09 April 2020
The Covid-19 pandemic increases the chances that other medicines won't work
ELIZABETH PISANI: The coronavirus is placing an unprecedented strain on global medicine production and supply systems
For a couple of years now, the World Health Organisation has been warning that fake and substandard medicines are on the rise globally. Until recently, the problem has been concentrated largely in countries where most people pay cash for medicines, and where medicine regulation is weak or non-existent. But the hyper-globalised pharmaceutical market is changing that. And the coronavirus pandemic, an equal-opportunity screwer-up of business-as-usual, is about to bring poor quality medicines to your medicine cabinet, wherever in the world you live.
And these issues aren’t just going to hit Covid-related meds, you understand. Rising demand, falling supply, public panic, knee-jerk nationalism and distracted regulators will increase the risk of getting bad medicines for diabetes, heart disease, depression, rheumatism, cancer and virtually everything else. In virtually every country.
The problem is rooted in two fundamental (and intertwined) mismatches in the global economy. First, we increasingly look to governments to ensure that demand for affordable medicines is met, while relying on profit-seeking companies to supply that demand. That leads to procurement and production practices that incentivise cost-cutting and undermine product quality.
Second, we want both the price-lowering (and pollution-outsourcing) efficiencies of a globalised supply chain, while simultaneously demanding security of supply at the national level. As the current pandemic is teaching us, you can’t have it both ways.
Demand for products needed for critical care, or that have actual or rumoured therapeutic effects against Covid-19, is already rising rapidly in all areas. At the same time, supply of raw materials is already falling, and that affects all medicines.
Wherever your medicines are made, the chances are they contain at least some ingredients that come from China, or a very small handful of other countries. For a few active ingredients, there’s only one producer, supplying every manufacturer of finished product worldwide.
China’s Zhejiang province, the world’s largest producer of active ingredients, was second-worst hit by Covid-19. The impact of the disruption was likely delayed because stocks are routinely built up before the Chinese New Year holiday, when the shutdown began. Northern Italy, another major centre of active ingredient production, has also been very badly hit.
China and other exporters of active ingredients will restrict exports to meet their own national needs, further limiting supply to manufacturers in other countries. These restrictions may be applied selectively for political reasons. The US is particularly vulnerable because of the ongoing trade dispute with China; the products that are in highest demand domestically in China, India and other active ingredient-producing countries will be worst hit.
Countries that manufacture finished medicines will also restrict exports of medicines in order to meet national demand. India, which is the world’s largest exporter of finished medicines, has already started doing just this.
And as countries and large institutions rebuild stockpiles, profiteering distributors might hold on to medicines too, trying to drive up the price. This will cause localised shortages. In some countries, where public budgets are especially strained, medicines may be drained out of the public health systems to fatten the cushion under the private sector.
All these supply restrictions will push prices up. Countries with limited budgets for health may cut the number of medicines they buy, leaving patients to pick up the tab. Added to this, restricted transport, especially air traffic, will push up the cost of distribution and reduce the timely delivery of medicines, creating localised shortages. Products such as vaccines, which need to be kept cold and transported quickly, will be especially at risk.
The all-encompassing nature of the coronavirus crisis and the extent of the response required will have knock-on effects, too. Manufacturers may face political pressure to switch production capacity to Covid-19-related medicines, disrupting the supply of other essential drugs. We’ve already seen car companies pressed into service to produce ventilators, but that’s fine, we can still drive last year’s car. When a maker of cancer drugs switches to making antivirals, the cancer patient dies.
A system-wide focus on Covid-19 coupled with disruptions to normal workflows will also derail routine public procurement systems in some countries, leading to auction failures and shortages in the public sector.
These various supply-side and procurement issues, combined with the inevitable political pressure to be seen to be providing medicines, will oblige more institutional buyers to source medicines from previously untested suppliers. This increases opportunities for falsifiers to introduce products to the supply chain – and for them to make a lot of money doing so.
As shortages push prices up, the profit margin for falsifiers will rise on lower-priced medicines, encouraging more falsification of high-volume items that people are desperate to get hold of. These include medicines for high-prevalence chronic conditions, including diabetes and cardiovascular diseases, and in some markets HIV, TB and malaria medicines
When products are in short supply, it’s a seller’s market. Quality-assured distributors are going to serve their best clients first, and to them, their best clients are the ones that pay top dollar, on time. In lots of countries, national health systems are strapped for cash as well as strapped up in red tape, and are particularly bad at paying bills on time. They’re going to be dumped by their regular suppliers, and may have to look elsewhere for stocks.
And with people stuck at home, or going to the health centre or pharmacy and facing empty shelves or sticker-shockingly high prices, sales of medicines on the internet – which is rife with falsifiers – will increase.
Meanwhile, any deterrent effect of robust regulation and enforcement will diminish as governments concentrate human and financial resources on limiting the spread and impact of the pandemic. With regulatory attention and laboratory capacity diverted, and restrictions on movement in force, oversight of supply chains will suffer, leading to a reduction in the already infinitesimally small proportion of products whose quality gets checked on import, or once they’re in the supply chain.
Less oversight will also encourage legitimate pharma companies – whose profit margins will be squeezed due to the restricted supply of raw materials and increased transport costs – to cut costs, compromising quality and leading to substandard production.
Fixing a system as vast and complex as that for the global production and supply of medicines so that it can better respond to crises is an enormous task – and one that clearly can’t be done in the midst of a pandemic. But in the meantime, analysis can at least flag up which medicines are most at risk, right now.
There are a range of factors that can be combined into an index for regulators to use as an early warning system to trigger inspections, and to warn pharmacists and the public to view particular products or sources of supply with caution.
That might be the best protection we have against fake or substandard medicines during the Covid-19 crisis. But when the next pandemic strikes, let’s hope we’ve learned some lessons from this one.
Elizabeth Pisani is an academic researcher and the director of Ternyata Ltd., a public health consultancy. She is also a Visiting Senior Research Fellow at the Policy Institute, King’s College London.