VMP Regulation

Efficacy of existing antimicrobials? Let’s support it by prundent use

Marketing 26 August 2021 News

Less than 6 months left before the new EU regulatory framework on veterinary medicinal products (VMPs) is applied. Implementing strategies aimed at the compliance with the rules. Implementing strategies aimed at the compliance to the rules is hard work, but we must remember that the reason behind the new law is of great magnitude: fighting antimicrobial resistance (AMR) to protect human health, animal health and the environment.

According to the recent WHO report on 2020 antibacterial agents in clinical and preclinical development¹, the research pipeline is still experiencing some difficulties in providing new effective antimicrobials. This is further feeding the development of AMR. WHO shows that the 43 antibiotics currently under clinical development are still insufficient to tackle AMR.

Moreover, the development and spread of AMR in the environment is also a growing concern that needs further research. A number of scientific studies have identified the potential negative impacts of resistant microorganisms or antimicrobials on the environment^2,3,4.

Although small, bacteria have superior evolutionary advantages: the speed of proliferation and the ability to quickly and effectively pass resistance information through generations.

This is why the new VMP Regulation will impose restrictions on the use of antimicrobials, such as in prophylaxis and metaphylaxis. The new rules will force all the operators in animal farming and linked sectors to do their best in control and prevention of microbial risks.

AMR is also a concern for food safety, since food products represent a potential route of exposure for everyone. Thus, efficiency and innovation, along with best management practices, are the key aspects to be implemented in the food supply chain, including primary production.

Reducing antimicrobials on dairy farms, deciding for their prudent use only when strictly necessary, will limit the ability of bacteria to develop further resistance mechanisms in our supply chain. Thus, it will put antimicrobial research in front of fewer challenges to face.

Working in this direction means preserving the efficacy of existing antimicrobials, thus allowing the research pipeline to take a breath and continue to put effort into finding new effective molecules.

The idea of developing harmless, effective, safe, sustainable solutions perfectly fits into this environment. By providing these solutions and appropriate management practices, OZOLEA aims at helping dairy farmers reduce the use of unnecessary antibiotics and improve their profitability.

Implementing OZOLEA solutions means deciding for being at the forefront against AMR, reducing antimicrobials, while indirectly supporting research in its path towards the development of new molecules useful for protecting human health.

¹ 2020 Antibacterial agents in clinical and preclinical development: an overview and analysis. Geneva: World Health Organization; 2021. Licence: CC BY-NC-SA 3.0 IGO. https://www.who.int/publications/i/item/9789240021303

² A more valuable manure for better crop productivity.

https://www.ozolea.it/a-more-valuable-manure-for-better-crop-productivity/

³ Making money by saving milk.

https://www.ozolea.it/making-money-by-saving-milk/

⁴ Water quality is important for dairy farmers.

https://www.ozolea.it/water-quality-is-important-for-dairy-farmers/

⁵ The action against AMR has an ethical, socio-economic, scientific and environmental scope.

https://www.ozolea.it/the-action-against-amr-has-an-ethical-socio-economic-scientific-and-environmental-scope/

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The action against AMR has an ethical, socio-economic, scientific and environmental scope

Marketing 12 August 2021 News

We said many times that tackling antimicrobial resistance (AMR) is the highest goal of the new VMP Regulation¹.

This new law is just one of the several actions taken by the European Union against this challenge. AMR could detrimentally lead to ethical, socio-economic, scientific and environmental negative effects for humanity. Thus, it deserves an ethical, socio-economic, scientific and environmental answer.

AMR is, first of all, a health issue, carrying around a serious social and economic burden. The estimation of its impact in the EU alone is 25,000 deaths per year. What would happen if no actions were taken? Millions of deaths are estimated globally, more than what cancer could do by 2050².

The social and economic burden has also been estimated. First, costs associated with healthcare would increase. Second, with a population suffering from infections caused by resistant bacteria, productivity would be hardly compromised.

An idea in figures? EUR 1.5 billion annually in healthcare costs and productivity losses as a consequence of AMR in the EU alone.

At the same time, the research, development, manufacture and marketing of new antimicrobial products has substantially slowed down in the last two decades.

Tackling AMR through effective and alternative strategies and tools will mitigate its detrimental impact on European society, contributing to economic growth and also reducing environmental pressure. In the past months, we deeply explored this issue from a dairy farming point of view^{3, 4, 5}.

Effective biosecurity strategies represent also an extra certainty for food security.

Efficiency and management, along with innovation, is all we can do, as dairy farmers, to help in the process of reversing AMR development.

The harmonization process, started with the new VMP Regulation and that will be possible through the implementation of a One-Health approach, means an EU answer to this big challenge. In addition, the fact that AMR has an international dimension makes this approach really necessary.

This is where the action against AMR has an ethical, socio-economic, scientific and environmental scope.

OZOLEA was founded in 2016, immediately after the 2015 WHO Global Action Plan on AMR. Since the beginning, its mission has been that of standing at the forefront of this fight, side by side with dairy farmers.

As a business activity and project, OZOLEA wants to spread all the best practices for udder and uterus issue management for dairy farming. For this reason, we have been disseminating the key aspects behind the new VMP Regulation: knowledge is the first tool to face this big challenge.

What is next? Finding and providing dairy farmers with all the possible strategies to accelerate the pace towards the compliance with new rules, always aiming at profit improvement.

¹ Reg. (EU) 2019/6 on veterinary medicines applicable from 28 January 2022: are we ready?

https://www.ozolea.it/reg-eu-20196-on-veterinary-medicines-applicable-from-28-january-2022-are-we-ready/

² COMMUNICATION FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT. A European One Health Action Plan against Antimicrobial Resistance (AMR)

https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52017DC0339&from=IT

³ Making money by saving milk.

https://www.ozolea.it/making-money-by-saving-milk/

⁴ A more valuable manure for better crop productivity.

https://www.ozolea.it/a-more-valuable-manure-for-better-crop-productivity/

⁵ Water quality is important for dairy farmers.

https://www.ozolea.it/water-quality-is-important-for-dairy-farmers/

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Traditional herbal products used to treat animals, what prospects?

Marketing 15 July 2021 News

Scientific literature highlights the potential of traditional herbal products to treat animals. For example, Bullitta and colleagues (2018)¹ reported 42 plant taxa traditionally used to treat animals among different traditional veterinary treatments.

The traditional approach to animal health care is based on the knowledge, methods, practices, skills acquired by members of communities, with differences among communities, as well as across regions. It also includes a large number of herbal remedies for diseases. This traditional knowledge has been disseminated across generations orally.

Since it has been developed by deliberate experimentation through the years, it is less systematic and less standardized than the current conventional approach to veterinary treatments.

Scientific research is exploring the literature to find evidence about traditional herbal products and treatments used in animal health care, aiming at further investigating their potential as medicinal products.

As per the Organic Production regulatory framework, phytotherapeutic, homeopathic and other products must be preferred to chemically synthesized allopathic veterinary medicinal products, including antibiotics, to treat animals. When herbal, homeopathic or other products are inappropriate for treatment, conventional medicines can be used under certain specific restrictions (e.g., longer withdrawal periods).

Thus, there is room for the application of traditional herbal products, but greater certainty is needed.

We have got few months left to get ready for the application of the New veterinary medicinal products law[Reg. (EU) n. 2019/6].

Since there is insufficient information to date on traditional herbal products used to treat animals, the Commission is called to examine the possibility of introducing a simplified system on the base of information provided by the Member States on the use of such products on their territory.

To create its legislative proposal (if appropriate), the Commission will report to the European Parliament and to the Council by 29 January 2027 on the EU use of traditional herbal products used to treat animals.

As per the legal definition of veterinary medicinal product, any product containing vegetable substances and fulfilling the conditions established in the definition² must follow the market authorization procedure and rules set up in the regulation.

Traditional herbal products for treating animals fall within this definition. Until a specific legislative framework is defined for these products, operators have to follow the procedure set up for other VMPs.

The assessment for traditional herbal products is needed since any product used to treat or cure animals must ensure an overall benefit-risk balance. Antimicrobial resistance development is one of the current biggest threats to human society and we cannot afford to misjudge risks.

For this reason, final users of VMPs should be careful at checking any product before using it on animals. As already discussed³, safe and prudent use on dairy farms is possible if products are clearly presented and if the final user is able to exclude misleading product from farm routine.

¹ Bullitta et al. Journal of Ethnobiology and Ethnomedicine (2018) 14:50.

DOI: https://doi.org/10.1186/s13002-018-0250-7

² Veterinary medicine product or not? OZOLEA’s innovative approach within the new regulatory framework.

https://www.ozolea.it/veterinary-medicine-product-or-not-ozoleas-innovative-approach-within-the-new-regulatory-framework/

³ Veterinary products clearly presented, safe use on dairy farms.

https://www.ozolea.it/veterinary-products-clearly-presented-safe-use-on-dairy-farms/

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Veterinary prescriptions and antimicrobials: new rules from 28 January 2022

Marketing 24 June 2021 News

The new rules for veterinary medicinal products (VMPs) are strategic restrictions and provisions also against the development of antimicrobial resistance (AMR).

In this fight, one key professional figure is and will be the veterinarian. With the new VMP Regulation¹, they will be further recognized as key qualified figures for an efficient One-Health approach² and also further protected from unfair practices, such as bribery.

The incorrect use of antimicrobials is a risk for public and animal health. Starting 28 January 2022, to prevent this risk, veterinary antimicrobials will only be available on veterinary prescription in all the EU Member states.

This harmonization is essential to ensure an EU profile against the development of AMR: currently, not all the EU Member states require veterinary prescriptions for antimicrobials, however they will with the application of Reg. (EU) n. 2019/6.

Veterinarians will be required to prescribe antimicrobials on the basis of their knowledge of AMR, their epidemiological and clinical knowledge and their understanding of the risk factors for the individual animal or group of animals.

Moreover, veterinarians are called to respect their professional code of conduct. Thus, they must ensure to avoid any conflict of interests when prescribing medicinal products, while recognising their legitimate activity of retail in compliance with national regulatory framework.

To the end of prudent use of antimicrobials, also the supply of VMPs by veterinarians will be restricted to that quantity needed to treat the animals under their care.

As set out by art. 34 of the VMP Regulation, competent authorities, when granting a marketing authorization, shall classify antimicrobial VMPs among the products classified as subject to veterinary prescription. By way of derogation, competent authorities may classify antimicrobials as not subject to veterinary prescriptions if they fulfill criteria set out in art. 34.3.

Prophylaxis and metaphylaxis are two different procedures that will be significantly restricted by the VMP Regulation. For example, we have already discussed³ the impact of the new rules on blanket dry cow therapy and the need of implementing the selective dry cow treatment.

Prophylaxis and metaphylaxis will be possible only by way of exception and only if there is a veterinary prescription (art. 105). The treatment will have to be justified by veterinarians after a clinical examination or any other proper assessment of the health status of the animal or group of animals. This assessment must occur before issuing the prescription.

Other relevant aspects concern quantities of antimicrobials supplied (limited to the amount required for the specific treatment or therapy) and the limited duration of the period of treatment prescribed.

Moreover, the new rules for supplying VMPs will strengthen the traceability system across the EU: we will spend a little time to go deeper into the issue. In Italy, since 2019 the supply of VMPs has been reinforced thanks to the electronic veterinary prescription system.

We already know many of the weapons we should use against AMR. The fact that the EU is making them mandatory is a good sign: it will make the EU harmonized and equivalent in all its member states, both from a health and economic perspective.

¹ Reg. (EU) 2019/6 on veterinary medicines applicable from 28 January 2022: are we ready?

https://www.ozolea.it/reg-eu-20196-on-veterinary-medicines-applicable-from-28-january-2022-are-we-ready/

² The One Health approach against antimicrobial resistance.

https://www.ozolea.it/the-one-health-approach-against-antimicrobial-resistance/

³ Blanket dry cow therapy, ban on prophylaxis from January 2022. Any alternative? Selective treatment.

https://www.ozolea.it/blanket-dry-cow-therapy-ban-on-prophylaxis-from-january-2022-any-alternative-selective-treatment/

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Veterinary products clearly presented, safe use on dairy farms

Marketing 10 June 2021 News

There is increasing attention to antimicrobial resistance (AMR). The European Union is a few months away from the application of the new regulation on veterinary medicinal products (VMPs), which will involve manufacturers, distributors, veterinarians, and final users.

The new principles for advertising and communication of VMPs will certainly help in gaining greater clarity within the single market. Furthermore, they will allow a more conscious use by pet owners and breeders, who will be better informed.

All that concerns the Reg. (EU) n. 2019/6¹ is an important, gradual and clear revolution in the world of VMPs. The ultimate goal is something higher, namely safeguarding animal and human health and the protection of the environment.

Experience has taught EU Member States that it is necessary to clearly distinguish the various veterinary products on the market from veterinary medicines.

How can we understand today what kind of product retailers, salesmen and other professionals are offering us? Let’s try, in a simple way, to find the essential aspects to avoid buying products that have particular properties and/or activities, though are not legal.

First, we need to see whether or not the product is proposed as having pharmacological, immunological or metabolic action. Let’s consider a product that shows, in the description, the word “antimastitic”.

Mastitis is a disease, more precisely the inflammation of the mammary gland caused mainly by bacterial infections.

The term “antimastitic” is generally used in the description of the pharmacotherapeutic group of veterinary drugs such as antibiotics for the treatment of udder infections with intra-mammary application.

Therefore, if we find “antimastitic” on a product, or in any case terms that suggest that the product performs a pharmacological action, we are in front of something that is configured as a veterinary medicinal product.

How do we check that it really is a medicine? The product must show the marketing authorization number (AIC in Italy) on the package. For instance, when a new drug is authorized, in Italy the Ministry of Health issues a document relating to the AIC and its specific characteristics. The document is public, thus a web check is the easiest thing to do.

In general, when veterinary medicinal products can be used only under veterinary prescription, this information must appear on the package. Some veterinary medicines do not require a veterinary prescription; however, this is not the case of intra-mammary products.

Thus, seek veterinary advice and exclude from your dairy farm routine those products that declare pharmacological action for intra-mammary use but which do not require a veterinary prescription.

Another relevant aspect concerns the route of administration, which must be consistent with the proposed commercial format: if the package indicates “external use” and actually contains an intra-mammary applicator, it is not a product to be trusted as there is risk of incurring reports for unauthorized use of the product.

Veterinary medicines are always accompanied by the package insert, which provides important information on marketing authorization number, active substances, dosage and animal species, withdrawal periods, therapeutic indications, contraindications and negative side effects, and much more.

When read carefully, this element also helps us to discriminate between a veterinary medicinal product and an illegal product.

Be careful also with products containing vegetable substances (plants) presented as having pharmacological properties (antimicrobial, antibacterial, anti-inflammatory, anti-edema, stimulator of the immune response, etc.): as already mentioned¹, these products fall within the old and new VMP legislation, therefore they need a marketing authorisation.

As we have already seen¹, the new Regulation on veterinary medicinal products will be revolutionary.

For this reason, OZOLEA chose, even before the definition of the new EU regulatory framework, to manufacture products that do not contain active substances, without the obligation of a veterinary prescription, legal in the European Union and in the USA.

OZOLEA-MAST is a veterinary device designed precisely to allow the milker to intervene when something is going wrong in the udder, without the need of waiting for signs of a full-blown mastitis, which instead would require the use of antibiotics and veterinary support. OZOLEA-MAST can be used in lactation and at dry-off.

¹ Veterinary medicine product or not? OZOLEA’s innovative approach within the new regulatory framework.

https://www.ozolea.it/veterinary-medicine-product-or-not-ozoleas-innovative-approach-within-the-new-regulatory-framework/

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Veterinary medicine product or not? OZOLEA’s innovative approach within the new regulatory framework

Marketing 6 May 2021 News

Since the very beginning, OZOLEA has always had two clear goals.

The first is finding solutions to help the farmer improve health management at herd level, by addressing udder issues that could lead to milk loss, and those relating to the uterus, which are generally followed by reduced fertility in dairy cows.

The second, as important as the first, is to put the dairy farmer at the forefront of the prudent use of antimicrobials for tackling antimicrobial resistance (AMR).

The starting point was precisely the concept of resistance to active substances. Today we are aware of the fact that it is a problem for human and animal health, food safety and the environment.

In animal husbandry, the sustainable and rational way of using medicines should include the application of biosecurity strategies and a disease management plan, defined along with veterinary advice.

The dairy farmer’s ability and the availability of products such as those proposed by OZOLEA allow to avoid the use of unnecessary antibiotics and other drugs.

OZOLEA has therefore designed products capable of creating an environment, in the udder and uterus, hostile to microorganisms without acting directly against them. They belong to the product category of veterinary devices.

Let’s take a step back to the definition of a veterinary medicinal product as per Reg. (EU) n. 2019/6¹. Knowing it will help us recognize the products available on the market.

Veterinary medicinal product means any substance (of human, animal, vegetable or chemical origin) or combination of substances which fulfils at least one of the following conditions: (a) it is presented as having properties for treating or preventing disease in animals; (b) its purpose is to be used in, or administered to, animals with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action; (c) its purpose is to be used in animals with a view to making a medical diagnosis; (d) its purpose is to be used for euthanasia of animals;

OZOLEA products consist of bioengineered food grade vegetable oils. They do not contain substances capable of carrying out pharmacological, immunological, metabolic actions. They cannot be used for disease treatment or prevention. They do not restore, correct or modify physiological functions. They are not designed to establish a medical diagnosis and, without a doubt, are not suitable for euthanasia.

OZOLEA tested them according to ISO standards, proving that they are non-cytotoxic products.

Furthermore, we have already focused on what antimicrobials² and biocides³ mean. The concept of “direct action on microorganisms” completely excludes OZOLEA products from the markets for these two types of products.

This is why OZOLEA products are veterinary devices, the definition of which is currently derived on the basis of the legislation in force for medical devices for human use.

To date, both in Italy and at EU level, there is no specific legislation that legally defines veterinary devices. However, Italy⁴ and other EU countries recognize this type of products on the market, with or without registration specifications for marketing.

The innovative and clear OZOLEA approach is not to fall into the definitions of veterinary medicinal product, antimicrobial and biocide, with the ultimate goal of fighting AMR.

Therefore, OZOLEA products are and will continue to be legal in the EU, but also in the United States⁵. The effort will have to be towards a harmonized EU standard for veterinary devices.

Insights

¹ Reg. (EU) 2019/6 on veterinary medicines applicable from 28 January 2022: are we ready?

https://www.ozolea.it/reg-eu-20196-on-veterinary-medicines-applicable-from-28-january-2022-are-we-ready/

² Why the enemy is resistance to antimicrobials and not only to antibiotics

https://www.ozolea.it/why-the-enemy-is-resistance-to-antimicrobials-and-not-only-to-antibiotics/

³ The fight against AMR also involves the correct presentation and proper use of biocides

https://www.ozolea.it/the-fight-against-amr-also-involves-the-correct-presentation-and-proper-use-of-biocides/

⁴ The Italian Ministry of Health has given indications about what veterinary devices are: http://www.salute.gov.it/portale/temi/p2_4.jsp?lingua=italiano&tema=Animali&area=veterinari

⁵ The Food & Drug Administration (FDA) clarified the definition of “Animal Medical Device”: https://www.fda.gov/animal-veterinary/products/animal-medical-devices

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The fight against AMR also involves the correct presentation and proper use of biocides

Marketing 29 April 2021 News

Milk producers know what biosecurity means, and they also know how much effort must be made in the stall to manage all the measures aiming at avoiding the introduction, development and spread of diseases in the dairy herd.

Everything we do for the purposes of biosecurity is prevention and control, two elements that need help from chemistry in certain situations.

Here are some examples: at milking, we use pre- and post-dipping products. Or, as per routine, we disinfect environments or the milking machine’s elements, eliminating microorganisms (not just bacteria!) that could infect our animals.

Same issue, with specific procedures, in the dairy processing.

To do this, chemistry must provide us with products that are effective, safe and of proven quality. And also authorised. All this goes through the so-called biocides market, which the European Union has defined by means of a complex legislative framework [BPR, Reg. (EU) no. 528/2012] and which are more types of products than only disinfectants.

Thus, if we want to buy a disinfectant product we must therefore ensure that it has been authorised as a biocide. The authorisation, which takes place at a national level, essentially validates the efficacy and safety of use of these products. It will be the product label that will tell us this.

But why do we need to be sure of this?

The first reason lies in the term biocide (Article 3 of the BPR). Biocides are substances that destroy harmful organisms or in any case, in the broad definition given by the BPR, make them harmless through chemical/biological processes, with the exclusion of mechanical or physical action.

So a detergent, which performs a mechanical or physical action, will never help us effectively in disinfection. On this, in Italy, in 2019 the Ministry of Health clarified any doubts. In the EU, an ongoing process is leading Member States to finalise the review of active substances used in biocides. The process is expected to be completed in 2024 and, from then on, only biocidal products containing substances included in the resulting EU lists can be authorised.

The second reason lies in an international aspect: the fight against antimicrobial resistance (AMR). We know that microorganisms also develop resistance to biocides (which are antimicrobials). Unfortunately, research on specific resistance to biocides has not reached levels of knowledge comparable to what is known about antibiotics.

It remains, as already said, that thinking of using any type of antimicrobial, regardless of its origin, as a weapon against AMR does not appear to be the right solution. Surely, we can safeguard their importance and reduce the impact on AMR by using the right products correctly.

Furthermore, it is equally important to have correct information from those who produce and supply these substances, especially as regards the scope of use and the correct conditions of use since this is what properly addresses the end user.

Let’s go back to veterinary medicines. Reg. (EU) no. 2019/6 establishes rules on the advertising of these products to essentially achieve the goal of proper promotion for adequate use and fair trade practices on the EU market.

Biocides, veterinary medicines and feed (think medicated feed) markets have long been very crowded places with important differences also due to the existence of specific national regulations. Experience has shown that it is necessary “to put emphasis on the distinction between feed and biocidal products, on the one hand, and veterinary medicinal products, on the other, because that distinction is often misrepresented in advertising” (observation no. 80 of the VMP Regulation).

The steps forward made by Reg. (EU) no. 2019/6 in terms of advertising, distinction between products and above all harmonization through various other regulations [such as the BPR, but also the new regulations on medicated feed – Reg. (EU) n. 2019/4] are extremely important for the veterinary, husbandry and dairy world of the European Union.

By giving unitary rules, the final effect will be that of being able to face the AMR with the same common vision and, concerning competitiveness, especially for milk producers, those disparities between one state and another will be reduced in terms of availability of inputs, with a little respite at least of costs for the management of biosecurity.

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Why the enemy is resistance to antimicrobials and not only to antibiotics

Marketing 15 April 2021 News

Resistance to active substances developed by microorganisms is an international phenomenon, with side effects estimated to be disastrous if there will be no rapid, coordinated and effective actions on a global level.

Thus, it is useful to make a brief focus on the terms used in the context of the fight against resistance to certain substances.

Let’s take the VMP Regulation as a reference: it is one of the EU laws that aims, among other objectives, at strengthening the EU campaign to tackle antimicrobial resistance. And it gives pretty clear definitions of antimicrobials and antimicrobial resistance.

Antimicrobial is any substance with a direct action on microorganisms used for treatment or prevention of infections or infectious diseases, including antibiotics, antivirals, antifungals and anti-protozoals.

Antimicrobial resistance means the ability of microorganisms to survive or to grow in the presence of a concentration of an antimicrobial agent which is usually sufficient to inhibit or kill micro-organisms of the same species.

Some important reflections emerge from the definitions of antimicrobials.

The first one is that antibiotics fall into a larger category, which is that of antimicrobials.

The second is that antimicrobials are used in a series of products. Resistance can be developed also to medical-surgical devices and biocides. Some simple examples are hand sanitizers we are currently using, sanitizers for environments, but also udder dipping and hygiene products used in pre-milking and much more.

The indication “any substance” shifts focus on the origin of these substances: synthetic, semi-synthetic or natural.

With the worsening of resistance to synthetic substances, the recent expectations placed on antimicrobials of natural origin are very high. However, defining and communicating products containing such substances is not that easy.

In fact, several mechanisms are involved in the resistance phenomena developed by microorganisms. These mechanisms do not exclude the likelihood of strengthening the ability to resist even when natural substances are present. An interesting reading is “Natural extracts stimulate membrane‐associated mechanisms of resistance in Gram‐negative bacteria” (Fadli et al., 2014).

The fight against antimicrobial resistance will also require attention to these risks. It is precisely for this reason that the term “antimicrobial” includes “any substance with a direct action on microorganisms“.

Therefore, each actor in the supply chain has to be aware that the solutions to be used in the fight against AMR must respond to the right balance between risk and benefit for the safeguard of human health.

Proposing alternative antimicrobials to those already of compromised efficacy due to AMR phenomena almost seems to be a second-best solution.

Putting nature against nature is correct, but is AMR itself to suggest a change of strategy.

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VMP Regulation: restrictions on the use in animals of critically important antimicrobials for humans

Marketing 1 April 2021 News

Reg. (EU) n. 2019/6 (VMP Regulation) will be applicable from 28 January 2022 and will deeply change the use of antimicrobials in veterinary medicine. Thus, this is something concerning also the dairy industry.

We discussed the impact on prophylactic treatments in a recent article (read Blanket dry cow therapy, ban on prophylaxis from January 2022. Any alternative? Selective treatment).

Among the key measures, the VMP Regulation forms the basis for restrictions on those products used both in human and veterinary medicines. The aim is preserving the efficacy of antibiotics that are of critical importance for the treatment of infections in humans. Restrictions on these products are needed since antimicrobial resistant bacteria can stem from the use of antimicrobials in food animals and spread to humans through the food chain.

Article 37 of the VMP Regulation establishes the reasons for refusal of marketing authorasitation of veterinary medicinal products (VMPs). In particular, in paragraphs from 3 to 6 are defined the rules for refusal of antimicrobial VMPs when they are reserved for treatment of certain infections in humans. Moreover, the European Commission shall adopt delegated acts to supplement the VMP Regulation “by establishing the criteria for the designation of the antimicrobials which are to be reserved for treatment of certain infections in humans in order to preserve the efficacy of those antimicrobials”. In doing this, it will consider the scientific advice of relevant Union agencies, namely EMA, EFSA and others.

Let’s step back a little and make an overview on current aspects related to critically important antibiotics (CIAs) for humans. They are the most important antimicrobial products for treating infections in humans. According to the World Health Organisation’s categorisation, CIAs can be Highest Priority (Category 1 – their use in prophylaxis in animals should be avoided) and High Priority (Category 2 – antibiotics that pose a threat to human health if used in animals).

In 2019, the WHO updated the CIA list. With it, WHO developed and implemented criteria to rank antimicrobial products on the basis of their relative importance in human health.

The aim of the list is to help preserve the effectiveness of antimicrobials available to humans today by promoting their prudent use both in human and veterinary medicine. It includes also the Highest Priority CIAs, namely: quinolones, 3rd and higher generation cephalosporins, macrolides and ketolides, glycopeptides, and polymyxins.

Being OZOLEA at the forefront in the fight against AMR in dairy cows, in particular studying and developing tools for supporting the udder tissue functionality, it is worth mentioning the reason why quinolones and cephalosporins, used in dairy cattle to treat clinical and sub-clinical mastitis caused by E. coli, are included in this Category.

Quinolones are one of the few available substances to treat serious Salmonella and E. coli infections in humans. Also, they are known for they ability to select for quinolone-resistant Salmonella and E. coli in animals. Same issue for 3-rd and higher generation cephalosporins: they are one of the few available therapies for serious Salmonella and E. coli infections in human medicine, particularly in children and are known to select for cephalosporin-resistant Salmonella and E. coli in animals. The incidence of human disease due to Salmonella and E. coli is substantially high: thus, they are needed as the last resort for treatment in human medicine.

At the EU level, last year the European Medicines Agency (EMA) updated its scientific advice, prepared by the AMEG (Antimicrobial Advice Ad Hoc Expert Group) on the categorisation of antibiotics. EMA encourages veterinarians to check and consider this update when prescribing antibiotics for animals. It does not replace general guidelines, and other aspects (Summary of Product Characteristics, restrictions around use in food-producing species, regional peculiarities of disease and AMR, national policies, etc.) should also be considered.

This document is in line with the One-Health approach (see OZOLEA’s article “The One Health approach against antimicrobial resistance”). The new classification introduced by the AMEG currently comprises four categories:

A) “Avoid”: it includes antibiotics currently not authorised in veterinary medicine in the EU. They may not be used in food-producing animals and may be used in individual companion animals only by way of exception;

B) “Restrict”: this category rank critically important antibiotics (quinolones, 3rd- and 4th-generation cephalosporins, polymyxins) in human medicine and their use in animals should be restricted to mitigate any risk related in public health;

C) “Caution”: this category refers to those antibiotics which alternatives in human medicine are generally available in the EU, but only few alternatives exist in specific veterinary indications. Their use should be made only when there are no clinically effective antimicrobials in Category D;

D) “Prudence”: it includes antibiotics intended to be used as first line treatments, whenever possible. These products can be used in animals prudently: therefore, users should avoid unnecessary use and long treatment periods, limiting group treatment to situations in which individual therapy is not feasible.

In EMA’s document, the route of administration was also considered to evaluate its impact on selection of AMR.

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The One Health approach against antimicrobial resistance

Marketing 18 March 2021 News

The fight against antimicrobial resistance deserves an urgent and coordinated approach, and many are the reasons why.

Humans coexist with animals in the same environment. The relationship is complex and interdependent. We deal with animals for food production and when they are wild and companion animals. This means that human health and animal health are strictly interconnected.

The environment where they live in also has a role in their relationship. All these connections can be a source for diseases which would impact public health, society and the economy. These diseases, commonly referred as zoonoses are transmissible from animals to humans and vice-versa through direct contact or with food, water, and environment.

This process involves resistant bacteria as well.

The principle that recognizes these interconnections between human and animal health is globally known by the term One Health, and the EU embraced this principle as a tool against antimicrobial resistance.

In June 2017, the European Commission adopted the EU One Health Action Plan against AMR. The aim was to call for effective action against this threat, which must be tackled in human and animal health and the environment. The prudent use of antimicrobials is vital to limit its spread. The action plan is built on 3 main pillars, which address its key objectives:

making the EU a best practice region;
boosting research, development and innovation;
shaping the global agenda.

From the implementation of this Action Plan forward, important updates aiming at strengthening EU’s response to AMR have been made. Among the key updates, it is worth citing the adoption of the Farm to Fork Strategy in May 2020, as we discussed previously (click here). This strategy is supported by the implementation of two new regulations [Reg. (EU) n. 2019/6 on Veterinary Medicinal Products (VMP Regulation) and Reg. (EU) n. 2019/4 on Medicated Feed (MF)], providing for a wide range of measures to tackle AMR and stimulate a more prudent use of antimicrobial products in animals.

At EU level, the AMR One-Health Network is chaired by the European Commission and involves government experts in human health and animal health, Commission experts, and the EU scientific agencies – namely ECDC, EMA, and EFSA. These agencies will provide scientific expertise on infection prevention, biosecurity measures and control practices in human healthcare and in animal husbandry for the reduction of infections and therefore the use of antimicrobials.

A One-Health approach is required to get better evidence, coordination, surveillance and control measures with a continuous and open dialogue between the European Commission, supported by all the experts above, and Member states.

The VMP Regulation is one of the tangible expressions of the efforts currently made by the EU against AMR. Its preamble n. 41 clearly defines the need of a One-Health approach to AMR: it is recognized as a complex issue, it has a cross-border dimension and implies a high economic burden for the society. Moreover, “its impact goes beyond its severe consequences for human and animal health and has become a global public health concern that affects the whole of society and requires urgent and coordinated intersectoral action in accordance with the ‘One Health’ approach.”

With the VMP Regulation, all the actors from the livestock sector are called to be part of this approach by proactively improving best practices throughout the production chain and building reciprocal and synchronized relationships. Let’s start getting ready for its application, there is lot of work to be done!