National Medicines Policy 2.0—what’s changed and what’s next?

 

Introduction

Australia’s first National Medicines Policy (NMP) was launched in 2000 with the aim of improving health outcomes for all Australians.¹ Developed in partnership with health professionals, consumers and the medicines industry, the NMP has underpinned safe and effective care for patients and communities. It has provided the fabric for medicines regulation and approvals (Therapeutic Goods Administration), affordable and timely access to medicines (Pharmaceutical Benefits Scheme), and quality and safe use of medicines (e.g. Australian Commission on Safety and Quality in Health Care, NPS MedicineWise before its closure). The NMP has also provided the impetus for a responsible and viable medicines industry in Australia to bring high-quality and safe medicines to the Australian community.

The NMP has been situated in a broader health policy framework and linked to federal funding in the health budget each year. Since the NMP was first launched, Australia has seen significant changes in healthcare systems, medicines subsidies, health services remuneration, digital technologies and the medicines industry.

In our article in 2020,² we highlighted the need for a revised NMP to ensure that consumers remain at the centre of the Policy and its implementation, embracing shared decision making. We called for the next iteration of the Policy to better represent vulnerable populations (older frail people; Indigenous Australians; migrants and refugees; those living with mental illness, disability or chronic ill health), and to be fit for purpose with the increasingly complex nature of therapeutics and health care, including the expansion of digital health.²

The Australian Government published the refreshed NMP (and a plain-language summary) in late 2022 after wide stakeholder consultation and feedback.³ The refreshed Policy retains and expands on the previous four central objectives, now referred to as central pillars (Box 1). It continues to focus on partnership with stakeholders across the sector, reinforcing people as the central tenet. These key features represented the strengths of the original policy.

 

Individuals and communities

The focus on supporting individuals and communities is critical to the refreshed NMP. There is greater emphasis on addressing health inequities experienced by vulnerable population groups. There is also increased focus on shared decision making and the involvement of people with a lived experience in the co-design, development, implementation and evaluation of related policies, strategies, programs and initiatives.

The NMP identifies that health, digital and medicines literacy are key enablers for delivering the objectives of the Policy, especially in the area of quality use of medicines. These are important developments that align Australia’s policy with international best practice.

 

Health professionals

The revised NMP has a strong emphasis on the role of health professionals in ensuring Australians benefit from the safe and appropriate use of medicines. The Policy articulates the need for professional leadership with an emphasis on collaboration and culture, something that seems to be missing at times from interprofessional debate over the changing scope of clinical practice for health professions.

The NMP emphasises the need for equitable, timely and affordable access to high-quality, person-centred care, provided by a suitably trained health professional. Workforce and education are identified as key enablers in delivering and implementing the NMP, to provide the highest standard of evidence-based care.

 

Medicines and medicines-related services

Importantly, the refreshed NMP allows for a much broader definition of ‘medicines’, to account for the expanding nature of therapeutics—no longer just small-molecular entities for disease control or prevention, but also gene therapies, vaccines and at times complex interdependent treatments and technologies that provide the promise of cure. In this context, co-dependent novel therapeutic products require coordination of Australia’s different health technology assessment bodies. For example, new genetic tests (to establish suitability for a new targeted medicine) are evaluated by the Medical Services Advisory Committee, whereas the value of the medicine itself is evaluated by the Pharmaceutical Benefits Advisory Committee.

There is also consideration that medicines are managed in a particular context to facilitate safe and appropriate use. The NMP refers to ‘medicines-related services’ including education, training and awareness programs, digital information and clinical decision-support systems, medication review services, and diagnostic services including for personalised medicines.³

 

Digital health

Digital health is at the backbone of modern healthcare systems.⁴ The refreshed NMP emphasises the need to adopt and embrace validated, secure, interoperable digital health technologies to drive improvements in access, quality, safety and efficiency, and promote continuity of medicines management.³

 

Medical research and the medicines industry

A feature of the previous policy was clear recognition of the need for partnership with a viable and responsible medicines industry. This is further extended in the refreshed NMP, which now also highlights the importance of a diverse, innovative research sector that generates high-quality evidence, strategies, systems and processes to support improvements in the quality use of medicines and medicines safety.

 

Providing the tools

At around the same time as the launch of the refreshed NMP, a range of revamped Guiding Principles was released.⁵ These valuable resources address medication management in residential aged care, in the community and during transitions of care, providing practical tools and guidance for policy implementation. For example, the Guiding Principles for Medication Management in the Community⁵ outlines 12 principles which cover medicines information, patient-held medicine lists, dose administration aids, medication review and effective communication about medicines, all of which are relevant to health professionals including general practitioners, pharmacists, nurse practitioners and nurses. These complement existing resources such as the Australian Medicines Handbook⁶ and Therapeutic Guidelines,⁷ and highlight best-practice approaches to medication management that, if implemented, will lead to some of the biggest gains in avoiding harm and improving the quality use of medicines.

Health professionals and their professional bodies should be supported and encouraged to use these Guiding Principles as a framework to implement the key elements of the NMP and embed them in professional practice standards.

 

What’s next?

Implementation of the NMP is the next big challenge, to avoid the risk of fragmentation and decentralisation. The pillars and principles articulated in the NMP need to be fully embedded into decision making in health care, whether this is health budget expenditure decisions or negotiating the next community pharmacy agreement.⁸

This will need smart systems and future investment in linked health data infrastructure to measure what matters when it comes to medicines and the importance they have in the care of people and families. Work is underway to develop a set of national indicators to measure progress against the NMP’s intended outcomes.

The elements reflected in health technology assessment, medicines regulation and innovation in the medicines industry can all be supported and processed with this refreshed NMP.

The 2022 NMP is intended to be a living document, reviewed and updated at least every 5 years.³

Conflicts of interest: Andrew McLachlan receives funding from the National Health and Medical Research Council (NHMRC), and the Sydney Pharmacy School receives a research scholarship from GlaxoSmithKline for a PhD student under Andrew’s supervision. Andrew has served as consultant on Australian Government committees related to medicines regulation, including the Therapeutic Goods Administration Advisory Committee on Medicines (2018–22), is Vice President of the Council of Pharmacy Schools Australia and New Zealand, and Chair of the Medication Oversight Committee, Australian Commission on Safety and Quality in Health Care.

Parisa Aslani has received funding from the NHMRC, Australian Research Council, Australian Government Department of Health and Aged Care, and Australian Commission on Safety and Quality in Health Care for projects related to medication adherence and quality use of medicines. Parisa conducts accreditation of pharmacy programs for the Australian Pharmacy Council and the Pharmacy Council of New Zealand, and is Vice President of the International Pharmaceutical Federation.

This article is peer-reviewed.

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