National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 1) (No. PB 15 of 2014)

Overview

The National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 1) amends the National Health (Listed drugs on F1 or F2) Determination 2010, which provides for the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). Enacted by the Parliament of Australia under the National Health Act 1953, this instrument addresses the need to update the list of drugs allocated to the F1 and F2 formularies. The policy objective is to ensure that listed drugs are appropriately categorised to facilitate effective management of the PBS, considering factors such as bioequivalence and therapeutic grouping. The determination adds four new listed drugs to F1 and makes an administrative amendment to the description of an existing drug to maintain consistency across different instruments.

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 1) applies to pharmaceutical companies that manufacture and supply drugs listed under the Pharmaceutical Benefits Scheme (PBS). These entities must comply with the allocation of their drugs to either the F1 or F2 formularies as stipulated by the National Health Act 1953. The amendment pertains to the listing of specific drugs, including arachidonic acid and docosahexaenoic acid with carbohydrate, carbohydrate, fat, vitamins, minerals and trace elements supplemented with arachidonic acid and docosahexaenoic acid, docosahexaenoic acid with carbohydrate, and triglycerides, long chain, into the F1 formulary. This amendment also includes an administrative change to the description of a drug to ensure consistency with the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The geographic reach of this legislation is national, operating under the Commonwealth jurisdiction. The Act allows for the revocation or variation of the Principal Determination under the authority of the Acts Interpretation Act 1901, unless specified otherwise. The amendment comes into effect on 1 March 2014 and constitutes a legislative instrument under the Legislative Instruments Act 2003.

Key Provisions

The National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 1) introduces changes to the National Health (Listed drugs on F1 or F2) Determination 2010, as detailed in section 85AB(1) of the National Health Act 1953. This amendment primarily focuses on the allocation of certain drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS), as outlined in section 84AC. The F1 formulary is designated for drugs with a single brand, while F2 is for drugs with multiple brands or those in a therapeutic group with other multi-brand drugs. This amendment adds four new drugs to F1: arachidonic acid and docosahexaenoic acid with carbohydrate, carbohydrate, fat, vitamins, minerals and trace elements supplemented with arachidonic acid and docosahexaenoic acid, docosahexaenoic acid with carbohydrate, and triglycerides, long chain. It also makes an administrative amendment to the description of the drug carbohydrate, fat, vitamins, minerals and trace elements for consistency with the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The Act imposes specific criteria for drugs to be placed in F1 or F2. For F1, a drug must have no listed brands that are bioequivalent or biosimilar and must not have been on F2 the day before the determination comes into effect, as per subsection 85AB(4). Drugs that do not meet these criteria for F1 are placed on F2, subject to statutory price reductions, price disclosure, and a guarantee of supply, as stipulated in the Act. In certain cases, a drug with a single brand combination item on the PBS will be placed on the administrative combination drug list instead of F1 or F2, under subsection 85AB(5). The Amending Determination ensures that the criteria and processes for drug allocation are adhered to, maintaining the integrity of the PBS formularies. Non-compliance with the provisions of the National Health Act 1953 or the Amending Determination can result in both civil and criminal consequences. Specifically, breaches of the Act may lead to penalties as outlined in section 85AB(6), which can include fines and imprisonment. The maximum penalties for such offences are stipulated in the Act and can vary based on the severity and nature of the breach. Pharmaceutical companies and entities must ensure that they comply with the Act and the determinations made under it to avoid these legal repercussions. Failure to do so may also result in administrative actions, such as revocation of PBS listing for the affected drugs. Consultation with relevant stakeholders is a critical part of the process before drugs are listed and allocated to the PBS formularies. This includes detailed discussions with the intended responsible persons and recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, composed of two-thirds members from consumer, health economist, practising community pharmacist, general practitioner, clinical pharmacologist, and medical specialist backgrounds, ensures that the recommendations are well-rounded and consider various perspectives. This thorough consultation process helps maintain the effectiveness and fairness of the PBS, ensuring that the drugs listed are both beneficial and appropriately allocated.