YOUR RIGHT TO CHOOSE HERBAL PRODUCTS STILL AT RISK AS SAHPRA DELIVERS LOW BLOW
In our Summer Edition 2019/20 we published a call to action ‘Your Body Your Right’ highlighting the consumer’s right to choose herbal products over pharmaceutical products, based on General Regulations to the Medicines and Related Substances Act, 101 of 1965 (Regulations, 2017) that were published on 25.8.2017.
In 2018 the ANHP (The Alliance of Natural Health Products) challenged whether the Minister of Health (MoH) and SAHPRA (South African Health Products Regulatory Authority) – formerly the Medicines Control Council under S35 of the Medicines Act – is empowered to regulate all complementary medicines as contained in the regulations. On 1.10.2020 the High Court ruled in favour of ANHP finding the actions of SAHPRA “unlawful”. This ruling had major implications for the complementary and alternative medicines (CAM) and heath and natural products industries; however, the court’s ruling, which may have been considered a fair judgment by many, has since been appealed by SAHPRA
In a media release issued by Dr Boitumelo Semete, CEO of SAHPRA on 29.10.2020 it was stated:
“On 1 October 2020 the Pretoria High Court delivered its judgment in the matter between the Alliance of Natural Health Products in South Africa (“ANHP”) v Minister of Health and SAHPRA. In the application ANHP sought to review and have set aside certain aspects of the General Regulations in relation to the regulation of complementary medicines, including health supplements, on the basis that the Minister acted ultra vires when promulgating the Regulations.
The Court found that The General Regulations promulgated on 25 August 2017 under General Notice 859 in GG 41064 are unlawful, to the extent that they apply to complementary medicines and health supplements that are not medicines or scheduled substances as defined in section 1 of the Act.
The declaration of invalidity is suspended for a period of twelve (12) months to allow the Authority to an opportunity to correct the defect. However, the Minister and SAHPRA have since filed an application for leave to appeal as it is their intention to appeal this judgment. Since the Minister and SAHPRA are appealing the judgment, this means that the judgment is stayed, pending the outcome of the appeal.
Therefore, the General Regulations under GG 41064 relating to the regulation of complementary medicines remain in force.”
In this response SAHPRA and the Minister of Heath clearly have no intention of taking a collaborative approach and to engage comprehensively with the natural health products industry and associations. It remains now, once again, to ‘play the waiting game’ as to whether or not the appeal is heard and bearing in mind that the ANHA may choose to interdict.
Should this judgment, however, be deemed fair and equitable, it would demand a different stance by SAHPRA and the Department of Health. Consultation and industry participation would be required and furthermore impact studies would need to be conducted to determine the potential risk of these onerous requirements in terms of licensing and the impact the enforced removal of thousands of CAMs, health products and supplements from the South African marketplace.
Given the current uncertainty, we will bring you a full report in a future edition once the outcome of the application by SAHPRA for leave to appeal is known. If leave is then granted, the appeal will proceed. If the appeal succeeds, the court can grant a new trial, or reverse or modify the prior judgment. If the appeal fails, the judgment stands and no further appeal is possible.
Your Body, Your Health, Your Choice, Your Constitutional Right
What can you do to make a difference? Take a Stand!
Traditional and Natural Health Alliance (THNA) https://www.tnha.co.za/ email: [email protected]
Health Products Association (HPA) https://www.hpasa.co.za/ email: [email protected]
A Covid-19 vaccine could be ready this summer.
Scientists warn it will be some time before life returns to normal. Once scientists finalise the vaccine, it will have to be reviewed by regulators and then government officials around the world will decide who should receive it first.
The Oxford/AstraZeneca vaccine is expected to be one of the first to be submitted for regulatory approval, along with Pfizer and BioNTech’s candidate.
Oxford Vaccine Trial chief investigator Prof Andrew Pollard cautioned, however: “Unfortunately it doesn’t mean we can all go back to normal immediately because it takes time to roll out vaccines.”
To vaccinate or not to vaccinate?
As we have seen internationally with debates over the wearing of masks and, more generally, with anti-vaccination activists everywhere, compulsion is not a simple matter. There are competing rights and duties on both sides.
Forcing an individual to be vaccinated is a violation of their fundamental right to personal autonomy, which informs the more specific right to bodily integrity. Basically, those rights mean every person can make decisions for themselves and what can and cannot be done to their bodies.
Pioneering chronic wound treatment…
uses patients’ own blood and combines technological innovation with the strengthening of the natural healing power of our bodies.
The chronic wound treatment uses the patient’s blood clot to heal wounds that would normally take longer to heal or not heal at all. Depending on the size of the wound, the treatment takes 5-10 weeks to heal.
According to a Wound Nurse Specialist at ActiGraft South Africa, Sr. Liezl Naude, for people living with chronic wounds, finding a treatment that is both efficient and non-invasive can be challenging.
“In any hospital, there are always, at any given time, patients with chronic wounds – i.e. people with cutaneous wounds, such as leg ulcers, pressure ulcers, diabetic ulcers and even car accident wounds,” says Sr. Naude.
Wounds become chronic because of poor blood circulation to the affected areas. ActiGraft South Africa introduced the treatment in May 2020 and it has saved many patients’ limbs from amputation thus far.
“The treatment combines technological innovation with the strengthening of the natural healing power of our bodies. First, a small amount of blood is taken from the patient and injected into a unique ‘clotting mould’ with medical reagents. The compound tissue is then placed over the wound and firmly dressed. Placing the tissue and dressing takes only about 10 minutes, but its effect is long-lasting. The biological components of this product rebuild the natural environment necessary for the healing process, create new blood vessels and promote the closing of the wound.
“With very little research on chronic wounds in South Africa, anybody that has a wound that does not heal within 30 days, must consider consulting a wound specialist. Symptoms of chronic wounds include wounds that do not follow the normal pathway of wound healing, swollen legs and poor blood circulation which causes cells to die and can also damage body tissue,” concludes Sr. Naude.
More information: actigraft.co.za