Treatment Action Campaign and Another v Rath and Others (12156/05) [2008] ZAWCHC 34; [2008] 4 All SA 360 (C) (13 June 2008)

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[2008] ZAWCHC 34
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Treatment Action Campaign and Another v Rath and Others (12156/05) [2008] ZAWCHC 34; [2008] 4 All SA 360 (C) (13 June 2008)

IN
THE HIGH COURT OF SOUTH AFRICA
(CAPE
OF GOOD HOPE PROVINCIAL DIVISION)
REPORTABLE
CASE NO: 12156/05
In the matter between
TREATMENT
ACTION CAMPAIGN
First
Applicant
SOUTH
AFRICAN MEDICAL ASSOCIATION
Second
Applicant
and
MATTHIAS
RATH
First Respondent
DR
RATH HEALTH FOUNDATION AFRICA
Second Respondent
SAM
MHLONGO
Third Respondent
DAVID
RASNICK
Fourth Respondent
ALEXANDRA
NIEWIECKI
Fifth
Respondent
ANTHONY
BRINK
Sixth Respondent
TREATMENT
INFORMATION GROUP
Seventh
Respondent
GOVERNMENT
OF THE REPUBLIC OF SOUTH AFRICA
Eighth
Respondent
DIRECTOR
GENERAL, DEPARTMENT OF HEALTH
Ninth
Respondent
CHAIRPERSON
MEDICINES CONTROL COUNCIL
Tenth
Respondent
REGISTRAR
OF MEDICINES
Eleventh Respondent
MEMBERS
OF THE EXECUTIVE COUNCIL FOR HEALTH
WESTERN
CAPE PROVINCE
Twelfth
Respondent
JUDGMENT DELIVERED
ON 13 JUNE 2008
ZONDI,
J
INTRODUCTION
[1] In this matter the
applicants launched an application against the respondents seeking
three forms of relief, namely declaratory,
mandatory and prohibitory.
[2] The
first applicant is the Treatment Action Campaign (“TAC”), a
company incorporated in terms of section 21 of the Companies
Act, 61
of 1973. The second applicant is the South African Medical
Association (“SAMA”) a representative body for medical doctors
in
South Africa.
[3] The
applicants’ principal complaint against the first to seventh
respondents (“Rath respondents”) is that they have been
systematically contravening various provisions of the Medicines and
Related Substances Act 101 of 1965 (“the Medicines Act”)
and they
seek an order declaring that their conduct is unlawful and an
interdict preventing the first to seventh respondents from
carrying
out the unlawful activities in violation of the Medicines Act. The
applicants contend that if the activities of the first
to seventh
respondents are unlawful then the eighth to ninth respondents
(“Government respondents”) are under a duty to take
reasonable
measures to prevent the aforesaid unlawful conduct and the applicants
maintain that the eighth to ninth respondents have
failed in their
duties to investigate the matter properly and to take reasonable
measures to prevent them.
[4] As
against the first to seventh respondents the applicants in the
amended notice of motion seek the following relief:
1. an order declaring
that the distribution and/or sale by the first and second respondents
and any of their agents of the products
Vitacor Plus, Epican Forte,
Lysin C Drink Mix and VitaCell in South Africa is unlawful, and
2. an order declaring
that the clinical trials conducted in South Africa by and/or under
the direction of first, second, third, fourth,
and fifth respondents
are unlawful.
3. an order interdicting
the first and second respondents from either directly or through
agents distributing and/or selling the
products Vitacor Plus, Epican
Forte, Lysin C Drink Mix and VitaCell in South Africa except in
accordance with provisions of the
Medicines and Related Substances
Act 101 of 1965
;
4. an order interdicting
the first to fifth respondents from conducting unauthorised clinical
trials in South Africa; and
5. an order interdicting
the first to seventh respondents from publishing false or misleading
advertisements concerning vitamins,
multivitamins and the products
Vitacor Plus, Epican Forte, Lysin C Drink Mix and Vita Cell.
[5] As against the eighth
to ninth respondents the applicants seek the following relief:
“5. It
is declared that the Eighth and Ninth Respondents are under a duty to
take reasonable measures to:
prevent the sale or
distribution of medicines contrary to the provisions of the
Medicines and Related substances Act 101 of 1965;
prevent persons
from conducting unauthorized clinical trials;
prevent persons
from publishing false or misleading advertisements concerning
medicines.
It is declared that
the Eighth and Ninth Respondents have failed to carry out their duty
referred to in paragraph 5 above, in that
they have failed properly
to investigate;
The legality of the
distribution and/or sale by the First and Second Respondents of the
products Vitacor Plus, Epican Forte, Lysin
C Drink Mix and VitaCell
in South Africa;
The alleged conduct
of unauthorized clinical trials in South Africa by the First,
Second, Third, Fourth, and Fifth Respondents;
The alleged
publishing by the First, Second, Third, Fourth, Fifth, Sixth, and
Seventh Respondents of false or misleading advertisements
concerning vitamins, multivitamins, and the products Vitacor Plus,
Epican Forte, Lysin C Drink Mix and VitaCell in South Africa.
The Eighth and Ninth
Respondents are ordered to take reasonable measures to investigate
the matters referred to in paragraph 6 hereof
and, in the light of
the facts revealed by such investigation, to take further reasonable
action in accordance with their duty
referred to in paragraph 5.
The Eighth and Ninth
Respondents are ordered to take reasonable measures to:
prevent the First
and Second Respondents from selling or distributing the products
Vitacor Plus, Epican Forte, Lysin C Drink Mix
and VitaCell in South
Africa contrary to the provisions of the
Medicines and Related
Substances Act 101 of 1965
;
prevent the First,
Second, Third, Fourth and Fifth Respondents from conducting
unauthorized clinical trials in South Africa.
prevent the First,
Second, Third, Fourth, Fifth, Sixth and Seventh Respondents from
publishing false or misleading advertisements
concerning the
products Vitacor Plus, Epican Forte, Lysin C Drink Mix and
VitaCell.
The Eighth and Ninth
Respondents are ordered within four weeks to present a report under
oath to this honourable court alternatively
to the Applicants as to
what they have done to give effect to the orders set out in
paragraphs 6 and 7, what further steps they
will take in this
regard, and when they will take such further steps.
The applicants shall
have a period of four weeks after service on them of the said report
to deliver their commentary under oath
on such report.
The Respondents shall
have a further period to two weeks after service upon them of the
Applicants’ commentary to deliver their
reply under oath to such
commentary.
The Applicants shall
be entitled, if so advised, to enroll the matter for hearing
thereafter for a determination of whether there
has been compliance
with paragraph 6 and 7 above and for such consequential relief as
they may seek.”
[6]
Mr
Budlender
appearing for the
applicants indicated that the applicants no longer seek relief
against the third, sixth and seventh respondents.
The third
respondent passed away while these proceedings were pending and the
matter had become settled as between the applicants
and the sixth and
seventh respondents.
[7] With
regard to tenth to twelfth respondents
Mr
Budlender
indicated that
the applicants are not seeking an order against any of them, save for
an order for costs in the event of opposing
the application.
[8] As
the applicants are seeking relief which is final in nature and the
parties have not requested that any factual disputes be
referred for
trial or oral evidence, such disputes must be resolved by applying
the test enunciated in
Plascon-Evans
Paints Ltd v Van
Riebeeck
Paints (Pty) Ltd
1984(3)
SA 623 (A) 634e-g, namely that the final interdict sought can be
granted only if the facts as stated by the respondents,
together with
the admitted facts in the applicants’ affidavits justify the
granting thereof.
Citation of the
Government of the Republic of South Africa
[9]
Mr
Moerane,
who appeared
together with
Mr Coppin
and
Mr Vally
for the eighth and ninth respondents, contended that the Government
of the RSA is not correctly before the Court. The applicants
allege
that they bring this application against the Government of the
Republic of South Africa represented by Dr Tshabalala-Msimang
in her
capacity as the Minister of Health in the National Government.
Referring to various provisions of the Constitution,
Mr
Moerane
argued that the
Minister of Health cannot represent the government. It is the
President who can do so. He submitted that in terms
of
section 2(1)
of the
State Liability Act 20 of 1957
, the Minister of the department
concerned must be cited as a nominal defendant.
[10] In
support of his contention,
Mr
Moerane
referred to the SCA
decision in
Jayiya v MEC
for Welfare, EASTERN CAPE
2004(2) SA 611 at para 5:
“
A litigant brings a
national or provincial department before Court by citing the
political head of the department in a representative
capacity. In the
case of the department of the National Government, this would be the
responsible Minister. In the case of a provincial
department it is
the responsible member of the executive council. That is what
section
2
of the
State Liability Act 20 of 1957
provides. The first
respondent should have been the only one. If this had been borne in
mind at the outset, some of the procedural
mishaps might have been
avoided.”
[11] I
agree with
Mr Moerane’s
contention. The applicants should have amended their notice of motion
to cite properly the Government of the Republic of South Africa.
Similarly the Director-General cannot represent the government. He
does not and cannot speak on behalf of the Government of the Republic
of South Africa. In their replying heads of argument the applicants
expressed their preparedness to accept an order that would be
directed against the Minister of Health. In the light of the
applicants’ concession I will proceed to deal with the matter on
the
basis that it is the Minister of Health who is before the Court
and not the Government of the Republic of South Africa.
Applicants’
Case
[12] In
their founding affidavit the applicants aver that the HIV/AIDS
pandemic is a major public health crisis in South Africa. They
state
that AIDS can be effectively treated with medicines which are known
generally as Antiretroviral (“ARVs”) which have been
registered
for this purpose by the Medicines Control Council. (“the MCC”)
They make a point that the ARVs are not the only means
of dealing
with HIV, but are an essential element of any effective treatment.
[13] The
applicants’ complaint against the first to seventh respondents is
that they carry out activities which the applicants believe
are
unlawful and place at risk the health and lives of people with AIDS.
The applicants allege that the first to seventh respondents
sell and
distribute medicines which are not registered, sell products
containing scheduled substances; make false and unauthorised
statements about efficacy of their medicines in treating or
preventing AIDS; conduct unauthorised and unethical clinical trials
on
people with AIDS; and finally they accuse the first to seventh
respondents of making false statements that ARVs are ineffective in
treating AIDS, and are poisonous and they discourage people with AIDS
from taking medicines which are an essential element of an
effective
treatment programme.
[14] It
is alleged by the applicants that the government authorities
including the eighth and ninth respondents are under a duty to
take
reasonable and effective steps to stop the unlawful activities of the
first to seventh respondents but they have failed to take
such steps
despite having been given evidence of unlawful activities of the
first to seventh respondents by the first applicant.
[15] In
support of this assertion that the ARVs can effectively treat AIDS,
the applicants rely on the expert opinion of Dr Francois
Venter, an
expert on the science of HIV/AIDS. Dr Venter explains that there is
consensus among all generally recognised scientific
institutions
dealing with the HIV epidemic that ARV treatment is the only current
specific treatment for HIV, and the only current
health intervention
that reverses the course of AIDS. He says it is a lifelong treatment.
He does, however, mention that malnutrition
and undernutrition have
an adverse impact on the health of people with HIV/AIDS. In his
opinion there is no scientific evidence that
vitamins or
micronutrients reverse the course of AIDS although a particular
combination in a particular dose does delay the onset
of AIDS in a
specific group of patients.
[16] Dr
Venter further states that the ARVs, when appropriately prescribed
and used, reduce morbidity and mortality in the vast majority
of
patients. He concedes that antiretroviral treatment can have side
effects and which can be fatal in some cases. He goes on to
say that
there is scientific consensus that the benefits of ARVs, when used as
a chronic life long treatment for people with advanced
HIV-disease,
far outweigh the risk associated with ARVs. The ARVs are registered
with MCC for treatment of HIV, and which means
they are considered
sufficiently safe and effective for the purpose of treating HIV. Dr
Venter says the MCC has not registered any
micronutrients for the
treatment of HIV.
[17] In
support of the claims that the first and second respondents had been
selling medicines in contravention of the provisions
of the Medicines
Act, the applicants refer to various affidavits deposed to by the
persons who obtained medicines from health facilities
allegedly run
by the first and second respondents. The applicants aver that the
products which various deponents obtained from health
facilities run
by the first and second respondents are all medicines by virtue of
their contents and the claims which are made by
the second
respondent.
[18] The
products which were allegedly obtained from the health facilities run
by the first and second respondents are a bottle, branded
as “Dr
Rath’s” Vitacor Plus, a bottle, branded as “Dr Rath’s”
Epican Forte, a bottle, branded as “Dr Rath’s” Lysin
C Drink
Mix, a bottle of Vitacell. The applicants sent a bottle of Vitacell
for analysis to Andrew Loft Gray, a pharmacist. Gray,
after analysing
the product, concluded that it was liable to registration. Gray says
Vitacell contains N-aceylesteine which is a
Schedule 2 substance in
terms of the Medicines Act and it can only be sold by a pharmacist or
a person listed in section 22A(5) of
the Medicines Act.
[19] It
is further averred by the applicants that the first to seventh
respondents have placed advertisements in newspaper and distributed
advertisements as pamphlets and posters through out the country in
which they make false claims about the treatment of AIDS using
multivitamins and micronutrients. The applicants state that these
advertisements are in breach of the Medicines Act. They refer to
various newspapers and publications in which the first to seventh
respondents made these false claims.
[20] The
claims in the advertisements include the following:
Micronutrients reverse
the course of AIDS.
Evidence from a pilot
study that micronutrients alone dramatically improve clinical
conditions and immune function of HIV/AIDS patients,
increasing
white blood cells, lymphocytes, monocytes, T-cells and CD4 counts.
Hundreds of studies have
found that AZT is profoundly toxic to all cells of the human body
and particularly to the blood cells of
our immune system.
Numerous studies have
found that children exposed to AZT in the womb suffer brain damage,
neurological disorders, paralysis, spacitity,
mental retardation,
epilepsy, other serious diseases and early death.
[21] The applicants
further aver that the first to seventh respondents conduct
unauthorised clinical trials in contravention of Regulations
made
under the Medicines Act. In this regard they refer to advertisements
in various newspapers and other publications in which the
respondents
admit to have been conducting clinical trials. In particular the
applicants refer to an advertisement which appeared
in The Mercury
newspaper dated 15 April 2005 stating:
“we
conducted a clinical pilot study in HIV-positive patients with
advanced AIDS. The goal of the study was to show that vitamins
and
other micronutrients alone reverse the course of AIDS, even in its
advanced stage… Thus, it was essential that none of the
parties had
received any ARV drugs before or during this nutritional programme.
The nutrient programme consisted of vitamins, minerals
amino acids
and certain other essential nutrients. Blood tests and clinical
evaluations were performed at the start and after four
weeks on the
nutrient programme. The results of this pilot study were so profound
that only one month that we decided to publish
the data of the first
15 patients without delay. After the completion of the study a
comprehensive report will follow”
[22] The
applicants also aver that the first and second respondents operate
health facilities in the Western Cape and one of these
is in
Khayelitsha. They state that the first and second respondents have
not been granted permission by the Medicines Control Council
(“MCC”)
to operate these health facilities at which they conduct clinical
trials. The applicants allege that the first to seventh
respondents’
advertisements are intended to persuade people with AIDS not to take
ARVs and in some instances they have succeeded
in doing so.
[23]
The applicants further aver that the government authorities are aware
of the illegal activities of the first to seventh respondents
but
have failed to act against them. The applicants allege that on
various occasions they brought the illegal activities of the first
to
seventh respondents to the attention of the government authorities
but they failed to act against the first to seventh respondents.
Respondents
Responses
[24] The
Rath respondents deny that they have carried out activities which are
violative of the Medicines Act. They aver that the
products
complained of are vitamins and nutritional supplements which are not
subject to registration in terms of the Medicines Act
and which ought
not to be classified as drugs or medicines. In particular first and
second respondents deny that they have ever sold
any nutritional
supplements or any other products at all in South Africa. They have,
however, donated nutritional substances to community
organisations in
the country without receiving remuneration and which in turn
distribute these products to members of the public
as part of a
vitamin programme. The Rath respondents deny having conducted
clinical trials in South Africa or having published false
and
misleading advertisements or having made unauthorised claims about
vitamins, multi-vitamins, including the nutritional products
in
question.
[25] The
first respondent accuses the first applicant of operating as a front
for the pharmaceutical industry. He says the leading
members of the
second applicant are connected to the pharmaceutical investment
interest through their professional careers and positions
they hold
in organisations heavily sponsored by the drug industry.
[26] He
dismisses as false the assertion that the ARVs can prevent the
development of AIDS in HIV infected patients. He characterises
these
drugs as being highly toxic and highlights their inability to prevent
or cure either HIV infections or the development of AIDS.
He
acknowledges that micronutrients are not a cure for AIDS. But he says
in the absence of an effective cure or a vaccine for AIDS
– and in
the face of the extreme toxicity of ARVs – they are an effective
and affordable way to halt progression and even reverse
the symptoms
of the AIDS disease.
[27] The
government respondents deny having failed to take steps against the
Rath respondents. The ninth respondent avers that he
is not aware
that the Rath respondents are acting unlawfully. In particular the
ninth respondent in his answering affidavit states:
“47. …The
first applicant had referred certain of its allegations against some
of the first to seventh respondents to the MCC
and to my office. The
MCC had asked for more information and Mr Andre Du Toit had
investigated, inter alia, the specific allegations,
i.e. that the
second respondent has been selling unregistered medicines and that it
has been unlawfully conducting clinical trials
for humans. His
investigation, thus far, did not confirm the allegations of the first
applicant…”
[28]
Mr D Potgieter
, who
appeared together with
Ms
Kusevitsky
on behalf of the
twelfth respondent, submitted that the suggestion that the twelfth
respondent as well as the Western Cape Provincial
government have not
fully complied with the duty to take reasonable steps to stop the
alleged unlawful activities of the Rath respondent,
was incorrect. He
argued that the twelfth respondent immediately took necessary steps
to refer the allegations by the Western Cape
Clinicians concerning
the first respondent to the MCC for attention.
Statement of Issues
[29] This
application concerns the following questions:
1.
whether the Rath respondents are distributing medicines in
contravention of the Medicines Act;
whether the Rath
respondents are conducting unauthorised clinical trials in
contravention of the Medicines Act;
whether
the Rath respondents are publishing unauthorised, false and
misleading advertisements concerning vitamins, multivitamins,
and
certain products produced by Dr Rath and the entities associated
with him; and
Whether the Government
has taken reasonable measures to investigate and put an end to such
activities.
The
question of lawfulness of the Rath respondents’ conduct must be
determined with reference to the applicable law, and in particular,
the Medicines Act.
Applicable Law
Meaning
of “Medicine”
[30] The
word “medicine” is defined in section 1 of the Medicines Act as:
“ any substance or
mixture of substance used or purporting to be suitable for use or
manufactured or sold for use in -
the diagnosis,
treatment, mitigation, modification or prevention of disease,
abnormal physical or mental state or the symptoms thereof
in man; or
restoring, correcting or
modifying any somatic or psychic or organic function in man, and
includes any veterinary medicine.”
[31]
Mr
Budlender,
appearing for
the applicants, submitted that first, there is no power vested in
anybody other than a Court to determine whether a
substance is a
medicine. A substance either is or is not a medicine in terms of the
definition. He argued that it is not registration
which determines
whether a substance is a medicine. If the substance as a matter of
objective fact falls within the definition then
it is a medicine.
Secondly he submitted that in certain circumstances a substance will
be a medicine if it is used for the defined
purpose or if it purports
to be suitable for use, for instance for-treating people or if it is
manufactured or sold for the purpose
of treating people. He argued
that the present substance sold or distributed by the first and
second respondents is a medicine because
they say the substance is
good for the purpose of treating or preventing HIV/AIDS. In support
of his contentions he referred the
Court to the case of
Reitzer
Pharmaceuticals (Pty) Ltd v Registrar of Medicines and Another
1998(4) SA 660 (T). I agree with
Mr
Budlender’s
submissions.
The question whether or not any particular substance is a medicine
must be determined with reference to the provisions
of the Act and
when its identity is being questioned. The attributes of the
substance and the claims made in respect of the substance
will
determine if it is a medicine within the meaning of the Medicines
Act.
[32]
Mr
Ntsebeza
, who appeared
together with
Mr Walther
for the first, second, third, fourth and fifth respondents, submitted
that the definition of “medicine” contended for by the
applicants
is wider than that contained in section 1 of the Medicines Act. He
argued that on the applicants’ construction even
Rooiboos Tea or
“Boereraad” remedies and other traditional remedies would fall
within the definition of a “medicine”. He
submitted that the
construction contended for by the applicants could never have been
the intention of the legislature. He contended
for a more
circumspect, practical and common sense approach.
[33]
Mr
Moerane
submitted that the
interpretation suggested by the applicant makes the definition of
“medicine” overbroad. He argued that such
an interpretation would
not allow for discriminating between water or a soft drink that is
claimed quenches “any thirst”. He
pointed out that the meaning of
“medicine” contended for by the applicants would result in the
word “medicine” losing its
meaning and could lead to absurd
result. In support of his contention,
Mr
Moerane
referred to
Reitzer
Pharmaceuticals
case, supra
at 683 E-F:
“ But
to return to applicant’s argument: water may be used for restoring,
correcting or modifying any somatic or organic function
in man namely
to quench thirst…”
Does that mean that
the Council may in terms of section 30 of the Act lay down
“prescribed requirements” in relation to water
used for drinking
purposes? Obviously that would be absurd. Parliament could never have
intended the Council to have authority to
prescribe requirements in
relation to water used merely for drinking purposes”
[34]
Mr
Moerane
submitted that to
avoid the glaring absurdity which could result if the literal meaning
of “medicine” was applied, a definition
of “medicine” has to
be qualified.
[35] The
question to be determined is the meaning of the word “medicine”
as used in the Medicines Act. The matter is essentially
one of
interpretation. The intention of the Legislature should be
ascertained from a study of the provisions of the Medicines Act
and
that the language of the Legislature should be read in its ordinary
sense.
[36] If
the meaning of the words using this approach is clear then such
meaning represented the intention of Parliament, the object
of
statutory interpretation always being to stamp a particular meaning
with the Legislature’s
imprimatur
by means of the fiction of
Parliament intent. (
Judicis
est ius dicere sed
non
dare.
)
[37] It
was, however, pointed out by Schreiner JA that:
“
what
seems a clear meaning to one man may not seem clear to another. This
consideration must also, I think, be borne in mind when one
refers to
the literal, ordinary, natural or primary meaning of words or
expressions. The ‘literal’ meaning is not something revealed
to
judges by a sort of authentic dictionary; it is only what individual
judges think is the literal meaning, if they employ that
term.”
(
Savage
v Commissioner for Inland Revenue
1951 (4) SA 400
(A) at 410 F-G).
[38] It was recently held
by Hurt AJA, delivering a majority judgment in the Supreme Court of
Appeal on 26 November 2007 that:
“
In
recent years courts have placed emphasis on the purpose with which
the Legislature has enacted the relevant provisions. The interpreter
must endeavour to arrive at an interpretation which gives effect to
such purpose. The purpose
(which
is usually clear or easily discernible) is used, in conjunction with
the appropriate meaning of the language of the provision,
as a guide
in order to ascertain the legislator’s intention (the so-called
method of ‘purposive
construction’).”
(
Commissioner
for South African Revenue Service v Airworld CC and
Another
Case no 672/06, Supreme Court of Appeal, at para [25]).
[39]
In the Concise Oxford English Dictionary “medicine” is described
as “a drug or other preparation for the treatment or
prevention of
disease.”
[40] It
is clear to me that the dictionary meaning of “medicine” is
limited to the drug for
treatment
or
prevention
of diseases. It only
includes two functions of the drug, namely
treatment
and
prevention
and
does not include other functions as set out in section 1 of the
Medicines Act, such, as the “diagnosis, mitigation, or modification
of disease” (section 1(a)) or “restoring, correcting or modifying
any somatic or psychic or organic function in man…” (Section
1(b). In the present matter the dictionary meaning of “medicine”
seems to have some limitations and therefore may not be used
as a
tool to ascertain the intention of the Legislature. It is therefore
clear that the Legislature intended the word “medicine”
to have a
wider than a dictionary meaning in order to achieve the object of
Medicines Act namely to control and regulate dissemination
of
medicines either inherently harmful or potentially so when misused.
The definition of “medicine” in the Act places more emphasis
on
the “use” of substance or mixture of substances. A substance or a
mixture of substances must be “used or purporting to be
suitable
for use or manufactured or sold for “use” in performing various
functions set out in the Act.
[41] It
is correct, as
Mr Ntsebeza
argued, that if one adopts a literal interpretation of the word
“medicine” Rooibos Tea or water used to quench thirst could fall
within the definition of “medicine”. That interpretation, would,
however, in my view be repugnant to the intention of the Legislature.
It
was pointed by Corbett AJ (as he then was) in
S
v Burger
1963 (4) SA (C)
304 at 308 A-C that:
“…where
the language of a statute is unambiguous and its meaning is clear,
the Court may only depart from such meaning if it leads
to absurdity
so glaring that it could never have been contemplated by the
Legislature or if it leads to a result contrary to the
intention of
Parliament as shown by the context or such other considerations as
the Court is justified in taking into account...”
[42] The
purpose of the Act is to protect the public against quackery through
assessing and controlling the quality, efficacy of the
medicines. It
is not the intention of the Legislature to control substances which
are ordinarily drunk by man such as Rooibos Tea
as long as such
substances are ordinarily used and there are no claims of their
medicinal efficacy. In my view the use of a particular
substance is
the determining factor in deciding whether or not it is a medicine.
If one adopts this approach one is able to limit
the seemingly
overbroad definition of “medicine”. To use
Mr
Ntsebeza’s
Rooibos Tea
example in order to emphasise the purpose of the Act, if a person
were to sell Rooibos Tea and to hold out to the public
that it could
cure arthritis Rooibos Tea could fall under the definition of
“medicine”. The reason for such finding would not
be difficult to
fathom: a number of people are likely to start using Rooibos Tea in
the hope that it would treat or prevent or cure
arthritis. The only
logical way to protect the public against such claims would be to
bring Rooibos Tea within the definition of
“medicine” so that its
quality, safety and efficacy could be controlled and regulated.
[43] With
this legal background I now turn to consider whether the substance
donated by the first and second respondents to South
African National
Civic Organisation (SANCO) for distribution to the community members
is a medicine. In their answering affidavit
the first and second
respondents do not deny that they distribute vitamins and nutritional
supplements. However, what is denied is
that these substances are
medicines or that they sell any of these substances. They say they
donate these substances to community
organisations in the country
without receiving any remuneration and the only product they donated
in large quantities is VitaCell
which was registered with the
Department of Health on 18 March 2004 as food supplement in terms of
the Foodstuffs, Cosmetics and
Disinfectants Act, 54 of 1972.
[44] They
deny that they are still donating Vitacor Plus, Epican Forte and
Lysin C Drink Mix. They aver that they ceased donating
these
substances many months ago, well before the launch of this
application. The applicants, in their replying affidavit, do not
seriously challenge the respondents’ averment in this regard. In
the circumstances in so far as there is a dispute of facts on
the
question whether or not the first and second respondents are still
distributing these three substances I will resolve it in favour
of
the first and second respondents and find that the first and second
respondents ceased distributing these three substances long
before
the launch of these proceedings. As the applicants are seeking an
interdictory relief there will be no need for such remedy
once the
alleged unlawful conduct complained of has ceased to exist. In other
words I find that the first and second respondents
still donate
VitaCell to Sanco.
[45]
I have already held that in determining whether or not a particular
substance is “medicine” for the purpose of the Medicines
Act one
must have regard to the use of a substance. Is it used for medicinal
purpose? In this case it is alleged by the applicants
that the first
respondent made claims in various media that the substances he
distributes cure or reverse the course of AIDS. The
substances are
medicines in that the first and second respondents distribute them
for use for medicinal purposes. It is therefore
necessary to bring
them under the ambit of the definition of “medicines” in order to
control and regulate their use. Members
of the public, because of
statements about their medicinal efficacy, will start using the
substances on the basis that, when taken,
they will cure or reverse
the course of AIDS. The control and regulation of these substances is
necessary in order to prevent confusing
messages being sent out to
the public about the treatment of AIDS. In the circumstances I find
that VitaCell is a medicine within
the meaning of the Medicines Act.
[46] Having
found that VitaCell is a medicine, the next question for
determination is whether the first and second respondents “sell”
VitaCell within the meaning of the Medicines Act. The determination
of this question is important because in terms of the Medicines
Act
certain medicines may not be sold unless they are registered.
Definition
of “Sell”
[47] In
terms of section 1 of the Medicines Act “Sell” means “sell by
wholesale or retail and includes import, offer, advertise,
keep,
expose, transmit, consign, convey or deliver for sale or authorise,
direct for sale or authorise, direct or allow a sale or
prepare or
possess for purpose of sale, and barter or exchange or supply or
dispose of to any person whether for a consideration
or otherwise”.
[48] It
is clear from this definition that the Act defines “sell” very
broadly. The consequence is that a person who offers or
advertises a
medicine or distributes it to other persons even without a charge
runs the risk of exposing himself to the application
of the Act. In
other words once the MCC has made a determination by way of
resolution that a particular medicine be registered, one
cannot
“sell” that particular medicine unless it is registered. The
definition of “sell” is very broad but has a narrow consequence.
[49] However,
Kriegler AJA (as he then was) in
Administrator,
Cape v Raats Röntgen
and
Vermeulen (Pty) Ltd
1992(1)
SA 245 (A) found that the meaning of “sell” was not as wide as it
appears to be. At 258 A-B he pointed out:
“
Notwithstanding
the wide ambit of t
he
words and the ostensibly diverse range of acts enumerated, there is
an identifiable common denominator characterising the whole.
That is
some transaction or action of a commercial or quasi-commercial nature
related, albeit remotely, to selling-or delivery pursuant
thereto-
with a view to consumption. That the word ‘supply’ was not
intended to apply – to the administration of an injection
by a
nurse at the bedside of the hospital or to a mother cajoling her
offspring to gulp a proffered spoonful of cough syrup.”
[50] It
was argued by
Mr Ntsebeza
on behalf of the Rath respondents that the word ”sell” ought to
be given a narrow meaning and should not be construed to include
the
conduct of the first and second respondents. He submitted that the
donation of vitamins by the first and second respondents to
a
community organisation cannot be construed as “selling”
[51] I
disagree with
Mr Ntsebeza’s
contention. It is clear from the Act that the meaning of “sell”
includes donation and the first and second respondents’ supply
of
VitaCell to Sanco constitutes a sale for the purpose of the Act. The
supply of substance does not have to be for consideration.
There is a
compelling reason for finding that the supply of VitaCell by the
first and second respondents constitutes a sale for the
purpose of
the Act. In this case not only do they donate VitaCell to Sanco but
they also actively promote its use by persons with
AIDS and monitor
its performance.
Whether
Rath’s products should be registered
[52] The
next question is whether VitaCell should be registered. The fact that
a substance is found to be a medicine does not automatically
render
it liable for registration. A requirement to register a medicine in
terms of the Medicines Act is based on the fact whether
it has been
called up for registration in terms of section 14 of the Medicines
Act. In other words the fact that a substance is a
medicine does not,
without having been called up for registration, make it an offence to
sell that substance without having it registered.
[53] The
Medicines Act makes provisions for the registration of medicines:
Section 14(1) and (2)
provides:
“
(1)
Save as provided in this section or sections 21 and 22A, no person
shall sell any medicine which is subject to registration by
virtue of
a resolution published in terms of subsection (2) unless it is
registered.
(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.”
Section
15(1) deals with the registration process and submission of the
application for the registration of medicines. In terms of
section
15(3) the MCC must approve the application if, after considering the
application and after investigating, it is satisfied
that the
medicine, in respect of which an application for registration is
made, is suitable for the purpose for which it is intended
and
complies with the prescribed requirement and is in the public
interest.
[54] It is clear that the
MCC performs an administrative function when it considers
applications for registration of medicines. Its
decision must comply
with the provisions of section 33 of the Constitution which provides
that everyone has the right to administrative
action that is
reasonable and procedurally fair. The decision of the MCC must be
reasonable within the meaning of the Promotion of
Administrative
Justice Act No.3 of 2000 (“PAJA”). What that means is that during
the registration process the manufacturers,
distributors or
wholesalers must have a hearing.
Section 19(1) provides:
“
no person shall
sell any medicine unless it complies with the prescribed
requirements.”
[55]
It is clear from the provisions of the Medicines Act that if the MCC
has by notice determined that a medicine or class or category
of
medicine is subject to registration then it is an offence to sell
that medicine or class or category of medicine unless it has
been
registered.
[56] The
Rath respondents aver that VitaCell does not need to be registered as
it is currently registered as a “food supplement
for distribution
and importation into South Africa in terms of the Foodstuffs,
Cosmetics and Disinfectants Act 54 of 1972 (“the
Foodstuffs Act”)”.
They accordingly contend that the call up notice issued and published
by the MCC in 2002 does not apply to
VitaCell.
[57] I
agree with
Mr Budlender
that a substance which is a medicine under the Medicines Act is not
governed by the Foodstuffs Act. In the light of the fact that
I have
already found that VitaCell is a medicine within the definition of
the Medicines Act, the Rath respondents may not rely on
the
provisions of the Foodstuffs Act as a basis for their argument that
VitaCell is not covered by the provisions of the Medicines
Act. The
provisions of the Medicines Act apply to VitaCell and not the
Foodstuffs Act.
[58] It
is the applicants’ contention that VitaCell is subject to
registration in terms of the Medicines Act pursuant to the call
up
Notice 204 of 2002. The Rath respondents and government respondents
argue that the applicants’ reliance on the Notice 204 of
2002 is
misplaced. They submit that Notice 204 of 2002 does not contain a
resolution in terms of section 14(2) to the effect that
products
containing vitamins, multivitamins and micronutrients are required to
be registered under the Medicines Act.
[59] In
terms of the Medicines Act, the Department of Health issued
Government Notice R 204 in the Government Gazette dated 20 February
2002. (“the 2002 Notice”). The 2002 Notice superseded all
previous call up notices including the 1985 call up notice.
Its heading reads as
follows:
“
CALL
UP NOTICE FOR MEDICINES FREQUENTLY REFERRED TO AS COMPLEMENTA
RY
MEDICINES IN TERMS OF THE MEDICINES AND RELATED SUBSTANCES CONTROL
ACT, 1965 (ACT 101 OF 1965)”.
[60] The
Preamble reads:
The
Medicines Control Council (MCC) has noted that there are increasing
numbers of medicines frequently called complementary medicines
being
sold in South Africa for which claims of safety, quality and efficacy
are being made without the approval of the MCC. The Complementary
Medicines Working Group of the MCC, after consultation with
stakeholders recommended to Council that a call up of the following
categories of medical products be undertaken, for purposes of which
certain specified exemptions in the application for registration
of a
medicine (MBRI) form will be allowed.
The
categories of the medicines frequently referred to as complementary
medicines should include:
“ 7
Nutritional substances that purport to have therapeutic or medicinal
effects”.
The submission of an
application in response to this call up would not constitute product
registration but should be considered a
primary step in the
registration process.
The data compiled from
this call up will enable Council to compile an audit of all products
currently available in the market place.
Council will review the
claims of safety, quality and efficacy for all identified products
and will determine whether any such claims
constitute a public health
hazard and act accordingly.
For
all products, Council will at a later stage determine which
additional Annexures of the MBR1 form will be required for
registration
purposes.
Any person who
contravenes this call up notice shall be subjected to the provisions
of Section 14 read with Section 29 (b) and (h)
and Section 30 of Act
101, 1965.
Council also noted
that similar unsubstantiated claims of safety, quality and efficacy
are being made with respect to African traditional
medicines that are
widely available in the market place. The MCC’s African Traditional
Medicines Working Group will be asked to
consider whether a similar
approach to a call up for the purposes of preparing an audit of these
products could be gainfully undertaken
at this time.
(b) the Medicines
Control Council established in terms of Section 2 of the Medicines
and Related Substances Control Act, 1965 (Act
101 of 1965) by virtue
of the powers vested in it by section 14(2) of the Act has by
resolution approved by the Minister of Health,
determined that, with
effect from the date of publication of this notice-
All preparations or
mixtures of substances that fall under the definition of a medicine,
including all dilutions, mixtures or derivations
of any substances
that are anthroposophical medicines, aromatherapeutic medicines,
ayurvedic medicines, Chinese traditional medicines,
energy
substances, homeopathic medicines, nutritional substances that
purport to have therapeutic or medicinal effects, western herbal
medicines, Unani-Tibb medicines, combination homoeopathic/ flower
essences, and combination complementary medicines,
shall
be subject to a call-up process instituted as a primary step towards
registration of such as medicines and shall be submitted
to the MCC
within six(6) months of the date of publication of this notice.
It is further notified
that under section 14(2)(b) of Act 101 of 1965, the abovementioned
resolution shall relate to medicines available
for sale or
distribution in the Republic on the date on which it comes into
operation and shall relate also to medicines that become
available
after the said date.”
[61] The
ninth respondent (the Director General) explains how in his
understanding the call up notice was intended to apply. He says:
“
28.3
I am informed by the tenth respondent that the 2002 notice was
designed to ensure that all complementary medicines, nutritional
substances that purport to have therapeutic or medicinal effects and
other scheduled substances are brought to the attention of the
MCC,
which would then decide which of the above products would be subject
to registration in order to enable the MCC to devise an
appropriate
system for their registration. The 2002 notice is not, and was never
intended to determine what is and is not a medicine
and furthermore,
which medicine is subject to registration and which not. The MCC
envisaged that the data collected from the call-up
would enable it to
compile an audit of all products currently available on the market,
and review the claims of safety, quality and
efficacy for all
identified products and determine whether any claims in connection
therewith constitute a public health hazard and
act accordingly.
28.6
The fact that the product contains a schedule 2 substance does not
necessarily make it a medicine. It is necessary for the MCC
to
resolve, and not for the Court to declare, that it is a medicine, as
envisaged in the Medicines Act, especially if the product
could also
be regarded as a f
oodstuff
or food supplement. Furthermore, it is for the MCC to resolve that
any particular product requires to be registered and the
MCC has to
have in place a system for its registration and regulation. It has
not been established, let alone beyond a reasonable
doubt, that the
products containing the schedule 2 substance have been dispensed by
persons not competent and qualified to do so
and that there has
accordingly been a transgression of section 22A(5) of the Medicines
Act.”
[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
Budlender’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 that it is for the MCC to resolve that any particular
substance requires to be registered. The term “medicine”
is
defined in the Medicines Act and if there is a dispute about the
nature of a 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.
[63] The
2002 call up notice is said to have superseded all call up notices
previously issued including the 1985 call up notice. There
is a
marked difference between the 1985 call up notice and the 2002 call
up notice. In terms of the 1985 call up notice all oral
preparations
which contained a vitamin or vitamins but excluding foodstuffs and if
they contained or exceeded per recommended total
daily dose any of
the respective doses stated in the notice, would be subject to
registration as medicines whether or not medicinal
claims were made.
The 1985 call up notice identified the criteria which had to be used
in determining whether oral preparations had
to be registered. To be
registered all oral preparations had to have attributes mentioned in
paras 1 and 2 of the notice. Claims
about the medicinal effect of the
oral preparations were irrelevant in determining whether they were
subject to registration. The
2002 call up notice, unlike the 1985
call up notice, is inelegantly worded and appears to be self
contradictory in terms.
[64] The
2002 call up notice, however, emphasises the therapeutic or medicinal
effect as a criteria for the registration of a nutritional
substance
as a medicine. The object of the call up notice as expressed in its
preamble is to address problems associated with complementary
medicines which are being sold in the country for which claims of
safety, quality and efficacy are being made. In my view it is not
the
purpose of the 2002 call up notice to subject to registration the
nutritional substances mentioned in the notice. Its primary
purpose
is to bring the substances about which medicinal claims are made to
the attention of the MCC for it in order to determine
the correctness
of the claims and whether the claims constitute a public health
hazard. The notice states categorically that submission
of an
application in its response would not constitute product registration
but would be considered a primary step in the registration
process.
The 2002 notice does not render the substances it identifies subject
to registration as medicines. It renders them “subject
to a call-up
process instituted as a primary step towards registration of such as
medicines.” In other words the substances identified
in the 2002
notice do not automatically become registrable.
[65] In
my view, the 2002 call up notice does not subject VitaCell to
registration even though medicinal claims are being made about
it. I
therefore hold that VitaCell is not subject to registration as a
medicine. The MCC must still determine the correctness of
its
medicinal claims and whether the claims constitute a public health
hazard. The purpose of the 2002 call up notice is to allow
the MCC
to determine whether the complementary medicines are registrable and
their scheduled status. This is necessary in order to
subject them to
the provisions of the pricing regulations. Pricing regulations may
not be applied to complementary medicines such
as VitaCell until
their scheduled status is established. What it means then is that the
Rath respondents should stop making claims
about efficacy of VitaCell
until it has been submitted to the MCC to review claims about its
safety, quality and efficacy.
Sale of Scheduled
Substances
[66] The
next question to determine is whether the Rath respondents sell
scheduled substances. The Rath respondents admit that they
are
donating VitaCell to Sanco. It is common cause that VitaCell contains
N-acetylcysteine which is a Schedule 2 substance under
the Medicines
Act. The Act defines scheduled substances to mean any medicine or
other substance prescribed by the Minister under
section 22A.
[67] Section
22A of the Medicines Act provides for the control of the distribution
of any product that contains scheduled substances.
In terms of
section 22A (5) of the Act any substance containing a schedule 2, 3,
4, 5 or 6 can only be sold or dispensed by a particular
class of
persons. It is the Rath respondents’ contention that they donate
VitaCell to Sanco which in turn distributes it to people
with AIDS
who are attended to and examined by a community physician, a
registered medical practitioner. There is a factual dispute
between
the applicants and the Rath respondents on the status of the people
who dispense VitaCell to persons who visit the SANCO
“clinics”.
The people who obtained VitaCell from Sanco “clinics” do however
confirm that they were seen by a doctor. In the
circumstances I will
accept that VitaCell was dispensed properly and in accordance with
the provisions of section 22 (A) of the Act.
In any event even if I
may be wrong in my reasoning there is another basis which supports my
view and it is the following: the fact
that VitaCell contains a
schedule 2 substance does not necessarily make it a scheduled
substance in the absence of its registration
and scheduling. It has
not been called up for registration. The 2002 Call Up Notice does not
call it for registration. It renders
it “subject to a call-up
process instituted as a primary step” towards its registration.
Ordinarily pricing regulations do not
apply to complementary
medicines. If VitaCell was a scheduled substance pricing regulations
would apply to it. The fact that the
pricing regulations do not apply
to VitaCell is indicative of the fact that it should not be regarded
as a scheduled substance. The
pricing regulations do not apply to
unscheduled substances. It is therefore difficult to determine the
Scheduled status of VitaCell
while it remains an unregistrable
complementary medicine.
Clinical Trials
[68] I
now turn to consider the question whether the Rath respondents
conduct unauthorised clinical trials. In support of the allegations
that the Rath respondents conduct unauthorised clinical trials, the
applicants refer to copies of advertisements placed on behalf
of some
of the Rath respondents in various newspapers, a copy of a pamphlet,
alleged quotations of statements downloaded from the
website of the
Rath Foundation, a transcript of an interview conducted between Radio
786 and the first respondent as well as a transcript
of an interview
which the first respondent conducted on P4 Radio. The applicants also
rely on affidavits of various persons who participated
in the
“clinical trials” conducted by the first and second respondents.
It is common cause that the Rath respondents whether
rightly or
wrongly did not have permission to conduct clinical trials.
[69] Clinical
trials are regulated by the Regulations promulgated under the Act.
They are contained in Government Notice R510 in Government
Gazette
24727 of 10 April 2003. Regulation 1 defines “clinical trial” as
follows:
“ An
investigation in respect of a medicine for use in humans that
involves human subjects and that is intended to discover or verify
the clinical, pharmacological or pharmacodynamic effects of the
medicine, identify any adverse events, study the absorption,
distribution,
metabolism and excretion of the medicine or ascertain
its safety or efficacy.”
[70] Regulation
34 regulates the conduct of clinical trials for humans. Regulation
34(1) provides as follows:
“
A person desiring
to initiate or conduct a clinical trial in respect of an unregistered
medicine, a new indication or new dosage regimen
of a registered
medicine or substance, shall apply to a Council on a form determine
by the Council for authority to conduct such
a clinical trial”
[71] Regulation
34(2) to (4) deals with the content of the application, the trial
protocol, and the information which is required
to be provided.
Clinical trials must be conducted in accordance with guidelines for
good clinical practice as determined from time
to time by the
Council. Regulation 34(6) requires the person conducting the trials
to submit regular progress reports to the Council.
Regulation 34(7)
empowers the Council to request information, inspect a clinical
trial, or withdraw the authorisation.
Regulation 34(5) contains
a prohibition:
“
No person shall
conduct clinical trials referred to in subregulation (1) without the
authorisation of the Council.”
[72] It
is correct that the term “clinical trial” has never been
judicially considered in South Africa. In
Health
Professions Council v Turner
[2002] JOL 9499
(ZS) the Supreme Court of Zimbabwe dealt with the
matter concerning the contravention of the provisions of section 15A
of the Drugs
and Allied Substances Control Act which defines
“clinical trial” as:
“
a systematic study in human beings or animals to establish the
efficacy of, or to discover or verify the effects or adverse
reactions of drugs…”
[73] The
court pointed out that the definition in the Act is largely a
subjective one. It held that a series of experimental treatments
with
a drug becomes a “
clinical
trial
” when the person
conducting them does so
“in
order to establish the efficacy of … or to discover or verify the
effects or adverse reactions of … drugs…”
The court found that the doctor in that matter had two objectives in
mind when he carried out the experimental treatments. The Court
went
on to say at page 12: “Primarily…
he
was concerned with helping his patients
.
But
inevitably, given that
he was and is a man with an enquiring mind, he was equally intent on
establishing the efficacy of or discovering
the effects or adverse
reactions of ‘povidone iodine’. To that extent, it seems to me,
it could be said that he was carrying
out a clinical trial.”
[74] Counsel
for the applicants argued that the activity of the Rath respondents
constituted clinical trials. The purpose of the activities
should be
looked at in order to determine the intention of the Rath
respondents.
In casu
the purpose was to establish the efficacy of VitaCell on people with
AIDS. That is what in fact the first respondent has been saying.
He
admitted that they
“conducted
a clinical pilot study in HIV-positive patients with advanced AIDS.
The goal of the study was to show that vitamins and
other
micronutrients alone reverse the course of AIDS, even in its advanced
stage. Thus it was essential that none of the patients
had received
any ARV drugs before or during this nutritional programme… Blood
tests and clinical evaluations were performed at
the start and after
4 weeks on the nutrient programme. The results of this pilot study
were so profound after only one month that
we decided to publish the
data of the first 15 patients without delay.”
[75] There
is no doubt in my mind that the activity of the Rath respondents,
though they prefer to characterise it as a clinical pilot
study, was
an investigation in respect of micronutrients for use in human beings
with AIDS and was intended to discover or verify
the clinical effects
of the micronutrients. It seems to me they were carrying out a
clinical trial. Although they deny that they
conducted clinical
trials, that denial, in my view, is, however, entirely inconsistent
with their own repeated statements none of
which they denied having
made. It appears to be an attempt to escape liability for their
widely proclaimed conduct now that its legality
is being challenged.
In my view, the Rath respondents’ activity, (conducting a clinical
pilot study) viewed subjectively constituted
a clinical trial as
defined in the Regulation. Their conduct was unlawful in that they
did not have a permission to run clinical
trials.
Making
False or Misleading Advertisements
[76] The
next question is whether the Rath respondents published false or
misleading advertisements. The applicants allege that the
Rath
respondents have contravened the provisions of section 20(1) (a) and
(b) of the Medicines Act. Section 20 of the Act prohibits
the
publication or distribution of false or misleading advertisements or
unauthorised claims concerning any medicine. It provides:
“  20
(1) No person shall-
(a)
publish or distribute or in any other manner
whatsoever bring to the notice of the public or cause or permit
to be
published or distributed or to be so brought to the notice of the
public any false or misleading advertisement concerning any
medicine;
or
(b)
in any advertisement make any claim to the effect
that the therapeutic efficacy and effect of any medicine
is other
than that stated by the council in terms of subparagraph (ii) of
paragraph (a) of section twenty-two or state or suggest
that any
medicine should be used for a purpose or under circumstances or in a
manner other than that stated by the council in terms
of subparagraph
(iii) or paragraph (a) of that section.
[77] Section
1 of the Act defines “advertisement” as follows:
“
Any
written, pictorial, visual or other descriptive matter or verbal
statement or reference -
appearing in any
newspaper, magazine, pamphlet or other publication; or
distributed to members
of the public; or
brought to the notice of
members of the public in any manner whatsoever which is intended to
promote the sale of that medicine
or scheduled substance”.
[78] The
applicants allege that the Rath respondents have made numerous claims
that vitamins and micronutrients in general, and the
Rath products,
in particular, can reverse the course of AIDS. The applicants, in
support of their averment, refer to an advertisement
placed by the
first respondent in the Business Day, on 18 February 2005, an
advertisement published in the New York Times and a pamphlet
which
was distributed in the Western Cape.
[79] It
is the applicants’ contention that the claims made by the Rath
respondents are false and to prove falsity of the claims,
the
applicants rely on the expert opinion of Dr Venter, an expert on
HIV/AIDS science. According to Dr Venter, although there is
some
evidence that a specific combination of multivitamin supplements in
specific doses slows down the progression of HIV to AIDS,
there is no
evidence that vitamins or micronutrients reverse the course of AIDS.
He states that the available scientific evidence
shows only that the
particular combination in a particular dose delays the onset of AIDS
in a specific group of patients. He says
the MCC has not registered
micronutrients for the treatment of HIV. He accordingly concludes
that the claims made by the Rath respondents
about micronutrients are
false and misleading.
[80] In
response to the applicants’ claims, some of the Rath respondents
filed their answering affidavits. The first respondent,
while
admitting having made placements in newspapers and other media,
denies that he and the second respondent placed a single product
advertisement in the South African media. He alleges that the public
health information they published, provided scientific facts
about
the role of vitamins and other micronutrients in relation to health.
They say this knowledge has been documented in the textbooks
of
biology for years. They allege that their micronutrients have health
benefits for people living with AIDS. They deny that the
only proven
therapy for AIDS patients are ARVs. They say nowhere in the world
have ARVs been registered to be sold as a cure for
AIDS. They aver
that ARVs are extremely toxic especially to the cells of the immune
systems. They make the point that, while not
being a cure,
micronutrients can reverse the disease-defining symptoms of AIDS and
significantly improve the quality of life people
living with AIDS.
[81] The
first respondent dismisses the expert opinions given by the
applicants’ experts on the basis that they lack any scientific
record in the area of micronutrients research or nutritional therapy.
He criticises Dr Venter’s expertise and dismisses his assertion
about the efficacy of micronutrients as a misleading information.
[82] The
question is whether the applicants have established the contravention
of the provisions of section 20 of the Medicines Act
by the first and
second respondents. It is clear that the provisions of section
20(1)(b) do not apply to the present case because
the MCC has not
made any claims about the therapeutic effect of VitaCell or what it
can be used for. Section 20(1)(a) therefore applies.
It is common
cause that the first respondent caused to be published in various
newspapers and pamphlets statements about micronutrients
and other
products of the second respondent. The next question is whether those
statements constitute “advertisement” as defined
in the Medicines
Act. In other words the statements must have been intended to promote
the sale of Rath’s products. In relation
to medicines or scheduled
substance an advertisement will be false or misleading if it can be
shown that the person who made it was
aware that it was incorrect.
This finding cannot be made in the present case because there is no
consensus amongst the experts upon
whom the parties rely for their
view on what the micronutrients can and cannot do to persons with
AIDS. The dispute cannot be resolved
on papers. However, in view of
the provisions of the 2002 call up notice the first and second
respondents must stop making claims
about the medicinal effect of
their products until their products in respect of which medicinal
claims are made have been submitted
to the MCC to review the
efficacy, quality and safety of those claims.
Conduct of
Government Respondents
[83] I
have found that the first, second, fourth and fifth respondents’
clinical pilot study constitutes clinical trials within
the meaning
of the Medicines Act and that such clinical trials are unlawful in
that they are not conducted in accordance with the
provisions of the
Act. I accordingly declared the respondents’ clinical trials
unlawful and to that end I have concluded that the
first, second,
third, fourth and fifth respondents’ should be interdicted from
conducting unauthorised clinical trials in South
Africa. I have also
found that the first to seventh respondents’ conduct, in publishing
advertisements concerning the efficacy
of VitaCell on persons with
AIDS, is unlawful in that the first to seventh respondents have not
submitted vitaCell to the MCC to
review its medicinal claims. I
accordingly concluded that the first to seventh respondents should be
interdicted from publishing
advertisements concerning the medicinal
effects of VitaCell on persons with AIDS pending the submission by
the first to seventh
respondents of VitaCell to the MCC to review its
medicinal claims.
[84] The
first question is whether the eighth (Minister of Health who is
properly before this Court) and the ninth respondents are
under a
duty to take reasonable measures to prevent the first to fifth
respondents from conducting unauthorised clinical trials and
to
prevent the first to seventh respondents from publishing
advertisements concerning medicinal effects of VitaCell on people
with
AIDS pending the submission of VitaCell to the MCC to review its
medicinal claims. The second question is whether eighth (Minister
of
Health) and ninth respondents have failed to carry out their duty.
[85] The
applicants allege that they have since February 2005 repeatedly
brought the unlawful conduct of the Rath respondents to the
attention
of the government. They say they have provided the government and the
MCC with the information at their disposal and have
attempted to
persuade them to take some action in this regard. They set out
details of their attempts. They contend that the Government
authorities are under a duty to take reasonable and effective steps
to stop the unlawful activities of the Rath respondents. They
say the
government authorities have failed to take such steps.
[86] It
is correct that in terms of the
National Health Act 61 of 2003
it is
the responsibility of the Minister of Health to endeavour to protect,
promote, improve and maintain the health of the population
and to
determine the policies and measures necessary to protect, promote,
improve and maintain the health and well-being of the population
(section 3).
The Minister of Health is assisted by the
Director-General who in terms of the
National Health Act is
responsible,
inter alia
,
to ensure the implementation of the National Health Policy.
[87] The
object of the Medicines Act is to control the quality, manufacture
and dissemination of medicines. It is the responsibility
of the
Director-General to enforce the provisions of the Medicines Act. Thus
in terms of section 26 of the Act the Director-General
may appoint
the inspectors for the proper enforcement of the Medicines Act. The
powers of the inspectors are contained in section
28 of the Act.
[88] It
is clear from the provisions of the
National Health Act that
the
eighth respondent primarily is under a duty to take reasonable
measures to ensure that the provisions of the Medicines Act, which
she administers, are enforced in order to protect, promote, improve
and maintain the health of the population of the country. The
ninth
respondent assists the eighth respondent in carrying out her primary
responsibilities under the
National Health Act by
ensuring that the
provisions of the Medicines Act are enforced. I therefore find that
the eighth and the ninth respondents are under
a duty to take
reasonable measures to prevent the first to fifth respondents from
conducting unauthorised clinical trials and to
prevent the first to
seventh respondents from publishing advertisements concerning
medicinal effects of VitaCell on people with AIDS
pending the
submission of VitaCell to the MCC to review its medicinal claims.
[89] The
next question is whether the eighth and the ninth respondents have
taken reasonable measures to carry out the identified
duty.
[90] In
deciding the question whether the eight and ninth respondents have
taken reasonable measures to prevent the unlawful conduct
of the
first to seventh respondents one should consider the provisions of
the Act within which the measures are to be taken. The
relevant
provisions are sections 26 and 28 of the Medicines Act.
“26.
Inspectors.
– (1) The Director-General may authorise such persons as
inspectors, as he may consider necessary for the proper enforcement
of
this Act.
(2) Every inspector
shall be furnished with a certificate signed by the Director- General
and stating that he has been authorised
as an inspector under this
Act.
(3) An
inspector shall, before he exercises or performs any power or
function under this Act, produce and exhibit to any person affected
hereby, the certificate referred to in subsection (2).
28.
Powers of
inspectors
. – (1)
An inspector may, at all reasonable times –
(a) enter upon –
(i) any place or premises from which –
(aa) a
person authorised under the Act to compound or dispense medicines or
scheduled substances;
(bb) the
holder of a licence as contemplated in section 22C (1) (b);
(cc) the holder
of a certificate of registration of a medicine,
conducts
business;
any place, premises,
vessel or aircraft if he or she suspects on reasonable grounds that
an offence in terms of this Act has been
or is being committed
thereon or therein or that an attempt has been made or is being made
to commit such an offence thereon or
therein; or
any private dwelling,
with the consent of the occupier or under the authority of a warrant
issued in terms of subsection (5) or
without a warrant in terms of
subsection (6);
(b) inspect any
medicine or scheduled substance, any book, record or documents that
the inspector believes on reasonable grounds
contains any information
relevant to the administration or enforcement of this Act;
seize
any book record, documents or medicines or scheduled substance or
take so many samples of any such medicine or scheduled substance
as
he or she may consider necessary for the purpose of testing,
examination or analysis in terms of this Act.
Where
on an application to the magistrate it appears to such magistrate
from information on oath that there are reasonable grounds
to
believe that-
...
entry
to that private dwelling is necessary for any purpose relating to
the administration
or
enforcement of this Act;
a
magistrate may issue a warrant authorising the inspector named
therein to enter that private dwelling subject to such conditions
as
may be specified in the warrant”
[91] The
eighth and ninth respondents reject the suggestion that they did not
act on the complaints received by them from the applicants
and other
relevant bodies. They say upon receiving the applicant’s complaints
about the Rath respondents’ unlawful activities,
they instructed
one Andre Du Toit in the Law Enforcement Unit to investigate the
claims. He found no independent evidence to support
the allegations
of unlawful acts of the Rath respondents. They say the Law
Enforcement Unit will continue to monitor the activities
of the
second respondent in order to obtain independent evidence of unlawful
conduct.
[92] The
ninth respondent admits that he is aware that the applicants had
submitted documents to the tenth respondent alleging that
some of the
first to seventh respondents were acting unlawfully. He says the
department through the offices of its Law Enforcement
Unit
investigated some of these allegations and found that there was
insufficient independent evidence to establish that any of the
respondents were acting unlawfully.
[93] One
of the allegations made against some of the first to seventh
respondents was that they were conducting unauthorised clinical
trials. In my view Du Toit had powers to investigate this allegation
in the light of the fact that the first respondent was publicly
announcing that he and other respondents had conducted clinical pilot
study and explained what the purpose of their study was. Mr
Du Toit
should have used the provisions of section 28(1)(a)(ii) of the Act by
entering upon the premises at which the clinical pilot
study was
being carried out in order to investigate the allegations which were
being made against some of the first to seventh respondents.
This is
what Du Toit should have done and in my view at least in so far as
the allegation concerning the conduct of unauthorised
clinical trials
is concerned, Du Toit did not sufficiently investigate the matter.
[94] The
applicants further allege that the investigation conducted by Du Toit
was insufficient because Du Toit does not explain the
nature and
extent of the investigation he conducted. The applicants do have a
point here. Neither the ninth respondent nor Mr Du
Toit has furnished
information as to the nature and extent of the investigation carried
out by Mr Du Toit. One of the applicant’s
complaints was that the
first respondent was selling a substance which contains
N-acetylcysteine, a schedule 2 substance, in contravention
of section
22 A(5) of the Act. The first respondent admits that VitaCell, which
it donated to Sanco, contains a N-acetylcysteine.
Section 22 A (6)
provides that a sale under section 22A (5) must only take place on
condition that “
all the
prescribed particulars of every sale shall be recorded in the
prescribed manner in a prescription book or other permanent
record
required to be kept in the prescribed manner
”.
But even if Du Toit had investigated the first and second
respondents’ conduct to establish a possible section 22A (5)
violation,
in my view his investigation would not have taken the
matter any further given the provisions of the 2002 call-up notice.
The 2002
call-up notice does not call up VitaCell for registration.
It merely subjects complementary medicines such as VitaCell “to a
call
up process instituted as a primary step towards registration of
such as medicines”. In other words VitaCell is not registrable
and
it is not an offence to sell a medicine which had not been called up
for registration. (
Novartis
SA (Pty) Ltd v
Ingelheim
Pharmaceuticals (Pty) Ltd, Johannesburg High Court
(WLD case no. 11880/03, Appeal case number 337/05). If a medicine has
been called up for registration it is an offence to sell it
before it
is registered unless written authority to sell it is granted in terms
of section 21. The fact that VitaCell contains a
schedule 2 substance
does not necessarily mean that it is a scheduled substance. Once it
is rendered registrable by the MCC, the
latter will determine its
scheduled status. In terms of the Government Notice R510, dated 10
April 2003, schedule 2 substances, unlike
schedule O substances, do
not include all substances which are subject to registration in terms
of the Act.
[95] In
the circumstances there is no basis for the suggestion that the
investigation conducted by Du Toit, at least in so far as
it related
to a possible section 22 A(5) violation, was lacking.
[96] The
ninth respondent, in justifying the decision not to investigate the
conduct of the first and second respondents, says the
MCC has not
passed a resolution to the effect that the products distributed by
the first and second respondents are medicines and
that they are
subject to registration. He says the department holds the view that
the products are food supplements and that there
is nothing
objectionable to their distribution. This view is incorrect. The MCC
may, by resolution approved by the Minister of Health,
determine that
certain medicines are subject to registration. But it does not have
the power to resolve that a particular product
is a medicine. The
question whether or not a substance is a medicine is determined with
reference to the provisions of the Medicines
Act dealing with the
meaning of a “medicine” and whether the substance makes medicinal
claims about itself. A substance which
falls within the definition of
“medicine” cannot be classified as foodstuff in terms of the
Foodstuffs Act.
[97] Even
if the Director-General had correctly granted permission to the
second respondent to import into the country VitaCell as
food
supplements in terms of the Foodstuffs, Cosmetics and Disinfectants
Act, the second respondent did not, however, comply with
the
conditions to which the permission was subject. In terms of the
letter dated 18 March 2004 the Director-General granted second
respondent permission to import and distribute in South Africa as a
food supplement VitaCell containing not more than 15 mg of NAC.
But
the VitaCell, which the second respondent imported into the country,
was found to contain 30 mg of NAC. It is therefore clear
that by
distributing VitaCell, which contained NAC in excess of the
permissible levels, the second respondent did not comply with
the
terms of the permit. In doing so it contravened the provisions of
section 2 of the Foodstuffs Act. But the complaint is not about
the
contravention of the provisions of the Foodstuffs Act. It is about
the violation of the Medicines Act.
Relief
[98] I
shall not make any order with regard to the relief sought against the
third, sixth and seventh respondents as they are now
out of the
picture. I have found that the supply by the Rath respondents of
VitaCell to Sanco constitutes a sale within the meaning
of the
Medicines Act. Such sale is, however, not prohibited because the MCC
has not determined that VitaCell should be registered
as a medicine
in terms of section 14 (2) of the Act. It is correct that medicinal
claims are made about it. It is also correct that
it contains a
scheduled substance. But the fact that it contains a scheduled
substance does not render it registrable in terms of
the 2002 notice.
In the circumstances the applicants are not entitled to the relief
sought in paras 1.1, 2, 5.1, 6.1 and 8.1 of amended
the notice of
motion.
[99] The
applicants seek an order interdicting the first to seventh respondent
from publishing false or misleading advertisements
concerning
vitamins, multivitamins, and other named products including VitaCell.
I will grant the relief sought in a modified form
and which will be
consistent with the provisions of the 2002 call up notice. In the
result I will grant an order interdicting the
first, second, fourth
and fifth respondents from publishing advertisements concerning the
efficacy of VitaCell on persons with AIDS
pending the submission of
VitaCell to the MCC to review medicinal claims made by the
respondents.
[100] The
applicants are also entitled to the relief sought in paras 5.2, 5.3,
8.2 and 8.3 as modified. The applicants are also seeking
an order in
which I should put the eighth and ninth respondents on terms to take
steps to implement the order. Though such an order
is competent I am,
however, not persuaded in the circumstances of the present case that
it is an appropriate order. There is nothing
to suggest that in the
light of my finding the eighth and ninth respondents will not take
steps to comply with the terms of the order.
[101] With
regard to the relief sought as against the twelfth respondent it is
clear that there was no legal basis for the applicants
to have
involved the twelfth respondent in the proceedings. It has complied
with its obligations in terms of the Medicines Act. Counsel
for the
applicants conceded that twelfth respondent has complied with its
obligations under the Act. The twelfth respondent was entitled
to
defend the application in order to set the record straight in the
light of the fact that very serious allegations of neglect and
misconduct were levelled against it.
Costs
[102] It is clear from
what I have said above that with regard to the relief sought by the
applicants in these proceedings, the applicants
have been
substantially successful as regards the first to seventh respondents.
The third, sixth and seventh respondents have, however,
fallen out of
the picture and are no longer before the Court. The applicants are
therefore entitled to an order that the first, second,
fourth and
fifth respondents be held liable jointly and severally, for 90% of
the applicants’ costs.
[103]
The applicants were, however, unsuccessful in their application
against the twelfth respondent. As indicated above, the applicants
have not satisfied the Court that they are entitled to any of the
substantive relief sought as against the twelfth respondent. In
the
circumstances I shall order the applicants to pay the twelfth
respondent’s costs such costs to include the costs of two counsel.
It is correct that the issues raised in these proceedings are of
considerable importance to the litigants and to the public in general
and that one should be cautious in awarding costs against litigants
who seek to enforce their constitutional right against the State
as
such orders may have an unduly inhibiting effect on other potential
litigants. (
Motsepe v
Commissioner for Inland Revenue
[1997] ZACC 3
;
1997 (2) SA 898
(CC) at 911 F- 912 A). But the costs award is
justified in this matter as the attack on the twelfth respondent’s
conduct was unfounded.
[104] As
regards the eighth and ninth respondents the applicants have
partially succeeded in the relief sought against them. The eighth
respondent should pay 10 % of the applicants’ costs.
Order
[105] In
the circumstances I make the following order:
1. It
is declared that the clinical trials conducted in South Africa by
and/or under the direction of the first, second, fourth and
fifth
respondents are unlawful.
2. The
first, second, fourth and fifth respondents are interdicted from
conducting unauthorised clinical trials in South Africa.
3. The
first, second, fourth and fifth respondents are interdicted from
publishing advertisements concerning the medicinal effects
of
VitaCell on persons with AIDS pending the submission by the
aforementioned respondents of the VitaCell to the MCC to review its
medicinal claims.
4. It is declared that
the eighth (Minister of Health) and the ninth respondents are under a
duty to take reasonable measures to:
4.1
prevent the first, second, fourth and fifth respondents from
conducting unauthorised clinical trials;
4.2.
prevent the first, second, fourth and fifth respondents from
publishing advertisements concerning the medicinal effects of
VitaCell
on persons with AIDS pending the submission by the aforesaid
respondents of VitaCell to the MCC to review its medicinal claims.
5. The
eighth and ninth respondents are ordered to take reasonable measures
to investigate the matters referred to in paragraph 4
hereof and, in
the light of the facts revealed by such investigation, to take
further reasonable action in accordance with their
duty.
6. The
first, second, fourth and fifth respondents are jointly and severally
ordered to pay 90% the costs of the applicants in these
proceedings.
7. The eighth and ninth
respondents are jointly and severally ordered to pay 10 % of the
applicants’ costs in these proceedings.
8. The applicants are
ordered to pay the costs of the twelfth respondent including costs
consequent upon employment of two counsel.
____________________
ZONDI,
J