Decision XXI/4: Essential-use nominations for controlled substances for 2010
The Twenty-first Meeting of the Parties decides:
Noting with appreciation the work done by the Technology and Economic Assessment Panel and its Medical Technical Options Committee,
Mindful that, according to decision IV/25, the use of chlorofluorocarbons for metered-dose inhalers does not qualify as an essential use if technically and economically feasible alternatives or substitutes are available that are acceptable from the standpoint of environment and health,
Noting the Technology and Economic Assessment Panel’s conclusion that technically satisfactory alternatives to chlorofluorocarbon-based metered-dose inhalers are available for some of the therapeutic formulations for treating asthma and chronic obstructive pulmonary disease,
Taking into account the Technology and Economic Assessment Panel’s analysis and recommendations for essential use exemptions for controlled substances for the manufacture of metered-dose inhalers used for asthma and chronic obstructive pulmonary disease,
Noting that the Meeting of the Parties is for the first time considering essential use nominations submitted by Parties operating under paragraph 1 of Article 5,
Noting also that the Medical Technical Options Committee stated in its report that it had difficulty assessing some of the nominations submitted by Parties in accordance with the criteria of decision IV/25 and subsequent relevant decisions owing to a lack of certain information,
Noting further that notwithstanding insufficient information referred to in the preceding paragraph the Medical Technical Options Committee gave due consideration to the health and safety of patients in regard to the amounts recommended,
Welcoming the continued progress in several Parties operating under paragraph 1 of Article 5 in reducing their reliance on chlorofluorocarbon based metered-dose inhalers as alternatives are developed, receive regulatory approval and are marketed for sale,
- To authorize the levels of production and consumption for 2010 necessary to satisfy essential uses of chlorofluorocarbons for metered-dose inhalers for asthma and chronic obstructive pulmonary disease as specified in the annex to the present decision;
- To request nominating Parties to supply to the Medical Technical Options Committee information to enable assessment of essential use nominations in accordance with the criteria set out in decision IV/25 and subsequent relevant decisions as set out in the Handbook on Essential Use Nominations;
- To encourage Parties with essential use exemptions in 2010 to consider sourcing required pharmaceutical-grade chlorofluorocarbons initially from stockpiles where they are available and accessible;
- To encourage Parties with stockpiles of pharmaceutical-grade chlorofluorocarbons potentially available for export to Parties with essential use exemptions in 2010 to notify the Ozone Secretariat of such quantities and a contact point by 31 December 2009;
- To request the Secretariat to post on its website details of the potentially available stocks referred to in the preceding paragraph;
- To request the Executive Committee to consider at its next meeting reviewing both of the chlorofluorocarbon production phase-out agreements with China and India with a view to allowing production of pharmaceutical-grade chlorofluorocarbons to meet the authorized levels of production and consumption specified in the annex to the present decision and any authorized amounts in the future years;
- That the Parties listed in the annex to the present decision shall have full flexibility in sourcing the quantity of pharmaceutical-grade chlorofluorocarbons to the extent required for manufacturing of metered-dose inhalers, as authorized in paragraph 1 above, either from imports or from domestic producers or from existing stockpiles;
- To request the Technology and Economic Assessment Panel and its Medical Technical Options Committee to organize and undertake a mission of experts to examine the technical, economic and administrative issues affecting the transition from CFC metered dose inhalers to CFC-free alternatives in the Russian Federation, and to report the results of this mission to the meeting of the thirtieth Open-ended Working Group. The Technology and Economic Assessment Panel is requested to examine:
- The status of transition in the enterprises manufacturing CFC MDIs;
- Technical, financial, logistical, administrative or other barriers to transition;
- Possible options to overcome any barriers and facilitate the transition.
Annex
Essential-use authorizations for 2010* of chlorofluorocarbons for metered-dose inhalers
Party |
2010 |
Argentina |
178 |
Bangladesh |
156.7 |
China |
972.2 |
Egypt |
227.4 |
India |
343.6 |
Iran (Islamic Republic of) |
105 |
Pakistan |
34.9 |
Russian Federation |
212 |
Syrian Arab Republic |
44.68 |
* Note that the USA exemption for 2010 was authorized under Decision XX/2