Medicine shortages will continue to worsen without political will to overhaul pricing and procurement systems, EU and Irish experts say

• Political will needed to implement measures that put patients’ needs first, panel discussion finds
• Latest Medicine Shortages Index climbs again this week to 249, an increase of 10 medicines in six days
• “Unlicensed medicines used to fill the shortages gap are not fulfilling the requirements of the Falsified Medicines Directive leading to risk” says industry expert, Sandra Gannon 
• “65% of pharmacists feel that patients’ outcomes are negatively impacted by medicine shortages” says President of the Irish Pharmacy Union, Dermot Twomey
• “Authorities need to meet in the middle and raise prices” says lead author of EC medicine shortages report, Thyra de Jongh
• “Data sharing and collaboration needed as a long-term solution” says international medicine supply-chain expert, Claudio Zurzica

Medicine shortages will continue to worsen without the political will to implement measures that put the needs of patients first, experts from Europe and Ireland said today in Dublin at a panel discussion examining medicine shortages.

The experts said an overhaul of procurement and pricing systems is needed to overcome weaknesses in the global supply chain and avoid acute shortages affecting Irish patients in the future.

They discussed other European countries that have already taken specific policy measures to date in response to the escalating medicine shortage issue. Portugal recently took the measure to increase medicine prices up to 5% in order to secure its medicine supply.

The UK offers significant pricing concessions for medicines that are in short supply, while other countries have tabled proposals for price increases to combat shortages. To date, the Irish Department of Health is yet to meaningfully respond to this deepening challenge.

The number of medicines in short supply in Ireland this week has already risen to 249, an increase of 10 since the latest release of the Medicine Shortages Index.

Pricing is a short-term solution that should be considered to ease medicine shortages, said Thyra de Jongh, lead author of a recent European Commission report on medicine shortages:

“Shortages are caused by a mismatch between demand and supply. I am hopeful that we may be able to get the demand side under control a bit better because we are currently experiencing surge demand for certain products in part because of seasonal epidemics.  But that does not change the reality on the supply side.

“Pricing related factors are quite specific to older off-patent and generic medicines because those types of medicines actually don’t have very high profit margins. We tend to think of medicines as outrageously expensive products, but for most of the generic medicines that you can get at the pharmacy over-the-counter, the margins are in the magnitude of cents. If the costs are going up, those margins will quickly evaporate. The prices on generics can’t just be raised because of the pricing policies on these medicines.

“What we are seeing currently in various European countries is a current awareness that market related factors need to be tackled. There is a necessity on the part of purchasing authorities to meet in the middle and raise prices. However, the systemic factors will need solutions with a longer-term span.

65% of pharmacists feel that patients’ outcomes have been negatively impacted by medicine shortages, said Dermot Twomey, president of the Irish Pharmacy Union (IPU), citing a recent members survey of 280 member pharmacies carried out by the IPU:

“Almost every pharmacist in Ireland has felt medicine shortages significantly increase this year. 97% of pharmacists that responded to our recent survey said they have felt that medicine shortages have significantly increased over the past year compared with 70% in 2020.”

Exempt Medical Products (EMPs) that are not licensed for use in Ireland are in high circulation in the system, as an effort to stem the shortages problem. These EMPs are often not covered in state reimbursement schemes, Mr Twomey added:

“EMPs that are off-license and come from other jurisdictions, not registered for use in Ireland, are often not reimbursable under the state schemes. Ultimately, it’s the patient that ends up paying out of pocket for the cost of these products.”

Prolific use of unlicensed medicines to cover medicines shortages undermines the regulatory process, said Sandra Gannon, CEO of Azure Pharmaceuticals:

“We estimate that about 3 million packs of EMPs (unlicensed medicines) were in use in the system in Ireland in 2022. That means that the Falsified Medicines Directive (FMD) system is being undermined as the authentication of packs cannot be guaranteed.

“If you look at all the effort that the industry, health care providers and hospitals have made to implement the FMD to prevent fraud and falsified medicines coming into the system, EMPs being used to cover shortages is becoming a serious issue.

Claudio Zurzica, an international medicine supply-chain expert, said data sharing and collaboration amongst nations, in the area of medicine procurement, is needed to overcome medicine shortages long-term.

“This is a call for action because this situation cannot go on. We agree that price is a factor and one way to overcome that in the long-term is to use technology to make predictions in real-time.

“If we connect data together, which happens in other industries, we can have insights that will allow us to see different patterns and predict demands. That would give us accurate insights about what is going to happen.

“The problems are global because the supply chain is global. But, on a national level, connecting all the information available and collaboration is what’s going to move us toward a real solution.”

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