Overview of the CFC MDI essential use process

1
Overview of the CFC MDI essential use process

• Prof Ashley Woodcock
• MD FRCP FMedSci
• University of Manchester

2
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/technical
  ly economically)
• CFCs not available from existing stocks

3
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

4
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

5
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

6
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
  2009.
• 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.

7

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

8
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

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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) RD-efforts to reformulate
  not shown
• Excess stock of CFC available
• Accounting framework not accurately completed

10
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

11
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?

12
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
  Partys 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