While SAMED is grateful for the three-year extension of the exemption of the medical devices from the provisions of 18A & 18B of the Medicines and Related Substances Act, we continue the advocacy we started prior to the granted exemption. We have approached the South African Health Products Regulatory Authority (SAHPRA) to gain an understanding of what their and the pricing committee’s plans and timelines are to finalise regulations pertaining to 18A & 18B of the Act.
SAMED proposed that, prior to finalising 18A & 18B draft regulations, consideration be given to allow for further comment and a phasing in of regulations to allow for industry to adjust and re-negotiate contracts already in place i.e. there should be at least a six month window period allowed for industry to comply. SAMED has previously submitted comments on the draft regulations where we indicated our support for the overarching objective and intent of 18A and B and the draft regulations i.e. to prevent perverse activities and ensure affordable medical devices and IVDs.
It is essential to SAMED that the exemption period granted to be used in a constructive way and leave sufficient time for industry to implement changes and adhere to any finalised regulations on the matter.