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[2014] ZAGPPHC 360
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Gelderma Laboratories South Africa (Pty) Ltd v Medicines Control Council and Others (54281/2013) [2014] ZAGPPHC 360 (12 June 2014)
IN
THE HIGH COURT OF SOUTH AFRICA
GAUTENG DIVISION,
PRETORIA
In the matter
between:
GELDERMA
LABORATORIES SOUTH AFRICA
(PTY)
LTD
...........................................................................................................................................
Applicant
and
MEDICINES
CONTROL
COUNCIL
...................................................................................
First
Respondent
DIRECTOR
GENERAL OF THE NATIONAL
DEPARTMENT
OF
HEALTH
..........................................................................................
Second
Respondent
MINISTER
OF
HEALTH
.....................................................................................................
Third
Respondent
ALLERGAN
PHARMACEUTICALS
(PTY)
....................................................................
Fourth
Respondent
LITHA
PHARMA (PTY)
LTD
..............................................................................................
Fifth
Respondent
CONQUEST SURGICAL
SUPPLIES (PTY)
LTD
….....................................................................................................................................
Sixth
Respondent
GLENMARK
PHARMACEUTICALS SOUTH
AFRICA
(PTY)
LTD
..........................................................................................................
Seventh
Respondent
JUDGMENT
Ismail J:
[1]
During the course of this judgment the parties will be referred to
Interchangeably as the applicant or Gelderma; the first respondent
or
‘
MCC’;
the second respondent or ‘the DG’; the third respondent
or ‘the Minister’
[2] This application
is opposed by the first to the third respondents. They are
collectively referred to as the ‘ government
respondents’.
[3] The fourth to
seventh respondents have not opposed the application. They have for
convenience been referred to as ‘the
competitors’ of the
applicant. No order is sought against them.
[4] The applicant
seeks an order declaring that:
(1.1) Medical
devices as defined in section 1 of the Medicines and Related
Substance Act 101 of 1965 (“The Medicines Act”)
are not
subject to registration in terms of section 14(2) of the Medicines
Act
(1.2) in absence of
the promulgation of appropriate regulations in terms of section 35(1)
xxvii) of the Medicines Act the first
respondent and / or the second
respondent are not empowered to deal with authorizing, regulating,
controlling, restricting or prohibiting
the registration,
manufacture, modification, importation exportation, storage,
transportation, sale or use of any medical device
or class of medical
devices in respect of its safety, quality and efficacy in the
Republic;
(1.3) The product
identified in annexure “FA1” to the founding affidavit
(“the Restylane products”) as emanating
from the
applicant are medical devices as defined in section 1 of the
Medicines Act;
(1.4) The Restylane
products are accordingly not subject to registration in terms of
section 14 (2) of the Medicines Act.
(2) Such parties who
oppose this application are ordered to pay the costs of this
application, including the costs of two counsel;
(3)
further and/ or alternative relief
Background
[5] On 5 February
2012 , the Port authorities detained a consignment of the applicant’s
dermal fillers imported for sale within
the country. The first
respondent was of the view that these products were not registered in
terms of section 14
of the Act.
[6] The first
respondent addressed a letter to applicants attorneys dated 17 April
2013 wherein it stated:
"
Please be informed
that we have perused the above mentioned letter and considered the
submissions set out therein.
We reiterate that
local anaesthetics fall under pharmacological classification 4,
category In terms of the regulations promulgated
(sic) Government
Notice R2025 of 15 December 1967.
Please take
further note that local anaesthetics have been called up for
registration in terms of call up notice of 5 July 1988.
Thus, your
product, Restalyne Filler with Lidocaine is subject6 to registration
in terms of section 14(2) of Medicine and Related
Substance Act of
1965 (Act 101 of 1965).
[7] Applicant’s
attorneys addressed a letter to the registrar of the first respondent
dated 24 April 2013 wherein they stated
the following:
“
3.
We wish to emphasise again that
;
although a
schedule substance, lidocaine supports
,
as per definition
of medical devices In the medicines Act, the operation of the device.
In this instance the product contains 0,3%
of lidocaine, a miniscule
amount that would not even be detectable in the patient’s
system after administration.
”
[8] The applicant
approached this court in order to obtain finality on the
classification of its dermal filler product range sold
under the
brand name Restylane (the Restylane products). The issue to be
determined is whether the Restylane products and in particular
those
containing Lidocaine, are medicines in terms of the Medicines and
Related Substances Act 101 of 1965 (the Act).
[9] This set in
motion the present proceedings before court. Not intending to
oversimplify the issue between the parties it appears
that the
question which needs to be determined is whether the dermal fillers
containing lidocaine is a medical device as the applicant’s
contends or whether it should be registered because it contains a
substance which is registrable.
[10] It would be
prudent for the purpose of a proper understanding of the matter if I
were to set out what is defined as a “medicine”
and what
a “devices” has been defined as in terms of the Act.
The term “medicine"
has been defined as follows:
“
means
any substance or mixture of substances used or purporting to be
suitable for use or manufactured or sold for use in-
(a) The diagnosis,
treatment mitigation, modification or prevention of
disease, abnormal
physical or mental state or the symptom thereof in man; or
(b) restoring,
correcting, or modifying any somatic or psychic or organic function
in man, and includes any veterinary medicine;
A “medical
device” has been defined a: Means any instrument, appliance,
material, machine, apparatus, implant or diagnostic
reagent-
(a) used or
purporting to be suitable for use or manufactured or sold for use in-
(i) the diagnosis,
treatment, mitigation, modification, monitoring or prevention of
disease, abnormal physical or mental states
or symptoms thereof;
or
(ii) restoring
correcting, or modifying any somatic or psychic or organic function;
or
(iii) the diagnosis
or prevention of pregnancy,
and which does not
achieve its purpose through chemical, pharmacological, immunological
or metabolic means in or on the human body
but which may be assisted
in its function by means; or
(b) declared by the
Minister by notice in the Gazette to be a medical device;,
Legal
Submissions made
[11] Mr Maleka SC
acting for the government respondents submitted during argument
before me that the applicant choose to bring this
application and it
sought a declarator. The applicant could therefore not argue on the
facts as there was no record. Had it brought
the application by way
of review or in term of Rule 53 there would have been a record of
what decisions were taken and the facts
could be gleaned from the
record.
As opposed to this
argument Mr Unterhalter SC submitted that the applicant could elect
to bring a dispute to court by various means.
It chose to bring its
case in this manner and it therefore had to make out its case in
order for it to succeed otherwise it would
fail. He submitted that
nothing precluded the applicant to seek relief in the manner it
sought.
[12] Permit me to
thank the parties for their input in this matter and more particular
for the helpful and informative heads of
arguments presented. The
court is grateful to both parties and would ‘borrow’ from
their input where necessary.
[13] The applicant’s
attorneys addressed a letter to the registrar of the first respondent
wherein the following was stated
at paragraphs 6 and 7:
“
6
This dispute can only be determined by the Courts. Our client has
instructed us To bring proceedings for declaratory relief so
as to
secure finality and certainty as to whether our client’s device
(and devices that compete with it in the South African
market) is
subject to registration.
7. Pending the
Court’s decision, our client will continue to trade in the
market in accordance with its view of the law. Needless
to say, if
the Courts should determine the matter against our client, our client
will comply fully and promptly with the law”
In response to this
letter the respondents relied upon Prof Hoek’s findings and in
the answering affidavit at paragraph 8.6
the deponent Dr Khomo stated
the following:
“
On
6 August 2013 Prof B Hoek came to the following conclusion and
recommended to council: ....
At para 8.7 of the
same affidavit the following is stated:
“
Because
of the side effects and uncertainty regarding their safety and
efficacy of repeated use of these products (which contain
hyaluroric
acid, with or without lidocaine) as well as the fact that the First
Respondent has registered some other hyaluronic
acid products, the
First Respondent regards the injectable dermal fillers gel as medical
products for registration purposes”
[14] When the first
respondent received the applicants letter dated 6 April 2013 (FA
2.77), a four page letter, it responded thereto
by a letter referred
to in para [5], supra. This response it appears was based on a
finding made by a clinical committee under
the auspicious of Prof
Hoek from the University of the Free State. The committee recommended
to the first respondent that the applicant’s
product should be
registered as a medicine.
[15] Prof B B Hoek’s
expertise in the field of dermal filler’s was questioned by the
applicant who averred that he is
a paediatrician and not a
dermatologist and thus not an expert in skin related matters. The
applicant, on the other hand, relied
on the view of Per Goran Heden,
a doctor of Medicine and a doctor of Philosophy in Plastic Surgery;
licensed specialist in Plastic
Surgery in Sweden and United Kingdom;
Associate Professor in Plastic Surgery at the Karolinska Institutet
and the founder and head
of the Akademikliniken, the largest private
hospital specialising in Plastic and Reconstructive Surgery in
Scandanavia. (his affidavit
appears at pages 778-787 of the papers).
In his affidavit at paragraph 6 he deposed that:
“
I
have been requested by Gelderma Laboratories south Africa (Pty) ltd
(Gelderma) to consider the definition of a “medical
device”
as
defined in section
1 of the Medicines and related Substances act No 101 of 1965 (“the
Medicines Act) and to express my opinion,
based on such definition
whether the Restylane products fall within the definition of a
“medical device” or not.
”
At paragraph 17.6 of
the affidavit he concluded :
“
17.6
Results of my investigation using restylane products containing
lidocaine from a Prospective clinical study have been published
in
peer- reviewed journal and the data provide conclusive evidence that
the small amount of lidocaine is added for patient comfort
during
injection, without any impact on the purpose of these Restyulane
products containing lidocaine and these Restylane products
are
medical devices.
independent expert
investigators have come to similar results and conclusions (Brandt F
and Bank D 2010)
[16] It was
submitted on behalf of the applicant’s that Dr Heden’s
expertise in the field was not challenged. This was
conceded by Mr
Maleka during argument before me.
[17] Mr Unterhalter
submitted that the fact that Prof Hoek’s committee recommended
to the first respondent that the dermal
fillers should be registered
as a medicine.
The resolution must
be approved by council and it is only the Minister who can regulate
that it be registered as a medicine. This
argument was further
developed to the extent that the recommendation of the committee
consisting of Prof Hoek, was at best a recommendation
of the clinical
committee.
At page 209 of the
papers, an e-mail sent from the Law enforcement Manager to Ms Keyser
the following appears:
“
According
to the clinical committee of the MCC, they are of the opinion that
the product should be registered in terms of section
14(2) of the
Medicines and Related Substances
Absent any evidence
that the Minister was approached to consider the recommendation, it
was at best a recommendation and / or an
opinion and nothing else.
Furthermore, the applicant’s product has not been called up for
registration. It was submitted
that there was no argument that the
product was a filler, nor was there any attempt in the answering
affidavit attacking the applicant’s
expert regarding his
findings of the product.
[18]
In view of the Minister not having ratified or approved the
recommendation there was nothing calling for the setting aside
of the
regulation and therefore the
Oudekrall
principle
applied.
[19] On behalf of
the applicant’s it was suggested that there was a serious
inconsistency on the part of the respondents.
In that the letter
dated 7 March 2013 stated that they took a decision regarding the
applicants products whereas at page 862 para
[8.6] of the record the
deponent deposes to Prof Hoek arriving at a decision and making
recommendations on the 6 August 2013. It
was submitted that this was
to say the least not possible.
[20] Section 14(2)
of the Act stipulates:
(2) (a) the council
may from time to time by resolution approved by the Minister,
determine that a medicine or class or category
of medicine or part of
any class or category of medicine mentioned in the resolution shall
be subject to registration in terms
of the Act.
(b) Any such
resolution may also relate only to medicines which are available for
sale in the Republic immediately prior to the
date on which it comes
into
operation in terms
of paragraph (c) or only to medicines which are not then so
available.
( c) Any such
resolution shall be published in the Gazette by the registrar and
shall come into operation on the date on which it
is so published.
[21] The applicant's
product has not been called up for registration and at best the
product was recommended by Prof Hoek’s
clinical committee that
it be registered. There is no evidence that the Minister or Council
itself approved of the recommendation
of the committee. The fact that
the substance is injected and that it has a minute amount of
lidocaine which is a registered substance
does not make the device a
medicine. The substance injected “does not achieve its purpose
through chemical, pharmacological,
immunological or metabolic means
in or on the human body but which may be assisted in its function by
means
The Lidocaine only
assist to the extent that it allows the patients comfort and is not
part of the formulation designed to improve
skin hydration, as
described by Dr Heden in para [17.4] of his affidavit.
It was submitted on
behalf of the applicant that the mere fact that Lidocaine is called
up for registration does not mean that the
device is registrable.
[22] The respondents
in their heads raised the point that the applicant should have come
to court by way of PAJA or they should
have exhausted the internal
remedies by appealing the decision . they should have followed the
appeal procedure. This aspect was
to an extent addressed in para
[11], supra.
Mr
Unterhalter relied upon the matter of
Treatment
Action Committee v Raath and Others
[2008]
4 All SA 360
( C ) and to para [62] thereof, where the court stated:
“
[62]
The question for determination is whether VitaCell is subject to
registration as a medicine.. The answer to this question will
turn on
the interpretation of the 2002 call up notice. I agree with Mr
Budiender’s
submission
that it is not for the MCC to decide whether the substance is a
medicine. It is for the courts to decide that question.
But it is
correct for the MCC to resolve that any particular substance requires
to be registered, nature of a substance requires
to be registered.
The term “medicine” is defined in the Medicines Ac and if
there is a dispute about the nature of
the substance it is for the
courts to make a determination whether or not a particular substance
is a medicine as defined in the
Medicines Act
[23] Mr Maleka
submitted that there was extensive communication between the parties
before the decision was made, to have the product
registered as a
medicine.
Firstly there was an
evaluation of the product by the committee and thereafter a decision
was taken. He therefore submitted that
a review ought to have been
brought as the court would then have had the record before it, in
order to determine the factual situation.
By seeking a declaratory
order instead of a review the applicant cannot rely on a factual
situation but only on a legal matrix.
[24] He submitted
that there was a decision taken by council based on the opinion of
Prof Hoek. The opinion of Prof Hoek was relied
upon by Council who
informed the applicant that its dermal fillers were subject to
registration. It was suggested that the first
respondent took a
decision that the applicants dermal fillers should be registered in
terms of the Act. Accordingly first respondent
advised Port authority
not to release applicant’s products which were subject to
registration.
[25]
Mr Maleka relying on the extract quoted in the
TAC
matter,
at para [22], supra, submitted that the court accepted that whether a
product is subject to registration in terms of the
Act is one for the
first respondent to determine. This he submitted was not surprising
since the registration of a substance is
within the purview of the
first respondent to protect the unsuspecting public who are unaware
of the composition and true nature
of such products or substances.
The first respondent
is of the view that the applicant’s dermal fillers which
containing Lidocaine is subject to registration
in terms of section
14(2) of the Act
Maleka submitted
that these dermal fillers contain Lidocaine which is a local
anaesthetic. Lidocaine is used to reduce pain in the
area of the skin
where the dermal filler is administered. This local anaesthetic was
one of the ‘main barriers ‘ to
the use of dermal fillers.
[27]
Counsel for the first respondent also submitted that the applicant
chose the wrong route in coming to court by seeking a declarator.
He
alluded to the fact that the applicant should have exhausted the
internal remedies available to it, namely to appeal the decision
of
the MCC or sought a review in terms of PAJA. In this regard he
alerted the court to the the matter of
Road
Accident Fund v Duma and others
2013
(6) SA 9
SCA dealing with the issue of serious injury for general
damages. At paragraphs [18] and [19] Brand JA stated:
“
[18]
Consideration of the high court’s judgments in the four cases
on appeal and those upon which they rely, all seems set
out from the
premise that it is ultimately for the court to decide whether the
plaintiffs injury was ‘serious’ so as
to satisfy the
threshold requirement for an award of general damages. Proceeding
from that premise, these decisions assume that
if the Fund should
fail to properly or timeously reject an assertion to that effect by
the third party, the rejection can be ignored.
If the medical
evidence before the court then shows that, on a balance, the
plaintiff was seriously injured, the court can proceed
to decide the
issue of general damages.
[19] That approach,
I believe, is fundamentally flawed. In accordance with the model that
the legislature chose to adopt, the decision
whether or not the
injury of a third party was serious enough to meet the threshold
requirement for an award for general damages
was conferred on the
Fund and not the court. That much appears from the stipulation in reg
3(3) ( c) that the Fund shall only be
obliged to pay general damages
if the Fund- and not the court- is satisfied that the injury has
correctly been assessed in accordance
with the RAF 4 form as
serious.....”
[28] It was
submitted by counsel that the court should be slow in exercising its
discretion in granting the declaratory orders which
the applicant
seeks as the MCC considered the issue of the applicant’s
product and acted in the public interest. For that
reason it was a
decision for the MCC to make, whether the product is a medicine or
not and not for the court to determine.
[29]
Cora Hoexter
in
her book
Administrative
Law in South Africa
dealing
with declaration of rights at pages 493/4 states:
“
As
the name suggest, a declaration of rights (also known as declaratory
orders) enables a court to declare the right of the parties
or to
state the legal position.
The
writer continued and referred to what O ‘Reagan J in
Rail
Commuters Action Group v Transnet Ltd t/a Metrorail
[2004] ZACC 20
;
2005
(2) SA 359
(CC) at para
[107]
said:
“
[107]
it is quite clear that before a court makes a declaratory order a
court must consider all the relevant circumstances. A declaratory
order is a flexible remedy which can assist in clarifying legal and
constitutional obligations in a manner which promotes the protection
and enforcement of our constitution and its values. Declaratory
orders, of course, may be accompanied by other forms of relief,
such
as mandatory or prohibitory orders, but may also stand on their own.
In considering whether it is desirable to order mandatory
or
prohibitory relief in addition to the declaratory, a court will
consider all the relevant circumstances.”
This paragraph
should be read in conjunction with what was stated in para [11],
supra.
[30] The applicant
also seeks an order declaring that:
“
1.2
in the absence of promulgation of the appropriate regulations in
terms of section 35 (1)(xxvii) of the Medicines Act the first
respondent and/or the second respondent are not empowered to deal
with the authorizing, regulating, controlling, restricting, or
prohibition the registration, manufacture, modification, importation,
exportation, storage, transportation, sale or use of any
medical
device or class of medical device in respect of its safety, quality
and efficacy in the Republic “
Mr Maleka submitted
that the court in the exercise of its discretion should not grant
such an order as the first respondent has
taken a decision. Mr
Unterhalter on the other hand submitted that if the respondents want
to have the applicants product declared
a medicine they should invoke
the provisions of section 35 of the Act which authorizes the Minister
in consultation with council
to make regulations.
This procedure has
not been followed and at best a recommendation was made to council by
the investigative committee in the absence
of the Minister having
been involved in the process.
[31] The Act in
terms of section 35 has a built in procedure for making regulations
in terms of section 35. It was submitted that
if the intention was to
promulgate regulations restricting or controlling a device it should
regulate it as such in terms of the
section. This procedure has not
been followed.
[32] For the reasons
set out above I am of the view that the following will be an
appropriate order.
(1) in absence of
the promulgation of appropriate regulations in terms of section 35(1)
(xxvii) of the Medicines Act the first respondent
and / or the second
respondent are not empowered to deal with authorizing, regulating,
controlling, restricting or prohibiting
the registration,
manufacture, modification, importation exportation, storage,
transportation, sale or use of any medical device
or class of medical
devices in respect of its safety, quality and efficacy in the
Republic;
(2) The product
identified in annexure “FA1” to the founding affidavit
(“the Restylane products”) as emanating
from the
applicant are medical devices as defined in section 1 of the
Medicines Act;
(3) Restylane
products are accordingly not subject to registration in terms of
section 14 (2) of the Medicines Act.
(4) The First,
Second and Third respondents are jointly and severally ordered to pay
the applicants costs. The one paying the others
are absolved.
Such costs to
include the costs of two counsel.
Ismail J
APPEARANCES:
For
the Applicant:
Adv
D Unterhalter SC assisted by Adv A C Botha
instructed by
Goldman Judin Inc, Johannesburg c/o Savage Jooste & Adams,
Pretoria
For
the First. Second & Third Respondents:
Adv
V Maleka SC assisted by
Adv M.S Mphahlele
instructed by The State Attorneys, Pretoria.
Date
of Hearing:
12
May 2014
Judgment
delivered:
12
June 2014.