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Europe: Euro Convergence: Experts discuss supply chain challenges, potential solutions

2024/05/17  RAPS

As regulators grapple with supply chain issues and preventing drug shortages, one expert says he foresees European regulators requiring manufacturers to include supply chain information in their marketing applications that could delay approvals.

Siegfried Schmitt, a vice president at Parexel, moderated a panel on 8 May at the 2024 RAPS Euro Convergence on how Europe is dealing with its supply chain shortage concerns. During a Q&A portion of the discussion, he opined that regulators may take additional steps to obtain supply chain information from manufacturers.

“When we look at the marketing authorization applications, I can foresee that a lot of information will have to be included in this in the future on how these supply chains will be set up, including the measures that one tries to implement to prevent shortages,” said Schmitt. “Would that perhaps prolong the process for getting approval? I could foresee that this may even require inspections of the supply chains.”

Rachel Harte, associate director for regulatory affairs at CAI, noted that while supply chain resiliency is an important issue for manufacturers, they would not welcome such a move. She said developing contingency plans and other factors, such as having details on the component and excipient suppliers not part of the marketing application, will be key to ensuring a more secure supply chain.

“In terms of extending timelines and including inspections, I think that’s a road that industry would prefer not to go down,” said Harte.

During the panel discussion, Harte noted that more than half of all drug shortages in the EU are due to quality and manufacturing problems, a quarter are due to commercial reasons, almost a tenth is due to failing to meet demand, 8% are due to distribution challenges, and only 4% are due to regulatory issues. She also noted that about half of drug shortages are due to shortages in tablets, and a quarter are due to injectables.

Harte also provided some tips for manufacturers to avoid supply chain issues, especially those due to quality and regulatory issues. For instance, she noted that regulatory timelines could vary significantly. If manufacturers are making post-approval changes, such as using a new active pharmaceutical ingredient (API) supplier, she said they should manage internal timeline expectations and keep regulators in the loop about changes that could affect supplies.

Harte also said that API-related shortages tend to affect generic drugmakers more, and companies should ensure they have contingency plans in place, such as having back-up API suppliers if the original supplier is unable to come through and ensure the contract manufacturing organization (CMO) that they work with comply with good manufacturing practices (GMP).

When considering potential supply chain disruptions, Harte said manufacturers should consider potential local and international events, the material needed to produce the product, and financial issues such as inflation.

Monica Dias, head of supply and availability of medicines and medical devices at the European Medicines Agency (EMA), also joined the discussion virtually. She noted that EMA has created an Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), which includes representatives from industry and patient stakeholder groups, the European Commission, member states, and EMA to address drug supply chain shortages.

Dias said that MSSG has several tools to address shortages of critical medical products, such as cooperation agreements with international organizations and regulators and increased communication and engagement with key stakeholders.

“What we’ve seen recently is that many of the critical shortages we have faced resulted from increases in demand, and in many cases, unexpected increases in demand, so it’s very important that we increase supply,” said Dias. “That’s why we’ve reached out to companies to increase production capacity when possible.”

“In some instances, that is not possible, so we needed to look at allocating stocks throughout Europe,” she added.

Dias said that in some situations, the agency has had to look at importing non-authorized products to fill the supply chain gap and has even had to import magistral formulations. She also noted that MSSG can control the distribution of products in critical shortage through measures such as rationing and limiting online sales and using regulatory flexibility such as allowing labeling exemptions, extending the product’s shelf life, and accelerating the marketing application of alternatives.

Dias said MSSG may recommend that manufacturers take certain measures to address supply chain shortages, such as increasing production capacity, diversifying their suppliers, monitoring the supply and demand of their product, using EU joint procurement mechanisms, keeping a safety stock, and getting regulatory support from competent authorities.

“The MSSG will look at the possibility of incentives for investment in particular areas for certain critical medicines,” Dias added. “The MSSG will not put this investment forward, but we’ll put the recommendation to the Critical Medicines Alliance (CMA) to look into and discuss the possibility of diverting investment to particular medicines for which we see that there is a lack in Europe.”

Dias also discussed the EMA’s European Shortages Monitoring Platform (ESMP), intended to launch in February 2025 to monitor, identify, and potentially prevent drug shortages. It will consist of a secure platform for drug companies to input data, one for national competent authorities, and a third platform open to the public to learn about potential shortages.

Dias noted that the proposed EU pharmaceutical legislation along with initiatives outlined in the European Commission communication on tackling medicine shortages in the EU are also intended to improve the security of supply for critical medicines and prevent shortages.

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