(Utkast) Delegert kommisjonsforordning (EU) .../... av 28. november 2022 om utfylling av europaparlaments- og rådsforordning (EU) 2016/429 med hensyn til regler for bruk av visse veterinærlegemidler for forebygging og kontroll av visse listeførte sykdommer
(Draft) Commission Delegated Regulation (EU) .../... of 28 November 2022 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council as regards rules for the use of certain veterinary medicinal products for the purpose of prevention and control of certain listed diseases
Utkast til delegert kommisjonsforordning sendt til Europaparlamentet og Rådet for klarering 28.11.2022
BAKGRUNN (fra kommisjonsforordningen)
(1) Regulation (EU) 2016/429 lays down rules for the prevention and control of animal diseases that are transmissible to animals or to humans, including rules on disease awareness, preparedness and control. In particular, Regulation (EU) 2016/429 lays down disease-specific rules for the prevention and control of diseases referred to in its Article 5. Regulation (EU) 2016/429 also provides that those disease-specific rules apply to species and groups of animal species that pose a considerable risk for the spread of specific diseases and that are listed as such in Commission Implementing Regulation (EU) 2018/1882
(2) In accordance with Article 46 of Regulation (EU) 2016/429, Member States may take appropriate and necessary measures concerning the use of veterinary medicinal products for listed diseases to ensure the most efficient prevention and control of those diseases. Certain veterinary medicinal products may interfere in the detection and diagnosis of diseases, and therefore in their prevention and control. This is particularly relevant for those listed diseases that are subject to stricter prevention and control measures in accordance with Regulation (EU) 2016/429. It is necessary to identify the veterinary medicinal products for which supplementing rules need to be developed pursuant to Article 47 of that Regulation and to establish restrictions or prohibitions to their use to ensure safe and effective prevention and control of certain listed diseases.
(3) Implementing Regulation (EU) 2018/1882 lays down the definitions of category A, B, C, D and E diseases, relying on disease prevention and control rules set out in Article 9(1) of Regulation (EU) 2016/429. Listed diseases referred to in Article 5 of Regulation (EU) 2016/429 that do not normally occur in the Union and for which immediate eradication measures are to be taken as soon as they are detected (‘category A diseases’) are subject to specific rules laid down in Article 9(1), point (a), of that Regulation. With a view to prevent the potentially devastating effects of category A diseases on animal health in the Union, it is necessary to harmonise the rules under which Member States may use veterinary medicinal products for the prevention and control of those diseases. Such rules should aim to ensure effective
revention of category A diseases and their immediate eradication in the case of an outbreak, as well as to prevent that the use of the veterinary medicinal products poses a risk for the spread of those diseases.
(4) It is necessary to lay down rules supplementing the rules on disease awareness and preparedness set out in Chapter 2, Title I of Part III of Regulation (EU) 2016/429 for certain listed diseases, in particular the rules on the use of veterinary medicinal products for disease prevention and control. Those supplementing rules and the rules set out in Regulation (EU) 2016/429 are closely linked and should be applied in tandem.
(5) Since both terrestrial and aquatic animals may be affected by category A diseases listed in accordance with Article 5 of Regulation (EU) 2016/429, certain general rules laid down in this Regulation should cover terrestrial and aquatic animals. This would help Member States facing an imminent risk of spread of a category A disease in their territory to immediately react under a harmonised framework, if needed. This is particularly important for aquatic animals, since disease-specific rules for the use of vaccines against category A diseases can only be developed for terrestrial animals for the time being, due to lack of scientific knowledge, combined with lack of experience and of availability of vaccines against aquatic category A diseases.
(6) Listed diseases referred to in Article 5 of Regulation (EU) 2016/429 which are to be controlled in all Member States with the goal of eradicating them throughout the Union (‘category B diseases’) are subject to specific rules laid down in Article 9(1), point (b), of that Regulation. Therefore, it is necessary to harmonise the rules under which Member States may use certain veterinary medicinal products for that purpose. Such rules should aim to ensure the effective eradication of category B diseases without detection and diagnostic interferences caused by any veterinary medicinal product.
(7) For listed diseases referred to in Article 5 of Regulation (EU) 2016/429 which are of relevance to some Member States and for which measures are needed to prevent them from spreading to parts of the Union that are officially disease-free or that have eradication programmes for the listed diseases concerned, as referred to in Article 9(1), point (c), of that Regulation (‘ category C diseases’), rules for the use of certain veterinary medicinal products, in particular for the use of vaccines in the context of eradication programmes are laid down in Commission Delegated Regulation (EU) 2020/689. For listed diseases referred to in Article 5 of Regulation (EU) 2016/429 for which measures are needed to prevent them from spreading on account of their entry into the Union or movements between Member States, as referred to in Article 9(1), point (d), of that Regulation (‘category D diseases’), rules for the use of certain veterinary medicinal products for the movements of animals within the Union are laid down in Commission Delegated Regulation (EU) 2020/688. Such rules should therefore not be replicated in this Regulation.
(8) In accordance with Article 46(3) of Regulation (EU) 2016/429, Member States are to take appropriate preventive measures concerning the use of veterinary medicinal products for scientific studies or for the purposes of developing and testing them under controlled conditions to protect animal and public health. It is necessary to facilitate the research and innovation as regards development of more effective and safer veterinary medicinal products to prevent and control listed diseases. Therefore, the rules laid down in this Regulation should not apply to the use of veterinary medicinal products for scientific studies or for the purpose of developing and testing them under controlled conditions to protect animal and public health, to avoid any unnecessary burden that may interfere in the development of new possibilities,
considering the specific risk-mitigating conditions under which veterinary medicinal products are used in those circumstances.
(9) Regulation (EU) 2019/6 of the European Parliament and of the Council lays down rules for the placing on the market, manufacturing, import, export, supply, distribution, pharmacovigilance, control and use of veterinary medicinal products. That Regulation lays down a definition of a veterinary medicinal product and definitions of certain categories of veterinary medicinal products. It also lays down conditions under which a competent authority may allow the use of an immunological veterinary medicinal product not authorised within the Union. The rules provided for in this Regulation should comply with those definitions as well as with the requirements laid down in Regulation (EU) 2019/6, for the placing on the market, manufacturing, import, export, supply, distribution, pharmacovigilance, control and use of veterinary medicinal products. Furthermore, the rules provided for in this Regulation should only aim to lay down specific conditions for the appropriate use or prohibition of use of veterinary medicinal products to prevent and control category A diseases and certain category B diseases in the Union, irrespective of the products’ origin, marketing authorisation or other characteristics.
(10) In accordance with Article 47 of Regulation (EU) 2016/429, the Commission may adopt rules when this is appropriate and necessary to prohibit the use of a certain veterinary medicinal product for a specific disease. Rinderpest has been recognised as a globally eradicated disease by the World Organisation for Animal Health (WOAH, founded as OIE) and all vaccinations against rinderpest have ceased throughout the world. Vaccination against rinderpest should therefore be prohibited by this Regulation.
(11) In addition, the currently available vaccines against infection with Mycobacterium tuberculosis complex (Mycobacterium bovis, Mycobacterium tuberculosis and Mycobacterium caprae) (MTBC), do not confer full protection in vaccinated animals and compromise tuberculin skin tests or other immunological tests relying on the use of tuberculin, for the distinction between vaccinated and infected animals. As a result, use of these vaccines in kept animals of listed species may jeopardise current bovine tuberculosis control and eradication policies, since it may not be possible to distinguish between vaccinated and infected animals. Vaccination against MTBC, in kept animals of listed species, should therefore also be prohibited by this Regulation.
(12) Some Member States currently allow the regular precautionary use of vaccines against Newcastle disease, for purposes other than responding to an outbreak. In addition, there are uses of vaccines against Newcastle disease as a requirement for movements, within the Union and for entry into the Union from third countries or territories. These uses have proven to be safe and effective in preventing the disease since there have not been outbreaks of Newcastle disease linked to the use of vaccines for such purposes. Therefore, the general prohibitions and restrictions for the use of vaccines against category A diseases laid down in this Regulation should not apply to such use of vaccines against Newcastle disease in those contexts.
(13) Moreover, some other veterinary medicinal products, such as hyper-immune sera, antimicrobials and some immunological veterinary medicinal products may, if used for the prevention and control of certain animal diseases, mask the presence of these diseases that may spread unnoticed in animal populations. This may hamper the early detection of the disease, and negatively affect its rapid eradication. This is in particular relevant for category A and B diseases, for which an immediate or timely eradication is essential. Therefore, it is appropriate to lay down certain restrictions for such veterinary medicinal products in this Regulation preventing their use in listed species for category A and B diseases.
(14) The competent authority of each Member State should be responsible for implementing disease prevention and control measures for category A diseases in terrestrial and aquatic animals. Vaccination may be a useful measure that may help prevent, control and eradicate some of category A diseases. Considering the pathogenic potential of these diseases and the potential risk of their spreading, derived
from the use of vaccines, it is necessary that vaccines administered against such type of diseases are used under the control of the competent authority and only when disease control measures need to be put in place to prevent and control the spread of the disease. Furthermore, in order to ensure an effective eradication and a consistent
application of all disease control measures, vaccination should be implemented in a structured manner according to an official vaccination plan. An official vaccination plan should include detailed information about the measures set out in it. The minimum information to be included in those official vaccination plans should be provided for in this Regulation.
(15) Given that vaccination may be an appropriate tool in some circumstances to control or eradicate a category A disease, while not in others, and that its use may sometimes have negative impacts (e.g. on trade), the competent authority should carry out a prior risk assessment before applying vaccination. Criteria for such assessment should be provided for in this Regulation.
(16) To ensure a coordinated EU approach, Member States should provide the Commission and the other Member States with a set of preliminary information before they apply vaccination against a category A disease. The Commission should review that information from Member States in accordance with Article 71 of Regulation (EU) 2016/429.
(17) Article 69 of Regulation (EU) 2016/429 provides for the possibility that the competent authority of a Member State uses emergency vaccination where relevant for the effective control of a listed disease in kept animals. To do that, the competent authority should develop an official vaccination plan for its implementation and establish vaccination zones taking into account certain requirements. This Regulation
should therefore lay down those requirements for emergency vaccination, the use of vaccines and the establishment of vaccination zones.
(18) The competent authority may implement such emergency vaccination in affected establishments or in not affected establishments as provided for in Commission Delegated Regulation (EU) 2020/687. Such establishments will normally be located in restriction zones, however they may also be placed outside such zones. Different emergency vaccination strategies should be applied to those situations. Vaccination implemented in affected establishments where vaccinated animals will be killed is considered as emergency suppressive vaccination. Emergency vaccination may also take place to prevent the spread of the disease in animal populations at risk of infection that are kept in establishments where the disease has not been suspected or confirmed in accordance with Delegated Regulation (EU) 2020/687. In such cases, the animals may be killed or kept alive under special conditions. Emergency vaccination may also be used in wild terrestrial animals when the risk of spreading of the disease in kept or wild terrestrial animal populations requires so. This Regulation should therefore develop those strategies and provide for the rules for their implementation, and for record keeping and reporting obligations that apply in all those circumstances.
(19) To prevent the spread of a category A disease or to avoid potential losses and the need to apply drastic disease control measures, Member States may decide to use preventive vaccination against a category A disease in its absence in a country or a zone. To this effect, specific rules should be laid down in this Regulation.
(20) Although vaccination has proved its capacity to help with prevention, control and eradication of several diseases, it may however, depending on the disease and type of vaccine used, mask in certain circumstances an underlying infection and affect the reliability of disease surveillance. Therefore, when vaccination is implemented, certain accompanying risk mitigation measures should be taken for the movement of vaccinated animals and their products.
(21) After the completion of emergency protective vaccination an exit strategy should enable Member States to demonstrate the absence of infection and to recover the health status they had prior to the outbreaks of the relevant category A disease and the use of vaccination. Such exit strategy should consist of a specific reinforced clinical and laboratory surveillance during the pre-defined recovery period for each specific category A disease.
(22) Specific conditions for each category A disease should be set out for implementing vaccination as regards the type of vaccines used, the size of the vaccination zones, the targeted animal populations, disease surveillance, movement restrictions for animals and their products, and recovery periods. This is the case for diseases for which sufficient experience and data are available from the application of rules in place, before the entry into application of Regulation (EU) 2016/429, from recent European Food Safety Authority (EFSA) opinions or from the relevant chapters of the WOAH Terrestrial Animal Health Code and WOAH Manual of Diagnostic Tests and Vaccines for Terrestrial Animals. For diseases for which sufficient experience and data are not available, disease specific measures cannot be provided for the moment. For those diseases general rules of this Regulation should apply,
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