Commission Expert Group on Safe and Timely Access to Medicines for Patients ("STAMP")

The STAMP expert group is set up to provide advice and expertise to the Commission services in relation to the implementation of the EU Pharmaceutical legislation, as well as programmes and policies in this field. The STAMP will exchange views and information about the experience of Member States, examine national initiatives and identify ways to use more effectively the existing EU regulatory tools with the aim to further improve safe and timely access and availability of medicines for patients.

Overview of the activities of the STAMP expert Group in 2015 – 2016.

9th Meeting of the STAMP Expert Group on 8 June 2018 (Brussels)

• Agenda

• Presentations and background documents (following agenda items):

  • 3 - Repurposing of established medicines/active substances

    • Background document

    • Presentation of proposal for repurposing framework

    • Proposal for repurposing framework clarifications

  • 4 - Activities related to real world data

    • Background document

    • Real world data introductory presentation

    • Real world evidence and big data presentation

    • Selected research activities presentation

    • Patient registries initiative presentation

  • 5 - Study report on the impact of pharmaceutical incentives on innovation, availability and accessibility of medicinal products

    • Presentation

  • 6 - EU activities relevant to timely patient access to innovative medicines

    • Ad hoc Synergy Group presentation

8th Meeting of the STAMP Expert Group on 8 December 2017 (Brussels)

• Agenda
• Presentations and background documents (following agenda items):
  • 3 - EU activities relevant to timely patient access to innovative medicines
    • a. Expert Panel on Effective Ways of Investing in Health - Opinion on Innovative payment models for high-cost innovative medicines
    • b. EURIPID - EURopean Integrated Price Information Database project
    • c. OECD access to medicines project
  • 4 - Ad hoc Synergy Group
    • Presentations Ad hoc Synergy Group
    • European Medicines Agency EUnetHTA work plan
  • 5 - Repurposing of established medicines/active substances
    • Background document
    • Presentation
  • 6 - Heads of Medicines Agency Subgroup on Timely Access
    • Presentation
• Record

7th Meeting of the STAMP Expert Group on 27 June 2017 (Brussels)

• Agenda
• Presentations and background documents (following the Agenda points):
  • 3 - Repurposing of established medicines/active substances
    • Background paper
  • 4 - United States 21^st Century Cures Act
    • Presentation by U.S. Food and Drug Administration
  • 5 - Compassionate use
    • Eurordis position paper on compassionate use programmes presentation
    • Presentation on Heads of Medicines Agencies activities on compassionate use programmes
    • Background paper
  • 6 - PRIME (PRIority MEdicines) scheme – first year of experience
    • Presentation by the European Medicines Agency
• Record.

6th Meeting of the STAMP Expert Group on 13-14 March 2017 (Brussels)

• Agenda
• Presentations and background documents (following the Agenda points):
  • Repurposing of established medicines/active substances session
    • Background paper
  • 3 - Off-label use of medicinal products
    • Background document
    • Presentation by the Commission services
    • Presentation by the Ministry of Health France
  • 4 - Activities of STAMP 2015 – 2016 and beyond
    • Report
  • 5 - Synergies with Health Technology Assessment (HTA) Network
    • Presentation by the Commission services
  • 7 - Adaptive pathways
    • a. ADAPT SMART - IMI - Presentation by ADAPT SMART representatives
    • b. Adaptive Pathways Pilot and Workshop - Presentation by the European Medicines Agency (EMA)
  • 8 - Conditional Marketing Authorisation
    • a. Report on ten years of experience at the European Medicines Agency, presentation by the EMA
  • 10 - Update on other EU initiatives relevant for timely patient access to innovative medicines – Presentation by the Commission services
    • Presentation by the Commission services
• Record.

5th Meeting of the STAMP Expert Group on 28 June 2016 (Brussels)

• Agenda.
• Presentations and background documents (following the Agenda points):
  • 3 - Repurposing of established medicines/active substances
    • Reflection paper.
    • Overview of questionnaire - presentation by the UK Medicines and Healthcare products Regulatory Agency.
  • 4 - Off label use of medicinal products
    • Report of the Belgian Healthcare Knowledge Centre: "towards a better managed off label use of drugs" presentation by the Belgium Federal Agency for Medicines and Health Products.
  • 5 - Health Technology Assessment (HTA) Network Reflection Paper on Regulatory and HTA issues
    • Presentation by the Commission services.
  • 6 - Update on European Medicines Agency activities
    • Adaptive Pathways presentation by the European Medicines Agency.
    • PRIority MEdicines (PRIME) Scheme presentation by the European Medicines Agency.
  • 7 - Council Conclusions on Strengthening the balance in the pharmaceutical system in the EU and its Member States
    • Presentation by the Netherlands Ministry of Health.
• Record.

4th Meeting of the STAMP Expert Group on 10 March 2016 (Brussels)

• Agenda.
• Presentations and background documents (following the Agenda points):
  • 3 - Repurposing of established medicines/active substances
    • Background paper and presentation by the UK Medicines and Healthcare products Regulatory Agency.
  • 4 - Real world evidence data collection
    • Background paper and presentation by the European Medicines Agency (EMA).
    • Member State experience presentation by the Italian Medicines Agency (AIFA).
  • 5 - Update on European Medicines Agency activities
    • a. Adaptive Pathways
      • Replies from Member States to the questionnaire on adaptive pathway pilot project and presentation by EMA.
      • The Presidency meeting on "Adaptive pathways / early access schemes" - presentation by the Netherlands Ministry of Health, Welfare and Sport.
    • b. PRIority MEdicines (PRIME) Scheme, CHMP scientific guidance on Conditional marketing authorisations, CHMP scientific guidance on Accelerated assessment update by EMA.
  • 6 - Compassionate use programmes
    • Background paper on compassionate use and presentation of the experience of Article 83 compassionate use opinions at EMA.
    • Industry experience of compassionate use opinions – presentation by the European Federation of Pharmaceutical Industries and Associations (EFPIA).
  • 7 - Personalised medicines
    • Commission funded research initiatives presentation by DG Research and Innovation.
    • Background paper and presentation by DG Health and Food Safety.
• Record.

3d Meeting of the STAMP Expert Group on 20 October 2015 (Brussels)

• Agenda.
• Presentations and background documents (following the Agenda points):
  • 3 - Regulatory tools for early access:
    • a. Conditional marketing authorisations (CMA)
      • Revised CHMP guidelines and summary of comments received during public consultation.
    • b. Accelerated assessment and PRIME scheme
      • Revised CHMP guidelines and summary of comments received during public consultation.
      • PRIME New scheme to support development of innovative medicines for unmet needs. Background document for discussion.
        Public consultation started on 26 October with the deadline for comments 23 December 2015. Further information can be found on EMA website.
    • c. Adaptive Pathways
      • Comprehensive discussion on policy related issues on the basis of current experience from the EMA's pilot project.
      • "Prescrire" presentation and position paper on adaptive pathways.
    • d. Cross-cutting issues for all tools
      • A holistic approach and communication about all regulatory tools.
  • 4 - Update on other EU initiatives relevant for timely patient access to innovative medicines
    • IMI projects.
• Record.

2nd Meeting of the STAMP Expert Group on 6 May 2015 (Brussels)

• Agenda.
• Presentations (following the Agenda points):
  • 3 - Regulatory tools for early access:
    • 3 a - CHMP Reflections on the experience with Conditional Marketing Authorisation.
    • 3 a - Conditional marketing authorisations (CMA).
    • 3 b - Regulatory tools for early access: Accelerated assessment procedure.
    • 3 c - Update on adaptive pathways pilot project.
  • 4 - Update on other EU initiatives relevant for timely patient access to innovative medicines:
    • 4 a - EU cooperation on HTA – latest developments.
    • 4 a - European network for Health Technology Assessment.
    • 4 b - The Network of Competent Authorities on Pricing and Reimbursement (CAPR).
  • 5 - Exchange of experiences from national routes (other than clinical trials) for making available medicines to patients before authorisation: early access schemes, compassionate use etc.
    • The UK Early Access to Medicines Scheme - Presentation by the Medicines and Healthcare products Regulatory Agency (MHRA).
  • 6 - Introduction of Ministry of Health Labour and Welfare of Japan(MHLW)/Pharmaceuticals and Medical Devices Agency (PMDA) and recent updates in Japan
    • Presentation.
• Record.

1st Meeting of the STAMP Expert Group on 27 January 2015 (Brussels)

• Agenda.
• Presentations (following the Agenda points):
  • 2. Scope and operation of the STAMP.
  • 4. Exchange of experiences from national routes (other than clinical trials) for making available medicines to patients before authorisation:
    • Presentation by the Federal Agency for Medicines and Health products-Belgium.
    • Presentation by the Ministry of Health France.
    • Presentation by the Spanish Agency of Medicines and Medical Devices.
  • 5. EMA's pilot project on Adaptive Licensing.
  • 6. Regulatory tools for early access
    • a. Results from the Escher project 'Improving the EU system for the marketing authorisation of medicines'.
    • b. FDA Breakthrough therapy designation program.
    • c. Experience with conditional marketing authorisations (CMA).
    • d. Member States' experience on results from the use of early access tools (conditional marketing authorisation, authorisation under exceptional circumstances, accelerated assessment).
• Record.

Additional information:

• Pharmaceutical Committee – Expert group on delegated acts – Meetings
• Notice to Applicants