Decision VIII/10: Actions by Parties not operating under Article 5 to promote industry’s participation on a smooth and efficient transition away from CFC-based MDIs

The Eighth Meeting of the Parties decided in Dec. VIII/10:

1. That Parties not operating under Article 5 will request companies applying for MDI essential-use exemptions to demonstrate ongoing research and development of alternatives to CFC MDIs with all due diligence and/or collaborate with other companies in such efforts and, with each future request, to report in confidence to the nominating Party whether and to what extent resources are deployed to this end and progress is being made on such research and development, and what licence applications if any have been submitted to health authorities for non-CFC alternatives;
2. That Parties not operating under Article 5 will request companies applying for MDI essential-use exemptions to demonstrate that they are undertaking individual or collaborative industry efforts, in consultation with the medical community, to educate health-care professionals and patients about other treatment options and the transition to non-CFC alternatives;
3. That Parties not operating under Article 5 will request companies applying for MDI essential-use exemptions to demonstrate that they, or companies distributing or selling their product, are differentiating the packaging of the company’s non-CFC MDIs from its CFC MDIs and are applying other appropriate marketing strategies, in consultation with the medical community, to encourage doctor and patient acceptance of the company’s non-CFC alternatives subject to health and product-safety considerations;
4. That Parties not operating under Article 5 will request companies manufacturing, distributing or selling CFC MDIs and non-CFC alternatives not to engage in false or misleading advertising targeted at non-CFC alternatives or CFC MDIs;
5. That Parties not operating under Article 5 will request companies applying for MDI essential-use exemptions to ensure that participation in regulatory proceedings is conducted with a view toward legitimate environmental, health and safety concerns;
6. That Parties not operating under Article 5 will request companies manufacturing CFC MDIs to take all economically feasible steps to minimize CFC emissions during the manufacture of MDIs;
7. That Parties not operating under Article 5 will request companies manufacturing, distributing or selling CFC MDIs to dispose of expired, defective, and returned MDIs containing CFCs in a manner that minimizes CFC emissions;
8. That Parties not operating under Article 5 will request companies manufacturing CFC MDIs to review annually CFC requirements and current MDI market forecasts, and notify national regulatory authorities if such forecasts will result in surplus CFCs obtained under essential-use exemptions;
9. That Parties not operating under Article 5 will request companies applying for MDI essential-use exemptions to provide information on the steps that are being taken to provide a continuity of supply of asthma and chronic obstructive pulmonary disease (COPD) treatments (including CFC MDIs) to importing countries;
10. That Parties not operating under Article 5 will request companies applying for MDI essential-use exemptions to provide information that demonstrates the steps being taken to assist the company’s MDI manufacturing facilities in Parties operating under Article 5 and countries with economies in transition in upgrading the technology and capital equipment needed for manufacturing non-CFC asthma and chronic obstructive pulmonary disease (COPD) treatments;
11. To request the Technology and Economic Assessment Panel to reflect paragraphs 1 through 10 above in a revised version of the Handbook on Essential-Use Nominations.