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6 July 2008

Experiences and lessons learned from essential use nominations in Article 2 Parties: European Community perspective Dr. Philippe Tulkens European Commission, DG Environment. 6 July 2008. Outline. Essential use ‘rules’ Key Features of European Community Transition Strategy

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6 July 2008

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  1. Experiences and lessons learned from essential use nominations in Article 2 Parties: European Community perspectiveDr. Philippe TulkensEuropean Commission, DG Environment 6 July 2008

  2. Outline • Essential use ‘rules’ • Key Features of European Community Transition Strategy • Essential elements of the successful implementation of EC’s transition strategy

  3. Essential use are temporary measures • Montreal Protocol Decision IV/25 is applicable to non-A5 Parties • Essential Use of CFCs when: • No technically or economically feasible alternative • Necessary for public health • No CFC’s available from recycling or recovery

  4. CFCs & Environment Public Health Requirement Phase Out of CFCs in MDIs Objectives of EC Transition Strategy:balancing environment and health concerns MDI manufacturing industry Regulations on Ozone Layer protection Health needs of citizens

  5. Key features of EC transition strategy(1) • Involvement of all stakeholders to promote the transition towards CFC-free MDIs while safeguarding patients health • Establishment of nomination and licensing processes defining clear criteria for demonstrating the essentiality of products with appropriate technical review of nominations • Health care professionals and patients training are part of the phase-out strategy

  6. Key features of EC transition strategy(2) • Phase-out by active ingredient and therapeutic category • Cooperation between EU Member States (MS) and the European Commission in stimulating non-essentiality declarations • Contacts with health authorities at MS level, and agreement between the Commission and MS on licensed volumes.

  7. Key features of EC transition strategy(3) • National circumstances are accounted for • Nominations forwarded one year of production year ahead to account for latest developments • Annual reporting to the Ozone Secretariat of products declared non essential in the EC • Annual update of database on MDIs provided to the Ozone Secretariat

  8. Results of EC’s transition strategy

  9. Essential elements of the successful implementation of EC’s transition strategy (1) • Patients health has been safeguarded • All stakeholders agreed on the steps to be undertaken in the phase-out process. • In the final phase, agreeing to a phase-out date has been essential • Leading industry’s efforts to develop CFC-free MDI have been instrumental. Other industry had to follow the leaders. IPAC contributed to progress. • Health authorities involvement has been key to the success of the process.

  10. Essential elements of the successful implementation of EC’s transition strategy (2) • The cost of the transition has been affordable • Discontinued reimbursement of CFC-MDIs in some MS has proved very effective • Rules have been strictly enforced (licensing system and checks) • Stock piling has been avoided by going further than requirements of decisions of the Parties. • Educating health care professionals and patients achieved much in facilitating the acceptance of the transition • Comparison of progress between EC Member States and with other Parties helped in keeping the momentum

  11. Difficulties in implementing EC’s transition strategy • Reducing exports to A5 Parties • Dealing with products which are not reformulated for business reasons and for which criteria defined in EC’s strategy would not be met (interpretation issues on availability of alternatives) • Case by case decisions on combination products • Transfers of stocks between companies in the final phase • Keeping health authorities concerned • Addressing cost concerns in social security reimbursement schemes and addressing industry’s concern to recover R&D expenses.

  12. Relevant elements for the transition in Art. 5 Parties • Technology for CFC-MDI is mature and available, also in some A5s • Experience in A2 Parties has demonstrated that CFC-free MDI are equivalent of CFC-MDI from a health point of view. • Other types of products should be explored such as Dry Powder Inhalers (DPIs) • Agreement with industry on the phase out should include a specific time table with a phase-out date from the production and placing on the market of CFC-MDIs • Stock piling should be prevented and use of stocks should be a pre-condition for granting production/import authorisations. • Companies involved should be monitored through reporting and licensing systems with appropriate checks • Health authorities should be involved throughout the phase-out process • Doctors and patients should be informed on the transition

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