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Schedule 4—New brands

Schedule 4 New brands

Part 1 Amendments commencing day after Royal Assent

National Health Act 1953

1  After subsection 85AB(4)

Insert:

          (4A)  For the purposes of working out whether paragraph (4)(a) or (b) is satisfied, a brand of a pharmaceutical item that has the drug is to be disregarded if:

                     (a)  both:

                              (i)  subsection 99ACB(3A) or (3B) applies to the brand of the pharmaceutical item that has the drug; and

                             (ii)  there is not another brand of the pharmaceutical item that has the drug that is a listed brand; or

                     (b)  both:

                              (i)  subsection 99ACB(3A) or (3B) applies to the brand of the pharmaceutical item that has the drug; and

                             (ii)  the drug is not on F2; or

                     (c)  both:

                              (i)  subsection 99ACB(3B) applies to the brand of the pharmaceutical item that has the drug; and

                             (ii)  the tenth anniversary of the drug in the pharmaceutical item being on F1 has not occurred.

2  Subsection 99ACB(1)

Omit “and (3)”, substitute “, (3), (3A) and (3B)”.

3  After subsection 99ACB(3)

Insert:

          (3A)  This section does not apply in relation to the new brand of the trigger item if:

                     (a)  the new brand of the trigger item is a new presentation of an existing listed brand of a pharmaceutical item; and

                     (b)  the determination day in relation to the new brand of the trigger item is on or before the fifth anniversary of the drug in the pharmaceutical item being on F1; and

                     (c)  the responsible person for the new brand of the trigger item is the same person as the responsible person for the existing listed brand of the pharmaceutical item; and

                     (d)  either of the following apply:

                              (i)  there is not another brand of the pharmaceutical item that has the drug that is a listed brand;

                             (ii)  the drug is not on F2.

          (3B)  This section does not apply in relation to the new brand of the trigger item if:

                     (a)  the new brand of the trigger item is a new presentation of an existing listed brand of a pharmaceutical item; and

                     (b)  the Minister has made a determination under section 99ACBA in relation to the new brand of the trigger item; and

                     (c)  the determination under section 99ACBA has not ceased to have effect.

4  At the end of Subdivision B of Division 3A of Part VII

Add:

99ACBA   Ministerial determination—brand of pharmaceutical item that is not a combination item is not a new brand

             (1)  If:

                     (a)  a brand of a pharmaceutical item (the trigger item ) is not a combination item; and

                     (b)  the brand of the trigger item:

                              (i)  is not a listed brand of the trigger item; and

                             (ii)  is a new presentation of an existing listed brand of a pharmaceutical item; and

                     (c)  the Minister is satisfied that the determination day in relation to the brand of the trigger item is to be after the fifth anniversary, and before the tenth anniversary, of the drug in the pharmaceutical item being on F1;

the Minister may determine, by notifiable instrument, that the brand of the trigger item is not a new brand for the purposes of section 99ACB.

             (2)  If the Minister makes a determination under this section in relation to the brand of the trigger item, it must be made before the determination day in relation to the brand of the trigger item.

             (3)  In making a determination, the Minister may have regard to:

                     (a)  any advice given by the Pharmaceutical Benefits Advisory Committee; and

                     (b)  any information provided by the responsible person for the brand of the trigger item; and

                     (c)  any other matter that the Minister considers relevant.

             (4)  A determination made under this section ceases to have effect on whichever is the earliest of the following:

                     (a)  the day that another brand of the pharmaceutical item becomes a listed brand;

                     (b)  the day that the drug in the pharmaceutical item does not satisfy all of the criteria for F1;

                     (c)  the tenth anniversary of the drug in the pharmaceutical item being on F1.

             (5)  In this section:

determination day has the same meaning as in paragraph 99ACB(1)(a).

5  Subsection 99ACD(1)

Omit “and (2)”, substitute “, (2) and (3)”.

6  After subsection 99ACD(2)

Insert:

             (3)  This section does not apply in relation to the new brand of the trigger combination item if:

                     (a)  all of the following apply:

                              (i)  the new brand of the trigger combination item is a new presentation of an existing listed brand of a pharmaceutical item;

                             (ii)   a declaration under subsection 85(2) is in force in relation to the drug in the pharmaceutical item;

                            (iii)  the determination day in relation to the new brand of the trigger combination item is on or before the fifth anniversary of the declaration under subsection 85(2) being made;

                            (iv)  the responsible person for the new brand of the trigger combination item is the same as the responsible person for the existing listed brand of the pharmaceutical item;

                             (v)  the drug is not on F2; or

                     (b)  all of the following apply:

                              (i)  the new brand of the trigger combination item is a new presentation of an existing listed brand of a pharmaceutical item;

                             (ii)  the Minister has made a determination under section 99ACEA in relation to the new brand of the trigger combination item;

                            (iii)  the determination under section 99ACEA has not ceased to have effect.

7  At the end of Subdivision C of Division 3A of Part VII

Add:

99ACEA   Ministerial determination—brand of pharmaceutical item that is a combination item is not a new brand

             (1)  If:

                     (a)  a brand of a pharmaceutical item (the trigger combination item ) is a combination item; and

                     (b)  the brand of the trigger combination item is a new presentation of an existing listed brand of a pharmaceutical item; and

                     (c)  a declaration under subsection 85(2) is in force in relation to the drug in the pharmaceutical item; and

                     (d)  the Minister is satisfied that the determination day in relation to the brand of the trigger combination item is after the fifth anniversary, and before the tenth anniversary, of the declaration under subsection 85(2) being made;

the Minister may determine, by notifiable instrument, that the brand of the trigger combination item is not a new brand for the purposes of section 99ACD.

             (2)  If the Minister makes a determination under this section in relation to the brand of the trigger combination item, it must be made before the determination day in relation to the brand of the trigger combination item.

             (3)  In making a determination, the Minister may have regard to:

                     (a)  any advice given by the Pharmaceutical Benefits Advisory Committee; and

                     (b)  any information provided by the responsible person for the brand of the trigger combination item; and

                     (c)  any other matter that the Minister considers relevant.

             (4)  A determination made under this section ceases to have effect on whichever is the earliest of the following:

                     (a)  the tenth anniversary of the declaration under subsection 85(2) being made;

                     (b)  the day that the drug is on F2.

             (5)  In this section:

determination day has the same meaning as in paragraph 99ACD(1)(a).

8  After subsection 101(4AC)

Insert:

Functions relating to determinations that brands are not new brands

       (4AD)  The Pharmaceutical Benefits Advisory Committee may give advice to the Minister in relation to whether the Minister should determine that a brand of a pharmaceutical item is not a new brand for the purposes of section 99ACB or 99ACD.

Part 2 Amendments commencing 1 July 2022

National Health Act 1953

9  Subsection 85AB(4A)

Repeal the subsection, substitute:

          (4A)  For the purposes of working out whether subsection (4) is satisfied, a brand of a pharmaceutical item that has the drug is to be disregarded if:

                     (a)  before 1 July 2022, subsection 99ACB(3A) or (3B), as in force before its repeal by the National Health Amendment (Pharmaceutical Benefits—Budget and Other Measures) Act 2018 , applied in relation to the brand of the pharmaceutical item; and

                     (b)  all of the following apply:

                              (i)  another brand of the pharmaceutical item has not become a listed brand;

                             (ii)  the drug is not on F2;

                            (iii)  the tenth anniversary of the drug in the pharmaceutical item being on F1 has not occurred.

10  Subsection 99ACB(1)

Omit “, (3A) and (3B)”, substitute “and (3A)”.

11  Subsections 99ACB(3A) and (3B)

Repeal the subsections, substitute:

          (3A)  This section does not apply in relation to the new brand of the trigger item if:

                     (a)  the new brand of the trigger item is a new presentation of an existing listed brand of a pharmaceutical item; and

                     (b)  before 1 July 2022, subsection 99ACB(3A) or (3B), as in force before its repeal by the National Health Amendment (Pharmaceutical Benefits—Budget and Other Measures) Act 2018 , applied in relation to the new brand of the trigger item; and

                     (c)  all of the following apply:

                              (i)  the drug is not on F2;

                             (ii)  the tenth anniversary of the drug in the pharmaceutical item being on F1 has not occurred;

                            (iii)  another brand of the pharmaceutical item has not become a listed brand.

12  Section 99ACBA

Repeal the section.

13  Subsection 99ACD(3)

Repeal the subsection, substitute:

             (3)  This section does not apply in relation to the new brand of the trigger combination item if:

                     (a)  the new brand of the trigger combination item is a new presentation of an existing listed brand of a pharmaceutical item; and

                     (b)  before 1 July 2022, paragraph 99ACD(3)(a) or (b), as in force before its repeal by the National Health Amendment (Pharmaceutical Benefits—Budget and Other Measures) Act 2018 , applied in relation to the new brand of the trigger combination item; and

                     (c)  both of the following apply:

                              (i)  the tenth anniversary of the declaration under subsection 85(2) relating to the drug in the pharmaceutical item being made has not occurred;

                             (ii)  the drug is not on F2.

14  Section 99ACEA

Repeal the section.

15  Subsection 101(4AD)

Repeal the subsection.