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