Combatting drug shortages in the EU: new guidance
New guidance for marketing authorisation holders has been released by the EMA to reduce the impact of drug shortages in the EU. Maurits Lugard and Anna-Shari Melin at Sidley Austin discuss the document and highlight its main points.
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have issued guidance for pharmaceutical marketing authorisation holders (MAHs) and regulators to mitigate drug shortages in the EU.
The documents released by the EMA explain to pharmaceutical industry stakeholders the actions they should undertake when faced with potential or expected medicinal scarcities.
Maurits Lugard, Partner and Anna-Shari Melin, Associate at law firm Sidley Austin, discuss certain aspects of the guidance, which they say “provides clarity,” to MAHs on the obligations that already exist under EU law.
Defining the situation
The MAH Guidance defines the term ‘medicinal product shortage’ as an event that occurs when “supply does not meet demand at a national level,” due to various reasons, which can have a serious impact on pharma as well as patients.
Having no previous common definition for medicinal shortages, this new guidance could lead to an improved understanding from MAHs which may improve their reporting to authorities. Lugard and Melin comment that the new definition is expected to contribute towards a “more consistent detection and management of shortages across the EU,” thus mitigating any potential supply chain issues.
The EMA aims for a “harmonised approach” between MAHs and regulators. Therefore, along with the framework the EMA sets out in the document, any issues with the supply chain should be effectively alleviated by MAHs working with regulators.
Actions for MAHs to take
The document advises MAHs that all shortages which are currently, or anticipated to, affect one or more EU member states need to be reported. The report suggests that these may be due to regulatory issues, quality defects or any other potential supply or manufacturing causes.
Therefore, the responsibility lies with MAHs for relaying any drug shortages within the EU. To mitigate any disruptions to the supply chain, MAHs must continuously monitor the supply and demand of their products, ensuring they have “open and continuous communication” with all their operators, including manufacturers, distributors and wholesalers.
Lugard and Melin highlight that the guidance requires MAHs to notify authorities in the EU at least two months before a product is absent from the market. In this event, a report must be handed to the relevant national authority by the MAH. For products licensed for use in the EU, the EMA must also be notified.
“Early communication of relevant information is essential in handling shortages,” says the document, suggesting that if a deficiency is reported as soon as possible, then potential solutions can be considered and implemented to reduce the effect on the industry and patients. The EMA suggests that an early warning may be critical in reducing the impact of medicinal shortages.
…any issues with the supply chain should be effectively alleviated by MAHs working with regulators”
Lugard and Melin agree, saying that adhering to the published guidance will allow for “early triaging, assessment and co-ordination of medicine shortages.”
MAHs should also be “particularly vigilant,” according to the guidance, at monitoring medicines that have no or only limited alternatives available, because of the potential effect on patients.
Therefore, following the document’s steps will support regulators, as all drug scarcities should be broadcasted to keep patients updated. The EMA also lists all shortages on its website and therefore must be made aware of any disruptions to supply.
Limitations of the system
Although Lugard and Melin say that the documents are an “important first step to provide clarity to MAHs,” they also argue that further guidance is required to address more “sophisticated situations” that could cause shortages. These include complex supply chains and the relocation of medicinal product manufacturing sites to low wage countries.
Another limitation that they highlight is the absence of any guidance for medicine shortages that may occur in the event of Brexit. The uncertainty of the UK’s exit from the EU extends to the pharmaceutical industry and the new guidance fails to clarify this situation.
Despite this, Lugard and Melin believe the new definition is an important first step for MAHs to improve the supply chain.
Results of the guidance
According to Lugard and Melin, MAHs should expect to see more scrutiny from regulators due to other new guidance for authorities. As such, they should consider a review of their supply chain and shortage detection processes to be aware of the conditions that authorities will be working under.
The guidance says that MAHs are in the “best position to assess relevant information, as they have visibility of their stock, both national and global, taking into account foreseen shipments from their manufacturers.” Therefore, the ability to oversee the entirety of the supply chain allows MAHs to anticipate potential shortages before they happen and report any issues quickly.
“MAHs must expect that, going forward, regulators will put a strong focus on the adequacy of companies’ supply management and shortage detection processes during inspections,” agree Lugard and Melin, highlighting the importance of a synchronised approach.
However, they expect the guidelines to evolve even further in the future: “In fact, we expect further guidance by the end of 2019, eg, on a metric to ‘measure’ shortages, aimed at facilitating management and monitoring of shortages across the EU.”
The new guidance for MAHs is intended to clarify what is meant by a medicinal shortage and to provide a structured framework to follow. This should reduce the impact of drug shortages, by enabling regulators to respond to supply chain disruptions.
Although there is the potential for the document to be refined further, Lugard and Melin suggest that it will improve the response of MAHs, as long as they understand and follow the guidance set out by the EMA.