47 Amendments of Molly SCOTT CATO related to 2014/0257(COD)
Amendment 40 #
Proposal for a regulation
Recital 7 a (new)
Recital 7 a (new)
(7a) This regulation aims at ensuring a high level of protection of both animal and human health while securing the protection of the environment. The precautionary principle should be applied and this Regulation should ensure that industry demonstrates that pharmaceutical substances or veterinary medicinal products produced or placed on the market have no unacceptably harmful effects on human or animal health or any unacceptable effects on the environment.
Amendment 47 #
Proposal for a regulation
Recital 27
Recital 27
(27) It is recognised that the potential effect of a product on the environment may depend on the volume used and the resulting amount of the pharmaceutical substance that may reach the environment. Therefore, where there is evidence that a constituent of a medicinal product for which a generic application for a marketing authorisation is submitted is a hazard for the environment, it is appropriate to require data on the potential effect on the environment in order to safeguard the environment. In such cases applicants should endeavour to join efforts in generating such data in order to reduce costs and to reduce testing on vertebrate animals. The system as it stood until now has led to duplicate testing, wasting resources, and lack of harmonisation of environmental risk assessments. The Pharmacovigilance system has to date not been able to compensate for the effects of this poor harmonisation. This particularly applies to veterinary medicinal products authorised before the environmental risk assessment requirement came into force. Therefore, the Commission should establish a substance-based review system for the environmental risk assessment of these veterinary medicinal products. The results of the review system would be published in so-called ‘monographs'.
Amendment 49 #
Proposal for a regulation
Recital 30
Recital 30
Amendment 50 #
Proposal for a regulation
Recital 30 a (new)
Recital 30 a (new)
(30a) In the interest of safety and public, animal and environmental health, the approval period for pharmaceutical substances and veterinary medicinal products should be limited in time. At the time of subsequent approvals, any developments in science and technology should be taken into account when any decision regarding the renewal of an approval is taken. The renewal of the approval should be for a period not exceeding 15 years.
Amendment 69 #
Proposal for a regulation
Recital 49
Recital 49
(49) It is necessary, in specific cases, orn specific cases it is necessary, from a public health and, animal health or environmental perspective, to complement the safety and efficacy data available at the time of authorisation with additional information following the placing of the product on the market. Therefore the obligation to conduct post-authorisation studies should be imposed on the marketing authorisation holder.
Amendment 82 #
Proposal for a regulation
Recital 65
Recital 65
(65) The verification of compliance with the legal requirements through controls is of fundamental importance to ensure that the objectives of the Regulation are effectively achieved across the Union. Therefore the competent authorities of the Member States should have the power to perform inspections at all stages of production, distribution and use of veterinary medicinal products and should publish annual control reports. In order to preserve the effectiveness of the inspections, authorities should have the possibility to perform unannounced inspectionsperform a certain percentage of unannounced inspections, to be determined by a delegated act.
Amendment 83 #
Proposal for a regulation
Recital 67
Recital 67
(67) In certain cases failures in Member States’ control system can substantially hinder the achievement of the objectives of this Regulation and may lead to the emergence of risks to public and animal health and the environment. Tohe Commission should ensure a harmonised approach to inspections throughout the Union, the Commissionand should be able to carry out audits in the Member States to verify the functioning of national control systems.
Amendment 120 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
2. An initial marketing authorisation for a veterinary medicinal product shall be valid for an unlimited period of timefive years.
Amendment 122 #
Proposal for a regulation
Article 5 – paragraph 2 a (new)
Article 5 – paragraph 2 a (new)
2a. After the first period of five years the marketing authorisation shall be limited to a period not exceeding 15 years. After that period the applicant may apply for another 15 years authorisation. The renewal assessment shall be based on the current state of scientific knowledge and techniques and must take into account adverse effects reported under Article 76.
Amendment 125 #
Proposal for a regulation
Article 7 – paragraph 2 – point a
Article 7 – paragraph 2 – point a
(a) documentation on the direct or indirect risks to public or animal health or the environment of use of the antimicrobial veterinary medicinal product in animals,
Amendment 127 #
Proposal for a regulation
Article 7 – paragraph 2 – point b
Article 7 – paragraph 2 – point b
(b) information about risk mitigation measures to limit antimicrobial resistance development related to the use of veterinary medicinal product, including specifications that the product is not to be used as a routine prophylactic or metaphylactic measure in food producing animals, and is not to be used in prophylactic group treatments where there has been no diagnosis of disease.
Amendment 130 #
Proposal for a regulation
Article 7 – paragraph 5 a (new)
Article 7 – paragraph 5 a (new)
5a. When applying for renewal, publicly available, peer-reviewed scientific literature on the active pharmaceutical substance and its relevant metabolites dealing with side-effects on human health, the environment and non-target species and published within the last 10 years before the date of submission of the dossier shall be added by the applicant to the dossier.
Amendment 156 #
Proposal for a regulation
Article 16 – paragraph 6
Article 16 – paragraph 6
6. AThe applicant shall submit to the competent authority or the Agency may require the applicant to provide safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment in case the marketing authorisation for the reference veterinary medicinal product was granted before 20 July 2000 or in case the second phase environmental risk assessment was required for the reference veterinary medicinal product.
Amendment 169 #
Proposal for a regulation
Article 28 – paragraph 3
Article 28 – paragraph 3
3. Where the application concerns an antimicrobial veterinary medicinal product, the competent authority or the Commission mayshall require the marketing authorisation holder to conduct post-authorisation studies in order to ensure that the benefit- risk balance remains positive with a view to the possible development of antimicrobial resistance.
Amendment 178 #
Proposal for a regulation
Article 30 – paragraph 1 – point c – point xiii
Article 30 – paragraph 1 – point c – point xiii
(xiii) special conditions for use, including restrictions on the use of antimicrobials in order to limit the risk of development of antimicrobial resistance, and specifying that the product is not to be used as a routine preventative measure in food producing animals, or in prophylactic group treatments where there has been no diagnosis of disease,
Amendment 184 #
Proposal for a regulation
Article 30 – paragraph 1 – point j a (new)
Article 30 – paragraph 1 – point j a (new)
(ja) Information from the environmental risk assessment of the product, in particular environmental endpoints and risk characterisation data, including ecotoxicological information on effects on non-target species and persistence of active substances and active metabolites in soil and water.
Amendment 185 #
Proposal for a regulation
Article 30 – paragraph 1 – point j b (new)
Article 30 – paragraph 1 – point j b (new)
(jb) ecotoxicological information including effects on non-target species and persistence of active substances and active metabolites in soil and water.
Amendment 187 #
Proposal for a regulation
Article 31 – paragraph 2 a (new)
Article 31 – paragraph 2 a (new)
2a. Where two products have the same therapeutic effect, comparative assessments may be carried out. Products that are hazardous to the environment or to the treated animals shall be substituted by less hazardous products.
Amendment 190 #
Proposal for a regulation
Article 32 – paragraph 1 – point d
Article 32 – paragraph 1 – point d
(d) the product is an antimicrobial veterinary medicinal product presented for use as performance enhancer in order to promote the growth of treated animals, or to increase yields from treated animals, or as a routine prophylactic in food producing animals, or to be added to feed or water for mass medication when no disease has been diagnosed in any of the animals ;
Amendment 193 #
Proposal for a regulation
Article 32 – paragraph 1 – point g a (new)
Article 32 – paragraph 1 – point g a (new)
(ga) the product is a substance of high concern;
Amendment 194 #
Proposal for a regulation
Article 32 – paragraph 1 – point g b (new)
Article 32 – paragraph 1 – point g b (new)
(gb) active substances within the product which meet the criteria for being persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to EMA guidelines, or are considered as having endocrine-disrupting properties that risk causing adverse effects in the environment;
Amendment 195 #
Proposal for a regulation
Article 32 – paragraph 1 – point h a (new)
Article 32 – paragraph 1 – point h a (new)
(ha) unacceptable side effects or secondary effects on the treated animal;
Amendment 264 #
Proposal for a regulation
Article 51 a (new)
Article 51 a (new)
Article 51a Feasibility study for monograph review system By the 1st June 2018, the Commission shall present a report to the European Parliament and the Council on establishing a substance-based review system (monographs) for the environmental risk assessment of veterinary medicinal products, to be accompanied by a legislative proposal if appropriate.
Amendment 265 #
Proposal for a regulation
Article 52 – paragraph 3
Article 52 – paragraph 3
3. The general public shall have access to information in the product database as regards the list of the authorised veterinary medicinal products, their summaries of product characteristics and package leaflets.
Amendment 266 #
Proposal for a regulation
Article 52 – paragraph 3 a (new)
Article 52 – paragraph 3 a (new)
3a. Commercial sensitivity must not be used as an excuse to deny citizens access to information about chemicals affecting their bodies and those of other non-target species in the wider environment. Maximal transparency shall be ensured while protecting the most commercially sensitive information.
Amendment 267 #
Proposal for a regulation
Article 54 – title
Article 54 – title
Collection of data on the sales and use of antimicrobial veterinary medicinal products
Amendment 269 #
Proposal for a regulation
Article 54 – paragraph 1
Article 54 – paragraph 1
1. Member States shall collect relevant and comparable data on the volume of sales and the use of veterinary antimicrobial medicinal products. These data shall include: (a) volume of sales in terms of weight and monetary value for each antimicrobial type; (b) use of antimicrobials including species treated, disease or infection being treated, and method of treatment.
Amendment 272 #
Proposal for a regulation
Article 54 – paragraph 1 a (new)
Article 54 – paragraph 1 a (new)
1a. These data should provide detail at least by species and by antibiotic class and on a per-farm level.
Amendment 277 #
Proposal for a regulation
Article 54 – paragraph 3 a (new)
Article 54 – paragraph 3 a (new)
3a. Member States shall collect relevant and comparable data on the volume of sales and the use of anti-parasitic and hormonal veterinary medicinal products, and make these available to the Agency.
Amendment 306 #
Proposal for a regulation
Article 70 – paragraph 3
Article 70 – paragraph 3
3. By way of derogation from Article 69, veterinary medicinal products authorised before 20 July 2000 as well as veterinary medicinal products authorised after that date but which were identified as potentially harmful to the environment in the course of the environmental risk assessment shall be reassessed, or have no environmental risk assessments or incomplete ones, shall be reassessed in line with Annex II before a harmonised summary of the product characteristics is prepared.
Amendment 311 #
Proposal for a regulation
Article 73 – paragraph 2 – point c
Article 73 – paragraph 2 – point c
(c) any environmental incidents observedadverse or unintended reaction observed in non-target species in the wider environment following administration of a veterinary medicinal product to an animal;
Amendment 319 #
Proposal for a regulation
Article 74 – paragraph 2
Article 74 – paragraph 2
2. The Agency shall, in collaboration with the Member States and the Commission, draw up the functional specifications for the pharmacovigilance database. These shall include environmental monitoring data which would report undesirable effects on non-target species in the ecosystem, and extend sources of inputs to the pharmacovigilance system to include observation and monitoring by specialists who are not necessarily veterinarians.
Amendment 323 #
Proposal for a regulation
Article 76 – paragraph 3
Article 76 – paragraph 3
3. Competent authorities mayshall, on their own initiative or on request from the Agency, request the marketing authorisation holder to collect specific pharmacovigilance data, in particular regarding the use of a veterinary medicinal product in specified animal species, in the context of public and animal health, safety of the persons administering the product, and the protection of the environment. The authority shall state in detail the reasons for the request and inform other competent authorities and the Agency thereof.
Amendment 374 #
Proposal for a regulation
Article 110 – paragraph 1 – point f a (new)
Article 110 – paragraph 1 – point f a (new)
(fa) the condition which is being treated;
Amendment 383 #
Proposal for a regulation
Article 110 – paragraph 3 a (new)
Article 110 – paragraph 3 a (new)
3a. In the case of antimicrobials critically important for human use, the prescribed medication may only be used for the animals examined by the person who issued the prescription. The prescribed medication may only be used for the diagnosed disease.
Amendment 385 #
Proposal for a regulation
Article 111 – paragraph 1 a (new)
Article 111 – paragraph 1 a (new)
1a. Antimicrobials may only be issued under prescription by a vet or a suitably qualified animal health professional to food producing animals after all the preventive measures listed under Annex 3a have been fulfilled. Preventative or prophylactic mass medication in drink or water when no disease has been diagnosed shall be prohibited. No antimicrobial group treatments should be permitted, except for where disease has been diagnosed in some of the animals.
Amendment 402 #
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, exceptionally treat the animal concerned with any of the following, with the exception of antimicrobial products used prophylactically in an individual or a group where there is no diagnosis of disease in any of the animals:
Amendment 419 #
Proposal for a regulation
Article 116 – paragraph 4 – subparagraph 1
Article 116 – paragraph 4 – subparagraph 1
The Commission may, by means of implementing acts, establish a list of veterinary medicinal products authorised in the Union for use in terrestrial animals which can be used for treatment of food- producing animals of an aquatic species in accordance with paragraph 1. This provision is strictly limited to closed aquatic systems with specific waste water treatment facilities. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Amendment 421 #
Proposal for a regulation
Article 116 – paragraph 4 – subparagraph 2 – point a
Article 116 – paragraph 4 – subparagraph 2 – point a
(a) risks to the environment if aquatic animals are treated with these medicinal products, in line with Annex II ;
Amendment 425 #
Proposal for a regulation
Article 118 – paragraph 1
Article 118 – paragraph 1
1. Antimicrobial medicinal products shall only be used in accordance with Articles 115 and 116 to treat conditions for which there is no other treatment available, and the use of which would not present a risk to public or animal health. once the applicable conditions outlined in Annex 3a have been fulfilled, and the use of which would not present a risk to public or animal health, and specifically is not for routine prophylactic use or a prophylactic group treatment where there is no diagnosis of disease.
Amendment 430 #
Proposal for a regulation
Article 118 – paragraph 2 – subparagraph 2 – point a
Article 118 – paragraph 2 – subparagraph 2 – point a
(a) risks to public health if the antimicrobial product is used in accordance with paragraph 1;, including the risks involved in using antimicrobials critical to human health in food producing animals.
Amendment 438 #
Proposal for a regulation
Article 125 – paragraph 1 a (new)
Article 125 – paragraph 1 a (new)
1a. The Commission shall ensure a harmonised approach to inspections and controls of veterinary medicines throughout the Union.
Amendment 441 #
Proposal for a regulation
Article 125 – paragraph 4 – subparagraph 2
Article 125 – paragraph 4 – subparagraph 2
Amendment 443 #
Proposal for a regulation
Article 125 – paragraph 6
Article 125 – paragraph 6
6. Inspection reports shall be uploaded to the appropriate database, with continuous access for all competent authorities. Final inspection results shall be made public.
Amendment 445 #
Proposal for a regulation
Article 128 – paragraph 3 a (new)
Article 128 – paragraph 3 a (new)
3a. The Agency and the Commission shall ensure a harmonised approach to veterinary medicine inspections.
Amendment 454 #
Proposal for a regulation
Article 141 – paragraph 1 – point h a (new)
Article 141 – paragraph 1 – point h a (new)
(ha) tackle the contribution of farming practices to the development of antimicrobial resistance, by building on the existing action plans of the Commission and Member States, specifically by developing and implementing strategies to: – reduce overall use, – reduce the use of antimicrobials that are critically important for human use, and – end routine prophylactic use. This work shall be laid out in a plan submitted to the Commission no later than two years from adoption of this Regulation. The plan shall contain targets for the reductions in use and a timetable for achieving reductions.
Amendment 460 #
Proposal for a regulation
Annex 3 a (new)
Annex 3 a (new)