19 Amendments of Peter LIESE related to 2023/0132(COD)
Amendment 310 #
Proposal for a directive
Recital 68
Recital 68
(68) While this Directive restricts the use of antimicrobials by setting certain categories ofsystemic antimicrobials under prescription status, due to the growing antimicrobial resistance in the Union, competent authorities of the Member States should consider further measures for examplea number of measures, including expanding the prescription status of antimicrobials or the mandatory use of diagnostic tests before prescription. Additionally, the combined use of several antimicrobial active substances may represent a particular risk with respect to the development of antimicrobial resistance. Such combined use should therefore only be prescriped in exceptional cases where the benefit-risk balance of the combination is favourable. Competent authorities of the Member States should consider such further measures according to the level of antimicrobial resistance in their territory and the needs of patients.
Amendment 384 #
Proposal for a directive
Article 1 – paragraph 2
Article 1 – paragraph 2
2. The provisions of this Directive shall apply to industrially produced medicinal products for human use intended to be placed on the market in Member States.
Amendment 407 #
Proposal for a directive
Article 1 – paragraph 10 – introductory part
Article 1 – paragraph 10 – introductory part
10. TIn accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union, and in line with the decisions of the European Court of Justice, this Directive shall not affect the application of national legislation prohibiting or restricting the following:
Amendment 496 #
Proposal for a directive
Article 4 – paragraph 1 – point 22
Article 4 – paragraph 1 – point 22
(22) ‘antimicrobial’ means any medicinal product with a direct action on micro-organisms used for treatment or prevention of infections or infectious diseases, including antibiotics, antivirals, antifungals and antifung-protozoals;
Amendment 505 #
Proposal for a directive
Article 4 – paragraph 1 – point 29 – point a
Article 4 – paragraph 1 – point 29 – point a
(a) a substance or a combination of substances intended tothat edit the host genome in a sequence-specific manner or that contain or consists of cells subjected to such modification; or
Amendment 508 #
Proposal for a directive
Article 4 – paragraph 1 – point 29 – point b
Article 4 – paragraph 1 – point 29 – point b
(b) a recombinant or synthetic nucleic acid used in or administered to human beings with a view to regulating, replacing or adding a genetic sequence that mediates its effect by transcription or translation of the transferred genetic materials or that contain or consists of cells subjected to these modifications;technologies that do not effect the DNA and/or the cell nucleus.
Amendment 541 #
Proposal for a directive
Article 4 – paragraph 1 – point 70
Article 4 – paragraph 1 – point 70
(70) ‘public service obligation’ means to guaranteensure permanently an adequate range of medicinal products to meet the requirements of a specific geographical area and to deliver the supplies requested within a very short time over the whole of the area in question.
Amendment 570 #
Proposal for a directive
Article 13 – paragraph 1
Article 13 – paragraph 1
Amendment 787 #
Proposal for a directive
Article 51 – paragraph 2
Article 51 – paragraph 2
2. Member States may set additional conditions on the prescription of antimicrobials, restrict the validity of medical prescription and limit the quantities prescribed to the amount required for the treatment or therapy concerned or submitting certain antimicrobial medicinal products to special medical prescription or restricted prescription. Member States shall ensure that the necessary capacities for appropriate testing and antigen rapid tests are available before the administration of an antibiotic substance, and shall finance such testing through their healthcare systems. A prescription for antibiotic products shall be subject to the following conditions, which shall become effective two years after the entry into force of this Directive: (a) be limited to the amount required for the treatment or therapy concerned; (b) only be prescribed for a limited duration to cover the period of risk when used as prophylaxis; (c) require a justification through diagnostic testing in accordance with Article 51 (2c), point i; (d) not be influenced by any form of economic incentive provided directly or indirectly to persons who prescribe medicinal products, given the risks associated with antimicrobial resistance.
Amendment 790 #
Proposal for a directive
Article 51 – paragraph 2 – subparagraph 1 (new)
Article 51 – paragraph 2 – subparagraph 1 (new)
Prior to the prescription of an antibiotic product, execpt in cases of emergency, the person qualified to prescribe is required to examine the sensitivity of the bacterial pathogens causing the illness (antibiogram).The antibiogram shall be conducted: (a) in the case of treatments with antibiotics;or (b) when changing the antibiotic product during a course of treatment;or (c) in the case of combined adminstration of antibiotics for one indication, except for authorised ready-made products containing a combination of antibiotic active substances;
Amendment 791 #
Proposal for a directive
Article 51 – paragraph 2 – subparagraph 1 (new)
Article 51 – paragraph 2 – subparagraph 1 (new)
By derogation from paragraph 2, subparagraph 1a of this article, an antibiogram is not required if: (a) The collection of samples would involve a risk of additional impairment to the health status of the patient to be treated;or (b) There is no suitable method available for the determination of the sensitivity of the pathogen; If, due to an emergency or the derogations outlined above an antibiogram cannot be performed, an appropriate rapid test must be conducted whenever possible.
Amendment 801 #
Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1
Article 56 – paragraph 3 – subparagraph 1
The marketing authorisation holder of a medicinal product placed on the market in a Member State shall, within the limits of its responsibility, ensure appropriate and continued supplies of that medicinal product to wholesale distributors, pharmacies orand persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.
Amendment 1359 #
Proposal for a directive
Article 87 – paragraph 1 – subparagraph 1 – point c – paragraph 1
Article 87 – paragraph 1 – subparagraph 1 – point c – paragraph 1
to conduct a post-authorisation environmental risk assessment study, collection of monitoring data or information on use, if there are concerns about the risks to the environment or public health, including antimicrobial resistance, due to an authorised medicinal product, or related active substance.
Amendment 1360 #
Proposal for a directive
Article 87 – paragraph 1 – subparagraph 1 – point c – paragraph 1 a (new)
Article 87 – paragraph 1 – subparagraph 1 – point c – paragraph 1 a (new)
Where the application concerns an antimicrobial medicinal product, the competent authority or the Member States shall require the marketing authorisation holder to conduct post-authorisation studies as outline in Article 87(1c) in order to ensure that the benefit-risk balance remains positive with a view to the possible development of antimicrobial resistance.
Amendment 1361 #
Proposal for a directive
Article 87 – paragraph 1 – subparagraph 1 – point c – paragraph 1 b (new)
Article 87 – paragraph 1 – subparagraph 1 – point c – paragraph 1 b (new)
Under the provisions of Article 87 (1d) Member States shall; (a) collect relevant and comparable data on the volume of sales and on the use of antimicrobial medicinal products used, to enable in particular the direct or indirect evaluation of the use of such products with the aim to monitor the development of antimicrobial resistances; (b) send collated data on the volume of sales and the use per types of antimicrobial medicinal products to the Agency. The Agency shall cooperate with Member States and with other Union agencies to analyse those data and shall publish an annual report. The Agency shall take into account those data when adopting any relevant guidelines and recommendations.
Amendment 1363 #
Proposal for a directive
Article 87 a (new)
Article 87 a (new)
Amendment 1364 #
Proposal for a directive
Article 87 b (new)
Article 87 b (new)
Article 87b Integration of Antimicrobial Usage Data in Human Medicine In accordance with Article 87 of this Directive, upon the completion of data collection and appropriate analysis, the Commission shall, if appropriate, propose the setting of benchmarks and the establishment of suitable reduction targets. These targets shall consider the specific circumstances of different medical specialties, focusing on the prudent use of antimicrobial medicinal products in human medicine.
Amendment 1448 #
Proposal for a directive
Article 166 – paragraph 1 – point l
Article 166 – paragraph 1 – point l
(l) continuously guaranteappoint full-line wholesalers, who shall, pursuant to Article 56 (3) continuously ensure the appropriate and continued supply of an adequate range of medicinal products to meet the requirements of a specific geographical area, and deliver the supplies requested over the whole of the area in question, within a reasonable timeframe, which shall be defined in the national legislation;
Amendment 1516 #
Proposal for a directive
Article 185 – paragraph 1 – point g – point i (new)
Article 185 – paragraph 1 – point g – point i (new)
i) no samples of medicinal products classified as antimicrobial may be supplied.