Australia introduces new bill to address drug shortages

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Inscribirse
eng / esp

Australia introduces new bill to address drug shortages

INICIO/Políticas y legislación | Posted 28/01/2022 0 Post your comment

Australia’s parliament has approved a new bill aimed at mitigating drug shortages in the country and ensuring that innovative medicines are accessible, available and affordable for all Australians.

The ‘National Health Amendment (Enhancing the Pharmaceutical Benefits Scheme) Bill 2021’ was passed by both houses of the Australian parliament on 13 December 2021.

The new bill amends the: National Health Act 1953 in order to provide for price reductions on the fifth, tenth and fifteenth anniversary of a drug listing on the Pharmaceutical Benefits Scheme (PBS) and when the first new brand of a drug lists on the PBS. The new bill also retains ministerial discretion to ensure that the minister can intervene if a legislated price reduction were to have an unintended consequence. In addition, it establishes a price reduction floor and stockholding requirements, for certain PBS listed brands that may be susceptible to global medicines shortages.

The bill also enables the new Strategic Agreements between the Commonwealth and the Generic and Biosimilar Medicines Association (GBMA) and Medicines Australia, which were agreed in September 2021 [1], to begin on 1 July 2022.

The bill has been welcomed by the Society of Hospital Pharmacists of Australia (SHPA), whose Chief Executive Kristin Michaels said that the ‘SHPA is committed to supporting policies and provisions which mitigate medicine shortages and ensure Australians can access their medicines without disruption’. She added that ‘Hospital Pharmacists are pleased to see the Federal Government taking further action to address medicines shortages, with these new Strategic Agreements requiring pharmaceutical sponsors to maintain four to six months’ stockholding of vital medicines at risk of supply disruption’.

The SHPA believes that the bill will provide certainty on the PBS pricing policy and ensure the PBS subsidy supports reliable medicines supply to Australia over the next five years and will also allow the Federal Government to achieve significant savings. The SHPA expect these savings will enable around AU$1.9 billion to be reinvested into the PBS to support the anticipated listing of more than AU$5 billion in new drugs and expanded patient access.

LATIN AMERICAN FORUM The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. View this week’s headline article: Diferencias en inmunogenicidad, farmacovigilancia y documentos legales en productos biológicos en América Latina Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Vea el artículo principal de esta semana: Diferencias en inmunogenicidad, farmacovigilancia y documentos legales en productos biológicos en América Latina Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.

Reference
1. GaBI Online - Generics and Biosimilars Initiative. New five-year medicines agreements in Australia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 28]. Available from: www.gabionline.net/generics/general/new-five-year-medicines-agreements-in-australia

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: Australian Parliament, SHPA