EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH REVOCATION INSTRUMENT 2012 (No. 1)
PB 55 of 2012
Authority
This instrument is made pursuant to subsection 84AE(3A) of the National Health Act 1953 (the Act), which provides that the Minister may vary or revoke a determination of co-marketed brands of a pharmaceutical item made under subsection 84AE(3) of the Act.
Purpose
The National Health Revocation Instrument 2012 (No. 1) (PB 55 of 2012) revokes the Determination made pursuant to subsection 84AE(3) of the National Health Act 1953 (PB 117 of 2009) which no longer has any function or purpose.
Section 84AE provides for the concept of co-marketed brands. Co-marketed brands of a pharmaceutical item are treated as a single brand of the item for the purposes of the criteria for allocating drugs to formularies in section 85AB. Multiple brand drugs are not eligible for F1 under the criteria set out in section 85AB. However, as co-marketed brands are treated as a single brand, listed drugs in co-marketed brands of a pharmaceutical item are not disqualified from being on F1.
Subsection 84AE(3) of the Act provides that the Minister may determine that two or more brands of a pharmaceutical item are co-marketed brands. Two listed brands of Clopidogrel with aspirin in the form Tablet 75 mg (as hydrogen sulfate) - 100 mg with manner of administration Oral (DuoCover and CoPlavix), were determined to be co-marketed brands in the Determination made pursuant to subsection 84AE(3) of the National Health Act 1953 (PB 117 of 2009).
Subsection 84AE(3A) of the Act provides that the Minister may vary or revoke a co-marketed brands determination so that co-marketed brands of a pharmaceutical item cease to be co-marketed brands provided certain conditions are met. Paragraph 84AE(3A)(b) of the Act provides that the Minister may vary or revoke the determination if there is a listing of another brand of the same pharmaceutical item as the co-marketed brands. On 1 October 2011 Clopidogrel with aspirin moved onto F2 with the Pharmaceutical Benefits Schedule (PBS) listing of a third brand of the same pharmaceutical item (Clopidogrel Winthrop plus aspirin). Therefore from 1 October 2011 the conditions were met for the Minister to have the power to revoke the determination of DuoCover and CoPlavix as co-marketed brands.
The instrument will take effect on the day after it is registered on the Federal Register of Legislative Instruments.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Consultation
This revocation is of a minor and machinery nature and no consultation was required.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health Revocation Instrument 2012 (No.1).
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
This Legislative Instrument is made pursuant to subsection 84AE(3A) of the National Health Act 1953 (the Act), which provides that the Minister may vary or revoke a determination of co-marketed brands of a pharmaceutical item made under subsection 84AE(3) of the Act.
This instrument revokes the Determination made pursuant to subsection 84AE(3) of the National Health Act 1953 (PB 117 of 2009) thereby providing that the two co-marketed brands of clopidogrel with aspirin in the form Tablet 75 mg (as hydrogen sulfate) - 100 mg with manner of administration Oral, DuoCover and CoPlavix, cease to be co-marketed brands on the commencement of this instrument.
Human rights implications
This legislative instrument engages Article 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