Awareness Seminar on CFC-Free Metered Dose Inhalers

1. Awareness Seminar on CFC-Free Metered Dose Inhalers Malaysia Transition Strategy9 May 2004 Comments of The International Pharmaceutical Aerosol Consortium

2. Background Who is IPAC? The International Pharmaceutical Aerosol Consortium is a group of companies that manufacture medications for respiratory diseases, including metered dose inhalers (MDIs), dry powder inhalers (DPIs), nebulisers, and oral tablets. IPAC’s members include: AstraZeneca, Aventis, Boehringer Ingelheim, Chiesi, and GlaxoSmithKline.

3. CFC MDI Transition: Background • IPAC fully supports the objectives of the Montreal Protocol. IPAC member companies have: • Invested significant resources to research and develop CFC-free alternatives and bring them to market • Worked closely with Montreal Protocol Parties, national regulatory authorities, and patient/physician stakeholders for more than a decade to promote a smooth,timely transition consistent with patient health and safety • Proactively and constructively engaged in policy discussions at international and national levels to assist in the development of national transition strategies

4. Status of CFC MDI Transition • Transition is underway in several non-Article 5(1) Parties (i.e., developed countries) • Several countries have phased-out single-moiety salbutamol MDIs • Japan • Australia • Canada • 12 European countries + Norway • Transition of single-moiety salbutamol MDIs is critical to the overall transition since these products represent at least half of the worldwide market • Completion of single-moiety salbutamol transition will significantly reduce CFC usage

5. Status of CFC MDI Transition • IPAC supports the following timelines for the cessation of the Essential Use Process for non-Article 5(1) (developed) countries: • End 2005 for single-moiety salbutamol CFC MDIs • End 2007 for all other CFC MDIs • These milestones should be achievable based on current and projected availability of CFC-free products Importantly, IPAC also advocates that these deadlines be subject to a “safety hatch” exception to protect patient health. Therefore, IPAC suggests that CFCs continue to be available for products that remain indispensable for patient care.

6. Status of CFC MDI Transition (cont’d) • Availability of CFC-free alternatives is a key factor in determining appropriate time for transition to occur for a particular product • The Technological and Economic Assessment Panel (TEAP) to the Montreal Protocol recommended that the most effective approach to achieving transition was government/industry cooperation to define a firm date by which CFC MDI sales should cease once sufficient alternatives are available. IPAC concurs with this assessment. • IPAC believes that since the majority of Article 5(1) Parties obtain their MDIs from non-Article 5(1) Parties, completing the transition in non-Article 5(1) Parties could result in economies of scale in CFC-free MDI production that will benefit Article 5(1) Parties

7. Status of CFC MDI Transition (cont’d) IPAC: • supports, in general, the transition strategy principles set forth in Malaysia’s draft Strategy Document that are, importantly, based on protecting patient health • suggests that any target deadlines for the conclusion of the transition not be implemented arbitrarily, but consistent with the availability of sufficient CFC-free alternatives to ensure patients needs are met