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Association Mieux Prescrire

AMP

Association Mieux Prescrire (AMP), is a non-for-profit continuing education organisation under the French law of 1901, and manages all of Prescrire's publications and programmes.

Lobbying Activity

Response to Targeted revision of the EU rules for medical devices and in vitro diagnostics

6 Oct 2025

Veuillez trouver ci-joint la contribution de Prescrire à l'appel à contributions concernant la révision ciblée des règles de l'UE relatives aux dispositifs médicaux et aux diagnostics in vitro.
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Response to Critical Medicines Act

2 Jul 2025

The attached document outlines the position of Prescrire on the proposal for a Critical Medicines Act.
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Response to Critical Medicines Act

19 Feb 2025

Prescrires response to the Call for evidence on a Proposal for a Critical Medicines Act (19 February 2025) Shortages of medicines are a long-standing problem in Europe and beyond. In our view the Critical Medicines Act should focus more on a better visibility on vulnerabilities of the supply chain including dependencies on non-European countries manufacturing and supply chain capacities. Thus, support measures for the security of supply should be built on the analysis of identified vulnerabilities and dependencies. Transparency on the supply chain As a prerequisite, the Critical Medicines Act should outline a transparency framework on the supply chain and the manufacturing process (raw material, active pharmaceutical ingredients, intermediate and finished products, stock levels, number of suppliers, producers, market size) to enable public authorities and manufacturers to identify vulnerabilities and dependencies at an early stage. For reshoring support or strengthening domestic capacity production, the Act should always consider if this helps to increase the number of suppliers and/or to lower the risk of dependency. Support or compensation measures should be linked to conditionalities for the effective strengthening of the supply chains and provision of critical medicines. The delivery of public support should be evaluated. In case of non-respect of conditionalities, the beneficiaries shall be required to fully refund the support received. Safety stocks Just in-time production demonstrated its limits and is posing a significant risk to public health, health systems and patients. The Critical Medicines Act should impose safety stocks coupled with penalties for companies that fail to comply with these requirements. Safety stocks could be managed at a European level in full transparency and fairly shared between Member States. Public and/or not-for profit production facilities The Act should promote public production facilities of critical medicines in Europe, as proposed by the European Parliaments Panel for the Future of Science and Technology (STOA) in 2021. Some years ago, public production took place in European countries. As many shortages concern off-patent products not interesting industrial suppliers, there is an open field for public and/or not-for-profit production. The European Union and Member States should provide funding for initiatives from public institutions and civil society aiming to establish sustainable not-for profit local production solutions of critical medicines. The European Commission, with the support of Member States, should make a mapping of such alternative solutions. Environmentally friendly production The call for evidence paper points out that projects might benefit from faster administrative procedures and regulatory and scientific support. We call on not to lower the environmental requirements and criteria. Support might be provided to sustainable production and manufacturing methods which preserve the environment.
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Response to Health technology assessment – Procedural rules for the assessment and management of conflicts of interest in joint wo

26 Jun 2024

Attached Prescrires response to the public consultation on the procedural rules for assessing and managing conflicts of interest in the framework of joint Health Technology Assessment activities.
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Response to Revision of the variation framework for medicines

28 Feb 2024

See attached Prescrires position paper on the proposed revision of the European Commission delegated regulation related to the examination of marketing authorisation variations with a focus on: robust marketing authorisations transparency medical devices
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Response to Evaluation and revision of the general pharmaceutical legislation

8 Nov 2023

Réponse de Prescrire à la consultation sur la révision de la législation générale de l'Union relative aux produits pharmaceutiques Les propositions législatives de la Commission européenne sont présentées comme tentant de répondre à plusieurs défis en matière de politique pharmaceutique, notamment : le renforcement de la sécurité dapprovisionnement des médicaments et la lutte contre les pénuries ; la disponibilité des médicaments dans tous les États membres de lUnion européenne ; la lutte contre la résistance aux antimicrobiens ; le développement de médicaments pour des besoins médicaux non satisfaits ; le maintien dun environnement compétitif pour lindustrie pharmaceutique en Europe. Pour Prescrire, plusieurs propositions sont les bienvenues, mais certaines devront être complétées. Dautres sont contreproductives voire dangereuses et devraient être rejetées. Il est regrettable que la Commission nait pas fait de propositions pour renforcer les normes réglementaires pour que lautorisation de mise sur le marché (AMM) des nouveaux médicaments soit davantage basée sur des preuves solides et des essais comparatifs randomisés, malgré les appels insistants et argumentés en ce sens de divers acteurs ces dernières années. Il appartient aux colégislateurs (Parlement et Conseil européens) daméliorer les propositions en vue de faciliter un accès à des médicaments utiles et efficaces, et à un prix abordable. Il est essentiel que le cadre réglementaire renforce les exigences et principes de base pour les AMM classiques, tout en présentant des assouplissements pour les situations exceptionnelles permettant de déroger ponctuellement au principe de base.
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Meeting with Tilly Metz (Member of the European Parliament) and European Patients' Forum (EPF) and

10 Oct 2023 · Pharma Package

Response to Revision of the variation framework for medicines

21 Sept 2023

Please find attached Prescrire's feedback to the consultation on the revision of the variation framework for medicines.
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Meeting with Maria-Manuel Leitão-Marques (Member of the European Parliament, Shadow rapporteur) and MedTech Europe and

20 Apr 2023 · Product Liability Directive

Meeting with René Repasi (Member of the European Parliament, Shadow rapporteur)

4 Apr 2023 · Exchange of views on the Product Liability Directive/ Produkthaftungsrichtlinie (PLD) - Staff Level

Meeting with Pascal Arimont (Member of the European Parliament, Rapporteur) and Insurance Europe and Application Developers Alliance

14 Mar 2023 · Revision of the Product Liability Directive

Meeting with Marc Botenga (Member of the European Parliament) and GLOBAL HEALTH ADVOCATES and

25 Jan 2023 · Covi committee

Meeting with Sara Cerdas (Member of the European Parliament) and European Public Health Alliance and

20 Jan 2023 · COVI Committee hearings and report

Response to Evaluation and revision of the general pharmaceutical legislation

27 Apr 2021

Prescrire's feedback to the roadmap and Inception Impact Assessment on the revision of the general pharmaceutical legislation is outlined in the attached document.
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Response to European Health Emergency Response Authority

23 Feb 2021

We welcome the opportunity to contribute to this first round of consultation on the establishment of a European Health Emergency Preparedness and Response Authority. The Covid-19 pandemic has illustrated the need for enhanced EU action and coordination in response to cross-border health threats. It has exposed weaknesses in the current framework regarding health emergency preparedness and responses. Any new initiative should therefore be built on lessons learnt from and management of current and previous crises. We would like to underline the following aspects which deserve particular attention: A strong and independent Agency with public health missions The Covid-19 pandemic illustrated the importance of public leadership and capacities to handle health emergency crises. A strong capable European Agency to prevent and to react to health emergencies should be of benefit for all Member states and their citizens. It would be helpful to state which missions related to health emergency preparedness and response are already tackled by existing agencies in particular ECDC and EMA. In case a European HERA would be established, this Agency should be agile, able to act quickly to deliver appropriate action to prevent, remove or limit damages. It should have a long-term vision supported by a predictable and substantial budget addressing the challenges. It should be an independent public driven agency with clear public health missions, not a private-public partnership. The Agency should act in the general public interest and respond to public health needs and act in full transparency. Effective governance and transparency The Inception Impact Assessment doesn’t provide detailed information on the governance process and structure of the Authority. Yet an effective governance is a cornerstone of enhanced preparedness and speedy action. The current crisis illustrated how a lack of transparency (for instance on vaccine contracts) undermines public trust. Effective governance, communication and transparency are key elements which should be integrated as building blocks of the new Authority or Agency to protect the general public interest. Public funding: transparency and conditionalities to safeguard the public interest The pandemic illustrated the crucial role of public funding needed to share risks and scale up countermeasure responses. However, there is currently no clear oversight on all public interventions (at the EU and national levels) related to the various R&D supports for health technologies and on production capacities (strategic point for vaccines). Member states and the European Institutions should be accountable on the use of public money. There should be full transparency on public support (at both national and EU level) and on R&D funding. In addition, public funding should come with conditionalities to guarantee affordability, accessibility and availability of health technologies, access to clinical data and research results and transparency on R&D costs. To ensure equitable access to essential health technologies, the European Commission and Member states should leverage the use of existing tools like TRIPS flexibilities and share of know-how. Vulnerabilities in global supply chains As stated in the Inception Impact Assessment, the pandemic unveiled existing vulnerabilities in global supply chains. We encourage the European Commission and Member states to launch an assessment of the organisation and functioning of the supply chains including an analysis of existing manufacturing capacities (private and public) in order to identify vulnerabilities and the bottlenecks that need to be overcome. This is not only important for health emergency preparedness and response but also to prevent and mitigate drug shortages which dramatically increased over the least years. Shortages of medicines entail considerable risks for the health and safety of patients. To fight this global threat, full transparency on the supply chain
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Response to Revision of the EU legislation on medicines for children and rare diseases

5 Jan 2021

See the Prescrire's response to the public consultation attached.
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

7 Jul 2020

Please find attached Prescrire's response to the pharmaceutical strategy roadmap.
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Response to Revision of EMA fees

15 Oct 2019

Dear Madam/Sir, Please find attached Prescrire's response to the EU Commission Inception Impact Assessment on the revision of the EMA Fee system. Best regards, Prescrire
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