1. SALDA Presentation to the Honourable Portfolio Committee on Health National Health Act Amendment Bill B25 -2011 13 March 2012

2. Who is SALDA The South African Laboratory Diagnostics Association Represents >90 % of the In Vitro Diagnostic or laboratory diagnostic industry Associate member of SAMED as IVD are defined as a medical device Promotes the field of IVD in the health sector and broader business community SALDA supports a quality framework that is truly independent and that does not duplicate recognised, existing quality systems

3. How does IVD add value to healthcare provision? Patient HCP orders test Laboratory tests sample Pathologist analyses results HCP receive report & makes therapeutic recommendation

4. How does IVD add value to healthcare provision? Patient HCP provides self- test / done by HCPs HCP makes therapeutic recommendation

5. Definition of IVD in the Medicines Act In vitro diagnostic medical device means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes. (as per Act 72 of 2008 (Amendment Act to Medicines and Related Substances Act No 101 of 1965))

6. Clause 79(1)(f) “quality assurance and quality management systems in the health sector” The manner in which this is phrased is likely to lead to duplication, and possibly conflicting standards and assessments being made It applies to the “health sector” and not only “health establishments” (hospitals, practices), this means that the mandate of the South African Health products Regulatory Authority (Act 72) is brought within the ambit of the OHSC SALDA recognises that this is not the intent, propose re-word (see submission)

7. What does Quality Management (QM) and Quality Assurance (QA) mean within IVD sector? QA is a PART of QM “QA is a set of activities intended to establish confidence that quality requirements will be met” “QM includes all the activities that organisations use to direct, control and coordinate quality. These activities include formulating a quality policy, setting quality objectives, quality planning, quality control, quality assurance and quality improvement” Source: ISO 9000 “Definitions” 2012

8. QM and QA already part of the IVD Value Chain Manufacturer Laboratory Doctor Patient R&D Manufacturing Marketing Sales Service Training Repairs R&D Manufacturing Marketing Sales Service Training Repairs Process blood samples -> Report on Result E.g. HIV,Chol Process blood samples -> Report on Result E.g. HIV,Chol Interpret Blood/ sample result -> Clinical Decision Treatment Interpret Blood/ sample result -> Clinical Decision Treatment Life style Monitoring Treatment Life style Monitoring

9. QM and QA mandates by other legislation Manufacturer Laboratory Doctor Patient R&D Manufacturing Marketing Sales Service Training Repairs R&D Manufacturing Marketing Sales Service Training Repairs Process blood samples -> Report on Result E.g. HIV,Chol Process blood samples -> Report on Result E.g. HIV,Chol Interpret Blood result -> Clinical Decision Treatment Interpret Blood result -> Clinical Decision Treatment Life style Monitoring Treatment Life style Monitoring Hazardous Substances Act (CE-mark required, i.e. ISO 13485) Act 72 of 2008 (IVD licensing & registration on quality, safety, performance) Hazardous Substances Act (CE-mark required, i.e. ISO 13485) Act 72 of 2008 (IVD licensing & registration on quality, safety, performance) Standards Act (SANAS: ISO 15189 – Medical Laboratories Requirements for Quality and Competence); duties of users ito Act 72; NHLS Act Standards Act (SANAS: ISO 15189 – Medical Laboratories Requirements for Quality and Competence); duties of users ito Act 72; NHLS Act Health Professions Act (scope of practice & ethical rules) Health Professions Act (scope of practice & ethical rules) OHSC: clearly delineated role on quality here CPA (consumers); Patient Rights Charter CPA (consumers); Patient Rights Charter

10. What are other countries doing? Internationally, quality bodies are totally independent from government organs –Although the intention is to create an independent body, the legislative provisions do not support such independence Standards are published for comment (prevents overlaps) and developed by experts Standards must be implemented and becomes an audit – no process and timelines as set internationally. SALDA recommends regulations to be mandated by clause 82A on this aspect) (See SALDA submission on country examples)

11. Other issues Objectives of the OHSC (clause 78) only includes “monitoring” but OHSC would accredit and enforce! Construct of OHSC similar to current MCC (i.e. juristic person and subject to PFMA), but does NOT guarantee that fees could be retained –OHSC must be a Schedule 3 PFMA entity, which normally requires a Board or similar oversight structure (e.g. CMS, SETA’s etc)

12. Thank you for your time! You are welcome to contact SALDA for more information: Chairperson: Mr Greg Northfield. greg@sepsci.co.za (011) 794-4117 Vice chairperson: Dr Terence Moodley terence.moodley@roche.com (011) 504- 4600 Executive Officer: exec@salda.org.za 0829018715greg@sepsci.co.zaterence.moodley@roche.comexec@salda.org.za