Sale of corrective eyewear equipment on the internet
Recommendations on how
to deal with the associated risks
in order to protect consumers
The European Union promotes the development of eCommerce, e.g. through the Internet. Directive 2000/31/CE that sets up a legal and fiscal framework for the European market. While sales in alternative, mainly eCommerce distribution channels bring various benefits to the consumer, they also present some serious risks, especially when the products sold are pharmaceuticals or medical devices, here particularly corrective eyewear equipment like spectacles and contact lenses..
This paper describes the importance of vision, issues around vision, analysis the risks linked to corrective eyewear equipment distribution through internet distribution channels (e.g. eCommerce) and makes recommendations on how to best protect consumers’ eye health and overall well being while maintaining the benefits of e-commerce and competition between the various distribution channels.
Vision, a very important sense
Medical and scientific experts consider that 80% of information from the environment is perceived through eyesight.
When driving, up to 90% of environment information is vision-related.
60% of European population needs visual correction in order to achieve best visual acuity and performance.
About 20% of French drivers have a non corrected visual defect.
Vision in early stages of life
Children’s and teenagers’ vision is constantly evolving and changing. This is why some European countries have more stringent national regulations that deal with vision of children and teenagers.
According DREES study, 25% children (5-6 years old) need visual correction and only 50% of them have visual correction.
Eyesight and UV
It is well known that UV rays are harmful for people’s skin.
They are also harmful for eyesight. Unprotected or extensive sun exposure of the eyes can result in a reduction in vision or even blindness (pterygium, pinguecula, age-related macular degeneration, non operable cataract …).
Today, many sunglasses marketed still provide insufficient UV protection against or do not provide the claimed protection.
Therefore, even uncorrected sunglasses need to be verified for their quality (enforcement of CE mark requirements at manufacturing within the EU and import for non EU production
12 -15 million people in the world become blind due to cataract every year.
W.H.O estimate that 20% of such cases (= 3 millions people per year) are likely caused by overexposure to UVR (Ultra Violet Radiation)
Vision correcting eyeware, classification as medical devices
In Europe, vision correcting eyeware (spectacles and contact lenses) are classified as medical devices.
The European directive n° 93/42/EEC on medical devices (issued in June 1993, revised in 2007 (effective by 2011)) governs the placing on the market of medical devices within the European Union. It defines the minimum requirements, the vigilance system etc. needed to be fulfilled by the manufacturers of such devices.
Spectacles are non-invasive devices and therefore in Class I (i.e. “under the sole responsibility of the manufacturers”).
Contact lenses are invasive and hence in Classes II a and IIb, pending on the respective indication, requiring certificate issued by a notified body.
Eye examination and vision correcting eyeware
In most European countries an eye examination (performed by a qualified Eye Care Professional (ECP = optometrists, ophthalmologists or opticians) is required to determine the visual defect(s). The results of this examination(s) are then used to provide / fit the most suitable optical product(s) to correct the individual visual defect(s), taking into consideration the individual needs of the consumer.
Until today, this examination can only be properly achieved in a physical, face-to-face meeting.
Regular eye exams (best yearly) lead to always updated correction and thus best vision for the user. They also help to detect severe, eyesight threatening issues in an early stage, allowing for an appropriate intervention that can often restore or preserve the precious eyesight.
In developed countries, 400 millions people have not visited their optometrists or ophthalmologists in the last 3 years.
Why are the role and the obligations of eye care practitioners so important?
Eye care practitioners or ECPs (ophthalmologists, optometrists, opticians, … depending on local regulations) do have a specific role in the distribution process of optical equipment.
For the sake of consumer protection, it is essential to implement the same high standards for the distribution online as for traditional retail of points of sale.
In particular, we highlight :
Vision care and information
Prevention : the ophthalmologist and/or the optometrist (depending on national regulations) has to be involved in the distribution process, as regular eye exams allow to guarantee the best prevention possible. In this respect, eye exam frequency is key
Counselling on best solution available for each patient / client
Measuring the personal characteristics of each patient / client: visual acuity, inter papillary distance, lens centering, frame mounting parameters, …
Product adaptation and morphology control : corrective eyewear are custom-made products and therefore require high precision in manufacturing and dispensing, to ensure that the patient/client is satisfied and safe with his equipment
Dealing with patient / client exceptions : in some countries, like France, more restrictive regulations are applied for less-then-16-year-old children, in terms of eye exam and ophthalmologist involvement. It is vital that online optical retail respect such local laws.
Current corrective eyeware distribution channels within the EU
Opticians and optometrists are the most common distribution channels for corrective eyeware. They split between independent shops and shops of chains. Some shops are integrated in supermarkets or other outlet types.
Some countries also see ophthalmologist selling contact lenses etc. while most do not allow medical doctors to sell products.
Ready to use eyeware (mainly readers) and non corrective sunglasses are also available in other distribution channels.
Ready to use eyeware rarely fit optimal the prescription of the individual user and should mainly serves as a short term, quick fix.
European consumers also have access to multiple global websites offering and selling corrective eyewear directly to them.
Sale of corrective eyewear equipment on the Internet for example varies from less than 1% (corrective spectacles) to around 10 - 25% for contact lenses.
The internet distribution channels are, however, developing rapidly.
Also, it is of importance to know that in general, counterfeits are more prevalent in internet distribution channels.
Consumer protection by proper product selection, fitting and follow-up
The involvement of the ECPs as described above is important.
Vision needs and eye conditions can vary widely from one individual to another.
This requires a series of measurements, using special instruments, personalized vision care counselling, product selection and adaptation / fitting.
The prescribing ECP also takes on the responsibility for the work and can be hold liable for it, too.
All this can best or even only be achieved face-to-face:
Perform the specific measurements with special instruments
Offer a personalized solution, taking into account
the individual needs,
the optimal correction type (ophthalmic lenses or contact lenses) based on
the eye measurements
the eye’s shape (contact lenses)
the face shape (frame)
Face-to-face contact also allows for best:
Guarantees the quality of the equipment to the consumer
Control product tracking and
Avoidance of counterfeiting
Assurance of the perfect long-term adaptation/fit and tolerance of the correction
Protection of the consumer’s personal and medical data
National regulations about the distribution of eyeware within the EU
National regulations for the sale of eyeware vary widely from one European country to the other.
Spain: Requires the intervention of an optometrist for the sale of corrective eyewear in traditional points of sale. Online retail is coherent with traditional retail, as the optometrist involvement is also required when corrective eyewear is sold through eCommerce websites. For contact lenses, the regulation requires the eCommerce company to have a physical location in Spain and the optometrist to be registered at the Spanish College of Optometry.
France: The intervention of an optician is required, both in traditional points of sale and for eCommerce. Moreover, in France, the opticians have the monopoly of corrective eyewear distribution. In 2008, the EU commission launched an infringement case on the free movement of corrective eyeware (contact lenses) against France. The current status of this is not known to this paper’s authors.
Germany: The intervention of an optician or optometrist is required when corrective eyewear is sold in traditional points of sale. But no optician or optometrist involvement seems to be required when corrective eyewear is sold through eCommerce or outside traditional points of sale, thereby creating differences between the different distribution channels in Germany.
Italy: The optician has to have a face-to-face meeting with the client to provide him with the appropriate corrective eyewear equipment. This should prohibit eCommerce for corrective eyewear in Italy, where in reality it does not.
UK: The sale of corrective eyeware is regulated by the Opticians Act. In its recent amendment (amendment 60), it regulated the sale of contact lenses in general, not fixed to any distribution channel. This law follows closely the Fairness to Contact Lens Consumer Act in the USA. The European Contact Lens industry sees this as the model for all of Europe.
Having a good vision is fundamental for education, human development, driving and life in general.
Adequate UV protection is also fundamental in preserving long term eyesight and eye health.
Existing laws about who can perform the eye exams reflect the concerns about and need of adequate consumer protection.
Providing optimal vision correction is based on the optimal measuring of the eye and combining these results with the individual needs.
Protecting each individual’s eyesight can only be achieved by offering highest quality corrective and protective eye care equipment, under the responsibility of an eye care professional.
Recommendations for online optical retail
Taking into account the above elements, EUROM-1 makes the following recommendations to be implemented within the European Union, to guarantee consumer protection.
Maintain highest consumer’s eye health protection by requiring adequate eye examinations, executed by qualified Eye Care Professionals. The results of which is a detailed specification of the exam’s results, as well as the chosen and fitted eyeware equipment.
Limit validity of the specification (usually a year), due to eye’s changing nature.
Oblige all distribution channels (eCommerce) to demand such a valid specification and verify its authenticity, before selling corrective eyeware.
Oblige all channels to provide only the specified products
Oblige Internet channels of distribution to provide adequate information and counselling, provided by a responsible and qualified optician / optometrist
Requiring Internet channels of distribution to link with qualified eye care practitioners that can provide face-to-face counselling, and checking compliance.
Require Internet channels of distribution to provide full disclosure on the products sold (brands, parameters, measurements etc.) similar to the ones provided in the regular channels to give the consumers the freedom to repeat the same purchase elsewhere or to get replacement parts
Require Internet channels of distribution to be able to execute recalls by recording all product and customer details for an adequate period of time, respecting the national data protection laws in doing so
Require Internet channels of distribution to take part in the post market surveillance (vigilance) systems as required by the European Medical Device Directive
Ensure that national authorities follow up on allegations about the use of counterfeit or other illegal practices in Internet channels of distribution or at the EU borders
Oblige offshore operating players to respect the European and national rules and regulations
Maintain and develop the responsibility of eye care professional in order to guarantee consumer protection in all distribution channels and particularly Internet.
The EUROM I is convinced that these recommendations provide the necessary minimum standard to best protect the consumer’s eye health when they purchase corrective and non corrective (sunglasses) eye care products, independent of the distribution channel.
December 18, 2009 Page /