Cyprus could oversee the completion of major European Union pharmaceutical legislation during its 2026 presidency, as the bloc advances reforms targeting antibiotic development and drug supply security.
The pharmaceutical package, currently under discussion, aims to address critical gaps in European drug research exposed during the COVID-19 pandemic. Elena Panagiotopoulou, Director of the Cyprus Pharmaceutical Services, said the reforms offer particular benefits for smaller member states facing market access challenges.
“The pharmaceutical package is not excluded from being completed and ‘closed’ during the Cypriot presidency of the EU in 2026,” Panagiotopoulou said.
Small state market challenges
Cyprus faces greater difficulties accessing innovative medicines compared to larger countries due to market size considerations by pharmaceutical companies, according to Panagiotopoulou.
“Being a state with a small population, Cyprus is affected more than larger states, mainly regarding the supply of new and innovative medicines due to the unprofitable size for pharmaceutical companies,” she said.
The proposed legislation includes mandatory registration and circulation of all new medicines across member states regardless of size “to ensure that no state will have an advantage over another.”
Antimicrobial resistance presents particular concerns for Cyprus, which recorded 140 deaths attributed to the condition in 2019, with another 547 related fatalities. “For us here in Cyprus, where we have increased rates, this particular issue is characterised as particularly critical,” Panagiotopoulou said.
Antibiotic development incentives
The package offers pharmaceutical companies vouchers granting additional commercial protection for developing new antibiotics. “To encourage industries to develop new antibiotics, a ‘voucher’ is offered that grants them an additional year of commercial protection for any of their pharmaceutical products,” Panagiotopoulou explained.
Approximately 70% of antibiotic-resistant bacterial infections occur in healthcare settings across the EU. Global projections estimate antimicrobial resistance could cause 10 million deaths annually by 2050, costing the world economy up to $100 trillion.
Supply chain reforms
“Drug shortages have been a serious problem in the EU for several years. The COVID-19 pandemic revealed our dependence on third countries for the supply of basic medicines and active pharmaceutical substances,” Panagiotopoulou said.
New regulations would require manufacturers to report shortages faster and develop prevention plans. The EU could establish critical medicine lists whilst monitoring availability.
Environmental provisions mandate companies conduct risk assessments addressing pharmaceutical waste. “Pharmaceutical residues from production, use and improper disposal demonstrably pollute water and soil, endangering the environment and public health,” Panagiotopoulou said.
The reforms target patient access to affordable medicines, supply chain security, and innovation incentives for rare disease treatments and paediatric medicines.
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