Group items tagged

Proposed changes to a European Union pharmaceuticals law will include stronger obligations for the supply of medicines and earlier notifications of shortages, EU Health Commissioner Stella Kyriakides said last week (January 17). Kyriakides told a session of the European Parliament that shortages of antibiotics are a growing problem for many European countries. She said the European Commission's proposal to revise the pharmaceuticals legislation is planned for March. "Our objective is and remains to secure access to medicines for all patients in need and to avoid any market disruption of medicines in the EU," Kyriakides said. Shortages of antibiotics have been reported in 26 European countries, the European Medicines Agency says. The unseasonably early upsurge in respiratory infections in Europe this winter and insufficient production capacity are the root causes of the shortages, Kyriakides said. Numerous EU lawmakers speaking at the session said the shortages needed to be tackled urgently. But experts say shortages of essential generic medicines like antibiotics are likely to be recurrent in Europe due to problems in the sector such as the gradual migration of generic manufacturing to Asia.

Adding to the growing evidence of global medicine shortages, a new study has revealed that the European generic medicines market is "not in shape" to help Europe meet its public health priorities. In the past decade, the rate of generic medicines withdrawals has risen by 12 per cent, while there has been a three per cent decrease in the launch of generic products, as per Teva Pharmaceuticals' recent analysis of IQVIA data. Within the mental therapeutic area, seven per cent of generic products disappeared between 2013 and 2023, while there was a seven per cent decrease in the availability of generic cancer medicines in just six years (2017-2022). These medicines were listed on the Union List of Critical Medicines to help avoid potential shortages, as the European Commission (EC) said this could cause "significant harm to patients and pose important challenges to health systems." While mature generic products constitute the majority of the List, they remain susceptible to withdrawals, despite containing products crucial for safeguarding Europe's public health, the Teva analysis report noted. Since 2013, the number of generic products for the treatment of schizophrenia and bipolar disorder has declined by 25 per cent, with Hungary and Bulgaria experiencing the biggest loss at 83 per cent and 58 per cent respectively.

When Ignasi Biosca-Reig heard there were shortages of amoxicillin in Spain, he quickly added shifts at his drug company's factories to boost production of the popular antibiotic. But a few extra shifts was as far as he could go. Much as he would have liked to significantly increase supplies, Biosca-Reig said he couldn't justify investing millions of euros in new production lines unless he was paid more for the generic drug to cover sharply rising costs. But, like many other European countries, Spain set the price manufacturers are paid for paediatric amoxicillin when the generic version of the drug was first launched in the country two decades ago, and it has barely budged since. "It's a non-business," said Biosca-Reig, chief executive of Spanish drugmaker Reig Jofre. "We wanted to react, but we had a problem," he said. "The costs go up, the price remains the same."