Delivery of expired medicines to Ukraine turns spotlight on Belgian drug rules
Belgium is facing a scandal after it was revealed that it sent medicines to Ukraine at the beginning of March, some of which reached their expiry date just three weeks after their arrival, RTBF reports.
The Belgian health ministry has stated that the solidarity operation took place urgently but transparently and that the Ukrainian authorities were aware of the conditions.
The operation dates back to the beginning of March. Immediately after the Russian invasion of Ukraine, Belgium offered humanitarian aid to Kiev: €3.4 million in medicines and medical supplies. The catch was that some of them came from a stock that was about to expire.
The minister of health Frank Vandenbroucke said the sending of almost expired medicines was justified by the emergency: "When a country is suddenly attacked, we must help its population, including the wounded who need urgent medical care,” he said. “ Everything possible must be done to save lives. To fail to react is to commit culpable negligence.
As early as 25 February, the federal health department proposed to Ukraine a list of medicines, an offer accepted the same day. We provided morphine and other drugs that could be used immediately, especially in operating rooms."
"Among this list were, it is true, products close to their expiry date. It should be emphasised that everything was done in good faith and that Ukraine accepted these products. But let's recognise that this is not the usual practice and that the approach has also been adapted for the second delivery in order to respect the standard period of six months before the expiry date."
Six months may be the standard period for Belgium but it is less than the 12 months recommended by the World Health Organization (WHO). The WHO estimates that drugs intended for donation must have a shelf life of at least one year. Belgium has therefore violated international directives, which the health ministry acknowledges. "It's true, but we had to act quickly," a spokesperson again reiterated.
In Belgium, the Federal Agency for Medicines and Health Products is the competent authority responsible for ensuring the quality, safety and efficacy of medicines. Its director, Xavier Decuyper, wants to reassure the public that people do not run a risk of life or death by using an expired drug.
"Of course, the expiry dates of drugs are important, they have a reason for being there and we must respect them as much as possible,” he said. “But as with most other products, they have a margin of safety that is such that we are not a day, a week or a month away. Producers take their precautions, we understand them, therefore the consumer or patient should not panic if the date is just over."
"There is, however, one condition: that the conditions of conservation are respected. It's like dairy products, for example yogurt, everyone knows that they remain edible a few days after their expiry date but only if they have stayed in the fridge. If they have been exposed to heat, they will deteriorate even before the use-by date. It is similar for drugs, but be careful, if there is no real danger to health by absorbing a drug that has recently expired, there is still a risk. It is the lack of effectiveness. If the drug does not work or works less well than expected, it is a kind of invisible risk but it exists, and it must be taken into account. The safest thing is obviously to use medicines and health products that are within the validity period."
It's not unusual to find vials, pills or ointments at home that have exceeded the expiry date. Instead of using them, the protocol is to take them to the nearest pharmacist. "Patients have to bring us their old medicines, it's free and easy, but only bring back medicines, not homeopathy, vitamins or herbal products,” said Valérie Lacour, a pharmacist in Brussels. “We have boxes provided for the harvesting and storage of these products that will then be destroyed in a secure way. It's important to prevent them from ending their lives in toilets and rubbish bins because there would be a risk of water pollution or accident if an animal or a human recovered them in a waste bin."
But should drugs be brought back as soon as the date has passed? Here too, the answer is nuanced: "You should know that the date communicated by the manufacturers corresponds to the date until which the quality of the product is guaranteed according to the tests carried out,” Lacour said. “ Beyond that, we don't know if they remain effective, maybe yes, maybe not. As a result, for some products such as painkillers or soothing creams, we can take the risk because it is limited. On the other hand, for antibiotics or drugs for the thyroid or against diabetes, it is probably better to stick strictly to the date because a possible lack of effectiveness can be damaging."
It also depends on the time elapsed. "A few days is not a big deal, a few months is sometimes problematic,” she added. “Even eye drops are no longer recommended four weeks after opening, for sunscreen it is one year. Finally, I would say that sometimes you have to rely on the smell or the appearance. A cream that smells abnormally bad, it should no longer be used, even if the date is still good, because it has not been well preserved. "