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. 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. 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

4. 4 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. 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. 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.”

7. 7 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

8. 8 SANBS and NBI Governance Relationship

9. 9 SANBS and NBI Legislative Differences

10. 10 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. 11 Definitions

12. 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

13. 13 Plasma Pools –Size Individual/small pools (12 or less donations) vs large pools (>12 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 Areas of concern (Continued)

14. 14 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….

15. 15 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).

16. 16 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)

17. 17 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).

18. 18 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.

19. 19 Conclusion Thank you for your time. We will be happy to answer any questions that you may have.