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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• Proposals
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
“Product”
“medicine”
“device”
“foodstuff” & “cosmetics”
Part 1: “Products”
How does IVD add value to healthcare provision?
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)
The IVD Value Chain
ManufacturerManufacturer LaboratoryLaboratory DoctorDoctor PatientPatient
R&DManufacturing
MarketingSales
ServiceTrainingRepairs
R&DManufacturing
MarketingSales
ServiceTrainingRepairs
Process blood samples ->Report on
ResultE.g.
HIV,Chol
Process blood samples ->Report on
ResultE.g.
HIV,Chol
InterpretBlood result
->Clinical Decision
Treatment
InterpretBlood result
->Clinical Decision
Treatment
TreatmentLife style
Monitoring
TreatmentLife style
Monitoring
Instrument (Capex) / Analyser + Reagent+ Service+ Interpretation= Blood Result Instrument (Capex) / Analyser + Reagent+ Service+ Interpretation= Blood Result
LaboratoryLaboratory
Patient’s Doctor
Patient’s Doctor PatientPatientPathologistPathologist
Medical Technologist
(“user”)
Medical Technologist
(“user”)
ManufacturerManufacturer WholesalerWholesaler PharmacistPharmacist
Patient’s Doctor
Patient’s Doctor
Patient (“user”)Patient (“user”) MedicineMedicine
Surveillance (adverse
reactions, etc)
Surveillance (adverse
reactions, etc)
IVD Value Chain different from …IVD Value Chain different from …
… Medicine Value Chain… Medicine Value Chain
ManufacturerManufacturer
Maintenance, etc
(surveillance)
Maintenance, etc
(surveillance)Clinical Engineer
“Product”
“medicine”
“device”
“foodstuff” & “cosmetics”
Part 2: “Legislative Proposals”
The importance of risk classification
e.g. Blood Grouping is a high risk to patient unless done by qualified personnel.
Implications of international tendering for this device?
“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
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
Bonusing, sampling, rebates: Certain practices enhance access & quality and should be allowed
Medicine ≠ devicesMedicines 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
What are other countries doing?
Most countries have separate sections,
chapters or Acts for devices and IVDs
What must be empowered in an Act?
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
Thank you for your time
Chairman: Mr H. Rootman. hennie@pathteq-qpl.co.za (011) 314-0048
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