1. Experiences and Lessons Learned from Essential Use Nominations in Developed Countries: Industry Perspectives Peter Blenkinsop on behalf of the International Pharmaceutical Aerosol Consortium

2. International Pharmaceutical Aerosol Consortium www.ipacmdi.com Who is IPAC? IPAC is an association of pharmaceutical companies that research, develop and manufacture medicines for the treatment of respiratory illnesses such as asthma and COPD IPAC has engaged in the essential use process under the Montreal Protocol since its inception IPAC is firmly committed to a timely and effective MDI transition that balances patient health and environmental concerns IPAC’s current members: AstraZeneca, Abbott, Boehringer Ingelheim, Chiesi Farmaceutici, GlaxoSmithKline, Inyx, and Sepracor

3. International Pharmaceutical Aerosol Consortium www.ipacmdi.com Overview Share IPAC’s perspectives on lessons learned from essential use process in non-Article 5 Parties Confirm IPAC’s commitments regarding MDI transition post-2009

4. International Pharmaceutical Aerosol Consortium www.ipacmdi.com Potential Hurdles and Challenges Continued availability of CFC MDIs even when CFC-free alternatives exist on market Companies “dual marketing” both CFC and CFC- free products for lengthy timeframes Transition to achieve environmental objectives may not be a priority for health authorities Patients and physicians may resist change Cost implications Lack of education Existing policies/regulations that discourage transition

5. International Pharmaceutical Aerosol Consortium www.ipacmdi.com Elements of an Effective Transition Strategy (I) Promote transition as a priority to health authorities Timely review and approval to market CFC-free alternatives by health authorities is central Undertake necessary domestic action regarding pricing/reimbursement for CFC-free alternatives Engage health authorities in development of transition strategy Send clear signals to patients, physicians, and marketplace on transition timing Establish concrete phase-out deadlines Lengthy phase-out timeframes can be counterproductive Ensure adequate legal structure and authority to enforce phase-out timeframes and ensure CFC MDIs do not remain on market US provides positive model

6. International Pharmaceutical Aerosol Consortium www.ipacmdi.com Elements of an Effective Transition Strategy (II) Comprehensive plan to educate patients, physicians and other stakeholders on the need for and benefits of MDI transition Coordination among all regulatory agencies, industry, and NGOs is key Example: US Stakeholders Group on MDI Transition (www.inhalertransition.org)www.inhalertransition.org Remove barriers to marketing of CFC-free alternatives (taxes, etc.)

7. International Pharmaceutical Aerosol Consortium www.ipacmdi.com Essential Use Process: Background Decision IV/25 provides the framework for essential use in Article 5 Parties, but it is just the beginning… In the more than a decade since Decision IV/25 was adopted, Parties have refined and elaborated on the process in positive ways, for example: Encouraging Parties to expedite review of marketing/licensing/pricing applications for CFC-free products (Decision VIII/11) Requiring MTOC/TEAP to make recommendations on essential use nominations by active ingredient (Decision XV/5) Requiring submission of “plans of action” on phase out of CFC MDIs (Decision XV/5) Promoting reasonable stockpile levels - i.e., “one year operational supply” (Decisions XVII/5, XVI/12, and XVIII/7) Discouraging introduction of new CFC MDIs (Decision XII/2)

8. International Pharmaceutical Aerosol Consortium www.ipacmdi.com Essential Use Process: Recommendations Apply existing Decisions of the Parties to Article 5 markets, as needed (TEAP/MTOC recommendation) Parties must adequately justify continuing need for essential use CFCs beyond 2009 Consider updates to the Essential Use Handbook (TEAP/MTOC recommendation) TEAP/MTOC are a valuable technical and expert resource and it is important to ensure that they have adequate data to assess requests from Article 5 Parties for essential use CFCs for MDIs

9. International Pharmaceutical Aerosol Consortium www.ipacmdi.com IPAC Commitments (I) To not seek new production of essential use CFCs after 2008 for use in MDIs intended for either Article 5 or non-Article 5 Parties, absent compelling evidence that existing stockpiles are unavailable – an exceptional and unlikely circumstance.

10. International Pharmaceutical Aerosol Consortium www.ipacmdi.com IPAC Commitments (II) To not engage in “dual-marketing” of a CFC MDI in a Party where the company has launched the corresponding CFC- free alternative (after an adequate parallel marketing period – no more than 12 months – needed for patient safety), unless infeasible because of government action or pre-existing contractual obligations.

11. International Pharmaceutical Aerosol Consortium www.ipacmdi.com IPAC Commitments (III) To not manufacture CFC MDIs for sale in Article 5 markets after 2009, except in the very narrow circumstance where: (i) the replacement for a CFC MDI has reached an advanced stage of research and development (i.e., phase III clinical trials); (ii) the product is essential for patients; and (iii) a relatively limited additional period of time is needed to accommodate a seamless transition to the direct replacement. It is anticipated that CFCs for these MDIs would be sourced from existing stockpiles, rather than from new production. Rationalizing small quantities of already produced CFCs to meet patient needs in Article 5 (as well as non-Article 5) Parties, rather than simply destroying all remaining stockpiles, is a pragmatic approach.

12. International Pharmaceutical Aerosol Consortium www.ipacmdi.com Questions?

13. International Pharmaceutical Aerosol Consortium www.ipacmdi.com Contact Information IPAC is pleased to serve as a resource to the Parties on these critical environmental and health issues. Please do not hesitate to contact us. Peter Blenkinsop IPAC Secretariat 1500 K Street, NW Washington, DC 20005 + 1 202 230 5142 peter.blenkinsop@dbr.com