Antimicrobial Resistance

Legislation

What is the problem?

Legislation is a key component in addressing the abuse, overuse, misuse and release of antimicrobials, and plays a vital role in regulating antimicrobial use (AMU) to minimize the risks of antimicrobial resistance (AMR). Legislation is essential for enhancing the sustainability of policy and technical objectives, and clarifying the roles and responsibilities of governments and other stakeholders in the fight against AMR. However, existing legislation relevant for AMU and AMR often fails to provide an appropriate regulatory answer to support public policies aimed at curbing AMR.

What can legislation do for AMR?

  • Prevent the introduction of counterfeit medicines and monitor the quality of veterinary drugs;
  • Ensure antimicrobials are labelled with the necessary warnings and instructions;
  • Serve to differentiate antimicrobials from other ‘feed additives’;
  • Limit the non-therapeutic uses of antimicrobials;
  • Foster alternative options to the use of antimicrobials through appropriate regulation;
  • Control waste potentially contaminated with antimicrobials;
  • Control residues of antimicrobials in food, feed, water and soil.

What could happen in the absence of adequate and appropriate legislation?

  • Flooding the market with counterfeit and/or poor quality veterinary medicines;
  • Inadvertent use of medicated feed without realizing the antimicrobial contents;
  • Prolific overuse and misuse of antimicrobials for non-therapeutic purposes;
  • Waste contaminated with antimicrobials discharged close to water sources;
  • Food, feed, water and soil contamination with antimicrobials resulting in contaminated products entering into the food chain.

AMR is a cross-sectoral issue. Addressing AMU and AMR related issues through legislation is a regulatory challenge because of the expanse of regulatory areas involved, the piecemeal adoption of regulatory approaches, and continuous scientific developments related to AMR that update the evidence base informing decisions.

Challenges and solutions: key regulatory areas for addressing AMR

To provide a comprehensive response to the cross-sectoral issue, regulatory instruments across several areas should contain AMU and AMR-related responses.

One of the most important instruments for addressing AMU is the regulatory framework for veterinary medicines. Attention should be paid to the legislation applicable to the authorization, production, importation, labelling, prescription, sale and use of veterinary medicines, to prevent the uncontrolled sale or use of antimicrobials, as well as the sale of counterfeited or low quality veterinary medicines. Medicated feed containing antimicrobials should also be considered as antimicrobials, and treated as such in regulatory instruments. The wider legal framework on feed and feed additives could also have a potential impact on AMR, especially in encouraging the development of alternatives to antimicrobials.

Similar concerns may arise regarding the approval of antimicrobials for crop production. The regulatory frameworks for pesticides, fungicides, fertilizers and other agricultural inputs should address the possibility that the release of antimicrobials could be passed to the animals, the human food chain, or have an impact on the environment.
Food safety legislation may also have a role in addressing AMR, by including provisions for the government to set up, monitor and control the maximum residue limits (MRL) of veterinary medicines in food.

Last but not least, the regulatory frameworks for waste, water, soil and the environment should also contain elements relevant for AMU and AMR, particularly to tackle discharge containing antimicrobial residues as well as resistant microorganisms from hospitals, feed mills, pharmaceutical plants, municipal waters, farms, etc. The regulatory framework in these areas could be key to regulating the activities carried out that may have an impact on AMR, and take into account the need to monitor and control contamination in soil and water. Water legislation should further deal with the aspects of water access and permissible water use of potentially contaminated water.

The full utilization of legislation as an effective tool to combat the rise of AMR also requires a broad approach of what can be included in legislation. From a regulatory standpoint, the fight against AMR takes place by promoting good practices in AMU and controlling misuses and bad practices. Legislation should not be considered just as a number of prohibitions and requirements because legislation can also serve to define policy priorities and to foster implementation of good production and management practices. The aim of legislation should be to ultimately enhance productivity while lowering the risks of AMR posed by the improper use of antimicrobials.

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