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

Regulationson Ozone Layer protection

Health needs of citizens

CFCs &Environment

Public HealthRequirement

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 strategyAllocated quantities of CFCs for MDIs

0

1000

2000

3000

4000

5000

6000

7000

8000

9000

1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

year

ODP tonnes of CFCs

EC nomination Agreed amount by PartiesEC licensed Reported use

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