July 15. 2024. 7:52

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Massive stockpiling of medicines increases patient risks, warns EU coalition

A coalition of six EU member states has warned against some countries’ massive stockpiling of medicines, warning that such practices might cause significant shortages in other parts of the European Union.

Ahead of the Health Council of the EU meeting on 21 June, Czechia, Cyprus, Malta, Romania, Slovakia, and Slovenia signed a non-paper emphasising the detrimental impact of excessive national stockpiling on the EU’s single market and solidarity principles.

The signatories acknowledge the right of individual countries to safeguard their populations by securing medicine supplies, but caution that these measures, if taken to extremes, can disrupt the balance within the EU.

The document also recalls that a year ago, EU states supported the establishment of a voluntary solidarity mechanism to address acute medicine shortages.

“However, before having a chance to test this solidarity mechanism in practice, several Member States have recently adopted national measures that might go against the solidarity principle and, as a result, may cause secondary unavailability of medicines by implementing excessive ‘stockpiling strategies,” reads the non-paper obtained by Euractiv; it continues, adding that such strategies can hinder the single market as well as the EU solidarity.

Germany, France and Austria

Czech Deputy Health Minister Jakub Dvořáček told Euractiv they are particularly worried about the German approach.

In Germany, health insurance companies are tendering and contracting pharmaceutical companies to obtain medicine supplies at reasonable prices. With the new law passed last year, companies entering these tenders must commit to a minimum supply stock of the average six months’ demand.

“We do not question the country’s right to secure patients’ access to medicine, but this should not negatively affect the general availability of medicines elsewhere,” Dvořáček said to Euractiv, adding that Germany is not alone in exploring such stockpiling measures, as similar initiatives are being discussed in Austria and France.

He warned that smaller markets could be disproportionately affected, leading to significant health risks for their populations. “It’s not certain who will be hit hardest, but it is clear that weaker, smaller markets will then be neglected,” he said.

“This could manifest itself as early as this autumn,” underscored Dvořáček, emphasising the urgency of addressing the issue, he explained: “We see this as an unconscionable move that could put patients in other countries at risk.”

EU recommendations needed

The non-paper calls for several actions to address the potential negative impacts of these national stockpiling measures.

It urges the European Commission to jointly propose recommendations for national stockpile strategies as soon as possible, while states that have already implemented stockpiling measures should re-evaluate them based on these recommendations, adhering to the spirit of European solidarity.

Additionally, states currently preparing their stockpiling strategies should take these recommendations into account.

It also calls for member states to openly share their intentions regarding stockpiling measures within relevant platforms.

Furthermore, the Commission is urged to analyse whether the national stockpiling measures already adopted comply with EU law.

As Czech deputy minister Dvořáček explained, Czechia was already in touch with German authorities to discuss the matter. Germany argues that its stockpiling measures will not negatively impact the markets. However, this assurance has not calmed the fears of member states that could be affected.

Dvořáček focused on concerns about the availability of antibiotics, medicines for chronic diseases, and seasonal medications. “We would like to see recommendations at the EU level on how to proceed with stockpiling – that is the easiest thing to do now,” he said.

Dvořáček also highlighted the importance of approaching stockpiling with discretion and plans that reflect the production capacity of pharmaceutical companies.

Pharma industry sounds alarm

Medicines for Europe, an industry group representing generic and biosimilar medicines manufacturers, has also raised concerns about the extensive national stockpiling requirements. In their recent report, they argue that such measures have unintended consequences that could exacerbate the very problems they aim to prevent.

According to Medicines for Europe, the additional costs and complexity for manufacturers reduce the economic viability of low-price or low-volume medicines, aggravating market consolidation, increasing the risk of shortages, and threatening patient access to medicines.

Furthermore, the industry argues that national stockpiles prevent manufacturers from reallocating stocks from one EU member state to another to mitigate shortages, as stockpiles are restricted to the national market.

“Medicines are manufactured to serve patients, not hoarding,” they emphasise. Medicines for Europe also caution that such stockpiling creates a false sense of security regarding the ability to mitigate a major shortage.

“We call for EU solidarity rather than national stockpiling obligations. The latter will lead to oversupply in large countries while exacerbating the risk of shortages elsewhere,” the industry group argued in a press release published ahead of Friday’s Health Council.

The generic pharmaceutical association also highlights the potential negative impact of the German legislation, arguing that “six months of antibiotic stockpiling in Germany will consume the needs of 10 other EU Member States in a segment where manufacturers are already producing at full capacity”.

Instead, the companies are calling for the establishment of a European strategic reserve targeted for the most critical medicines at the EU level.

[By Aneta Zachová, Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]

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