Over last 40 years Pharmaceuticals has aligned around The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines as they have developed...
How will the EU ruling on fluorinated greenhouse gases impact the inhaled pharmaceutical industry?
Mar 31, 2023 | Published by Paul Hardman
Climate change is among the most important issues facing us and future generations. Whilst climate change is inevitable to some degree, and humans have faced large changes in the Earth’s climate throughout our history, the rate at which the climate is now changing is rapid due to modern human society. How the rate of change can be slowed to buy us time to deal with changes is being taken seriously by most of the world’s leaders.
In the European Union, a proposal for a regulation on fluorinated greenhouse gases has been developed, which describes the gradual phasing out of gases with a high global warming potential.
Due to working in the inhaled pharmaceutical industry, I am particularly interested in how these regulations affect metered dose inhalers (MDIs). I am also personally invested in these changes as my wife suffers from asthma, and I have witnessed on more than one occasion how her rescue medication, the Ventolin Evohaler, has saved her life in situations where she has struggled to breathe.
MDIs contain propellants with global warming potential, and the life-saving medications that many people rely on will be phased out. There is hope; many replacement products are being developed that use the same active pharmaceutical ingredients that can be delivered similarly by using propellants but with a lower propensity to increase global warming. There are also dry powder inhaler alternatives that do not require propellants.
The EUs proposed regulation sets a timeframe for change and encourages member states and the European Medicines Agency to cooperate to allow a smooth approval process without “affecting accessibility, availability, and affordability of essential medicines.”
MDIs are currently an affordable therapy for life-threatening conditions such as asthma. Although updating these medications to use propellants with reduced global warming potential will require significant investment in research and development; the industry coped with this situation in the past when the Montreal protocol led to the phasing out of CFCs. This brings much promise for the future of MDIs in the ongoing treatment of respiratory illness and much hope for future generations as anthropogenic climate change is treated more seriously.