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The article discusses the controversy surrounding off-label prescribing of bevacizumab for age-related macular degeneration in the United Kingdom, highlighting the clash between therapeutic goods regulation and clinical practice. In Australia, the Therapeutic Goods Act 1989 strictly regulates the use of therapeutic goods, making it a criminal offense to import, export, or supply medicines not included in the Australian Register of Therapeutic Goods. Off-label prescribing is considered a distinct and unapproved therapeutic good under the Act, raising questions about the legality of such practices. The article suggests amending legislation to align with clinical reality and address the ambiguity surrounding off-label prescribing. [Extracted from the article]

The article discusses the increasing cost barriers to medication access in Australia based on the 2022–23 Patient Experience Survey data released by the Australian Bureau of Statistics. It highlights that women, younger individuals, and those in poorer health are particularly affected by these barriers. The data also show that Australians are more likely to experience cost barriers to care if they are younger, in poorer health, or socio-economically disadvantaged. The article emphasizes the need for more comprehensive data on medication non-adherence and affordability to inform evidence-based policy reforms and improve medicine access for all Australians. [Extracted from the article]

Most new medicines entering the market are high‐cost speciality drugs. These drugs can cost tens to hundreds of thousands of dollars per course of treatment and in some cases millions of dollars per dose. Approximately half of all spending on medicines is projected to target only 2–3% of patients, raising important questions about resource allocation. While there is no doubt that breakthrough innovations have transformed clinical care in some disciplines, it is also true that cost is becoming one of the primary barriers to treatment access and that many new medicines do not provide value commensurate with their prices. This article examines pricing trends, the reasons for high prices and their implications for access and clinical practice. [ABSTRACT FROM AUTHOR]

The Medicines Repurposing Program was launched on 1 March 2024. It provides a pathway for registering and subsidising off-label medicines of significant public health benefit but which sponsors have no financial incentive to pursue. This article provides a short overview and critical analysis of the program. One concern that emerges is that commercial sponsors still retain de facto veto power over which off-label uses are prioritised and so have the capacity to sway the process. Simple suggestions are proposed to help mitigate this risk. What is known about the topic? The Medicines Purposing Program (MRP) provides a pathway for non-industry actors to have off-label uses of medicines approved and funded if deemed to be of public benefit. What does this paper add? Commercial sponsors can easily sway the prioritisation and selection of candidates under the MRP in their favour, so strategies are recommended to counter this risk. What are the implications for practitioners? The MRP provides an opportunity for the medical community to directly nominate off-label medicines uses for approval and funding improving access to medicines, but only if commercial interests do not intervene. [ABSTRACT FROM AUTHOR]

Australians who cannot access medicines locally are able to find most medicines for sale online. Australia's therapeutic goods legal regime permits individuals to purchase medicines directly from overseas suppliers via the Personal Importation Scheme. Individuals can either import medicines for their own use or that of an immediate family member. For some patients, importing medicines is the only way they can access the medicines they need due to lack of availability or affordability in Australia. This article analyses the therapeutic goods law to clarify offences that may apply to those who import medicines for their own use or that of an immediate family member. Considering the findings, legislative amendments are recommended for the purpose of protecting patients who import medicines for legitimate health care needs. [ABSTRACT FROM AUTHOR]