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EXTRA DIVISION, INNER HOUSE, COURT OF SESSION |
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Lady PatonLord ClarkeLord Emslie |
[2008] CSIH 64P818/06OPINION OF THE COURT delivered by LADY PATON in the cause HYALTECH LIMITED Petitioners: for Judicial Review of a
decision of the Medicines and Healthcare Products Regulatory Agency (MHRA) _______ |
Petitioners and Reclaimers:
Cormack, Solicitor-Advocate;
McGrigors LLP
Respondents (MHRA): Brodie; Office of the Solicitor to the Advocate
General for
Introduction
[1] Hyaltech
Limited manufactures medicinal products and medical devices. One of its products comprises two ampoules of
Visthesia Topical ("Topical") and a hypodermic syringe containing Visthesia
Intracameral ("Intracameral"). The items
are packaged in a cardboard box with an information leaflet, and are sold for
use during cataract surgery.
[2] Topical is a
viscoelastic solution, applied to the surface of the eye. It contains sodium hyaluronate which hydrates
and lubricates the cornea, and lidocaine which acts as a local
anaesthetic. Intracameral is also a
viscoelastic solution containing sodium hyaluronate and lidocaine, but in
different proportions. Intracameral is
injected into the anterior chamber of the eye creating a space within which
surgery can take place with a reduced risk of mechanical damage to ocular
structures.
[3] In 2002, a
question arose whether Topical and Intracameral should be classified as
medicinal products or as medical devices in terms of
[4] The relevant
licensing authority in the
[5] The MHRA
considered the Advice issued by the Review Panel, together with other
material. They then issued a final
determination dated
[6] A debate took
place before Lord Macphail. On
Background information: European market and information leaflets
[7] Hyaltech
market Topical and Intracameral throughout
[8] In 2002,
Hyaltech's Information for Use leaflet (IFU 2002) contained the following
passage:
"Uses
Visthesia topical hydrates and
lubricates the surface of the eye in preparation for intraocular surgery, with
analgesia.
Application 5 minutes before
intraocular surgery enables hydration of the surface tissue and diffusion of
the analgesic through the viscous solution to be absorbed directly onto the
cornea. A second application immediately
before surgery supplements the initial application to provide hydration,
lubrication and analgesia of the cornea for the early stages of the surgical
procedure.
The viscous solution brings the anaesthetic
into intimate contact with the corneal epithelium through which it is
absorbed. Anaesthesia occurs rapidly
usually within 5 minutes. The duration
of effect is normally 20 to 30 minutes."
[9] During 2003
the relevant licensing authority in
"Uses
Visthesia topical hydrates and
lubricates the surface of the eye in preparation for and during intraocular
surgery.
Application before intraocular
surgery enables hydration of the corneal epithelium cells. It ensures that the cornea stays clear and
hydrated throughout the surgery and is not compromised. The lubricating properties ensure that a
clean small incision can be made with minimal damage.
A second, supplementary, application
is used only if needed.
Lidocaine is incorporated in the
topical viscoelastic solution as an ancillary anaesthetic agent. It should be included in the ophthalmic
surgeon's routine anaesthetic regimen."
[10] If Topical
were to be classified in the United Kingdom as a medicinal product (rather than
a medical device), Hyaltech would experience some administrative difficulties
as the classification would be different from that generally accepted in the
rest of Europe (although not officially tested in any European country other the
Netherlands, and thus possibly open to challenge elsewhere in Europe: cf Optident
Limited v Secretary of State for
Trade and Industry [2001] 3 C.M.L.R. 1, Lord Slynn of Hadley at pages
9 to 10). Moreover the cost and time
involved in making an application to the MHRA for the relevant medicinal
product licence would be respectively about £250,000 and two and a half
years. Until licensed, Hyaltech would be
unable to sell Topical in the
The regulatory
framework
[11] As counsel for the MHRA suggested during
the reclaiming motion, a simplified version of the various definitions might be
as follows: a "medical device" has a
mechanical action, whereas a "medicinal product" has a chemical action. However the regulations and the Directive are
not so straightforward. Relevant
passages include:
[12] The Medical Devices Regulations 2002: The Medical Devices Regulations 2002
(implementing inter alia Directive
93/42/EEC of
"'medical device' means an
instrument, apparatus, appliance, material or other article, whether used alone
or in combination, together with any software necessary for its proper
application, which -
(a) is
intended by the manufacturer to be used for human beings for the purpose of -
(i) diagnosis,
prevention, monitoring, treatment or alleviation of disease,
(ii) diagnosis,
monitoring, treatment, alleviation of or compensation for an injury or
handicap,
(iii) investigation,
replacement or modification of the anatomy or of a physiological process, or
(iv) control
of conception; and
(b) does not achieve its principal intended action [italics
added] in or on the human body by pharmacological, immunological or metabolic
means, even if it is assisted in its function by such means,
and includes devices intended to
administer a medicinal product or which incorporate as an integral part a
substance which, if used separately, would be a medicinal product and which is
liable to act upon the body with action ancillary to that of the device; ..."
[13] MEDDEV:
The European Commission published guidelines to assist in the
practical application of the Medical Devices Directive 93/42/EEC. The relevant version is referred to as MEDDEV
2.1/3 rev
"A.2 General
principles
The principal intended action [italics added] of a product may be
deduced from:
·
the
manufacturer's labelling and claims
·
scientific
data regarding mechanism of action.
Although the manufacturer's claims
are important, it is not possible to place the product in one or other category
in contradiction with current scientific data.
Manufacturers may be required to justify scientifically their rationale
for classification of borderline products ...
A.5
Medical devices incorporating a
medicinal substance with ancillary
action
It follows from the definition of a
medical device that devices may incorporate substances as an integral part
which, if used separately, may be considered to be a medicinal product. This is specifically addressed in article
1(4) MDD which makes it clear that such products are devices, provided that
the action of the medicinal substance is ancillary to that of the device,
as reflected in the product claim and as supported by the scientific data
provided by the manufacturer of the devices."
[14] The Medical Devices Directive
93/42/EEC: The Medical Devices
Directive 93/42/EEC, which the 2002 Regulations implement, contains the
following definitions in Article 1:
"2.
For the purposes of this
Directive, the following definitions shall apply:
(a) 'medical
device' means any instrument, apparatus, appliance,
material or other article, whether used alone or in combination ... intended by
the manufacturer to be used for human beings for the purpose of: ...
- ... replacement or modification of
the anatomy or of a physiological process ...
and which does not achieve its
principal intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by
such means; ...
4.
Where a device incorporates,
as an integral part, a substance which, if used separately, may be considered
to be a medicinal product within the meaning of Article 1 of Directive
65/65/EEC [the precursor of Directive 93/42/EEC] and which is liable to act
upon the body with action ancillary to that of the device, that device must be
assessed and authorized in accordance with this Directive.
5.
This Directive does not
apply to:
(c)
medicinal products covered by Directive 65/65/EEC"
[15] Medicinal products: Finally, "medicinal product" is defined
in the Medical Devices Regulations 2002 by reference to article 1.2 of
Directive 2001/83/EEC, which (as amended) provides that a medicinal product is:
"Any substance or combination of
substances presented as having properties for treating or preventing disease in
human beings;
Any substance or combination of
substances which may be used in or administered to human beings either with a
view to restoring, correcting or modifying physiological functions by exerting
a pharmacological, immunological or metabolic action, or to making a medical
diagnosis."
The Advice of the Review Panel
[16] The Advice of
the Review Panel was in the following terms:
"INDEPENDENT REVIEW PANEL ON
BORDERLINE PRODUCTS
MEETING
HELD ON
Hyaltech Ltd.
Visthesia & Visthesia Light
FINDINGS
The Panel considered the oral and
written representations of the MHRA (Borderline Section) and Hyaltech Ltd. In light of the fact that there was no
dispute in relation to whether Visthesia and Visthesia Light bore any medicinal
claims, the Panel did not consider whether the first limb of the definition of
'medicinal product' ("Any substance or combination of substances presented for
treating or preventing disease in human beings or animals") as per Article 1 of
Directive 2001/83/EEC was satisfied. The
Panel therefore, only had to consider whether the second limb of the definition
of 'medicinal product' ("Any substance or combination of substances which may
be administered to human beings or animals with a view to making a medicinal
diagnosis or to restoring, correcting or modifying physiological function in
human beings or in animals is likewise considered a medicinal product") was
satisfied. The Panel found that
Visthesia and Visthesia Light fell within the second limb of the definition of
a medicinal product.
ADVICE
The Panel advised
that Visthesia and Visthesia Light are relevant medicinal products and subject
to the provisions of The Medicines for Human Use (Marketing Authorisations Etc)
Regulations 1994 (S.I. 1994/3144) as amended by The Medicines for Human Use
(Marketing Authorisations Etc.) Amendment Regulations 2000 (S.I. 2000/292).
REASONS FOR ADVICE
The products Visthesia
and Visthesia Light are presented as kits comprising an intracameral, a
viscoelastic cannula and two topical ampoules containing sodium hyaluronate
(3mg/ml) and lidocaine hydrochloride (20mg/ml).
The topical ampoules are the components under review.
The definition of medical device in
Regulation 2(1) of the Medical Devices Regulations 2002 includes devices
incorporating a medicinal product 'which is liable to act upon the body with
action ancillary to that of the device'.
By definition therefore, a product cannot be classified as a device if
the medicinal component is more than merely ancillary.
It is well documented that lidocaine
is an established medicinal substance with a local anaesthetic action i.e. its
effects will modify physiological functions in human beings. Anaesthesia is an essential part of surgery
and lidocaine is commonly used by surgeons at the start of a cataract
operation. Lidocaine has no effect on
the action of the hyaluronate, whereas the hyaluronate has a synergistic effect
on the lidocaine.
After having considered all the
information available, including the witness statements and evidence, the
patent, the claims of the manufacturer (both original and current), other
literature and the presentations made by both parties, the Panel held that the
anaesthetic element in the products Visthesia and Visthesia Light is not an
ancillary medicinal product, but has a separate and substantial action of its
own. The lidocaine is not liable to act
on the body with an action ancillary to that of the device itself. Accordingly, neither Visthesia nor Visthesia
Light can be considered as a medicinal device for the purposes of the Medical
Devices Regulations 2002.
The Panel, therefore, considered that
Visthesia and Visthesia Light fall within the second limb of the definition of
a medicinal product as stated in Article 1 of Directive 2001/83/EEC."
The second final determination of the MHRA
[17] The second final determination of the
MHRA, issued by letter dated
"NOTICE OF FINAL DETERMINATION IN ACCORDANCE
WITH REGULATION 3A OF THE MEDICINES FOR HUMAN USE (MARKETING AUTHORISATION ETC)
REGULATION 1994, AS AMENDED
VISTHESIA(tm) & VISTHESIA(tm) LIGHT
I refer to your request for a review
of the MHRA's Provisional Determination that the above named products are
medicinal products.
As you are aware, the Independent
Review Panel for Borderline Products heard full argument from lawyers [representing]
both parties and considered all relevant information and has advised that the
above products would fall within the second limb of the definition of a
medicinal product. I enclose a copy of
their findings for your information.
In making its determination the
Agency has considered afresh all relevant information, including the advice of
the Independent Review Panel for Borderline Products, your comments and the
additional information provided and gives notice that it has determined on
behalf of the licensing authority that the topical components in both Visthesia(tm) and Visthesia Light(tm)
are relevant medicinal products.
Accordingly these products are
subject to the provisions of The Medicines For Human Use (Marketing
Authorisations Etc) Regulations 1994 (S.I. 1994/3144), as amended. ('the Marketing Authorisations
Regulations'). The reasons for this
decision are as follows.
[The MHRA quoted regulation 2(1) of the 2002 Regulations, and
continued:]
"In making this determination it is
necessary to consider the meaning of 'intended purpose', 'principal intended
action' and 'ancillary'. The definition
in Directive 93/42/EC ('the Directive') and the Medical Devices Regulations is
supplemented by Guidance issued by the European Commission: the Medical Devices Guidance Document, or MEDDEV. The Guidance is authoritative but not legally
binding. The MHRA accepts the relevance
of these matters, although it notes that they are not exhaustive of the
material which may be considered; nor
are they set out in either the Directive or the Medical Devices Regulations.
Under the Directive:
Intended purpose relates to the question of whether
the product has, overall one of the four purposes set out in [the definition of
'medical device']. This is determined by
having regard to the data supplied by the manufacturer in the labelling,
instructions for use and promotional materials.
Insofar as the Guidance makes reference to manufacturers' claims, where
the product remains unchanged, this is not limited to current claims. The issue of
manufacturer's intent is determinative only at the initial stage of deciding
whether a product has, overall, one of the four purposes which would suffice to
make it a device (eg the purpose of investigation, replacement or modification
of the anatomy or of a physiological process).
The principal intended action of the product is to be determined
objectively. Although the Guidance (p3)
states that the principal intended action may be deduced from manufacturers'
claims and scientific data, it notes that it is not possible to categorise a
product in contradiction with current scientific data and that manufacturers
may be required to justify scientifically their classification rationale. The question of whether or not such action is
achieved by pharmacological, immunological or metabolic means can only be
addressed by scientific evidence.
Taking into account the examples
given in the Guidance, MHRA is of the view that: Ancillary action, in relation to the
principal intended action, is an action which is insignificant or of little
importance; or an action which is
subsidiary or auxiliary, or which supplements or provides support, to the
principal intended action.
Because the definition of medical
device includes devices incorporating a medicinal product 'which is liable to
act upon the body with action ancillary to that of the device' it does not
include devices incorporating medicinal products whose action is more than
'ancillary'. Such devices do not come
within the scope of the Medicinal Devices Regulations and are to be regulated
as medicines. The question of whether a
medicinal component of a device has an ancillary action is to be determined
according to whether it is 'liable' to have an ancillary action, not whether it
is intended by the manufacturer to have an ancillary action. If an action is more than ancillary, this
does not necessarily mean that it must be a principal intended action.
The Guidance states that the issue of
whether the action of a medicinal component is ancillary is to be decided in
the light of 'the product claim' and the 'scientific data provided by the
manufacturer of the devices' (para. A.5).
It is important to note that manufacturers' claims cannot prevail over
scientific data (para. A.2).
The Present Case
The products Visthesia(tm)
and Visthesia Light(tm) are presented as kits and therefore each of the components
needs to be considered individually. The
kits contain two 0.3ml topical ampoules of a sterile viscous solution
comprising of 0.3% sodium hyaluronate and 2% lidocaine hydrochloride in
phosphate buffered saline which is used prior to intraocular surgery. In this case, because the function of sodium
hyaluronate is that of a medical device it is necessary to consider whether the
combination production could be classified as a medical device.
Whilst the Agency takes the view that
the intracameral and the viscoelasitic cannula components of each kit are
appropriately controlled as medical devices, the Agency considers the topical
ampoules in each kit to be medicinal products.
The Agency and Hyaltech Limited agree that the topical component of
Visthesia is intended to be used for human beings for the purpose of
investigation, replacement or modification of the anatomy or of a physiological
process. The intended purpose is clearly
to facilitate intraocular surgery.
The ingredient lidocaine is an
established topical anaesthetic which acts by preventing the generation and
transmission of impulses along nerve fibres and at the nerve endings. If used separately it fulfils the definition
of a medicinal product and would be regulated as such. Lidocaine clearly acts by a pharmacological
mechanism and it is agreed between us that lidocaine is a medicinal product.
A product falls outside of the
definition of a device if the action of the anaesthetic component is more than
ancillary. It is therefore for the
Agency to determine whether the action of the lidocaine in the topical
components is ancillary to the purpose of the topical component as a
whole. Whether or not such action is
ancillary is a question of fact.
In the present case, MHRA is of the
view that the lidocaine component is liable to have an effect on the body which
is more than ancillary because:
1) The
evidence suggests that the anaesthetic function of Visthesia Topical is of
greater, or at least equal, importance relative to the wetting function served
by the sodium hyaluronate.
2) Even
if that is not the case, it is the Agency's view that the anaesthetic function
of Visthesia Topical is at least a significant, independent function of the
product and cannot properly be regarded as ancillary.
Evidence in support of MHRA's
conclusions includes:
Publications"
[The MHRA noted publications which had been referred to, and
continued:]
"Expert
Opinion
From the expert evidence, it can be deduced that:
Topical anaesthetic is routinely used
in cataract surgery in the
Even where anaesthesia is given by
injection subsequent to topical anaesthesia, topical anaesthesia clearly plays
an important role in anaesthetizing the eye.
The opinion of Mr Mackintosh indicates that an injection would not
normally be given without prior local anaesthesia. Although Mr Mackintosh states that he
would add additional topical anaesthetic, he notes that Visthesia can fulfil
that function:
'A fault in the descriptive use of
this product in Hyaltech's literature is that it emphasises using it
preoperatively, but does not stress that it should be used during the operation....'.
The experts disagreed over the
function of the topical sodium hyaluronate.
Mr Singh noted that it had an important role as a wetting agent,
but was not needed for lubrication because the eyelid does not blink during
surgery. Mr Mackintosh described
its function both in terms of wetting and lubrication. Whether or not sodium hyalunorate is a more
novel or interesting compound than lidocaine, as suggested by
Mr Mackintosh, is not relevant to this determination. The legal test is whether or not the action
is ancillary. Mr Mackintosh does
not suggest that the topical anaesthetic in Visthesia is unimportant.
Expert evidence shows that the
product is intended to facilitate surgery in two ways, by providing anaesthesia
and acting as a wetting agent. Both
experts agree that wetting and anaesthesia are essential for surgery. The fact that two substances with two
different objectives are used in combination does not, of itself, reduce either
objective to an ancillary role."
[The MHRA then referred to the Inventor's Statement, the
Manufacturer's Information, the CIBA Vision Press Release 2002, and the Product
Name, and continued:]
"Changes
to the Information for Use leaflet
During our investigation, the Information For Use leaflet was significantly
amended in 07/2003 in order to place less emphasis on the role of the
anaesthetic claim relating to lidocaine.
However, the product formulation has not altered in any way and the
action of the lidocaine in the topical ampoules remains to provide anaesthesia for
cataract surgery. The change in the
manufacturer's claim does not reflect any change in the scientific evidence of
the anaesthetic effect of lidocaine [or] the concentration contained in the
product or as to how the product is used.
For the reasons set out above, MHRA
has determined that the topical components in Visthesia and Visthesia Light
fall outside of the definition of medical device in the Medical Devices
Regulations and are relevant medicinal products for the purposes of the
Marketing Authorisations Regulations.
Withdrawal of the Product from the Market
The Marketing
Authorisations Regulations do not make provision for a staged withdrawal from
the market of an unlicensed medicinal
product. I must therefore ask you to
cease the sale and supply of this product with immediate effect and to
confirm in writing, within twenty one days of the date of this letter, that you
have made the necessary arrangements to do this. Please provide copies of your company's
notices or letters setting this in motion.
If that assurance is not received within twenty one days, supported by
evidence of compliance, I shall refer the matter to the Agency's Enforcement
Group."
Submissions on behalf
of Hyaltech
[18] The
submissions on behalf of Hyaltech were ultimately restricted to the contention
that the Lord Ordinary had erred in failing to hold that the MHRA had acted ultra vires by making material errors of
law, in particular errors in construction, and errors by taking irrelevant
matters into account and leaving relevant matters out of account (grounds of
appeal 2.1 to 2.5, 2.7 to 2.8). Grounds
of appeal 1.1 to 1.6, focusing on the alleged failure of the Review Panel to
provide proper and adequate reasons in their Advice, were not insisted
upon. Mr Cormack on behalf of Hyaltech
moved the court to grant the reclaiming motion;
to recall the interlocutor of the Lord Ordinary dated 15 May 2007 save
insofar as it repelled Hyaltech's first plea-in-law; to sustain Hyaltech's second to fourth
pleas-in-law; and to grant the final
orders sought in statements 3.2 to 3.5 of the petition, namely declarator that
the final determination was ultra vires, reduction
of that final determination, suspension of the purported notice requiring the
cessation of the sale and supply of Topical, and expenses. As an alternative, in the event that the
court found that disputed facts required to be clarified before a view could be
reached, it was submitted that this court should order a hearing of evidence on
specified issues before the Lord Ordinary.
Errors in construction
[19] Mr Cormack
submitted that the MHRA had erred in law in that they had wrongly construed the
Medical Devices Regulations 2002. The
proper method of construing the definition of "medical device" in regulation
2(1) was to ascertain, objectively, "the principal intended action in or on the
human body". That was to be obtained
from the manufacturer's literature, claims, labelling and promotional material,
and checked against the scientific data.
The final words of the definition of "medical device" in regulation
2(1), namely "and includes devices intended to administer a medicinal product
or which incorporate as an integral part a substance which, if used separately,
would be a medicinal product and which is liable to act upon the body with
action ancillary to that of the device", reflected article 1.4 of the
Directive, and made it clear that a product could still be a medical device
although it was assisted in its function by excluded means (namely
pharmacological, immunological or metabolic means). However those final words did not add
anything to the preceding words. In
particular the final words did not impose an additional test, or a more stringent
test, than the preceding words. Those
words were merely for the avoidance of doubt, with the word "ancillary" having
the restricted meaning of "subordinate" (rather than the range of meanings
adopted by the MHRA, namely insignificant, of little importance, subsidiary or
auxiliary, or supplementary or providing support). The only question at issue was whether the
principal intended action was achieved by the device by non-excluded
means. Examples of medical devices were
given in paragraph A.3 of the MEDDEV Guidelines. One example (bone cement) illustrated the
correct approach to construction: the "principal intended action" of the device
(as ascertained from the manufacturer's claims and scientific data) was the
adhesive function; the integral
pharmacological substance (namely, an antibiotic, which could be used
separately) was "ancillary" in the sense of "secondary or subordinate".
[20] Applying the
proper construction of the 2002 Regulations to the product Topical, it was
clear that the principal intended action of the device was the hydration of the
surface of the eye during cataract surgery.
Hyaltech did not claim that the lidocaine provided all necessary
anaesthesia during the cataract operation.
The manufacturer thus intended the lidocaine to have a subsidiary role
in the product. Accordingly on a proper
construction of the Regulations, ascertaining the "principal intended action"
of the device, the action of the lidocaine was subordinate to the action of the
device, and was not, as the MHRA had found as a matter of fact, of equal if not
greater importance. It was an error to
ascertain, as a matter of fact, the actual properties and effects of lidocaine: the correct approach was to focus upon the
manufacturer's intention.
[21] Summarising
Hyaltech's position on construction, Mr Cormack submitted that, as a matter of
law, the correct approach to the construction of the definition of "medical
device" in regulation 2(1) involved five steps.
The decision-making body had to:
1. ascertain,
on an objective assessment of the manufacturer's intention, whether the product
was intended to be used for human beings, in the present case for the
replacement or modification of the anatomy or of a physiological process: regulation 2(1) definition of "medical
device" paragraph (a)(iii);
2. identify
the intended action(s) of the material, on a consideration of the
manufacturer's claims and scientific data;
3. in
the event that there was more than one intended action, decide, with reference
to the manufacturer's claims and scientific data, which of the intended actions
was the principal intended action;
4. consider,
on the basis of scientific evidence, whether the principal intended action was
achieved by pharmacological, immunological or metabolic means;
5. in
the event that the principal intended action was identified as being achieved
by pharmacological, immunological or metabolic means, or in the event that no
one intended action could be categorised as "principal", then the material
could not fall within the definition of a medical device and could not fall
within the additional words at the end in the definition of medical device in
regulation 2(1) - which words were inserted merely "for the avoidance of
doubt".
Thus the proper construction of those additional words did
not impose an extra step in the test for ascertaining whether a product was a
medical device. The words simply made
clear that an item could qualify as such a device as a result of the
application of the five steps set out above, despite containing something
pharmacological. The result of the
application of those steps was that the action of that additional
pharmacological substance was ancillary in the sense that it was not the
principal intended action, and the word "ancillary" meant "secondary" or
"subordinate". It was difficult to see
how the 2002 Regulations could operate if any other approach to construction
were to be adopted. Thus on a proper
construction of the 2002 Regulations, there had to be one single principal
intended action. If there were two
principal intended actions, the product could not be categorised as a medical
device.
[22] In concluding his
chapter on construction, Mr Cormack submitted that the Lord Ordinary should
have held that there were material errors of law going to the root of the
issues to be determined. In particular
the MHRA had misconstrued the steps of statutory interpretation by (i) applying
as a step in relation to the integral medicinal substance a test other than the
required test of "principal intended action", leading the MHRA at page 4 of the
determination to an erroneous characterisation of the very issue for
determination; and (ii) by adopting an
erroneous meaning of "ancillary". Those
errors of law resulted in the MHRA's failure to address matters in the proper
way, namely ascertaining the intended action of the product, and the principal
intended action (having regard to the manufacturer's claims and scientific
data). The MHRA had failed to undertake
the relevant objective assessment of the intention of the manufacturer, having
regard to the current claims of the manufacturer and the scientific data.
Irrelevant matters taken into
account, and relevant matters left out of account
[23] IFU leaflets: Mr Cormack submitted that the MHRA, having
noted the alterations made to the IFU leaflets between 2002 and 2003 (see
paragraph [9] above), were obliged to address the question whether the
manufacturer's current claims were
consistent with the classification of Topical as a medical device. Yet that question appeared not to have been
addressed. Thus the MHRA had erroneously
left out of account the fact that the current IFU leaflet was consistent with
the classification of Topical as a medical device.
[24] Mr Mackintosh's evidence: Mr Mackintosh, a consultant ophthalmic
surgeon, gave evidence to the MHRA. In
paragraph [95] of his opinion, the Lord Ordinary concluded, correctly in Mr
Cormack's submission, that the MHRA had misunderstood a sentence of that
evidence. As was clear from the Lord
Ordinary's comments in paragraph [95], the MHRA had taken the sentence to mean
that Mr Mackintosh did not consider Topical as useful during surgery for the
effect of the hyaluronate in improving corneal clarity, whereas that was not in
fact the case. The MHRA had thus taken
irrelevant factors into account.
[25] Misconstruction of the patent: The
MHRA had misconstrued certain passages in the patent, as noted by the Lord
Ordinary in paragraphs [76] and [99] of his Opinion. It was not possible to hold those
misconstructions to be minor, as had the Lord Ordinary. On the contrary, they were highly
material. Thus the MHRA had left
relevant factors out of account, and had taken irrelevant factors into account.
[26] In concluding
the chapter on matters erroneously taken into account or left out of account,
Mr Cormack submitted that the Lord Ordinary had erred in refusing to hold that
the determination of the MHRA had been vitiated by those errors.
Watt v
Lord Advocate and Pharma Nord (UK) Ltd
[27] In the course
of the debate, reference was made to Watt
v Lord Advocate 1979 S.C. 120 and
R v Medicines Control Agency, ex parte Pharma Nord (UK) Ltd 1998 3
C.M.L.R. 109. Mr Cormack accepted that
the court should be cautious about interfering with the decision of a
specialist body in a complex specialist field.
However Hyaltech's contention was that the MHRA had made material errors
of law, as outlined above. They had
asked themselves the wrong question. The
issue was judicially reviewable as it fell outwith the category of intra vires error of law referred to in Watt.
The court was being asked to exercise the restrained supervisory
jurisdiction outlined in Pharma Nord (UK)
Ltd.
Possible reference to the European
Court of Justice
[28] On behalf of
Hyaltech, it was accepted that if the court considered that there was doubt as
to the proper construction of regulation 2(1) of the 2002 Regulations
(implementing Directive 92/42/EEC), a reference could be made to the European
Court of Justice.
Submissions on behalf
of the MHRA
[29] Counsel for
the MHRA moved the court to refuse the reclaiming motion and to adhere to the
interlocutor of the Lord Ordinary.
The construction adopted was correct
[30] Counsel
accepted that, when construing regulation 2(1), the first question was what was
the manufacturer's intent, and whether the use fell within one of the four
articulated grounds (set out in paragraph [12] above). Thus reference could be made to the
manufacturer's claims, labelling, and advertisements, and also to scientific
data, and an objective view of the principal intended action reached. To that extent, counsel did not disagree with
Mr Cormack. However when one reached the
clause at the end of the definition of "medical device" in regulation 2(1)
beginning with the words "and includes", the issue of "principal intended
action" did not arise. There was no
mention of principal intended action in that clause. On the contrary, the words directed the
decision-maker to decide a question of fact on the basis of scientific and
medical judgment, namely whether the action of the lidocaine was ancillary to
that of the device. Further, on a proper
construction, the word "ancillary" could have the range of meanings referred to
by the MHRA and the Lord Ordinary.
Different circumstances might require different meanings.
[31] Counsel
further submitted that if the intention of the manufacturer were held to come
into play when construing the clause at the end of the definition of "medical
device" in regulation 2(1), the manufacturer would be the arbiter as to whether
the product was, or was not, a medical device.
That could not be correct. The
2002 Regulations implemented a Community Directive which had as its aim the
safety of patients and the identification of appropriate regulatory regimes,
all as set out in the preamble to the Directive 93/42/EEC. The 2002 Regulations were concerned with
"borderline products", in other words with products in relation to which there
was quite obviously some doubt about which regulatory regime should apply. Where something which appeared to be a
medical device "incorporate[d] as an integral part a substance which, if used
separately, would be a medicinal product", the decision-maker was directed to
assess the various components of the device, and to decide as a matter of fact
whether the substance in question "[was] liable to act upon the body with
action ancillary to that of the device".
The regulation was intended to achieve an objective assessment of that
factual question, and it would be surprising if the manufacturer's opinion were
to be determinative.
[32] The
construction contended for by Hyaltech deprived article 1.4 of the Directive
(and the final words of the definition of medical device in the 2002
Regulations) of any meaningful purpose.
By contrast, the MHRA had correctly adopted a purposive construction of
the regulatory framework, which had the effect that the decision-making body
determined which regulatory regime should apply in order to achieve the
protection of the patients. Neither the
Directive nor the Regulations suggested that there could not be two principal
intended actions. Thus the MHRA were
entitled, at page 4 of their determination, to find that:
"1) The
evidence suggests that the anaesthetic function of Visthesia Topical is of
greater, or at least equal, importance relative to the wetting function served
by the sodium hyaluronate.
2) Even if that is not the case, it
is the Agency's view that the anaesthetic function of Visthesia Topical is at
least a significant, independent function of the product and cannot properly be
regarded as ancillary".
In a specialist area, it was for the specialist
decision-making body to make the decision.
No irrelevant matters taken into
account, or relevant matters left out of account
[33] IFU leaflets: Counsel submitted that the MHRA had taken
into account the wording of the 2002 leaflet, and compared it with the changed
wording of the 2003 leaflet. They
concluded that there had been a change of emphasis in the wording so far as
anaesthesia was concerned, but that the product remained unchanged. In so doing the MHRA could not be said to
have taken irrelevant matters into account, or to have left relevant matters
out of account.
[34] Mr Mackintosh's evidence: It was not necessary for the MHRA to
record in their determination every part of Mr Mackintosh's evidence. What they had noted in relation to his
evidence did not reveal any error or misunderstanding. Again therefore the MHRA had not been
demonstrated to have taken irrelevant matters into account, or to have left
relevant matters out of account.
[35] Patent:
The MHRA may have misunderstood parts of the patent. However in the whole context, any such
misunderstanding was immaterial.
Watt v
Lord Advocate and Pharma (Nord) UK Ltd
[36] In response to a discussion
which developed during Mr Cormack's submissions, counsel for the MHRA reminded
the court of a line of Scottish authority to the effect that a specialist
decision of a specialist body, made within their jurisdiction, addressing the
correct question, should not be interfered with by the Court of Session exercising
its supervisory jurisdiction, even although the court might consider the
decision to be erroneous. An intra vires error could not be
challenged. Authorities mentioned, but
not discussed in any detail, included Watt
v Lord Advocate 1979 S.C.
120; O'Neill
v Scottish Joint Negotiating
Committee for Teaching Staff 1987 S.L.T. 648, at page 650; Rae v CICB 1997 S.L.T. 291, at page
295F-J; Milton v Argyll and Clyde
Health Board 1997 S.L.T. 565, at page 568 B-E; Diamond
v PJW Enterprises Ltd 2004 S.C. 430
at page 441 et seq. Counsel
nevertheless accepted that circumstances could be envisaged in which a body
such as the MHRA might make a significant error, and that it would be
unfortunate if judicial review were not available. Also in Pharma
Nord (UK) Ltd, Lord Woolf envisaged a supervisory jurisdiction in
circumstances such as the present, albeit a jurisdiction which should be
exercised with great caution.
Ultimately, counsel did not seek to persuade the court that the present
case should be governed by the authorities referred to, or that the reclaiming
motion should be refused on the basis of those authorities alone.
Possible reference to the European
Court of Justice
[37] Counsel for
the MHRA accepted that the court had an obligation to refer the case to the
European Court of Justice in the event that there was any real doubt about the
proper construction of article 1.4 as implemented in the 2002 Regulations. However he contended that the MHRA's
construction was correct, and that it was not necessary to make a reference.
Discussion
The proper construction
[38] It was submitted on behalf of Hyaltech
that, as a matter of law, the only proper construction of regulation 2(1) of
the Medical Devices Regulations 2002 was as set out in paragraphs [19] to [22]
above. That construction meant that the
decision-maker had to ascertain, objectively, "the principal intended action in
or on the human body" of the item in question.
There could only be one principal intended action, and that had to be
ascertained from the manufacturer's literature and claims, checked against
scientific data. In the case of Topical,
applying the five-step method of construction contended for, the principal
intended action was the hydration of the cornea, with the anaesthetic effect of
lidocaine being ancillary in the sense of secondary or subsidiary. Thus Topical was properly categorised as a
"medical device". By failing to adopt
the proper construction, and by holding that the anaesthetic effect of
lidocaine was not ancillary and that the final words of the definition of
"medical device" in regulation 2(1) could not be satisfied, the MRHA had
misdirected themselves and had made a material error of law going to the root
of the issues to be determined. The Lord
Ordinary should so have held, and should have reduced the second final
determination.
[39] We do not
agree, for several reasons:
[40] First, a
purposive approach to construction should be adopted in respect of regulation
2(1), which implements Directive 93/42/EEC of
[41] Secondly, the
construction advanced by Hyaltech is strained and artificial. It requires certain precise steps to be
followed (all as set out in paragraph [21] above); a reading-in of the words "for the avoidance
of doubt" at the beginning of the final words of the definition of medical
device in regulation 2(1); the treatment
of those final words (and thus their source, article 1.4 of the Directive) as
otherwise superfluous, adding nothing to the preceding text; the ignoring of the plain meaning of the
words "liable to act upon the body" (which in our view must be a question of
fact to be ascertained by the specialist body rather than a matter to be
determined by the manufacturer's intention);
and finally, restricting the meaning of "ancillary" to "secondary or
subsidiary". In relation to that last
point, "the courts have repeatedly warned against the dangers of taking an
inherently imprecise word, and by redefining it thrusting on it a spurious
degree of precision.": Lord Mustill at page 28H of R v Monopolies and Mergers
Commission [1993] 1 W.L.R. 23. In
our view, there is nothing in either the Directive or the 2002 Regulations
justifying such a restricted meaning of "ancillary", and indeed circumstances
can be envisaged in which the spectrum of meanings offered by the word may be
required to give effect to the underlying purpose of the Directive and the
Regulations. In some contexts the proper
meaning may be "insignificant", or "of little importance", or "subsidiary", or "auxiliary",
or "which supplements or provides support".
We do not therefore accept Mr Cormack's argument that, having identified
a principal intended action of a device, there is no need to assess whether the
anticipated action of an integral pharmacological substance is ancillary to the
action of the device. On the contrary,
in our opinion that second question has to be addressed, and if the integral
pharmacological substance is not considered to be "liable to act upon the body
with action ancillary to that of the device" (construing "ancillary"
appropriately according to context), then the correct classification cannot be
that of "medical device".
[42] A third reason
for rejecting Mr Cormack's argument is that the construction contended for by
Hyaltech does not sit easily with the hypothesis contained in the final words
of the definition of medical device in regulation 2(1). As noted previously, the final words are:
"and includes devices intended to
administer a medicinal product or which incorporate as an integral part a
substance which, if used separately, would be a medicinal product and which is
liable to act upon the body with action ancillary to that of the device".
In the present case, the manufacturer obviously did not
intend the component lidocaine to be used separately from the compound Topical,
having intentionally incorporated the lidocaine in the compound. Thus to focus upon the manufacturer's
intention for the purposes of the hypothesis referred to above is to focus upon
nothing: the manufacturer did not
address or consider the hypothesis upon which the comparison is to be made.
[43] Fourthly, we
do not accept that either the Directive or the 2002 Regulations excludes the
possibility of two or more principal intended actions of a medical device. Yet it is fundamental to the construction
advanced on behalf of Hyaltech that a medical device must have only one principal
intended action.
[44] In conclusion,
we are not persuaded that the construction advanced on behalf of Hyaltech is,
as a matter of law, the proper construction.
[45] By contrast,
we are satisfied that the construction adopted by the MHRA cannot be
criticised. That construction does not require the reading-in of the words "for
the avoidance of doubt". It does not
render the final words of the definition of medical device in regulation 2(1)
otiose or superfluous. It does not
restrict the meaning of "ancillary" to "subsidiary or secondary". It adopts the plain meaning of the words
"liable to act upon the body".
Significantly, the construction fulfils the purpose underlying the
Directive and the 2002 Regulations in that it is the independent specialist
body and not the manufacturer who decides, on the basis of all the
circumstances (including the manufacturer's claims and scientific data), what
effect the lidocaine is liable to have on the human body, and whether or not
the action of the lidocaine is ancillary to that of the device. Thus the specialist body, free from
commercial pressures or financial interests, fulfils the important role of
protecting the health and safety of patients, users, and others.
[46] Further, the
construction adopted by the MHRA does not require reference to a non-existent
factor in the course of applying the hypothesis contained in the final words of
the definition of medical device in regulation 2(1). As noted in paragraph [42] above, the
manufacturer quite clearly did not intend the lidocaine to be used separately,
and thus such an intention cannot meaningfully be attributed to the
manufacturer.
[47] Finally, the
construction adopted by the MHRA permits the identification of two or more
principal intended actions of the device.
There is therefore no artificial constraint limiting the outcome of any
assessment to one (but not more) principal intended action.
[48] It is
accordingly our view that the construction adopted by the MHRA cannot be
criticised. The construction is
certainly not one which, in law, the MHRA were not entitled to adopt. We have not identified any further possible
constructions which might also be correct.
Accordingly, as we are in no real doubt about the proper construction,
we do not consider it necessary to make a reference to the European Court of
Justice.
Criticisms relating to the MHRA's
treatment of the evidence
[49] IFU leaflets: It is well settled that administrative bodies
such as the MHRA must give clear and adequate reasons, intelligible to the
informed reader: Wordie Property Co Ltd v Secretary of State for Scotland 1984
S.L.T. 345. However there is no
requirement that they must give a detailed summary of each and every piece of
evidence and the conclusion to be drawn therefrom. In our view, it was not necessary for the
MHRA to make a specific finding in their determination that the current IFU
leaflet was consistent with the classification of Topical as a medical
device. We do not accept that the lack
of such an express finding indicates that the MHRA erroneously left that factor
out of account. On the contrary, the
MHRA specifically noted the change in wording in the leaflets, commenting that:
"The change in the manufacturer's
claim does not reflect any change in the scientific evidence of the anaesthetic
effect of the lidocaine ...".
That comment could be interpreted as observing that although
the wording of the manufacturer's claim had been altered to make it more
consistent with classification as a medical device, significantly, the product
itself had not changed. The MHRA were
entitled to take such a view. We do not
therefore accept that the MHRA erred in their treatment of the IFU leaflets.
[50] Mr Mackintosh's evidence: In paragraph [95] of his Opinion, the Lord
Ordinary concluded that the MHRA had misunderstood a sentence of Mr
Mackintosh's evidence. On that basis, Mr
Cormack on behalf of Hyaltech contended that there must be a concern that the
MHRA had taken irrelevant factors into account.
In our view, however, it was the Lord Ordinary who made a minor error in
paragraph [95] when he stated that the MHRA must have misunderstood Mr
Mackintosh when they noted in their determination that Mr Mackintosh claimed
that:
"A fault in the descriptive use of
this product in Hyaltech's literature is that it emphasises using it pre-operatively,
but does not stress that it should be used during the operation ..."
The Lord Ordinary made the following observation in paragraph
[95] of his Opinion:
"It seems clear that what Mr
Mackintosh meant was that the product should be used during the operation
because of the utility of the sodium hyaluronate in improving corneal clarity."
In our opinion, the MHRA clearly accepted that Mr
Mackintosh's view was that the function of hyaluronate was "wetting and
lubrication" of the surface of the eye:
see page 5 of their second final determination, under the heading
"Expert Opinion". In the sentence in the
determination quoted above, the MHRA were simply drawing attention to Mr
Mackintosh's view that Hyaltech's literature seemed to emphasise the use of Topical
before (rather than during) the operation, and that such an emphasis was
inaccurate. Bearing in mind the terms of
the 2002 IFU leaflet, quoted in paragraph [8] above, Mr Mackintosh was perhaps
entitled to take such a view, and it
might be thought that the inaccurate emphasis was corrected in the 2003 IFU
leaflet by the insertion of the words "and during" between the words "in
preparation for" and "intraocular surgery".
We do not therefore accept that the MHRA misconstrued the evidence of Mr
Mackintosh.
[51] The patent:
It was argued that the MHRA had misunderstood passages in Topical's
patent. Reference was made to the Lord
Ordinary's Opinion at paragraphs [76] and [99].
We accept that the MHRA may have misunderstood parts of the patent. However bearing in mind the many other
adminicles of evidence which the MHRA properly understood and took into
account, we agree with the Lord Ordinary that any such misunderstanding was, in
the circumstances, minor.
[52] Conclusion:
We are not satisfied that any material error arose in the MHRA's
construction of the regulations or in their treatment of the evidence. The Lord Ordinary was in our view correct in
reaching that conclusion. Nor do we
consider that there is any need for a referral to the European Court of Justice. The reclaiming motion should be refused.
Postscript: Watt v Lord
Advocate and Pharma Nord (UK) Ltd
[53] In the circumstances, there is no need for
us to reach any view, following on certain dicta
in Watt v Lord Advocate 1979 SC 120 and other cases, on the exact scope of
the court's jurisdiction in Scotland to review a decision of a specialist
administrative body where the challenge to it is that the body misapplied the
relevant law. In this case, there has
been no misapplication of the relevant law.