At this moment, the novel coronavirus outbreak isnt causing problems for Europes medicines supply. But thats almost certain to change, industry experts warn — and at the worst possible time.
Two weeks after the COVID-2019 spread was declared a public health emergency by the World Health Organization, it shows no signs of abating. As of February 13, the WHO said there were almost 47,000 lab-confirmed cases of the virus, most of them in China, which has quarantined tens of millions to contain the spread.
“Were this epidemic to develop into a global pandemic, most countries will face shortages of essential medicines at a time where they would need them the most,” warned the European Fine Chemicals Group, which represents manufacturers of active ingredients in medicines.
While Europe is one of the worlds top manufacturers of drugs, the raw ingredients often come from China or India. This dependence on Asia was already a source of alarm at the EUs highest political levels, with shortages and impurities prompting calls for action in both Brussels and national capitals.
Now the coronavirus, which is shutting down factories in China and preventing authorities from making sure plants are up to snuff, is on track to exacerbate existing shortages.
“Were taking a balanced view of any risk.” — Gary Slack, executive at BSI
“We have seen there might be a possibility [of the] risk of shortages of supplies due to the coronavirus,” said German Health Minister Jens Spahn at an emergency meeting with his EU counterparts in Brussels Thursday. “We know many active ingredients are made in China, particularly in Hubei province.”
Calm before the storm?
So far, say industry officials and regulators, so good. The European Medicines Agency hasnt received any reports of supply disruptions, a spokesperson said, echoing reports from trade associations for both innovative medicines manufacturers and those who make cheaper, generic versions.
“So far we have had no indication” of long-term problems for medicines availability, said Thomas Cueni, head of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA).
“Unless,” he added, “disruption because of the novel coronavirus is sustained over several months.”
Several factors related to the outbreak can disrupt the supply. Factory closures and worker quarantines to prevent the spread of the disease are an obvious issue. Then theres the potential shutdown of shipping infrastructure from the region, or extra controls on imports and exports.
Another problem is inspections. Regulators from the U.S. and EU countries regularly inspect foreign facilities to make sure their manufacturing is up to code. Following discoveries of widespread impurities of blood pressure and heartburn medicines these checks are proving all the more essential. Yet with travel shutting down, some checks in China and Southeast Asia are already being postponed, the EMA said — although at this point, those delays arent expected to have a practical impact.
Generic medicines, which are often produced with a razor-thin profit margin or even at a loss for some essential treatments, are especially threatened by limited supply options. For some drugs, 80 percent of the initial ingredients come from outside the U.S. and EU, leaving them “vulnerable to any incident that may disrupt the supply chain,” said European Fine Chemicals Group.
European generics producers are watching the situation in China very closely, said the head of their Brussels lobby Medicines for Europe, Adrian van den Hoven.
The Chinese government faces a “Catch-22 situation,” he said. “On the one hand, they have to keep the economy going. On the other hand, theyre taking very severe measures to try and contain the spread of the virus.”
Companies were already bracing for a bit of a gap, he said. Manufacturing always slows down around the Chinese new year, which coincided with early international scrutiny about the infection. And while there are no immediate problems, “if this extends for several more weeks or several months, it could lead to supply issues for our manufacturers,” he said.
Industry in India, the worlds No. 1 producer, is already raising the alarm. Umang Vohra, a top boss at Indian pharma giant Cipla, told the Financial Times that most companies are on track to start running out of supplies this month if Chinese factories dont turn the lights back on.
A drop-off in generics doesnt just affect costs. The off-patent sector dominates the supply of some essential medicines, including 80 percent of prescription antibiotics. And a shortage of medicines that arent absolutely necessary could still cause widespread human misery: As both the flu and the flu-like COVID-2019 reach their peaks, the supply of cough and cold meds could be interrupted.
“If the outbreak expands way beyond what it is now in terms of numbers or into other countries,” said IFPMAs Cueni, “then we probably get into uncharted territory.”
When it comes to medical devices, the global shortage of face masks has gotten most of the attention.
But a broader array of medtech products could also see supply problems if they come from countries crushed under the coronavirus epidemic.
In Europe, its up to often private companies called notified bodies to verify the safety and efficacy of medical devices. Part of their job is to audit factories, and that process is already facing disruption.
“Action should be taken to avoid crises in the future.” — Adam Vojtěch, Czech Health Minister
Oversight authorities already have a set of guidelines for extraordinary circumstances, like wars or major weather events or pandemics — and thats kicking in for the coronavirus, said Gary Slack, an executive at BSI, one of Europes largest notified bodies.
“Were taking a balanced view of any risk,” Slack said. Audits can be delayed for as much as six months, and there are ways to perform some remotely. “ObviouslRead More – Source