National Health (Listed drugs on F1 or F2) Amendment Determination 2011 (No. PB 9 of 2011)

Overview

The National Health (Listed drugs on F1 or F2) Amendment Determination 2011 is a legislative instrument made under the National Health Act 1953. This determination, issued by the Australian Government and prepared by the Office of Legislative Drafting and Publishing within the Attorney-General’s Department, aims to address the need for updating the list of drugs that are available under the Pharmaceutical Benefits Scheme (PBS). The determination was enacted to amend the National Health (Listed drugs on F1 or F2) Determination 2010, ensuring that the list of approved drugs reflects the latest therapeutic advancements and medical needs. The policy objective behind this amendment is to provide continued access to essential medications, thereby supporting public health and the efficient use of healthcare resources. The determination specifically updates the list by adding certain drugs to Schedule 1 and making modifications to Schedule 2, such as the addition of new therapeutic agents and the removal of others that no longer meet the criteria for inclusion. This amendment ensures that the PBS remains responsive to changes in medical practices and patient needs, maintaining its role as a cornerstone of Australia's health care system.

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2011 amends the National Health (Listed drugs on F1 or F2) Determination 2010, providing specific changes to the list of drugs covered under the National Health Act 1953. This legislation applies to entities involved in the supply, prescription, and administration of listed drugs in Australia, impacting pharmaceutical companies, healthcare providers, and possibly individual healthcare practitioners. The Amendment Determination operates within the Commonwealth jurisdiction, ensuring a unified approach to the regulation of listed drugs across Australia. Notably, this instrument does not specify exclusions, exemptions, or thresholds but rather focuses on the precise amendment of drug listings. The application and scope of the Act can be further extended or restricted through subordinate instruments, which may introduce additional regulations or clarifications as necessary.

Key Provisions

The National Health (Listed drugs on F1 or F2) Amendment Determination 2011 (PB 9 of 2011) modifies the National Health (Listed drugs on F1 or F2) Determination 2010 by adding and removing specific drugs from the lists on Schedule 1 and Schedule 2. According to section 1 of the Determination, this amendment allows for the inclusion of "Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides" and "Azacitidine" and "Dutasteride" in Schedule 1, while removing "Valaciclovir". Similarly, section 1 also adds "Clindamycin" and "Perindopril with amlodipine" to Schedule 2, and removes "Clarithromycin". The Determination imposes obligations on parties involved in the regulation and provision of pharmaceutical benefits, particularly concerning the inclusion and exclusion of specific drugs on the F1 and F2 lists. Pharmaceutical companies and health practitioners must ensure that they are compliant with these changes by updating their records and practices to reflect the amendments. For example, healthcare providers must be aware of the inclusion of new drugs in Schedule 1 and the exclusion of others, adjusting their prescriptions and patient care plans accordingly. Breach of the requirements set out in this Determination may lead to various consequences. The National Health Act 1953 provides for both civil and criminal penalties for non-compliance. Civil penalties can include fines and other financial penalties, while criminal penalties may include imprisonment. The specific maximum penalties are not detailed within the Determination itself but would be outlined in the broader provisions of the National Health Act 1953. It is essential for parties to adhere to the updated lists to avoid any legal repercussions associated with non-compliance.