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 1.Essential use ‘rules’ 2.Key Features of European Community Transition Strategy 3.Essential elements of the successful implementation of EC’s transition strategy

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

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

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 Key features of EC transition strategy (1)

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. Key features of EC transition strategy (2)

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 Key features of EC transition strategy (3)

Results of EC’s transition strategy

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.

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 Essential elements of the successful implementation of EC’s transition strategy (2)

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.

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