Clinical supplies & logistics
thousands of times over – the global pharmaceutical industry was worth around $1.5tn in 2022 – and you may start to understand just how globalised the sector is. Clearly, it’s a trend that’s reflected in specific countries too. From being mostly self- sufficient in the 1960s, the United States now imports around a quarter of its drugs, a figure that rises to 90% across the Atlantic in Britain. The story is much the same around technology, with China importing $50bn worth of medical equipment in 2021 alone. This interconnectedness isn’t hard to understand; with pharmaceutical manufacturers churning out products that are ever more complex, cross-border trade is crucial to success. It goes without saying, meanwhile, that any geopolitical turbulence, whether in the form of pestilence or war, can ravage these tangled arrangements. That’s especially true when it comes to clinical trials, more reliant on speed and efficiency than commercially available medications, and facing more serious theoretical hurdles. Not that the situation is hopeless. Between new technology, better political intelligence and a more subtle appreciation of how the world actually works in practice, there’s plenty that trial conveners can do to keep their supply chains flowing, even if the risk of some unforeseen catastrophe is never far away.
Chaos theories Tom Cotter has been thinking about supply chains for much of his professional life. Working across international healthcare, from Nigeria to Haiti to Panama, he’s seen first-hand just how globalised the pharmaceutical sector has become. Since July 2022, Cotter has been president and executive director at Healthcare Ready – a non-profit focused on developing medical supply chain resilience across borders. No wonder Cotter emphasises that there’s plenty to reflect on – particularly in light of recent emergencies. “We saw the limitations of a truly globalised medical supply chain during Covid- 19,” he argues, adding that the biggest disruptions tended to come from right at the start of the supply chain, with API suppliers in the developing world struggling to cope with lockdowns and travel bans. The statistics doubtless bolster Cotter’s argument. As early as April 2020, for instance, almost two-thirds of industry players expressed concern at the impact the pandemic could have on getting drugs from factory to patient. These worries were borne out in practice too. In Tanzania, 90% of community pharmacies reported a shortage of essential products, including paracetamol, which was in short supply across the developed and developing world at various periods throughout the pandemic. According to research by McKinsey,
Clinical Trials Insight /
www.worldpharmaceuticals.net
Covid-19 tripled US drug shortages, along the way costing hospitals more than half a billion dollars. Nor, of course, is the pandemic the only disruption to suddenly accost global pharma. Before the Russian invasion, Ukrainian drugs contributed $1.3bn to the country’s economy. Once Putin’s tanks rolled in, foreign companies unsurprisingly needed to find new partners in a hurry.
Trial drugs are almost always transported by land or air for the sake of speed and stability.
“There were a lot of public-private partnerships that worked really well – essentially government throwing money at the industry to absorb the risk.”
Tom Cotter
If commercial supply chains are clearly vulnerable, other insiders point to the particular pressures faced by clinical trials. To a certain extent, that’s a function of their rising complexity. As Steve Jacobs says, he now has colleagues conducting studies across 80 countries. All the better to secure a larger sample size, but as the president at Global BioPharm Solutions continues, the really important factor here is the medications themselves. If approved drugs can typically be mass-produced – the precise molecule needed has already been identified – trials require far more specialised shipments. That’s doubly true, Jacobs adds, with the new generation of gene therapies, not least when the most sensitive medications need to be stored at -190°C. Add in the demands of shareholders, and trial drugs are almost always transported by land or air as opposed to slower but more reliable ships – which can cause problems when no-fly zones are established or extreme weather conditions ground flights.
90%
The percentage of its drugs the UK now imports.
Healthcare Distribution Association
29
Pierre-Yves Babelon/
Shutterstock.com
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