Drug shortage due to Estonian packaging requirement and parallel trade

A pharmacist (picture is illustrative).
A pharmacist (picture is illustrative). Source: AFP/Scanpix

Pharmacies are forced to send patients back empty-handed more and more often as supply difficulties mean some drugs are simply not available. Medicinal products can be in short supply everywhere in Europe, while there have also been cases of pharmaceuticals wholesalers marketing cheap drugs meant for Estonia elsewhere.

Medicines' supply disruptions are a problem everywhere in Europe, while the situation of patients in Estonia is made more difficult by Estonian packaging requirements and parallel trade," Aktuaalne kaamera reported.

"Pharmaceutical manufacturing takes place in only a few factories, and if something happens to these technologies, if there are problems with quality control systems, the entire world feels it," said Riho Tapfer, head of the Association of Pharmaceutical Manufacturers of Estonia.

While manufacturers are obligated to give two months' notice of supply problems, the State Agency of Medicines often learns about it once the drug runs out in pharmacies.

These problems could persist for years; for example, acne drug Dalacin hasn't been available in Estonia since 2016.

"Estonia is a small peripheral country with its own language. The latter is often the reason why other countries have some drugs we don't. Medicines authorized for sale must come in Estonian packaging," said Elsa Leiten from the agency's inspection division.

Even though Tapfer does not believe it to be the main problem in terms of supply, he admits Estonian pharmacies can run out of drugs for which the Health Insurance Board has negotiated a very good price.

"Europe has free movement of goods and services, meaning that drugs meant for Estonian patients, delivered and handed over to wholesalers by the manufacturer, end up being sold somewhere else," Tapfer said.

He gave a simple example, saying that if a manufacturer promises Estonia 400 doses of a drug at a favorable price and 200 doses of it are then exported, some patients in Estonia will miss out because the price was only for 400 doses.

Exporters must currently notify the State Agency of Medicines five days after drugs are exported, while Tapfer believes it would be sensible to require wholesalers to notify the agency beforehand. That would allow the latter to ask traders whether exporting particular quantities could cause supply problems. Leiten said that the agency has the right to ban export of medicinal products.

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Editor: Marcus Turovski

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