National Medicines Policy 2.0: a vision for the future.

Australia’s National Medicines Policy was launched 20 years ago with the aim of improving health outcomes for all Australians. It was developed in partnership with healthcare professionals, consumers and the pharmaceutical industry The key parts of the Policy focus on timely access to high-quality and affordable medicines and their safe and judicious use. It also supports a viable and responsible pharmaceutical industry Since the Policy was first launched, Australia has seen significant changes in healthcare systems, medicines subsidies, health services remuneration, digital technologies and the pharmaceutical industry Medicines themselves have also changed, as have consumers’ expectations. To respond to these changes, the National Medicines Policy needs to be updated with a greater focus on implementing and measuring outcomes (c) NPS MedicineWise 2020.

Introduction

In October 2019, the health minister, Greg Hunt, announced there would be a review of Australia’s National Medicines Policy.

The policy was one of the first of its kind when it was implemented in 1999.1 It provides overarching policy direction focusing on four interconnected pillars:

timely access to medicines that are affordable to individuals and the community

high-quality medicines that are safe and effective

the quality use of medicines

maintenance of a viable and responsible medicines industry.

These objectives remain as important and relevant to the nation now as they did in the 1990s.

Why do we need an update of the National Medicines Policy?

The overall goal of the National Medicines Policy is to optimise health outcomes for Australians through a collaborative partnership with key stakeholders. This remains fundamental to the health of the individual at all levels of the health system. However, the last two decades have seen substantial changes in people’s expectations, as well as changes in healthcare and information systems, medicines themselves (e.g. biologicals and biosimilars, and precision medicine), medicines subsidies and health services remuneration, digital technologies, and the pharmaceutical industry.2,3 These changes have challenged the very foundations of the National Medicines Policy.

There were calls for a review of the National Medicines Policy five years ago,2 and more recently this has gathered pace.3 There are some critical issues that need to be comprehensively addressed when updating the National Medicines Policy (see Box).

Consumers and healthcare professionals

Consumers seeking and receiving health care have evolved over the last two decades.4 They have better access to information (and advertising) via the internet and online networking groups, and rightly expect to be more informed and involved in their own health. People expect to receive high-quality, safe and effective health care that is tailored to their needs while reducing their out-of-pocket costs.5

People are living longer. They have more chronic health conditions and so are taking multiple concurrent medicines. The use of complementary and alternative therapies continues to be high.6 In addition to polypharmacy, other challenges that have escalated over the past 20 years include poor outcomes for people living with mental illness7 (especially indigenous Australians),8 antimicrobial resistance, and the continuing burden of medication-related harms. These place a considerable strain on healthcare systems, policies and budgets with effects rippling towards the community through social and welfare services.

Healthcare professionals now see a wider spectrum of people4 and are more cognisant of the gap in the health and well-being of vulnerable members of the community. This includes indigenous Australians, frail older people, people living with mental illness as well as migrants and refugees.

Healthcare professionals are more aware of people’s literacy and health literacy levels, their social determinants of health and their beliefs and opinions about treatments. There is also now a wider range of health professionals involved in prescribing, with an important need for consistent and rigorous training and credentialling to ensure the quality use of medicines. The healthcare provider has also changed with expanding scopes of practice, which in some cases may be seen as blurring of the traditional boundaries of practice.

The healthcare environment

The healthcare environment has changed since the National Medicines Policy was first put in place. Care is increasingly being delivered in people’s homes, and in community health centres and outreach centres. Hospital stays have been reduced, and continuity of care from hospitals to primary care settings and to people’s homes or residential care is becoming increasingly important. However, there remain noticeable gaps in care which can lead to preventable harm. With the ageing population, older people are often accompanied by family members and carers, who have an increasingly important role in their care and advocacy. Family members, including young children, remain the primary translators for migrants and refugees due to limited interpreter services within the health system.

Equitable access and medicine remuneration

Advances in technology and pharmaceutical products, personalised (precision) medicine, and tailored and targeted delivery of health care are a double-edged sword. On the one hand, these developments provide the promise of significantly improved health care, but on the other hand, there is increased complexity, cost and expectations for the delivery of effective and high-quality health care. This is matched with increasing demands on ever tighter health budgets. Together this poses a substantial challenge for maintaining a viable and responsible medicines industry.

Further complexity includes the need to restrict the use of some medicines to address challenges like antimicrobial resistance and misuse of prescription opioids. The increasing co-dependency of medicines, devices and diagnostics means we need to rethink how we remunerate and incentivise industry to develop new antimicrobials. Providing remuneration and incentives based on sales of medicines, as determined by their unit price multiplied by volume of sales, is no longer a rational approach when medicines need to be used judiciously.

Jurisdictional differences in affordable access to expensive and off-label medicines remain inequitable. National leadership and disruption of our current medicines funding mechanisms are needed to address this.

Health services

Increasing preventive care and self-care, as well as self-management are considerations in the management of chronic medical conditions. Non-pharmacological therapy for chronic medical conditions is delivered by medical and allied health professionals. Such health services and their appropriate remuneration should be considered alongside drug treatment options when providing tailored services to people.

Digital health

Digital health initiatives provide some of the most significant opportunities to improve the quality and coordination of health care. They could potentially have a major impact on quality use of medicines and implementation of the National Medicines Policy.

Strategies such as a national digital health record system, electronic medication management and real-time prescription monitoring provide a platform to reduce preventable harms and improve the quality use of medicines. However, they need to be fully implemented across the health sector to realise these benefits.

Connected information systems can assist in the development of data repositories and management systems to optimise collation, storage and analysis of real-world data and data collected through research. These can be used to inform health policy and other health-related decisions.

Future directions

The National Medicines Policy and the web of systems, policies, guidelines and legislation within it need a reboot. This shake-up needs to account for advances in digital technology, knowledge, and understanding of how people currently access and expect to access healthcare in the future, before it is constrained by such practicalities as cost and resource issues. An essential element of this reboot will be a clear plan and commitment to implementation strategies so that the impact and benefits of the Policy are realised.

Planning a reboot should not only consider the evolution of the National Medicines Policy to better reflect the current environment, but also how it can be reviewed at more timely intervals. This is important as new therapies emerge that create new challenges and opportunities to improve health care, or indeed cause harm.

A greater focus is needed in the next iteration of the National Medicines Policy on measuring health outcomes that are valued and relevant to patients. These outcome data are important to support health funding decisions. Improved access to real-world data in medicines use and patient-relevant outcomes (including safety) must be a priority.

Australians need to be empowered to seek health care in a dynamic and progressive world. In the quest for a healthy and long life, we need to aim for an agile and dynamic national health and medicines policy that continues to foster shared partnerships to deliver optimal health outcomes for the nation.

Patient-centred focus• Vulnerable people matter – older frail people, indigenous Australians, migrants and refugees and those living with mental illness, disability, or with chronic ill health.Medication safety• Medication safety and the systems to monitor medicines harms are priorities.• Alignment with WHO Global Patient Safety Challenge: Medication without harm which focuses on high-risk situations and transitions of care, polypharmacy and high-risk medicines.Medicines cost and access• Affordable medicines for governments and consumers. Out-of-pocket consumer costs can be a barrier to medicines access and health care.• Equitable access to expensive and off-label medicines between jurisdictions.• Medicines supply – shortages pose a major challenge. Supply chains are vulnerable because of the global consolidation of the medicines industry.Digital health• Digital health initiatives e.g. My Health Record, electronic medication management and real-time prescription monitoring.• Connected data repositories and management systems to improve collation, storage and analysis of health data, and inform health policy and health-related decisions.Stakeholder partnerships and collaboration• Closer partnerships between National Medicines Policy stakeholders to support policy implementation.Legislation• Up-to-date legislation and regulatory frameworks to support the increasing complexity of therapeutic interventions and devices are essential to protect the public.