Australia's National Medicines Policy is outdated and in need of review

How will issues such as disruptive innovation, precision medicine and climate change affect Australia's medicines policy going forward?

Australia's National Medicines Policy (NMP) was developed cooperatively between the government, the pharmaceutical industry, health care professionals and consumers. The NMP seeks to provide overarching policy direction around four interlinked pillars: timely access to the medicines that Australians need and at an affordable cost; medicines meeting appropriate standards of quality, safety and efficacy; quality use of medicines; and maintaining a responsible and viable medicines industry.1 The policy was finalised in 1999 and was an effective framework for the interaction of the major players in Australia's health system with respect to the quality use of medicines in Australia.1 Outcomes from the original NMP include the introduction of the National Prescribing Service (now called NPS MedicineWise), which improved health outcomes relating to the quality use of medicines;2 guiding frameworks for federal government health policy changes delivered by the Department of Health; and substantial savings to government generated by pharmaceutical innovations since the development of the NMP.3

However, a broad comprehensive review of the NMP itself and the progress in achieving its objectives has never been undertaken, to our knowledge.

Australia was one of the first countries to drive the development of national medicines policies globally.4,5 Since 1999, there has been a significant increase in the number of countries with national medicines policies such that, by 2011, 80% of countries had a national medicines policy and many countries had even updated their original policies, with Australia now lagging behind.6,7

Changing landscape

In 1999, the top five medicines in Australia's Pharmaceutical Benefits Scheme (PBS) by cost were two statins, an antipsychotic, and two drugs for the treatment of peptic ulcers (Box). These were all small molecule medicines.8 At this time, the human genome had not yet been sequenced, smartphones were not ubiquitous, social media did not exist, and there was concern in Australia that the cost of the PBS was unsustainable.10

Recent figures show that the most expensive medicines listed in the PBS are the ones for curing hepatitis C.9 There is also an increased number of personalised biological therapies, highlighting that the medicines and technologies used to treat disease today are a world away from those used 20 years ago (Box). Almost none of the diseases treated by the top ten medicines in 1999 feature in the 2018 list.

Technological change raises many issues about personalised medicine and genetic testing, and even about the very definition of a medicine or a disease. For example, the new chimeric antigen receptor T cell therapies for treating cancer are covered under the Medicare Benefits Schedule, which was not considered under the original NMP, and the increasing number of tumour‐agnostic medicines entering the market that rely on a specific cellular biomarker are measured by in vitro diagnostic tests rather than a pathological definition of cancer.

How medicines are prescribed and dispensed has changed. Pharmacists, dentists and nurses are increasingly prescribing and administering certain prescription medicines. Thus, the way that patients receive their medicines has evolved in ways not foreseen in 1999.

The PBS policy environment has changed enormously. The PBS has been split into two formularies with different pricing policies (F1 for single brand drugs and F2 for drugs that have multiple brands). Price disclosure has been introduced and expanded, which has led to substantial price cuts for hundreds of PBS‐listed multiple brand generic medicines, resulting in lower prices for patients and changing market dynamics. This downward price pressure may also be contributing to the increasing number of medicine shortages, which were less likely in 1999. Various structural reforms to the PBS policy and processes have occurred through negotiated agreements between the government, the pharmaceutical industry and the pharmacy sector, as well as some reforms resulting from international trade agreements. Private health insurance reforms, including the private health insurance rebate, the Medicare levy surcharge, and lifetime health cover, have changed the complexion and role of private health insurance.

The government institutions that deliberated and managed the medicines policy in Australia have evolved. Peak bodies such as the Australian Pharmaceutical Advisory Council (APAC), the Pharmaceutical Health and Rational Use of Medicines Committee and the Pharmaceutical Benefits Pricing Authority were abolished in the past 10 years. The Pharmaceutical Industry Working Group — a joint ministerial‐led industry and health dialogue group — was disbanded under the Australian Government deregulation agenda after 2013. Joint medicines policy conferences with the Australian Government, patient groups, health care practitioners and the pharmaceutical industry came and went through the 2000s. However, dialogue and policy development has continued under alternative arrangements, such as the strategic agreements signed between industry sectors and the Commonwealth.

Patients and their behaviour have evolved since the end of the 20th century. The Australian population has grown, aged and changed. The ageing of the population together with the steady growth in over‐the‐counter and complementary medicines have changed the consumer profile.11,12 Of course, the use of the internet and social media today by consumers and patients were not dreamed of when Australia's NMP was developed. Today patients have access to much more information on medicines through the internet and social media. Research from the United States identifies a growing segmentation of the consumer and patient market for medicines and health care based on factors such as use of internet technology, preparedness to shop around for health care options, and a focus on competitiveness and value for money.7,13 Such trends are likely to be replicated in Australia. Where and how consumers obtain their information and who they believe on health issues have changed radically.

These factors have empowered the community but raise questions in many areas of health care and regulation, be it the relevance of national restrictions on accessing medicines information in an internet age or concerns about the volume of misinformation available on the internet and social media. Digital health also brings with it concepts such as telemedicine, artificial intelligence, big data, electronic health records and digital therapeutics. None of this is addressed in Australia's NMP.

Changes in the business sector that develops and supplies medicines to the Australian community have been substantial. The increase in availability of generic medicines following patent expiries and the development, rationalisation and changes in Australia's biotechnology and pharmaceutical industries have seen new companies develop. Research and development and manufacturing facilities have gone through cycles, while restructuring in the pharmaceutical sector has seen Australia's role in the global environment change with globalisation and the emergence of Asia. Reforms and changing business models in pharmacy, distribution and general practice and the challenge of direct distribution in the wholesale market have also affected medicines policy. The oscillating importance of science, technology, intellectual property and industrial policy in health care affects research and development, support for clinical trials and the development of Australian medical breakthroughs. Industrial standards and regulations have evolved substantially in areas such as industry self‐regulation of ethical conduct, pharmacy and doctor standards, and the growing transparency of these interactions.

A new National Medicines Policy

The world and Australia today are nothing like they were back in 1999. Even if the four pillars in the original policy stand the test of time, the issues around them have evolved.

The NMP should be comprehensively reviewed with a brief to involve all stakeholders in the medicines system in a broad consultation process, including dialogue, forums and conferences. One of the strengths of the development and implementation of the NMP was the process that brought together the different parties, and this should form the basis for further reform. Consultation should involve groups such as government, consumers, health care professionals and industry.

The review should consider the strategic background and issues that influence Australia's medicines policy environment today and into the future to improve the health outcomes of Australians. How will disruptive innovation, digital and information technologies, precision medicine, the interaction of medicines with devices and diagnostics, changing consumer preferences in areas such as complementary medicines, an ageing population, climate change, immigration, the geopolitical and economic environment, and the emerging economies in the world affect Australia's medicines policy environment going forward?

The review should include an evaluation of the impact of the existing NMP and its four pillars on health policy and health outcomes for the broader community.

There are many issues that should be considered as part of the review, some of these have been outlined earlier. A thematic review of national medicines policies from various countries include areas not addressed in Australia's current NMP:

• pharmaceutical waste disposal and environmental protection;
• management and disposal of unsafe and unwanted medicines;
• antimicrobial resistance and antibiotics;
• information technology, data analysis, web‐based systems;
• electronic media;
• patient responsibility and health literacy;
• health workforce planning and development;
• intellectual property; and
• globalisation, international cooperation and global health issues.5

Finally, there is a need for an awareness campaign for policy makers, politicians, the private sector, stakeholders and the community on what the NMP is and what it does.

Conclusion

Australia's NMP has served the country well and has been an important reference guide for some of the complex medicines policy issues faced both in Australia and internationally. A review of the NMP is overdue and could not be timelier with its 20th anniversary fast approaching.