33 Amendments of Annie SCHREIJER-PIERIK related to 2014/0257(COD)
Amendment 51 #
Proposal for a regulation
Recital 33
Recital 33
(33) Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide. Many of the antimicrobials used in animals are also used in humans. Some of those antimicrobials are critical for preventing or treating life-threatening infections in humans. In order to fight antimicrobial resistance a number of measures should be taken. It needs to be ensured that measures are proportionally applied in both the humane and animal sector. And appropriate warnings and guidance are included on the labels of veterinary antimicrobials. Use not covered by the terms of the marketing authorisation of certain new or critically important antimicrobials for humans should be restricted in the veterinary sector. The rules for advertising veterinary antimicrobials should be tightened, and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products.
Amendment 61 #
Proposal for a regulation
Recital 38
Recital 38
(38) If an antimicrobial is administered and used incorrectly, this presents a risk to public or animal health. Therefore antimicrobial veterinary medicinal products should only be available on veterinary prescription. Persons having the right to prescribe have a key role in ensuring prudent use of antimicrobials and consequently t. Veterinarians have a legal obligation which is part of their professional code of conduct. They should not be influenced, directly or indirectly, by economic incentives when prescribing those products. The animal health industry and the veterinarians should together promote responsible use. Therefore the supply of veterinary antimicrobials by those health professionals should be restricted to the amount required for treatment of the animals under their care.
Amendment 63 #
Proposal for a regulation
Recital 38 a (new)
Recital 38 a (new)
(38a) Prudent use of antimicrobials is a cornerstone in addressing antimicrobial resistance. The Guidelines for prudent use, drafted by the Commission, need to be considered by Member States.
Amendment 64 #
Proposal for a regulation
Recital 38 a (new)
Recital 38 a (new)
(38a) In order to facilitate prudent use, there is an imperative need for rapid, reliable and efficacious veterinary diagnostics both to identify the cause of disease as to perform antibiotic sensitivity testing. This will facilitate correct diagnosis, allow for a targeted use of antibiotics, avoiding the use of critically important antibiotics, and therefore restrain from the development of antibiotic resistance. There is clear need for future innovation specifically for on- site diagnostics, and a need to reflect whether more harmonisation or EU regulation in this sector is needed.
Amendment 80 #
Proposal for a regulation
Recital 62
Recital 62
(62) Where medicinal products are authorised within a Member State and have been prescribed in that Member State by a member of a regulated animal health professioveterinarian for an individual animal or group of animals, it should in principle be possible for that veterinary prescription to be recognised and for the medicinal product to be dispensed in another Member State. The removal of regulatory and administrative barriers to such recognition should not affect any professional or ethical duty for dispensing professionals to refuse to dispense the medicine stated in the prescription.
Amendment 114 #
Proposal for a regulation
Article 4 – paragraph 1 – point 24
Article 4 – paragraph 1 – point 24
(24) ‘veterinary prescription’ means any prescription for a veterinary medicinal product issued by a professional person qualified to do so in accordance, provided or dispensed by a veterinarian, to the owner or the person taking care of the animal(s) only if he/she has examined the animals and made a diagnosis before the prescription or has personal knowledge of the condition of the animals in order to prescribe the correct medicine. A writh applicable national law;ten or electronic prescription is always required when the medicine is not dispensed by the prescriber.
Amendment 148 #
Proposal for a regulation
Recital 33
Recital 33
(33) Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide. Many of the antimicrobials used in animals are also used in humans. Some of those antimicrobials are critical for preventing or treating life-threatening infections in humans. In order to fight antimicrobial resistance a number of measures should be taken. It needs to be ensured that any measures to be put in place are proportionately applied to both human and animal sector. Appropriate warnings and guidance are included on the labels of human and veterinary antimicrobials. Use not covered by the terms of the marketing authorisation of certain new or critically importantthe highest priority critical antimicrobials for humans as defined by the WHO should be restricted in the veterinary sector. The rules for advertising veterinary antimicrobials should be tightened, and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products.
Amendment 151 #
Proposal for a regulation
Recital 36
Recital 36
(36) The development of new antimicrobials has not kept pace with the increase of resistance to existing antimicrobials. Given the limited innovation in developing new antimicrobials it is essential that the efficacy of existing antimicrobials is maintained for as long as possible. The use of antimicrobials in veterinary medicinal products may accelerate the emergence and spread of resistant micro-organisms and may compromise the effective use of the already limited number of existing antimicrobials to treat human infections. Therefore the misuse of antimicrobials should not be allowed.
Amendment 156 #
Proposal for a regulation
Recital 37 a (new)
Recital 37 a (new)
(37a) As Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide there must soon also action be taken in the field of human medicine for example in the form of an instrument incentivising the development of new antibiotics for human use similar to that already proposed within this regulation.
Amendment 163 #
Proposal for a regulation
Recital 38
Recital 38
(38) If an antimicrobial is administered and used incorrectly, this presents a risk to public or animal health. Therefore antimicrobial veterinary medicinal products should only be available on veterinary prescription. Persons having the right to prescribe have a key role in ensuring prudent use of antimicrobials. Veterinarians have a legal obligation as part of their professional code of conduct and consequently they should not be influenced, directly or indirectly, by economic incentives when prescribing those products. Therefore the supply of veterinary antimicrobials by those health professionals should be restricted to the amount required for treatment of the animals under their care.
Amendment 251 #
Proposal for a regulation
Article 4 – paragraph 1 – point 24
Article 4 – paragraph 1 – point 24
(24) 'veterinary prescription‘ means any prescription for a veterinary medicinal product issued by a professional person qualified to do so, provided or dispensed by a veterinarian, to the owner or the person taking care of the animals only if he/she has examined the knowledge of the condition of the animals and made a diagnosis before the prescription or has personal knowledge of the condition of the animals to make a diagnosis and prescribe. A written or electronic prescription is always required when the medicine is not dispensed by the prescriber but instead by another dispenser (pharmacy), in accordance with applicable national law;
Amendment 339 #
Proposal for a regulation
Article 79 – paragraph 4 a (new)
Article 79 – paragraph 4 a (new)
4a. Competent authorities and the Agency shall ensure that veterinarians receive feedback on adverse events reported and regular feedback on all adverse reactions reported.
Amendment 360 #
Proposal for a regulation
Article 107 – paragraph 2
Article 107 – paragraph 2
2. PersoVeterinarians qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail antimicrobial products only for animals which are under their care and only after examination and diagnosis or recent animal health visit, and only in the amount required for the treatment concerned.
Amendment 369 #
Proposal for a regulation
Article 109 – paragraph 3 – subparagraph 1 – introductory part
Article 109 – paragraph 3 – subparagraph 1 – introductory part
Those manufacturers and suppliers shall keep detailed records of the following information in respect of each purchase and sale transaction:
Amendment 370 #
Proposal for a regulation
Article 109 – paragraph 3 – subparagraph 1 – point d
Article 109 – paragraph 3 – subparagraph 1 – point d
(d) name and address of the supplier in the event of purchase, or of the recipient in the event of sale.
Amendment 379 #
Proposal for a regulation
Article 110 – paragraph 2
Article 110 – paragraph 2
2. A veterinary prescription shall only be issued by a person qualified to do soveterinarian in accordance with applicable national law.
Amendment 398 #
Proposal for a regulation
Article 115 – paragraph 1 – introductory part
Article 115 – paragraph 1 – introductory part
1. By way of derogation from Article 111, where there is no authorised veterinary medicinal product in a Member State for a condition affecting a non-food producing animal, the veterinarian responsible may, under his/her direct personal responsibility and in particular to avoid causing unacceptable sufferingthe interest of animal health and welfare, exceptionally treat the animal concerned with the following:
Amendment 404 #
Proposal for a regulation
Article 116 – paragraph 1 – introductory part
Article 116 – paragraph 1 – introductory part
1. By way of derogation from Article 111, where there is no authorised veterinary medicinal product in a Member State for a condition affecting a food-producing animal of a non-aquatic species, the veterinarian responsible may, under his direct personal responsibility and in particular to avoid causing unacceptable suffering,the interest of animal health and welfare exceptionally treat the animal concerned with any of the following:
Amendment 477 #
Proposal for a regulation
Article 51 – paragraph 1
Article 51 – paragraph 1
1. A UnionEuropean Union wide database on veterinary medicinal products (‘product database') shall be set up and maintained by the Agency.
Amendment 643 #
Proposal for a regulation
Article 79 – paragraph 4
Article 79 – paragraph 4
4. Competent authorities and the Agency shall provide the general public, veterinarians and other healthcare professionals with all important information on adverse events relating to the use of a veterinary medicinal product in a timely manner electronically or through other publicly available means of communication. Competent authorities and the Agency shall ensure that veterinarians receive feedback on adverse events reported and regular feedback on all adverse reactions reported.
Amendment 733 #
Proposal for a regulation
Article 109 – title
Article 109 – title
Retail of anabolic, anti-infectious, anti- parasitic, anti-inflammatory, hormonal, immunological or psychotropic veterinary medicinal products
Amendment 736 #
Proposal for a regulation
Article 109 – paragraph 1
Article 109 – paragraph 1
1. Only manufacturers, wholesale distributors and retailers authorised specifically to do so in accordance with applicable national law shall be allowed to supply and purchase veterinary medicinal products which have anabolic, anti- infectious, anti-parasitic, anti- inflammatory, hormonal, immunological or psychotropic properties or substances which may be used as veterinary medicinal products having those properties.
Amendment 741 #
Proposal for a regulation
Article 109 – paragraph 3 – subparagraph 1 – introductory part
Article 109 – paragraph 3 – subparagraph 1 – introductory part
Those manufacturers and suppliers shall keep detailed records of the following information in respect of each purchase and sale transaction:
Amendment 744 #
Proposal for a regulation
Article 109 – paragraph 3 – subparagraph 1 – point c
Article 109 – paragraph 3 – subparagraph 1 – point c
(c) quantity received or supplied;
Amendment 745 #
Proposal for a regulation
Article 109 – paragraph 3 – subparagraph 1 – point d
Article 109 – paragraph 3 – subparagraph 1 – point d
(d) name and address of the supplier in the event of purchase, or of the recipient in the event of sale.
Amendment 746 #
Proposal for a regulation
Article 110 – paragraph 1 – point a
Article 110 – paragraph 1 – point a
(a) identification of the animal or class of animal under treatment;
Amendment 751 #
Proposal for a regulation
Article 110 – paragraph 1 – point f
Article 110 – paragraph 1 – point f
(f) active substance or name of the prescribed product;
Amendment 757 #
Proposal for a regulation
Article 110 – paragraph 2
Article 110 – paragraph 2
2. A veterinary prescription shall only be issued by a person qualified to do soveterinarian in accordance with applicable national law.
Amendment 795 #
Proposal for a regulation
Article 111 – paragraph 2 a (new)
Article 111 – paragraph 2 a (new)
2a. Antibacterial veterinary medicinal products must not be used on food- producing animals for prophylactic purposes except for preoperative or perioperative purposes or in drying-off therapy. They must not under any circumstances be used to improve breeding performance or compensate for poor animal husbandry.
Amendment 803 #
Proposal for a regulation
Article 112 a (new)
Article 112 a (new)
Amendment 804 #
Proposal for a regulation
Article 112 b (new)
Article 112 b (new)
Article 112 b Reduction of therapy approaches based on antibacterial substances (1) In order to facilitate the effective reduction regarding the use of pharmaceuticals which contain antibacterial substances, anyone who engages in animal husbandry has to: 1. determine, respectively, two months after the disclosure of the key figures of the in accordance with paragraph 112b established therapy prevalence, if the biannual therapy prevalence concerning his reared animal species, and considering the type-of-use during the elapsed time frame, lies above the average therapy prevalence. 2. take immediate record of the results of the assessment under #1 (2) In a case where the operational, biannual therapy prevalence of the animal husbandman with respect to his business lies above the biannual average, the animal husbandman under consultation of a veterinarian has to assess the reasons that may have led to exceeding the average, and how the treatment of his cattle with pharmaceuticals containing antibacterial substances may be decreased. If the assessment of the animal husbandman comes to the result that a therapy by means of the concerned pharmaceuticals may be reduced, the husbandman has to take all necessary steps in order to accomplish the reduction. The husbandman has to consider the wellbeing of his cattle and guarantee the required medical care. (3) Member States may determine measures extending beyond the above mentioned requirements
Amendment 807 #
Proposal for a regulation
Article 115 – paragraph 1 – introductory part
Article 115 – paragraph 1 – introductory part
1. By way of derogation from Article 111, where there is no authorised veterinary medicinal product in a Member State for a condition affecting a non-food producing animal, the veterinarian responsible may, under his/her direct personal responsibility and in particular to avoid causing unacceptable sufferingthe interest of animal health and welfare, exceptionally treat the animal concerned with the following:
Amendment 835 #
Proposal for a regulation
Article 116 – paragraph 1 – introductory part
Article 116 – paragraph 1 – introductory part
1. By way of derogation from Article 111, where there is no authorised veterinary medicinal product in a Member State for a condition affecting a food-producing animal of a non-aquatic species, the veterinarian responsible may, under his direct personal responsibility and in particular to avoid causing unacceptable sufferingin the interest of animal health and welfare, exceptionally treat the animal concerned with any of the following: