Tony Abbott (Warringah, Liberal Party, Leader of the House) Share this | Link to this | Hansard source

I present a supplementary explanatory memorandum to the bill and I seek leave to move government amendments as circulated on sheets QH359 and PL298 together.

Leave granted.

I move amendments (1) to (21) on sheet QH359:

(1)    Schedule 1, item 34, page 10 (lines 8 to 29), omit subsection 84AE(3) (including the note), substitute:

Ministerial determination

        (3)    The Minister may, by legislative instrument, determine that 2 or more brands (the co-marketed brands) of a pharmaceutical item (the co-marketed item) are co-marketed brands of the co-marketed item if the co-marketed brands satisfy the following:

             (a)    within 4 months of the first of the co-marketed brands of the co-marketed item being included on the Australian Register of Therapeutic Goods, applications are made to include the other co-marketed brands of the co-marketed item on the Register;

             (b)    the first determination that is made under subsection 85(6) in relation to a brand of the co-marketed item is made only in relation to the co-marketed brands of the co-marketed item;

             (c)    no determination is in force under subsection 85(6) in relation to a brand of a pharmaceutical item that has the same drug as the co-marketed item (other than the co-marketed brands of the co-marketed item).

Note:   For the purposes of paragraph (c), the brand mentioned in that paragraph may be same as one of the co-marketed brands, or the pharmaceutical item mentioned in that paragraph may be the same as the co-marketed item.

(2)    Schedule 1, item 34, page 11 (before line 18), insert:

Determinations

(3)    Schedule 1, item 34, page 11 (after line 20), after subsection 84AG(1), insert:

     (1A)    If the Minister proposes to make a determination under paragraph (1)(a), the Minister must obtain the advice in writing of the Pharmaceutical Benefits Advisory Committee in relation to the proposed determination.

(4)    Schedule 1, item 34, page 12 (after line 7), at the end of section 84AG, add:

Regulations

        (6)    On the day on which this section commences, the regulations may prescribe one or more therapeutic groups.

(5)    Schedule 1, item 63, page 17 (lines 1 to 7), omit paragraphs 85AB(4)(a) and (b), substitute:

             (a)    there are no brands of pharmaceutical items that:

                   (i)    have the drug; and

                  (ii)    are bioequivalent; and

                 (iii)    are listed brands of the pharmaceutical items on any day in the relevant period;

             (b)    there are no brands of pharmaceutical items that:

                   (i)    have another listed drug that is in the same therapeutic group as the drug; and

                  (ii)    are bioequivalent; and

                 (iii)    are listed brands of the pharmaceutical items on any day in the relevant period;

(6)    Schedule 1, item 63, page 17 (lines 12 to 14), omit paragraph 85AB(5)(b), substitute:

             (b)    there are no brands of combination items that:

                   (i)    have the drug; and

                  (ii)    are bioequivalent; and

                 (iii)    are listed brands of the combination items on any day in the relevant period.

(7)    Schedule 1, item 63, page 17 (after line 14), at the end of section 85AB, add:

        (6)    In this section:

relevant period means the period that consists of:

             (a)    the day before the day the determination under subsection (1) comes into force; and

             (b)    the day the determination under subsection (1) comes into force.

(8)    Schedule 1, item 81, page 26 (line 17), omit “another listed brand”, substitute “the new brand, or another listed brand,”.

(9)    Schedule 1, item 81, page 29 (after line 12), at the end of subsection 99ACC(6), add:

           ; (c)    section 99ADH.

(10)  Schedule 1, item 81, page 30 (before line 5), before subsection 99ACD(2), insert:

     (1A)    This section does not apply in relation to the new brand of the trigger combination item if:

             (a)    the trigger combination item is in a class of pharmaceutical items to which a 12.5% administrative price reduction has applied; or

             (b)    another combination item that has the same drug and manner of administration as the new brand of the trigger combination item is in a class of pharmaceutical items to which a 12.5% administrative price reduction has applied; or

             (c)    if the drug in the trigger combination item is in a therapeutic group—a combination item that:

                   (i)    has another drug that is in that group; and

                  (ii)    has the same manner of administration as the new brand of the trigger combination item;

                      is in a class of pharmaceutical items to which a 12.5% administrative price reduction has applied.

(11)  Schedule 1, item 81, page 30 (line 8), omit “another listed brand”, substitute “the new brand, or another listed brand,”.

(12)         Schedule 1, item 81, page 30 (after line 13), at the end of subsection 99ACD(2), add:

      ; or (c)    if the drug in the trigger combination item is in a therapeutic group—a combination item that:

                   (i)    has another drug that is in that group; and

                  (ii)    has the same manner of administration as the new brand of the trigger combination item.

(13)  Schedule 1, item 81, page 32 (line 10), subparagraph 99ACE(1)(c)(ii), omit “; and”, substitute “;”.

(14)  Schedule 1, item 81, page 32 (after line 10), at the end of paragraph 99ACE(1)(c), add:

            (iii)    if the drug in the new combination item is in a therapeutic group—a combination item that has another drug that is in that group and has the same manner of administration as the new brand of the new combination item; and

(15)  Schedule 1, item 81, page 34 (lines 7 to 9), omit all the words from and including “reduction day,” to and including “column 2.”, substitute:

reduction day, by the following:

             (d)    the percentage specified in column 3 of the table for the section referred to in column 2;

             (e)    if there is a staged percentage for the listed brand of the pharmaceutical item for the reduction day—the amount specified in column 3 of the table for the section referred to in column 2.

(16)  Schedule 1, item 81, page 34 (lines 25 to 27), omit all the words from and including “reduced” to and including “and”, substitute:

                      reduced by more than:

                   (i)    the percentage specified in column 3 of the table for the section referred to in column 2; or

                  (ii)    if there is a staged percentage for the listed brand of the pharmaceutical item for the reduction day—the amount specified in column 3 of the table for the section referred to in column 2; and

(17)  Schedule 1, item 81, page 38 (line 29), omit “must”, substitute “may”.

(18)  Schedule 1, item 81, page 38 (line 31), omit “each of those days”, substitute “a reduction day”.

(19)  Schedule 1, item 81, page 39 (lines 8 and 9), omit subsection 99ACK(4), substitute:

        (4)    The percentages prescribed for each brand of the pharmaceutical item must not total more than 25%.

(20)  Schedule 1, item 83, page 60 (before line 23), before subsection 101(4AB), insert:

Function relating to Minister’s determination of therapeutic groups

  (4AA)    If the Committee is of the opinion that the Minister should, or should not, determine a therapeutic group, the Committee must advise the Minister accordingly.

(21)  Schedule 1, item 96, page 63 (before line 27), before paragraph 96(2)(a), insert:

I move amendments (1) to (17) on sheet PL298:

(1)    Schedule 1, item 4, page 3 (lines 18 to 20), omit the item.

(2)    Schedule 1, item 34, page 12 (line 13), after “bioequivalent”, insert “or biosimilar”.

(3)    Schedule 1, item 63, page 17, proposed subparagraph 85AB(4)(a)(ii), after “bioequivalent”, insert “or biosimilar”.

(4)    Schedule 1, item 63, page 17, proposed subparagraph 85AB(4)(b)(ii), after “bioequivalent”, insert “or biosimilar”.

(5)    Schedule 1, item 63, page 17, proposed subparagraph 85AB(5)(b)(ii), after “bioequivalent”, insert “or biosimilar”.

(6)    Schedule 1, item 71, page 21 (line 21), after “bioequivalent”, insert “or biosimilar”.

(7)    Schedule 1, item 81, page 25 (line 21), after “bioequivalent”, insert “or biosimilar”.

(8)    Schedule 1, item 81, page 28 (line 18), after “bioequivalent”, insert “or biosimilar”.

(9)    Schedule 1, item 81, page 29 (line 29), after “bioequivalent”, insert “or biosimilar”.

(10)  Schedule 1, item 81, page 43 (line 20), after “bioequivalent”, insert “or biosimilar”.

(11)  Schedule 1, item 81, page 51 (line 19), after “bioequivalent”, insert “or biosimilar”.

(12)  Schedule 1, item 81, page 52 (line 1), after “bioequivalent”, insert “or biosimilar”.

(13)  Schedule 1, item 81, page 52 (line 9), after “bioequivalent”, insert “or biosimilar”.

(14)  Schedule 1, item 81, page 53 (line 17), after “bioequivalent”, insert “or biosimilar”.

(15)  Schedule 1, item 81, page 53 (line 25), after “bioequivalent”, insert “or biosimilar”.

(16)  Schedule 1, item 81, page 58 (line 17), after “bioequivalent”, insert “or biosimilar”.

(17)  Schedule 1, item 81, page 59 (line 3), after “bioequivalent”, insert “or biosimilar”.

I think the amendments are uncontentious. We are providing for the Pharmaceutical Benefits Advisory Committee to provide the minister with advice in respect of the formation of new therapeutic groups. We are providing for proportionate price reductions for combination drugs. We are providing for lower price reductions for some on-patent drugs in the F2 formulary and we are adding the term ‘biosimilar’ to the term ‘bioequivalent’ in the bill to take account of the fact that there are complex biological drugs coming into our system as well as the more traditional, much simpler drugs. These are the amendments. I do not believe that they are contentious and I commend them to the House.

Stephen Smith (Perth, Australian Labor Party, Shadow Minister for Education and Training) Share this | Link to this | Hansard source

The member for Gellibrand, the shadow minister for health, is unavailable as a result of an electorate commitment; she has leave from the House. My instructions are, as the minister has outlined, that on the face of it these amendments look consistent with the bill and appear to be non-contentious. Certainly, that is the case with those amendments which relate to ‘bioequivalent’ as compared with ‘biosimilar’, and the minister has explained that both in his second reading reply and in his brief contribution on the committee stage amendments.

The more substantive amendments are as outlined by the minister and appear to be consistent with the thrust of the legislation. In any event, as the minister has alluded to, there is to be a Senate inquiry. If there are any technical deficiencies which interested parties see with the amendments, I am sure the minister, in the usual way, will be only too happy to accommodate any technical suggestions which add to the elegance of the bill.

Question agreed to.

Bill, as amended, agreed to.