Order No. D1-225 “On the Approval of the Description of the Regulation for the Deliberate Release into the Environment of GMO or Placing of GMO in the Market” of 29 April 2004 of the Minister of Environment of the Republic of Lithuania (Official Gazette, No. 71-2487, 2004; No. 124-4710, 2006), the notifier may provide information the disclosure of which can damage its competitiveness and therefore it should be considered confidential. In such case the notifier must provide the Ministry of Environment with documents supporting the said confidential nature, and it must be possible to verify such documents.
The following information cannot be considered confidential:
- the general description of the genetically modified organism/organisms and its/their product/products, the notifier’s name/corporate name and address, the goal, location and the intended purpose of the release into the environment;
- methods and plans for monitoring of genetically modified organism/organisms and its/their product/products and for response to critical situations;
- environmental risk assessment;
- information provided in the application.
Having consulted with the notifier, the Ministry of Environment shall decide which information will be considered confidential and shall inform the notifier about its decision in writing. The Ministry of Environment shall not provide third parties with any confidential information shared or contained in announcement received; it shall protect intellectual property rights related to the received data.
The confidentiality of commercial and industrial information is governed by the Law on Competition of the Republic of Lithuania (Official Gazette Valstybes Žinios, 1999, No 30-856) which defines commercial secrets.

Respectfully,
Gintare Blazauskiene (NFP)
GMO Division
Nature Protection Department
The Ministry of Environment of Lithuania
posted on 2012-06-12 06:55 UTC by Mrs. Gintarė Blažauskienė, Ministry of Environment
RE: Theme 6: Confidentiality [#3548]
Article 23 of the Cartagena Protocol on Biosafety deals with public awareness and participation. The issue of public access to information is closely related and is integral to meaningful and effective facilitation and implementation of biosafety public awareness, education and participation. As such, Article 21 on 'confidential information' needs to be implemented in a manner that is consistent with Article 23 and the spirit and objectives of the Biosafety Protocol.

During the Cartagena Protocol negotiations, the Africa Group (supported by a number of other developing countries) argued that a provision on protection of trade secrets and confidential business information was not necessary since these are already adequately protected under other related laws. The World Trade Organization’s (WTO) Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) already provides for such protection with prescribed criteria. The provision in the Cartagena Protocol remained, and evolved from 'confidential business information' to 'confidential information'.

Parties will therefore have to be clear about defining the scope and conditions for claims for protection of confidential information in national biosafety laws. It is important to emphasize that the regulatory authorities have the right to all information necessary for decision-making and that Article 21 only refers to information that is confidential in relation to the public. Any claims for confidentiality need to be justified by the applicant, and negotiated with the authorities in question. For example, under the TRIPS Agreement, if information is not disclosed, this is because that information is secret in the sense that it has commercial value, that is is not generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question, and has been subject to reasonable steps, by the person lawfully in control of the information, to keep it secret.

Experience reaffirms that it is only in an open and transparent system that all available information, views and assessment can be brought together to ensure sound and responsible collective decision-making. Since the possible consequences of hazards posed by LMOs to the environment and human health are serious, information disclosure to the public and especially scientists in the public domain is crucial. As such, Article 21(6) of the Protocol provides an important safeguard to ensure the information as spelled out therein is not kept confidential.

Lim Li Ching
Third World Network
posted on 2012-06-12 12:47 UTC by Ms. Li Ching Lim, Third World Network
RE: Theme 6: Confidentiality [#3586]
During the Negotiations of the Cartagena Protocol a number of countries pressed for a provision on confidential information, 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. The negotiations on this issue resulted in article 21 of the protocol. 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. 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”.
O.A.El-Kawy
(edited on 2012-06-15 17:57 UTC by Ossama Abdelkawy)
posted on 2012-06-15 17:52 UTC by Mr. Ossama Abdelkawy, Syrian Arab Republic
RE: Theme 6: Confidentiality [#3560]
1. We do not have national laws or procedures which determine the information which is described as confidential, but having left with the Protocol Cartagena, it is article 21 subparagraphs 1, 2, 3, 4, 5 which is in force. 

2. The reasons which justify certain information on the biosafety, confidential are initially the implementation of article 21 of Protocol and the fact that it is about an intellectual work from where the application of the right relating to the intellectual property.

3. The principal challenges relating to the confidentiality are:  how long is it necessary to regard them as confidential?  And how to preserve the confidentiality so certain citizens belonging to the National Committee of biosafety or other structures managing the biosafety know about this information?

4. Information relating to paragraph 6 of article 21 is not qualified the confidential ones.  It is about: 
– the name and the address of the author of the notification;
– a general description of the organism or LMO;
– a summary of the evaluation of the risks of impact on the conservation and the durable use of biological diversity, holding account also health risks human; 
– Methods and plans of emergency intervention.
posted on 2012-06-13 09:08 UTC by Mr. Comlan Marcel KAKPO, Ministère de l'Environnement, de l'Habitat et de l'Urbanisme
RE: Theme 6: Confidentiality [#3574]
The Philippines' National Biosafety Framework, specifically Part VII, Section 15 of the Department of Agriculture Administrative Order #8 better known as "RULES AND REGULATIONS FOR THE IMPORTATION AND RELEASE INTO THE ENVIRONMENT OF PLANTS AND PLANT PRODUCTS DERIVED FROM THE USE OF MODERN BIOTECHNOLOGY", address the issue on Confidential Business Information, to wit:

A. If there are portions of the applications mentioned in this Order which contain trade secrets or confidential business information, each page of the application containing such information shall be marked "Commercial-in-Confidence" (CIC) by the applicant. In addition, portions of the application which are deemed "CIC"shall be so designated. The applicant shall also submit one (1) copy of the application with all the CIC deleted, but marked with "CIC deleted" on each page where the CIC was deleted. If an application does not contain any CIC, then the first page of all copies submitted to BPI shall be marked "No CIC".
B. In no case, however, shall the following information be considered CIC:
1. Name and address of the applicant;
2. Description of the regulated article;
3. Description of the intended destination (including all intermediate and final
destinations), uses, and distribution of the regulated article;
4. Summary of the risk assessment of the effects of the regulated article on the environment and human health;
5. Where appropriate, description of the proposed procedures, processes and safeguards which will be used by the applicant to prevent escape and dissemination of the regulated article at each of the intended destinations;
6. Description of the methods and plans for emergency response in case of accidental release of the regulated article into the environment; and
7. Description of the proposed method of final disposition of the regulated article.
C. BPI shall inform the applicant if the information the latter identified as CIC does not qualify for such treatment and shall provide it an opportunity for consultation and review of its decision prior to disclosure to any third party.
D. An applicant may refer to data or results from applications previously submitted by other applicants: Provided, that (i) the information, data or results are not CIC, or (ii) if the otherwise, the previous applicants have given their consent in writing to the use of their confidential information, data or results.
posted on 2012-06-14 03:19 UTC by Ms. Julieta Fe L. Estacio, Philippines
RE: Theme 6: Confidentiality [#3575]
In Malaysia, an applicant can apply for confidentiality of any commercial and industrial information. The criteria for grant of confidentiality is identical to that in the WTO Trade Related Intellectual Properties Rights (TRIPS) Agreement Article 39(2)(a)-(c). Any such information cannot then be disclosed to the public. This is made explicit in sections 14(c) and 59 of the Malaysian Biosafety Act.

Regards
Johnny Andrew
Department of Biosafety
Malaysia
posted on 2012-06-14 03:49 UTC by Johnny Anak Andrew
RE: Theme 6: Confidentiality [#3583]
Bethia Daniel, Ministry of Sustainable Development, Energy, Science and Technology, Saint Lucia

1. What laws and/or procedures are in place in your country to determine which biosafety information is to be considered confidential information?

No laws in place as yet just a draft framework.


2. What is/are the reason(s) for your country to have certain type of biosafety information confidential?

There are only two instances when biosaftey information may be considered to be confidential:
(a) If it may cause panic
(b) If it can be a matter if national security

However, this may not have been included in the draft framework.


3. What are the major challenges with confidential information and how can they be addressed?

One major challenge with confidential information is that it may leak out. Persons who are responsible for “concealing” this information may have friends, who would then have friends, …and so forth. And in a small island like Saint Lucia, with about 160 000 people, the “bad” news would spread like wild fire.

One way in which this can be addressed is through heavy fines and penalties which can be written into the law for anyone contravening it.


4. Is information available according to paragraph 6 of Article 21?

That has been included in the draft framework.
posted on 2012-06-15 12:59 UTC by Ms. Bethia Daniel, Ministry of Sustainable Development, Energy and Science and Technology
RE: Theme 6: Confidentiality [#3587]
The provisions of Article 21 of the Cartagena protocol specify the basic procedure for ensuring protection of confidential information provided under the procedures of the Protocol; address the situations where the Party of import and the notifier disagree as to whether particular information should be treated as confidential or not, and where the notifier decides to withdraw a notification; set out a general obligation to protect confidential information received under the Protocol; and  specify categories of information which shall not be considered confidential.

- 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 to take steps to ensure that the confidentiality of the information in question is protected. 

- 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.  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). 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).
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. It 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.

- 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.
O.A.El-Kawy
(edited on 2012-06-15 18:13 UTC by Ossama Abdelkawy)
posted on 2012-06-15 18:10 UTC by Mr. Ossama Abdelkawy, Syrian Arab Republic
RE: Theme 6: Confidentiality [#3601]
1. What laws and/or procedures are in place in your country to determine which biosafety information is to be considered confidential information?
        The Article 21 of the Cartagena Protocol on Biosafety works in the Republic of Belarus in full. There is no other procedure to determine which biosafety information is to be considered as confidential information in the national legislation.

2. What is/are the reason(s) for your country to have certain type of biosafety information confidential?
The only one reason is - adherence to the Cartagena Protocol.

3. What are the major challenges with confidential information and how can they be addressed?
Belarus has no experience in dealing with confidential biosafety information. 

4. Is information available according to paragraph 6 of Article 21? 
     There is no information according to paragraph 6 of Article 21 because non-pathogenic LMOs were not imported in Belarus.

BCH NFP Elena Makeyeva, Belarus
posted on 2012-06-16 13:33 UTC by Assoc. Prof. Elena Makeyeva, Belarus
RE: Theme 6: Confidentiality [#3611]
As stated in the previous part of this online discussion, 'the public' includes experts in a wide range of fields such as biosafety, ecology, biology, agriculture, medicine and related or cross-cutting fields such as bee keeping and more. All of these can provide relevant and additional information, science and expertise on - but not limited to - biosafety, risk assessment, monitoring etc.

But in order to do so they - and thereby the public in general - needs access to the complete information: about the LMO, the research done with it, the locations of releases, etc.

Declaring any of this information as confidential, weakens biosafety.
posted on 2012-06-17 12:19 UTC by Ms. Antje Lorch, Ecoropa
RE: Theme 6: Confidentiality [#3621]
The National Biosafety Commission on the base of notification request may get decision on which information should be considered confidential and should not be published or disseminated. According to national regulation, the following information could not be considered as confidential:
-general description of LMOs,
- name and contact information of notifier;
-the scope of LMOs introduction or use;
-a previous experience with this specific LMOs;
- if this LMOs prohibited in the EU;
- the location of the intended release to the environment;
- Report on risak assessment on environment and human health;
- monitoring plan;
- measurement for wast treatment of LMOs;
-Emergency plan.
posted on 2012-06-18 10:21 UTC by Angela Lozan
RE: Theme 6: Confidentiality [#3635]
In response to question 3 (What are the major challenges with confidential information and how can they be addressed?), the Global Industry Coalition would like to emphasize that regulatory approval is essential to re-assure growers and consumers that plant biotechnology products meet established regulatory standards for quality and safety. Regulatory data are submitted to authorities with the understanding that certain elements designated as confidential business information (CBI) will be protected by confidentiality rules. CBI is information that is exempt from public disclosure by regulatory authorities. If disclosed, it could be detrimental to the proprietor’s business interests or the safety and privacy of researchers.  Failure to adequately protect CBI discourages the research and development of innovative products by the plant science industry.

For highly regulated industries, such as the plant biotechnology sector, required data submissions to regulatory authorities often contain CBI. This poses a challenge for safeguarding confidentiality on a global basis. Without the express consent of the data owners CBI must not be shared with third parties. The Cartagena Protocol on Biosafety calls for the protection of CBI while providing for appropriate public information and participation.

[…] Each Party shall protect confidential information received under this Protocol, including any confidential information received in the context of the advance informed agreement procedure of the Protocol. Each Party shall ensure that it has procedures to protect such information and shall protect the confidentiality of such information in a manner no less favourable than its treatment of confidential information in connection with domestically produced living modified organisms.

[…] The Party of import shall not use such information for a commercial purpose, except with the written consent of the notifier.

A common understanding on what constitutes CBI is required in order to address the challenges of maintaining CBI. By adopting the following recommendations regulatory authorities could help prevent CBI disclosure:
• Clarity of procedure: Registrants and regulatory authorities should discuss and mutually agree on measures to safeguard CBI while data are in the custody of the national authorities.
• Training: Ongoing training/capacity building for industry and government officers should be strongly encouraged.
• Clarity of rules: National authorities should publish data confidentiality rules which should contain data management and custody procedures.
• Withdrawal of CBI: When data is submitted for CBI consideration, the regulatory authority should swiftly issue a preliminary decision. If the data owner and regulatory authority disagree on what should be considered CBI, the applicant has the right to withdraw the submission. In such a case the regulatory authority cannot make any use of any information contained in the withdrawn submission.
• Accountability: National authorities should appoint officers who will be accountable for handling confidential studies. The officers should receive proper training and be liable for the maintenance of confidentiality.
• Recommended procedures: Security measures for printed applications typically include printing reports on security paper containing watermarks or other hidden identification tools that regulators can readily identify.
• Identification of CBI: Applicants should easily identify that data which is CBI and provide a reference checklist to the regulatory authority detailing all the information claimed as CBI.  One suggestion to consider is to request applicants to provide two versions of their dossiers: one which provides all information as required by applicable law, and one that has CBI redacted according to any applicable CBI limitations. This would provide clarity to the authorities on what they are able to share with the public, and at the same time would make it clear that the authorities themselves have received the complete dataset required by law, enabling them to complete their assessment.
• Records of Regulatory Authorities: Regulatory authorities should record the registrants’ names, filing dates, time, and list of filed data with definite indication of what CBI is contained in the regulatory dossiers.
• Legal verification of filing process: In jurisdictions where certification from Notaries Public can accompany the filing process, it is recommended to minute the submission of the CBI.
• Secure storage and access to CBI: Once CBI is submitted to regulatory authorities, it should be immediately stored under secure conditions. It is recommended that every access is recorded in logs, where date, time and purpose of the visit are indicated.
• Public access: Regulatory authorities should never make CBI available for review by the public in reading rooms or other facilities. In jurisdictions where the public is permitted to review regulatory dossiers, reading room facilities should be made available for non CBI data.
• Non-disclosure of CBI: Evaluating officers shall refrain from disclosing CBI in evaluation reports.
• Emergency measures concerning secure storage of CBI: Security and emergency protocols detailing how data should be managed in case of emergencies (e.g., fire, flooding, earthquake,) should be in place.
(edited on 2012-06-18 21:15 UTC by Sarah Lukie)
posted on 2012-06-18 20:59 UTC by Ms. Sarah Lukie, Croplife International, Global Industry Coalition