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[2016] ZAGPPHC 1157
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Omegalabs (Pty) Ltd v Medicines Control Council and Others (32570/2015) [2016] ZAGPPHC 1157 (7 December 2016)
IN
THE HIGH COURT OF SOUTH AFRICA
(GAUTENG
DIVISION, PRETORIA)
CASE
NO: 32570/2015
DATE:
7/12/2016
REPORTABLE
OF
INTEREST TO OTHER JUDGES
In
the matter between:
OMEGALABS
(PTY)
LTD
Applicant
and
THE
MEDICINES
CONTROL
COUNCIL
First
Respondent
DIRECTOR-GENERAL:
DEPT
OF
HEALTH
Second Respondent
MINISTER
OF
HEALTH
Third Respondent
MEC
FOR HEALTH: GAUTENG
PROVINCE
Fourth Respondent
JUDGMENT
NGALWANA
AJ
A.
The Issue
[1]
The Medicines and Related Substances Act, I 01 of 1965
("the
Medicines
Act")
defines
"medicine"
as
"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 symptoms thereof in
man; or
(b)
restoring, correcting or modifying any
somatic or psychic or organic
function in man,
and
includes any veterinary medicine "
[2]
The term
"medical
device"
is
defined in the same Medicines Act as
"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 the symptoms
thereof; or
(ii)
restoring,
correcting
or
modifying
any
somatic
or
psychic
or organi
c
function; or
(iii)
the diagnosis
o
r
prevention o
f
pregnancy,
and
which
does
not
achieve
its
pur
pose
through
chemical, pharmacological,
immunological
or
metabolic
means
in
or
on
the
human body
but
which
may be
assisted
in
its fnction
by
such
means
; or
(b)
declared by the Minister by notice in the Gazette to be a
medical device,
and
includes
an
y
part
or
an accessory
of a medical
device
"
(my
emphasis)
[3]
It seems clear from these definitions that
"medicine"
is
a substance classified as
"medicine"
by
reference to the
use
to which it is put, while a
"medical device"
is an instrument classified
as
"medical device"
by reference to the
means
by
which
it
achieves
its
purpose
.
The significance of this distinguishing feature
will become clear later in this judgment when I explain
what the
classification process entails.
[4]
The issue before Court is a complex one. The applicant approaches
this Court for an order
"1.
[urgency].
2.
Declaring that:
2.1
the products identified in annexure "FAJ " to the founding
affidavit ("the Dermalex products'')
are medical devices as
defined in section 1 of the Medicines [and Related Substances] Act
No. 101 of 1965, as amended ("the
Medicines Act'');
2.2
in absence of the promulgation of appropriate regulations in terms of
section 35(J)(xxvii) and/or
(:xxviii) 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 the Dermalex
range of products in respect of its safety, quality and efficacy in
the Republic;
2.3
the Dermalex products are not subject to:
2.3.1
registration in terms of section 14(2) of the Medicines Act;
2.3.2
Government Notice R424 in Government Gazette No 3815 of 23 March 1973
in terms of which various
"medicines" under pharmacological
classification 13 "Dermatological Preparations"
.
. . have been called up for registration in terms of section 14(2) of
the Medicines Act;
3.
…
4.
Directing any party who opposes this application, jointly and
severally the one paying the other to be absolved, to pay the costs
of this application, including the costs of two counsel where
engaged"
[5]
The Dermalex products in question (described by Counsel as some sort
of
"cream"
that serves a purpose not
dissimilar to a band-aid) are either
"medicines"
as contended by the respondents, or
"medical
devices"
as contended by the applicant.
[6]
But that is a subordinate question. The pre-eminent and more complex
question is whether classification or categorization or
documentation
of the Dermalex products either as
"medicines"
or
"medical devices"
is a function or competency
of a Court of law, or that of a statutory functionary (the Medicines
Control Council or MCC) established
by the Medicines Act to, among
other things, regulate the licensing of medicines and medical
devices. Put differently, the pre-eminent
question is, in my view,
whether this Court is invited by the applicant to, as its Counsel
would have it, make a decision that
entails simply the interpretation
of a statute as regards whether the Dermalex products fit the
"medicine"
definition or the
"medical
device"
definition, or whether this Court is, as
Counsel for the Respondents would have it, invited to make a decision
that involves a highly
technical and evidence-laden evaluation of
deeply contested medical and scientific matters. For convenience let
us term this
the Jurisdiction Question.
It relates to
prayer 2.1 of the notice of motion.
[7]
A separate and self-standing question which relates to prayer 2.2 of
the notice of motion is whether the promulgation of appropriate
regulations is an absolute condition-precedent to the exercise by the
MCC of the power
"t
o
deal
with
authorizing,
regulating,
controlling,
restricting
or
prohibiting
the registration,
manufacture,
modification,
importation,
exportation,
storage, transportation,
sale
or
use of the Derma/ex
range
of
products in respect
of its safety,
quality
and
efficacy
in
the
Republic" .
I
call this
the
Regulations
Question.
[8]
A third question which relates to prayer 2.3 of the notice of motion
is whether section 14(2) of the Medicines Act applies to
the Dermalex
products. I label this
the Section 14(2) Question.
[9]
Each of these three questions requires a different approach. The
Regulations
Question
and
the
Section
14(2) Question
entail an exercise in statutory
interpretation. Not so, however, the
Jurisdiction
Question
which,
nbecause the applicant places its Dermalex products in the
"medical
device"
camp, entails an inquiry not only into
whether these are
instruments
(in contra distinction to
substances
) but also an assessment of the
means by
which
they achieve their purpose
. I
address each of these questions in turn.
B.
The
Jurisdiction Question
[10]
As indicated earlier, the question under this rubric is whether this
Court is invited to make a decision that entails simply
the
interpretation of the Medicines Act as regards whether the Dermalex
products fit the
"medicine"
definition or the
"medical device"
mould, or whether this Court is
invited to make a decision that involves a highly technical and
evidence-laden evaluation of deeply
contested medical and scientific
matters.
[11]
Which of these two approaches is an appropriate one to follow must be
determined by the definition of the box in which the
applicant claims
that its Dermalex products belong - the
"medical device"
definition. The reason for this is that the subordinate question
that this Court is called upon to answer is not so much whether
the
Dermalex products fit the
"medicine"
definition
but rather whether they fit the
"medical
device"
definition. The significance of this distinction lies in the fact
that, on a proper construction of both definitions, an answer to
the
inquiry whether the products are or are not
"medicines"
will not tell us whether or not they are
"medical
devices".
In this regard, I incline more towards the test
proposed by the applicant's Counsel - namely, whether in achieving
their
purpose
the Dermalex products do so
"through
chemical, pharmacological, immunological
or metabolic
means
in or on the human
body
[although
they]
may
be
assisted
in [their]
function
by
such
means"
- than the test contended
for by Counsel for the respondents, namely, whether the products are
not
"medicines".
[12]
In a sense (to use an antiquated analogy in this age of Global
Positioning System or GPS) the respondents' Counsel is inviting
the
Court to locate Marrakesh using the map of South America. However
diligently one may pore over the labyrinth that is the map
of South
America, one will never locate Marrakesh there. The same is true of
trying to ascertain whether the Dermalex products
are
"medical
devices"
by asking whether or not they are
"medicines".
By their very definition,
"medicines"
are
substances
that owe their classification as
"medicines"
to the
use
to which they are put;
"medical devices
" are
instruments
classified as devices by reason of the
means by which
they
achieve their purpose. That is why asking the question whether or not
a substance is a
"medicine"
cannot tell one
whether or not an
instrument
is a
"medical
device".
[13]
Thus, it seems to me the subordinate question must be whether the
Dermalex products achieve their diagnostic, mitigation, monitoring,
modification and prevention purpose
"through
chemical,
pharmacological, immunological
or metabolic
means in or on the human body [or are] assisted
in
[their]
function
by
such
means".
In my view, such an assessment entails making
a decision that involves a highly technical and evidence-laden
evaluation of deeply
contested medical and scientific matters, as is
demonstrated by the differing views propounded by the parties'
respective experts.
A Court of law is not equipped or has no
particular proficiency to make that assessment. The Medicines Control
Council is.
[14]
In
Minister of Environmental
Affairs
and
Tourism and Others v Phambili Fisheries
(Pty)
Ltd; Minister
of Environmental
Affairs
and
Tourism and
Others v
Bato
Star
Fishing
(Pty)
Ltd
2003 (6) SA 407
(SCA) the Court, in a review
setting, made the need for judicial deference on matters outside
judicial proficiency quite clear
when it said:
"Judicial
deference
is
particularly
appropriate
where
the
subject-matter
of
an administrative
action
is
very
technical or of a kind
in
which a Court
has
n
o
particular
proficiency.
"
[1]
[15]
On appeal to the Constitutional Court, in
Bato
Star
Fishing
(Pty) Ltd
v Minister
of
Environmental
Affairs
and
Tourism
and
Others
2004 (4) SA 290
(CC), the principle of judicial deference was
endorsed in these words:
"The
use
of the word 'deference
'
may give
rise to misunderstanding
as
to the true
function
of a
review
Court.
This
can
be
avoided
if
it is realised that
the
need
for
Courts
to
treat decision-makers
with
appropriate
deference or respec
t
flows
not
from judicial
courtesy
or etiquette but from
the
fundamental constitutional
principle
of
the
separation
of
powers
itself. "
[2]
[16]
The Constitutional Court continued:
"In
treating
the decisions of administrative
agencies
with the appropriate respect, a Court is recognising th
e
proper
role of the
Executive
within the
Constitution.
In
doing
so
a
Court
should
be
careful
not
to
attribute
to itself
superior
wisdom
in relation
to matters
entrusted
to other
branches of
government.
A
Court
should
thus
give
due
weight
to
findings
of
fact and
policy
decisions
made by those with special expertise and experience in
the field.
The
extent
to
which
a
Court
should
give
weight
to
these
considerations
will
depend
upon
the
character
of
the
decision
itself, as
well as
on the identity of the decision-maker. A decision that requires an
equilibrium to
be
struck
between
a
range
of
competing
interests or considerations
and
which
is
to be taken
by a
person
or
institution
with
specific expertise in
that
area must be shown respect by the Courts
.
. .
"
[3]
[17]
Before this Court is an application not for the review of a decision
of the Medicines Control Council but for a raft of declaratory
orders. Even so, I can conceive of no reasonable basis why judicial
deference should not be observed in equal measure in a collateral
challenge as it is in a review application.
[18]
The
Medicines
Control
Council
is
the
body
that
is
specifically
set
up under
the Medicines Act to issue
licenses
for the
manufacture,
import,
export, distribution and wholesale of not only
"medicines"
but
also
"medical
devices
"
.
[4]
In
order
to
do
that,
it
must surely
also
have
the
competence
to
determine
whether the
Dermalex
products achieve their diagnostic, mitigation, monitoring,
modification and
prevention
purpose
"through
chemical,
pharmacological,
immunological or metabolic means in
or
on the human body [or are] assisted in [their]
function
by
such means"
.
That is
an exercise that self-evidently calls for technical assessment
steeped in the medico-scientific
discipline.
A Court of
law -
except
perhaps for
a
few
omniscient
sages
who
may
have
stumbled
into
law
as a
discipline
purely
out
of
intellectual
curiosity
after
finding
practice
in
the
disciplines
of medicine
and science
unfulfilling
and dull -
has no
particular proficiency in such matters.
[19]
Thus, in my view this is an exercise best performed by the Medicines
Control Council.
[20]
On
this
finding,
it
is not
necessary
to
consider
and
pronounce
upon
the
parties'
expert
evidence
(and the
question
of a
possible
dispute
of facts
arising as
a
corollary
of
that
exercise)
and
other
points
raised by
the
respondents'
Counsel
as
regards
prematurity
of
the
application,
failure
to
exhaust
internal
remedies, the
application
to
strike
out,
the
application
of
the
Promotion
of Administrative Justice
Act,
3
of
2000
(PAJA),
delay
in
launching
this
application,
and all the
authorities
invoked
by
Counsel
in aid of
pressing those points
home.
It is
also
not
necessary
to
pronounce
upon
a point
which,
in
its
articulation
though
not
labelled
as
such,
sounded
like
a
peremption
point.
[5]
I
thus
expressly decline to deal with those points.
[21]
In finding as I do, I part company with two judgments of this Court
on which Counsel for the applicant places considerable
reliance. In
my view, both judgments are with respect either distinguishable or
quite wrong.
[22]
The
first
of
these,
Gelderma
Laboratories
SA (Pty)
Ltd
v
Medicines
Control
Council
and
Others
(54281/2013)
[2014]
ZAGPPHC 360
(12
June 2014),
comprises,
without
much
more,
a
summary
of
Counsel's
submissions,
quotations from the record and excerpts from
judgments
referred to
by Counsel, and rounds off by granting the orders sought by the
applicant, ostensibly
"[flor
the
reasons
set
out
above"
[6]
•
Absent,
regrettably,
is
a
proper
assessment
of
Counsel's
respective
submissions,
an interrogation
of the
judgments
referred to
by
Counsel
and, all
told,
a
healthy
dose of
what Justice BR
Southwood,
in his book
titled
Essential
Judicial
Reasoning,
calls
"the
reasoning
process
relevant
to the
situation
which has been laid down in the case law
"
[7]
[23]
At best,
the
ratio
decidendi
in
the
judgment
is implied
in one paragraph in which
the
Learned
Judge
seems
to
suggest
that
the
reason
for
granting
the
orders
[8]
sought
was
failure
by
the
Minister
to
promulgate
regulations
for
the
regulation of
"medical
devices
"
[9]
•
The
Learned Judge says:
"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.
"
[10]
[24]
But this was not
even
the
issue that
the Learned
Judge
identified
as
"the
question
which
needs
to
be
determined".
The
issue
identified
by
the
Learned
Judge for determination was
"whether
the dermal
fillers
containing
lidocaine
is a
medical
device
as
the
applicant
contends
or
whether
it
should
be
registered because
it
contains
a
substance
which
is
registrable "
[11]
(sic).
So,
the
Learned
Judge
appears to
have posited
one
question
for
determination
but
in fact
determined the case on a quite different question.
[25]
In any event, even on the question posited but not quite answered by
the Learned Judge by way of didactic reasoning, whether
or not a
product containing one or other chemical or substance is to be
classified as a
"medical device"
is, for
reasons already discussed earlier, in my view not a question that
falls within the proficiency of a Court of law. It is
thus not
surprising that the Learned Judge simply declares, without more, that
the products in question are
"medical
devices"
and are, for that reason, not subject to registration in terms of
section 14(2) of the Medicines Act. In order to answer that question
proficiently, the Learned Judge would have had to embark upon a
medico scientific assessment of the products in question,
something at which the MCC is adept, but not so a Court of law.
[26]
But even the
ratio
decidendi
is in my view with
respect not correct. There is nothing in the Medicines Act that is
reasonably capable of the construction placed
by the Learned Judge on
section 35(1)(xxvii), namely, that absent a set of regulations the
MCC is denuded of any power to authorize,
regulate, control, restrict
or prohibit the registration, manufacture, modification, importation,
exportation, storage, transportation,
sale or use of any
"medical
device"
or class of
"medical
devices"
or
"medicines"
in respect of its safety,
quality and efficacy. I deal with this issue in greater detail under
the Regulations Question
rubric below.
[27]
The
second
judgment,
Allergan
Pharmaceuticals
(Pty) Ltd
v
Medicines Control Council
and
Others
[2015]
3
All SA 173
(GP),
starts
off
with an
endorsement of the
Gelderma
ratio
decidendi
described
earlier in this
ju
d
gment
.
[12]
[28]
Then,
after
trawling
the
evidence
of
expert
witnesses
to
discover
that
similar products
are
classified
and
documented
as
"medical
devices"
elsewhere
in some parts of the world, and citing a Cape High Court
judgment
in
Treatment
Action
Campaign
and Another
v
Rath and Others
[2008]
4 All SA 380
(C)
("the
Rath case
"
)
for the
proposition
that
"it
is
not for
the
Medicines
Control
Council
to
decide
whether
a
substance
is
a
medicine,
but
that
it
is
a
question
to
be
decided
by a
court"
[13]
the
Learned
Judge
concluded
that
"the
Optive
range
of
products
[14]
are
(sic)
medical
devices
and
not subject
to
registration,
absent
any regulations
to
do so
"
[15]
,
and
granted
the
orders
sought
by
the
applicant
which
are similar
to those sought here and in the
Gelderma
case.
[29]
The approach of the Court in the
Allergan judgment
is
in my view with respect an unhappy one for a number of reasons.
29.1
First, the
Gelderma
judgment is not authority for the
proposition that it is for a Court and not the Medicines Control
Council to decide whether a substance
is a
"medicine"
or a
"medical device".
In an un-numbered
paragraph lodged between paragraphs [22] and [23] of that judgment,
the Learned Judge merely recorded that Counsel
for the applicant
"relied
upon
the
[Rath
case]"
for that proposition. The Learned Judge himself
did not so find.
29.2
Second, the fact that similar products are registered or classified
as
"medical
devices"
elsewhere in the
world, with no discernible appreciation of what process was followed
in those countries to so classify those products
there, is in my view
not a helpful form of assessment in order to conclude that South
Africa should simply follow those countries'
example.
29.3
Third, there is no indication that classification of similar products
as
"medical
devices"
in those
other countries was made by Courts of law.
29.4
Fourth, the significance, if any, of classification of similar
products as
"medical devices"
in other
so-called
"benchmark"
countries is a matter for
debate among experts at the Medicines Control Council, and if the
applicant should be unhappy with the
outcome there it may then appeal
internally under section 24 of the Medicines Act and, if still
aggrieved by the outcome of the
appeal, approach the Courts on review
if there should be grounds for such relief. There is nothing in
section 24 that suggests
that appeals are confined to decisions made
in respect only of
"medicines''.
The section says,
"[a]ny
person
aggrieved
by
a
decision
of
the
council
may
. . .
appeal
against
such
decision
to
an
appeal committee
appointed by
the
Minister
for th
e
purposes
of
the
appeal
concerned".
29.5
Fifth, the judgment of the Cape High Court in
Rath
cannot,
on a proper construction, mean that a body such as the MCC has no
power to classify products either as
"medicines
"
or
"medical devices"
when it was set up to
regulate
"medicines"
and other related
substances. It seems to me the import of that judgment must be that
the Court is the final arbiter in these matters
on
t
he
ordinary grounds of review
of the MCC's decision. That
is not to second-guess the decision of the MCC as regards the
correctness of its classification.
If the decision is not taken on
review, then it is final.
29.6
Sixth, in any event, the context of the
Rath judgment
must
not be lost. The case had to do with a request for multifarious
orders, against numerous and disparate respondents, including
alleged
failure of organs of state to perform their duties and so the Court
being called upon to intervene and compel them to do
so.
29.7
Seventh, if the
Rath
judgment, properly construed, meant to
convey that only the Courts have the power to decide whether a
substance is a
"medicine"
or not, then I disagree
with the correctness of that decision. A Court of law has no
particular proficiency in matters such as these
that entail a
medico-scientific assessment of highly technical matters that are
deeply contested among experts. In any event, even
if it were
correct, a Cape High Court judgment of a single Judge does not bind
this division.
29.8
Eighth, as
in
the
Gelderma
judgment
the
Learned
Judge in
the
Allergan
judgment
posits
two
questions
for
determination
but decides
the
case
on
a
third.
The
first
question
identified
by
the Learned
Judge
was
"whether
the
Optive
products
constitute
medicines
or
medical
devices "
[16]
;
the
second was
"whether
the
Optive
range
of
products
was
called
up for
registration
.
.
.
as
medicines
in
terms
of
section
14(2)
of
the
Medicines
Act"
[17]
•
But the
case appears to have been decided on the absence of regulations as
the
Learned
Judge
concludes,
"Given
what
has
been
set
out
above,
the
Optive
range
of
products are
medical
devices
and
not
subject
to
registration,
absent
any regulations
to
do
s
o"
(my
emphasis).
29.9
Ninth, this finding can in my respectful view not be correct because
it is the Medicines
Act and not the absent regulations that confer
upon the MCC the power to regulate medicines and other related
substances. For example,
section 22C(l )(b) confers upon the MCC the
power to license, among other things, the
import,
export,
manufacture,
distribution
and wholesale of
"medical
devices".
In order to do that it must have the
competency and power to classify a product either as a
"medicine"
or a
"medical
device".
The
applicant describes itself as
"the sole
importer
and
distributor
of various
non-prescription or
over-the-counter products''.
I
deal with this issue immediately below under the rubric
"the
Regulations
Question".
[30]
For all these reasons, the declaratory order sought in paragraph 2.1
of the notice of motion cannot be granted.
C.
The
Regulations
Question
[31]
As already indicated above, section 22C(
1)(b)
of
the
Medicines
Act confers upon the Medicines Control Council the power to issue
licenses for the manufacture,
import,
export,
distribution
and
wholesale
of not
only
"medicines"
but
also
"medical
devices"
.
[18]
It thus
seems
to
me
that
if
the
Medicines
Control
Council
has the
power
to
license
the
manufacture,
import,
export
and
distribution
of medical
devices,
it must
of
necessity
also have
the power
and competence to classify and register
"medical
devices"
and
does not require the Minister
first to
make
regulations
in order to
do
so.
After
all, it is
the Medicines
Act, not
the regulations,
that
confers on
the Medicines
Control
Council the power to license the manufacture, import, export and
distribution of
"medical
devices".
[32]
In this
regard,
I with
respect
associate
myself
with
the
dictum
of this
division, in
a
judgment
delivered
after both the
Gelderma
and
Allegan
judgments, in
Telkom
SA
Soc
Limited
v
Mncube
NO
and
Others;
Mobile
Telephone
Networks
(Pty)
Ltd
v
Pillay
NO and Others; Cell C (Pty)
Limited
v The Chairperson of
!
CASA
and
Others;
Dimension
Data Middle East &
Africa
(Pty)
Ltd
t/a
Internet
Solutions v
!
CASA
and
Others (5531
1
1
2015;
7702
9
1
2015;
82287
1
2015)
[2016] ZAGPPHC
93
(26
February
2016)
where
the Learned Judge
said:
[19]
:
"[31]
The
fact
that
there
were
no
regulations
in place which
governed
the
application,
does
not
mean
the
application
could
not
properly
be
considered.
In
the
absence
of regulations
contemplated
in
sections
13(2)
[20]
and
31(3)(
c
)
[21]
of
the
EC
Act at
the
time
the
application
was lodged, Neotel
and
Vodacom
nevertheless provided
information
in terms of the Regulations
in
respect of the Limitation
of
Ownership and
Control
of Telecommunication Service
s
.
.
.
[32]
In
Verstappen
v
Port
Edward
Town
Board
&
Others
1994
(3)
SA 569
(D&CLD)
it
was
held that the
Minister's
failure
to promulgate regulations foreshadowed in section 20(2) of the
Environment Conservation Act
No
73
of
1989
did
not
render
lawful
the
conduct of the local
authority
in
operating
a
waste
disposal
site
without
a
permit. In view of th
e
fact
that
no regulations dealing wi.th waste management have
bee
n
promulgated
under
that
Act,
Magid J
said
the following
at
537 E-G:
"If
some
person
desires
to
'establish, provide
or
operate' a
waste disposal
site
he requires
a
permit from the Minister
to do
so.
And
if
the Minister has
failed to prescribe the form on which such application is made or the
information which must accompany it, such
person may make an
application to the Minister in whatever
reasonable
form
he
desires, furnishing
all
such
information
as
the
Minister
might
reasonably
be
likely
to need.
If
the
Minister
were
to decline
to
deal
with
the
application
because
it
was
not on
the
appropriate form or did not contain sufficient information, I
have no doubt at all that any Court would hold such a decision by the
Minister to be so grossly unreasonable as to justify review. That
is not to say, of course, that the Minister would not be
entitled to
require that such an applicant furnish such further information as
might reasonably be
required
to
enable
the
Minister
properly to
assess
the
merits
of
the application.
"
[33]
I
associate
myself
with
this
approach. The absence
of
applicable regulations
does
not
render
the application
submitted,
or
the procedure followed
thereafter,
unlawful. The
EC
Act itself
provides
a
statutory framework and ICASA
was
therefore
entitled,
in
my view,
to exercise
its statutory powers
in terms of sections
13(1) and 31(2A) of the EC
Act
(the transfer of control of an individual licence
and the transfer of control of a radio
frequency
spectrum licence
respectively)
with
regard
to
the application.
I
therefore
conclude
that
this
ground
of
review
falls to
be dismissed.
"
[33]
Thus, there is no impediment to the applicant making submissions to
the Medicines Control Council (a body that is statutorily
mandated to
perform that function and is better equipped to do so) for
classification of its Dermalex products as
"medical
devices"
by reason only of the Minister not
yet having promulgated the regulations contemplated in section
35(1)(xxvii) of the Medicines
Act.
[34]
Thus, the prayer for a declaratory order in paragraph 2.2 of the
notice of motion cannot be granted.
D.
The Section 14(2) Question
[35]
The section reads:
"
14
Prohibition
on
the
sale
of
medicines
which
are
subject
to registration and are not registered
(1)
….
(2)
(a) The council may from time to time by resolution approved by the
Minister, determine that a medicine or class or category
of medicines
or part of any class or category of medicines mentioned in the
resolution shall be subject to registration in terms
of this Act.
(b)
Any such resolution may also relate only to medicines which were
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 were 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. "
[36]
There can be no dispute that on a plain reading of this provision
only
"medicines"
can be called up for registration.
All that is required is a resolution of the Medicines Control Council
published in the Government
Gazette and the Minister's approval. But
the applicant cannot resort to self-help by declaring unilaterally
that its Dermalex products
are
"medical devices"
and then say they are therefore not subject to a call-up under
section 14(2). As I have already discussed earlier in this judgment,
that similar products are classified as
"medical
devices"
elsewhere in the world is not
decisive. The Medicines Control Council must be given space to do its
job and determine whether the
Dermalex products are
"medicines"
or
"medical
devices".
If it should
determine that they are
"medical
devices'',
then the section would find no application. But if it should
determine that they are
"medicines"
then it can call
them up for registration as such.
[37]
Thus, the prayer for the declaratory orders in 2.3 of the notice of
motion cannot be granted.
E.
Discretion
[38]
Declaratory relief is granted on the exercise of the Court's
discretion.
[39]
For all the reasons discussed in this judgment, I can conceive of no
compelling factors that would sway me to exercise discretion
in
favour of granting the declaratory orders sought. To do so would, in
fact, be to encourage a resort to self-help.
[40]
In the result, the application is dismissed with costs.
_______________________
V
NGALWANA
ACTING
JUDGE OF THE HIGH COURT
Date
Heard:
24 November 2016
For
the Applicant:
B Leech SC; AC Botha
Instructed
by:
Werksmans
Attorneys
For
the Respondents: G Marcus SC;
Rajab-Budlender
Instructed
by:
State
Attorney (Pretoria)
Date
of Judgment:
07 December 2016
[1]
At paragraph [53]
[2]
At paragraph
[46]
[3]
At paragraph [48]
[4]
For example, section 22C(
l)(b)
reads:
"Subject
to the provisions of this section
(a)
. ..
(b)
the council m
ay, on application in the prescribed manner and
on payment of the prescribed fee,
issue to a manufacturer.
wholesaler
or
distributor
of
a
medicine or
medical
device
a licence
to
manufacture.
import
or
export.
act as a wholesaler
of or d
istribute, as the case
may be, such medicine or
medical d
evice, upon such
conditions as to the application of such acceptable quality
assurance principles and good manufacturing and distribution
practices as the council may
determine.
"
(emphasis
supplied)
[5]
It was suggested that the applicant had made a
"comprehensive
submission"
to the
Medicines
Control
Council for a determination
of this
very
issue
(what I term the subordinate question) that this Court is now called
upon to determine, thereby indicating a contrary intention
to
launching these proceedings as a collateral challenge. A decision of
the Medicines Control Council was pending still at the
time of the
launching of this application.
[6]
At paragraph
[32]
[7]
LexisNexis ©2015
[8]
".
.
.
declaring
that:
(1.1)
Medical devices as defined in section I 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 I 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 I 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"
[9]
A topic dealt with later in this
judgment
under the rubric
"the
Regulations
Question".
[10]
At paragraph [31]
[11]
At
paragraph
[9]
[12]
The endorsement appears in
paragraph
[7] of
the
Allergan
judgment
[13]
At
paragraph
[50]
[14]
Dubbed ophthalmic lubricants in that case
[15]
At paragraph [53]
[16]
At paragraph [9]
[17]
At
paragraph
[46]
[18]
The section reads:
"Subject
to the provisions of this section
(c)
...
(d)
the council may
, on application in the prescribed manner and
on payment of the prescribed fee,
issue to a manufacturer.
wholesaler or distributor of a
medicine or
medical device a
licence to manufacture, import or export, act as a
wholesaler of or distribute
, as the case may
be,
such
medicine or
medical device
, upon such
conditions as to the application of such acceptable quality
assurance principles and good manufacturing and distribution
practices as the council may determine. "
(emphasis
supplied)
[19]
Cell-C sought to have a decision o
f
ICASA
set
aside on review on the ground that
ICASA
exercised
a power
before applicable regulations has been promulgated,
[20]
The section, which deals with the transfer of transfer of individual
licenses and or change of ownership, reads:
"(2)
An
application for
permission to let,
sub-let,
assign,
cede
or
in any
way
transfer
an
individual
licence, or assign, cede or transfer
control of an individual licence may be made to the Authority
in the
prescribed
manner
."
(my emphasis)
[21]
This section deals with radio frequency spectrum licenses and reads
as follows:
"(3)
The Authority may, taking into account the objects of the Act,
prescribe procedures and criteria for-
(a)
….
(b)
….
(c)
permission to assign, cede, share or in any way transfer a
radiofrequency spectrum licence,
or assign, cede or transfer
control of a radiofrequency spectrum licence as contemplated in
subsection (2A). "