SAMED submitted commented on the draft Public Procurement Bill as informed by the Market Access Committees, legal input, and member inputs. Some of the points made have been highlighted below:
- The South African Health Products Regulatory Authority (“SAHPRA”): Procurement policies and practices must align with that of the legislative and regulatory requirements for medical technology. Procurement officers in the institutions must be aware of the requirements on bidders emanating from the Act and SAHPRA, particularly bids for medical devices and technology. Bidders in the health sector must be compliant with the Act and SAHPRA as part of the criteria for qualification to bid.
- National Health Act 61 of 2003: The medical technology industry has a responsibility to ensure that those who buy or use their technology have the legal right to do so.
- Health Professions Act 56 of 1974: HPCs are prohibited from owning shares in a medical device company unless such company is a publicly listed company and there are also strict rules in the Health Professions Act that govern the relationship between HPCs and the medical device industry. These must be taken into consideration when procuring from medical technology companies. And the healthcare institutions and healthcare professionals working therein must have the skills and knowledge to check that these requirements are adhered to and form part of the criteria for qualification to bid.
- National Health Insurance Bill (NHI Bill): The procurement of health products (medicines and medical devices and technology) under this Bill must take into consideration the provisions of the NHI Bill and the two must be aligned for such procurement and ensure that there are no conflicts. SAMED expressed in its submission that the NHI Bill is not clear on how medical technology will be procured. SAMED has highlighted several points from our NHI submission.
- General Comment: The Bill aims to create a single regulatory framework and SAMED is in support of this initiative, but needs to be consolidated with care to not omit any requirements
- Best Practice: It is also recommended that the basis of procurement, especially of medical technology in South Africa, move away from a price-based procurement model to that of a value/outcome-based one and be structured to take into consideration all factors that impact procurement of medical technologies, and consider for example outcomes and life-cycle cost of delivery and services.
- Encourage Innovation: Procurement must include innovative products. The South African private sector is more open to innovation than the public sector, which is one of the causes of disparities between private and public healthcare. This must be improved upon in SA.
- Differentiation between medical technology and pharmaceutical products: How procuring authorities view and treat medical technology is very critical. It must be recognised that the terms of contracting medical technology will not be similar to those of procuring a pharmaceutical product. It is recommended that there be a separate contract and bid documents for medical devices that is customised for the specific purpose of procuring medical devices.
Download the SAMED submission here.