CALL TO ACTION
Introducing RAGNA Call To Action to UN General Assembly, September 2024
On 14 May 2024, the Regulatory Agencies Network against AMR (RAGNA) held a webinar introducing their Call to Action to the UNGA meeting in September 2024. The call presents five key recommendations resulting from the mapping and prioritisation done by the network, as presented below. A pdf version with the key points is available for download here.
The webinar was recorded and is available to watch for two weeks, until May 29, by cklicking here.
RAGNA can be contacted at RAGNA@lakemedelsverket.se
RAGNA a global forum of regulators, key players in combating antimicrobial resistance (AMR) and contributing to global solutions
There are strong links between AMR, the antimicrobial cycle, the role of regulators, and international instruments on antimicrobial usage. Effective regulation and responsible use of antimicrobials throughout their life cycle – from production to disposal – is paramount to effectively address AMR. Regulatory agencies, particularly those overseeing human and veterinary medicines, have significant influence in ensuring good manufacturing processes, facilitating controlled access to safe, effective and high-quality antimicrobials, while also preventing their disposal into the environment. The UNGA High-Level Meeting on AMR in September offers a great opportunity to boost this agenda. To better inform Member States as they craft this meeting’s political declaration, Regulatory Agencies Global Network Against AMR (RAGNA) has prepared a list of key recommendations voicing the joint inputs of international regulators across the human and animal veterinary medicines sectors:
RAGNA recommendations to prevent and mitigate impacts due to AMR:
1 Countries should strengthen One Health multisectoral regulatory governance of medicines.
As a multi-sectoral challenge, AMR demands a One Health lens when applying regulatory frameworks. Similarly, National Action Plans on AMR (NAPs) should be multi-sectoral and multi- disciplinary with coordination mechanisms that are sustainable, accountable, and appropriately equipped with human and financial resources. To facilitate communication and aid coordination, countries are encouraged to develop robust regulatory networks across human, animal, plant, and environmental sectors, incorporating international guidance in the management of human and veterinary medicinal products throughout their lifecycle, and in other areas relevant to AMR.
2 Medicines registration and authorization processes should ensure quality, efficacy and safety of antimicrobials and protect the environment.
Benefits of regulatory registration and authorization procedures are numerous, and given their importance, should be coordinated by National Regulatory Authorities (NRAs). Application of good manufacturing practices is key, ensuring safety, efficacy, and quality of antimicrobials while reducing environmental impact by minimising antimicrobial discharge to the environment through waste and wastewater management interventions. To promote responsible and prudent use of antimicrobials, and to reduce the likelihood of AMR development and spread, several considerations should be covered in the registration process. These should include an assessment of environmental risks from human and veterinary medicinal products, relevant restrictions or precautions for use of the medicinal products, and admission of only registered products to market. To improve access, countries may wish to employ mutual recognition, harmonization, or regulatory reliance strategies to increase product registration. Where this is not possible, countries should utilise existing tools and support mechanisms to facilitate registration. Countries are also urged to enable product registration to assist the development of alternatives to antimicrobials, and to encourage manufacturers to expand applications to smaller markets. Regulatory frameworks should include the surveillance and reporting of substandard and falsified antimicrobials of human and veterinary use.
3 Managing access and promoting prudent and responsible use of antimicrobials to reduce their need and use and preserve efficacy for future generations.
Access to antimicrobial products should be ensured for prudent, responsible, and sustainable use. Countries are encouraged to develop national lists of essential medicines using tools such as the WHO Essential Medicines List; access to these medicines should be guaranteed. Development and implementation of diagnostic testing and access to relevant and correct information are both key for the prudent and responsible use of antimicrobials. Countries should implement legislation on appropriate labelling (including the correct dosage regimen, expiration, directions to contact the authorized professional in cases of treatment failure, safe and proper disposal, and withdrawal periods for food-producing animals) to ensure that such information is available to prescribers and users of antimicrobials. Legislation reserving the prescription of antimicrobials to authorized professionals only and restricting the over-the-counter sale and unauthorized sales of antimicrobials (including over the internet) should be implemented and enforced, without compromising human and animal health. Similarly, since antimicrobials should be used only when necessary, countries are encouraged to prevent the marketing or advertising of antimicrobials to the public and remove incentives to those prescribing and using antimicrobials, whilst promoting sustainable public procurement practices. Regulatory frameworks should impose restriction on the use of critically important antimicrobials for humans and animals (based on WHO Medically important Antimicrobials and the WOAH list of Antimicrobials of Veterinary Importance) to safeguard access to quality and efficacious products. Countries should actively act towards ending non-veterinary medical use.1
4 Multisectoral monitoring and surveillance efforts to support AMR policies and interventions.
Countries are urged to allocate financial resources in national budgets to establish, improve, and maintain national AMR monitoring and surveillance systems for informed decision-making processes. Collaboration across the One Health spectrum is key to surveillance efforts, and this should be reflected in the creation of national integrated surveillance mechanisms as part of multisectoral National Action Plans for AMR, with all actors and sectors sharing responsibility for data collection and use, and information sharing. Countries should continue the reporting of imports and sales data of antimicrobials and commit to move towards the reporting of antimicrobial use and adverse reactions to treatment - including treatment failures - by those who administer antimicrobials in the future. This stepwise approach aims to facilitate monitoring of antimicrobial consumption in humans and animals and to allow a post-marketing authorization regulatory assessment to evaluate benefit/risk and recommendations for use.
5 Equitable research and development of antimicrobials and alternatives to antimicrobials including vaccines and diagnostic tests across sectors.
Preventative actions for infectious diseases should be put in place to preserve the effectiveness of antimicrobials, while development of new antimicrobials and alternatives to antimicrobials is also urgently needed. Collaboration between actors in the research and development process is essential to expediate timelines. Regulators should actively facilitate the development of new and alternative human and veterinary medicinal products, whilst ensuring infection prevention and control, and promoting biosecurity and biosafety measures to reduce the need for antimicrobials and avoid discharges into the environment.
[1] ’Non veterinary medical use of antimicrobial agents’: means the administration of antimicrobial agents to animals for any purpose other than to treat, control or prevent infectious disease; it includes growth promotion. ’Growth promotion’: means the administration of antimicrobial agents to animals only to increase the rate of weight gain or the efficiency of feed utilisation. (WOAH Terrestrial Animal Health Code, Chapter 6.9, Article 6.9.2)