How digitalisation can drive global medicine access

Over the past 30-40 years, technology advancements have helped improve global access to health practitioners and diagnoses. Even in rural areas and lower-income countries, patients are frequently now able to communicate with medical professionals via telemedicine, a resource that was previously unheard of. This has made healthcare more accessible, but without a way to “download” actual medicine, availability challenges remain. According to the World Health Organization, 2 billion people globally still don’t have access to basic medicine.

The big pharmaceutical companies increasingly understand the need to address this issue urgently. The recent decision by US pharmaceuticals giant, Pfizer to offer all its patented drugs on a not-for-profit basis to 45 lower-income countries points to a new trend for the sector’s leading players to make their products more affordable and accessible to the world’s poorest people.

We have already seen AstraZeneca and Johnson & Johnson choosing to price their coronavirus vaccines at cost during the pandemic.  Access to Medicine Foundation’s 2021 Access to Medicine Index, shows progress is being made more broadly, with other pharmaceuticals giants like GSK and Novartis already having mature approaches in place to improve access.

Yet, there is more to be done, and pharmaceutical companies have a responsibility to take action. According to the Index, “Pharmaceutical companies have a unique role to play here, as they have the capacity to develop urgently needed health products and to improve products’ availability across socioeconomic divides.”

Key role of digitalisation

For the kinds of approaches outlined above to be sustainable, they must be backed up by a focus on digitalisation aimed at driving long-term efficiencies. There is a major challenge to address here.

The good news is that global pharmaceutical companies are now rising to the challenge and starting to embrace digital transformation, with the FDA’s Advanced Manufacturing initiative and the International Society of Pharmaceutical Engineers’ (ISPE) Pharma 4.0 framework to improve efficiencies and drive faster drug manufacture.

The links between digitalisation and delivering pharmaceuticals to market more quickly and providing better access to those drugs are becoming ever clearer. According to a 2021 research study, Culture Reimagined: How Pharmaceutical Firms Can Use Data and AI with Confidence, companies that have a more advanced digital culture use data effectively across all aspects of drug manufacture. Eighty percent of such “digital culture leaders” in the research say their vaccine manufacturing capacity will be significantly impacted by digital technologies going forward.

There is certainly no straightforward “one size fits all” solution to how pharmaceutical companies can better contribute to global medicine access. But for those prioritising access-to-medicine strategies as a top business priority or initiative for the UN’s Sustainable Development goals, digitalisation is a viable path to turn to.

Delivering efficiencies across the board

Digitalisation is enabling pharmaceutical companies to experience efficiencies that were simply not possible just a decade ago. Today, digital technologies are having a ripple effect on everything from product quality and yield to on-time delivery. Digital transformation is optimising outcomes across the entire pharma value chain and evolving traditional supply chains to be more resilient.

Take electronic batch records as just one example of digital transformation. Electronic batch records, together with automated product release, contain the logic and rules that enforce manufacturing workflows, improve data integrity, minimise opportunities for error, and limit held inventory waiting to be released.

In another example, predictive and prescriptive maintenance give pharma companies sufficient prior warning that a piece of equipment is degrading. They can then take action before a costly breakdown occurs or avoid taking equipment offline for scheduled maintenance that may not be required.

The more efficiencies gained, the quicker and more cost-effectively a drug can be commercialised. When production is leaner, there are fewer faulty batches, reduced product costs and faster time to market.

According to consultancy, McKinsey, pharmaceutical companies demonstrate an estimated 70% improvement in overall equipment effectiveness with the use of artificial intelligence. Naturally, this can have a trickle-down effect on pharma’s ability to make medicine more available and less expensive, without sacrificing margins.

Optimising for better drug design 

Despite these positive indicators, the access challenge remains a difficult hurdle to overcome. One of the issues is that considerations for how novel and mass-market drugs will be made available in underserved areas are not always factored into the up-front design of the medicine and this often limits distribution.

Once a drug is approved, it is cumbersome and expensive to re-configure manufacturing processes and subsequent revalidation. This means specific distribution needs that may be required for vaccines in remote areas, for example, are not easily accommodated.

We witnessed this with the Covid-19 vaccine, which required cold chain storage which is difficult in rural, tropical climates and has made global Covid-19 vaccine distribution challenging.

Digital workflows powered by data are bringing drug design considerations to the fore. Digitalisation has been transformative in the visibility and insights pharma manufacturers have gained across the value chain. With more data, that can be optimised with Industrial AI and advanced analytics, pharma manufacturers can learn from existing processes and improve drug design.

For instance, modern Process Analytical Technology (PAT) is a powerful enabler of quality by design principles and process analytics. It allows manufacturers to monitor critical quality and performance attributes to ensure final product quality in a compliant environment. Modern PAT ensures stringent process design, monitoring and control, rather than resorting to identifying poor quality by inspection after the fact.

Digital technologies like PAT that improve drug design and mitigate issues before they arise, can help de-risk, distribution variables that add complexity to global medicine access. Critical decisions on how to get new drugs, (as well as common drugs for chronic conditions like diabetes), into the hands of under-served communities can be thoughtfully considered with more visibility and foresight into the entire drug design and manufacture process. Decisions such as where a drug or vaccine will be manufactured, the cost, how it will be shipped, requirements to administer, and local clinic accessibility, no longer need to be made retrospectively.

Uniting efficiency and visibility in the drug manufacturing process

Any pharmaceutical company looking to improve its access strategies should consider starting early in the pipeline with small batches of new drugs. The incurred business risk is smaller when access is considered at the onset of small batch drug design and distribution, and efficiencies are already embedded into the manufacturing process with the help of digital solutions. Then, with a successful initiative under its belt, the organisation has a proven framework to scale going forward as it hones its access strategy.

As the world’s population continues to grow, so will the demand for medicine and the pressure on the pharmaceutical industry to meet the challenge of a more sustainable world. Operational efficiency and visibility brought on by digital transformation can help strengthen the role pharmaceutical manufacturers are already plating in improving the equitable access to and availability of medicine around the world.

- The author, Raman Bhatnagar, is Vice President and General Manager Pharma at AspenTech.

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