Over the last several months, SAMED has been advocating for the extension of the exemption for medical devices from sections 18A and 18 B within the Medicines and Related Substances Act. These sections pertain to the supply of medical devices and IVDs according to a bonus system, rebate system and other incentive schemes and sampling of medical devices and IVDs.
We have been acutely aware of the risk the expiry posed to the sustainability of our members and the need for certainty to remain compliant with the law. We took these concerns very seriously and SAMED has extensively campaigned on behalf of members for exemption extension beyond the 31 December 2021 expiry. Through our Code Committee, SAMED approached the Pricing Committee, then the National Department of Health and finally the South African Health Products Regulatory Authority (SAHPRA) on why the medtech sector should be exempt from the 18A & B provisions, including the impact that a failure to do so would have on the sustainability of medical technology suppliers and providers.
As your association, it was vital for us to work to resolve this matter on your behalf and we are pleased to announce that the exemption has been issued for another three year period ending 17 December 2024. Members are still bound to all clauses of the Medical Device Code of Ethical Marketing and Business Practice.
SAMED supports the prohibition of:
- Regulation 5(a) a discount in respect of rebates only and these should be differentiated from discounts. Rebates reward the user after utilization at a certain rate, volume or value and therefore influences the behaviour of users in anticipation of a reward. And this results in perversity and non-transparent transactions.
- Regulation 5(b) payment for marketing, promotion, and advertising
- Regulation 5(c) fees for shelf space
- Regulation 5(e) loyalty fees or similar fees.
- Regulation 5(f) director’s fees etc
- Regulation 5(g) entertainment costs, meals and disbursements etc.
- Regulation 5(h)&(i) payment or contribution by a supplier towards any recurring expenditure etc
- Regulation 5(k) unjustified credit payments which have the effect of an inducement.
- Regulation 5(l) formulary and protocol listing payments to any customer or any person who is able to influence such a listing
Section 18A(2) provides that the Minister may provide acceptable and prohibited acts. The minister has only provided prohibited acts. The industry may interpret this to mean that anything that is not prohibited under the draft regulations is automatically acceptable by virtue of such exclusion. In order to avoid such a situation, SAMED proposes that the Minister prescribes acceptable acts.
SAMED supports acceptable acts framed within the context of bringing value to the patient/patient care and should be free of perversity and non-transparent transactions. Acceptable acts could include volume discounts, settlement discounts, donations, sampling and demonstration products, placement of equipment, including consignment stock and loan sets, devices in a retail setting and data and registry fees (suppliers support registries by contributing to cost thereof and in return access learnings and information. Data is used to support coverage, reimbursement, and value analysis).
As always, SAMED will keep a watching brief on this and will take up any further calls to action should the need arise.