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PETITION
TO THE MINISTER OF HEALTH AND THE SOUTH AFRICAN HEALTH
PRODUCTS REGULATORY AUTHORITY (SAHPRA).
ATTENTION:
The Hon. Aaron Motsoaledi
The Minister of Health
Private Bag X828
PRETORIA
Ms. Portia Nkambule
The Acting Chief Executive Officer
South African Health Products Regulatory Authority (SAHPRA)
Meiring Naudé Road
Brummeria
PRETORIA
Dear Sir / Madam,
Today I was informed that CBD
oil and CBD-containing products for medicinal use were
scheduled as prescription-only medicines (Schedule 4
medicines) in South Africa, and that other CBD and CBD-containing
products in safe, low suggested daily intakes used as
dietary supplements (for maintaining health a wellness),
skincare and food ingredients are now banned Schedule 7
narcotics.
I also learned that all CBD oil
and CBD-containing products which have until recently been
imported into South Africa are now being actively seized by
the Port Health Authority under the instructions of the
SAHPRA, thereby severely curtailing the public’s continued
access to them in future.
This will have the unintended consequence
of expanding an unregulated black market of such products,
and
whereby the unsuspecting public will potentially be put at
risk from unscrupulous sellers who may sell products of
questionable quality and safety.
Scheduling CBD as a prescription-only
drug or banned supplement is not in line with what is
happening in many other progressive countries around the
world, where CBD oil and CBD-containing products are sold
legally as dietary supplements and food and skincare product
ingredients.
This is also contrary to the
recommendations of the World Health Organisation’s Expert
Committee on Drug Dependence, who in November 2017 declared
that CBD not be regulated by international Medicines
Regulatory Authorities as controlled or scheduled substance.
I object to now being forced to
visit a medical doctor and to pay for a costly consultation
fee to access CBD oil and CBD-containing products, as no
doctors are formally trained in the use CBD in South Africa. Few will be
willing to prescribe it.
I also object to having to
persuade a medical doctor to apply for a Section 21
Exemption Permit to obtain CBD for my personal use, as the only
foreign approved CBD-containing medicines which will be allowed
into the country on such a permit for a maximum period of
three months will be CBD isolates produced by pharmaceutical
companies and not full-spectrum hemp-derived CBD. This
option will be highly inconvenient, frustrating and
unaffordable.
Currently there is only one
foreign approved and patented CBD drug (containing only CBD),
and which
is unaffordable for most South Africans. The drug branded EPIDIOLEX® currently costs $23 000 [+/- R325 000] for a
year’s supply.
Take note that I have the right to make my own
decisions about how I maintain my health and wellness. I
want to have the right to choose safe, affordable and
responsibly manufactured CBD oil and CBD-containing
products in future.
I therefore call upon you to
urgently reverse your irrational and overly-restrictive
scheduling of CBD oil and CBD-containing products, and allow
for them to be accessed freely as over-the-counter /
non-prescription products.
Approved over-the-counter CBD
products should minimally:
-
be full spectrum CBD
products derived from hemp, with less than 1 part per
million of THC (tetrahydrocannabinol), rendering them
non-psychoactive and non-habit-forming,
-
be limited to an acceptable
safe upper daily intake limit,
-
be produced with appropriate
Good Manufacturing Practice (GMP),
-
Be regulated in terms of
what health claims may or may not be allowed on the
products, their labels, and associated marketing
materials.
CBD can be regulated as both a
non-prescription and prescription-only substance in products
in terms of the Medicines Act, with a clear separation
between them being made on the product’s daily dosage and
label claims. This has been already
done for many health products / medicines in South Africa.
I support the TNHA's current High
Court action to review your previous scheduling decision in
November 2017 in
this regard.
Please do the right thing and align the scheduling of CBD to international best practice,
and the WHO’s recommendations.
Please respect my Constitutional
Right to have full control over my own health and bodily
integrity (Chapter 2, Section 12 - SA Bill of Rights).
I call upon you to lift the current ban on all CBD imports
without a Section 21 Exemption Permit which was recently imposed by your instruction to the Port Health
Authority.
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