Discussing Pre-Pandemic Strategies and Drug Shortages
How will the biopharma industry evolve over the next 10 years? We speak with experts from Sartorius and the USP.
What we asked: “Looking ahead to the next 5–10 years, what will be the key disruptors and/or what can be improved upon in the pharma industry?”
Response from: Miriam Monge, Head of Marketing Strategy and Customer Advocacy, Sartorius
One thing that could dramatically change the pharmaceutical industry would be to adopt the lessons we learned during the pandemic around collaboration.
To that end, BioPhorum Supply Resilience is scoping out a “crisis response team” to proactively manage industry readiness and response from “detection to escalation” of any future crises impacting our biopharmaceutical manufacturing industry.
The question is, how can we act collectively? There is a need today for a consistent voice that’s representative of all major biopharma agencies, but separate from the guidance of the pharmaceutical industry – because our production processes and requirements are so starkly different, all the way down to the molecule.
For example, during the COVID-19 pandemic, 182 separate vaccine projects were initiated. When similar events occur in the future, we must be able to work with agencies and organizations such as CEPI, GAVI, and the WHO to collectively decide how many projects receive approval, and prioritize supply efficiently.
As the WHO Director-General Tedros Adhanom Ghebreyesus puts it, ‘The world must be ready to respond to the next pandemic. When the next pandemic comes knocking — and it will — we must be ready to answer decisively, collectively, and equitably.’
Response from: Tony Lakavage, Senior Vice President for Global External Affairs, USP
Over the past 10 years, we have watched drug shortages increase while the market for generic medicines has become a race to the bottom where purchasers focus almost solely on the lowest price. According to our findings and other studies, price erosion at the center of the drug shortage crisis is causing industry contraction.
Over two-thirds of the medicines we use today are generics. Nearly every approved drug that is off patent today has one or more generic competitors, compared to only 35 percent prior to the passage of the Hatch-Waxman Act in 1984. The generics industry has saved American taxpayers nearly $3 trillion over the past ten years, according to some estimates, and even more for patients worldwide.
However, with the current state of the industry, the savings and access to treatment that generics provide are at risk. Unsustainably low prices are forcing manufacturers to leave the market because of razor-thin margins or a lack of resources to invest in infrastructure and quality improvement. The length of drug shortages, including for life-saving medicines, increased from two to three years from 2022 to 2023.
Low prices for generics do not reflect, nor do they provide, a viable return on investment to justify redundancy in manufacturing or next-generation quality improvements. Without intervention, the industry will remain in crisis, and we risk not being able to get critical generic medicines to patients when they need them. As we look to the next 10 years and beyond, policy makers must begin implementing systemic changes that will ensure patient access to necessary medicines – including incentivizing supply chain quality, resilience, and reliability; promoting payment reforms; investing in capabilities to increase supply chain visibility; and strengthening modern manufacturing technologies. We must address the multifaceted issues that have undermined the generics market.
Read over 100 other views on the future of the pharma industry on our special web page.
