BETA

40 Amendments of Max ORVILLE related to 2023/0132(COD)

Amendment 151 #
Proposal for a directive
Recital 3 a (new)
(3 a) In parallel of this revision, the Union should build a new European pharmaceutical ecosystem to accelerate research and development of a new medicinal product and support innovation through the establishment of public- private partnerships, the multiplication of University Hospital Institutes, centres of excellence and bioclusters.
2023/11/21
Committee: ENVI
Amendment 153 #
Proposal for a directive
Recital 3 b (new)
(3 b) With the financial support from the Horizon Europe programme, the Union should participate to the establishment of a sustainable network of centres of excellence complementing each other to enable transnational research in ATMPs or other related innovative therapeutic modalities relevant to the future treatment of any diseases. These scientific and technical centres are expected to provide access and advance translatable, quality-controled technologies, share data, and build capacity to assist industrial and academic developers of ATMPs. They are also expected to explore the establishment of connections with clinical networks.
2023/11/21
Committee: ENVI
Amendment 220 #
Proposal for a directive
Recital 48
(48) While pricing and reimbursement decisions are a Member State competence, cooperation in this area is essential in order to avoid that decisions in one Member State create shortages in other Member States. For this reason, the Pharmaceutical Strategy for Europe announced actions to support cooperation of Member States to improve affordability. While the price paid within a given Member State reflects the preference of a national health system, more coordination on pricing and procurement could contribute to more equal and timely access to medicines, including for Member States with lower purchasing power. The Commission may support joint price negotiation with pharmaceutical companies, as per the Beneluxa Initiative on Pharmaceutical Policy and the Valletta Declaration. The Commission has transformed the group of National Competent Authorities on Pricing and Reimbursement and public healthcare payers (NCAPR) from an ad- hoc forum to a continuous voluntary cooperation with the aim to exchange information and best practices on pricing, payment and procurement policies to improve the affordability and cost- effectiveness of medicines and health system’s sustainability. The Commission is committed to stepping up this cooperation and further supporting information exchange among national authorities, including on national pricing, reimbursment and public procurement of medicines, while fully respecting the competences of Member States in this area. The Commission may also invite NCAPR members to participate in deliberations of the Pharmaceutical Committee on topics that may have an impact on pricing or reimbursement policies, such as the market launch incentive.
2023/11/21
Committee: ENVI
Amendment 225 #
Proposal for a directive
Recital 49
(49) Joint procurement, whether within a country or across countries, can improve access, affordability, and security of supply of medicines, in particular for smaller countries. Member States interested in joint procurement of medicines can make use of Directive 2014/24/EU47 , which sets out purchasing procedures for public buyers, the Joint Procurement Agreement48 and the proposed revised Financial Regulation49 . Upon request from the Member States the Commission may support interested Member States by facilitating coordination to enable access to medicines for patients in the Union as well as information exchange, in particular for medicines for rare and chronic diseases, antibiotics and generic and biosimilar medicinal products. _________________ 47 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). 48 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU. 49 COM/2022/223 final.
2023/11/21
Committee: ENVI
Amendment 308 #
Proposal for a directive
Recital 67
(67) The provision of information to healthcare professionals and to patients on the appropriate use, storage and disposal of antimicrobials is a joint responsibility of marketing authorisation holders and of Member States who. Member States should ensure appropriate collection system for all medicinal products.
2023/11/21
Committee: ENVI
Amendment 316 #
Proposal for a directive
Recital 69 a (new)
(69 a) A progressive reform towards unitary packaging of medicines, in particular in hospital pharmacies, could result in a decrease of the materials used for the packaging of medicines, a reduction of the carbon footprint of the transport of medicines, a reduction in medicines waste, a better management of pollution from pharmaceutical waste, a prevention of tension and shortages of medicines, and an innovative tool to fight against antimicrobial resistance. The use of single dose unit containing all usefull information, in hospital environnement, could represent an improvement in favor of minimizing the risk of medication errors and therefore increased patient protection.
2023/11/21
Committee: ENVI
Amendment 324 #
Proposal for a directive
Recital 70
(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorisation should be refused. The ERA should be updated when new data or knowledge about relevant risks become available. The Commission may explore creating an ecolabeling of medicinal products which respect the ERA's guidelines during their entire life cycle.
2023/11/21
Committee: ENVI
Amendment 357 #
Proposal for a directive
Recital 123
(123) Certain Member States impose on wholesalers who supply medicinal products to pharmacists and on persons authorised to supply medicinal products to the public certain public service obligations. Those Member States should be able to continue to impose those obligations on wholesalers established within their territory. They should also be able to impose them on wholesalers in other Member States on condition that they do not impose any obligation more stringent than those that they impose on their own wholesalers and provided that such obligations may be regarded as warranted on grounds of public health protection and are proportionate in relation to the objective of such protection. Member States should also impose certain obligations of public services to wholesalers within the limits of their responsibilities to ensure that medicinal products made available on one market are not placed on another market to avoid creating a shortage for patients.
2023/11/21
Committee: ENVI
Amendment 359 #
Proposal for a directive
Recital 123 a (new)
(123 a)Pharmacists have always had a role in primary care, particularly to compound, dispense and sell medicinal products that patients need, to provide advice on their proper use and possible adverse effects and to support patients suffering of acute and chronic illnesses. As responsible for dispensing the medicinal products, pharmacists also monitor their proper use and compliance by the patient, provide advice in particular to avoid the risks of iatrogenics (all the undesirable effects caused by taking one or more medications) and carry out medication reviews. In an hospital environment, hospital pharmacists are even setting up pharmaceutical consultations and designing personalised pharmaceutical plans, in cooperation with health professionals, patients and carers. Hospital pharmacists and community pharmacists could play a major role in the progressive use of electronic package leaflets.
2023/11/21
Committee: ENVI
Amendment 363 #
Proposal for a directive
Recital 128
(128) Member States have varying levels of digital literacy and internet access. In addition, patient and healthcare professional needs may differ. It is therefore necessary that Member States have a discretion on the adoption of measures enabling the electronic provision of product information while ensuring that no patient is left behind, taking into account the needs of different age categories and the different levels of digital literacy in the population, and making sure that product information is easily accessible to all patients. Member States should progressively allow the possibility for electronic product information, while ensuring full compliance with the rules on protection of personal data, and adhere to harmonised standards developed at EU level. Based on the findings from hospital pilots, the obligation to provide a paper leaflet should be lifted for medicinal products not intended for self- administration by the patient.
2023/11/21
Committee: ENVI
Amendment 367 #
Proposal for a directive
Recital 130
(130) The use of multi-language packages can be a tool for access to medicinal products, in particular for small markets and in public health emergencies. Where multi-language packages are used, Member States may allow the use on the labelling and package leaflet of an official language of the Union that is commonly understood in the Member States where the multi- language package is marketed. While electronic medicinal product information will facilitate their redistribution between Member States, language requirements on labels will remain a challenge. Removing the obligation for an official language and introducing the obligation to use the international non-proprietary name for medicinal products not intended for self- administration by the patient, in addition to providing electronic product information, could improve the availability of medicinal products and enable easier redistribution between Member States.
2023/11/21
Committee: ENVI
Amendment 387 #
Proposal for a directive
Article 1 – paragraph 2
2. This Directive shall apply to medicinal products for human use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process.
2023/11/21
Committee: ENVI
Amendment 395 #
Proposal for a directive
Article 1 – paragraph 5 – point c a (new)
(c a) medicinal product prepared in advance, in duly justified cases, by the pharmaceutical department of a hospital (‘hospital formula’). Hospital formulae are supplied on medical prescription to one or several patients by the hospital’s pharmaceutical department.
2023/11/21
Committee: ENVI
Amendment 396 #
Proposal for a directive
Article 1 – paragraph 5 – point c b (new)
(c b) radiopharmaceuticals, prepared in hospitals, health centres or clinics, by pharmacists or other persons legally authorised in the Member State concerned to carry out such process, or in accordance with a pharmacopoeia and if the radiopharmaceutical is intended to be used in-house, for diagnostic as well as therapeutic applications.
2023/11/21
Committee: ENVI
Amendment 400 #
6. Medicinal products referred to in paragraph 5, point (a), may be prepared in duly justified cases in advance by a pharmacy serving a hospital, on the basis of the estimated medical prescriptions within that hospital for the following seven daysaccording to appropriate stability.
2023/11/21
Committee: ENVI
Amendment 408 #
Proposal for a directive
Article 1 – paragraph 10 – point a
(a) the sale, supply or use of medicinal products as contraceptives or abortifacients;deleted
2023/11/21
Committee: ENVI
Amendment 419 #
Proposal for a directive
Article 2 – paragraph 1
1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared on a non-routine basis in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner and a hospital pharmacist, in order to comply with an individual medical prescription for a custom-made product for an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’).
2023/11/21
Committee: ENVI
Amendment 430 #
Proposal for a directive
Article 2 – paragraph 2 a (new)
2 a. Member States may authorise the cross-border exchange of advanced therapy medicinal products prepared under hospital exemption in case of shortages of critical medicines or to ensure the treatment of patients affected by rare diseases, in the absence of other solutions.
2023/11/21
Committee: ENVI
Amendment 434 #
Proposal for a directive
Article 2 – paragraph 3
3. Member States shall ensure that advanced therapy medicinal products prepared under hospital exemption comply with the requirements equivalent to thegood pharmacy preparation practices that are adapted to hospital proceesses and based on good manufacturing practices and traceability for advanced therapy medicinal products referred to in Articles 5 and 15 of Regulation (EC) No 1394/200769 respectively, and with pharmacovigilance requirements equivalent to those provided for at Union level pursuant to [revised Regulation (EC) No 726/2004]. _________________ 69 Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 1).
2023/11/21
Committee: ENVI
Amendment 497 #
Proposal for a directive
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, antiparasitics and antifungals;
2023/11/21
Committee: ENVI
Amendment 550 #
Proposal for a directive
Article 6 – paragraph 2 – subparagraph 1 (new)
The marketing authorisation application shall include the results of controlled clinical trials randomised versus an established medicinal product of proven therapeutic value with clinical endpoints or versus placebo in case of lack of established medicinal product of proven therapeutic value. Any other design shall be duly justified and accepted only for exceptional situations.
2023/11/21
Committee: ENVI
Amendment 593 #
Proposal for a directive
Article 17 – paragraph 3
3. The marketing authorisation holder shall ensure, wherever possible, that the antimicrobial may be dispensed per unit in a number corresponding to the quantities corresponding to the duration of treatment. If an antimicrobial can not be dispensed per unit, the marketing authorisation holder shall ensure that the pack size of the antimicrobial corresponds to the usual posology and duration of treatment.
2023/11/21
Committee: ENVI
Amendment 596 #
Proposal for a directive
Article 17 – paragraph 3 – subparagraph 1 (new)
Pharmacists should play a role in antimicrobial stewardship, including advising on the prudent use of antibiotics and other antimicrobials, as well as their correct disposal.
2023/11/21
Committee: ENVI
Amendment 618 #
Proposal for a directive
Article 22 – paragraph 3
3. The applicant shall also include in the ERA risk mitigation measures to avoid or where it is not possible, limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment. When necessary, it shall also include information on available techniques and on the techniques that will be used to reduce the discharges and emissions of the medicinal product, in particular those occuring in manufacturing effluents before these effluents leave the manufacturing sites.
2023/11/21
Committee: ENVI
Amendment 632 #
Proposal for a directive
Article 22 – paragraph 4
4. The ERA for antimicrobials shall include an evaluation of the risk for antimicrobial resistance selection in the environment due to the entire manufacturing supply chain inside and outside the Union, use and disposal, including also by the healthcare professionnals and patients, of the antimicrobial taking into account, where relevant, the existing international standards that have established predicted no effect concentration (PNECs) specific for antibiotics.
2023/11/21
Committee: ENVI
Amendment 668 #
Proposal for a directive
Article 23 – paragraph 4 a (new)
4 a. The Agency shall ensure that the ERA is followed by clear recommandations to the marketing authorisation holders on how to respect the guidelines and to fulfill the requirements in the future.
2023/11/21
Committee: ENVI
Amendment 763 #
Proposal for a directive
Article 47 – paragraph 1 – point d
(d) the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant, with the exception of medicinal products authorised before 30 October 2005 to avoid restricting patients' access to existing treatments;
2023/11/21
Committee: ENVI
Amendment 771 #
Proposal for a directive
Article 51 – paragraph 1 – point e
(e) is an antimicrobial of systemic administration; or
2023/11/21
Committee: ENVI
Amendment 789 #
Proposal for a directive
Article 51 – paragraph 2
2. Member States may setdecide to make an antimicrobial other than those referred to in paragraph 1 point (e) subject to prescription, and 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 by authorising the use of pre-cut blister units or submitting certain antimicrobial medicinal products to special medical prescription or restricted prescription.
2023/11/21
Committee: ENVI
Amendment 1383 #
Proposal for a directive
Article 105 – paragraph 2
2. Marketing authorisation holders shall not refuse to consider reports of suspected adverse reactions received electronically or by any other appropriate means from patients, carers or healthcare professionals.
2023/11/21
Committee: ENVI
Amendment 1397 #
Proposal for a directive
Article 112 a (new)
Article112a Medicines under additional monitoring 1. The Agency shall, in collaboration with the Member States, set up, maintain and make public a list of medicinal products that are subject to additional monitoring. That list shall include the international non-proprietary names and active substances of: (a) medicinal products authorised in the Union that contain a new active substance which was not contained in any medicinal product authorised in the Union; (b) any biological medicinal product not covered by point (a) that was authorised after [date of implementation]; (c) medicinal products that are authorised pursuant to this Regulation, subject to the conditions referred to in point (f) of Article 12(4), point (a) of Article 20(1) or Articles 18, 19, 30 or 113; (d) medicinal products that are authorised pursuant to [revised Directive 2001/83/EC], subject to the conditions referred to in points (b) and (c) of the first paragraph of Article 44, Article 45, or point (a) of the first subparagraph of Article 87(1) thereof. At the request of the Commission, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products that are authorised pursuant to this Regulation subject to the conditions referred to in points (d), (e) or (g) of Article 12(4), point (b) of Article 20 (1) or Article 46(2), may also be included in the list referred to in paragraph 1 of this Article. At the request of a national competent authority, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products that are authorised pursuant to [revised Directive 2001/83/EC] subject to the conditions referred to in points (a), (d) or (f) of the first paragraph of Article 44, point (b) of the first subparagraph of Article 87 or Article 100(2) thereof, may also be included in the list referred to in paragraph 1 of this Article. 2. The list referred to in paragraph 1 shall include an electronic link to the product information and to the summary of the risk management plan. 3. In the cases referred to in points (a) and (b) of paragraph 1 of this Article, the Agency shall remove a medicinal product from the list five years after the Union reference date referred to in Article 108(5) of [revised Directive 2001/83/EC]. In the cases referred to in points (c) and (d) of paragraph 1 of this Article, the Agency shall remove a medicinal product from the list once the conditions have been fulfilled. 4. For medicinal products included in the list referred to in paragraph 1, the summary of product characteristics and the package leaflet shall include the statement ‘This medicinal product is subject to additional monitoring’. The statement shall be preceded by an inverted black triangle, and shall be followed by a standardised explanatory sentence. 5. The Agency shall, in cooperation with the competent authorities, develop and conduct awareness campaigns on the promotion of information about medicines under additional monitoring. Those campaigns shall be intended to raise awareness amongst healthcare professionals, patients, consumers and the general public of the pharmacovigilance system and the additional monitoring of medicines.
2023/11/21
Committee: ENVI
Amendment 1457 #
Proposal for a directive
Article 167 – paragraph 3 a (new)
3 a. To ensure continued supply to patients, the wholesale distributors shall not be authorised to supply medicinal products in another Member State should this, in any way, prevent them from covering the needs of the patients in the Member States concerned.
2023/11/21
Committee: ENVI
Amendment 1474 #
Proposal for a directive
Article 177 – paragraph 1 – subparagraph 1 (new)
Member States shall monitor the digital market services or products, websites, applications likely to broadcast advertising for prescription medicinal products for which advertising is prohibited according to article 177, paragraph 1.
2023/11/21
Committee: ENVI
Amendment 1545 #
Proposal for a directive
Article 195 – paragraph 2
2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend, revoke or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder, with the exception of medicinal products authorised before 30 october 2005 to avoid restricting patients' access to existing treatments.
2023/11/21
Committee: ENVI
Amendment 1555 #
Proposal for a directive
Article 196 – paragraph 1 – point f
(f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder, with the exception of medicinal products authorised before 30 october 2005 to avoid restricting patients’ access to existing treatments.
2023/11/21
Committee: ENVI
Amendment 1565 #
Proposal for a directive
Article 200 – paragraph 4 – subparagraph 1
The competent authority of the Member State may process personal health data from sources other than clinical studies, including real world data, to support their public health tasks and, in particular, the evaluation and monitoring to medicinal products, for the purpose of improving the robustness of the scientific assessment or verifying claims of the applicant or marketing authorisation holder.
2023/11/21
Committee: ENVI
Amendment 1588 #
Proposal for a directive
Article 207 – paragraph 1 – subparagraph 1 (new)
Member States shall promote awareness- raising and educational campaigns for the general public on the environmental risks of pharmaceuticals and on how to improve disposal practices.
2023/11/21
Committee: ENVI
Amendment 1590 #
Proposal for a directive
Article 208 – paragraph 1
1. In order to guarantee independence and transparency, the Member States shall ensure that members of staff of the competent authority responsible for granting authorisations, rapporteurs and experts concerned with the authorisation and surveillance of medicinal products have no financial or other interests in the pharmaceutical industry that could affect their impartiality and their independance. These persons shall make an annual declaration of their financial interests and update them annually and whenever necessary.
2023/11/21
Committee: ENVI
Amendment 1594 #
Proposal for a directive
Article 208 – paragraph 2 a (new)
2 a. 3. The multidisciplinarity of experts may constitute a guarantee of the independence and impartiality of their work.
2023/11/21
Committee: ENVI
Amendment 1598 #
Proposal for a directive
Article 216 – paragraph 1
By [OP please insert the date = 10 years following 18 months after the date of entering into force of this Directive], the Commission shall present a report to the European Parliament and the Council on the application of this Directive, including an assessment of the fulfilment of its objectives and the resources required to implement it, in particular regarding the prolongation of data protection period to take into account the evolution of scientific knowledge and innovation.
2023/11/21
Committee: ENVI