International Pharmaceutical Aerosol Consortium
IPAC
The International Pharmaceutical Aerosol Consortium (IPAC) was formed in 1989 in response to the mandates of the Montreal Protocol on Substances that Deplete the Ozone Layer and fully supported a timely and effective transition away from chlorofluorocarbons (CFCs) used in pressurised metered dose inhalers (pMDIs) under the Montreal Protocol that balanced patient health and environmental concerns.
ID: 602537137644-70
Lobbying Activity
Response to Update of format of F-gas labels
3 Jun 2024
The International Pharmaceutical Aerosol Consortium (IPAC) welcomes the opportunity to share comments on the draft implementing regulation regarding the format of labels for products containing fluorinated gases (F-gases). IPACs comments focus on labelling for metered dose inhalers (MDIs) for which extensive product labelling is required through medicinal product regulations. Please see the attached for details on our feedback.
Read full responseResponse to Review of EU rules on fluorinated greenhouse gases
24 Jun 2022
The International Pharmaceutical Aerosol Consortium (IPAC) and its members support the EU’s goal of net carbon neutrality. As detailed in the attached Position Paper, we call on EU legislators to devise the phase-down of medical F-gases in the EU in a way that maintains access to critical medicines for patients, allows for adequate time for a truly sustainable transition to a new generation of propellants for metered-dose inhalers (MDIs), and safeguards EU-based health innovation and manufacturing.
We stress the importance of the final legislative text to ensure: (1) a phase-down schedule that reflects the time needed by 2030 for the MDI sector to advance a global transition for a full range of MDI therapies to gases with much lower global warming potential (GWP) to reduce climate impact; (2) accelerated health regulatory pathways for lower GWP inhaled medicines and removal of medical-grade low GWP HFCs from the scope of this Regulation; (3) safeguards for the use of medical-grade F-Gases only for production of MDIs; (4) enforceable safeguards against loss of patient access to medicines and a formalized periodic review process; (5) provisions for the export of MDIs that are consistent with import relief mechanisms; and (6) safeguards for the continued competitiveness of European industry. Please see the attached for further details and information. IPAC welcomes the opportunity to share perspectives on the European Commission’s Proposal.
Thank you.
Read full responseMeeting with Caroline Boeshertz (Cabinet of Executive Vice-President Valdis Dombrovskis)
9 Nov 2021 · Fluorinated Gases regulation
Response to Review of EU rules on fluorinated greenhouse gases
5 Sept 2020
The International Pharmaceutical Aerosol Consortium (IPAC) represents major pharmaceutical companies – AstraZeneca, Boehringer Ingelheim, Chiesi Farmaceutici, GlaxoSmithKline, and Kindeva – which research, develop, and manufacture products for the treatment of respiratory illnesses such as asthma and chronic obstructive pulmonary disease (COPD).
IPAC member companies market Dry Powder Inhalers (DPIs), Soft Mist Inhalers (SMIs) and Pressurised Metered Dose Inhalers (HFC pMDIs). All of these products play an important role in patient care. As no one inhaler type is suitable for all patients, maintaining access to a diverse range of therapeutic choices is paramount to ensure consistent respiratory care and continuity in therapy.
IPAC believes that the patient should be at the heart of any proposed change to inhaler therapies, and effective management of respiratory disease should be the primary measure of success, using the best device(s) for each individual. Careful and effective communication of the options and treatment guidance, combined with correct technique and adherence to the prescribed treatment regimen will help to improve patient outcomes. Where respiratory symptoms are stabilized and well controlled, and reliance on reliever therapies reduced, an overall reduction in carbon footprint will likely follow. IPAC therefore recommend that the consultation process also involves relevant Clinician and Patient Groups.
IPAC recognizes that the medical grade HFCs used in current pMDIs, whilst having significantly less environmental impact compared with the CFCs they replaced, still have a high global warming potential (GWP). IPAC members continue to develop and market sustainable innovations, such as low carbon inhalers, DPIs, and reusable SMIs. Furthermore by investing in next generation HFC propellant with significantly lower GWP, pMDIs with a lower carbon footprint compared with current pMDI products are in development. These developments will ensure this delivery platform continues to be an option for patients that need it, in a more climate friendly format that will have minimal impact on treatment. IPAC recommends that the pMDI exemption from the phase-down obligations in the F-Gas Regulation should continue for at least the next five years, including reporting requirements to track trends in medical use of current HFCs. Developing low GWP pMDIs, in tandem with adoption of additional patient-centric approaches to symptom control and improving the recovery of used inhalers, reusability of inhalers and/or recycling where appropriate, will support the overall goal of minimizing the environmental impact of respiratory care.
IPAC was formed in 1989 and fully supported a timely and effective transition away from chlorofluorocarbons (CFCs) used in pMDIs under the Montreal Protocol that balanced patient health and environmental concerns. The European Commission, Member State health/environmental authorities, industry, clinicians, and patient groups worked together to accomplish a seamless transition for patients in Europe. Further detail on the background is available in Ensuring Patient Care published by IPAC (available: www.ipacinhaler.org/). IPAC engaged as a stakeholder in the development of the current F-Gas Regulation (EU) No 517/2014 and also with the European Climate Change Programme. IPAC supported and continues to support the exemption for pMDIs in the current Regulation, as well as the obligation for reporting of quantities used in the production of pMDIs. This exemption serves as a signal of the important patient care issues and the need to avoid disruptions in supply. IPAC believes that significant environmental progress can be achieved while simultaneously improving patient health. We have prepared a white paper on patient care issues (attached) which has been submitted to the UK NHS’ Low Carbon Inhalers Working Group. We request an interview as the consultation continues.
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