For the 2021 BioPharmaDispatch conference on May 17th, we thought we’d share our Top 5 takeaways from Valeur. The event had over 350 attendees from across industry, patient groups and government. People seemed buoyant after seeing familiar faces and sitting in an audience with peers again. Here are some of the moments that stood out.
1. COVID-19 vaccines have put a spotlight on the industry
In an industry that is normally so distanced from being able to communicate directly with consumers, the impact of COVID-19 was summed up well by Will Delaat AM and former chair, Medicines Australia, who said it had been a major disruptor to the industry. The introduction of COVID-19 vaccines had impacted the image of the industry too. “No one could spell Pfizer or AstraZeneca 12 months ago….now people know about mRNA, manufacturing, stockpiling medicines and it’s all linked to the PBS ultimately”. David Learmonth former Deputy Secretary, Department of Health agreed about the disruptive nature of COVID-19, expressing concern about security of supply with medicines: “Everyone’s supply chain has been exposed and that’s uncomfortable”.
In describing the Australian experience with COVID-19 vaccines, Liz Chatwin, Managing Director, AstraZeneca and Anne Harris, Managing Director, Pfizer relayed stories about their journey with bringing vaccines to market. Engagement with the Health Minister calling daily and navigating the challenges of helping politicians driven by soundbites were all new ground. Managing the complexity of producing and sourcing the new COVID-19 vaccines was no easy task to message. The sheer difficulty became apparent when Anne Harris shared that the ‘Pfizer vaccine has 280 components sourced from over 80 sites’. A show of hands in the audience revealed ~10% of the audience had received their vaccinations so far however this was likely a reflection of the eligibility of the audience. The cost of the COVID-19 vaccinations in Australia was stated at $7.2bn, whereas the cost of all other vaccines combined is $400-500m, according to Brendan Shaw, former Chief Executive, Medicines Australia.
2. The policy environment in 2021 is far more transactional
The Department of Health has fewer longstanding players which means there is information asymmetry, according to Jane Halton AO PSM, chair, CEPI and GBMA. Her comments highlight that people don’t have the longevity, history or knowledge compared to five years ago. This has implications with the language used and assumptions made about stakeholders’ knowhow and what’s relevant. She also went on to comment that “the policy environment in 2021 is far more transactional” when asked about the current role of policy in relation to Health.
3. PBS decision making is largely delegated
“One of the few areas of law where the Minister delegates their authority to the Department” is how Felicity McNeill PSM, Better Access Australia, described the current operating model for decision making around the PBS. This creates challenges when decision making responsibility rests within the Department and there are areas that the Minister could weigh in on. In relation to the review of PBS decisions, Felicity made mention of the “lack of use of internal review rights by the industry”, which was notable and is a mechanism that industry could consider in future.
In terms of following due process, it was interesting to have confirmation that COVID vaccines did not go through the PBAC or regular mechanisms and that Telehealth did not go through MSAC. “PBAC/MSAC is now old world, and one health authority is needed that puts the patient at the centre. Digital therapeutics also needs to be part of the system and it’s not clear currently” Felicity added.
4. There's inequity for marginalised patients with the PBS
After hearing from Annie Madden, Harm Reduction Australia, it became clear that there is one group of patients in Australia who are treated inequitably. Patients with dependence have been supported by the PBS with reimbursed medicines on the journey to addiction but are not supported trying to navigate their way out. The PBS was never designed to be punitive but for this group of patients, it is. Patients are out of pocket significantly every month and there appears no clear reason that this decision could not be changed today with support from the Minister. Instead, an enquiry has been established, so in the meantime, patients receiving treatment for opioid addiction will continue to be treated inequitably by the PBS.
5. Could a Parliamentary Inquiry and National Medicines Policy ignite some reform?
On the policy front, Felicity McNeill stated the “National Medicines Policy (NMP) has been delayed in terms of going through and the urgency is not there”. According to Felicity, Medicines Australia needs to request the National Medicines Policy review to ensure it happens.
The Parliamentary Inquiry into New drugs and novel medical technologies received submissions from a vast array of stakeholders. How they bring this together with meaningful outcomes left many questioning what this could look like. In a session with Jody Fassina from Insight and Nick Campbell from Nexus APAC group, the take home message for the industry was to “pay attention to the recommendations from this Inquiry”. Will the Inquiry or NMP bring about reform or change? The speakers across the day seemed to have mixed sentiments.
AM= Order of Australia
AO= Order of Australia (Office of the Order)
PSM= Public Service Medal
CEPI= Coalition for Preparedness Innovations
GBMA= Generic Biosimilar Medicines Association