Decision XVIII/7: Essential-use exemptions for Parties not operating under paragraph 1 of Article 5 for controlled substances for 2007 and 2008
Noting with appreciation the work done by the Technology and Economic Assessment Panel and its Medical Technical Options Committee,
Taking into account the Technology and Economic Assessment Panel’s expectation that production of metered-dose inhalers containing chlorofluorocarbons should cease by the end of 2009 and, based on its analysis and monitoring of the transition to chlorofluorocarbon-free treatments of asthma and chronic obstructive pulmonary disease over the last decade, the Panel’s assessment that global phase-out of chlorofluorocarbon-based metered-dose inhalers will be achievable by 2010,
Considering the Technology and Economic Assessment Panel's conclusion that technically satisfactory alternatives to chlorofluorocarbon-based metered-dose inhalers are available for short‑acting beta-agonists and other therapeutic categories for asthma and chronic obstructive pulmonary disease,
Mindful that, according to decision IV/25, chlorofluorocarbon use for metered-dose inhalers shall not qualify as essential if technically and economically feasible alternatives or substitutes are available that are acceptable from the standpoint of environment and health,
Welcoming the fact that the United States has demonstrated its commitment in its domestic process to allocate only the minimal amount necessary to protect public health, having issued a proposed regulation that would allocate 125.3 tons for 2007,
Mindful that paragraph 8 of decision XII/2 allows the transfer of chlorofluorocarbons between metered-dose inhaler companies,
- To authorize the levels of production and consumption for 2007 and 2008 necessary to satisfy essential uses of chlorofluorocarbons for the production of metered-dose inhalers for asthma and chronic obstructive pulmonary disease specified in annex III to the present report;
- That Parties not operating under paragraph 1 of Article 5 of the Montreal Protocol, when licensing, authorizing, or allocating essential-use exemptions for chlorofluorocarbons for a manufacturer of metered-dose inhalers for asthma and chronic obstructive pulmonary diseases, shall take into account pre- and post-1996 stocks of controlled substances as described in paragraph 1 (b) of decision IV/25, such that no more than a one-year operational supply is maintained by the manufacturer;
- That Parties not operating under Article 5 will request companies applying for metered‑dose inhaler essential use exemptions to demonstrate that they are making efforts, with all due diligence, on research and development with respect to chlorofluorocarbon-free alternatives to their products and are diligently seeking approval of their chlorofluorocarbon-free alternatives in their domestic and export markets aimed at transitioning those markets away from the chlorofluorocarbon products;