LITIGATION SUSPENDED

legislation

On 14 May 2014 the HPA took drastic action to protect the rights of the South African health products industry. The association served legal papers on the Minister of Health (MoH) and the Medicines Control Council (MCC) to challenge the CAMS Regulations and Guidelines published by the South African Department of Health (DoH) on 13 November 2013. These unconstitutional regulations had the potential to bring the industry to its knees. “The HPA was the ONLY association to take positive action to protect our industry, all its stakeholders, allied businesses and the consumer,” says HPA Chairman Norman Fels. Now, after protracted and costly legal interactions, the HPA has agreed to suspend litigation on condition that the DoH engages appropriately with industry to find a mutually acceptable compromise to resolve the current legislative challenges and ensure CAMS-appropriate Regulations and Guidelines. The HPA does, however, reserve the right to reinstate litigation if a mutual solution is not attained.

The original Regulations and Guidelines have been amended and comments to these were timeously submitted by the HPA and other stakeholders. Those who submitted were invited to give 30-minute presentations to the Complementary Medicines Council (CMC) – acting for the DoH – on 30 March 2015. The meetings were chaired by Professor Peter Eagles. In the HPA presentation, Fels pointed out that the most feasible and acceptable regulatory solution to the problem of CAMS regulations is the listing system, an alternative considered by the DoH, MCC and CAMS stakeholders in the 1990s. “The only time we were all happy and on the same page was in 1998, when the SAMMDRA Act was tabled – this was acceptable to all parties,” states Fels. “This structure envisaged a separate directorate for CAMS with its own Registrar and a fully empowered CMC. And then the wheels came off. Now we’re just fiddling around with semantics. Things are being made absurdly complex when they could be absolutely simple.”

Fels reiterates that the listing system is the only way to deal with the situation, especially if regulations are going to include commercially available African Traditional Medicine products. “The fact that the regulations have been republished indicates that government realises that they need to be amended, but to do this effectively and create a workable solution for all parties, government needs to consult with the CAMS industry. This is now happening and, as long as we make meaningful progress, we won’t put the gloves back on and resume litigation.”

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