Overview of the CFC MDI essential use process Prof Ashley Woodcock MD FRCP FMedSci University of Manchester

History of Essential Uses and the Montreal Protocol January 1996, all use of CFCs banned in developed countries. January 2010 ……also in Article 5 countries After 1996, CFC for MDIs only via the Essential use process, if approved by Parties. Decision IV/25 – Essential use of CFCs only for products –necessary for public health –without adequate alternatives (medically/technically & economically) –CFCs not available from existing stocks

Current CFC MDI essentiality criteria Only MDIs for asthma and COPD are exempted under the essential use process in non Article 5 Parties. –Not nasal sprays –Not topical sprays –Not where suitable alternatives already exist, e.g. for EC and US not for salbutamol in recent years

MTOC review Nominations for essential uses reviewed by MTOC/TEAP annually Future CFC requirements in countries that manufacture MDIs either for domestic use or for export Last years for EC (2009) Russian Federation (2009) and USA (2010)? Likely in 2009 (for 2010), from Article 5 Parties who are CFC MDI producers

MTOC 3 Co chairs: Pons Tope Woodcock Experts – A5, 9; EU 4; US 5; Aus/Japan 2. Annual review EUAs for 12 years Remarkable Consensus Assess CFC request from Parties against IV/25 Information from Parties and Experts Recommendation reviewed by TEAP

The essential use process 2008 Application from MDI manufacturer Sep.-Oct 2008 Government review and preparation of Nov-Dec 08. nomination Deadline for essential use nomination to 31 Jan the Ozone secretariat. MTOC and TEAP review/recommend Mar.-Apr 09. OEWG recommendation June-July 09 MOP decision Sep.-Nov.09 THEN….CFC can be produced 2010 ______________ Further: Accounting framework to be submitted by 31 Jan.

Accounting Framework Following approval of exemption by Parties, accounting framework tracks amounts of essential use CFCs produced, used, exported in product, destroyed and stored from year to year

The Handbook on Essential Use Nominations Describes the Essential Use Process Presents Essentiality criteria, as given in relevant MOP Decisions Provides a framework (Recommended Form) and additional information for submission of the Nomination

Some reasons for MTOC to consider “Not recommended” The disease and/or treatment not regarded essential Alternative (but not identical drug substance?) available as HFC MDI or DPI Therapeutic value questioned or not endorsed by medical experts and/or international therapy guidelines For combination product where individual components are available separately as HFC MDIs Diligent (and real) R&D-efforts to reformulate not shown Excess stock of CFC available Accounting framework not accurately completed

Matters for Article 5 Parties to consider in justifying essential use nominations (1) National strategies, with clear phase-out timetable Number of technically feasible alternatives available; information on availability and affordability critical Pricing policies unfavorable to CFC-free alternatives not a reason for essential use CFCs (eg tax on imports of HFC MDIs) Elaborate research and development efforts

Matters for Article 5 Parties to consider in justifying essential use nominations (2) Dual marketing of CFC MDIs and their CFC-free alternatives after adequate post-marketing period of not more than 12 months not a reason for essential use CFCs Exporting countries to demonstrate in nominations that importing countries consider CFC MDIs to be essential Sourcing CFCs from existing stockpiles in preference to new production -- transfer of global stockpiles need to be investigated Need to consider ‘end-game’ - destruction facilities A5 manufacturers unlikely to source sufficient, scarce, expensive, pharmaceutical grade CFCs?

Essential use process for final campaign Article 5 Parties’ essential use nominations submitted by 31st January 2009 for CFC production in 2010 Include accurate forward projections of annual quantities of CFCs required for MDI manufacture for 2010 and for each year thereafter until each Party’s phase-out date Modifications to essential use process and Handbook to accommodate Article 5 Parties in final stages of transition - for consideration by Parties at OEWG/MOP