IPAC was formed in the late 1980s in response to the threat of phase-out of chlorofluorocarbons (CFCs) in metered dose inhalers in order to minimize the risks to patients and fully supported a timely and effective MDI transition balancing patient health and environmental concerns. IPAC was instrumental in securing the “essential use” process to allow continued production of CFCs for medical uses and provide time for companies to research and develop CFC-free alternatives.
IPAC recommends that any phase down of HFCs is structured to ensure that adequate, safe, and secure supplies of HFCs remain available to meet patient need over the long term.
Protecting the Availability of HFCs for Medical Inhalers and Ensure Patient Care
For decades, CFC-based MDIs served as the “gold standard” for treating patients with asthma and other respiratory illnesses. In response to the mandates of the Montreal Protocol, pharmaceutical manufacturers undertook an exhaustive search for chemically, environmentally, and medically suitable alternative to CFCs. Once HFCs emerged as the single viable alternative propellant, companies jointly conducted multi-year pre-clinical safety testing programs. In parallel, individual companies embarked on lengthy, resource-intensive efforts to research and develop HFC-based alternatives to their specific CFC MDI formulations. Reformulating MDIs with HFCs was an enormously complex and time-consuming effort. It was not a simple case of substituting one propellant for another. Rather, most CFC MDI components proved incompatible with HFCs and had to be newly engineered. Each new HFC product was required to undergo the rigorous testing, regulatory review, and approval process associated with researching and developing new drug products.
Compelling patients to switch from safe and effective treatments for environmental, rather than health, reasons was an unprecedented and costly undertaking presenting numerous challenges. It is critical that the transition to HFC MDIs and other CFC-free alternatives proceed toward closure in the US without questions or concerns regarding the long-term availability of pharmaceutical-grade HFCs.
No alternative medical propellant to HFCs currently exists. IPAC companies manufacture and market dry powder inhalers (DPIs) and other inhalation therapies not requiring an aerosol propellant. However, not all devices are compatible with all drug products, or suitable for all patients. Selecting a therapy for a patient, including choosing a device, is a complex process driven primarily by the physician and patient. It is imperative to preserve a range of therapeutic options for patients.
“Inhaled therapy is the mainstay of treatment for asthma and COPD. MDIs are currently the most widely used inhalation device and millions of patients around the world rely on these products to manage their chronic, lifetime illnesses effectively.”
Paul Wright, IPPC/TEAP Special Report: Safeguarding the Ozone Layer and the Global Climate System, 2005, Chapter 8 Medical Aerosols
IPAC was recipient of the "Partners Award" from the Ozone Secretariat, UNEP, for playing a critical role in the development or implementation of the Montreal Protocol