SAFLII Note: Certain personal/private details of parties or witnesses have been redacted from this document in
compliance with the law and SAFLII Policy
IN THE HIGH COURT OF SOUTH AFRICA
(GAUTENG DIVISION, PRETORIA)
(1) REPORTABLE: YES
(2) OF INTEREST TO OTHER JUDGES: NO
(3) REVISED.
DATE:
SIGNATURE
Case No: 2024-130119
In the matter between:
NOVO NORDISK (PTY) LTD Plaintiff / Applicant / Appellant
and
iDexis COMPOUNDING SPECIALISTS Defendant / Respondent
(PTY) LTD t/a SENTRA PHARMACY,
RUAAN LOUW,
SOUTH AFRICAN HEALTH PRODUCTS
REGULATORY AUTHORITY,
SOUTH AFRICAN PHARMACY COUNCIL
JUDGMENT
The judgment and order are published and distributed electronically.
PA VAN NIEKERK, J
Summary: Application for interim inte rdict restraining First and Second Respondents from
compounding, marketing or selling medicine containing semaglutide primarily on the ground that
they contravene section 14(1) of the Medicines and Related Substances Act no 101 of 1965 and
are thus contravening the law. First Respondent rel ies on section 14(4) of Medicines Act for
defence, stating that the active pharmaceutical ingredient in its product is similar to the active
pharmaceutical ingredient found in Applicant’s product, which is registered. Third and Fourth
Respondents conducted an investigation and served an enforcement notice on First Respondent
two weeks before application heard. First and Second Respondents raised point of mootness
and that relief claimed by Applicant is final in effect because it is not an order claimed pending
final relief.
Held: Mootness point dismissed on ground that enforcement notice disputed by First and
Second Respondents and the enforcement notice does not have effect of suspending impugned
activities while First Respondent conveyed intention to proceed with impugned activities which
are illegal. On interpretation of relief sought in notice of motion relief claimed is a temporary
interdict pending the finalisation of internal remedies against decision(s) of Third and/or Fourth
Respondents which includes possible review application. Section 14(4) of act 101 of 1965 to be
interpreted restrictively to mean that the last sentence thereof refers to the same medicine and
not a similar medicine. Temporary interdict granted.
INTRODUCTION:
[1] Applicant (“Novo Nordisk”) is a private company, duly registered in terms of the laws of
the Republic of South Africa and is the authorised importer and distributor in South
Africa of medicines containing semaglutide branded as “Ozempic” and “Wegovy”. Novo
Nordisk is related to Novo Nordisk in Denmark, a pharmaceutical company which is the
developer and producer of Ozempic and Wegovy.
[2] First Respondent (“iDexis”) is a private company duly registered in terms of the laws of
the Republic of South Africa with main place of business situated in Silverton, Pretoria .
iDexis is the holder of a retail pharmacy licence and specialise as a compounding
pharmacy.
[3] Second Respondent (“Louw”) is a qualified pharmacist and the only shareholder and
director of iDexis. In the founding affidavit of Novo Nordisk the deponent discloses that
a CICP search rendered 3 different entities all bearing in some or other form the title
“iDexis”, all related to Louw. In the First- and Second Respondents’ answering affidavit
which was deposed to by Louw, he avers that iDexis conducts business as a retail and
compounding pharmacy while he and the other two entities (of which he is also the sole
shareholder and director) are not involved in the business of a retail pharmacy or in
compounding or manufacturing of medicines. The relief sought by Novo Nordisk is
opposed by both iDexis and Louw.
[4] Third Respondent is the South African Health Products Regulatory Authority
(“SAHPRA”) which is established in terms of section 2 of the Medicines and Related
Substances Act No. 101 of 1965 (as amended) (“ the Medicines Act” ). SAHPRA is
tasked with the regulation and control of the importation-, manufacture- and distribution
of medicines and related substances in the Republic of South Africa and bestowed with
the powers of investigation and enforcement . SAHPRA filed no papers and did not
oppose to application.
[5] Fourth Respondent is the South African Pharmacy Council (“SAPC”), established in
terms of section 2 of the Pharmacy Act 53 of 1974 (“Pharmacy Act”) and tasked with
the promotion of the provision of pharmaceutical care and inter alia also to develop,
maintain and control universally acceptable standards for the practice, professional
conduct and control of persons registered in terms of the Pharmacy Act. SAPC filed no
papers and did not oppose the application.
[6] Save for an order condoning non -compliance with the relevant rules and seeking to
enrol the application as an urgent application during December 2024, Novo Nordisk
seeks the following relief in the notice of motion:
“2. The first and second respondents are interdicted and restrained from, directly or
indirectly, through any other person or entity:
2.1 manufacturing or supplying, whether by compounding or otherwise, any
medicine containing semaglutide;
2.2 marketing and advertising or otherwise displaying for sale any medicine
containing semaglutide which is being compounded; and
2.3 marketing and advertising that its compounded semaglutide containing
medicine has been approved by the third respondent.
3. The order in paragraph 2 above is effective immediately and will remain operative
pending:
3.1 the outcome of the third and fourth respondents’ respective
investigations into the manufacturing and supply by the first and second
respondents of medicine containing semaglutide; and
3.2 in the absence of any decision by either the third or fourth respondents,
within six months of the date of this order, prohibiting the first and second
respondents from manufacturing and supplying any medicine containing
semaglutide, the outcome of proceedings to be instituted by the
applicant, which shall be instituted within eight months of the date of this
order, to –
3.2.1 review the decisions (or failure to take decisions) by the third
and/or fourth respondents; and/or
3.2.2 declare that the first and second respondent’s conduct
constitutes a violation of the Medicines and Related Substances
Act 101 of 1965 and the General Regulations published under
GN 859 in GG 41064 on 25 August 2017 and amounts to
unlawful competition; and/or
3.2.3 seek final interdictory relief against the first and second
respondents.
4. The costs of the application, including the costs of senior and junior counsel on
scale C, are to be paid by the first respondent and any other respondent which
opposes the matter.
5. Further and/or alternative relief.”
[7] Effectively, Novo Nordisk seeks an order interdicting Idexis and Louw from
manufacturing, supplying, marketing, advertising or displaying for sale any medicine
containing semaglutide pending the outcome of an investigation by SAHPRA and SAPC
into the alleged illegal manufacture and supply of medicine containing semaglutide by
iDexis and Louw. Paragraph 3.2 of t he notice of motion provides for the interdict to
operate as an order pending a possible review against any decision of SAHPRA and/or
SAPC following the anticipated investigation and/or final interdictory relief being sought
by Novo Nordisk. On 26 May 2026 Novo Nordisk filed a notice of intention to amend the
notice of motion by insertion of the words “ final and operative” between the words “any”
and “decision” in the existing paragraph 3.2 of the notice of motion as quoted supra.
Novo Nordisk seeks the amended relief because SAHPRA subsequently conducted an
investigation and delivered a n enforcement notice (to which more reference will be
made herein later) on the First Respondent on 21 May 2026 . In my view the
amendment is unnecessary as will transpire hereunder.
[8] As will be set out hereafter, the relief sought by Novo Nordisk is essentially found on the
averment that iDexis contravenes applicable statutory - and regulatory provisions
because it compounds medicine containing semaglutide as active component which
has not been registered by SAHPRA. iDexis oppose the application on the basis that its
practise of compounding medicine containing semaglutide is compliant because it is
allowed to compound medicine containing semaglutide under the provisions of section
14(4) of the Medicines Act because Ozempic which contains semaglutide is registered
by SAHPRA. However, as set out above, after an investigation conducted by SAHPRA
and SAPC at the premises of iDexis , they concluded that iDexis is not compliant in
various respects and essentially the investigation by SAHPRA and SAPC confirms the
reasons advanced by Novo Nordisk in its founding affidavit why it avers that Idexis is
acting in contravention of the Medicines Act.
[9] Apart from opposing the application on the merits, iDexis raised the following points of
law:
[9.1] That the relief claimed in the notice of motion has become moot by virtue of
the SAHPRA enforcement notice dated 21 May 2026;
[9.2] That the nature of the relief sought by Novo Nordisk is not temporary , but
that the interdict sought is final in effect and that Novo Nordisk has not
satisfied its onus to prove a clear right;
[9.3] That Novo Nordisk ’s application to introduce further evidence in three
subsequent supplementary affidavits filed during May and June 2026 should
be disallowed.
[10] Save for the legal points raised by iDexis as set out supra, the answering affidavit filed
on behalf of iDexis is replete with legal submissions and argument on the evidential
value of a substantial portion of the founding affidavit on the basis that the deponent
expressed opinions in respect of which the deponent is not qualified . It also contains
legal argument on the status of documents annexed to the founding affidavit, and legal
submissions that the case of Novo Nordisk’ is found on primary facts without supported
secondary facts in support thereof . These points are not dealt with individually.
Deponent to the founding affidavit of Novo Nordisk is clearly qualified to express any
opinions of a scientific nature as it applies to the issues in casu . However, the
averments of that deponent do not require findings of a scientific nature but essentially
relates to the classification of certain substances by SAHPRA within the regulatory
framework. The other points are disposed of by the findings made in this application.
[11] During the hearing of the application , further argument , namely that the point of
mootness should be argued first as it may be dispositive of the matter , was raised by
iDexis. Counsel acting on behalf of Novo Nordisk argued that the point of mootness is
closely related to the merits (with reference to the events which occurred subsequent to
the investigation by SAHPRA) and that it may be prejudicial to the parties if the point of
mootness required separate and prior consideration by the Court because it may lead
to a postponement of the remainder of the issues. Because iDexis filed comprehensive
heads of argument on the point of mootness, and because I held the view that the point
of mootness could be disposed of without delaying the matter , I ruled that the point of
mootness be dealt with first . After hearing argument, I dismissed the point of mootness
raised by iDexis. Reasons for that order will be provided hereunder.
[12] Considering the arguments advanced on behalf of the parties, as well as the respective
affidavits filed on behalf of the parties, the issues to be determined against the relevant
factual background can conveniently be summarised as follows:
[12.1] Is the nature of the order sought by Novo Nordisk a temporary interdict or
final in effect?
[12.2] Should the three further replying affidavits filed on behalf of Novo Nordisk
be admitted?
[12.3] Did Novo Nordisk establish grounds which entitles Novo Nordisk to the relief
claimed in the notice of motion ? That issue stands to be determined by
analysing the evidence against the following:
[12.3.1] The applicable statutory provisions;
[12.3.2] The grounds advanced by Novo Nordisk, labelled in the
application as six different “illegality complaints”;
[12.3.3] Did Novo Nordisk satisfy the legal requirements for the relief
which it claims?
BACKGROUND TO THE PROCEEDINGS:
[13] Ozempic is a glucagon-like peptide 1 (GLP-1) agonist which is primarily directed at the
treatment of Type 2 Diabetes and related cardiovascular conditions. An agonist is a
substance that mimics the actions of a neurotransmitter or hormone to produce a
response when it binds to a specific receptor in the brain. Until 11 February 2025
Ozempic was the only registered medicine in South Africa which contained s emaglutide
as its active pharmaceutical ingredient (“ API”). Semaglutide had been shown to have a
significant weight loss benefit and for that reason Novo Nordisk Denmark developed
another product which contains semaglutide , labelled Wegovy, and which is indicated
for chronic weight management or chronic obesity. Wegovy was registered by SAHPRA
on 11 February 2025 and is the only other registered medicine in South Africa which
contains semaglutide as its API. At the time when the application was launched by
Novo Nordisk, Ozempic was registered for use at the treatment of Type 2 Diabetes and
related cardiovascular conditions and no product containing semaglutide as its API was
registered for the treatment of chronic obesity or for use in weight management.
Wegovy was thereafter registered with SAHPRA as a medicine with semaglutide as its
API for use in chronic weight management and management of chronic obesity and is
the only such medicine registered by SAHPRA for that indication. Ozempic and Wegovy
are injected by syringe in carefully monitored dosages, and only available on
prescription by a medical practitioner who must monitor the patient.
[14] Ozempic has taken the world by storm as it is a unique, effective and highly sought
after medicine. The demand for Ozempic caused world -wide shortages of the product.
The reputation of semaglutides as an effective weight -loss agent did not go unnoticed
and a proliferation of similar products came onto the international market. iDexis was
alive to the opportunity created in the lucrative weight-loss products market when there
was a chronic shortage of Ozempic in South Africa . That is when iDexis started to
compound medicine which contains semaglutide as API (“the iDexis product” ). The
iDexis product is widely used for weight -loss management and is presently dispensed
to approximately 84500 patients per month. It is also injected by syringe in a similar
manner to Ozempic and Wegovy.
[15] It is common cause that semaglutide is a scheduled substance that must be registered
by SAHPA and that any medicine containing semaglutide as API is subject to
registration under section 14( 1) of the Medicine Act. It is common cause that the API
used by iDexis (semaglutide) in the iDexis product is sourced from unknown sources
not fully disclosed in the iDexis answering papers, is not registered with SAHPRA, and
that the iDexis product is not a registered medicine under section 14(1) of the
Medicines Act. The iDexis product has therefore never been tested, evaluated or
subjected to trials by SAHPRA.
[16] The cause of action of Novo Nordisk is based on the allegation that iDexis competes
unlawfully with Novo Nordisk because Novo Nordisk is a reputable entity with an
establish reputation for producing semaglutide containing medicine , having compl ied
with the stringent requirements and evaluation for registration, while iDexis is abusing
the process of compounding under section 14(4) of the Medicines Act to compete in the
same market as Novo Nordisk with a product which has not been clinically tested, not
approved by SAHPRA, is of d ubious origin and therefore potentially dangerous . Novo
Nordisk avers that it is of right entitled to seek termination of the illegal conduct of
iDexis. Novo Nordisk also complains about other contraventions of the Medicines Act
by iDexis, alleging that it is advertising the iDexis product contrary to the provisions of
section 14(4) of the Medicines Act. Novo Nordisk further accuses iDexis of making
misleading statements about the iDexis product to the public and medical practitioners
because it disseminate false information to them that the iDexis product is registered
and approved by SAHPRA.
[17] In the founding affidavit the deponent on behalf of Novo Nordisk sets out facts which
illustrate that Novo Nordisk, with the assistance of its attorney of record, lodged
complaints against iDexis at SAHPRA during the early part of 2024. SAHPRA
undertook to investigate the issue and requested Novo Nordisk not to proceed with
legal proceedings, pending the finalisation of an investigation to be conducted by
SAHPRA on the impugned activities of iDexis. After various inquiries were made on
behalf of Novo Nordisk to SAHPRA on the progress of the investigation of the
complaints, with no satisfactory feedback or result, Novo Nordisk launched the
application on an urgent basis during December 2024. Various procedural and
interlocutory issues raised by iDexis thereafter frustrated the finalisation of the matter
interlocutory issues raised by iDexis thereafter frustrated the finalisation of the matter
and it was only during 2026 that the matter was enrolled on the Special Motion Court of
this division pursuant to a judicial case management meeting before the Acting Deputy
Judge President of this division.
[18] After final enrolment of the matter, and after affidavits were exchanged, SAHPRA
inspectors conducted an inspection of iDexis on 11 May 2026 at its premises situate in
Silverton, Pretoria. Pursuant to this inspection, SAHPRA addressed a notice of
enforcement action to iDexis on 21 May 2026 (“the enforcement notice”), which reads:
“SAHPRA WRITTEN NOTICE OF ENFORCEMENT ACTION ENF/2026/0008
RE; WRITTEN NOTICE OF ENFORCEMENT ACTION
On 11 May 2026, an inspection was conducted at IDEXIS (Pty) ltd, trading as Sentra
Pharmacy, located at 5[...] M[...] Street, Silverton, Pretoria, 0187. The inspection was
carried out by Inspectors from the South African Health Products Regulatory Authority
(SAHPRA), appointed by the Chief Executive Officer in terms of the Medicines and
Relates Substances Act, Act 101 of 1965, as amended (the Medicines) Act. The scope
of the inspection encompassed Good Manufacturing Practice (GMP) and Regulatory
Compliance, with the following inspectors serving as the designated SAHPRA
inspectors; Samu Motshitela, Daphney Mokgadi Fafudi, Masilo Mopai, Coceka
Ntantala, Taariq Laing, Talhah Norath, Hlalefang Mogaila and Ramarumo Chepape.
The inspection was undertaken jointly by SAHPRA and the South African Pharmacy
Council (SAPC), with Professor Neelaveni Padayachee representing SAPC in her
capacity as the Good Pharmacy Practice Inspector.
The inspection identified CRITICAL compliance deficiencies and GMP contraventions at
the site, hereinafter referred to as iDexis:
1. The inspection revealed evidence of illegal importation, including the false
declaration of Active Pharmaceutical Ingredients (AIPs) imported without
SAHPRA approval. These APIs were intended for the manufacture of
Semaglutide, Tirzepatide, as well as the combination product containing both
Semaglutide and Tirzepatide.
2. It was determined that iDEXIS does not perform fundamental quality control
testing on imported Active Pharmaceutical Ingredients (APIs). Specifically, the
company fails to conduct essential tests such as identiy verification and assay
analysis, which are required to confirm that the substance is precisely what it
purports to be and to establish the exact quantity or potency of the API present
in the imported materials.
3. The inspection confirmed that illegal compounding activities were being
undertaken involving Schedule 4 substances, specifically Semaglutide,
Tirzepatide, and a combination product containing both. These substances
were compounded without valid prescriptions and distributed to retail and
community pharmacies, as well as to medical practitioners who do not hold
dispensing licences.
4. During the inspection, Dr Ruaan Louw described their activities as
manufacturing. It was clarified to him that manufacturing cannot be undertaken
without a valid SAHPRA licence and corresponding registered products. He
indicated that the terms manufacturing and compounding were used
interchangeably. The inspection team was informed that three batches, each
comprising approximately 400 pen -set doses per day, were being produced.
These batches included Tirzepatide, Semaglutide, and a combination product
containing both substances, amounting to a total of approximately 1,200 doses
per day. Production was reported to occur without prescriptions and involved
supply to pharmacies and medical practitioners who do not hold dispensing
licences.
5. iDEXIS Products allocated expiry date of six months from the date they were
produced, which contravenes the conditions of compounding.
6. Dishonesty – The inspection team was informed by the Pharmacist Assistant
that compounds that on 11 May 2026, day of inspection there were no
products produced however in the next room we found labelling and packaging
of products taking place that he later mentioned.
7. The inspection identified the illegal advertising of Schedule 4 substances. The
website was found to be promoting Semaglutide, Tirzepatide, and a comination
product containing both, with specific therapeutic indications.
8. The APIs were not properly named e.g. one labeled ‘Sema’ was mentioned to
be Semaglutide.
9. These were stored in a freezer with icepacks and there were no termperature
control/monitoring device.
10. The room allocated for producing Semaglutide, Tirzepatide and combination
Semaglutide and Tirzepatide products did not meet the requirements of the
Aseptically Prepared Products:
a. The site did not have a proper facility design that has sterile
manufacturing classification Grade A, background B, C and D.
b. The facility did not have an HVAC system which is a requirement in
aseptially sterile products manufacturing to maintain adequate airflow,
temperature and humidity control in the facility.
c. The equipment that was used in the facility to sterilise the packaging
material was not appropriate. The facility used autoclave to sterilise glass
which is inadequate in sterile manufacturing as dry heat is required
sterile manufacturing.
d. The housekeeping measures were inadequate as the premises were
untidy, with walls that are dusty and the raw boxes of materials that they
used to manufacture the products were placed on the floor.
e. Lack of SOPs for the process of producing the aseptic formulations, poor
and inadequate documentation (no proper formulation records), batch
manufacturing document did not list/stipulate all the ingredients nor
materials and measurements to make products. In addition, finished
products yields recorded did not match of the actual products prouced.
Incomplete/irregular batch manufacturing records with product quantities
not reconciling with the records and there no validated methods
available.
f. iDEXIS inicated they do not keep any retention samples, no samples
kept for any prior produced batches on-site.
g. The inspection established that no retention samples are maintained for
previously produced batches. The entity indicated that retention samples
are not kept for any products manufactured.
h. The facility does not perform maximum permitted microbial
contamination level during qualification.
i. The facility does not perform media fill.
j. The facility did not have the appropriate gowning procedures in place.
k. The filling area was used as storage for different materials.
l. The API used was not tested prior to use, and COA from the
manufacturers was not available.
m. The was no pharmacovigilance system for the reporting of Adverse Drug
Reactions at all.
SAHPRA seized products containing Semaglutide, Tirzepatide and Semaglutide and
Tir. These were based on the findings above -mentioned which contravene various
sections of the Medicines Act such as Contravening Section 14 regarding compouding
read with Regulation 3 on conditions of compounding of Schedule 4 substances,
contravening Section 18 on advertising read with Regulation 42 regarding advertising of
Schedule 4 substances (compounded) to the public which include indications.
SAHPRA resolved that:
1. Product Recall process be implemented for Semaglutide, Tirzepatide and
Semaglutide / Tirzepatide combination products.
a. The entity must immediately contact all clients who received the
aforementioned products, instruct them to discontinue use, and arrange
for the return of all distributed items.
2. The Compounding of all aseptically prepared sterile products be stopped
immediately and the room used to produce these be closed.
3. SAHPRA will recommend to SAPC that the license for compounding on
iDEXIS be reviewed based on current activities called manufacturing.
4. A follow -up inspection be conducted on all other products by IDEXIS and
related activities.
You are therefore to provide a written response regarding the corrective and
preventative actions (CAPA) with evidence of implementation of such actions, within 20
working days of receipt of this letter.
Failure to do so will result in SAHPRA effecting criminal proceedings fully enforcing the
Medicines Act which will result seizing of other product/s affected in terms of Section
28(1)(c) of the Medicines Act, informing the License revocation or suspension in terms
of Section 22E of the Medicines Act process, Declaration of the product/s as
undesirable in terms of Section 23 of the Medicines Act and effecting of criminal
proceedings.
Any submissions you may wish to make in response to this notice should reach
SAHPRA within 20 calendar days of the date of this notice.”
[19] The findings of the investigation as recorde d in the enforcement notice materially
support the complaints of Novo Nordisk. The enforcement notice requires iDexis to
provide reasons why enforcement action should not be taken and does not have the
effect of an order. iDexis released a press statement of its intention to challenge the
findings on review and recorded that it disputes the findings. In Court, that was also the
attitude of iDexis. Against that background, the issues for determination are dealt with
hereunder.
IS THE ORDER CLAIMED FINAL IN EFFECT OR TEMPORARY?
[20] On behalf of iDexis it was argued that, because Novo Nordisk seeks an interdict
pending the finalisation of the investigation by SAHPRA, the interdict sought is final in
effect and not a temporary interdict. In support of this argument iDexis relied on the
Masuku judgment1 where, in an application seeking an interdict against the execution of
a sentence of death imposed on the applicant pending a petition in terms of section 327
of the Criminal procedure Act (as it was then) , the Court held that it is not a temporary
interdict “in the technical sense” because the interdict sought was not an order pending
final relief and litigation. For that reason, so it was held, the requirements for a
temporary interdict, insofar as it differs from the requirements for a final interdict , did not
apply in that matter. Relying on that judgment, the argument advanced on behalf of
iDexis came down to the submission that, because there is no final determination of the
respective rights of the parties by a Court of law envisaged in the order as framed in the
1 Masuku v Minister van Justisie en Andere 1990 (1) SA 832 (A) para 841-d.
notice of motion, and the SAHPRA investigation not constituting legal proceedings, the
relief is final in nature because it can endure “in perpetuity”.
[21] In my view the authority relied upon by iDexis does not apply in casu as the facts are
clearly distinguishable. In the Masuku judgment the order was sought pending the
exercise of a statutory right to seek clemency, which is not a judicial process and does
not have scope for review or appeal. As set out hereunder, the relief claimed in casu is
claimed pending the exercise of statutory powers by SAHPRA and SAPC, which results
in a decision which may be appealed against in terms of a n internal remedy and which
is subject to judicial review.
[22] The nature of a temporary interdict was described as follows in the judgment of National
Gambling Board:2
“An interim interdict is by definition ‘a court order preserving or restoring the status quo
pending the final determination of the rights of the parties. It does not involve a final
determination of these rights and does not affect their final determination’.
The dispute in an application for an interim interdict is therefore not the same as that in
the main application to which the interim interdict relates. In an application for an interim
interdict the dispute is whether, applying the relevant legal requirements, the status
quo should be preserved or restored pending the decision of the main dispute. At
common law, a court’s jurisdiction to entertain an application for an interim interdict
depends on whether it has jurisdiction to preserve or restore the status quo. It does not
depend on whether it has the jurisdiction to decide the main dispute”.
2 National Gambling Board v Premier, Kwazulu Natal and Others 2002 (2) SA 715 (CC) at para 49.
[23] On an analysis of the notice of motion (without amending such notice in terms of the
application to amend the notice of motion) the relief is sought pending the outcome of
the Third and Fourth Respondents’ respective investigations .3 In terms of the notice of
motion provision is also made for the operation of the order sought by Novo Nordisk
pending the review of any decisions taken by Third and/or Fourth Respondents 4 and
the institution of proceedings by Novo Nordisk to achieve a final determination of its
rights, in the absence of a proper decision by SAHPRA.5
[24] In terms of section 24A (1) of the Medicines Act a decision of SAHPRA may be
appealed against to an Appeal Committee and in terms of section 24A(5) any person
aggrieved by the decision of the Appeal Committee may approach the High Court for
judicial review. In my view the reference to “ the outcome” of the Third and Fourth
Respondents’ respective investigations as used in para 3.1 of the notice of motion c an
only be construed to mean an outcome in terms of the provisions of the Medicines Act,
which includes the right to an appeal and the right to approach the High Court for a
review of that appeal. Those rights follow ex lege and is implied in the term “… the
outcome of the investigation ”. On the evidence provided , iDexis has already indicated
its intention to oppose the enforcement notice referred to supra, and it is clear that,
whatever decision is eventually taken by SAHPRA, either Novo Nordisk or iDexis will
apply to have such decision reviewed by the High Court.
[25] It follows that it is incorrect to argue that the envisaged order will endure into perpetuity.
In my view the order sought by Novo Nordisk in the notice of motion ( even if not
3 Notice of motion, para 3.1.
4 Notice of motion, para 3.2.1
5 Vide: notice of motion, para 3.2.
amended) constitutes a temporary interdict because it is an order pending the final
determination of the respective parties’ rights, either by a decision of SAHPRA and/or
SAPC or the review of any such decision.
SHOULD THE THREE SUPPLEMENTARY AFFIDAVITS OF NOVO NORDISK BE
ALLOWED?
[26] Novo Nordisk’ s first supplementary affidavit was deposed to on 21 April 2026 and
serves to introduce the fact that a business rescue application was launched against
iDexis during May 2025 (a fact never disclosed by iDexis in the answering affidavit or
thereafter), and further that an application was instituted by the South African Revenue
Services during October 2025 to intervene in the business rescue application because
iDexis is in debt with the South African Revenue Services for a n amount of money
exceeding R32 000 000.00 (thirty two million rand) . It also contains a price list prepared
by iDexis during October 2025 which reflects prices for the products that it
manufactures, which includes medicines containing s emaglutide. Finally, it includes a
draft guideline on synthetic peptides prepared by SAHPRA for public comment which
was published on 3 March 2026.
[27] The second supplementary affidavit was deposed to by the attorney of record for Novo
Nordisk on 25 May 2026 and seeks to introduce communication to stakeholders issued
by SAHPRA on 15 May 2026 which serves to warn the industry about the use of
unregistered peptide products and a media release issued by SAHPRA and SAPC on
23 May 2026 which refers to a “ Crackdown on unlawful manufacturing of unregistered
GIP-1/GLP medicines” . The peptide warning reminds the industry about the
requirements of registration of peptides and reads as follows:
“Key legal requirements include:
• Registration is required; any peptide product that claims to treat, prevent, diagnose,
cure, or change body functions must be registered with SAHPRA before it can be
sold was required in South Africa.
• Licences are required; manufacturers, importers, distributors, and wholesalers must
hold valid SAHPRA licences.
• Evidence is required; registration applications must include scientific and clinical data
showing safety, quality and effectiveness.
• Good Manufacturing Practice (GME); manufacturers must follow internationally
recognised GME standards to help ensure consistent quality and purity.
• Accurate labelling; products must have clear labels, including ingredients, intended
use, directions, warnings and storage information”.
[28] The media statement referred to in th e second supplementary affidavit relates to the
fact that SAHPRA and SAPC made findings after an investigation on the unlawful
compounding of the iDexis product, and the illegal importation of a semaglutide base by
iDexis. It contains the following statement:
“The investigation revealed that the company was producing and supplying medicines
under the pretext of ‘compounding’, but outside the legal framework permitted under
South African law. While compounding is strictly limited to the preparation of medicines
for individual patients based on a valid prescription, the facility was found to be
manufacturing and marketing GIP/GLP -1-based products, including semaglutide,
tirzepatide, and combination formulations, for broader commercial distribution,
particularly for weight management purposes”.
[29] The second supplementary affidavit further contains correspondence between the legal
representatives of iDexis and Novo Nordisk as well as a statement published by Novo
Nordisk in response to the media statement of SAHPRA and SAPC. In that statement
iDexis clearly disclose its rejection of the findings of the investigation and records its
intention to challenge the findings of that investigation.
[30] In a third supplementary affidavit deposed to by the attorney of record acting on behalf
of Novo Nordisk, the latest correspondence obtained from SAHPRA is annexed as well
as the enforcement notice dated 21 May 2026.
[31] iDexis opposed the application by Novo Nordisk to introduce the evidence contained in
the aforesaid supplementary affidavits and counsel acting for iDexis referred to
authorities to arrive at the submission that it is only in exceptional circumstances that
further affidavits will be received. Counsel for iDexis argued that the reasons why it was
not produced timeously, the degree of materiality of the evidence, the stage which the
particular litigation has reached, the general need for finality in judicial proceedings, and
the balance of prejudice to Novo Nordisk if the application is refused , and prejudice to
the Respondent if it is granted are factors to consider, and, so argued counsel, iDexis
will be prejudiced if the supplementary replying affidavits be admitted.
[32] In my view, the objection to the introduction of the evidence in the supplementary
affidavits is ill-founded, for the following reasons:
[32.1] The evidence introduced in the three supplementary affidavits all relate to
facts which fell within the domain of iDexis but only came to the knowledge
of Novo Nordisk, after the pleadings have closed . Save for the reference to
the business rescue application and subsequent intervention application by
SARS, the remainder of the evidence so introduced took place in
approximately the last month before the matter was set down for hearing,
and in certain respects literally a week before the matter was to be heard.
There is thus no issue of the deliberate withholding of evidence by Novo
Nordisk until a late stage, nor is the fact that the evidence is only now
produced an issue at all attributable to Novo Nordisk;
[32.2] There can be no procedural prejudice to iDexis because of the introduction
of the evidence. In relation to the business rescue application and the SARS
application, iDexis was aware that a business rescue application was
launched and was aware of the intervention application by SARS and its
alleged indebtedness to SARS. In the founding affidavit , on the issue of a
lack of a suitable alternative remedy, Novo Nordisk stated that iDexis will
not be able to satisfy a judgment for any damages awarded to Novo
Nordisk. Th at statement was denied by iDexis but the existence of its
substantial liability to SARS was not disclosed and neither did iDexis at any
further stage in the proceedings disclose the fact that it was under business
rescue. In my view these facts were material facts which iDexis should have
realised were facts to be disclosed to the Court and iDexis cannot be
allowed to object to the introduction of those facts by Novo Nordisk;
[32.3] The facts in relation to press releases of SAHPRA and SAPC disclosing
their findings and the enforcement notice can similarly not prejudice iDexis.
Evidently both Novo Nordisk and iDexis foresaw an investigation by
SAHPRA and/or SAPC at the time when the application was launched, and
the ultimate result of that investigation plays a pivotal role in the present
litigation between Novo Nordisk and iDexis. In the absence of any
enforcement action by SAHPRA at the time when the opposing affidavit was
prepared, iDexis capitalised on th at fact by stating that the absence of an
investigation by SAHPRA confirmed the legality of its impugned
compounding practises. SAHPRA and SAPC were joined in these
proceedings but elected not to file opposing affidavits and iDexis attempted
to use their silence to strengthen its case . However, the fact that SAHPRA
and SAPC conducted an investigation, published their findings and served
an enforcement notice on iDexis is relevant , not only in relation to that
defence raised by iDexis, but also in relation to the determination of the
future conduct of the matter . In my view iDexis’ attempt to prevent those
facts to be ventilated in Court is an attempt to obstruct a proper ventilation
of important issues relating to alleged illegal conduct that prejudice the
citizenry. The fact that the two statutory bodies which were joined in the
proceedings conducted an investigation in relation to issues before this
Court, and in terms of their statutory powers took action and arrived at
findings which are materially related to the issues in casu , are facts over
which neither Novo Nordisk nor iDexis have control and are facts which a
Court, in grappling with these issues, should be informed of. There is no
basis in law, substantive or procedurally, on which iDexis can object to that
evidence.
[33] In conclusion, the supplementary affidavits are admitted.
THE MEDICINES ACT:
[34] In order to consider the legality complaints of Novo Nordisk it is necessary to refer to
the relevant statutory framework within which the respective entities conduct their
business. The Medicines Act informs in its preamble that it objects include inter alia for
the registration of medicines and related substances intended for human and for animal
use, to provide for the establishment of a Medical Control Council as a juristic person
for the control of medicines and scheduled substances and medical devices , and to
provide for the prohibition of the sales of medicines which are subject to registration and
are not registered. Sections 2 and 2A of the Medicines Act provide for the
establishment of a council which is a regulatory watchdog bestowed with investigative -,
compliance-, and remedial powers to enforce the provisions of the Act which include the
following relevant provisions:
[34.1] Section 14(1) prohibits the sale of any medicine, medical device or IVD (In
Vitro Diagnostic) which is subject to registration;
[34.2] The authority (SAHPRA) may from time to time determine that a medicine,
medical device or IVD shall be subject to registration in terms of the Act.
That declaration is published in the Government Gazette.
[35] The only exception to the sale of medicine which is subject to registration in terms of
section 14(1) of the Medicines Act, is found in section 14(4) of the Act which reads:
“The provisions of sub-section (1) shall not apply in respect of the sale of any device –
(a) compounded in the course of carrying on his or her professional activities by a
pharmacist, veterinarian or person who is the holder of a licence contemplated
in section 22C(1)(a), for a particular patient in a quantity not greater than the
quantity required for treatment as determined by the medical practitioner,
pharmacist, practitioner or veterinarian or
(b) compounded by a pharmacist in a quantity not greater than that prescribed by
regulation for sale in the retail trade, subject to the conditions likewise
prescribed or in a quantity for a particular person or animal as prescribed by a
medical practitioner or a dentist or a veterinarian or a practitioner or a nurse or
other person registered under the Health Professions Act 1979 and referred to
in section 22A, as the case may be,
if such medicine does not contain any component the sale of which is prohibited by this
Act or any component in respect of which an application for registration has been
rejected, and is not or has not been advertised; provided that the active components
of such medicine appear in another medicine which has been registered under
this Act”. (accentuated in this judgment and interpreted hereunder)
[36] Section 15 of the Medicines Act prescribes the procedure for the application of
registration of a medicine while section 16 of the Medicines Act provides the authority
with the power to cancel registration of medicine under certain conditions. Without
referring to the specific sections of the Medicines Act (being not of material relevance
herein) a perusal of the Act empowers SAHPRA to issue and/or cancel licences, to
appoint inspectors, to provide the inspectors with substantial powers of entrance,
inspection, seizure of stock, taking samples and analysing samples to determine
compliance with the Act. A contravention of section 14(1) of the Act as quoted supra
and various other stated provisions of the Act, if contravened, constitutes an offense
under section 29 of the Act and may be liable to a fine or imprisonment in terms of
section 30 of the Act.
[37] The internal Appeal and review remedies provided in the Medicines Act were dealt with
in paragraph 23 above. A quotation from relevant authority describing the objects of the
Medicines Act follow hereunder.
NOVO NORDISK’S LEGALITY COMPLAINTS AND THE APPROACH OF THE COURT
[38] In the founding affidavit Novo Nordisk establish six grounds, referred to as “ complaints
of illegality”, wherein it sets out in substantial particularity the alleged contravention by
iDexis of various provisions of the Medicines Act and related regulations. One of these
complaints was that iDexis compounds medicine for the treatment of weight loss and/or
obesity which contains semaglutide while Ozempic is only registered for the treatment
of Type 2 Diabetes and related cardiovascular conditions. Where iDexis based its
defence on the averment that the API used in the iDexis product is the same as the API
of Ozempic, the compounding of a medicine containing semaglutide for a purpose other
than the registered indication of Ozempic was illegal. As the matter evolved new facts
emerged and it was disclosed that iDexis imports semaglutide from an offshore
producer, while in the meantime Wegovy was approved for weight loss and the
treatment of obesity. Semaglutide is therefore now also registered for that indication,
and that related complaint fell away. However, it was replaced with a new ground of
complaint, namely that iDexis imports a scheduled substance without SAHPRA
authorisation and sells it on a wholesale basis without authorisation. The remaining
original legality complaints can conveniently be summarised as follows:
[38.1] The API of the iDexis product is not the API found in Ozempic and is
therefore not an API registered under the Medicines Act . iDexis can
therefore not rely on section 14(4) of the Medicines Act ; As will be set out
hereunder, this is the dispositive issue between the parties;
[38.2] The iDexis product is not an alternative medicine. Compounding a medicine
containing semaglutide frustrate the purpose of section 14(4) of the
Medicines Act which permits compounding only where a patient, for some
legitimate reason, cannot be treated with the registered product;
[38.3] iDexis advertise its product, contrary to section 14(4) of the Medicines Act,
read together with regulation 3(2), which emphatically prohibits the
advertising or display for sale of any compounded medicine;
[38.4] While section 14(4) of the Medicines Act restrict the compounding of
medicines to a particular patient, for a prescribed time and in limited
quantity on specific prescription by the relevant health practitioner of the
patient, iDexis embarked on a large -scale commercial production and sale
of the iDexis product under the guise of compounding in terms of section
14(4) of the Medicines Act;
[38.5] iDexis published and disseminated false and/or misleading statement s on
the iDexis product, falsely claiming that it is a product approved by SAHPRA
for weight loss management, and that it was tested and approved at a
SAHPRA approved laboratory.
[39] When considering the legality complaints of Novo Nordisk for purposes of a temporary
interdict as framed in the notice of motion, the approach to be adopted is different from
the approach to be adopted for the final determination of the parties’ respective rights.
The requirements for an interim interdict w ere established in the oft-quoted judgment of
Setlogelo6 and it is established law that the requirements for a final interdict are more
stringent that the requirements for an interim interdict. In a recent judgment7 the learned
Judge referred to Setlogelo and with reference to the applicable authorities conveniently
described the approach of the Court on dealing with the facts in an application for a
temporary interdict as follows:
“[19] A party must prove its case on a balance of probabilities to obtain a final
interdict, as in any other civil matter. A final interdict may be obtained on
application if it passes the Plascons -Evans8 test where a dispute of fact has
arisen on the affidavits in motion proceedings – ‘… a final order, whether it be
an interdict or some other form of relief, may be granted if those facts averred
in the applicant’s affidavits, which have been admitted by the respondent,
together with the facts alleged by the respondent, justify such an order. The
power of the court to give such final relief on the papers before i t is not
confined to such a situation. In certain instances, the denial by respondent of
the fact alleged by the applicant may not be such as to raise a real, genuine or
bona fide dispute of fact …’9.”
6 Setlogelo v Setlogelo 1914 AD 221.
7 Main and Another v Branco and Others (2022/018293) [2025] ZAGPJHC 24 (20 January 2025) at paragraph 19.
8 Plascons-Evans Paints Ltd v Van Riebeeck Paints (Pty) Ltd 1984 (3) SA 623 (A).
9 Plascons-Evans supra at 653H-I.
[20] A different approach is followed when a party applies for an interim interdict, as
set out in Webster 10 and confirmed in Gool. 11 To determine whether an
applicant has established a prima facie case though open to some doubt, the
court will approach the matter as follows:12
‘The proper manner of approach I consider is to take the facts as set out by the
applicant, together with any facts set out by the respondent which the applicant
cannot dispute, and to consider whether, having regard to the inherent
probabilities, the applicant could on those facts obtain final relief at a trial. The
facts set out in contradiction by the respondent should then be considered. If
serious doubt is thrown on the case of the applicant he could not succeed in
obtaining temporary relief’.13
[40] The remarks made by the Court in National Gambling Board 14 as quoted earlier also
applies in relation to the approach of the Court in these proceedings. Considering the
aforesaid approach to be adopted, Novo Nordisk’s legality complaints will be dealt with
hereunder. In my view, it is not necessary to deal with the six different complaints
summarised supra individually. On an analysis of the disputes as it evolved in the
respective affidavits and heads of argument, as well as during argument in Court, it
became clear that the definitive issue is namely whether iDexis is correct where it says
that the API of the iDexis product is an API which has been registered in terms of the
Medicines Act , and which will thus allow iDexis to compound legally within the
10 Webster v Mitchell 1948 (1) SA 1186 (W) at 1189.
11 Gool v Minister of Justice and Another 1955 (2) SA 682 (C) at 688E.
12 Webster supra.
13 Gool supra considered that the phrase ‘could not succeed’ should read ‘should not succeed’.
14 National Gambling Board v Premier, Kwazulu-Natal and Others [2001[ ZACC 8; 2002 (2) SA 715 (CC) at para 49.
framework provided by section 14(4) of the Medicines Act . That finding will be
dispositive of the relief sought by Novo Nordisk. Whether iDexis advertise compounded
medicine and/or compounds medicine containing Semaglutides on a commercial scale
outside the intended scheme of section 14(4) of the Medicines Act are in my view not
factors which , viewed in isolation, would convince a Court to exercise a discretion to
grant a n interdict against iDexis which would prevent iDexis from continued legal
compounding under section 14(4) because those instances of contravention do not
constitute conduct which may carry a potential risk to the public at large.
[41] Should the contrary be found, namely that iDexis compounds medicine which contains
an API which is not registered by SAHPRA, by implication that finding will confirm the
merits of the complaints of Novo Nordisk as set out in paragraphs 37.1, 37.4,
and 37.5 above and support the relief claimed in prayers 2.1, 2.2 and 2.3 of the notice
of motion.
CAN iDEXIS RELY ON SECTION 14(4) OF THE MEDICINES ACT BECAUSE THE API IN
THE iDEXIS PRODUCT APPEARS IN ANOTHER MEDICINE WHICH HAS BEEN
REGISTERED?
[42] In response to the dispositive illegality complaint by Novo Nordisk, iDexis avers that
semaglutide appears in Ozempic (and now also Wegovy) which are registered by
SAHPRA in terms of the Medicines Act, which fact therefore allows iDexis to
compound medicine containing semaglutide , because section 14(4) of the Medicines
Act provides for that exception to section 14(1) of the Medicines Act . The operative part
of section 14(4) of the Medicines Act on which iDexis rely is the very last sentence of
that section which reads; “Provided that the active components of such medicine
appear in another medicine which has been registered under the provisions of the Act”.
[43] In support of the iDexis contention that the compounding of iDexis is “ perfectly lawful”,
the following submissions are made in heads of argument filed on behalf of iDexis
namely:
“79. The Medicines Act and/or the Medicines Act regulations:
79.1 …
79.2 does not require that the active components in the compounding
medicine must originate from the same source as that of the registered
medicine. All that is required under the Act is that the compounding
medicine must contain the same active component.
79.3 does not prohibit the compounding of a medicine by making use of an
active component that is found in a medicine that is intended to be used
for a different purpose”.
[44] The case of Novo Nordisk is entirely different . In short, Novo Nordisk contends that the
semaglutide which appears in the Idexis product does not appear in Ozempic or
Wegovy, and iDexis can thus not rely on section 14(4) of the Medicines Act. This
dispute evolved in a peculiar manner in the pleadings. Prior to the institution of the
application, Novo Nordisk was alerted to th e defence of iDexis as summarised in its
heads of argument and quoted above before the application was launched, because in
correspondence preceding the application that defence was recorded by iDexis to deny
any illegality on its part. Novo Nordisk therefore set out to explain in its founding
affidavit that semaglutide as found in Ozempic and W egovy are biological product s
which cannot readily be replicated . This was done in order to illustrate that the iDexis
product simply cannot contain an API which appears in Ozempic or Wegovy. In support
of that statement, it was averred that, because Novo Nordisk Denmark manufactures its
own semaglutide which is a biological product, and because Novo Nordisk does not
supply its semaglutide to anyone else, let alone compounding pharmacists, it is simply
not possible for iDexis to compound medicine which contains the same API as the API
which appears in Ozempic. In that regard it is stated in the founding affidavit:
“91. Not only is iDexis non -compliant with the requirement that ‘the active
components of [its] medicine appear in another medicine which has been
registered under the [Medicines] Act’, but it is incapable of ever complying with
it insofar as semaglutide is concerned. The reason for this is that semaglutide
is a biological medicine as opposed to a clinically synthesised medicine.
SAHPRA describes biological medicines, or ‘biologics’ as they are commonly
referred to, as ‘products that are produced from living organisms or contain
components of living organisms – this includes a variety of biological
medicines derived from human, animal, or microorganisms by biotechnology’.
The relevance of semaglutide being a biologic lies in the fa ct that biologics
cannot be replicated in the way that chemically synthesised medicines can.
The FDA describes this distinction in the following helpful terms, which I
consider to be correct:
‘In contrast to most drugs that are chemically synthesised and their structure is
known, most biologics are complex mixtures that are not easily identified or
characterised. Biological products, including those manufactured by
biotechnology, tend to be heat sensitive and susceptible to microbial
contamination. Therefore, it is necessary to use aseptic principles from initial
manufacturing steps, which is also in contrast to most conventional drugs’.”
[45] The aforesaid facts imply, so averred Novo Nordisk in the founding affidavit, that the
version of iDexi s, namely that it is compounding with a product that is registered, with
reference to Ozempic and Wegovy, is devoid of all truth. In this regard it is stated in the
founding affidavit:
“92. What this means is that the active component of a biologic cannot simply be
replicated in the way the active component of a chemically synthesised
medicine can. This distinction is manifest in the difference between generic
medicines, on the one hand, and so -called ‘biosimilars’ on the other. Whereas
generic medicines are able to use the same active components as originator
medicines because it is easy to replicate the small molecule compounds
manufactured through chemical synthesis, biosimilars are comprised of
biological medicines which are merely similar to the approved biological
medicines and which have the same benefit and risk as the original biologics
albeit that they are not exact copies thereof due to the variability of biologics”.
[46] In answer to the aforesaid, iDexis set out to illustrate its case that the semaglutide
which is used in the iDexis product is found in Ozempic and W egovy, which would bring
its impugned compounding practise squarely within the ambit of section 14(4) of the
Medicines Act. This case evolved through two different answering affidavit s. In the first
answering affidavit which was filed during January 2025, it was opined by Louw that
semaglutide is not a biological product and iDexis denied that the semaglutide as API in
Ozempic and Wegovy are biological products. In support of that statement a report of a
laboratory, referred to as the “ Clinical Partners Report ” was annexed which recorded
that it tested both the iDexis and Novo Nordisk products, and concluded that they have
the same amino acids , and the same number (31) of amino acids, linked in exactly the
same sequence. A further report of SEDEK laboratories ( “the Sedek report ”) was
annexed which recorded that a comparative analysis of the respective semaglutide
bases as found in the iDexis product and Ozempic indicated that they are “identical”.
The case of iDexis in its first answering affidavit was thus not that the active ingredient
in the iDexis product is found in Ozempic or W egovy, but that it is “ identical”.
Notwithstanding the nature of the dispute, iDexis steadfastly refused to disclose its
source of semaglutide.
[47] Novo Nordisk then filed its replying affidavit during April 2025. I response to th e iDexis
case, it provided extensive evidence of an expert nature, explaining that the
semaglutide produced by Novo Nordisk Denmark is a biological product extracted form
yeast, and that it is registered by SAHPRA as a biological product. The replying affidavit
contained extensive reference to the different “pathways to registration” of different sub-
categories of biological medicines as will be referred to hereunder.
[48] Of particular importance in th e r eplying affidavit filed by Novo Nordisk is the expert
evidence of Me Michele K Dougherty, who is the head of US regulatory Affairs at
Eliquent Life Sciences, United States. She has extensive experience in science and
risk-based assessments of the quality module of regulatory submissions for
recombinant therapeutic protein products and has policy development experience on
the implementation of the biosimilar review pathway in the United States. She has
experience in managing the review of original and supplemental Biologics Licence
Applications, filed at the FDA (Federal Drug Agency) including submissions for
biosimilars and therapeutic products. She opined that the conclusion of iDexis, based
on the Clinical partners report and the SEDEK report, that the API in the iDexis product
is “identical” to that which appears in Ozempic and W egovy, is incorrect. She opined
that a description of “ identical” must also relate inter alia to the process of
manufacturing and purification of the tested product because it impacts on efficacy and
patient safety. Efficacy and patient safety are impacted in semaglutide product s by
product related impurities (e.g. peptide impurities) and process impurities (e. g. residual
host cell protein, exogenous DNA, solvents). Absent information on the origin, date of
manufacture, process of manufacturing and safety protocols in the manufacturing
process, which all affect the eventual efficacy and patient safety, it cannot be stated that
the products are identical. She concludes by stating that neither of the two reports on
which iDexis rely provides any information which can conclude that the semaglutide
tested on behalf of iDexis will provide the same level of efficacy and safety that the
Novo Nordisk products which has a proven record in that respect.
[49] During February 2026, s ome nine months after the Novo Nordisk replying affidavit was
filed, iDexis filed an affidavit which it termed “ First and second respondents’ revised
answering affidavit”. In my view, on proper construction, this second answering affidavit
is a disguised duplication to the replying affidavit filed by Novo Nordisk , dealing with the
proverbial shoe that pinched . In that revised answering affidavit it was persisted by
Louw that semaglutide is not a biological product , this time supported by a joint expert
Louw that semaglutide is not a biological product , this time supported by a joint expert
opinion of Professors Dr Markus Depfenhart and Dr Anne Grobler . However, careful
scrutiny of that joint opinion does not support the averment that the joint opinion
supports the statement that semaglutide is not a biological product. The crux of that
opinion, insofar as the classification of semaglutide as either a biological - or synthetic
product is concerned, is contained in paragraphs 20 and 21 of the report of which reads
as follows:
“20. The use of solid -phase peptide synthesis (SPPS) produces semaglutide as a
clinically homogenous active pharmaceutical ingredient, free of host -cell
contaminants, unintended post translation modifications, and batch -to-batch
variability technically encountered in biologics. These characteristics render
the product suitable for pharmaceutical compounding under appropriate GMP
conditions (expert opinion, paragraphs 4.1 to 5.4).
21. Misclassification of chemically synthesised semaglutide as a biological
medicine would be scientifically unsound and inconsistent with international
regulatory practice. Such misclassification would have unjustified
consequences for lawful pharmaceutical compounding and patient access to
essential treatment (expert opinion, paragraphs 7.1 to 7.4)”.
[50] The paragraph as quoted clearly does not opine that semaglutide is not a b iological
product but serves to opine that it is incorrect to classify a chemically synthesised
semaglutide as a biological medicine. The fact that iDexis has a misplaced reliance on
the joint opinion is confirmed by the fact that the joint opinion proceeds to explain the
alleged advantages of producing semaglutides via solid -phase peptide synthesis as
against the recombinant production of semaglutide in eukaryotic expression systems
such as yeast (e.g. Saccharomyces cerevisiae ) because the last mentioned potential
for post-translational modifications to occur unintentionally as part of the host’s cellular
machinery. In lay -man’s terms, it explains the advantages of producing synthesised
peptides over the biological process of production.
[51] After explaining the differences between the solid-phase peptide synthesis processes of
producing semaglutide and the production of semaglutide in the eukaryotic expression
systems, the joint experts opine that:
“In our view, and in alignment with the positions of both the EMA and FDA, semaglutide
and tirzepatide – when produced via solid -phase synthesis in chemically ideal form –
should be classified as synthetic peptides.”
[52] On proper consideration, the joint opinion confirms that there is a difference between
semaglutides produced from biological products such as yeast, and semaglutides
produced by chemical synthesis. This difference will become more relevant hereunder.
[53] The evidence advanced by Novo Nordisk on the process of the manufacture of
semaglutide used as API in Oz empic and W egovy, being of a biological origin is not
(and cannot) be disputed by iDexis. The evidence is clear that the semaglutide
developed and manufactured by Novo Nordisk Denmark is a biological product
extracted from yeast and it remained common cause that Ozempic and W egovy are
registered as biological medicines by SAHPRA. The case eventually advanced by
iDexis in Court, succinctly summarised, is that the semaglutide used as API in the
iDexis product, is a synthetic peptide, with a molecular structure similar to the Ozempic
API.
[54] The case of iDexis is therefore no longer based on the averment that the semaglutide
used by iDexis in its compounded medicines is the same as the semaglutide developed
by Novo Nordisk, but is based on the averment that it is similar to that product. The
similarity between the respective API products , so argue iDexis, allows iDexis to
compound its semaglutide component under the exemption as contained in the last
sentence of section 14(4) of the Medicines Act. It is common cause that the
semaglutide developed by Novo Nordisk was evaluated, tested and approved by
SAHPRA, that semaglutide is a scheduled substance that requires registration and
approval by SAHPRA , and that the semaglutide used by iDexis in its product is not
approved by SAHPRA. The definitive issue is therefore namely whether the established
similarity of the two respective semaglutide components allows iDexis to compound its
product under section 14(4) of the Medicines Act.
[55] In my view, the fact that the two products are similar but not the same, does not allow
iDexis to compound medicine which contains a synthetically produced semaglutide as
API which had not been approved and registered with SAHPRA. This is based on the
fact that SAHPRA, for purposes of registration of medicines, clearly distinguish between
biological- and synthetically produced products, and also on a proper interpretation of
section 14(4) of the Medicines Act as is set out hereunder.
[56] SAHPRA has different pathways for the registration of “Orthodox Medicine ” and
“Biological Medicine ” medicines. Novo Nordisk referred extensively to the guidelines
published by SAHPRA in relation to the pathways to comply with the registration
requirement under section 14(1) of the Medicines Act. Biological Medicines , according
to SAHPRA , are defined as …” products that are produced from living organisms or
contain components of living organisms – this includes a variety of biological medicines
derived from human, animal, or microorganisms by using biotechnology ”. It is under this
category that semaglutide produced by Novo Nordisk Denmark was tested, approved
and registered. The registration pathways for orthodox medicines, which are described
as conventional pharmaceutical products derived from chemical synthesis, include the
sub-types of “ Baseline” (products registered before certain regulatory changes); “New
Chemical Entity ” (for entirely new active ingredients); and “ New Generic ”( for generic
versions of already registered medicines).
[57] The pathways for registration of biological medicines include the sub -types of “New
Biological” (for original biological products); “ New Biosimilar” (for products similar to an
already registered biological medicine) and “ New Vaccines ” (for preventative or
therapeutic vaccines).
[58] Each of these registration pathways differ in terms of requirement for testing, trials,
quality control during manufacture, safeguards against contamination, efficacy, and risk
assessment. Novo Nordisk further illustrated, by reference to the different sub -
categories of biological medicines, the rigorous quality control measures required for
Biosimilars which are defined by SAHPRA as “….biological products that are very
similar to a reference biologic and for which there are no clinically meaningful
differences in terms of safety, purity, and potency”.
[59] The fact that SAHPRA clearly distinguish between biological products and biosimilar
products and requires different pathways to registration of these products is cogently
illustrated by the SAHPRA published draft Quality and Clinical Guideline on Synthetic
Peptides which contains the following:
“The current biosimilar regulatory pathway is not possible for applications for human
products containing chemically synthesised peptides since these fall outside the
definition of biological substance. Nevertheless, the basic principles to demonstrate
biosimilarity; being high similarity in terms of structure, biological activity and efficacy,
safety and immunogenicity profile, should be considered for synthetic peptide
development programmes using biological medicinal product as reference.
SAHPRA will assess the quality of the peptide drug with respect to its impact on safety
and efficacy. The evaluation process will look into the complexity of the peptide and its
clinical use, the process- and product- related factors that may impact the quality, safety
and efficacy of the proposed synthetic peptide medicinal product and it will be indicated
whether additional studies ( in vitro or in vivo) are needed to address any residual
uncertainty related to the quality, safety and efficacy of the peptide medicinal product”.
[60] The aforesaid guideline illustrate that SAHPRA, the statutory regulatory body who is
appointed as the industry watchdog to protect the citizenry, draws a clear distinction
between biological medicines and other categories and sub -categories of medicines
and does not regard semaglutides produced from biologics , biosimilars, or
semaglutides produced by chemical synthesis as the same or similar for purposes of
registration. The fact that iDexis provided evidence to illustrate the similarity between
the semaglutide in its product and that produced by Novo Nordisk Denmark is
irrelevant, because (on the version of iDexis) it is not a biological product . The fact that
there is a difference between a chemically synthesised peptide and a peptide derived
from biologic origin is illustrated by analysis of the SAHPRA guideline from which the
quotation above is extracted, and was aptly illustrated by the joint expert report relied
on by iDexis. Where the iDexis defence relies on section 14(4) of the Medicines Act on
the basis that the API in the iDexis product has been approved in another medicine
(Ozempic and/or Wegovy) that defence is therefore rejected.
[61] However, the aforesaid defence of iDexis must also be rejected on another
consideration. In my view a purposive interpretation of the last sentence of section
14(4) of the Medicines Act is dispositive of the dispute. That sentence reads:
“Provided that the active components of such medicine appear in another medicine
which has been registered under this Act”.
[62] iDexis contends that this means that the API must be “ similar”, while it was argued on
behalf of Novo Nordisk that this sentence should be interpreted to mean “ the same”.
The relevant principles in relation to the interpretation of legal instruments as set out by
the Supreme Court of Appeal in Endumeni15 can concisely be summarised as follows:
[62.1] The statute must be interpreted having regard to the document as a whole
under circumstances dependent upon its coming into existence;
[62.2] Consideration must be given to the language used in the light of the
ordinary rules of grammar and syntax, the context in which the provision
appears, the apparent purpose to this it is directed and the material known
to those responsible for its production;
[62.3] The process is objective, not subjec tive. A sensible meaning is to be
preferred to one that leads to insensible or unbusinesslike results;
15 Natal Joint Municipal Pension Fund v Endumeni Municipality 2012 (4) SA 593 (SCA) para 18.
[62.4] The inevitable point of departure is the language of the provision itself, read
in context and having regard to the purpose of the provision and the
background to the preparation and production of the document.
[63] In Pharmaceutical Manufacturers Association of SA and Another 16, referring to a
judgment of Kriegler AJA (as he then was) in the matter of Administrator, Cape v Raats,
Rontgen and Vermeulen(Pty) Ltd , the purpose of the Medicines Act w as described as
follows:
“Manifestly the Act was put on the statute book to protect the citizenry at large.
Substances for the treatment of human ailments are as old as mankind itself; so are
poisons and quacks. The technological explosion of the twentieth century brought in its
wake a flood of pharmaceuticals unknown before and incomprehensible to most. The
man in the street — and indeed many medical practitioners — could not cope with the
cornucopian outpourings of the world -wide network of inventors and manufacturers of
medicines. Moreover, the marvels of advertising, marketing and distribution brought
such fruits within the grasp of the general public. Hence an Act designed, as the long
title emphasises, to register and control medicines . The enactment created a tightly
meshed screening mechanism whereby the public was to be safeguarded; in general
any medicine supplied to any person is, first, subject to stringent certification by experts;
then it has to be clearly, correctly and comprehensively packaged and labelled and may
only be sold by certain classes of persons and with proper explanatory information; to
round it out detailed mechanisms for enforcement are created and ancillary measures
are authorised”.
16 Pharmaceutical Manufacturers Association of SA and Another; In re: Ex parte President of the Republic of South Africa and
Others 2000 (2) SA 674 (CC) at para 61.
[64] In the context of the Medicines Act as a whole, and with specific regard with the fact
that the Act is inter alia designed to protect the public at large against untested,
unregistered, potentially hazardous medicines by seeking stringent registration
requirements, it follows that section 14(4) should be interpreted restrictively in a manner
that will not allow the unscrupulous circumvention of section 14(1) of the Medicines Act.
It therefore implies that the last sentence of section 14(4) cannot be interpreted to refer
to a “ similar active component” but must be interpreted to refer to “ the same active
component”. In my view, it is a matter of logic and common sense that the active
component of a scheduled medicine, which requires a stringent registration process ,
can never be allowed into medicine without the scrutiny of SAHPRA, and without the
proper stringent screening process envisaged in terms of the Medicines Act and
regulations, by relying on “ similarity” subjectively determined, under the guise of
compounding in terms of section 14(4).
[65] When regard is had to the SAHPRA Industry guidelines, the different pathways to
registration of medicines, and the findings of the SAHPRA and SAPC investigation as
recorded in the enforcement notice, it is clear that SAHPRA interprets section 14(4)
restrictively and will not sanction the compounding of medicine using a n API which is
“similar” or “identical” to the active ingredient which appears in another medicine which
is registered but requires that it is “the same”. This Court must have regard to that
interpretation of SAHPRA.17
[66] Considering the aforesaid interpretation of section 14(4) of the Medicines Act and the
evidence of iDexis to the effect that the Semaglutide which forms the active component
of the product compounded by iDexis is not the same as the Semaglutide used in
17 Marshall NO and Others v Commissioner, South African Revenue Service 2019 (6) SA 246 (CC) at para 10.
Wegovy and Ozempic, but in fact a synthesised peptide, the compounding of medicine
containing Semaglutide by iDexis contravenes the provisions of section 14(4) of the
Medicines Act.
[67] The aforesaid finding therefore renders it unnecessary to deal with the remainder of the
illegality complaints as advanced by Novo Nordisk.
DID NOVO NORDISK SATISFY THE REQUIREMENTS OF A TEMPORARY INTERDICT:
[68] While seeking the interdictory relief, it was averred in the founding affidavit that Novo
Nordisk seeks that relief in its own interest as well as in the public interest. Acting in
own interest, it was submitted on behalf of Novo Nordisk that the following remarks of
Solomon J in Patz v Greene18 are appropriate:
“Everyone has the right, in my opinion, to protect himself by appeal to a court of law
against loss caused to him by the doing of an act by another, which is expressly
prohibited by law. Where the act is expressly prohibited in the interest of a particular
person, the court would presume that he is bone fide, but where the prohibition is in the
public interest, then any member of the public who can prove that he has sustained
damage is entitled to his remedy”.
[69] The Medicines Act was promulgated to protect the citizenry at large, through a “ tightly
meshed screening mechanism whereby the public was to be safeguarded”. 19 As set out
above, the preamble to the Medicines Act and the remarks of the Constitutional Court in
relation to the purpose of that Act is quoted in above confirms, in my view, that a Court
18 Patz v Greene 1907 TS 427 at 433.
19 Pharmaceutical Manufacturers supra, para 61 and authorities quoted therein.
should not allow the continuation of any activity which falls under the provisions of the
Medicines Act to continue unabated, if it appears prima facie that such conduct may be
contrary to the provisions of the Medicines Act. When it is established that a party is
engaged in an ongoing illegality which is also a criminal offence, the Court has no
discretion to allow the continuation of that unlawful conduct, because to do so would
subvert the doctrine of legality and undermine the rule of law as was held in Lester.20
[70] In the Lester judgment it was held that, where breach of a statutory provision is
established which is also a criminal offence, the Court will only withhold its discretion to
grant an interdict in exceptional circumstances. In my view the authorities referred to
imply that, once a party establish a right which is infringed by illegal conduct for
purposes of an interdict, the enquiry into the remaining requirements for an interdict,
final or temporary, falls away. This is so because to refuse such an interdict on the
basis that one and/or more of the other requirements are not met will result in the Court
allowing illegal conduct to continue which is a dereliction of the duty of the Court to
uphold the rule of law. Notwithstanding, the issue of whether Novo Nordisk satisfied the
requirements of a temporary interdic t will be dealt with concisely because the finding of
illegality is based on a n interpretation of the relevant statutory provision which have not
been subjected to appeal yet, and in the interest of recording this Court’s findings on
those issues.
[71] In my view Novo Nordisk clearly established a prima facie right worthy of protection by
way of a temporary interdict, and that it appears to be in the interest of the citizenry at
large to be protected from the impugned activity of iDexis in the form of compounding
medicines with semaglutide as API, for the following reasons:
20 Lester v Ndlambe Municipality and Another 2015 (6) SA 283 (SCA) at para 23.
[71.1] The interpretation of section 14(4) of the Medicines Act as set out supra
together with the common cause fact that the Semaglutide which forms the
API of the medicine compounded by iDexis is not the same as the API of
Ozempic and Wegovy in relation to manufacturing, source or approval
confirms, at least prima facie, that iDexis acts unlawfully and thus compete
unlawfully with Novo Nordisk;
[71.2] In my view t he enforcement notice issued by SAHPRA and SAPC on 21
May 2026 supports the averments made by Novo Nordisk in relation to the
illegal conduct of iDexis. It was strenuously argued on behalf of iDexis that
the notice ha s no evidential value as it is nothing more than hearsay
evidence and should be disregarded. I disagree. The notice emanates from
a statutory body bestowed with powers of investigation which refers to an
investigation conducted by inspectors who found very serious instances of
non-compliance by iDexis with the Medicines Act. Those findings are
disputed by iDexis and for that reason iDexis is at liberty to employ the
remedies available in terms of section 24A of the Medicines Act as well as
the review remedy afforded in terms of PAJA as provided for in terms of
section 24A(4) of the Medicines Act. However, pending the resolution of any
disputes which may follow, I am of the view that this Court cannot ignore the
fact that SAHPRA, in all material respects , confirms the evidence provided
in support of the illegality complaints of Novo Nordisk. This Court cannot
ignore the interpretation which the relevant statutory body gives to the laws
that govern it;
[71.3] In summary, the impugned conduct of iDexis infringes on the right of Novo
Nordisk not to be unlawfully competed against , as well as the right of the
public to have access to compliant medicines which is approved by the
statutory authority in South Africa (SAHPRA) , and is prima facie, if not
clearly, unlawful.
DID NOVO NORDISK ESTABLISH IRREPARABLE HARM:
[72] In my view the fact that Novo Nordisk will suffer irreparable harm, should the relief
claimed by Novo Nordisk not be granted, is patently obvious with regard to the following
facts:
[72.1] iDexis is insolvent and under business rescue and will therefore not be able
to satisfy any claim for damages;
[72.2] The scale upon which Novo Nordisk compound s medicines contrary to the
relevant statutory provision is of such a grand scale (on its own version, up
to 84 500 patients per month) that it will be extremely difficult for Novo
Nordisk to compute any damages claim, even if iDexis was able to comply
with such a claim;
[72.3] The fact that both SAHPRA and a prominent manufacturer of semaglutide
products published bulletins warning the general public against the practice
of compounding of medicines in South Africa using Semaglutides which
have not been approved, in my view, speaks for itself.
[73] In summary, on the available evidence Novo Nordisk clearly established the element of
irreparable harm.
THE BALANCE OF CONVENIENCE:
[74] In the founding affidavit Novo Nordisk avers that it is an international business with an
impressive annual turnover. Novo Nordisk categorically declares that it is able to pay
any amount of damages which iDexis may prove to have suffered, should it be found
that the compounding of Semaglutide products by iDexis were legally compliant. This
averment is not disputed by iDexis.
[75] In my view it is a matter of logic and common sense that a Court will not allow conduct
which is established prima facie to be un lawful, to continue pending a full and final
determination of that conduct either by way of an internal remedy or review, simply
cause an interim order will inconvenience the Respondent. The potential prejudice to
Novo Nordisk and especially the citizenry is a factor which far outweighs the potential
prejudice to iDexis.
[76] In my view, considering the aforesaid and the nature of the dispute between the parties,
the balance of convenience favours the grant of interim relief to Novo Nordisk.
DOES NOVO NORDISK HAVE A SUITABLE ALTERNATIVE REMEDY:
[77] The only alternative remedies available to Novo Nordisk are the institution of an action
for damages and/or the remedies provided in sections 24 and 24A of the Medicines Act.
These remedies are clearly not suitable alternatives, because while those remedies are
pursued by Novo Nordisk, the unlawful conduct of iDexis may continue with the
resultant prejudice already dealt with above. The history of this matter, where Novo
Nordisk complained about the illegal compounding and ancillary conduct of iDexis to
SAHPRA almost two years ago, and SAHPRA eventually complying with their statutory
duty just days before this matter went to Court, cogently illustrate this point. In the
meanwhile, iDexis have dispensed a medicine containing an unregistered, untested,
potentially dangerous medicine to 84500 patients per month. This fact speaks for itself.
CONCLUSION:
[78] In the premises, Novo Nordisk has satisfied the requirements for the relief it seeks in
the notice of motion. For sake of clarity the order made hereunder is a temporary
interdict pending the finalisation of the remedies which Novo Nordisk and iDexis may
have in terms of section 24(4) of the Medicines Act as well as a review under PAJA as
envisaged in section 24A(4) of the Medicines Act.
THE REASONS FOR DISMISSING THE POINT OF MOOTNESS RAISED BY IDEXIS:
[79] In the matter of Solidariteit Helpende Hand NPC21 the following was held:
“[12] The general principle is that a matter is moot when a court’s judgment will
have no practical effect on the parties. This usually occurs where there is no
longer an existing or live controversy between the parties. A court should
refrain from making rulings on such matters, as the court’s decision will
21 Solidariteit Helpende Hand NPC and Others v Minister of Cooperative Governance and Provisional Affairs (104/2022) [2023]
ZASCA 35 (21 March 2023) at para 12.
merely amount to an advisory opinion on the identified legal questions,
which are abstract, academic or hypothetical and have no direct effect”.
[80] In support of the aforesaid comments the Supreme Court of Appeal referred to the
Constitutional Court’s judgment of AB and Another v Pridwin Preparatory School and
Others22 at paragraph 50.
[81] iDexis argued that the matter has become moot by virtue of the compliance notice
served by SAHPRA on iDexis on 26 May 2026 . That notice, so argued counsel on
behalf of iDexis, renders the relief sought by Novo Nordisk moot because there is no
longer any triable issue.
[82] On an analysis of that notice, the matter is far from over. The notice merely serves to
inform iDexis of certain findings made by SAHPRA, and the intention of SAHPRA to
invoke certain enforceable action. iDexis is required to respond and provide reasons
why such corrective action should not be enforced by SAHPRA. The response of iDexis
to that notice forms part of the record, and clearly conveys the intention of iDexis to
oppose the stated intention of SAHPRA to subject iDexis to enforcement action, to
review any decisions taken by SAHPRA, and to proverbially fight to the bitter end. The
notice does not have the effect of an order which prevents iDexis from continuing to
compound the iDexis product, and the declared intention of iDexis is to do exactly that.
[83] The relief which Novo Nordisk seeks is therefore neither academic nor hypothetical and
the point of mootness was therefore dismissed.
COSTS:
22 AB and Another v Pridwin Preparatory School and Others 2020 (5) SA 327 (CC).
[84] Novo Nordisk and iDexis resp ectively seek punitive costs against each other. Novo
Nordisk avers that iDexis acts unlawfully and has frustrated the attempts of Novo
Nordisk to obtain relief by pursuing frivolous interlocutory procedures, while iDexis
accuse the deponent of the founding affidavit and replying affidavits of being dishonest
and also accuse Novo Nordisk of solely acting in its own commercial interests under the
guise of acting in the public interest.
[85] In my view there is no merit in the accusations levelled by iDexis against Novo Nordisk
in support of its claim for punitive costs. It is within th e rights of Novo Nordisk to insist
on protection against unlawful competition . Furthermore, Novo Nordisk has subjected
itself to a process of stringent screening and testing of its products by SAHPRA, in the
public interest and in compliance with its duty to obey the law.
[86] However, insofar as the conduct of iDexis and Louw is concerned, the following needs
to be remarked:
[86.1] iDexis failed to disclose material facts in its answering affidavit. The
materiality of that issue has been dealt with above. Louw is the deponent of
that affidavit and the withholding of that information is solely attributable to
Louw;
[86.2] The answering affidavit initially filed by iDexis includes references to the fact
that SAHPRA has not taken any steps to prevent iDexis from compounding
medicines containing Semaglutide. That fact was relied on by iDexis in
support of its ill -conceived stance that it is compounding lawfully. However,
when the enforcement notice was served on iDexis, it failed to bring the
existence of that notice to the intention of the Court and when Novo Nordisk
did so by way of a supplementary affidavit, iDexis objected to that evidence.
In Court it was argued on behalf of iDexis that the enforcement notice has
no evidential value and should not be considered by the Court. This is an
untenable legal argument. This proverbial change of tack is in stark contrast
to the attitude adopted by iDexis in the initial answering affidavit that the
failure of SAHPRA to take any steps should be construed as compliance by
iDexis with the relevant statutory provisions . The unavoidable inference is
that iDexis attempted to prevent material evidence to be placed before
Court in an improper manner;
[86.3] The opposing affidavit of iDexis is replete with legal submissions on the
admissibility of evidence, whether or not there are secondary facts in
support of primary facts in Novo Nordisk’s founding affidavit, and
argumentative averments which serves no purpose but to cloud the issues.
This conduct of raising a proverbial smoke screen continued in the form of
the point of mootness which is so devoid of merit that the fact that it was
raised can only draw an inference of mala fides. The same applies to the
argument that the nature of the relief sought by Novo Nordisk is that of a
final interdict;
[86.4] Louw, on his own version, is a pharmacist and qualified himself as expert
witness in the opposing affidavits. In the face of overwhelming evidence that
semaglutide found in Ozempic and W egovy is deemed by SAHPRA to be a
biological product and that the semaglutide found in the iDexis product is a
synthetic peptide which requires registration because it is not the same
product as found in Ozempic, Louw persisted (until constrained to concede)
to opine that semaglutide as found in Ozempic is not a biological product.
Louw attached the joint expert report referred to above to the second
answering affidavit and requests the Court to make findings which are not
supported by that report. This conduct was a deliberate attempt to cloud the
issues, capitalising on the perception that a Court, lacking the expert
knowledge of Louw, will be unable to give its own interpretation to a
complicated scientific report. Louw refused to disclose the source of the
semaglutide which is used by him and the entity he controls in compound ed
medicine. The conduct of Louw will be sanctioned by ordering him to be
jointly and severally liable for costs with the entity he controls;
[86.5] Apart from the aforesaid consideration, the mere fact that iDexis refused to
terminate its practise of compounding medicines containing Semaglutide in
the face of overwhelming evidence contained in Novo Nordisk’s respective
affidavits to the effect that there is a difference between the Semaglutide
contained in Ozempic and Wegovy to th e semaglutide used in the iDexis
product, and in the face of the compliance notice issued by SAHPRA, in my
view speaks volumes for the ca llous disregard which Louw and iDexis have
for the safety of the citizenry and their right to be protected against medicine
which is not properly tested and approved by SAHPRA.
[87] Considering the aforesaid, I exercise my discretion to order that punitive costs be
awarded.
In the result, the following order is made:
1. First and second Respondents are interdicted and restrained from, directly or indirectly,
through any other person or entity:
1.1 manufacturing or supplying, whether by compounding or otherwise, any medicine
containing semaglutide;
1.2 marketing and advertising or otherwise displaying for sale any medicine
containing semaglutide which is being compounded;
1.3 marketing and advertising that its compounded semaglutide medicine has been
approved by the Third Respondent;
2. The order in paragraph 1 above and the sub -paragraphs thereof shall operate with
immediate effect and will remain operative pending:
2.1 the outcome of any decisions taken by Third and/or Fourth Respondents
(including the exhaustion of applicable internal statutory appeal/review remedies)
following Third and Fourth Respondents’ respective investigations into the
manufacturing and/or supply of medicine containing semaglutide by First and/or
Second Respondents;
2.2 in the absence of any decisions taken by either Third or Fourth Respondents
within six months from date of this order in terms whereof Third and/or Fourth
Respondent prohibits First and Second Respondents to manufacture and/or
supply medicine that contains semaglutide, the outcome of any proceedings to be
instituted by applicant to be instituted within eight months after date of this order
to-
2.2.1 review the decisions (or failure to take a decision) by the Third and/or
Fourth Respondents: and/or
2.2.2 declare that the First and Second Respondents’ conduct constitutes a
violation of the Medicines and Related Substances Act 101 of 1965 and
the General Regulations published under GN 859 in GG 41064 on 25
August 2017 and amounts to unlawful competition; and/or
2.2.3 seek final interdictory relief against the First and Second Respondents.
3. First and Second Respondents are ordered, jointly and severally, the one paying the other
to be absolved, to pay the cost of the application on the attorney-and-client scale, including
costs of two junior and one senior counsel, taxed on Scale C.
_________________________________
P A VAN NIEKERK
JUDGE OF THE GAUTENG DIVISION,
PRETORIA
DATE OF HEARING 10 June 2026
DATE JUDGMENT HANDED DOWN 22 June 2026
APPEARANCES
FOR APPLICANT A. Botha SC, with him A. Molver and B. Mazibuko
INSTRUCTED BY Adams & Adams, Pretoria
FIRST AND SECOND RESPONDENTS S. Maritz SC , with him S.
Maritz
INSTRUCTED BY Pierre Marais, Pretoria
THIRD AND FOURTH RESPONDENTS No
appearance