NHS requires pharma companies to obtain BSI Kitemark for antibiotic subscription model for antimicrobial resistance

Antibiotic manufacturers for antimicrobial resistance must achieve BSI Kitemark certification as per the new mandate by the NHS

According to the National Health Services (NHS)'s new mandate, pharmaceutical companies seeking to participatign its Antimicrobial Product subscription model must certify to the BSI Kitemark for minimised risk of Antimicrobial Resistance (AMR)

This move is part of the NHS's strategy to tackle the growing global threat of AMR by ensuring that antibiotic manufacturers adhere to stringent environmental controls.

The NHS antibiotic subscription model is the first of its kind globally, offering pharmaceutical companies a fixed annual fee based on the value and availability of their antimicrobials to the NHS, rather than the quantity consumed.

The innovative approach aims to stimulate the development of new antibiotics while addressing the environmental impact of their production.

The NHS antibiotic subscription model is a ground-breaking incentive program as the first in the world to pay companies a fixed annual fee for antimicrobials based on the value of the drugs to the NHS, and their availability, instead of the volumes used.

The BSI Kitemark certification requirements aligns with the UK's 2024-2029 National AMR Action Plan that recommends the adoption of standards that mitigate AMR in the environment.

Effective immediately, antibiotic manufacturers must achieve BSI Kitemark certification, demonstrating their control over waste discharge during production.

This requirement aims to prevent antibiotic waste from contaminating the environment, which is a key factor in the emergence of resistant bacteria.

The BSI AMR certification program, established in 2023, has already certified over 25 antibiotic products, including those from industry leaders like Novartis, Sandoz, and Teva.

The Kitemark provides independent verification that manufacturers are adhering to the AMR Industry Alliance’s standards by effectively managing antibiotic waste streams.

Courtney Soulsby, BSI Global Director for Healthcare Sustainability, praised the NHS's decision, stating:

“Taking action against the growing threat from AMR and reducing waste discharge from the manufacturing process into the environment will help safeguard patients, protect antibiotic efficacy for future generations and help support the long-term fight against AMR, accelerating progress towards a sustainable world.”

David Glover, NHS Assistant Director of Medicines Analysis, emphasised the significance of the initiative, noting:

“Antimicrobial resistance is one of the world’s biggest health threats and the launch of our new subscription model represents a major step forward in the development of next-generation antibiotics for patients."

"Making the BSI Kitemark certification a requirement of the model will help create trust that antibiotic manufacturers are controlling their waste streams from production effectively to mitigate environmental and resistance threats and is another sign of the NHS’ commitment to fostering innovation and collaboration for the benefit of patients.”

AMR, identified by the World Health Organization (WHO) as one of the top ten global health threats, has been linked to approximately 5 million deaths worldwide in 2019, with 1.27 million directly attributable to resistant bacteria.