EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2013 (No. 8)
PB 39 of 2013
Authority
This legislative instrument is made under sections 84AF, 84AK, 85, 85A, 88 and 99AEH of the National Health Act 1953 (the Act).
Purpose
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to delist eight brands of pharmaceutical items from the Pharmaceutical Benefits Scheme (PBS) and related matters due to the inability of two responsible persons (drug companies) to comply with their guarantee of supply obligations under section 99AEB of the Act.
Paragraph 99AEH(2)(a) of the Act allows the Minister, by legislative instrument, to revoke a subsection 85(6) determination that a guaranteed brand of a guaranteed item is a listed brand where a responsible person for a guaranteed brand is unable to supply the guaranteed brand on one or more occasions.
The Minister’s delegate, having had regard to matters set out in subsection 99AEH(3) of the Act, is delisting the Cavstat and Rosuvastatin GH brands of the listed drug rosuvastatin in each of the forms tablet 5 mg (as calcium); tablet 10 mg (as calcium); tablet 20 mg (as calcium); and tablet 40 mg (as calcium). These brands were first listed on 1 June 2013.
The delisting will not impact the availability of these strengths of rosuvastatin tablets to patients, as other substitutable brands are available on the PBS. The drug companies are able to apply to relist these brands on the PBS with appropriate assurances of continuity of supply.
Consequential to the delisting of the brands, determinations relating to those brands only are also revoked under sections 84AF (responsible person), 84AK (pack quantity), 85 (prescription circumstances), 85A (maximum quantity and number of repeats for particular purposes) and 88 (PBS prescriber).
Subsection 33(3) of the Acts Interpretation Act 1901 is relied upon for the consequential revocations.
Consultation
The companies responsible for the delisting brands gave notice to the Department on 3 June 2013 that they were unable to supply their products. A letter was sent to the companies by the Department of Health and Ageing on 3 June 2013 indicating that consideration was being given to application of consequences under section 99AEH of the Act, and seeking further information to assist in making that decision. Following receipt of responses from the companies a decision was made about delisting these brands.
This Instrument commences on 1 July 2013.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013
(No. 8)
(PB 39 of 2013)
This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Legislative Instrument
The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013
(No. 8) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 by delisting eight brands of pharmaceutical items that contain the drug rosuvastatin due to the inability of the companies responsible for the brands to meet the obligation to supply their brands set out in section 99AEB of the National Health Act 1953.
Human rights implications
This legislative instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.
The PBS is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines.
Conclusion
This Legislative Instrument is compatible with human rights because it advances the protection of human rights.
Adriana Platona
Assistant Secretary
Pharmaceutical Evaluation Branch
Pharmaceutical Benefits Division
Department of Health and Ageing