NHS requires compliance with BSI Kitemark™ to promote responsible antibiotic manufacturing

Suppliers will need to certify to BSI Kitemark for Minimized Risk of Antimicrobial Resistance (AMR)

13 August 2024 – Pharmaceutical companies bidding for the newly launched NHS Antimicrobial Product subscription model will be required to demonstrate the steps they are taking to promote responsible antibiotic manufacturing and minimize the risk of antimicrobial resistance by certifying to a key antibiotic manufacturing standard, the healthcare service has announced.

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. Not only is this program encouraging urgently needed innovation in pharmaceutical antimicrobial research and development, it is also setting requirements to drive real progress on the topic of AMR in the Environment. This NHS tender requirement aligns strongly with the recently launched 2024-2029 UK National AMR, where one of the recommendations references the adoption of the standard and BSI certification.

From today, it will be requirement for antibiotic manufacturers applying for the NHS Antimicrobial Product Subscription Model tender to achieve certification to the BSI Kitemark for Minimized Risk of AMR certification - evidencing that antibiotic manufacturers have appropriately controlled waste discharge into surrounding environment. In the absence of regulatory drivers, the use of procurement requirements, such as this one from the NHS, will unlock potential for scaling efforts to combat AMR in the Environment and the wider AMR threat. 

The announcement follows reports that approximately 5 million global deaths were related to AMR in 2019, with 1.27 million deaths directly caused by AMR bacteria^[1]. AMR is identified by the World Health Organization as one of the top ten global health threats.

The AMR certification program was developed in 2023 by BSI, the business improvement and standards company, to confirm the responsible manufacturing of antibiotics in the global supply chain. Over 25 antibiotic products have now successfully been certified, including from Novartis, Sandoz and Teva.

The Kitemark certification provides independent verification of the steps being taken to comply to the AMR Industry Alliance’s standard by ensuring antibiotic waste streams containing active pharmaceutical ingredient (API) and drug products are appropriately controlled during manufacturing. Certification will be a clear sign that NHS suppliers are taking necessary steps to ensure antibiotics are produced responsibly, helping to minimize risk of releasing antibiotic waste emissions into the environment.

Courtney Soulsby, BSI Global Director, Healthcare Sustainability, said: “The NHS has taken a critical step forward in making compliance to the BSI Kitemark a requirement for antibiotic suppliers. 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, said: “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 occurs when bacteria, viruses, fungi and parasites change over time and no longer respond to medicines. As a result of drug resistance, antibiotics and other antimicrobial medicines become ineffective, and infections become difficult or impossible to treat. Pharmaceutical manufacturers face the challenge of controlling waste to maintain safe concentrations of discharge into the environment.

The AMR certification involves an initial evaluation against the standard’s requirements and will be maintained by annual surveillance to verify ongoing maintenance of the appropriate controls. Like all BSI certification programs, it is rigorous and challenging for organizations to achieve.

Visit the BSI website for more information on the AMR Kitemark https://page.bsigroup.com/nhs-bsi-amr

[1] https://www.bbc.com/future/article/20240709-why-cleaning-sewage-out-of-uk-waterways-could-stop-amr-superbugs

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