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Decision XVIII/16: Difficulties faced by some Article 5 Parties manufacturing metered-dose inhalers which use chlorofluorocarbons

Recognizing that Parties operating under paragraph 1 of Article 5 must reduce consumption of Annex A, group I, controlled substances (chlorofluorocarbons) by 85 per cent of their baseline by 2007 and complete the phase-out of those substances by 1 January 2010, including chlorofluorocarbons used in metered-dose inhalers for the treatment of asthma and chronic obstructive pulmonary disease,

Bearing in mind that, according to paragraph 7 of decision IV/25, essential-use controls will not be applicable to Parties operating under paragraph 1 of Article 5 until the phase-out dates applicable to those Parties,

Recognizing the potential uncertainty of supplies of pharmaceutical grade chlorofluorocarbons in the near future and the impact on people’s health and local businesses if national manufacturing plants which depend on imports of those substances cannot predict their availability,

Aware that the phase-out of chlorofluorocarbon‑based metered-dose inhalers in Parties not operating under paragraph 1 of Article 5 is likely to be complete by the phase-out deadline for Parties operating under Article 5 and that most of the metered-dose inhalers used by patients in many Parties operating under paragraph 1 of Article 5 are imported from Parties not operating under paragraph 1 of Article 5,

Acknowledging that some Parties operating under paragraph 1 of Article 5 have adopted metered-dose inhaler transition strategies, as encouraged by decision XII/2, but noting that most Parties operating under paragraph 1 of Article 5 have yet to put in place national or regional transition strategies and that Parties that produce metered-dose inhalers will be unable to finalize such strategies unless technology conversion is included in their national plans,

Understanding, therefore, that there is a need for further measures to facilitate the transition to non-chlorofluorocarbon treatments for asthma and obstructive pulmonary disease in Parties operating under paragraph 1 of Article 5,

Mindful that in some cases a regional approach to transition may be the most efficient,

Noting that Parties not operating under paragraph 1 of article 5 have made substantial progress in replacing chlorofluorocarbon‑based metered-dose inhalers with alternative products but that at the present time still require a limited amount of pharmaceutical grade chlorofluorocarbons to produce metered‑dose inhalers, as demonstrated by current essential-use exemption requests granted by the Parties,

Taking into account that decision XVII/14 calls for the Eighteenth Meeting of the Parties to consider taking a decision addressing the difficulties faced by Parties operating under paragraph 1 of Article 5 on metered-dose inhaler transition,

  1. To request the Executive Committee of the Multilateral Fund for the Implementation of the Montreal Protocol to consider as a matter of urgency the funding of projects in relation to those Parties operating under paragraph 1 of Article 5 that experience difficulties due to high consumption of chlorofluorocarbons for manufacturing metered-dose inhalers, in order to facilitate the transition from chlorofluorocarbon‑based metered-dose inhalers;
  2. To request the Executive Committee to consider within the context of the existing Multilateral Fund guidelines to review its decision 17/7 with regard to the existing cut-off date for consideration of metered-dose inhaler conversion projects consistent with the reality of the pace of technological advances in the metered-dose inhaler sector;
  3. To request the Implementation Committee under the Non-compliance Procedure of the Montreal Protocol to consider all possible options on how to address the potential non-compliance difficulties of some Parties operating under paragraph 1 of Article 5 resulting from their high proportion of chlorofluorocarbon consumption in the metered-dose inhaler sector;
  4. To further request the Implementation Committee to give special consideration to the situation of such Parties, particularly in the context of paragraph 4 of the non-compliance procedure of the Protocol, in the light of information received from the Parties concerned and having due regard to health considerations;
  5. To consider again the matter referred to in paragraphs 3 and 4 at the twentieth Meeting of the Parties in 2008;
  6. To request the Executive Committee to consider including on the agenda of the United Nations Environment Programme thematic regional workshops, information to clarify the steps required to advance the transition from chlorofluorocarbon metered-dose inhalers;
  7. To request each Party not operating under paragraph 1 of Article 5 receiving essential‑use exemptions for the production or import of chlorofluorocarbons to manufacture metered-dose inhalers for export to Parties operating under paragraph 1 of Article 5 to submit to each importing Party a detailed export manufacturing transition plan for each manufacturer where the exports of an active ingredient to that Party exceed 10 metric tonnes, specifying the actions that each manufacturer is taking and will take to transition its exports to chlorofluorocarbon-free metered-dose inhalers as expeditiously as possible in a manner that does not put patients at risk;
  8. That each manufacturer’s export manufacturing transition plans should include specific details for each of the manufacturer’s export markets and for each metered-dose inhaler by active ingredient concerning:
    1. Timing of submission to the health authority of marketing applications for chlorofluorocarbon-free alternatives, expected approval and launch of such alternatives and withdrawal of associated chlorofluorocarbon product or products;
    2. Indicative information on facilitative pricing, licensing and/or technology transfer arrangements under consideration;
    3. Contribution to, and participation in, programmes for educating health care professionals, government health authorities and patients about the transition to chlorofluorocarbon-free treatments for asthma and chronic obstructive pulmonary disease;
  9. Consistent with decision IV/25 and paragraph 4 of decision XII/2, to request each Party referred to in paragraph 7 of the present decision, when deciding whether to nominate essential-use volumes for and/or grant essential-use licenses to a manufacturer, to take into account the manufacturer’s efforts to implement its export manufacturing transition plan and its contribution to transition towards chlorofluorocarbon-free metered-dose inhalers;
  10. To request each Party referred to in paragraph 7 to submit each year to the Technology and Economic Assessment Panel, as part of the Party’s essential-use nomination, a report summarizing the export manufacturing transition plans submitted, taking care to protect any confidential information;
  11. To request the Technology and Economic Assessment Panel to consider such reports in its assessment of each Party’s essential-use nominations;
  12. To request the Technology and Economic Assessment Panel to assess and report on progress at the twenty-seventh meeting Open-ended Working Group and to report to the Nineteenth Meeting of the Parties on the need for, feasibility of, optimal timing of, and recommended quantities for a limited campaign production of chlorofluorocarbons exclusively for metered-dose inhalers in both Parties operating under paragraph 1 of Article 5 and Parties not operating under paragraph 1 of Article 5.