No. 43/2007 The role of the state in establishing a public cord blood stem cell bank i

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1 No. 43/2007 The role of the state in establishing a public cord blood stem cell bank i By Professor Vernon Louw MMed MBChB (Stell), Int.Med (Stell), Certified Clinical Haematologist (Leuven, Belgium) Associate Professor and Head: Clinical Haematology, Department of Medicine, Faculty of Health Sciences, University of the Free State Professor Anthon du P Heyns MD, DSc, MCPath (SA) Consultant, Transfusion Medicine

2 Cord blood as a source of stem cells is rapidly changing the face of regenerative transplantation. 1 The voluntary donation of cord blood cells to public umbilical cord blood (UCB) banks resembling blood donation, is an example of a social justice health model that encompasses ethical citizenship and altruism. 2 Public UCB banks have indeed made van Rood s proposal of international transplant-sharing associations a reality. 3 Such allogeneic tissue networks, formed by linking international registries, are scientifically and ethically easier to justify than private UCB banks that store autologous stem cells for use only by the donor or a close relative. Public UCB banks also address the issues of inequitable access to stem cell transplantation caused by stem cell shortages, and the lack of genetic diversity of the stem cells in systems, such as the South African Bone Marrow Registry, that rely on voluntary peripheral blood stem cell donations. 4 The issue of providing facilities for the treatment of diseases with stem cells is however more complex than fulfilling a medical need. The view that the need for a public stem cell bank is a given, is flawed even if one accepts that many patients die because of a lack of stem cell transplant material. It is more fitting to regard a public UCB bank as an ideal. This view is persuasive considering that relatively few countries do have such facilities and that public UCB banks are almost universally confined to developed countries. 1 Accepting the pivotal role of the state as the regulatory authority, the other key question is the role and responsibility of the state to finance the start-up and maintenance costs of a public UCB bank. The cost of such a facility is considerable. It is estimated that the absolute minimum requirement to satisfy the needs of the South African public may be a public UCB bank with 10,000 cord blood units that represent the most common haplotypes mirroring the ethnic diversity of the population. Such a bank will equitably equalize the chances of access to a matched transplant. Although each country should analyze cost-benefit, 5,6 the cost for a usable banked cord blood unit is about R9,000; 7 this translates to R90 million for the establishment of a South African public UCB bank. The total cost of such a program becomes evident if one accepts the very optimistic estimate that the probability of using a banked unit will be 1% per year. 4 Extrapolating to a 10-year program the cost per unit will thus be at least R20,000. This capital outlay however in time will be recovered if the program keeps growing and the cord blood units are sold on a fee-for-service basis.

3 This high cost of establishing and maintaining a public UCB bank must be seen in the context of its actual and potential therapeutic usage. This again is complicated by the already very high overall medical costs of treating patients who may benefit from the addition of umbilical cord stem cell transplantation to their therapy. It is estimated that at this stage of development, about 1:100,000 of the population per year may gain from a regenerative transplant. Such a level of service however is not available in any country and at best only 50% of the needs for haemopoeietic cell transplantation are satisfied. 1 The general lack of cord blood as a source of stem cells has limited UCB transplants to about 8,000 worldwide to date, but this number is rising rapidly. The crux of the matter therefore is whether establishing a public UCB bank is a health priority in South Africa. The Bill of Rights 8 addresses the issue. Although all have the right to access to health care services, this is qualified by the statement that the state must take reasonable legislative and other measures, within its available resources, to achieve the progressive realization of such a right. The policy decisions on health priorities and how to spend the Rands available for health thus are not medical scientific issues but societal decisions. The National Health Act 9 recognizes this and although it broadly states which health issues should be addressed, the Act makes provision for the establishment of a National Health Council and a National Consultative Health Forum respectively to advise the Minister on policy concerning any matter that affects the health of the population, and to facilitate communication and interaction of stakeholders. It embraces policy, priorities and norms relating to the equitable provision and financing of health services and the responsibilities for health of the individuals and the public and private sector. Preventative medicine and providing basic health care to the population are the current priorities in South Africa. The state at this stage therefore would not consider a public UCB bank a priority. This is not an ethical issue, but a health priority issue in the face of economical constraints. Finally, is there a way forward? First, the state should recognize the growing importance of regenerative medicine and that it has a responsibility to play an active role to determine how this need can best be satisfied in the South African context. It is accepted that the state should regulate all cell banks, private and public, to ensure quality standards and ethical practices. The state should also recognize that the private sector should play an important role in establishing stem cell banks. Beyond

4 this role, the state, as part of good policy decision-making, should take the initiative and convene an appropriate forum to discuss what would be an appropriate policy in this regard, how a public UCB bank can possibly be funded, and to rank regenerative medicine as a health priority. Although the state could consider establishing and funding a public cord blood bank with no involvement from the private sector, this is unlikely to occur. Similarly, it is unlikely that the private sector will be willing to finance a public UCB bank. We believe that the state and the private sector should consider entering into a public-private initiative to establish and maintain a not-for-profit public UCB bank. The venture will be sustainable if the cord blood units are made available on a fee-for-service basis. Such a facility would benefit all South Africans and address the moral and ethical issues that relate to inequitable medical services, and the disparate donor/recipient availability of stem cells in this country. REFERENCES 1. Jain KK: Cell Therapy - Technologies, Markets and Companies (2007). A Jain PharmaBiotech Report. Accessed July 7, 2007 at 2. Titmuss RM: The gift relationship. The New Press, New York, NY, USA, Van Rood J: A proposal for international cooperation in organ transplantation: Eurotransplant; in Curtoni ES, Mattiuz PL, Tosi RM (eds): Histocompatibility Testing, p Copenhagen, Denmark, Munksgaard, Du Toit ED, Schlapoff TE, Wood L, Jacobs P: The South African Bone Marrow Registry (SABMR): a 10-year review Transfus Apher Sci 27:190-8, Howard DH, Maiers M, Kollman C, Logan B, Gragert L, Setterholm M: A cost benefit analysis of increasing cord blood inventory levels. On cord blood: Establishing a National Hernatopoietic Stem Cell Bank Program (2005) p Washington DC, USA, The National Academies Press 6. Health Council of the Netherlands. Ethical Aspects of Cost-utility Analysis. 4th Forum of National Ethics Councils in EU Countries, Amsterdam, 22 December Presentations and discussion. The Hague: Health Council of the Netherlands, 2005; publication no. A05/01 7. Querol S: Cord blood banking: ethical and cost-benefit aspects. ISBT Science Series (2007) 2, Constitution of the Republic of South Africa, 1996, Chapter 2, Bill of Rights. Accessed July 7, 2007 at 9. The National Health Act, 2004 (Act 61 of 2003). Government Gazette Vol 469, July 2004

5 i The views expressed in this paper are those of the author and do not necessarily reflect the views of the Centre for International Political Studies (CiPS) or the University of Pretoria