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Phaseout of CFCs in metered dose inhalers
The Commission has formulated a Community strategy to phase out chlorofluorocarbons (CFCs) from metered dose inhalers.
Communication of 23 October 1998 from the Commission to the Council and the European Parliament: Strategy for the phaseout of CFCs in metered dose inhalers [COM(98) 603 final - Official Journal C 355 of 20.11.1998].
CFCs are one of the substances depleting the ozone layer whose production and consumption was prohibited in the Community in 1995. However, they are still available for use in metered dose inhalers for the treatment of asthma and chronic obstructive pulmonary disease (COPD) by virtue of a derogation for essential uses provided for in the Montreal Protocol and in Regulation (EC) 3093/94 (replaced by Regulation (EC) No 2037/2000).
By Decision IX/19 of the Montreal Protocol, the European Community and the other parties to the Protocol agreed to present, before 31 January 1999, a transitional strategy for the phaseout of CFCs in metered dose inhalers. By adopting the present communication the Commission seeks to meet this obligation. It recommends the measures which the Member States will have to take to promote the transition to non-CFC treatments for asthma while safeguarding the health and safety of patients. It also outlines how the Commission intends to discharge its responsibility, in accordance with Regulation (EC) 3093/94 (replaced by Regulation (EC) No 2037/2000), to determine each year the quantities of CFC to be authorised for essential use in metered dose inhalers.
As soon technically and economically acceptable substitute solutions are available, it will no longer be possible to regard CFCs as "essential" and they will therefore have to be withdrawn. A certain number of inhalers without CFCs have already been successfully placed on the Community market, i.e. dry power inhalers (DPIs) and inhalers with hydrofluorocarbon propellants (HFC) instead of CFCs.
The strategy defines precise criteria to determine when substitute solutions for the various products or categories of products with CFC propellant will be available and when the derogation for essential uses may be discontinued. These criteria guarantee that CFCs will be discontinued in certain products only if a sufficient number of appropriate substitutes has become available.
In general patients make the transition without difficulty if there has been proper preparation, coordination and instruction. The communication includes advice for the competent authorities of the Member States on the best way to ensure a harmonious transition safeguarding patients' health. Awareness campaigns aimed at the public authorities, professionals (doctors, nurses and chemists) and patients should be organised to ensure rapid acceptance of medications without CFCs.
The strategy strongly promotes the early transition of all patients in the Community to treatments without CFCs and it is flexible enough to take due account of the specific requirements of patients in each Member State. It encourages the use of DPIs wherever possible but also makes provision for the replacement of metered dose inhalers by HFC inhalers in Member States where the use of the former is more widespread.
The communication also recognises the importance of the export of metered dose inhalers for patients outside the Community who depend on these products, and also for Community producers. The transition will take place very rapidly within the Community but a certain quantity of CFC for essential uses will still be necessary to meet export demands. However, the strategy clearly states that once substitutes are available they should be promoted everywhere, especially among manufacturers, so as to prevent unnecessary long-term dependence on CFCs.
A necessary component of the strategy to phase out CFCs in metered dose inhalers is an efficient and rational procedure for authorising the placing on the Community market of products without CFCs. Cooperation among the Member States, the Commission and manufacturers is proposed in the communication to streamline and speed up authorisation procedures. Moreover, the competent authorities must no longer issue any authorisations for new inhalers containing CFCs.
The speeding-up of evaluation procedures must not compromise the health and safety of patients. The Commission emphasises that they principal objective of evaluation and authorisation procedures is to guarantee that medicines for which authorisation is requested meet all the necessary criteria as regards quality, harmlessness and effectiveness.