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SALDA Presentation to the Honourable Portfolio Committee on Health

SALDA Presentation to the Honourable Portfolio Committee on Health. Medicines and Related Substances Amendment Bill - 5 August 2008 -. What are we covering. SALDA IVD Definition Exploring the Lab Section 18 (A) to (C) of the Act International Tendering Similarities with other Countries

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SALDA Presentation to the Honourable Portfolio Committee on Health

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  1. SALDA Presentation to the Honourable Portfolio Committee on Health Medicines and Related Substances Amendment Bill - 5 August 2008 -

  2. What are we covering • SALDA • IVD • Definition • Exploring the Lab • Section 18 (A) to (C) of the Act • International Tendering • Similarities with other Countries • Proposals

  3. What is SALDA • The South African Laboratory Diagnostics Association • Represents >90 % of the In Vitro Diagnostic(IVD) or laboratory diagnostic industry • Associate member of SAMED, as IVD is defined as a medical device • Support regulation of our industry to ensure quality healthcare to the South African patient SALDA wants a framework to be established by the Act which will ensure effective regulation, in the interest of patient safety and quality

  4. “Product” Part 1: “Products” “medicine” “foodstuff” & “cosmetics” “device”

  5. How does IVD add value to healthcare provision?

  6. SALDA proposal on the insertion of a definition of IVD in the 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. This includes reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles (refer GHTF). (for more detail, refer our submission)

  7. The IVD Value Chain Manufacturer Laboratory Doctor Patient R&D Manufacturing Marketing Sales Service Training Repairs Process blood samples -> Report on Result E.g. HIV,Chol Interpret Blood result -> Clinical Decision Treatment Treatment Life style Monitoring Instrument (Capex) / Analyser + Reagent+ Service+ Interpretation= Blood Result

  8. Maintenance, etc (surveillance) Clinical Engineer IVD Value Chain different from … Medical Technologist (“user”) Pathologist Patient’s Doctor Patient Manufacturer Laboratory … Medicine Value Chain Patient’s Doctor Surveillance (adverse reactions, etc) Manufacturer Wholesaler Pharmacist Patient (“user”) Medicine

  9. “Product” Part 2: “Legislative Proposals” “medicine” “foodstuff” & “cosmetics” “device”

  10. The importance of risk classification e.g. Blood Grouping is a high risk to patient unless done by qualified personnel.

  11. Implications of international tendering for this device?

  12. “Fourth hurdle” • = barrier to market entry on non-scientific grounds • Why getting market access is important • the development of appropriate healthcare solutions, • the development of science and technology, and • creating appropriate technical skills on the use of the device, and similar devices, for South Africa. What would have happened if the 1st HIV tests were not allowed to be sold in SA

  13. Bonusing, sampling, rebates: Certain practices enhance access & quality and should be allowed

  14. Bonusing, sampling, rebates: Certain practices enhance access & quality and should be allowed • Cross-merchandising agreements (e.g photo copier & cell phone contracts) • Instrument & product evaluation • Warranties • Pro bono provision • Transparency in economies of scale SOLUTION: s18A&B to refer to regulations to define acceptable practices, and outlaw unacceptable practices S18C: SALDA has a Code of Ethics which could be issued in terms of this section

  15. Medicine ≠ devices Medicines bill has several requirements that are not appropriate to IVD’s • Cannot sample this device before registration • Cannot accommodate labeling on immediate outer container of this device • No package inserts, but user manuals, etc • This device has no therapeutic efficacy • No pharmacist, but medical technologists, pathologists, engineers, etc

  16. What are other countries doing? Most countries have separate sections, chapters or Acts for devices and IVDs

  17. What must be empowered in an Act?

  18. SALDA proposal Proposal 1: • Alignment with global trends in emerging and mature regulatory authorities • Delete the word “medical device” from product definition • Insert proposed definition of medical device and IVD into definition section • New chapter/section created for Medical devices and IVD in Act • Capture the nuances of the industry • Prevent loopholes • Ensure effective implementation structure Proposal 2: Alternative: • specific wording changes to make Act implementable and effective – refer Annexure B of submission

  19. Thank you for your time Chairman: Mr H. Rootman. hennie@pathteq-qpl.co.za (011) 314-0048

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