December 2023 39 In a last minute attempt to avoid a disaster for around 6 000 dogs suffering from Cushing’s Disease, the South African Health Products Regulatory Authority (SAHPRA) and V-Tech this week agreed to cooperate and find practical ways of solving the unique problems faced by veterinarians in treating their animal patients. V-Tech is the largest provider of compounding services in South Africa, with satellite facilities in Namibia and Zambia, and currently offers over 800 different formulations of veterinary medicine to veterinarians. SAHPRA originally refused to release a recent shipment of Trilostane to V-Tech, which has been importing the substance for a decade, on the basis that this active pharmaceutical ingredient (API) was not contained in another registered medicine in South Africa. V-Tech maintained that Trilostane was never called up for registration and therefore certain provisions of the Medicines Act do not apply. V-Tech, in realising the potentially disastrous effect this ban could have for pets suffering from Cushing’s Disease, urgently approached the Court for interim relief to prevent animals from suffering needlessly. Dr Johan Oosthuyse, the CEO of V-Tech, and himself a veterinarian, said that the company is delighted to have reached an amicable agreement with SAHPRA on this matter. “The outcome of our negotiations has been productive and positive, with the CEO of SAHPRA, Dr Boitumelo Semete-Makokotlela, playing an instrumental role in reaching agreement to have the shipment released immediately. This is good news for both veterinarians and pet owners, as the medication we compound using Trilostane will now be available again.” He added that both parties have agreed to work together to find long-term solutions to the unique challenges faced by the South African veterinarian pharmaceutical industry, particularly in respect of certain medications. “We both recognise that we have a national asset in terms of the diverse animal species we have in South Africa, and that we need to ‘think out of the box’ to find workable solutions to finding effective and safe medicines to treat them in a responsible and safe way within the regulatory framework.” Dr Oosthuyse said that the support of and contribution by the South African Veterinary Association (SAVA), and more specifically, Mr Gert Steyn, had been invaluable in helping SAHPRA to realise this was an exceptional case, and in assisting the parties involved to arrive speedily at a satisfactory outcome. v Technical I Article V-Tech and SAHPRA reached agreement in Court to release Trilostane for the treatment of Cushing’s Disease Release for SAVA Vet News
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