Mr. Ashley Woodcock, co chair of the Medical Technical Options Committee (MTOC), reported on the essential use nominations for metered dose inhalers (MDIs).

These medications can be given either via a metered dose inhaler with a spacer or via a nebulizer with both appearing to be equally effective.

Essential use nominations for 2006 and 2007 of chlorofluorocarbons for metered dose inhalers approved by the Parties at the Seventeenth Meeting (metric tonnes)

Essential use nominations for 2006 and 2007 of chlorofluorocarbons for metered dose inhalers approved by the seventeenth Meeting of the Parties (metric tonnes)

For the Russian Federation, TEAP had recommended an upward revised quantity of 400 tonnes for 2006 to guarantee an adequate supply of MDIs for patients.

To authorize the following levels of production and consumption necessary to satisfy essential uses of chlorofluorocarbons for metered dose inhalers for asthma and chronic obstructive pulmonary disease

To facilitate the depletion of stockpiles, the Committee suggested that the Parties might wish to consider allowing the transfer of allocations and stockpiles between MDI manufacturers and between different active ingredients.

That decision required, among other things, that nominating parties submit plans for the phase out of metered dose inhalers the sole ingredient of which is salbutamol.

In that regard, he noted that decision XV 5 which required the designation of essential use recommendations and allocations according to active ingredient, could have the unintended consequence of making it more difficult to deplete stocks, and suggested that Parties might wish to consider the advantages of retaining flexibility to transfer allocations and stockpiles between MDI manufacturers and different active ingredients to minimize new CFC production.

To authorize the levels of production and consumption necessary to satisfy essential uses of chlorofluorocarbons for metered dose inhalers for asthma and chronic obstructive pulmonary diseases as specified in the annex to the present decision, subject to the conditions established by the Meeting of the Parties in paragraph 2 of its decision VII 28

The detailed plan submitted by the United States of America indicated that from the end of 2008, it would no longer be legal to sell CFC based salbutamol MDIs in the United States.

With regard to the 2006 nomination of the United States of America, the representative of the United States of America said that his country had made a great deal of progress in the reduction of use in CFC consumption for MDIs.

The Panel also noted that the United States stockpiles amounted to 1,521 tonnes at the end of 2004, and that that figure did not include pre 1996 stockpiles, which might satisfy regulatory requirements for use in MDIs.

On a positive note, Mr. Gonzalez highlighted the significant progress that had been made in addressing metered dose inhalers containing CFCs, and congratulated both industry and Governments for their partnership which had been instrumental in achieving that progress.

No new 2006 nominations for essential use exemptions were submitted. Two Parties, the United States and the Russian Federation, submitted new requests for essential use exemptions for CFCs for MDIs applicable to the year 2007.

A representative of an industry association urged Parties not to authorize essential use exemptions for CFC containing salbutamol MDIs for countries in which there are approved CFC free alternatives, as in her view this contravened decision IV 25 and she called for a reduced level for the United States.

At their sSixteenth Meeting, the Parties to the Protocol reviewed and approved the requestsCFC metered dose inhaler, of certain countries for essential uses of exemptions for CFCs for metered dose inhalers nominationsfor 2006.

When electrocardiograms (ECG) data from all of the phase I studies are analysed, no significant alteration is appreciated in any of the parameters after administering bilastine at single doses (up to 11 times the therapeutic dose), nor at multiple doses (up to 10 times the therapeutic dose).