Psychoactive Substances Bill

  • enacted
34 Authority must protect confidential supporting information relating to application for approval
  • (1) This section applies if the Authority has received an application for approval of a psychoactive product under section 31 that includes confidential supporting information specified in, or given in relation to, the application.

    (2) The Authority—

    • (a) must, during the protected period, take reasonable steps to ensure that the confidential supporting information is kept confidential to the Authority; and

    • (b) must not use that confidential supporting information for the purposes of deciding whether to grant any other application for approval of a psychoactive product.

    (3) Despite subsection (2), the Authority may, during the protected period, disclose the confidential supporting information referred to in subsection (1)

    • (a) to 1 or more of the following:

      • (i) the World Health Organization:

      • (ii) the Food and Agriculture Organization:

      • (iii) any regulatory agency of a WTO country:

      • (iv) any person or organisation or class of persons or organisations approved by the regulations; and

    • (b) to 1 or more of the following persons or organisations if the Authority is satisfied that the person or organisation will take reasonable steps to ensure that the confidential supporting information is kept confidential:

      • (i) the advisory committee:

      • (ii) the Expert Advisory Committee on Drugs established under section 5AA of the Misuse of Drugs Act 1975:

      • (iii) any adviser for the purpose of obtaining advice about the psychoactive substance to which the confidential supporting information relates:

      • (iv) a government department or statutory body for the purposes of the government department or statutory body.

    (4) In this section,—

    confidential supporting information includes—

    • (a) trade secrets; and

    • (b) information that has commercial value that would be, or would be likely to be, diminished by disclosure

    protected period means, in relation to confidential supporting information, a period beginning on the date on which the Authority receives that information and ending on the day that is 5 years after the date on which the Authority received the application for approval to which the information relates

    WTO country means a country that is a party to the Agreement Establishing the World Trade Organization adopted at Marrakesh on 15 April 1994.

    Compare: 1981 No 118 ss 23A–23C