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| |  UNEP Takes Critical Steps To Phase-Out CFCs In Asthma Inhalers SAN JOSE, Costa Rica, Dec. 2, 1996 -- The following was issued today by 3M Pharmaceuticals: Recently, after a year of careful analysis and discussions, the United Nations Environment Programme (UNEP) Parties to the Montreal Protocol took action to begin the phase-out of CFC-containing metered dose inhalers (MDIs) used by patients with asthma and other respiratory conditions. While CFCs are safe when used as propellants in drugs, they are harmful to the earth's ozone layer. The UNEP Montreal Protocol charges signatory countries with implementing the phase-out of CFCs and other ozone depleting substances. Among other things, depletion of the ozone layer causes skin cancers, cataracts and affects the human immune system. This phase-out of CFC-containing MDIs has become possible because CFC-free alternatives are becoming available around the world. UNEP's action ensures a smooth and efficient transition while protecting the health and safety of patients. CFC-containing MDIs are the last remaining commercial use of CFCs in developed countries and they have enjoyed a temporary exemption from the ban on CFCs for over nine years. MDI manufacturers, who are charged with reformulating their CFC-containing MDIs to CFC-free alternatives, received a strong message from the UNEP action that the exemption is ending and that phase-out is beginning. UNEP's action signals the end of CFC use in commercial products around the world. Significantly, in September 1997, UNEP will return to Montreal for its annual meeting and to celebrate the tenth anniversary of the signing of the Montreal Protocol which called for the worldwide phase-out of CFCs. NOTE: The complete text of the UNEP action on MDIs accepted by vote of the parties on Nov. 27, 1996 is attached in its entirety. Complete Text Of The UNEP Action On MDIs Annex I Draft Decisions The Eighth Meeting of the Parties decides: Decisions VIII/8. Actions by non-Article 5 (1) Parties to promote industry's participation in a smooth and efficient transition away from CFC-based MDIs 1. That non-Article 5 (1) Parties will request companies applying for MDI essential use exemptions to demonstrate ongoing research and development of alternatives to CFC MDIs with all due diligence and/or collaborate with other companies in such efforts and, with each future request, to report in confidence to the nominating Party whether and to what extent resources are deployed to this end and progress is being made on such research and development, and what license applications if any have been submitted to health authorities for non-CFC alternatives. 2. That non-Article 5 (1) Parties will request companies applying for MDI essential use exemptions to demonstrate they are undertaking individual or collaborative industry efforts, in consultation with the medical community, to educate health care professionals and patients about their treatment options and the transition to non-CFC alternatives. 3. That non-Article 5 (1) Parties will request companies applying for MDI essential use exemptions to demonstrate that they, or companies distributing or selling their product, are differentiating the packaging of the company's non-CFC MDIs from its CFC MDIs and are applying other appropriate marketing strategies, in consultation with the medical community, to encourage doctor and patient acceptance of the company's non-CFC alternatives subject to health and product safety considerations. 4. That non-Article 5 (1) Parties will request companies manufacturing, distributing or selling CFC MDIs and non-CFC alternatives not to engage in false or misleading advertising targeted at non-CFC alternatives or CFC MDIs. 5. That non-Article 5 (1) Parties will request companies applying for MDI essential use exemptions to ensure that participation in regulatory proceedings is conducted with a view toward legitimate environmental, health and safety concerns. 6. That non-Article 5 (1) Parties will request companies manufacturing CFC MDIs to take all economically feasible steps to minimie CFC emissions during the manufacture of MDIs. 7. That Non-Article 5 (1) Parties will request companies manufacturing, distributing or selling CFC MDIs to dispose of expired, defective and returned MDIs containing CFCs in a manner that minimizes CFC emissions. 8. That Non-Article 5 (1) Parties will request companies manufacturing CFC MDIs to review annually CFC requirements and current MDI market forecasts, and notify national regulatory authorities if such forecasts will result in surplus CFCs obtained under essential use exemptions. 9. That Non-Article 5 (1) Parties will request companies applying for MDI essential use exemptions to provide information on the steps that are being taken to provide a continuity of supply of asthma and COPD treatments (including CFC MDIs) to importing countries. 10. That Non-Article 5 (1) Parties will request companies applying for MDI essential use exemptions to provide information that demonstrates the steps being taken to assist the company's MDI manufacturing facilities in Article 5 in countries and countries with economies in transition in upgrading the technology and capital equipment needed for manufacturing non-CFC asthma and COPD treatments. 11. To request the Technical and Economic Assessment Panel to reflect paragraphs 1 through 10 above in a revised version of the Handbook on Essential Use Nominations. Decision VIII/8 bis. Measures to facilitate a non-Article 5 (1) Party transition from CFC-based MDIs The Parties note that a transition is occurring from the use of CFC-based MDIs to non-CFC treatments for asthma and COPD. In order to ensure a smooth and efficient transition, and protect the health and safety of patients, non-Article 5 (1) Parties are encouraged: 1. To promote between national environmental and health authorities on the environmental, health and safety implications of any proposed decisions on essential use nominations and MDI transition policies. 2. To request their national authorities to expedite review of marketing/licensing/pricing applications of non-CFC treatments of asthma and COPD, provided that such expedited review does not compromise patient health and safety. 3. To request their national authorities to review the terms for public MDI procurement and reimbursement, so that purchasing policies do not discriminate against non-CFC alternatives. Decision VIII/9. Information gathering on a transition to non-CFC treatments for asthma and chronic obstructive pulmonary disease for non- Article 5 (1) Parties 1. To note with appreciation the work done by the Technology and Economic Assessment Panel and its Technical Options Committee pursuant to Decision IV/25 of the Fourth Meeting of the Parties and Decision VII/28 of the Seventh Meeting of the Parties; 2. To note with appreciation that one new non-CFC based MDI for one active ingredient has now entered the market in some countries, and that others are anticipated over the next one to three years. Other non-CFC treatments and devices already provide a suitable alternative for many patients in some non-Article 5 (1) Parties. 3. To request non-Article 5 (1) Parties that have developed a national transition strategy to report to the Panel and its relevant Technical Options Committee on the details of that national transition strategy for non-CFC treatments of asthma and chronic obstructive pulmonary disease (COPD) in time for meetings of the Technical Options Committee, beginning in 1997; 4. To request the Technology and Economic Assessment Panel to further examine and provide a progress report to the Ninth Meeting of the Parties and a final report to the Tenth Meeting of the Parties on issues surrounding a transition to non-CFC treatments of asthma and COPD in non-Article 5 (1) countries that is fully protective of public health. In so doing, the Technology and Economic Assessment Panel should consult with international bodies, such as the World Health Organization and other institutions representing health care professionals, patient advocacy groups and private industry, and with national bodies and governments. The Technology and Economic Assessment Panel should consider: (a) In the context of a transition phase, how decisions taken within the Montreal Protocol framework and national strategies might complement each other; (b) The impact on the right and ability of patients in Article 5 (1) countries, in countries with economies in transition, in Article 2 countries with large disadvantaged communities and in importing countries to receive CFC-based MDIs where medically acceptable and affordable alternatives are not available due to reductions in non Article 5 (1) essential use exemptions for CFC-based MDIs; (c) The influence of potential transferable essential use exemptions as well as existing and potential trade restrictions by individual countries on a smooth transition and access to affordable treatment options; (d) The international markets and fluidity of trade in CFC-based MDIs as well as alternative treatments for asthma and COPD; (e) The implications for patient sub-groups who may have continuing compelling medical needs after a virtual phase-out; (f) The range of regulatory and non-regulatory incentives for, and impediments to, research and development of alternative treatments for asthma and COPD and market penetration of alternative treatments for asthma and COPD; (g) The degree to which dry powder inhalers (DPIs) and other treatment options may be considered medically acceptable and affordable alternatives to CFC-based MDIs in consultation with the above bodies, and as a result, the factors which may influence their ability to act as substitutes in different countries; (h) The relative implications for the phase-out of ozone depleting substances of different policy options that facilitate the transition to non-CFC treatments; (i) Steps that could be taken to facilitate access to affordable non-CFC treatment options and technology. Decision VIII/17. Revised Proposal on Illegal Imports and Exports of Ozone-depleting Substances 1. To note with appreciation the report prepared by the Secretariat on Illegal imports and exports of ozone-depleting substances. 2. To urge each non-Article 5 (1) Party that has not already done so to establish a system requiring validation and approval of imports of any used, recycled or reclaimed ozone-depleting substances before they are imported. Importers should sufficiently demonstrate to approving authorities that the ozone-depleting substances have indeed been previously used. 3. To request each non-Article 5 (1) Party to report to the Secretariat by the Ninth Meeting of the Parties on their establishment of the system described in paragraph 3 above. 4. That the exception in Decision IV/24 (which provides that the import and export of recycled and used controlled substances not be taken into account in the calculation of the Party's consumption level) shall not apply to any non-Article 5 (1) Party that has not established by 1 January 1998 a system such as that described in paragraph 3 above. 5. To request the Ninth Meeting of the Parties to consider instituting a system to require validation and approval of exports of used and recycled ozone-depleting substances from all Parties. Decision VIII/20 bis. Non-compliance by the Czech Republic with the halon phase-out by 1994 4. The draft decision contained in CRP. 6 was approved without amendment for submission to the Meeting of the Parties for its consideration. The text of the draft decision is contained in Annex I to the present document.
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