The South African Health Products Regulatory Authority (SAHPRA) has again unwittingly overstepped its authority, putting the health of the country’s domestic canine population at unnecessary risk.
This comes as SAHPRA has placed an embargo on the latest shipment of Trilostane into South Africa by V-Tech, the largest veterinary compounding pharmacy in Southern Africa, after a sudden change in stance by the regulatory authority, which now requires the substance to be registered as a medicine in terms of the Medicines Act.
Trilostane is currently the only active pharmaceutical ingredient (API) available globally that can be used safely and effectively in the treatment of Cushings Disease in dogs.
Dr Johan Oosthuyse, the CEO of V-Tech, says that the devastating impact of this sudden and unexpected embargo on the lives of many domestic animals is unethical and irresponsible, a view that is supported by a majority of veterinarians in the country who use the treatment to manage this potentially life-threatening disease in their patients.
“Cushings Disease is a truly horrible condition, affecting an increasing number of dogs. Without access to this critical API, we simply won’t be able to deliver what has proved to be a highly effective, safe and affordable treatment for the disease, which could result in the needless suffering of thousands of domestic animals.”
It also means that affected dogs could suffer additional complications, ultimately leading to a cruel death for canines with Cushings, a fairly common hormonal condition that affects the adrenal gland causing the over-production of cortisone, which eventually leads to full-blown organ failure. Dogs on the treatment manage to live healthy lives with very few complications but do need to remain on medication for the duration of their lives in order to do so.
“We fully believe that SAHPRA has mistakenly overstepped its mandate in this case, perhaps as a lack of understanding of the technicalities relating to the classification of Trilostane. The documentation we have received to date certainly indicates this is the case.
“We have been importing the substance for almost a decade and are firmly of the view that Trilostane belongs to a category of medicine that has never been called up for registration. Effectively, Trilostane is an anti-hormone, a unique substance that falls into a category that there is no classification for. To demand that the substance after all this time be regulated in such a haphazard way makes no sense. This is also against the backdrop that it is obviously not a scheduled substance but an API.”
Dr Oosthuyse adds that SAHPRA has also been attempting to regulate complementary medicines for the past 10 years without any success. “However, in that instance, at least they were forced into a public participation process.”
Since no response has been received to date, V-Tech has been left with no option other than to go to court to seek relief on behalf of the veterinary fraternity, and of course, in the public’s interest.
“This is not the first time we have had to resort to such a drastic measure with SAHPRA, and it is truly unfortunate that we have no other option other than this to make sure vets still have access to this vital treatment.”
In the absence of public sector commitment to deliver its legislative mandate, V-Tech, like many other companies in South Africa, is increasingly having to turn to the courts to seek remediation at the behest of the public and taxpayers.
“Our efforts have the full backing of the South African Veterinary Association, which represents over 1,800 registered veterinarians in the country.”
According to Dr Oosthuyse, V-Tech only has about a week’s worth supply of Trilostane available, and so is acting in the interest of the veterinary profession – and their canine patients. SAHPRA was alerted to the position and consequences well in advance but has chosen not to engage V-Tech in finding a solution for the problem SAHPRA incorrectly perceived to exist.
“This is by no means our most profitable product, but as a responsible and concerned organisation operating in the animal health industry, we see it as our constitutional duty to ensure this treatment continues to be freely available to vets and so we will take whatever action is deemed necessary to do so. We simply cannot stand by and see animals suffering pointlessly as a result of a blunder by SAHPRA.”
Dr Oosthuyse concluded that the inevitable question is whether regulatory authorities like SAHPRA properly apply their minds before imposing restrictions on private entities that can have devastating effects on society and industries. “The recent delay in action to vaccinate South African chicken flocks against Avian Influenza jumps to mind immediately.”
