6. The principal Act is amended by inserting, immediately after section 15, the following sections:“Protection of confidential supporting information about innovative pesticides |
15A.—(1) Where the Director receives, or has received not more than 5 years before the commencement of the Control of Plants (Amendment) Act 1998, an innovative pesticide application and confidential supporting information, the Director, during the protected period in relation to that confidential supporting information —(a) | shall take reasonable steps to ensure that the confidential supporting information is kept confidential to the Director; and | (b) | shall not use the confidential supporting information for the purposes of determining whether to grant any other application. |
(2) For the purposes of this section and section 15B, unless the context otherwise requires —“application” means an application for registration of a pesticide under section 15; |
“confidential information” includes —(a) | trade secrets; and | (b) | information that has commercial value that would be, or would be likely to be, diminished by disclosure; |
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“confidential supporting information” means confidential information given —(a) | in, or in relation to, an innovative pesticide application; and | (b) | about the pesticide that is or was, as the case may be, the subject of that application; |
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“Director” includes any public officer authorised under section 5A to carry out registration of pesticides under section 15; |
“ingredient” includes a chemical or biological entity; |
“innovative pesticide application” means —(a) | in relation to an application made after the commencement of the Control of Plants (Amendment) Act 1998, an application that refers to an active ingredient —(i) | that is an active ingredient of the pesticide to which the application relates; and | (ii) | that has not, before that application is received by the Director, been referred to in any other application as an active ingredient of the pesticide; and |
| (b) | in relation to an application made before the commencement of the Control of Plants (Amendment) Act 1998, an application that referred to an active ingredient —(i) | that is or was, as the case may be, an active ingredient of the pesticide to which the application related; and | (ii) | that had not, before the application was received by the Director, been referred to in any other application as an active ingredient of the pesticide; |
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“protected period”, in relation to confidential supporting information relating to an innovative pesticide application received by the Director, means a period of 5 years from the date the innovative pesticide application is or was, as the case may be, received by the Director. |
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Circumstances where protection under section 15A does not apply |
15B.—(1) Notwithstanding section 15A, the Director may, during the protected period in relation to confidential supporting information —(a) | disclose that confidential supporting information, or use that confidential supporting information for the purposes of determining whether to grant any application other than the application to which it relates or related, as the case may be —(i) | with the consent of the applicant who made the application to which the confidential supporting information relates or related; or | (ii) | if that disclosure or use is, in the opinion of the Director, necessary to protect the health or safety of members of the public; |
| (b) | disclose that confidential supporting information to a Government department or statutory body for the purposes of the Government department or statutory body if, in the opinion of the Director, the Government department or statutory body will take reasonable steps to ensure the confidential supporting information is kept confidential; or | (c) | disclose that confidential supporting information to any one or more of the following:(i) | the World Health Organisation; | (ii) | the Food and Agriculture Organisation; | (iii) | any regulatory agency of a WTO Country; | (iv) | any committee established under section 15(3); | (v) | any person or organisation, or a person or an organisation within a class or classes of persons or organisations, approved by any rules made under this Act, if the disclosure is in accordance with such conditions as may be specified in the rules. |
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(2) The power to grant consent under subsection (1)(a)(i) may be exercised by a person other than the applicant referred to in that subsection if —(a) | that applicant —(i) | has notified the Director in writing that that other person may grant that consent; and | (ii) | has not notified the Director in writing that that person’s authority to grant that consent has been withdrawn; or |
| (b) | that applicant’s rights in respect of the relevant confidential supporting information have been transferred to that person and the applicant or that other person has notified the Director in writing of the transfer. |
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(3) For the purposes of this section, “WTO Country” means a country that is a party to the Agreement establishing the World Trade Organisation adopted at Marrakesh on 15th April 1994.”. |
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