https://www.cidrap.umn.edu/resilien...rite-laws-other-tactics-reduce-drug-shortages
Countries look to rewrite laws, other tactics to reduce drug shortages
Mary Van Beusekom, MS
Today at 2:43 p.m.
Resilient Drug Supply
Still dealing with this winter's shortages of antibiotics and painkillers, the European Union (EU) Commission, for example, plans to publish a draft of the largest overhaul of medical laws in 20 years on April 26, Reuters reports.
Although pharmaceutical companies decry the measures, the EU may shorten the period of time drug companies receive for patents in order to expedite the availability of cheaper generics. "But in an attempt to improve access to medicines across the EU, the Commission will offer companies an option to gain back at least one year of exclusivity for a product if they launch it at the same time in all 27 member states," Reuters said.
Allowing temporary imports, stockpiling
In Australia, the Therapeutic Goods Administration (TGA) recently announced that to alleviate drug shortages, it is now authorized to approve the temporary import or supply of a drug approved in another country as a substitute—as long as it had been registered at one time in Australia, according to The Pharma Letter.
The TGA said the authorization includes drugs that have been discontinued, suspended, or cancelled from the registry but can still help patients without other therapy options. Before the change, the TGA could temporarily approve import and supply of an alternative drug from overseas only if it was currently registered in Australia. Drug companies are also now required to notify the TGA of changes to the expected shortages and of shortage resolutions.
In Australia, the Therapeutic Goods Administration recently announced that to alleviate drug shortages, it is now authorized to approve the temporary import or supply of a drug approved in another country as a substitute—as long as it had been registered at one time in Australia.
In a commentary published in MacLean's, Shoo Lee, MBBS, PhD, retired neonatologist and professor emeritus at the University of Toronto, advocated for Canada to create a list of essential medicines (eg, oncology drugs, anesthetics, antibiotics, drugs used for diagnostic imaging). Then at least 6 months of those drugs should be stockpiled and tracked in real time with every distribution or replenishing, he said.
"To ensure the stockpile is always full, the federal government could establish a Crown corporation to manufacture these essential drugs. In the event of a national shortage—which, sadly is certain to occur again—production can be ramped up to meet demand," Shoo wrote.
A long-term solution, he said, would be to onshore pharmaceutical manufacturing and use new technologies to streamline the output of active pharmaceutical ingredients (APIs) and allow drug makers to efficiently scale up production as needed.
"Young children shouldn’t be running fevers because we can't secure something as simple as children's Tylenol, and our solution can't be to order two million bottles to get parents to stop complaining," Shoo wrote. "We can't wait for the next war—or pandemic-sized meltdown—to motivate us. We should always be prepared."
US onshoring may not be best answer
In the United States, the Brookings Institution recently hosted a panel of supply-chain experts to address persistent US supply-chain shortages, Endpoints News reports. Panelist Tom Bollyky, of the Council on Foreign Relations, said a more viable alternative to onshoring may include better cross-border movement of goods, including predictable rules that will be put in place in a crisis such as the pandemic.
"The vast majority of [export restrictions on essential drugs] were longer than three months in duration, many of them over a year," he said of difficulties moving COVID-19 vaccines across borders. "Relatively few of them were notified to the WTO [World Trade Organization] according to WTO rules and in many cases that slowed the production by discouraging investment in cross border supply chains."
Panelist Tanya Alcorn, Pfizer senior vice president for sterile injectables and biotech operations, said that onshoring of APIs, for example, is very expensive and that it may not be possible to bring all the raw materials onshore.
"We diversify across different suppliers," she said. "We have redundancy and suppliers, and we'd rather create that trustful partnership with suppliers versus trying to do everything ourselves. We can't do everything ourselves. It's just not feasible. It's not practical."
Countries look to rewrite laws, other tactics to reduce drug shortages
Mary Van Beusekom, MS
Today at 2:43 p.m.
Resilient Drug Supply
Countries around the world—including the United States—have been grappling with serious drug shortages for decades. And now, spurred by the shock of the COVID-19 pandemic, some are rewriting laws and proposing other responses to shore up access to affordable medications.Still dealing with this winter's shortages of antibiotics and painkillers, the European Union (EU) Commission, for example, plans to publish a draft of the largest overhaul of medical laws in 20 years on April 26, Reuters reports.
Although pharmaceutical companies decry the measures, the EU may shorten the period of time drug companies receive for patents in order to expedite the availability of cheaper generics. "But in an attempt to improve access to medicines across the EU, the Commission will offer companies an option to gain back at least one year of exclusivity for a product if they launch it at the same time in all 27 member states," Reuters said.
Allowing temporary imports, stockpiling
In Australia, the Therapeutic Goods Administration (TGA) recently announced that to alleviate drug shortages, it is now authorized to approve the temporary import or supply of a drug approved in another country as a substitute—as long as it had been registered at one time in Australia, according to The Pharma Letter.
The TGA said the authorization includes drugs that have been discontinued, suspended, or cancelled from the registry but can still help patients without other therapy options. Before the change, the TGA could temporarily approve import and supply of an alternative drug from overseas only if it was currently registered in Australia. Drug companies are also now required to notify the TGA of changes to the expected shortages and of shortage resolutions.
In Australia, the Therapeutic Goods Administration recently announced that to alleviate drug shortages, it is now authorized to approve the temporary import or supply of a drug approved in another country as a substitute—as long as it had been registered at one time in Australia.
In a commentary published in MacLean's, Shoo Lee, MBBS, PhD, retired neonatologist and professor emeritus at the University of Toronto, advocated for Canada to create a list of essential medicines (eg, oncology drugs, anesthetics, antibiotics, drugs used for diagnostic imaging). Then at least 6 months of those drugs should be stockpiled and tracked in real time with every distribution or replenishing, he said.
"To ensure the stockpile is always full, the federal government could establish a Crown corporation to manufacture these essential drugs. In the event of a national shortage—which, sadly is certain to occur again—production can be ramped up to meet demand," Shoo wrote.
A long-term solution, he said, would be to onshore pharmaceutical manufacturing and use new technologies to streamline the output of active pharmaceutical ingredients (APIs) and allow drug makers to efficiently scale up production as needed.
"Young children shouldn’t be running fevers because we can't secure something as simple as children's Tylenol, and our solution can't be to order two million bottles to get parents to stop complaining," Shoo wrote. "We can't wait for the next war—or pandemic-sized meltdown—to motivate us. We should always be prepared."
US onshoring may not be best answer
In the United States, the Brookings Institution recently hosted a panel of supply-chain experts to address persistent US supply-chain shortages, Endpoints News reports. Panelist Tom Bollyky, of the Council on Foreign Relations, said a more viable alternative to onshoring may include better cross-border movement of goods, including predictable rules that will be put in place in a crisis such as the pandemic.
"The vast majority of [export restrictions on essential drugs] were longer than three months in duration, many of them over a year," he said of difficulties moving COVID-19 vaccines across borders. "Relatively few of them were notified to the WTO [World Trade Organization] according to WTO rules and in many cases that slowed the production by discouraging investment in cross border supply chains."
Panelist Tanya Alcorn, Pfizer senior vice president for sterile injectables and biotech operations, said that onshoring of APIs, for example, is very expensive and that it may not be possible to bring all the raw materials onshore.
"We diversify across different suppliers," she said. "We have redundancy and suppliers, and we'd rather create that trustful partnership with suppliers versus trying to do everything ourselves. We can't do everything ourselves. It's just not feasible. It's not practical."