Although the world has rightly focused attention on the ongoing Covid-19 pandemic since the end of 2019, we have still one big challenge to face: antimicrobial resistance (AMR). Sadly, the scientific literature is stressing how Covid-9 may worsen the development of AMR. Institutions worldwide have already put on paper strategies to tackle AMR, and some are now clearly defined by specific regulatory frameworks.
In May 2020, the European Commission adopted the Farm to Fork Strategy, which aims to help address the EU’s path towards sustainable food systems. With respect to AMR, the objective of the strategy is to halve overall EU sales of antimicrobials for farmed animals and in aquaculture by 2030. Reg. (EU) n. 2019/6 on Veterinary Medicinal Products (VMP Regulation), repealing Directive 2001/82/EC, is one of the regulatory tools that will support all the players in this process. It will be applicable from 28 January 2022 and one question now arises: are we from the livestock sector ready with effective strategies to comply with these new rules?
The VMP Regulation sets out rules for the sale, manufacture, import, export, supply, distribution, control and use of VMPs. It aims to: modernization of the regulatory framework; boost innovation in veterinary medicines; increase their availability and strengthen the EU’s campaign against AMR. It is one of the laws of a package designed for the improvement of animal and human health which includes other two relevant Regulations for livestock farming [Reg. (EU) n. 2019/4 on medicated feed and Reg. (EU) n. 2019/5 on procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency].
In addition to clearly establishing the definition of veterinary medicinal products, among the key measures, the new law brings innovation into the legal framework since it specifies harmonized labelling requirements, adopts a simpler system for decisions on exceptions and a risk-based approach to pharmacovigilance. Important details are also defined for promoting availability of VMPs by stimulating innovation and competition.
Law harmonization usually makes changes to the way things are currently done, so will Reg. (EU) n. 2019/6: it will reinforce the EU’s strategy against AMR by introducing a ban on the preventive use of antibiotics in groups of animals (prophylaxis) and a ban on the preventive use of antimicrobials via medicated feed. It will bring restrictions on the use of antimicrobials as a control treatment (metaphylaxis) to prevent a further spread of infection, a reinforced ban on the use of antimicrobials for promoting growth and increasing yield in addition to the prohibition established in 2006. Moreover, it will reserve to humans only certain antimicrobials that are critical for them and the collection of data on sale and use of antimicrobials will be mandatory for EU countries. It will also establish several measures for the careful and responsible use of such products and science-based maximum limits for cross-contamination of feed with antimicrobials.
The international dimension of the development of AMR deserves attention: for this reason, for exports into the EU, non-EU countries will have to honor the ban on antimicrobials for promoting growth and increasing yield, as well as the restrictions on such products when specifically reserved for human use in the EU.
By setting such high standards of quality, safety, efficacy for VMPs, this Regulation intends to meet common concerns related to the protection of public and animal health and of the environment.
When it comes to changes such as those that will be introduced by Reg. (EU) n. 2016/9, less than 11 months is a pretty short range of time to get ready with solutions and tools that can contribute to reverse the pattern of the development of AMR. There is no doubt of the importance of joining our forces in a One-Health approach, helping livestock farmers to strengthen their ability to build the road towards the management of biosecurity in animals and farms.
At OZOLEA, we have been working hard for many years to be part of this big challenge and got experience from the field. Now, we are definitely ready to tackle AMR: are we in this together?