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The Seventeenth Meeting of the Parties decided:
1. to consider at the Eighteenth Meeting of the Parties a possible decision which would address the difficulties that some Parties operating under paragraph 1 of Article 5 may face in relation to metered-dose inhalers;
2. to request the Executive Committee of the Multilateral Fund to examine situations such as these and consider options that might assist this potential situation of non-compliance;
3. to request the Executive Committee to consider appropriate regional workshops to create awareness and educate stakeholders, including doctors and patients, on alternative metered-dose inhalers and on the elimination of chlorofluorocarbons in metered-dose inhaler uses and technical assistance to Article 5 Parties to phase out this use;
4. to request the Open-ended Working Group at its twenty-sixth meeting to consider the issue.
(UNEP/OzL.Pro.17/11, Decision XVII/14).
The Forty-eighth Meeting of the Executive Committee decided to request the Secretariat, in consultation with relevant implementing agencies, to prepare a paper for submission to the 49th Meeting outlining options for addressing the situation of countries referred to in decision XVII/14 of the Seventeenth Meeting of the Parties.
(UNEP/OzL.Pro/ExCom/48/45, Decision 48/36, para. 151 (c)).
The Forty-ninth Meeting of the Executive Committee decided:
(a) to request the Governments of Bangladesh and Egypt, assisted by the relevant implementing agencies, to include the following in the 2007 and 2008 annual implementation programmes of their national CFC phase-out plans:
(i) specific activities that were technically viable and economically feasible that could be implemented in the shortest possible period of time to achieve the greatest reduction in consumption of CFCs, such as the introduction of non-CFC drop-in refrigerants for servicing refrigeration equipment and/or cost-effective equipment retrofits;
(ii) assessment of the feasibility of importing recovered and recycled CFCs for servicing existing refrigeration equipment;
(iii) within the flexibility for reallocating approved funds provided in the agreements between the Governments concerned and the Executive Committee, consider establishing stockpiles of pharmaceutical-grade CFC for use in metered-dose-inhaler (MDI) production facilities, if technically feasible and economically viable;
(b) to request the Government of Bangladesh to submit to the 50th Meeting a proposal for the development of a transition strategy for the phase-out of CFC based MDIs. In developing its strategy, Bangladesh was invited to consider, among other things:
(i) accelerating the replacement of CFC-MDIs with hydrofluoroalkane-MDIs and/or other non-CFC alternatives (i.e. dry powder inhalers) by multi national companies that had already introduced those products in other Article 5 Parties;
(ii) inviting multinational companies manufacturing CFC-MDIs in Bangladesh to provide information demonstrating the steps being taken to assist the earliest possible changeover to the manufacture of non-CFC asthma and chronic obstructive pulmonary disease treatments in Bangladesh;
(iii) to facilitate the earliest possible completion by the leading nationally owned manufacturer of MDIs in Bangladesh of the manufacturing facilities for non-CFC MDIs currently under implementation;
(c) to request the Government of Egypt to finalize as soon as possible the preparation of a project for the phase-out of CFCs in the manufacture of MDIs that had been approved for UNIDO at the 45th Meeting of the Executive Committee, addressing any compliance-related issues; and
(d) to request the Fund Secretariat to update document UNEP/OzL.Pro/ExCom/49/39, taking into account any new information that might come to light and the implications of decisions to be taken at the Eighteenth Meeting of the Parties, and to present the revised paper to the Executive Committee at its 51st Meeting.
(UNEP/OzL.Pro/ExCom/49/43, Decision 49/33, para. 143).
(Supporting document: UNEP/OzL.Pro/ExCom/49/39).
The Eighteenth Meeting of the Parties decided:
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:
(a) 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;
(b) Indicative information on facilitative pricing, licensing and/or technology transfer arrangements under consideration;
(c) 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.
(UNEP/OzL.Pro.18/10, Decision XVIII/16).
The Fifty-first Meeting of the Executive Committee decided:
(a) that Article 5 Parties with plants manufacturing CFC-metered-dose inhalers (MDIs) should be advised of the timing on which to begin considering the need for essential use exemptions beyond the 2010 phase-out date and that the preparation of a nomination for essential use exemptions might begin in 2007 for submission to the Parties for their consideration in 2008;
(b) that the Executive Committee would need to consider further the availability of pharmaceutical grade CFC after 2010 in light of the Technology and Economic Assessment Panel reports to the 27th Meeting of the Open-ended Working Group and the Nineteenth Meeting of the Parties on campaign production of CFCs for MDIs in Article 5 and non Article 5 Parties;
(c) that the Executive Committee might consider on a case-by-case basis the submission of requests for project preparation for the conversion of CFC-MDI production facilities on the understanding that they must include a comprehensive justification from the country concerned for the need to receive assistance and, as a minimum, should provide the following detailed information:
(i) name of nationally owned CFC-MDI manufacturing facilities, the date when the CFC production lines were established and the production capacity of each production line;
(ii) type of CFC-MDI products manufactured, active ingredients used, annual production output (units/year);
(iii) growth patterns of CFC-MDI production over the past five years;
(iv) whether any of the CFC-MDI manufacturing plants were contemplating alternatives to CFC-MDIs and what those alternatives were;
(v) each production facility’s plans for phasing out CFC consumption; and
(vi) the number of non-CFC MDIs and dry-powder inhalers sold or distributed within the Party, by active ingredient, brand/manufacturer, and source;
(d) that the Executive Committee would consider on a case-by-case basis requests for transition strategies to non-CFC MDIs in Article 5 Parties that did not have MDI manufacturing facilities, in accordance with decision 45/54, when the need for a strategy had been fully demonstrated and documented through the submission of the following information for the previous three years:
(i) CFC and non-CFC MDIs and dry-powder inhalers: sold or distributed within the Party, by active ingredient, brand/manufacturer, and source;
(ii) non-CFC MDIs and dry-powder inhalers: date approved, authorized for marketing, and/or launched in the territory of the Party;
(iii) CFC and non-CFC MDIs and dry-powder inhalers: estimated cost by active ingredient and source.
(UNEP/OzL.Pro/ExCom/51/46, Decision 51/34 para. 170).
(Supporting document: UNEP/OzL.Pro/ExCom/51/39).
With respect to metered-dose inhaler (MDI) investment activities in the business plans, the Fifty-fouth Meeting of the Executive Committee decided:
(i) that all information required under decision 51/34 and the additional supporting data in the following paragraphs had to be submitted for consideration by the Executive Committee by the 55th Meeting to provide ample time for project initiation before the 2010 phase-out and to avoid, to the extent possible, the need for essential-use exemption requests;
(ii) that all requests for MDI investment projects should be submitted for consideration by the Executive Committee no later than the 56th Meeting, and that any request submitted to a later meeting would not be considered eligible for funding under the criteria in decision 51/34;
(iii) that in submitting information required under decision 51/34, and for the associated project preparation proposal, the country should provide documentation and certify that the facilities producing MDIs and seeking funding were producing CFC MDIs in the year in which the national phase-out plan (NPP) or sector plan had been prepared;
(iv) to clarify that only MDI production in place in the year in which remaining eligible CFC consumption for the NPP or sector plan had been established was eligible for funding through the Executive Committee so as to ensure that all MDI projects were treated in an equal manner;
(v) that information submitted under decision 51/34 in respect of project proposals should clearly describe: the volumes of CFCs associated with MDIs manufactured for domestic sale as compared with the amounts of CFCs used to manufacture MDIs for export; the volumes of CFCs associated with national MDI manufacturers; and the volumes of stockpiled CFCs currently and in the past in order to facilitate the smooth transition from CFC MDIs and to mitigate the need for a temporary essential-use exemption request;
(vi) that project proposals under decision 51/34 should provide detailed information demonstrating that the commitment for co-financing represented at least 30 per cent of total project costs (minus support costs); and
(e) to urge bilateral and implementing agencies to continue their efforts to implement approved projects to ensure the expected phase-out of 28,201 ODP tonnes in 2008.
(UNEP/OzL.Pro/ExCom/54/59, Decision 54/5(d) para. 49(d)).
(Supporting document: UNEP/OzL.Pro/ExCom/54/6).
The Twentieth Meeting of the Parties decided:
1. to request that the Technology and Economic Assessment Panel present a report to the Twenty-First Meeting of the Parties, preceded by a preliminary report to the Open-ended Working Group at its twenty-ninth meeting, concerning:
(a) the potential timing for final campaign production, taking into account, among other things, the information submitted in the nominations for 2010 and that some Parties operating under paragraph 1 of Article 5 may prepare essential use nominations for the first time for the Twenty-First Meeting of the Parties;
(b) options for long-term storage, distribution, and management of produced quantities of pharmaceutical-grade chlorofluorocarbons before they are needed by Parties, including existing methods used by Parties not operating under paragraph 1 of Article 5;
(c) options for minimizing the potential for too much or too little chlorofluorocarbons production as part of a final campaign;
(d) contractual arrangements that may be necessary, considering the models currently used by Parties not operating under paragraph 1 of Article 5 that submit essential use nominations consistent with decision IV/25;
(e) options for reducing production of non-pharmaceutical-grade chlorofluorocarbons, together with options for final disposal of such chlorofluorocarbons;
2. to request the Multilateral Fund Secretariat to report to the Open ended Working Group at its twenty-ninth meeting on the status of agreements to convert metered-dose inhaler manufacturing facilities located in Parties operating under paragraph 1 of Article 5 and the implementation of approved projects.
(UNEP/OzL.Pro.20/9, Decision XX/4).
The Fifty-seventh Meeting of the Executive Committee decided:
(a) to request the relevant implementing agencies to submit to the Secretariat a report on the status of implementation of the metered-dose inhaler (MDI) investment projects approved so far by the Executive Committee, no later than 10 April 2009;
(b) to request the Secretariat to circulate, intersessionally, the amended report on the status of agreements to convert MDI manufacturing facilities in Article 5 countries and implementation of approved projects to Members of the Executive Committee , for their comments, no later than 30 April 2009; and
(c) to submit the revised report, cleared by the Chair of the Executive Committee, to the 29th Meeting of the Open-ended Working Group of the Parties, no later than 15 May 2009.
(UNEP/OzL.Pro/ExCom/57/69, Decision 57/40, para.203).
(Supporting document: UNEP/OzL.Pro/ExCom/57/67).
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