EMA Tackles Antibiotic Resistance

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 01-30-2015 13:16


The European Medicines Agency (EMA), the European Center for Disease Prevention and Control (ECDC), and the European Food Safety Authority (EFSA) have issued a joint report to examine the issues of antibiotic resistance. The analysis was carried out at the request of the European Commission and combines data from five European monitoring networks that gather information from the European Union (EU) member states, Iceland, Norway, and Switzerland. The joint report will inform the European Commission’s action plan against the rising threats from antimicrobial resistance. The data will also contribute to establishing methodologies and priorities in the fight against the development of antimicrobial resistance. The report is the first in a series of reports that EMA, EFSA, and ECDC are planning to publish based on the data collected by various monitoring networks.

The ‘ECDC/EFSA/EMA first joint report  provides an integrated analysis of the consumption of antimicrobial agents and occurrence of antimicrobial resistance in bacteria from humans and food-producing animals. It  also identifies data limitations that need to be addressed to allow further analysis and conclusions to be drawn. These include additional data on antimicrobial consumption by animal species, data on antimicrobial consumption in hospitals in more European countries, and monitoring of resistant bacteria in the normal flora from both healthy and diseased people. This integrated approach for research among the agencies aims to make better use of existing data and strengthen coordinated surveillance systems on antimicrobial consumption and antimicrobial resistance in human and veterinary medicine and to allow policy makers to decide on the best way to tackle antimicrobial resistance in humans and animals.

"Access to accurate data on the use of antimicrobials and the occurrence of antimicrobial resistance is an essential step to develop and monitor policies that minimize the development of resistance and keep antimicrobials effective for future generations," said the EMA in a statement.

The issue of antibiotic resistance is an growing policy issue, which includes implications for drug development and funding to support the development of new antibiotics. In January 2015, President Barack Obama issued the Administration's fiscal year (FY) 2016 budget, which includes $1.2 billion in federal funding for combating and preventing antibiotic resistance. The amount nearly doubles the amount of federal funding and builds on other recent efforts announced in September 2014. The funding is targeted to improve antibiotic stewardship; strengthen antibiotic resistance risk assessment, surveillance, and reporting capabilities; and drive research innovation in the human health and agricultural sectors.

In September 2014, President Obama signed an Executive Order launching federal efforts to combat the rise in antibiotic-resistant bacteria. The Administration also issued its National Strategy on Combating Antibiotic-Resistant Bacteria, which outlined steps the US government will take to improve prevention, detection, and control of resistant pathogens. In addition, the President’s Council of Advisors on Science and Technology released a report with recommendations for addressing the problem of antibiotic resistance. The Centers for Disease Control and Prevention (CDC) estimates that each year at least two million illnesses and 23,000 deaths are caused by antibiotic-resistant bacteria in the United States. The CDC also reports that antibiotic-resistant infections account for at least $20 billion in excess direct healthcare costs and up to $35 billion in lost productivity due to hospitalizations and sick days each year.

See related stories:

"White House Seeks $1.2 Billion in Funding for Antibiotic-Resistant Initiatives;"

"US Senate Introduces Legislation for New Drug Approval Pathway for Drug-Resistant Antibiotics;"

"New Life for Antibiotics."

Source: European Medicines Agency


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