The government proposes fines for pharmaceutical companies that fail to notify drug shortages in time
According to a press release from the Swedish Medicines Agency, the sharply increased number of cases last year is presumably linked to rising inflation, increased manufacturing costs and increased global demand.
Last year, a total of 1,615 pharmaceutical packages were reported as residue - just over 90% of these concerned human medicines, and just under 10% veterinary medicines.
In the vast majority of cases, replaceable alternatives were available, according to the Swedish Medicines Agency, which notes, however, that the situation creates many problems, worries and extra work for patients, as well as pharmacies and healthcare staff.
The Swedish Medicines Agency also criticises the lack of precaution on the part of pharmaceutical companies. 65% of all shortage notifications in 2022 were made either on the same day or after the shortage arose. Only 3% of the notifications were made two months before the estimated start date of the shortage, which is the basic requirement.
“At present, pharmaceutical companies are required to report residual situations to the Swedish Medicines Agency, but the regulatory compliance is not adequate, and the notifications are often made too late,” says Johan Andersson in the press release.
The pharmacy industry also expresses dissatisfaction with pharmaceutical companies. In an article on DN debate this weekend, Johan Wallér, CEO of Sweden’s Pharmacy Association, demanded tougher measures on manufacturers but also smoother reporting and regulations in Sweden.
“For patients, drug shortages lead to anxiety, stress, health problems and, in the worst case, life-threatening situations. For the pharmacists, these problems mean that they spend an increasingly large part of their working time on problem solving – working time that would normally be spent giving advice on and ensuring good drug use,” he writes.
He shares the Swedish Medicines Agency’s criticism of poor foresight.
“Manufacturers need to improve on reporting in time before stocks are running out, not on the same day or after the shortage has occurred,” writes Johan Wallér.
This Tuesday the government presented a bill aimed specifically at improving medicine access.
The government proposes, among other things, that it should be possible to collect penalty fees from companies that do not fulfil their obligations to inform about future shortage situations.
The bill also emphasises the importance of good stocking of necessary healthcare products by regions and municipalities, and it states that the government may, if necessary, “consider a statutory obligation to have healthcare products in stock”.
“Today, the pharmaceutical supply is more vulnerable than before, which is largely due to a trend towards global value chains and reduced stock holding. Faster information about emerging shortages and strengthened stock keeping will make the pharmaceutical supply safer,” says Health Minister Acko Ankarberg Johansson in a press release.
The trade association for the pharmaceutical companies in Sweden, Lif, believes that the proposal put forward by the government could have the opposite effect and instead worsen the availability of medicines.
”Contrary to the purpose of the proposal to secure access to medicines, the result will have serious consequences for the supply of medicines and entail great risks for patients. The industry takes a big responsibility in the matter of the pharmaceutical supply. There is room for improvement and the industry is not opposed to penalty fees being introduced, but in order not to create a situation where the result is the direct opposite of the purpose, the fees must be at a reasonable level”, says Anders Blanck, CEO Lif, in a statement.
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