KARACHI, March 14 The manufacture, sale and use of asthma inhalers containing chlorofluorocarbons (CFCs), which are known to harm the ozone layer, is to end by Dec 31, 2009, across the country under the 1987 Montreal Protocol on Substances that Deplete the Ozone Layer.

However, the federal environment secretary said at a seminar on Saturday that since the demand for CFC-based inhalers was not expected to be met solely by more expensive imported CFC-free alternatives, Pakistan had submitted a request to the Ozone Secretariat for Essential Use Nominations of CFC to allow manufacture of inhalers using the chemical past the Dec 31 deadline, until all manufacturers had been converted.

Pakistan signed the Montreal Protocol in 1992 under which the country has to phase out the use of ozone layer-depleting products, including CFCs.

Saturday's workshop on the transition strategy for phasing out CFC-metered dose inhalers (MDIs) in the country was the first of its kind, and was organised by the Ozone Cell of the Federal Ministry of Environment in collaboration with the United Nations Environment Programme (UNEP) and United Nations Development Programme (UNDP).

A number of stakeholders, including physicians and representatives of pharmaceutical companies and government agencies attended the workshop.

While there is currently no data on the number of CFC-propelled inhalers used in the country, participants of the workshop were told that about 12 per cent of the population, or 19.8 million people, suffered from asthma or chronic obstructive pulmonary diseases (COPD), which would necessitate the use of MDIs.

Currently three pharmaceutical firms produce CFC-based MDIs and their total annual production is approximately 3.95 million units. At present, CFC MDIs are considered by patients to be an affordable option when it comes to controlling their illnesses.

A major concern for patients, therefore, is the fact that the replacement for CFCs - hydrofluoroalkines (HFAs) - may be more environmentally friendly, but they also cost about thrice as much. Stakeholders believe that rescue or emergency CFC-propelled inhalers are used by thousands of users for daily control of air passage diseases.

Current HFA-propelled inhalers, however, cost three times as much as CFC-MDIs, and they will remain unaffordable until generic versions are made, according to a consultant chest physician. He added that HFA inhalers would give a “softer blast” as compared to CFC inhalers.

Relaxation of deadline

requested

The chief guest at the workshop, Secretary of the Ministry of Environment Imtiaz Inayat Elahi, said that Pakistan was committed to contributing to global efforts for the conservation of the environment. He said that Pakistan had taken various steps for the preservation of the environment over the past two decades, and was a party to a number of international conventions/protocols and multilateral environment agreements, including the Montreal Protocol.

He added that, with the financial and technical support of foreign agencies, the Pakistan government had already converted its industries in the foam, refrigeration, metal-cleaning and fire-fighting sectors from ozone-depleting substance (ODS) based technology to ozone-friendly technology.

At a November 2008 meeting in Doha, two of the three manufacturers of CFC MDIs in Pakistan were given funding to convert their manufacturing processes from ODS-based technology to more environmentally friendly options.

Mr Elahi mentioned that Pakistan was in full compliance with regard to the import and consumption limits of ODS under the Montreal Protocol, and it had also imposed a ban on the import of CFC-based compressors, although the ban was not obligatory for signatories of the Protocol.

The federal environment secretary informed those present at the seminar that under the provisions of the Montreal Protocol, production and consumption of CFCs would cease by Dec 31, 2009, but CFCs would still be required for the production of MDIs in order to cater to patients suffering from asthma or COPDs.

In view of the preparations for non-CFC inhalers to be produced locally, which would definitely take some more time, Mr Elahi said the demand for inhalers could not be met solely through expensive imported CFC-free MDIs. Pakistan, therefore, along with four other countries in the region, had recently submitted a request to the Ozone Secretariat for Essential Use Nominations of CFC to allow manufacturing of CFC-MDIs beyond 2009, until all CFC-MDI manufacturers had converted to HFA-MDI production, he said.

'Targets met'

In his presentation on the 'implementation of ODS phase-out programme under Montreal Protocol', the deputy programme manager of the Ozone Cell, Maqsood Akhtar, said that Pakistan had phased out the consumption of 91 per cent of first-generation ozone-depleting substances, which was above the 85 per cent reduction target cited in the Protocol.

The objective of the awareness and information exchange workshop in Karachi was to evolve a transition strategy for CFC-based MDIs to be converted to CFC-free technology.

Kristine Whorolow, Chief Executive Officer, National Asthma Council, Australia, provided her expertise and knowledge to various stakeholders on the CFC MDIs issue, while Shaofeng Hu, Programme Officer, United Nations Environment Programme, Bangkok, and Anil Sookdeo, Programme Specialist, United Nations Development Programme, Bangkok shared information and experience with national stakeholders on what is a global issue.

In November 2008, the Multilateral Fund Secretariat of the Montreal Protocol approved a fund of US$457,000 to phase out the use of CFCs at two MDI manufacturers. The fund, which is distributed through the UNEP and UNDP, will also be used to evolve a national strategy for the transition to CFC-free MDI technology, including awareness and information exchange activities.

In addition to the transition of manufacturers to CFC-free manufacturing, laws and regulations will need to be formulated in order to facilitate the adoption of CFC-free alternatives. These laws will likely ban the sales and distribution of CFC MDIs.

The main components of all MDIs include the active ingredient, formulation excipients eg solubilising agents, suspending agents, lubricants, the propellant(s) (a liquefied gas), a metering valve, a canister and an actuator. It is the propellant in the MDIs, along with the solvent for the active ingredient, that use CFCs.

The chemical action of chlorine and bromine released by man-made CFCs causes damage to the ozone layer, which blocks harmful ultraviolet rays emitted by the sun.

Holes in the ozone layer have been blamed for increasing the risk of skin cancer and cataracts in humans, as well as for causing global warming, decreased crop yields and other harmful environmental effects, according to researchers.