35 Amendments of Erik POULSEN related to 2023/0132(COD)
Amendment 218 #
Proposal for a directive
Recital 47
Recital 47
(47) To ensure dialogue among all actors in the medicines lifecycle, discussions on policy issues related to the application of the rules related to prolongation of regulatory data protection for market launch shall take place in the Pharmaceutical Committee. The Commission may invite bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 or national bodies responsible for pricing and reimbursement, as required, to participate in the deliberations of the Pharmaceutical Committee.
Amendment 220 #
Proposal for a directive
Recital 48
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.
Amendment 222 #
Proposal for a directive
Recital 48
Recital 48
(48) While pricing and reimbursement decisions are a Member State competence, tcooperation and dialogue with all stakeholders in this areas could help to avoid that decisions in one Member State contribute to unavailability in other Member States. The Pharmaceutical Strategy for Europe announced actions to support cooperation of Member States to improve affordability. 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 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.
Amendment 225 #
Proposal for a directive
Recital 49
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.
Amendment 237 #
Proposal for a directive
Recital 50
Recital 50
(50) The establishment of a criteria- based definition of ‘unmet medical need’ is required to incentivise the development of medicinal products in therapeutic areas that are currently underserved. To ensure that the concept of unmet medical need reflects scientific and technological developments and current knowledge in underserved diseases, the Commission should specify and update using implementing acts, the criteria of satisfactory method of diagnosis, prevention or treatment, ‘remaining high morbidity or mortality’, 'negative impact on quality of life', ‘'relevant patient population’ following scientific assessment by the Agency and with input from patient organisations and other relevant stakeholders. The Agency will seek input from a broad range of authorities or bodies active along the lifecycle of medicinal products in the framework of the consultation process established under the [revised Regulation (EC) No 726/2004] and also take into account scientific initiatives at EU level or between Member States related to analysing unmet medical needs, burden of disease and priority setting for research and development. The criteria for ‘unmet medical need’ can be subsequently used by Member States to identify specific therapeutic areas of interest.
Amendment 252 #
Proposal for a directive
Recital 54
Recital 54
(54) Micro, small and medium-sized enterprises (‘SMEs’), not-for-profit entities or entities with limited experience in the Union system should benefit from additional time to marketsubmit an application for pricing and reimbursement for a medicinal product in the Member States where a Member State has requested it and the marketing authorisation is valid for the purposes of receiving additional regulatory data protection.
Amendment 256 #
Proposal for a directive
Recital 55
Recital 55
(55) When applying the provisions on market launch incentives, mMarketing authorisation holders and Member States should do their utmost to achieve a mutually agreed supply of medicinal products in accordance with the needs of the Member State concerned, without unduly delaying or hindering the other party from enjoying its rights under this Directive.
Amendment 308 #
Proposal for a directive
Recital 67
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.
Amendment 316 #
Proposal for a directive
Recital 69 a (new)
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.
Amendment 321 #
Proposal for a directive
Recital 70
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 refusedcould be refused. Refusal of a marketing authorization should not be considered if the medicinal product can be authorized under the conditional marketing authorization process or the Temporary Emergency Marketing Authorization in order to not prohibit or delay patient access to medicines. The ERA should be updated when new data or knowledge about relevant risks become available.
Amendment 357 #
Proposal for a directive
Recital 123
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.
Amendment 359 #
Proposal for a directive
Recital 123 a (new)
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.
Amendment 363 #
Proposal for a directive
Recital 128
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.
Amendment 367 #
Proposal for a directive
Recital 130
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.
Amendment 395 #
Proposal for a directive
Article 1 – paragraph 5 – point c a (new)
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.
Amendment 396 #
Proposal for a directive
Article 1 – paragraph 5 – point c b (new)
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.
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.
Amendment 419 #
Proposal for a directive
Article 2 – paragraph 1
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’).
Amendment 430 #
Proposal for a directive
Article 2 – paragraph 2 a (new)
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.
Amendment 434 #
Proposal for a directive
Article 2 – paragraph 3
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).
Amendment 497 #
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, antiparasitics and antifungals;
Amendment 593 #
Proposal for a directive
Article 17 – paragraph 3
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.
Amendment 596 #
Proposal for a directive
Article 17 – paragraph 3 – subparagraph 1 (new)
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.
Amendment 618 #
Proposal for a directive
Article 22 – paragraph 3
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.
Amendment 632 #
Proposal for a directive
Article 22 – paragraph 4
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.
Amendment 668 #
Proposal for a directive
Article 23 – paragraph 4 a (new)
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.
Amendment 763 #
Proposal for a directive
Article 47 – paragraph 1 – point d
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;
Amendment 764 #
Proposal for a directive
Article 47 – paragraph 1 – point d
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 in cases where the medicinal product does not qualify for conditional marketing authorization or the Temporary Emergency Marketing Authorization;
Amendment 1383 #
Proposal for a directive
Article 105 – paragraph 2
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.
Amendment 1474 #
Proposal for a directive
Article 177 – paragraph 1 – subparagraph 1 (new)
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.
Amendment 1545 #
Proposal for a directive
Article 195 – paragraph 2
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.
Amendment 1555 #
Proposal for a directive
Article 196 – paragraph 1 – point f
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.
Amendment 1565 #
Proposal for a directive
Article 200 – paragraph 4 – subparagraph 1
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.
Amendment 1588 #
Proposal for a directive
Article 207 – paragraph 1 – subparagraph 1 (new)
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.
Amendment 1598 #
Proposal for a directive
Article 216 – paragraph 1
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.