Joint Submission:

South African National Blood Service (SANBS) &

Natal Bioproducts Institute (NBI):

National Health Bill (B32 of 2003)

19 August 2003

Cape Town

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Joint Submission: SANBS & NBI

• Technical submission made jointly on behalf of SANBS and NBI– Prof. Anthon du P Heyns – CEO SANBS– Mr Duncan Armstrong –

Executive Director / Applicant NBI

• Duly authorised by the respective Board of Directors

• Ultimately representative of the Blood Donors of South Africa

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Support for a single blood transfusion licence• Safety

– Optimal procurement and use of safe blood – Unified testing system

• Quality – Standardised product quality, underpinned by policies

and procedures promotes product safety and efficacy.

• Sustainability – Economy of scale and resource sharing

• Availability – Optimal and equitable use of blood as a national

resource – Self-sufficiency of blood products – Self-sufficiency and quality of plasma for fractionation

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National Health Bill, 2003

“58(1) The Minister must establish a blood transfusion service by granting a license to a non-profit organisation, which is able to provide a blood transfusion service throughout the territory of the Republic”

(c) has the sole right to provide a blood transfusion and blood fractionation service in the Republic.”

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Introduction to SANBS and NBI

• Both SANBS and NBI ….– Have close governance and strategic links– Are registered and operate as Section 21 “not for

profit” companies– Are the largest providers of specialised blood

product services to both the public and private sectors:

• SANBS provides about 83% of all blood transfusion services in SA (exclusively in all provinces, except for Western Cape Province and a part of the Northern Cape Province).

• NBI is the largest fractionation centre in SA and the only one capable of providing a comprehensive national fractionation service

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SANBS and NBI Governance Relationship

NBI Board(Separate legal entity)directors nominated

by SANBS Board

Inland RegionBoard

M ajority of BloodDonors

East Coast RegionBoard

M ajority of BloodDonors

S A N B S B o ard12 non-Executive Donor Directors + 5 Executive Directors +

5 non-Executive "expert" directors (including NBI) +1 non-Executive DOH director nom inated by the Minister of Health

M in is te r o f Hea lthdelegates Blood Transfusion to

a not-for-profit organisation and issues asingle licence in terms of the National Health Bill

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SANBS and NBI Legislative Differences

S A N B S /N B I R e la tio n sh ip - D iag ra m atic R ep re sen ta tion

S A N B SL icen se d in te rm s o f

H U M A N T IS S U E A C T(N a tio na l H e a lth A c t)

S A N B SS e ctio n 21

"n o n p ro fit" Co m p a ny

S A N B SO rg an isa tion

S A N B S B O A R D

N B IL icen se d in te rm s o f

M e d icin e s A c t &P h a rm a cy A ct

N B IS e ctio n 21

"n o n p ro fit" Co m p a ny

N B IO rg an isa tion

N B I B o a rd

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Regulatory differences SANBS and NBI• External Regulation of SANBS and NBI are

different– SANBS

• Licensed Blood Transfusion Service• Human Tissue Act, No 65 of 1983 (currently)

– NBI• Licensed Pharmaceutical Manufacturing Company• Medicines and Related Substances Control Act, No 101 of

1965• Pharmacy Act, No 53 of 1974

• Legislative and operational differences form the basis for why blood transfusion and blood fractionation should not be regarded in the same manner

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DefinitionsBLOOD TRANSFUSION

BLOOD FRACTIONATION

- Source material: Donated Human Blood

- Source material: Human plasma (by-product)

- Testing, processing, storage and distribution

- Processing, testing, manufacture, and distribution (S4 medicines)

- Individual donations and small pool products (12 or less donations)

- Large pool products (greater than 12 and can be up to 15 000 donations or more)

- Known as BLOOD PRODUCTS

- Known as PLASMA DERIVED MEDICINAL PRODUCTS

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Recommendation

• The National Health Bill be amended to delete provisions that the national blood transfusion service have the sole right to provide blood fractionation services in the Republic.

• Specifically delete references to Blood fractionation service appearing in Sections 58(2)(c) and 58(3).

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Definition of “Blood Product”• In keeping with the aforementioned discussion

and specifically the distinction between products of a blood transfusion and blood fractionation service, it is also recommended that the definition of a blood product be amended as follows:“Blood product” means any product derived or produced from twelve or less human blood donations, including circulating progenitor cells, bone marrow progenitor cells and umbilical cord progenitor cells.(Underlined text denotes new text)

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Definition of “Blood Product”

Reasoning

This amendment will draw a clear distinction between blood products (made from 12 or less donations) and plasma derived medicinal products (greater than 12 donations).

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Conclusion• By means of a conclusion SANBS and NBI

would like to re-confirm that:– Fully support the objects and intent of the Bill wrt

creation of a single national blood transfusion service.

– SANBS is ideally poised to deliver on the expectations of this bill

– For reasons highlighted in this presentation we do believe, however, that the link between blood transfusion and blood fractionation services is unwarranted and unnecessary.

– The bill be amended as outlined in this submission– Avoid conflict in legislation.

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Conclusion

Thank you for your time.

We will be happy to answer any questions that you may have.