Around the Globe
Australia National Medicines Policy Revision Reshaped by Community Feedback

Richard Day
University of New South Wales
@osbornidayius

A

ustralia’s National Medicines Policy (NMP), gazetted in 2000, is being revised and the draft policy was made available for final, widespread community and stakeholder feedback. Final public consultations closed on March 2, 2022.

The NMP was conceived in the late 1990s as a guide to the availability and use of medicines in Australia. But even more than this, the NMP has applied to the “research, development, regulation, manufacture, evaluation, supply, and access” to medicines in Australia over the last two decades. Most significantly, it introduced the overarching principle and goal of quality use of medicines (QUM). QUM is the judicious, safe, and appropriate use of medicines based on people’s needs and health professionals’ obligations to support all communities to achieve the best possible health outcomes.

Outstanding Success

The NMP has been outstandingly successful for the community, healthcare professionals, industry, and government in Australia. Significant examples, among many others, include NPS MedicineWise (an independent, nonprofit, evidence-based organization established in 1998 with the primary aim of promoting quality use of medicines) and the Australian Medicines Handbook, Therapeutic Guidelines, and National Prescribing Curriculum for medical students, pharmacists, and nurses provided via NPS MedicineWise. More importantly, the value arising from stakeholder engagements and interactions has fostered solutions to such challenging problems as access to medicines in remote parts of Australia, the safe disposal of unwanted medicines, and high-quality consumer medicine information, to name only a few. The support of evidence-based interventions (e.g., academic detailing in support of QUM to health professionals) and national advertising programs in support of QUM (e.g., sensible use of antibiotics) have had significant effects on improving prescribing quality. (Direct-to-consumer advertising of prescription medicines is not permitted in Australia.)

This revision of the NMP, the first after 22 years, was called for by Australia’s Minister for Health, the Hon. Greg Hunt MP, “in recognition of the substantial changes to the health landscape since the policy was published in 2000.” This revision also recognizes the significant contribution of the NMP and its central component of QUM to improving health outcomes for all Australians. The aim of the draft new policy is “to create the environment, in which the appropriate structures, processes and accountabilities enable medicines and medicines-related services to be accessible in an equitable, safe, timely, and affordable way and to be used optimally according to the principles of person-centered care and the quality use of medicines, so that improved health, social and economic outcomes are secured for individuals and the broader community.”

An Expert Advisory Committee chaired by Deputy Chief Medical Officer Michael Kidd AM and supported by Lloyd Sansom AO, Janette Donovan, Sarah Dineen-Griffin, and David Herd (who bring expertise in medicines policy, clinical practice, consumer engagement, and the pharmaceutical industry) is assisting the Minister of Health in revising the Policy. The Committee’s public consultations, bilateral interviews, and virtual group discussion began August 31, 2021, and ended mid-November 2021. A virtual webinar forum discussed key themes from these consultations in December 2021. The 156 submissions, and 194 consultations from 135 organizations, were summarized in a Discussion Paper. The draft “refreshed” policy was then prepared.

Medicines covered by the NMP include prescription, over-the-counter, complementary/traditional, and biologic medicines, gene therapies, cell- and tissue-engineered products, and vaccines. The draft “refreshed” policy consists of four central pillars:

  • Timely, equitable, and reliable access to necessary medicines at a cost that individuals and the community can afford: the central role of the widely supported and appreciated Pharmaceutical Benefits Scheme that provides subsidized medicines for all Australians is relevant to this pillar.
  • Medicines meet appropriate standards of quality, safety, and efficacy: the well-regarded Therapeutic Goods Administration (TGA) is relevant to this pillar.
  • Quality use of medicines and medicines safety: NPS MedicineWise, TGA, and many other entities and organizations are relevant here.
  • Responsive and sustainable medicines industry, including nonprescription medicines and research sector with the capability, capacity, and expertise to meet current and future health challenges: increasing numbers of medicines shortages, reliance on ex-Australian suppliers, COVID-19 stresses, etc., are all relevant to this pillar.

The Principles of the proposed refreshed NMP and how they work together have been summarized as person-centered; equitable; partnership-based; accountable and transparent; sharing responsibility; innovative; evidence-based; and sustainable.

The draft refreshed policy states that these Principles should be evident in all aspects of the NMP, starting from the design of programs, strategies, and initiatives. In addition, seven enablers and governance structures and interactions have been summarized clearly and proposed as essential for the success of the NMP. The importance of respectful partnership and collaboration across stakeholders is emphasized as critical for the success of the NMP. The Draft Updated National Medicines Policy is a well-developed policy summarized in the below illustration and is now awaiting final modifications. Many interested stakeholders anticipate that the Federal Government will “gazette” the NMP in the first or second quarter of 2023.
Summary of Australia’s NMP from Draft National Medicines Policy - Consultation Document.
Summary of Australia’s NMP from Draft National Medicines Policy – Consultation Document.
Final public consultations closed on March 2, 2022. Now, all stakeholders eagerly anticipate the final, refreshed NMP that promises to be highly influential for Australia’s citizens and pharmaceutical sector through the coming decades.
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