Joint Submission: South African National Blood Service (SANBS)

1
Joint Submission South African National Blood
Service (SANBS) Natal Bioproducts Institute
(NBI) National Health Bill (B32 of 2003)

• 19 August 2003
• Cape Town

2
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

3
Agenda

• Submission
• Introduction to SANBS and NBI
• Relationship
• External Regulatory Differences
• Blood Transfusion vs Blood Fractionation Services
• Definitions
• Areas of Concern
• Recommendation
• Blood Products
• Proposed Definition Amendment
• Reasoning
• Conclusion

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Submission

• SANBS and NBI
• Fully support the objects of the bill
• Specifically support the provisions of Chapter 8
  relating to the control of the use of tissue,
  blood, blood products and gametes in humans
• Support the establishment of a single licensed
  Blood Transfusion Service for RSA
• Concern
• Link seemingly established between blood
  transfusion and blood fractionation services is
  unwarranted and should be removed (section 58 of
  the bill)
• Object of this presentation is to explain our
  concern and request consideration for an
  amendment.

5

• 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

6
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
9
SANBS and NBI Legislative Differences
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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

11
Definitions
12
Areas of concern

• Plasma
• National self sufficiency
• Significant progress, unfortunately not yet
  achieved
• Vulnerable in key therapeutic areas (cryo)
• Patient needs has the highest priority
• Pharmacy Act
• Scheduled medicines
• Who may buy and/or sell/dispense medicines
• Blood transfusion services are not licensed in
  terms of this Act
• Potential conflict in legislation

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Areas of concern (Continued)

• Plasma Pools
• Size
• Individual/small pools (12 or less donations) vs
  large pools (gt12 donations)
• Role of MCC inspectorate in verifying compliance
  with cGMP
• Pharmaceutical companies (other than NBI)
• Licensed to sell plasma-derived medicines
• Future of the products offered by these companies
• Licensed in terms of the Pharmacy Act and the
  Medicines and Related Substances Control Act

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Recommendation

• BEARING IN MIND
• That the manufacture, sale and distribution of
  plasma derived medicinal products are regulated
  as Schedule 4 medicines
• That the provision of plasma products is not only
  restricted to fractionation centres such as NBI,
  but also to commercial pharmaceutical companies
  who import and sell these products and that
• Blood Tranfusion would have to be licensed and
  comply with stipulations of existing medicine
  legislation before it can be legally permitted to
  manufacture, buy and/or sell S4 medicines.
• IT IS OUR RECOMMENDATION THAT.

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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.