Decision XV/5: Promoting the closure of essential-use nominations for metered-dose inhalers
The Fifteenth Meeting of the Parties decided in Dec. XV/5:
Recognizing that Parties themselves have the ultimate competence, responsibility and accountability for the protection of the health and safety of their citizens, and for their actions to protect the ozone layer,
Acknowledging the urgent need to accelerate the phase-out of CFC-containing metered-dose inhalers in Parties not operating under paragraph 1 of Article 5 and the importance of safe, effective and affordable metered-dose inhalers for public health and medical care,
Bearing in mind the work of the Technology and Economic Assessment Panel drawing on the database established by decision XIV/5,
Aware in particular that CFC-free salbutamol metered-dose inhalers are available in most Parties not operating under paragraph 1 of Article 5,
Mindful of the 2003 assessment of the Panel, which concludes that the development of CFC-free metered-dose inhalers, their registration and launch into a market cannot alone lead to a full uptake in the market without appropriate domestic regulatory action,
- That the present decision shall not affect the operation of paragraph 10 of decision VIII/9 relating to the authorization of a quantity of CFCs in an emergency situation;
- To request that Parties not operating under paragraph 1 of Article 5, when submitting their nominations for essential-use exemptions for CFCs for metered-dose inhalers, specify, for each nominated use, the active ingredients, the intended market for sale or distribution and the quantity of CFCs required;
- To request the Technology and Economic Assessment Panel and its Technical Options Committee to make recommendations on nominations for essential-use exemptions for CFCs for metered-dose inhalers from Parties not operating under paragraph 1 of Article 5 with reference to the active ingredient of the metered-dose inhalers in which the CFCs will be used and the intended market for sale or distribution and any national transition strategy covering that intended market which has been submitted according to decision XII/2 or decision IX/19;
- That no quantity of CFCs for essential uses shall be authorized after the commencement of the Seventeenth Meeting of the Parties if the nominating Party not operating under paragraph 1 of Article 5 has not submitted to the Ozone Secretariat, in time for consideration by the Parties at the twenty-fifth meeting of the Open-ended Working Group, a plan of action regarding the phase-out of the domestic use of CFC-containing metered-dose inhalers where the sole active ingredient is salbutamol;
4 bis. That no quantity of chlorofluorocarbons for essential uses shall be authorized after the commencement of the Twenty-First Meeting of the Parties if the nominating party operating under paragraph 1 of Article 5 has not submitted to the Ozone Secretariat, in time for consideration by the parties at the twenty-ninth meeting of the Open-ended Working Group, a preliminary plan of action regarding the phase-out of the domestic use of chlorofluorocarbon-containing metered-dose inhalers where the sole active ingredient is salbutamol;
- That the plans of action referred to in paragraph 4 above must include:
- A specific date by which time the Party will cease making nominations for essential-use exemptions for CFCs for metered-dose inhalers where the sole active ingredient is salbutamol and where the metered-dose inhalers are expected to be sold or distributed on the market of any Party not operating under paragraph 1 of Article 5;
- The specific measures and actions sufficient to deliver the phase-out;
- Where appropriate, the actions or measures needed to ensure continuing access to or supply of CFC-containing metered-dose inhalers by Parties operating under paragraph 1 of Article 5;
- To request each Party not operating under paragraph 1 of Article 5 to submit to the Ozone Secretariat as soon as practicable for that Party specific dates by which time it will cease making nominations for essential-use exemptions for CFCs for metered-dose inhalers where the active ingredient is not solely salbutamol and where the metered-dose inhalers are expected to be sold or distributed on the market of any Party not operating under paragraph 1 of Article 5;
- To request the Technology and Economic Assessment Panel to report, in time for the twenty-fourth meeting of the Open-ended Working Group, on the potential impacts of the phase-out of CFCs in Parties not operating under paragraph 1 of Article 5 on the availability of affordable inhaled therapy in Parties operating under paragraph 1 of Article 5;
- To request the Ozone Secretariat to post on its web site all data submitted pursuant to decision XIV/5 that are designated non-confidential by the submitting Party;
- To request the Technology and Economic Assessment Panel to modify the Handbook on Essential Use Nominations to reflect the present decision.