Friday, July 18, 2025

THE EU HAS DECLARED WAR ON ANTIMICROBIAL RESISTANCE - CYPRUS IN THE SPOTLIGHT

 Filenews 18 July 2025 - by Marilena Panagi



Incentives for pharmaceutical companies to invest in the discovery and manufacture of new antibiotics are being promoted, among others, by the European Union, in an effort to strike at the antimicrobial resistance that is now testing all European health systems. The tens of thousands of deaths recorded every year due to the available antibiotics to act effectively against the various microbes are of particular concern to all the competent National Authorities and the case of Cyprus is indicative. According to the latest officially recorded data of the Ministry of Health, over a period of one year (2019) 140 deaths were recorded, which were attributed to antimicrobial resistance, while another 547 deaths were related to it, with the trend increasing in the following years.

At the same time, the EU, through the "package of measures for medicines", which is under discussion, will attempt to fill the huge gap that seems to be observed on European soil in research, innovation and the development of new therapies in general by pharmaceutical companies based on its territory.

The latest pandemic and the significant shortages of medicines and raw materials, have actually highlighted Europe's nakedness in this sector but also the perhaps wrong practice of the past that led to the complete dependence of EU member states on third countries.

The "package of measures on medicines" is not excluded to be completed and "closed" during the Cypriot presidency of the EU in 2026.

Speaking to "F", the Director of Pharmaceutical Services, Elena Panayotopoulos, analyzed all the parameters of the large regulatory framework promoted at the European level, emphasizing the benefits for Cyprus, which, being a state with a small population, is more affected than the larger states, mainly in terms of the supply of new and innovative medicines due to the unprofitable for the pharmaceutical industries. of its size.

Medicines package: New EU rules

The aim of the package, said Ms Panayotopoulos, is "to update the current rules on medicines and at the same time to maintain the competitiveness of EU industry. The goal is to better meet the needs of patients and support innovation."

The 'package', in simple terms, includes new rules for all medicines, including those intended for rare diseases ('orphan medicines') and for children. It also includes a recommendation on strengthening action to combat antimicrobial resistance (AMR), i.e. the ability of microorganisms to survive despite their exposure to drugs designed to kill them."

As far as antimicrobial resistance is concerned, there are plans to provide incentives for pharmaceutical companies to promote the production of new antibiotics.

"To encourage industries to develop new antibiotics, a 'voucher' is offered that grants them an additional year of commercial protection (exclusive right to sell a product without direct competition from generics or biosimilars) for any of their pharmaceutical products."

The need for the management of antimicrobial resistance, while reducing the consumption of existing antibiotics "that lead to antimicrobial resistance", explained the director of pharmaceutical services, arises from the overall European data "and for us here in Cyprus, where we have increased percentages, this issue is characterized as particularly critical".

Trends of a significant increase in the number of infections and deaths

It is estimated that the continued increase in antimicrobial resistance will lead to around 10 million deaths worldwide each year

At the EU level, the latest data show a significant increase in the number of infections and deaths attributed to infections for almost all combinations of antibiotic-resistant bacteria, especially in healthcare settings.

· Around 70% of cases of antibiotic-resistant bacteria infections were health-related infections

· It is estimated that the continued increase in antimicrobial resistance will lead to around 10 million deaths worldwide each year and a 2% to 3.5% reduction in global gross domestic product

· By 2050, it will cost the global economy up to $100 trillion. 

Furthermore, the package includes actions aimed at:

– To meet the needs of patients through timely and equitable access for all to safe and affordable medicines,

– Security of supply and addressing shortages by improving the availability of medicines for all patients, and

– Enhancing innovation and competitiveness by providing incentives to drug manufacturers to invest in new formulations, antibiotics and medicines for rare diseases and diseases affecting children.

"Shortages of medicines have been a serious problem in the EU for several years. The COVID-19 pandemic has revealed our dependence on third countries for the supply of essential medicines and active pharmaceutical substances, as well as weaknesses in the existing legal framework," said Ms Panayotopoulos.

The new arrangements, he added, are expected "to improve monitoring and addressing shortages. Drug manufacturers may be required to inform authorities more quickly about shortages, draw up prevention plans and take measures to address critical shortages. In addition, the EU can draw up a list of critical medicines and monitor their availability, including actions aimed at making it mandatory to register and market all new medicines in all Member States, regardless of size, to ensure that no one country is superior to another."

"The package aims to address these challenges, for example by providing further incentives to drug manufacturers and streamlining regulatory processes."

Finally, "we have the issues concerning the environment, "the residues of medicines from the production, use and improper disposal have been proven to pollute water and soil, endangering the environment and public health. The proposed new rules require companies wishing to place medicines on the market to carry out environmental risk assessments and take risk mitigation measures."