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Schedule 1—Reporting medicine shortages and discontinuation of supply of medicine

Schedule 1 Reporting medicine shortages and discontinuation of supply of medicine

   

Therapeutic Goods Act 1989

1  Subsection 3(1)

Insert:

reportable medicine has the meaning given by section 30EH.

shortage of a medicine in Australia has the meaning given by section 30EI.

2  After Division 2A of Part 3-2

Insert:

Division 2B Reporting medicine shortages and discontinuation of supply of medicine

30EF   Reporting medicine shortages

             (1)  A person in relation to whom a reportable medicine is included in the Register must notify the Secretary of any shortage of the medicine in Australia. The person must do so:

                     (a)  for a shortage that has a critical impact—as soon as possible, but no later than 2 working days, after the first day the person knows, or ought reasonably to have known, of the shortage; or

                     (b)  in any other case—before the end of 10 working days beginning on the first day the person knows, or ought reasonably to have known, of the shortage.

Note:          For reportable medicine , see section 30EH. For shortage of a medicine in Australia, see section 30EI.

Critical impact

             (2)  The shortage of a medicine in Australia at a particular time has a critical impact if, at that time, the medicine is included in an instrument under section 30EJ.

             (3)  The shortage of a medicine in Australia at a particular time also has a critical impact if:

                     (a)  either:

                              (i)  at that time, there are no registered goods that could reasonably be used as a substitute for the medicine; or

                             (ii)  at that time, there are other registered goods that could reasonably be used as a substitute for the medicine but the other registered goods are not likely to be available in sufficient quantities to meet the demand for the other registered goods that is likely to arise because of the shortage; and

                     (b)  the shortage has the potential to have a life-threatening impact on, or a serious impact on the physical or mental health or functioning of, persons who take, or who may need to take, the medicine.

Notification requirements

             (4)  A notification under subsection (1) must:

                     (a)  be in accordance with a form that is approved, in writing, by the Secretary; and

                     (b)  contain the information required by that form.

             (5)  An approval of a form may require or permit information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

Civil penalty

             (6)  A person contravenes this subsection if:

                     (a)  the person is subject to a requirement under subsection (1); and

                     (b)  the person contravenes the requirement.

Maximum civil penalty:

                     (a)  for an individual—100 penalty units; and

                     (b)  for a body corporate—1,000 penalty units.

Exception

             (7)  Subsection (6) does not apply if:

                     (a)  paragraph (1)(a) and subsection (3) apply in relation to the shortage but subsection (2) does not; and

                     (b)  as a result of steps taken by the person, it was reasonable for the person to assume that paragraph (1)(b) applied in relation to the shortage; and

                     (c)  the person complied with paragraph (1)(b) in relation to the shortage.

30EG   Reporting discontinuation of supply of medicine

             (1)  A person in relation to whom a reportable medicine is included in the Register must notify the Secretary of any decision (the discontinuation decision ) of the person to permanently discontinue the supply of the medicine in Australia. The person must do so:

                     (a)  if the discontinuation is likely to be of critical impact:

                              (i)  at least 12 months before the discontinuation is proposed to occur; or

                             (ii)  if the person is unable to comply with subparagraph (i)—as soon as practicable after the decision is made; or

                     (b)  in any other case:

                              (i)  at least 6 months before the discontinuation is proposed to occur; or

                             (ii)  if the person is unable to comply with subparagraph (i)—as soon as practicable after the decision is made.

Note:          For reportable medicine , see section 30EH.

Critical impact

             (2)  The discontinuation of the supply of a medicine in Australia is likely to be of critical impact if, when the discontinuation decision is made, the medicine is included in an instrument under section 30EJ.

             (3)  The discontinuation of the supply of a medicine in Australia is also likely to be of critical impact if:

                     (a)  either:

                              (i)  when the discontinuation decision is made, there are no registered goods that could reasonably be used as a substitute for the medicine; or

                             (ii)  when the discontinuation decision is made, there are other registered goods that could reasonably be used as a substitute for the medicine but the other registered goods are not likely to be available in sufficient quantities to meet the demand for the other registered goods that is likely to arise because of the discontinuation; and

                     (b)  the discontinuation has the potential to have a life-threatening impact on, or a serious impact on the physical or mental health or functioning of, persons who take, or who may need to take, the medicine.

Notification requirements

             (4)  A notification under subsection (1) must:

                     (a)  be in accordance with a form that is approved, in writing, by the Secretary; and

                     (b)  contain the information required by that form.

             (5)  An approval of a form may require or permit information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

Civil penalty

             (6)  A person contravenes this subsection if:

                     (a)  the person is subject to a requirement under subsection (1); and

                     (b)  the person contravenes the requirement.

Maximum civil penalty:

                     (a)  for an individual—100 penalty units; and

                     (b)  for a body corporate—1,000 penalty units.

Exception

             (7)  Subsection (6) does not apply if:

                     (a)  paragraph (1)(a) and subsection (3) apply in relation to the discontinuation but subsection (2) does not; and

                     (b)  as a result of steps taken by the person, it was reasonable for the person to assume that paragraph (1)(b) applied in relation to the discontinuation; and

                     (c)  the person complied with paragraph (1)(b) in relation to the discontinuation.

30EH   What is a reportable medicine?

             (1)  For the purposes of this Act, registered goods are a reportable medicine if:

                     (a)  the goods are medicine; and

                     (b)  either:

                              (i)  the medicine contains one or more substances included in Schedule 4 or 8 to the current Poisons Standard; or

                             (ii)  the medicine is determined in an instrument under subsection (2).

             (2)  The Minister may, by legislative instrument, determine medicine for the purposes of subparagraph (1)(b)(ii).

             (3)  The Minister must not determine a medicine unless the Minister is satisfied of either or both of the following:

                     (a)  the medicine is critical to the health of patients in Australia;

                     (b)  the notification to the Secretary of any shortage of the medicine, or of any decision to permanently discontinue the supply of the medicine, in Australia would be in the interests of public health.

30EI   When is there a medicine shortage?

                   For the purposes of this Act, there is a shortage of a medicine in Australia at a particular time if, at any time in the 6 months after that particular time, the supply of that medicine in Australia will not, or will not be likely to, meet the demand for the medicine for all of the patients in Australia who take, or who may need to take, the medicine.

30EJ   Medicines Watch List

             (1)  The Minister may, by legislative instrument, determine medicine for the purposes of subsections 30EF(2) and 30EG(2).

             (2)  The Minister must not determine a medicine unless the Minister is satisfied that any shortage of the medicine, or any permanent discontinuation of the supply of the medicine, in Australia has the potential to result in:

                     (a)  significant morbidity in patients in Australia; or

                     (b)  the death of one or more patients in Australia.

3  After paragraph 31(1)(j)

Insert:

                    (ja)  if the goods are a reportable medicine and the medicine is registered in relation to the person:

                              (i)  whether or not there is a shortage of the medicine in Australia; or

                             (ii)  if there is a shortage of the medicine in Australia—the shortage; or

                            (iii)  any decision of the person to permanently discontinue the supply of the medicine in Australia;

4  Application provisions

(1)       Section 30EF of the Therapeutic Goods Act 1989 , as inserted by this Schedule, applies in relation to a shortage of a medicine in Australia that arises on or after the commencement of this item, whether the medicine was included in the Register before, on or after that commencement.

(2)       Section 30EG of the Therapeutic Goods Act 1989 , as inserted by this Schedule, applies in relation to a decision to permanently discontinue the supply of a medicine in Australia that is made on or after the commencement of this item, whether the medicine was included in the Register before, on or after that commencement.