Responsible Inhaler Development in Article 5 Countries: Navigating the Scientific, Regulatory, Political and Commercial Challenges
Woodcock A.
Respiratory Drug Delivery 2010. Volume 1, 2010: 121-130.
Abstract:
The successful elimination of CFCs has been critical for environmental protection of the ozone layer and climate change. Exemption for inhaled therapy has been important in protecting patient health. Just as final CFC MDI phase-out seemed imminent, it has become clear that about a dozen developing countries (“Article 5 Parties;” A5) will continue to use CFC MDIs in 2010. Crucially they provide inhalers at affordable prices to patients in Article 5 Parties. Several Montreal Protocol funded projects to convert manufacturing companies in these countries are nearing completion while other countries are delayed. For example China is projecting its need for CFCs until 2014. Supplies of pharmaceutical grade CFC have been potentially compromised by an EU decision to cease exports, and with smaller volumes driving prices up and making production economically nonviable, A5 Parties will have to make an “Essential Use” nomination in Jan 2010 to acquire CFCs to make CFC MDIs beyond the current deadlines. The final phase-out of CFC MDIs will require careful management to avoid patient harm. The Montreal Protocol and its 20 year history, serves as a valuable and useful model for international debate and collaboration, especially as we move to bring global climate change under control.
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