Insurance associate director Mark Copsey and operations director Hana Te Reo explain the importance of buying aesthetic products from authorised supply chains and the dangers of parallel imports
The temptation to save a few pounds when purchasing consumables such as dermal fillers and botulinum toxins may seem an attractive option when running an aesthetic business; anything to improve your bottom line, right? However, many of the discounted offers and cheap cosmetic injectables promoted directly to aesthetic practitioners via email, social media, or marketplace sites are not always the great deal they might appear at first glance and are, in most circumstances, so-called ‘grey market’ or ‘parallel importations.’
This article will explore the concept of parallel imports, explaining why buying your cosmetic injectables from unofficial suppliers will risk invalidating your insurance, voiding product warranties, and will mean you are putting yourself at risk if something goes wrong with your treatment.
Parallel importation is a legal practice and refers to non-counterfeit, legitimate products, but they have been imported from another country without the permission of the intellectual property owner (the manufacturer).1,2 This may include products which were not intended to be sold in the EU, thus do not have the appropriate CE markings and manufacturing compliance. For example, batches of a well-known dermal filler brand may be produced by the manufacturer for sale in non-EU countries. It may or may not include different languages on the packaging and is likely to be missing CE mark labelling for the EU (and UK whilst we transition post-Brexit). Such products may be bought at attractive prices by parallel importers for sale at a small per unit profit in the UK. The same is true for EU-destined products, where currency fluctuations can make it attractive to buy stock in Euros for resale in Pound Sterling. This denotes the ‘grey area’ of their existence as they are being sold outside of the authorised distribution channels.
Within the last few years, we have seen a significant growth in online pharmacies and social media-based sales reps targeting aesthetic practitioners with the offer of cheap deals or bulk buys for many of the injectable brands available from leading pharmaceutical companies – everything from dermal fillers, injectable lipolytics, and weight loss drugs to unlicensed botulinum toxins.
This is usually achieved by individuals either bulk buying through approved distributors or subsidiaries in other territories, who may or may not be aware of the final destination of the products that are being purchased from them. Similarly, some medics in other territories may gain advantages from onward sale of stock that they have sourced legitimately for their territory.
Many sellers appear legitimate; they may be linked to other businesses such as UK-based training academies, claim a presence or sales base in the UK, or have an existing pharmacy business. However, be warned that many are offering brands that they are not approved to directly sell within the UK, thus can only be supplying parallel imported products. As a buyer, unless you ask, you are often none the wiser that you are not getting products that are genuinely fit for sale in this territory.
Some appear even less legitimate – often targeting non-healthcare practitioners who struggle to source products from official routes. They may approach practitioners asking to be a Facebook friend or contact practitioners using direct messaging apps. Many of these operators do not have a fixed address, business name, or pharmacy licence and seek payment through PayPal or even direct bank transfer. Many are simply scammers – they take your money, block you, and have no intention of honouring the purchase, leaving you out of pocket with no recourse.
Pharmaceutical companies are committed to meeting the highest standards through stringent quality control and quality assurance processes. Prescription-only medicines (POMs) are manufactured according to good manufacturing practice (GMP) regulations and medical devices sold in the UK are CE marked (moving to UKCA marking post-Brexit).3 They maintain full visibility and traceability across their entire supply chain, with an end-to-end approach that supports patient safety. Sadly, these companies are not immune to either counterfeit products or the movement of their goods from multiple resellers.
Businesses who have exclusive rights to be a distributor for a dermal filler brand in the UK and Ireland have entered a contractual obligation which ensures that the products they distribute within this territory are approved under regulations and come from these traceable sources. They will then create official wholesale routes with chosen pharmacies to disseminate the products within the marketplace via a managed supply chain. If you buy from one of these official distributors, or direct from a local subsidiary of the manufacturer, which may also be an option, you can be guaranteed that you are receiving a product that was destined for sale in the UK and Ireland. It can be traced back from the moment of manufacture, has been continuously stored appropriately, and is safe to use on your patient. Should you encounter any complications during use, or failures with the syringe, then you have a guaranteed route for advice, assistance, and recompense with the distributor or subsidiary.
Approved supply chains mean that practitioners can be certain of the traceability of medical devices that they buy, that correct storage and handling has taken place, and that only products earmarked for use in the UK are in circulation.
Through parallel imports, there is no way of ensuring correct handling whilst the products are in the supply chain because their journey cannot be sufficiently traced. As noted in individual package inserts, products such as Profhilo require specific storage temperatures and handling between 0° and 25°C and must not be frozen or exposed to heat sources to ensure the safety of your patients. Other cosmetic injectables, like botulinum toxins, can require uninterrupted cold chain storage as detailed in their summaries of product characteristics. The lack of reliable information with grey market products concerning storage temperatures and handling means that products could be damaged, defective, compromised in both efficacy and safety, or even expired. This all poses a significant risk to patient safety, as often identified in the manufacturer’s guidance for particular products.
To ensure that products distributed via official supply chains are fully traceable in cases of product recalls, many pharmaceutical companies, distributors, and subsidiaries implement tracking systems which can, by barcode, track each box in every location after leaving the manufacturing site on its onward journey to the end user. This might not be the case if purchased from a supplier who operates outside the official supply chain with no direct links to either manufacturer or a distributor/subsidiary.
As an aesthetic clinician, if you purchase grey imports then you have bought product from an unapproved source and the authorised UK distributor/subsidiary will not support your actions. This can have far reaching implications for both your business and clinical practice.
An unauthorised wholesaler will not have sourced their products directly from either the authorised country distributor or the originating manufacturer/pharmaceutical company, thus neither will have a relationship with such sellers or have any means of controlling the products that they sell.
All injectable products carry unique stickers – which should be kept and documented within patient notes, and include batch numbers, dates of manufacturer and expiry.
The authorised distributor can tell if the batch number of the product that you used on a patient was part of their managed supply chain. Purchasing grey imported products often voids warranties with both the authorised distributor and the originating manufacturer which would apply had you used official and recognised supply chain routes. If you have a problem, such as an adverse reaction to a product, you may also find that the unauthorised wholesaler is also unresponsive, and you find yourself out in the cold with no support to manage the situation. Seeking advice on social media forums should not be a replacement for advice from an authorised distributor as we often see incorrect information is being given by people not directly involved with the brand.
One of the biggest risks posed by purchasing grey market products is invalidating your medical malpractice insurance. Hamilton Fraser Cosmetic Insurance policies would not cover any practitioner that performed cosmetic procedures using unauthorised products, and this will be the case for other insurance providers too.
When you take out an insurance policy, you are paying for the reassurance of legal and financial support should something go wrong with the treatments you perform. By purchasing products from unauthorised sources, you are inadvertently invalidating your cover from the outset, because this could put your patients at risk of harm. It is important that you make sure all products have been sourced from reputable and listed suppliers and that your standards of product choice are always maintained. Sadly, many practitioners are unaware of the dangers of invalidating their cover, either through ignorance or genuine error, when deciding where to source the products that they use on their patients.
In the event of a claim on your policy, your insurer will request proof of the manufacturer and the batch code of the product used. The product batch stickers should always be included in the patient’s file and in some cases the insurer may also require a purchase invoice, if there is an issue with the product or if there was a claim for stock damage from fridge failure, for example. If it transpires that the product was not purchased from an authorised supplier, then the claim can be repudiated and your policy may be cancelled because you, as the policyholder, have violated policy conditions in relation to product sourcing. It is therefore best practice to keep receipts, ensuring that they are from a reputable source, to avoid the risk of the insurer declining cover and the policy being void due to non-compliance with policy conditions.
Similarly, you risk invalidating your policy by training to use a specific brand of injectable product with a company who is not approved by the manufacturer. Most approved training certification is accessed directly through the authorised UK and Ireland distributor or the country subsidiary. They may also authorise individual training providers to offer training using their approved educators.
Like many things within the UK aesthetic sector, regulation on training and certification is poor and there are a multitude of businesses offering CPD or accredited training in the use of branded products without any manufacturer approval or scrutiny of their training materials. This can lead to inadequate and potentially dangerous instruction, risking patient safety. Investing in unauthorised and unapproved training courses will render the certificate that you show to your insurer simply not worth the paper it is written upon. Always seek manufacturer-approved training certification by speaking directly to the approved territory distributor, country subsidiary, or original manufacturer for guidance. In addition, check with your insurer whether there are any other conditions when it comes to training, for example, Hamilton Fraser requires that training for injectables is taught by a medical professional.
If you are not sure who the authorised stockists or wholesale pharmacies are for your preferred brands, do not be afraid to ask the UK distributor/subsidiary for a list. You can also contact the manufacturer directly for country guidance; many often list distribution information by territory on their website. Not every aesthetic product wholesaler is contractually approved to sell every brand, even if they are a well-known and reputable provider, they may still stock grey imports for those brands which they are not authorised to sell. The Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA) also provide a database (EudraGMDP) to allow healthcare practitioners to identify legally operating pharmacy suppliers.4
Hopefully, this article has made you carefully consider where you buy your cosmetic injectable products. Practitioners are encouraged to purchase products from the manufacturer’s selected group of pharmacies or distributors. Whatever you are buying in this field, you should look at quality, substance, and a high level of support services alongside price rather than just price alone.
Deliberately or knowingly buying products not intended for the sale in the UK on the grey market could cause physical harm to your patients as well as reputational and financial harm to you and your business. Do you really want to be practising aesthetics knowing that neither your insurer nor the authorised distributor has your back if there is a complication and a claim against you? Sleep easy, choose your products and suppliers wisely.
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