SALDA Presentation to the Honourable Portfolio Committee

on Health

National Health ActAmendment Bill B25 -2011

13 March 2012

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

How does IVD add value to healthcare provision?

Patient

HCP orders testLaboratory tests sample

Pathologist analyses results

HCP receive report & makes therapeutic

recommendation

How does IVD add value to healthcare provision?

Patient

HCP provides self-test / done by HCPs

HCP makes therapeutic

recommendation

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))

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)

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

QM and QA already part ofthe 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/ sample

result->

Clinical Decision

Treatment

InterpretBlood/ sample

result->

Clinical Decision

Treatment

TreatmentLife style

Monitoring

TreatmentLife style

Monitoring

QM and QA mandates by other legislation

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

HazardousSubstances Act

(CE-mark required, i.e. ISO 13485)Act 72 of 2008 (IVD licensing &

registration on quality, safety,

performance)

HazardousSubstances 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 andCompetence);

duties of users ito Act 72;

NHLS Act

Standards Act (SANAS:

ISO 15189 – Medical

Laboratories Requirements for

Quality andCompetence);

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

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)

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)

Thank you for your time!

You are welcome to contact SALDA for more information:

Chairperson: Mr Greg Northfield. greg@sepsci.co.za (011) 794-4117Vice chairperson: Dr Terence Moodley terence.moodley@roche.com (011) 504-4600Executive Officer: exec@salda.org.za 0829018715