Document pewr6b8j2KGOG31RZEeBXwdM7

THE VOICE OF EUROPEAN CONTACT LENS AND LENS CARE INDUSTRY Economic and Social impact of total ban on PFAS for the RGP contact lens sector EUROMCONTACT survey 2022 Survey run from 22nd July 2022 to 1st September 2022 Focused on Eye Care Professionals Survey circulated to ECOO and ECLSO members ECOO - European Council of Optometrists and Opticians ECLSO - European Contact Lens Society of Ophthalmologists 2 Impact of total ban on PFAS on Eye Care Professionals Survey run from 22.07.22 to 01.09.22 - Practices located in EU-27, UK and CH - Impact of total ban on PFAS: . Turnover reduced by a minimum of 30% and up to 85%... . Redundancy of staff ranging from 1/3 of the practice at minimum up - European Council of Optometrists and Opticians : cover 150 000 ECP in the EU - ECOO estimates: 1/3 of the 150 000 practicians would be impacted 3 Impact of total ban on PFAS on RGP contact lens' wearers Testimonials from Eye Care Professionals Keratoconus Patients, Patients with corneal graft or other corneal scars would be unable to work or drive. Their quality of life will be significantly impacted... Innovation and technological progress could never compensate for the loss of this special lens. The quality of life of patients depends on these lenses The forced return to glasses would have dramatic consequences such as reduced quality of life, inability to work, poorer social integration; and for children in orthokeratology, an increase in myopia. 4 EUROMCONTACT surveys 2023 Survey to polymer manufacturers and RGP contact lenses manufacturers on industrial & environmental impacts of a PFAS ban Survey run from 5th May 2023 to 1st June 2023 37 participants Survey to Eye Care Professionals on potential PFAS ban and its impact on patients Survey run from 23rd March 2023 to 30th May 2023 513 participants Survey circulated to EUROMCONTACT/ EFCLIN members EUROMCONTACT - European association of the contact lens and lens care manufacturers EFCLIN - European Federation of the contact lens and IOL industries Survey circulated to ECOO and ECLSO members ECOO - European Council of Optometrists and Opticians ECLSO - European Contact Lens Society of Ophthalmologists 5 Results of the survey to polymer manufacturers and RGP contact lenses manufacturers on industrial & environmental impacts of a PFAS ban Economic impact of total ban on PFAS on RGP contact lenses manufacturers Location of polymer & RGP contact lenses production Employment and potential of job losses in Europe Impact on turnover Number of companies in Europe Most respondents are located in Europe (Spain, Italy, Switzerland, UK, Netherlands, Germany, Austria, Slovakia, Sweden, France, Croatia, Belgium) Some are located outside Europe (USA, Japan, Israel...) 4000 jobs in Europe linked to the manufacturing of RGP contact lenses. Assuming that a ban on PFAS means that RGP materials can no longer be manufactured, the impact in terms of the number of job losses in Europe is estimated at 2 278. Assuming that a ban on PFAS means that RGP materials and all types of rigid lenses can no longer be manufactured, the annual turnover of the companies would decrease by 54% on average. Estimated 60 RGP contact lens manufacturing laboratories impacted in the EU by the potential PFAS ban. A total ban on PFAS would result in the closure of most companies. 7 Waste generated Waste management Environmental impact of total ban on PFAS on RGP contact lenses Annual estimate tonnage of PFAS waste and emissions generated from the manufacture of rigid buttons and rigid contact lenses for the EU market : 2 742 kg / year Today, waste containing PFAS is treated through : - Incineration (55%) - Landfilling (33%) - Recycling (11%) 8 Alternatives to PFAS for RGP contact lenses Regarding the availability, technical and economic feasibility, of alternatives to PFAS to manufacture RGP, would you say that... alternatives are already available on the market substitution is technically and economically feasible but more time is required to substitute substitution is not technically or economically feasible ? Information on the status of R&D processes for finding suitable alternatives R&D has been conducted but no alternatives which has same properties as PFAS has been found. The unique characteristics of fluoroacrylates as admixtures in RGP polymers cannot be replaced equivalently. Approximately, other material formulations can be explored with an even higher siloxane and alkyl acrylate content. There will be more lens deposits and more hygienic user problems. The likelihood to find an alternative is considered very low. Among the 37 surveyed companies, no one has alternatives already available on the market If successful, the R&D process would in any case be extensive : 1. Monomer synthesis - 2. Polymer development - 3. Clinical trials - 4. Material regulatory testing, clinical work and approvals -5. Customer regulatory approvals (MDR) - Additional clinical work. The majority of respondents (53%) considers that it would take around 10 years only to obtain regulatory approval to market your lens designs in new, PFAS-free materials 9 Outcome of the survey to Eye Care Professionals on potential PFAS ban and its impact on patient Profile of respondants Where is your practice located ? UK : 92 Switzerland : 26 11 Profile of respondants Does your practice supply and fit contact lenses ? Of your patients that use contact lenses, what is the percentage using RGP contact lenses in your practice (including scleral, orthokeratology, keratoconus, hybrid lenses etc) ? 12 Alternative treatment for patients If RGP contact lenses were no longer available, approximately what percentage of your current RGP patients : - could you no longer treat ? Average : 52% of patients What conditions would you no longer be able to treat in your patients if RGP contact lenses were no longer available? - would be treated with alternative, but less effective, modalities ? Average : 29% of patients 81% of RGP patients would be no longer treated or treated with less effective alternatives 13 Impact on the quality of life of patients What do you anticipate to be the impact for patients who cannot be treated by means of RGP contact lenses due to a total ban on PFAS? Please estimate what percentage of your current RGP patients would have a visual acuity less than 6/12 (20/40) in both eyes if you could only use soft contact lenses or glasses to correct their vision. Average : 44% of current RGP patients would have a visual acuity less than 6/12 in both eyes 14 Impact on the quality of life of patients What, if any, specific health and safety risks to patients do you think would arise if you can no longer treat them with RGP lenses? 15 Impact of time-limited derogation on RGP prescription - shortage risk for patients in the short term If there was uncertainty over the future of rigid contact lenses due to the potential PFAS ban, would this make you less likely to prescribe rigid contact lenses? 16