Recently declared a ‘global threat’ by the World Health Organisation, the Coronavirus has spread rapidly, from its initial outbreak in China’s Wuhan province to having reported cases in 24 other countries (and rising). This virus represents a real threat to the pharmaceutical industry and its supply chain, as well as to the health of the population at large.
There is a heavy reliance on China for essential medicines and medical supplies. In particular, China is the world’s largest supplier of active pharmaceutical ingredients (APIs), responsible for around 40% of global production and supplying the ingredients for the makers of generic and innovator drugs alike. In the UK, 80-90% of generic medicines used in the NHS are imported, with China among the top five providers outside the EU. Such global dependency has arisen, in part, through the cost-saving incentives that the Chinese pharmaceutical market offers.
The outbreak has rendered this Chinese drug supply vulnerable. Chinese facilities contribute an unknown proportion of APIs for approximately 370 essential drugs. The exact percentage of these products that are single-sourced, i.e. totally reliant on Chinese active ingredients, is uncertain because pharmaceutical companies regard such information as proprietary. There is clearly an inherent risk in focussing a supply chain in a single country.
Whilst most drug manufacturers are based along the east coast (in the provinces of Zhejiang, Jiangsu and Shandong), a long way from ground zero in the centrally-located Wuhan, the virus has now been detected in every province. There are now more than 35,000 confirmed cases worldwide. In addition to a diminished workforce, a growing swathe of travel bans and other countermeasures to try to restrict the spread of the virus, not to mention the possibility of international embargos, further threatens manufacturers’ ability to sustain production levels. The full impact is unlikely to be known for many months to come.
In response to the virus, with the support of the Coalition for Epidemic Preparedness Innovations (CEPI), programs are already underway at Inovio Pharmaceuticals and Moderna to develop Coronavirus vaccines. Through CEPI, GlaxoSmithKline will also make its adjuvant technology available to help the University of Queensland in Australia expand its rapid vaccine production system. The adjuvant should reduce the amount of antigen necessary for each vaccine, enabling more people to be treated faster with available antigen supplies. Gilead is making efforts to re-purpose its drug remdesivir, originally developed to treat Ebola, having allegedly just received the green-light from the Chinese Food and Drug Administration for a clinical trial to take place in Wuhan. There are currently no approved vaccines for the Coronavirus. The integrity of the global pharmaceutical supply chain for medicines to treat many different diseases, not just the fate of those who contract the Coronavirus, may hinge on the ability to develop a treatment sooner rather than later.