The European Commission proposed two new regulations in April 2022, in order to more strictly control fluorinated greenhouse gases and substances that deplete the ozone layer (ODS), and make Europe climate neutral by 2050.

Fluorinated gases are those artificially created by humans with the aim of improving industrial processes, and which contribute to the so-called "greenhouse effect". For the most part, they are used in the refrigeration and air conditioning industry, fire extinguishing, aerosols, and thermal and electrical insulation foams. Likewise, they are used as a propellant in some inhalers (called “pressurized”) indicated for people affected by prevalent chronic diseases such as COPD (chronic obstructive pulmonary disease) and asthma, or rare diseases such as Cystic Fibrosis or Alpha-1, fundamentally, to ensure that the medicine reaches the lungs efficiently.

According to the experts during the webinar of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR), the Climate Change and Respiratory Health, and published by Fenaer (Spanish Federation of Associations of Patients with Allergy and Respiratory Diseases), inhalers account for 0,05% of all greenhouse gases; and the gases flPharmaceutical use emissions account for less than 0,1% of total emissions, and this would include not only inhalers but also other equipment and processes in the medical field, according to the Report on Emission Factors prepared by the Ministry for the Ecological Transition and the Demographic Challenge.

At the Lovexair Foundation, we support initiatives in favor of protecting the environment and against climate change, such as Breathe Life 2030, the World Health Organization's global campaign for clean air, and Breathe Vision 2030, a collective initiative of patient organizations and scientific societies in Europe, and we take on the challenge of generating actions to preserve the health of our planet and the quality of the air.

However, we are concerned that these measures do not take into account the impact of the transition on the lung health of people who live with chronic pathologies. In this sense, we understand that these regulations, scheduled to be implemented as of July 1, 2022, may affect the production and distribution of medication, so we call on officials, health authorities and government control agencies to guarantee access to supplies for pharmacological treatments.

The respiratory community does not always have the option to choose between one product or another. In addition, we are in a transitional stage in the substitution of devices in style, use and effectiveness, once approved by the regulatory system of the drug agency. In this phase we always prioritize the health and quality of life of people and access to medicine that can benefit them.

For this reason, and to the extent that the industry continues to develop alternative devices, which are available to all users, and which satisfactorily meet all these criteria (clinical and environmental), we request that well-being, health and safety be taken into account. of the most vulnerable people, such as those affected by chronic and rare respiratory diseases.

Without a doubt, we encourage the pharmaceutical industry to continue betting on research, innovation and the production of environmentally responsible, safe and guaranteed application systems and thus promote a positive and realistic transition, in accordance with the Sustainable Development Goals. (ODS) to promote Health and reduce the carbon and CO2 footprint.

Shane Fitch

President of the Lovexair Foundation

Go to public consultation: Fluorinated greenhouse gases: review of EU regulations (2015-2020)

Statement (English)

Guarantee the rights of respiratory patients

The Green Deal: phasing down fluorinated greenhouse gases and substances that deplete the ozone layer

The European Commission proposed two new regulations in April 2022, to more strictly control fluorinated greenhouse gases and ozone depleting substances (ODS), and make Europe climate neutral by 2050.

Fluorinated gases are those artificially created by humans with the aim of improving industrial processes, and which contribute to the so-called “greenhouse effect”. For the most part, they are used in the refrigeration and air-conditioning industry, fire extinguishing, aerosols, and thermal and electrical insulation foams. They are also used as a propellant in some inhalers (called "pressurized") indicated for patients with prevalent chronic disease such as COPD and asthma or rare conditions such as Cystic Fibrosis or Alpha-1, mainly to ensure that the medicine reaches the lungs efficiently.

According to experts who met during the Spanish Pulmonary and Thoracic Society SEPAR webinar: Climate Change and Respiratory Health & published by Fenaer (Spanish Federation of Associations of Patients with Allergy and Respiratory Diseases), inhalants account for 0.05% of all greenhouse gases; and fluorinated gases for pharmaceutical use account for less than 0.1% of total emissions, and this would include not only inhalers but also other equipment and processes in the medical field, according to the Report on Emission Factors prepared by the Ministry for the Ecological Transition and the Demographic Challenge.

At Lovexair Foundation, we support initiatives in favor of protecting the environment and against climate change, such as Breathe Life 2030, the World Health Organization's global campaign for clean air, and Breathe Vision 2030, a collective initiative led by patient organizations and scientific societies in Europe, and we take on the challenge of generating actions to preserve the health of our planet and air quality.

However, we are concerned that these measures do not take into account the impact during the transition process, on the health of people who live with chronic pathologies.

In this sense, we understand that these regulations, scheduled to be implemented as of July 1, 2022, may affect the production and distribution supply chains and stocks of medication available, so we call on all officials, health authorities and government agencies to guarantee access continues to all pharmacotherapeutic treatments and adequate supply chain stocks to be preserved, to meet patient population requirements during this transition period.

The respiratory community does not always have the option to choose between one product or another. What's more we find ourselves in an era geared towards the substitution of devices in style, use and effectiveness, once they are approved by the medical regulatory authorities. In this phase we must always prioritize peoples' health & quality of life and access to medication which could be of benefit.

For this reason, and to the extent that the industry continues to develop alternative devices, which are available to all users, and which satisfactorily meet all these criteria (clinical and environmental), we request that well-being, health and safety be taken into account for the most vulnerable people, in particular for people affected by chron ic and rare respiratory diseases.

Undoubtedly, we support all pharmaceutical industry to continue to spur forward their commitment to research & innovation, for reliable and safe production systems, for improved environmentally-responsible devices and applications for pharmacotherapeutic administration and thus promote a positive and realistic transition, in accordance with the Sustainable Development Goals (SDG) to promote Health and reduce the carbon and CO2 footprint.

Shane Fitch

President of Lovexair Foundation

Go to public consultation: Fluorinated greenhouse gases – review of EU rules (2015-20)