Source : 'The Pink Sheet'
European shortages of particular medicine classes due to the COVID-19 pandemic are not likely to be significant over the summer, but there will be risks to the supply chain in the event of a second wave of the virus in autumn. Demand for products used in intensive care units, such as neuromuscular blockers, are likely to rise significantly, a new industry report suggests.
To help industry prepare for these risks, countries need to take action now and use the summer months to restock critical ICU medicines and develop a sustainable strategy for future crisis preparedness, according to the report, by two pharmaceutical industry associations, EFPIA and Medicines for Europe, together with the consultancy, Kearney.
The COVID-19 crisis has placed a “tremendous burden” on healthcare systems and increased demand for ICU medicines, especially for sedatives, analgesics, vasopressors and neuromuscular blockers (NMBs), the report. “The surge in demand for these medicines led to global concerns about potential shortages and a challenge to ensure sufficient supply during the first wave of the outbreak.”
While industry and EU regulators have taken steps to increase supplies and have avoided the most acute drug shortages, a supply risk remains, particularly for NMBs.
Moreover, as lockdown restrictions are slowly lifted, the lack of a vaccine and limited herd immunity mean “a second COVID-19 wave is a risk that countries should prepare for,” the report says. “Additional factors, such as the demand for medicines from global COVID-19 hotspots outside of Europe, depleted safety stocks that were absorbed during the first wave, or the restart of elective surgery, place further strain on the industry.”
In order to estimate demand for critical medicines in a potential second COVID-19 wave, the industry bodies and Kearney developed three different scenarios of how demand might develop in the autumn – best case, base case and worst case. To identify where medicine shortage risks were likely, a further analysis by the consultancy compared the data with the supply/manufacturing plans of key European pharmaceutical companies.
The best-case scenario estimates include a 50% fall in COVID-19 related deaths compared with the first wave, and about 33,150 new ICU patients between 1 October and 30 November this year. The worst-case scenario is a 50% increase in new deaths and 99,459 new ICU patients in the same period.
The report says governments should consider the “tourism factor” when planning for a second COVID-19 wave, noting that popular holiday destinations are likely to re-open for tourists in the summer months and “this is currently not figured into the second wave projection.”
By way of example, it says that Greece had 28 million visitors in 2018, almost three times the country’s population. Tourism numbers for 2020 are likely to be significantly lower than this, but if,, say, the country had 10 million visitors this summer, this would “double Greece’s population susceptible to COVID-19 infection.”
Possible disruptions to the supply of active pharmaceutical ingredients (APIs) has been a key concern during the pandemic, but the report says that a survey of marketing authorization holders “suggests that API challenges currently do not seem to pose a major risk for the industry.”
MAH’s were asked: “Do you experience notable API challenges that pose a significant threat to manufacturing in terms of quantity, quality or time of delivery?” In response, only a few manufacturers said they had “at least one notable API challenge” and these were restricted to NMBs and sedatives. NMBs are used in patients undergoing mechanical ventilation for acute respiratory problems in order to improve oxygenation and decrease ventilator-induced lung injury.
“Generally, API supply does not seem to be a major risk factor,” the report says, although “capacity constraints may cause manufacturing bottlenecks.” There is an implicit warning against complacency. This conclusion “needs to be corroborated from the perspective of non-EU manufacturers”.
EFPIA and Medicines for Europe say the pharmaceutical industry is encouraging direct collaboration with governments to rapidly produce a “clear joint plan for resupply” in the event of a second wave of COVID-19, and that “transparent exchange of information” regarding patients’ needs is necessary “in the spirit of joint crisis preparation.”
By Ian Schofield