Transforming the National Medicines Policy with a vision for the future

Pharma News: Australia’s National Medicines Policy (NMP) was launched 22 years ago. Since the NMP was first launched, Australia has seen significant changes in the healthcare environment. The review of the NMP will begin in August 2021 and a stakeholder consultation process involving a call for public submissions will support the review.

In an interview with Health Industry Hub, Elizabeth de Somer, CEO of Medicines Australia reflected on the the important gaps relating to the current NMP and the key considerations in transforming it to meet the needs of patients, healthcare professionals and the pharma industry.

Health Industry Hub: What are the top issues relating to the current NMP that no longer meet the needs of the healthcare ecosystem?

Elizabeth de Somer: As a high-level policy document the National Medicines Policy (NMP) has stood us in good stead for the last 20 years. Its objectives are still sound; timely access to medicines, high-quality medicines that are safe and effective, quality use of medicines and maintenance of a viable and responsible medicines industry.

The gap in the current NMP is that there is no measure and KPIs to ensure that the policy is delivering on its objectives.

The data shows that there are long delays to accessing medicines. If you’re operating a cost containment model where patients cannot get access to breakthrough, cutting-edge therapies when diagnosed, are you actually using medicines appropriately?

We have seen criticisms of Consumer Medicines Information (CMI) not being easily available to patients. There is no longer a measure to see if a CMI is appropriate.

We also do not want an industry that is viable. We want a medicines industry that is thriving. How do we ensure that the industry can grow and continue to invest in new medicines?

A new area of focus is valuing medicines from a patient perspective. What do patients think is valuable? What do patients think is timely? What are patients’ opinions of how they should be incorporated into the decision-making process for access to medicines?

We also need to consider the global impact on Australia’s medicines system including the domestic capability, value pricing and access environment, research and development and intellectual property environment. As Australia represents only 1% of the global market, how does our policy dovetail into the policies in the rest of the world?

Most importantly, who is accountable for delivering on the NMP and how do we prove that we are achieving those accountabilities?

Health Industry Hub: What are the key considerations in transforming the NMP?

Ms de Somer: We have presented our views in the submission to the parliamentary inquiry led by the House of Representatives Standing Committee on Health, Aged Care and Sport.

Patients have changed. Technology has changed information and patients are more empowered and informed. They have an opinion, and that opinion should be brought into the decision making process.

Professor Andrew Wilson, Chair of the PBAC, has noted that there are times when the patient’s lived experience or the patient outcomes have really informed the decision making for the Committee.

However, this should happen earlier in the process. Patients should be at the centre of decision making and not as an afterthought. That may involve looking at patient evidence in a different way and beyond randomised controlled trials and the normal hierarchy of evidence. Perhaps there is scope to consider real world evidence and patient reported outcomes.

Another consideration is that new medicines are seen as a cost and not seen as an investment. Dr Michael Freelander MP raised this in the context of rare diseases and paediatrics from his experiences. The costs to the siblings and the family cannot be measured in an HTA value environment. However, it is very significant if you diagnose and treat patients early and get them back into a level of normal life.

Additionally, the interaction of medicines with devices and diagnostics shifts the focus to where it is going to get funded. Each bucket of money, whether it is state or federal government, is looking to cost shift or minimise the expenditure instead of looking at the value.

Importantly, there is currently no consideration in the NMP regarding the use of digital technology or digital health records which could improve the safe use of medicines in the future.

How do you modernise the NMP at a high level to take account of things that might become digital therapeutics or digital support tools, but leave it flexible enough to accommodate the next technology that we have not even imagined yet.

Health Industry Hub: Which key stakeholders will be involved in the NMP review?

Ms de Somer: The NMP has to be consumer driven because the patient has to benefit from the policy.

Professor Michael Kidd AM will Chair the review Committee. The other members of the Committee have not been publicly announced yet. My understanding from earlier announcements is that it will have consumer, clinician and industry representation.

We have to make sure that not only is it driven by what consumers need in the NMP but that it has all of the other stakeholders in the ecosystem engaged in making submissions to make sure it is fit for purpose.

Health Industry Hub: How do policy makers facilitate an agile NMP that is reviewed frequently and continues to foster partnerships to deliver optimal health outcomes?

Ms de Somer: A gap in the current NMP is a sustained governance framework. We need a process for accountability and measurables. In implementing a new NMP, there should be an action plan, a governance framework, measures and KPIs, and a structure that enables it to be reviewed at regular periods of time.

In the first NMP there was a committee to review the policy and health outcomes. There was also a quality assurance reference group that looked at patient information. Those two committee groups were deconstructed under a deregulation agenda.

In the new NMP, structure and processes are critical in holding the government and all the stakeholders accountable for their contributions to the policy.