United Kingdom Supreme Court

The main features of the Carmen bra

"A mastectomy bra which is worn by post-operated women, following amputation of a breast or breasts. The bra is especially designed to hold silicone breast forms and has left and right pockets to hold the breast forms firmly in place. The other design features which differentiate the mastectomy bra from an ordinary bra are the wide padded straps which help support the weight of the breast form and help to avoid undue stress associated with neck/shoulder problems for the post operated women. The bra is also designed to ensure the breast form itself does not show and therefore has a specific cut and shape dissimilar to a conventional bra."

As the FTT found, it was designed not solely for post-mastectomy use, but also for patients who had had a lumpectomy (removal of a tumour), or following breast reconstruction.

"The most noticeable differences between the two garments (were) that the mastectomy bra had two side supports on the outside of each breast, which were absent in the normal brassière which we saw, and the straps in the mastectomy bra were positioned centrally over the breasts whereas in the normal bra the straps were marginally over to the sides. It was Mrs Seehaus's evidence that the area under the bust was not elasticated, however, we do not accept this evidence, it appearing to us that there was some give in that area. She also referred to the fact that there was more fabric used to cover what might be called the cleavage, ie the middle part of the bra, than would be found in a normal brassière." (para 17)

(Mrs Seehaus was product manager for the German parent company of the appellant.)

"We find that there is not one of the above features which may not be found in an ordinary brassière, although the positioning of the pockets to hold the breast form in conjunction with the higher cup to cover it is not such as would usually be found in an ordinary brassière where the opening is more normally used in conjunction with a low cut bra, and where it is found, it is in order to insert padding to create an appearance of a larger bust; the central positioning of the straps is a feature which we accept it would be unusual to find in a normal brassiere." (para 19)

They referred to evidence that, as an alternative to a mastectomy bra, the same (or in some respects a better) result might be achieved by "a new system in which breast forms are attached by adhesive strips to the thorax wall" (para 24). They accepted also that one purpose of the breast form and the bra taken together was "the lessening of the psychological impact of having had the mastectomy" (para 25). Later in their judgment, they rejected arguments that it had some other medical purpose than containment of the breast form:

"On examination of the mastectomy bra we could find no evidence that its function was not just the containment of the breast form, but was also the prevention of shoulder pain and problems arising from the absence of lymph nodes." (para 33)

The CN system

"[The CN] is based on the customs classification scheme agreed and used internationally by a large number of countries, called the Convention on the Harmonised Commodity Description and Coding System ('HS'). The EU is a party to this Convention. The HS consists of some 5,000 groups of goods with 6-digit codes. The CN integrates the HS but in addition contains further subdivisions with 8-digit codes, specifically adapted for the EU. Both the HS and the CN have explanatory notes ('HSEN' and 'CNEN' respectively), which are prepared by experts. Courts generally give weight to these notes even though they are not legally binding."

The current version of the CN takes effect under EEC Regulation 2658/87, as updated by EU Regulation 927/2012.

"Orthopaedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances; artificial parts of the body; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability."

"2. ...

(b) Other parts and accessories, if suitable for use solely or principally with a particular kind of machine, instrument or apparatus, or with a number of machines, instruments or apparatus of the same heading ... are to be classified with the machines, instruments or apparatus of that kind.

6. For the purposes of heading 9021, the expression 'orthopaedic appliances' means appliances for:

- preventing or correcting bodily deformities; or

- supporting or holding parts of the body following an illness, operation or injury ..."

The European cases

"[T]he intended use of a product may constitute an objective criterion in relation to tariff classification if it is inherent in the product, and such inherent character must be capable of being assessed on the basis of the product's objective characteristics and properties."

As noted by Arden LJ in the Court of Appeal (para 54), Advocate General Kokott in her opinion in Uroplasty gave more detailed guidance as to the structured or "hierarchical" approach which may be required by the various headings and subheadings of the CN. However, the area of dispute in this appeal is narrowly defined by reference to the scope of a single subheading (9021), so that issues of hierarchy do not appear to arise.

"It must be made clear at the outset that, when the court is requested to give a preliminary ruling on a matter of tariff classification, its task is to provide the national court with guidance on the criteria which will enable the latter to classify the products at issue correctly in the CN, rather than to effect that classification itself, a fortiori since the court does not necessarily have available to it all the information which is essential in that regard. In any event the national court is in a better position to do so." (para 26)

Turbon 1 and 2

"... according to the HS explanatory note relating to heading 8473, '[t]he accessories covered by this heading are interchangeable parts or devices designed to adapt a machine for a particular operation, or to perform a particular service relative to the main function of the machine, or to increase its range of operations'." (para 12)

In the court's view this test was not satisfied:

"While the cartridges are interchangeable, they are not designed to adapt the printers for a particular operation, or to perform a particular service relative to their main function, or to increase their range of operations, within the meaning of the HS explanatory note relating to heading 8473. Such cartridges merely enable ESC printers to fulfil their usual function, namely, the transcription on to paper of work produced with the aid of a computer." (para 32)

"made up of two elements which, when considered separately, may each be classified under one heading, namely subheadings 3215 90 80 or 8473 30 90 of the CN, but neither of those headings covers the goods as a whole." (para 19)

It was therefore necessary, under the general rules, to determine which element provided the "essential character". On this point the court held that the ink was determinant, with the result that the correct classification was 3215 90 80:

"Even if an ink cartridge ... is constructed in such a way that the Printer does not function in the absence of that cartridge, the fact remains that the ink contained in the Cartridge is the most important factor for the purpose of using the goods at issue. In fact, the ink cartridge is not inserted in the printer in order to make the printer itself function but specifically to supply it with ink. Therefore, the ink must be regarded as determining the essential character of an ink cartridge, such as that at issue in the main proceedings." (para 23)

"... as the court correctly held in its first judgment (para 32) it is not possible to classify the ink-cartridges under CN heading 8473 as an 'accessory'. As the explanatory note to HS heading 8473 makes clear, only something which enables the principal item to perform a function over and above its standard functions counts as an accessory. This is not the case with the ink-cartridges, which, though necessary to enable the printer's standard functions, do not enable anything beyond that." (para 56)

Unomedical

"The bags are manufactured from PVC foil and injection-moulded plastic components. The bags are designed to function together with a standard balloon catheter, but are imported and sold without the catheter. The function of the bags is to collect urine, at the same time ensuring a sterile environment around the catheter and facilitating observation, measurement and sampling of the drained urine." (para 15)

The dialyser bags performed a similar function (para 17). The court observed that catheters and dialysers were provided for by specific subheadings under 9018, and that the drainage bags could only be included in that classification on the basis that they were parts or accessories under note 2(b) (para 27).

"... the court, ruling on the scope of those concepts in connection with heading 8473 of the CN for the purpose of classifying ink cartridges for printers, stated that the notion of 'parts' implies a whole for the operation of which the part is essential and that the notion of 'accessories' implies an interchangeable part designed to adapt a machine for a particular operation, or to increase its range of operations, or to perform a particular service relative to the main function of the machine." (para 29)

Applying the same approach to chapter 90 note 2(b), it held that neither test was satisfied:

"36. Neither the urine drainage bag for catheters nor the drainage bag for dialysers is indispensable for the functioning of those instruments or apparatus. It is apparent that catheters do not depend on the presence of a urine drainage bag in order to function and, similarly, that dialysers do not depend on the presence of a drainage bag in order to carry out dialysis, since the process of cleansing blood is complete at the time when the bag is used, that bag serving only to collect the liquid drained ...

37. The latter finding cannot be called into question by the fact that dialysers work only when a bag is attached. In that regard, suffice it to state, as the European Commission points out, that, were it not for the security mechanism with which that apparatus is fitted, the dialysis process could be carried out without a bag, that security mechanism being the sole link between the apparatus and the bag ...

38. Likewise, those bags do not enable the instruments and apparatus to be adapted for a particular operation, nor do they increase their range of operations, or enable them to perform a particular service connected with their main function. A drainage bag attached to a catheter has the sole purpose of collecting liquid drained after the catheter itself has fulfilled its own function, which is to drain the urine present in the bladder. For its part, a drainage bag for a dialyser does not enable that apparatus to perform operations other than that for which it is designed, namely that of cleansing blood."

The issues in the appeal

Orthopaedic appliances

"We agree that the Carmen mastectomy bra does not, in isolation, correct the deformity caused by the absence of a natural breast but, as the FTT made clear, it does support the breast form which is an artificial part of the body. We reject Mr Singh's submissions that note 6 does not apply to artificial body parts. It seems to us that the fact that CN heading 9021 includes artificial parts of the body such as artificial joints and eyes and that note 6 to chapter 90 specifically refers to heading 9021 suggests that 'parts of the body' in note 6 refers to artificial parts of the body as well as natural ones. We consider that, whether applying the Advocate General's analysis in paras 66 - 69 of her opinion in Uroplasty or note 6 to chapter 90 of the CN, the Carmen mastectomy bra is an orthopaedic appliance because it performs the function of the missing muscles and tissue in supporting or holding the breast form or forms ..." (para 69)

"they display characteristics which distinguish them, in particular by the materials of which they are made, their method of operation or their adjustability to the patient's specific handicaps, from ordinary belts and supports for general use." (court para 45)

Neither of these cases provide any direct assistance on the issue before us.

Appliance to compensate for a defect or disability

"CN 9021 (set out above) refers where relevant to 'appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability'... Note 6 (see above) relates specifically to heading 9021. The Appellant relies on this note for its submission that the mastectomy bra is used to prevent or correct bodily deformities. The breast form could not compensate for the deformity without a mastectomy bra because there is no way that it could achieve its desired compensatory effect on its own, there being nothing to hold it in place. The mastectomy bra itself corrects the deformity caused by the absence of relevant muscle structure that previously held in place a natural breast. It is only through the combination of breast form and mastectomy bra that the existing bodily deformities can be corrected, further bodily deformities prevented and the relevant part of a woman's body (whether artificial or otherwise) be supported or held. The mastectomy bra cannot perform any corrective functions on its own without being used in conjunction with the breast form and therefore it cannot come within 9021." (para 32)

As I understand it, the UT did not disagree on the FTT's application of this part of 9021 itself, but thought that a different result should be reached under the second indent to note 6.

"The MB in fact falls outside note 6 on the findings of the FTT because it supports the breast form and it is the breast form which corrects the deformity. There is no difference for this purpose between a disability and a deformity." (para 72)

She found support by the HS Explanatory Notes:

"As Mr Singh submits, the HSENs make it clear that the heading 9021 does not apply to products which merely alleviate a condition. They must compensate for a defect or disability even though this is not expressly stated in the heading to be a required characteristic of each of the items mentioned in the heading. It would follow that an article within the particular category on which Amoena relies - 9021 90 90 - would also have to compensate for a defect or disability in the sense given in the HSENs." (para 65)

On the findings of the FTT, it was the breast form which compensated for the defect or disability; the bra was worn solely to keep it in place (para 67).

Artificial parts of the body

The Upper Tribunal

"57. ... In our view, an accessory is not merely something which is used in conjunction with an item: an accessory must also contribute something to the item. We consider that an accessory must provide some additional functionality or enhance the performance of the item. An accessory is an optional improvement to the product whereas a part is something that is essential or integral to the functioning of the item.

...

61. In our view, the Carmen mastectomy bra is a part of or accessory to the breast form in that the bra is used in conjunction with the breast form to enable both to function as a prosthesis for the natural breast that has been wholly or partly removed or reconstructed. As the FTT held ... the mastectomy bra cannot perform any corrective functions on its own without being used in conjunction with the breast form. We consider that finding to indicate that the bra is a part or accessory. We do not regard the fact that neither the bra nor the breast form would be a satisfactory prosthesis for the natural breast on their own as meaning that the bra cannot be a part or accessory for use with the breast form ..."

(I note that they also found some support for their approach in a short reference to note 2(b) in the opinion of the Advocate General in Uroplasty. However, given the very different facts, and since this reference related to an alternative ground not adopted by the court itself, I doubt whether any real assistance can be gained from that passage.)

The Court of Appeal

"36. The CJEU applied Turbon, noting that in that case the CJEU had held that:

'the notion of parts implies a whole for the operation of which the part is essential and that the notion of 'accessories' implies an interchangeable part designed to adapt a machine for a particular operation or to increase its range of operations.' (para 29).

37. The CJEU further held that this was the meaning of parts or accessories in chapters 84 and 85, and that the same meaning applied in note 2(b) to chapter 90 (para 34).

38. The bags could not be a part of the dialyser or catheter since they were not essential to the functioning of either instrument. Those appliances could function without a bag.

39. The bags were also not 'accessories' since they did not improve the performance or functionality of the dialyser or catheter.

40. As to this case, the MB is not a part of the breast form in the sense given in Unomedical since it is not essential to the operation of the breast form. (The breast form may be, and in some instances is, simply strapped to the body.) The function of the breast form is to simulate the appearance of the natural body. It is not a question of whether the wearer perceives the breast form to be, or have become, a part of her body as the question of classification must always be determined by reference to the objective characteristics of the article in question.

41. In my judgment, contrary to the submission of Mr Eicke, the MB is also not an accessory of the breast form for the purposes of chapter 90. It does not improve the performance of the breast form or give it any additional functionality which it is not capable of having without the MB."

I note that Arden LJ's quotation from the guidance relating to HS8473 omitted (without explanation) the second part of the test "or to perform a particular service relative to the main function of the machine": see para 14 above.

"In any normal parlance the MB would surely be an accessory to the breast form. It holds it up. Certainly, there was evidence that there were other means, apart from MBs, for securing breast forms, but in one way or another something has to be done to prevent the form simply sliding down the body and out of place. The MB is, therefore, in my view, as a matter of simple common sense, an accessory designed to perform that imperative function in relation to the breast form." (para 86)

That view also accorded with the dictionary definitions of accessory as "contributing as an adjunct" or "auxiliary" (para 90).

"97. For my part, I would have thought that a printer cartridge was classically something which 'performs a particular service relative to the main function of' the printer, namely to enable it to print, but apparently not."

However, he accepted that this decision could not be distinguished on the basis that it was directed to a different part of the CN, given that the same approach had been applied to heading 9021 in Unomedical.

"100. So, is the MB an accessory to the breast form in the sense that it 'perform[s] a particular service relative to the main function' of the breast form. As might be understood from the above, I think that, on any natural meaning of these words, it does precisely that; it holds it in place and prevents it sliding off the body, even if there may be other devices that are capable of achieving that result.

101. Is that enough for us to hold that the MB is an 'accessory' to the breast form, if the law that we have to apply is that an ink cartridge for a printer does not perform such a service for the printer? Regrettably, I feel constrained to hold that the answer is 'No'."

Discussion

Conclusion