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Cord Blood Regulations by Nationality
Please skip to the region or country of interest (in alphabetical order):
Cord blood banking started in the United States, but is rapidly being adopted all over the world. However, the legal status of cord blood can vary enormously from one country to another.
Cord blood banking started in the United States, but is rapidly being adopted all over the world. However, the legal status of cord blood can vary enormously from one country to another.
- In the United States, blood and organs are regulated differently; a blood donation can be sold, whereas an organ donation cannot be sold.
- In the European Union, all body parts are regulated the same way, and none can be sold.
- In some countries, the government can confiscate unused body parts, such as post-birth placentas, and use them for research or sell them.
next step...
NORTH & SOUTH AMERICA
Brazil -- background on social structure
The following paragraph of information about health care in Brazil is taken from a March 2004 interview with Carmem Bonfim, who is a transplant physician with the Stem Cell Transplantation Service in Curitiba, Brazil, and has a special interest in children with immunodeficiencies:
Brazil is a large country with a population of 166 million and a birthrate of 3 million per year. Despite its natural beauties, well-known throughout the world, it is also a country with a high level of inequality. In Brazil, the top 10% of the population has almost 50% of the national income, while the bottom 50% gets a little more than 10%. According to the United Nations, the Human Development Index for Brazil (position 73) lags behind that of high-income countries and some countries of East-Asia, but it is slightly higher than that of the Middle-East and considerably greater than most of South-Asia. The public health system is not well organized and it is very difficult for a poor patient with a rare and ‘expensive' disease to be able to get treatment. On the one side, there are extremely specialized medical centers, where a patient can find everything he or she might need, but on the other side, there are doctors working without any equipment or medicine.
The cost of medication is out of reach for many cancer patients in Brazil. Following the election of President Lula da Silva, government officials attempted to slow down or freeze the rising cost of drugs. Law 10.752 of October 2003 created a new pricing agency called CMED, under the auspices of Anvisa (Agencia Nacional de Vigilancia Sanitaria , or National Health Safety Monitoring Agency, the Brazil equivalent of teh USA FDA). For those drugs which are included in the regulated list, CMED determines price rises using a combination of the official consumer price index and indices of production within the pharmaceuticals sector, relative to overall industrial output. In theory, CMED has the authority to decide which drugs are included within its annual price adjustments, potentially allowing the government some control over drug prices. In practice, many cancer drugs are still imported and not affordable to the typical citizen.
An example of an imported drug which is marketed direct to patients is the "Patient Assistance Program" (PAP) for Brazilians taking the cancer drug Glivec (Gleevec in the USA) manufactured by Novartis. The national health system of Brazil (Sistema Unica de Saude or SUS) included Glivec in its formulary at a 2004 priceof $25 USD per 100mg capsule. However, Glivec is frequently not available through the SUS.
Reference:
Jan2005 Healthy Skepticism International News 23:1: New Definition of "Patient Assistance Program" in Brazil, by Joana Ramos, MSW
There are grass-roots charities helping patients in Brazil. The most well-known is SLIBA, founded by Jorge Araujo in memory of his son Bernardo, who died of leukemia in 1998. Another is Casa Hope (Hope House) in São Paulo, whicih is like the American Ronald McDonald House Charities.
The following paragraph of information about health care in Brazil is taken from a March 2004 interview with Carmem Bonfim, who is a transplant physician with the Stem Cell Transplantation Service in Curitiba, Brazil, and has a special interest in children with immunodeficiencies:
Brazil is a large country with a population of 166 million and a birthrate of 3 million per year. Despite its natural beauties, well-known throughout the world, it is also a country with a high level of inequality. In Brazil, the top 10% of the population has almost 50% of the national income, while the bottom 50% gets a little more than 10%. According to the United Nations, the Human Development Index for Brazil (position 73) lags behind that of high-income countries and some countries of East-Asia, but it is slightly higher than that of the Middle-East and considerably greater than most of South-Asia. The public health system is not well organized and it is very difficult for a poor patient with a rare and ‘expensive' disease to be able to get treatment. On the one side, there are extremely specialized medical centers, where a patient can find everything he or she might need, but on the other side, there are doctors working without any equipment or medicine.
The cost of medication is out of reach for many cancer patients in Brazil. Following the election of President Lula da Silva, government officials attempted to slow down or freeze the rising cost of drugs. Law 10.752 of October 2003 created a new pricing agency called CMED, under the auspices of Anvisa (Agencia Nacional de Vigilancia Sanitaria , or National Health Safety Monitoring Agency, the Brazil equivalent of teh USA FDA). For those drugs which are included in the regulated list, CMED determines price rises using a combination of the official consumer price index and indices of production within the pharmaceuticals sector, relative to overall industrial output. In theory, CMED has the authority to decide which drugs are included within its annual price adjustments, potentially allowing the government some control over drug prices. In practice, many cancer drugs are still imported and not affordable to the typical citizen.
An example of an imported drug which is marketed direct to patients is the "Patient Assistance Program" (PAP) for Brazilians taking the cancer drug Glivec (Gleevec in the USA) manufactured by Novartis. The national health system of Brazil (Sistema Unica de Saude or SUS) included Glivec in its formulary at a 2004 priceof $25 USD per 100mg capsule. However, Glivec is frequently not available through the SUS.
Reference:
Jan2005 Healthy Skepticism International News 23:1: New Definition of "Patient Assistance Program" in Brazil, by Joana Ramos, MSW
There are grass-roots charities helping patients in Brazil. The most well-known is SLIBA, founded by Jorge Araujo in memory of his son Bernardo, who died of leukemia in 1998. Another is Casa Hope (Hope House) in São Paulo, whicih is like the American Ronald McDonald House Charities.
Brazil's cancer institute "INCA"
In January 2004, a political patronage scandal rocked Brazil's national cancer institute, "Instituto Nacional de Cancer" ( INCA ), in Rio de Janeiro: Dr. Daniel Tabak, a renowned oncologist who had been director of the BMT service (CEMO) at INCA for the past 16 years, resigned in protest over instances of political patronage that he says have damaged the operations of the program. He has been complaining of problems at INCA since mid-2003, when Pres. Lula's Health Minister Humberto Costa appointed a non-oncologist to run INCA. Six months ago, this director appointed one of his relatives, who is married to a prominent Rio politician, to run INCA's hospital. According to Dr. Tabak, due to the inexperience of the hospital director, the hospital was thrown into total chaos, has run out of many medicines, and is not able to treat patients properly.
Mostly recently, there is evidence that in at least two cases, politicians used their influence to arrange for constituents to receive bone marrow transplants from unrelated donors, paid for by INCA, ahead of the other 2300+ patients who are waiting their turn to receive treatments. There is also concern that in one of these cases, a hospital in Recife got credentialed to perform such transplants as part of the political favor.
Counter charges were leveled against Tabak for having a conflict of interest by also engaging in private business. This is quite common for physicians in Brazil, because they earn very little income from working in the public sector. Dr. Tabak's other interests include: his private oncology practice, a company offering chemotherapy, and the company "Stemcell Transplantes de Medula", which was to offer patients autologous transplants, but has not been operational. Dr. Tabak maintains that the real issues are insufficient funding and poor management of the total cancer program.
Brazil's Senate will be investigating the above scandals. Meanwhile, Dr. Luiz Fernando Bouzas, the founder of Brazil's first public cord blood bank, has been appointed to replace Dr. Tabak as head of INCA. Dr. Bouzas was a partner with Dr. Tabak in the company Stemcell Transplantes de Medula, but severed those ties two years ago.
Credit for translating Portugese news reports: Joana Ramos, MSW, Cancer Resources & Advocacy
References:
Brazil bone marrow registries
Brazil has long had a desperate need to increase sources of stem cells for transplants. According to the charity SLIBA, 70% of patients cannot find a matching bone marrow donor. The SLIBA website is an excellent source of information on stem cell banks operating in Brazil and regulations pertaining to bone marrow (Medula Óssea) or cord blood (Cordão Umbilical). The national bone marrow registry REDOME ("Registro Nacional de Doadores de Medula Óssea") relies primarily on agreements to search other international registries.
In 2000, The Max Foundation of USA won Betinho prize money from the International Development Research Center (IDRC) in Canada for the express purpose of establishing a bone marrow registry in Brazil. It was named "VidaMax" (website since removed). However, the HLA types of the donors were never released, so in effect there was no registry. This was reported in a NYTimes expose about The Max Foundation.
Finally, in Oct. 2004 the German Registry of bone marrow donors, DKMS, began sponsoring a bone marrow registry in Brazil called MEDULA. The website for MEDULA is hosted by ABRALE, the the Brazilian Leukemia & Lymphoma Association. This is not unusual, as DKMS also operates in the USA as DKMSamericas.
Brazil cord blood banking
The first public cord blood bank in Brazil was founded in 2002. As reported by LF Bouzas et al. at the 2003 meeting of the International Society for Cellular Therapy:
On 18 July 2003, the "Agência Nacional de Vigilância Sanitária" passed Legislação Resolução -- RDC nº 190 which defines responsibilities and obligations for cord blood banks.
In Sept 2004, establishment of a public cord blood banking network in São Paulo state was announced in by Agência Estado "SÃO PAULO RECEBE REDE PÚBLICA DE CORDÃO UMBILICAL". "São Paulo state now has a public cord blood bank. With the name of "Redecord" (cord network), it comprises a partnership between the Faculdade de Medicina de Ribeirão Preto (RP Medical School), the Universidade Estadual de Campinas (Unicamp), and one private sector institution, the Hospital Albert Einstein." The article on Redecord goes on to say that Redecord will be the largest branch of Brasilcord. "Our goal is to have 12 thousand blood samples within 5 years, according to Carlos Alberto Morera Filho, director of the Albert Einstein Teaching and Research Institute." (Translation credit to Joana Ramos, MSW). The number 12,000 seems shockingly low to cover the needs of patients in a country as large and ethnically diverse as Brazil. In testimony before the US congress, Pablo Rubinstein, M.D., of the NY Cord Blood Center (member NETCORD) proposed that 150,000 cord blood units are needed to cover the United States.
Expansion of the public cord blood network was announced in Oct 2005 by Dr. L.F. Bouzas. He said the public system of cord blood banks will add two more banks in early 2006, located in Ribeirão Preto and Campinas, both in the interior of the state of São Paulo. Bouzas pointed out that since Sept 2004 in Brazil, more than half of the stem cell transplants from unrelated donors used cord blood, but 90% of the transplanted cord blood had to be imported. Economically, it makes sense to develop a native supply: The current cost of an imported stem cell unit is around US$ 30 thousand, equivalent to R$ 70 thousand. Whereas in Brazil, the cost of freezing a unit is US$ 1.5 thousand - approximately R$ 3.5 thousand. According to Dr. Bouzas, the average cost of creating a public cord blood bank in Brazil, from the planning stage (construction and equipment) to full operation, comes to US$ 666.34 thousand (R$ 1.5 million).
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In January 2004, a political patronage scandal rocked Brazil's national cancer institute, "Instituto Nacional de Cancer" ( INCA ), in Rio de Janeiro: Dr. Daniel Tabak, a renowned oncologist who had been director of the BMT service (CEMO) at INCA for the past 16 years, resigned in protest over instances of political patronage that he says have damaged the operations of the program. He has been complaining of problems at INCA since mid-2003, when Pres. Lula's Health Minister Humberto Costa appointed a non-oncologist to run INCA. Six months ago, this director appointed one of his relatives, who is married to a prominent Rio politician, to run INCA's hospital. According to Dr. Tabak, due to the inexperience of the hospital director, the hospital was thrown into total chaos, has run out of many medicines, and is not able to treat patients properly.
Mostly recently, there is evidence that in at least two cases, politicians used their influence to arrange for constituents to receive bone marrow transplants from unrelated donors, paid for by INCA, ahead of the other 2300+ patients who are waiting their turn to receive treatments. There is also concern that in one of these cases, a hospital in Recife got credentialed to perform such transplants as part of the political favor.
Counter charges were leveled against Tabak for having a conflict of interest by also engaging in private business. This is quite common for physicians in Brazil, because they earn very little income from working in the public sector. Dr. Tabak's other interests include: his private oncology practice, a company offering chemotherapy, and the company "Stemcell Transplantes de Medula", which was to offer patients autologous transplants, but has not been operational. Dr. Tabak maintains that the real issues are insufficient funding and poor management of the total cancer program.
Brazil's Senate will be investigating the above scandals. Meanwhile, Dr. Luiz Fernando Bouzas, the founder of Brazil's first public cord blood bank, has been appointed to replace Dr. Tabak as head of INCA. Dr. Bouzas was a partner with Dr. Tabak in the company Stemcell Transplantes de Medula, but severed those ties two years ago.
Credit for translating Portugese news reports: Joana Ramos, MSW, Cancer Resources & Advocacy
References:
- 20Jan2004 JB online: Médico relata pressões políticas
- 20Jan2004 JB online: Repreensão em Brasília
- 20Jan2004 JB online: Crise no Inca começou há seis meses
- 21Jan2004 JB online: Sucessor de Tabak é sócio em empresa
- 19Jan2004 CruzeiroNet Brasil: Políticos podem estar furando a fila no Centro de Transplante de Medula Óssea
- Jan2004 Agencia Senado: Lúcia Vânia propõe convocação de Humberto Costa para explicar caso Inca
Brazil bone marrow registries
Brazil has long had a desperate need to increase sources of stem cells for transplants. According to the charity SLIBA, 70% of patients cannot find a matching bone marrow donor. The SLIBA website is an excellent source of information on stem cell banks operating in Brazil and regulations pertaining to bone marrow (Medula Óssea) or cord blood (Cordão Umbilical). The national bone marrow registry REDOME ("Registro Nacional de Doadores de Medula Óssea") relies primarily on agreements to search other international registries.
In 2000, The Max Foundation of USA won Betinho prize money from the International Development Research Center (IDRC) in Canada for the express purpose of establishing a bone marrow registry in Brazil. It was named "VidaMax" (website since removed). However, the HLA types of the donors were never released, so in effect there was no registry. This was reported in a NYTimes expose about The Max Foundation.
Finally, in Oct. 2004 the German Registry of bone marrow donors, DKMS, began sponsoring a bone marrow registry in Brazil called MEDULA. The website for MEDULA is hosted by ABRALE, the the Brazilian Leukemia & Lymphoma Association. This is not unusual, as DKMS also operates in the USA as DKMSamericas.
Brazil cord blood banking
The first public cord blood bank in Brazil was founded in 2002. As reported by LF Bouzas et al. at the 2003 meeting of the International Society for Cellular Therapy:
- "The CBB-INCA (National Cancer Institute – Brazil) program is a initiative of Brazilian Government designed to reduce the time for donor search, to minimize the difficulty of finding a donor and to keep the investment efforts in the country. It was established in Feb 2001 as the first CBB program in Brazil and the center of a Brazilian Net of CBB to be developed in the future. The collection activity started in May/2002 and 173 units (15 used for standardization) were collected till Feb/2003, 614 mothers were interviewed. Collection is performed at one specialized maternity hospital in Rio de Janeiro, with about 40 births a day, by a dedicated CBB staff after delivery of the placenta.... Donations are typed for HLA-A, B and DR at medium resolution level and the units are included in the Brazilian Bone Marrow Volunteer Donor registry database."
On 18 July 2003, the "Agência Nacional de Vigilância Sanitária" passed Legislação Resolução -- RDC nº 190 which defines responsibilities and obligations for cord blood banks.
In Sept 2004, establishment of a public cord blood banking network in São Paulo state was announced in by Agência Estado "SÃO PAULO RECEBE REDE PÚBLICA DE CORDÃO UMBILICAL". "São Paulo state now has a public cord blood bank. With the name of "Redecord" (cord network), it comprises a partnership between the Faculdade de Medicina de Ribeirão Preto (RP Medical School), the Universidade Estadual de Campinas (Unicamp), and one private sector institution, the Hospital Albert Einstein." The article on Redecord goes on to say that Redecord will be the largest branch of Brasilcord. "Our goal is to have 12 thousand blood samples within 5 years, according to Carlos Alberto Morera Filho, director of the Albert Einstein Teaching and Research Institute." (Translation credit to Joana Ramos, MSW). The number 12,000 seems shockingly low to cover the needs of patients in a country as large and ethnically diverse as Brazil. In testimony before the US congress, Pablo Rubinstein, M.D., of the NY Cord Blood Center (member NETCORD) proposed that 150,000 cord blood units are needed to cover the United States.
Expansion of the public cord blood network was announced in Oct 2005 by Dr. L.F. Bouzas. He said the public system of cord blood banks will add two more banks in early 2006, located in Ribeirão Preto and Campinas, both in the interior of the state of São Paulo. Bouzas pointed out that since Sept 2004 in Brazil, more than half of the stem cell transplants from unrelated donors used cord blood, but 90% of the transplanted cord blood had to be imported. Economically, it makes sense to develop a native supply: The current cost of an imported stem cell unit is around US$ 30 thousand, equivalent to R$ 70 thousand. Whereas in Brazil, the cost of freezing a unit is US$ 1.5 thousand - approximately R$ 3.5 thousand. According to Dr. Bouzas, the average cost of creating a public cord blood bank in Brazil, from the planning stage (construction and equipment) to full operation, comes to US$ 666.34 thousand (R$ 1.5 million).
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Canada:
For many years, the only public cord blood bank inCanada was Alberta Cord Blood Bank. Founded in 1996, they are a non-profit organization serving all of Canada. The Alberta Cord Blood Bank is located in Edmonton, Alberta, and was founded by John J. Akabutu, M.D., a professor of pediatrics at the University of Alberta. Only parents aged 36 and under with no family history of health problems areeligible to donate to the public cord blood bank. In Feb. 2006, the Edmonston Journal reported that the public cord blood bank had run out of federal and provincial funding in 2003. "Since then it's been a struggle to get funding," Akabutu admitted in an interview. "We've been scraping and begging monies around to try to keep a public bank afloat." Thus, in 2005 the Alberta Cord Blood Bank began offering private banking too, as a means to generate income.
In 2004, a public banking service called Victoria Angel Registry of Hope was started by the private cord blood bank Cells for Life of Toronto, Ontario. The public bank is named after a baby girl whose cord blood saved her mother's life. At present, these units are only listed in-house, not on a public registry.
Also in 2004, a public bank named Héma-Québec launched services in Québec. Initially they are only collecting from two hospitals. Direct inquiries to sangdecordon@hema-quebec.qc.ca
Health Canada (the name of the Canadian Ministry of Health) is the national agency which governs Regulations for Human Cells, Tissues and Organs for Transplantation. In addition, the Canadian Standards Association (CSA), Canada’s leading developer of standards and codes, has developed general transplantation standards at the request of Health Canada. The CSA standards apply to the use of human cells, tissues, and organs for transplantation and assisted reproduction purposes. The CSA standards can be purchased on-line at www.csa-intl.org.
All cord blood banks operating in Canada are required to follow the guidelines from Health Canada and CSA. Notice that the adoption of a consistent approach for all transplants is modeled on the European Union, and unlike the United States, where blood and organs are under different rules. Also, Canada does not have an accreditation program comparable to the AABB in the United States, hence many Canadian banks are applying for AABB accreditation.
However, the standards in Canada are unclear on the subject of testing for West Nile Virus (WNV). Health Canada's guidelines require WNV testing for donors of cells, tissues, and organs. See: “Guidance for Industry-Measures to prevent West Nile Virus Transmission Through Cells, Tissues and Organs for Transplantation and Assisted Reproduction” (
The result of the unclear regulations regarding West Nile Virus are tow-fold: First, it is not included in the standard processing fees of private cord blood banks in Canada. Second, some cord blood banks will perform this test for an extra fee, either all the time or only during "mosquito season", and some banks do not. It is up to the consumer to make a decision of whether they feel this service is important.
In related news, in Dec 2004 the Canadian Blood Services announced a new website, www.transfusionmedicine.ca. The website is primarily oriented towards helathcare professionals, but is also intended to educate consumers and donors.
For those Canadian companies which are publicly traded, financial filings can be obtained from SEDAR, The System for Electronic Document Analysis and Retrieval for the Canadian Securities Administrators (CSA).
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Chile:
Fundación Nuestros Hijos is an organization dedicated to helping poor children in Chile receive treatment. In addition, the organization works to help families bear the financial and psychological burdens of the cancer experience.
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Colombia:
In January 2005, the government of Colombia established a public program of banking umbilical cord blood through the Universidad de Antioquia. The cost of the program will be paid through the national health plan, according to an article in the Santiago Times (the article is mainly about the founding of the private cord blood bank VidaCel in Santiago, Chile). According to Dr. Alejandro Montoya, of the private Colombian cord blood bank Redcord in Bogotá, it is illegal in Colombia to export any anatomic component. Thus, international cord blood banks cannot collect from Colombia.
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Mexico:
The National Bone Marrow Unrelated Donor Registry is called DONORMO, which stands for Registro Nacional de Donadores No Relacionados de Medula Osea. A link to facilitate registration with DONORMO (Mexico City Tel. (5255) 5341 - 4569) is maintained by The Andy Fund, www.andy.org.mx. An affiliated organization is BACECU, Cordo Blood Stem Cell Registry, headed by Dr. Clara Gorodezky. Also see Fundacion Comparte Vida, or Sharing Life
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United States:
Please refer to the section of this web site on "Ethical & Legal Issues" in cord blood banking.
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next step...
ASIA & AUSTRALIA
Australia:
A national program of collecting cord blood donations for the public was started in 1995 and includes the Sydney Cord Blood Bank (SCBB) as well as collecting hospitals and banks in Melbourne and Brisbane. They collect anonymous cord blood donations for use by any patients, in Australia or overseas, needing a stem cell transplant. The cord blood units are listed at the Australian Bone Marrow Donor Registry (ABMDR) and the information is available worldwide through the website of the Bone Marrow Donors World Wide (BMDW).
In Australia, processing stem cells for transplant is regulated by the government body called the Therapeutic Goods Administration (TGA). Under these regulations, cord blood banks are considered manufacturers of therapeutic goods. A cord blood bank cannot supply transplants in Australia unless they are on the list of Australian Manufacturers Licensed by the TGA. Please note that some cord blood banks in Australia are only partially licensed to process cells, but NOT to release them for transplant.
The Sydney Morning Herald reported on 21 Sep 2002 that the federal Health Minister launched the $20 million National Cord Blood Collection Network, a formal alliance of state banks planned in the 2000 budget. The aim is to collect 20,000 donations from the general population and 2000 from the Aboriginal one by 2005, which will provide adequate tissue matching for 95% of Australians in need.
Teenagers and Young Adults (TYAs) with cancer are more likely to survive in Australia than in the USA. This was the result of a research study presented at the 4th International Conference on Teenage and Young Adult Cancer Medicine on Friday, 31 March 2006. The study author,Prof. Archie Bleyer of the Cancer Treatment Center, St Charles Medical Center, Bend, Oregon, attributes the higher survival in Australia to the fact that all Australians have national health insurance.
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A national program of collecting cord blood donations for the public was started in 1995 and includes the Sydney Cord Blood Bank (SCBB) as well as collecting hospitals and banks in Melbourne and Brisbane. They collect anonymous cord blood donations for use by any patients, in Australia or overseas, needing a stem cell transplant. The cord blood units are listed at the Australian Bone Marrow Donor Registry (ABMDR) and the information is available worldwide through the website of the Bone Marrow Donors World Wide (BMDW).
In Australia, processing stem cells for transplant is regulated by the government body called the Therapeutic Goods Administration (TGA). Under these regulations, cord blood banks are considered manufacturers of therapeutic goods. A cord blood bank cannot supply transplants in Australia unless they are on the list of Australian Manufacturers Licensed by the TGA. Please note that some cord blood banks in Australia are only partially licensed to process cells, but NOT to release them for transplant.
The Sydney Morning Herald reported on 21 Sep 2002 that the federal Health Minister launched the $20 million National Cord Blood Collection Network, a formal alliance of state banks planned in the 2000 budget. The aim is to collect 20,000 donations from the general population and 2000 from the Aboriginal one by 2005, which will provide adequate tissue matching for 95% of Australians in need.
Teenagers and Young Adults (TYAs) with cancer are more likely to survive in Australia than in the USA. This was the result of a research study presented at the 4th International Conference on Teenage and Young Adult Cancer Medicine on Friday, 31 March 2006. The study author,Prof. Archie Bleyer of the Cancer Treatment Center, St Charles Medical Center, Bend, Oregon, attributes the higher survival in Australia to the fact that all Australians have national health insurance.
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China:
On 14 April 2005 the OpenNet Initiative released its report Internet Filtering in China 2004-2005 (58 page pdf). The report was released to the U.S.-China Economic and Security Review Commission's public hearing on China's State Control Mechanisms and Methods. Testimony about the report was provided by John G. Palfrey, Jr. of the Berkman Center for Internet and Society at Harvard Law School. The OpenNet Initiative is a collaboration among the University of Toronto, Harvard University, and the University of Cambridge.
As of summer 2004, there are about four million leukaemia patients waiting for bone marrow transplants in mainland China. However, there are not enough blood donors for the Chinese public, let alone registered bone marrow donors. The World Health Organisation states that a country needs 4% of its population to donate blood in order to have a sustainable national blood bank. In China, only 2% of the population currently donates blood. Recently, the Ministry of Health has issued permits for Umbilical Cord Stem Cells Storage to two private companies, in hopes of increasing transplant options for patients. The first company is Shanghai Stem Cells Technology Co Ltd., and the second is Golden Meditech, a company incorporated in the Cayman Islands and listed on the Growth Enterprise Market of the Hong Kong stock exchange.
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On 14 April 2005 the OpenNet Initiative released its report Internet Filtering in China 2004-2005 (58 page pdf). The report was released to the U.S.-China Economic and Security Review Commission's public hearing on China's State Control Mechanisms and Methods. Testimony about the report was provided by John G. Palfrey, Jr. of the Berkman Center for Internet and Society at Harvard Law School. The OpenNet Initiative is a collaboration among the University of Toronto, Harvard University, and the University of Cambridge.
As of summer 2004, there are about four million leukaemia patients waiting for bone marrow transplants in mainland China. However, there are not enough blood donors for the Chinese public, let alone registered bone marrow donors. The World Health Organisation states that a country needs 4% of its population to donate blood in order to have a sustainable national blood bank. In China, only 2% of the population currently donates blood. Recently, the Ministry of Health has issued permits for Umbilical Cord Stem Cells Storage to two private companies, in hopes of increasing transplant options for patients. The first company is Shanghai Stem Cells Technology Co Ltd., and the second is Golden Meditech, a company incorporated in the Cayman Islands and listed on the Growth Enterprise Market of the Hong Kong stock exchange.
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India:
As of 2005, India is the seventh largest and second most populous country in the world. India has a population of 1.1 billion people, half of them are under age 25, and the birth rate is approximately 20 million per year, all of which makes India one of the largest birth markets in the world. A recent series of economic reforms aimed at deregulating the country and stimulating foreign investment have created emerging market opportunities.
Unfortunately, very few Indian cancer patients receive bone marrow transplants. A cover story published in Express Healthcare Management, Aug 2005, claims that only 200 Indian patients per year (out of a population of 1.1 billion!) are receiving treatment in 15 facilities. The cost of a bone marrow transplant is generally around Rs 6-8 lakh for autologous and Rs 10-12 lakh for allogeneic transplant ("lakh" means 100,000). But -- “Only a small fraction of BMT cost can be reimbursed through insurance,” says Dr. P S R K Sastry, consultant medical oncologist, Tata Memorial Hospital, Mumbai. Since Indians can't afford advanced healthcare in Indian hospitals, the services are sold to foreigners as "medical tourism". Some websites advertising transplants in india are Mediescapes and the government Ministry of Tourism site www.tourismofindia.com.
For Indians, another obstacle to stem cell therapies is a lack of matching donors for allogeneic transplants. India does not have a registry of bone marrow donors, and South Asians are under-represented in the registries of the USA and Europe. Two groups which are working to increase South Asian membership in the USA are South Asian Marrow Association of Recruiters (SAMAR) and MatchPia.org.
The first cord blood repository in India was established by the company Reliance Life Sciences (RLS), which incorporated in 2001. Their programme is primarily oriented towards public banking.
Plans to set up a national network of public cord blood banks were announced in 2005. The Indian government signed a deal with the Korean company Histostem (see the section on Korea) to set up a bank in Mumbai, with additional centres planned for Delhi, Chennai and Kolkata. Ultimately, these centres will offer regenerative stem cell therapies, like the Histostem hospital in Korea for medical tourists. An article in MedIndia says that the government has a 10% equity stake in the venture, and the CEO of Histosem is US citizen Mike Shen. Donors to the program must pay $280, but in return are promised matching cells should they be needed. Histostem has ambitious plans to collect 400,000 units of cord blood in the next three years.
The first strictly private cord blood bank in India is LifeCell, owned by Asia Cryo-Cell Pvt Ltd (ACCPL), an affiliate of the American bank Cryo-Cell International that is located in Chennai and began operations in late 2004. The start-up funding for LifeCell is guaranteed by Abusha Investment & Management Services Private Limited, whose CEO is also a large stakeholder in Shasun Chemicals and Drugs Limited, a $60 million Indian company that is the world’s largest manufacturer of ibuprofen. The CEO of Asia Cryo-Cell Pvt. Ltd. is S. Abhaya Kumar. By April 2006, Rediff India Abroad reported that LifeCell had 12 collection centres in India and intends to expand into Malaysia and Dubai.
A new centre exclusively for stem cell transplants will be operational in Chennai in 2006, reports Rediff India Abroad. The transplant centre is a joint venture of Lifecell, which will invest Rs 150 million, and Sri Ramachandra Medical Centre, which will provide 15,000 sq. ft. of space in their hospital in Chennai. One can only imagine how many medical tourists will be served by this facility, and wonder how many Indian citizens can afford its services.
Meanwhile, Saneron Asia and Saneron India announced plans to begin trials of cord blood treatments for ALS (Lou Gehrig's Disease). These companies are both affiliates of Saneron CCEL, which itself is an affiliate of Cryo-Cell International in the USA. Saneron India will accept patients at the new transplant centre in Chennai, and Saneron Asia will accept patients at Tzu Chi General Hospital in Hualien, Taiwan, under team leader Dr. Shinn-Zong (John) Lin M.D., Ph.D.
As of Jan 2006, Reliance, Histostem, and LifeCell were the only 3 companies licensed by the Indian Council of Medical Research (ICMR), to store cord blood stem cells. However, during 2005, an explosion of foreign companies announced plans to open cord blood banks in India:
Unfortunately, the health care sector of India is not immune to scams and con artists. For example, the Mumbai newsline published an article in Jan 2006 about the new health magazine "Josh". Josh is distributed to all ICICI bank gold card holders. Josh advertises a stem cell storage service and lists 13 Mumbai physicians on their Medical Advisory Board. However, the listed physicians did not know that their names had been used.
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Japan:
As of 2003, there are 11 public cord blood banks in Japan. The first private cord blood bank, Stem Cell Institute, opened in Aug 1999. Japan is a world leader in the use of cord blood for unrelated transplants. Over the four years from 1999 to 2003, the Japan Cord Blood Network has grown from providing 4% of total transplants in Japan to 43%!
The ethical guidelines of the Japanese government which covers cord blood banking, titled "Ethics Guideline for Human Genome/Gene Analysis Research" are published in English (dated March 29, 2001) at the website: http://www.biol.tsukuba.ac.jp/~macer/eghgr.htm This document was posted by the Eubios Ethics Institute, a nonprofit group that aims to stimulate the international discussion of ethical issues, and how we may use technology in ways consistent with "good life" (eu-bios).
The Japanese government regulations for cord blood banking are titled, "Technical Guidance of Operation for Cord Blood Transplantation", and are not available on the internet (?). This regulation was written by MLHW (Ministry of Labor, Health & Welfare) in 1998 originally for public cord blood banks.
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As of 2005, India is the seventh largest and second most populous country in the world. India has a population of 1.1 billion people, half of them are under age 25, and the birth rate is approximately 20 million per year, all of which makes India one of the largest birth markets in the world. A recent series of economic reforms aimed at deregulating the country and stimulating foreign investment have created emerging market opportunities.
Unfortunately, very few Indian cancer patients receive bone marrow transplants. A cover story published in Express Healthcare Management, Aug 2005, claims that only 200 Indian patients per year (out of a population of 1.1 billion!) are receiving treatment in 15 facilities. The cost of a bone marrow transplant is generally around Rs 6-8 lakh for autologous and Rs 10-12 lakh for allogeneic transplant ("lakh" means 100,000). But -- “Only a small fraction of BMT cost can be reimbursed through insurance,” says Dr. P S R K Sastry, consultant medical oncologist, Tata Memorial Hospital, Mumbai. Since Indians can't afford advanced healthcare in Indian hospitals, the services are sold to foreigners as "medical tourism". Some websites advertising transplants in india are Mediescapes and the government Ministry of Tourism site www.tourismofindia.com.
For Indians, another obstacle to stem cell therapies is a lack of matching donors for allogeneic transplants. India does not have a registry of bone marrow donors, and South Asians are under-represented in the registries of the USA and Europe. Two groups which are working to increase South Asian membership in the USA are South Asian Marrow Association of Recruiters (SAMAR) and MatchPia.org.
The first cord blood repository in India was established by the company Reliance Life Sciences (RLS), which incorporated in 2001. Their programme is primarily oriented towards public banking.
Plans to set up a national network of public cord blood banks were announced in 2005. The Indian government signed a deal with the Korean company Histostem (see the section on Korea) to set up a bank in Mumbai, with additional centres planned for Delhi, Chennai and Kolkata. Ultimately, these centres will offer regenerative stem cell therapies, like the Histostem hospital in Korea for medical tourists. An article in MedIndia says that the government has a 10% equity stake in the venture, and the CEO of Histosem is US citizen Mike Shen. Donors to the program must pay $280, but in return are promised matching cells should they be needed. Histostem has ambitious plans to collect 400,000 units of cord blood in the next three years.
The first strictly private cord blood bank in India is LifeCell, owned by Asia Cryo-Cell Pvt Ltd (ACCPL), an affiliate of the American bank Cryo-Cell International that is located in Chennai and began operations in late 2004. The start-up funding for LifeCell is guaranteed by Abusha Investment & Management Services Private Limited, whose CEO is also a large stakeholder in Shasun Chemicals and Drugs Limited, a $60 million Indian company that is the world’s largest manufacturer of ibuprofen. The CEO of Asia Cryo-Cell Pvt. Ltd. is S. Abhaya Kumar. By April 2006, Rediff India Abroad reported that LifeCell had 12 collection centres in India and intends to expand into Malaysia and Dubai.
A new centre exclusively for stem cell transplants will be operational in Chennai in 2006, reports Rediff India Abroad. The transplant centre is a joint venture of Lifecell, which will invest Rs 150 million, and Sri Ramachandra Medical Centre, which will provide 15,000 sq. ft. of space in their hospital in Chennai. One can only imagine how many medical tourists will be served by this facility, and wonder how many Indian citizens can afford its services.
Meanwhile, Saneron Asia and Saneron India announced plans to begin trials of cord blood treatments for ALS (Lou Gehrig's Disease). These companies are both affiliates of Saneron CCEL, which itself is an affiliate of Cryo-Cell International in the USA. Saneron India will accept patients at the new transplant centre in Chennai, and Saneron Asia will accept patients at Tzu Chi General Hospital in Hualien, Taiwan, under team leader Dr. Shinn-Zong (John) Lin M.D., Ph.D.
As of Jan 2006, Reliance, Histostem, and LifeCell were the only 3 companies licensed by the Indian Council of Medical Research (ICMR), to store cord blood stem cells. However, during 2005, an explosion of foreign companies announced plans to open cord blood banks in India:
- CordLife Sciences (India) Private Limited is a division of the Singapore bank CordLife, owned by the Australian company Cygenics. CordLife plans to establish a laboraroty in Kolkata (Calcutta), in partnership with Strassenburg Pharmaceuticals, which already has a GMP-compliant laboratory in Kolkata. The Managing Doirector of Strassenburg Pharmaceuticals, Mr. Deepnath Roy Chowdhury, is also VP of the Indian Drug Manufacturer's Association for Eastern India.
- Cryobanks International India Private Limited plans to open a laboratory in New Delhi as an affiliate of Cryobanks International of Altamonte Springs, FL
Unfortunately, the health care sector of India is not immune to scams and con artists. For example, the Mumbai newsline published an article in Jan 2006 about the new health magazine "Josh". Josh is distributed to all ICICI bank gold card holders. Josh advertises a stem cell storage service and lists 13 Mumbai physicians on their Medical Advisory Board. However, the listed physicians did not know that their names had been used.
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Japan:
As of 2003, there are 11 public cord blood banks in Japan. The first private cord blood bank, Stem Cell Institute, opened in Aug 1999. Japan is a world leader in the use of cord blood for unrelated transplants. Over the four years from 1999 to 2003, the Japan Cord Blood Network has grown from providing 4% of total transplants in Japan to 43%!
The ethical guidelines of the Japanese government which covers cord blood banking, titled "Ethics Guideline for Human Genome/Gene Analysis Research" are published in English (dated March 29, 2001) at the website: http://www.biol.tsukuba.ac.jp/~macer/eghgr.htm This document was posted by the Eubios Ethics Institute, a nonprofit group that aims to stimulate the international discussion of ethical issues, and how we may use technology in ways consistent with "good life" (eu-bios).
The Japanese government regulations for cord blood banking are titled, "Technical Guidance of Operation for Cord Blood Transplantation", and are not available on the internet (?). This regulation was written by MLHW (Ministry of Labor, Health & Welfare) in 1998 originally for public cord blood banks.
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Korea:
Cord blood banking and stem cell research are both very popular in South Korea. The first cloning of human embryo was reported in 2004 (Science, 12 March 2004, p.1669) by a consortium of scientists in led by Woo Suk Hwang at Seol national University in South Korea. The next year, his team announced they had created 11 new lines of human embryonic cells (Science, 19 May 2005, p.1). Their success rate implied a 10-fold increase in the efficiency of the laboratory process of Somatic Cell Nuclear Transfer (SCNT). Part of the success was attributed to the use of freshly-harvested oocytes from young, fertile women, instead of left over eggs from fertility treatments. A few months later, Hwang's team announced the creation of Snuppy, the first cloned dog. These successes made Hwang an international celebrity and a national hero.
Another famous news report from Korea was the Nov 2004 case of a woman paralyzed for 19 years who could walk again. The woman's name is Hwang Mi-Soon, 37, and she walked at a press conference just a few weeks after cord blood stem cells were injected into her spinal cord. The medical research team was co-headed by Chosun University professor Song Chang-hun, Seoul National University professor Kang Kyung-sun and Han Hoon, Ph.D, from the Seoul Cord Blood Bank (SCB). At that time the inventory of the Seoul Cord Blood Bank (English info) was stated to be 45,000.
However, the Seoul Cord Blood Bank is not a government institution, but a program of the for-profit company Histostem. Han Hoon is the CEO of Histostem . Histostem collects cord blood donated by pregnant women in exchange for the promise of free stem cell treatment if the baby needs it within five years. To extend the guarantee for 10 years, they pay a premium of 270,000 won (268 dollars). The April 2005 inventory of Histostem is stated to be 60,000 cord blood units. Han Hoon stated in an interview , "What you are looking at is the world's largest inventory of cord blood units kept in one place". (Correction: the three largest private cord blood banks in the United States, CBR, Cryo-Cell, and Viacord, have inventories that are comparable or bigger). The news report states that Histostem plans to go public on the Korea Kosdaq stock exchange.
In July 2005, Histostem announced plans to open the world's first hospital devoted exclusively to stem cell therapy. The treatments would be based on stem cells from umbilical cord blood. The hospital would be located on Korea's southern resort island of Jeju, and would open for medical tourism by 2007.
Despite great enthusiasm in the private biotech sector, the government of South Korea has been slow to set up ethical and legal guidelines for the collection of umbilical cord blood. In April 2005, Donga.com broke the story that OB/Gyn's were harvesting cord blood without consent . They are taking it from mothers who are unconscious for C-section and selling it for research use at the price of 150,000 won (about $560) per collection. This is comparable to the going price of cord blood sold for research in the US. Officials at the South Korean Ministry of Health and Welfare admitted there were no laws requiring consent for the "recycling of umbilical cord blood". However, by Nov 2005 police made their first arrest under a Jan 2005 biotethics law, cracking down on human egg brokers who were selling ova to infertile women in korea and Japan. The donors were paid between 3 and 5 million won, and the eggs were resold for about 17 million won.
In the fall of 2005, international news was dominated by the tragic downfall of cloning pioneer Woo Suk Hwang. The first negative reports started with rumors that the human eggs used by Hwang's lab had been donated by Hwang's staff members. This violated international ethical guidelines against senior scientists using bological donations from their underlings. It emerged on further investigation that the staff members had also received financial rewards for their egg donations. The head of Seoul's MizMedi Women's Hospital and a collaborator with Hwang, Sung Il Roh announced publicly in late Nov that he paid the women about $1500 each for "transportation expenses". A panel convened by SNU later found that the total number of human eggs Hwang's team used for the past three years was 2061, extracted from 129 donors.
In mid-Nov 2005, Dr. Gerald P. Schatten withdrew from his collaboration with Hwang and asked that his name be removed from the famous paper in Science. Schatten, a biologist at the University of Pittsburgh, was the leading American in the collaboration.
The next revelation came out in Dec 2005: 9 of the 11 new human cell lines had been faked.
The full extent of the debacle emerged on 10 Jan 2006, when an investigation by Seoul National University concluded that all of the human stem cell results, going back to the original 2004 paper, were scientific forgery. However, Snuppy really is a cloned dog.
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Malaysia:
A National Cord blood bank was established in July 2002. As of June 2003, Malaysia is also served by three banks for private storage. Health Minister Datuk Chua Jui Meng estimated that 200 children in Malaysia require stem cell transplants annually.
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Singapore:
The diminuitive island-state of Singapore has become one of the leading bio-tech centers in Asia. The people of Singapore are very ethnically diverse, comprising 75% Chinese (southern mainly), 20% Malays (originated from Indonesia, Malaysia), 4% Indians (originated from southern and northern India) and 1% mixed.
Although Singapore is home to two private cord blood banks (see the summary page), it took some convincing to get the government to resurrect their public cord blood bank, which had collected 900 units and provided two transplants before it lost funding. A proposal pushed by Dr. Tan Poh Lin, Dr. Fidah Alsagoff, and Ms. Laurene Kwek succeeded in raising the necessary funds to re-open the public bank. Despite initial plans to open by the end of 2004, the public bank opened in Sept 2005. Initially, cord blood collection is offered at two hospitals which service about 40% of births in Singapore, but eventually it will be offered at all public hospitals.
The public Singapore Cord Blood Bank (SCBB) has grown by Sept 2007 to hold an inventory of 2500 collections. In Sept 2007, it was announced that the SCBB became the 3rd cord blood bank outside the US (after Taiwan and Israel) to join the NMDP cord blood bank network. Like the financial operations of other public banks, the collections will be free, but units released for transplant will cost $26,000. In the event that a child who donated to the bank later needs a transplant, the services will be free. The Medical Director of the public Singapore Cord Blood Bank is Dr. William Hwang Ying Khee, a haematologist who is also Vice President of the Bone Marrow Donor Program in Singapore. He has written a short story about a family going through birth and donating to the public bank.
The stories of several patients who received transplants through the public Singapore Cord Blood Bank (SCBB) are available on-line. Toddler Hoh Sin Jun (story1, story2) was the first patient, receiving a transplant for Severe Combined ImmunoDeficiency (SCID). The second recipient was five year old Jayjay, who was diagnosed with Hyper-IgM Syndrome, a different type of immunodeficiency.
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Taiwan:
The island of Taiwan is served by at least three home-based private cord blood banks (see the Asia section of the summary page). In an April 2005 interview with the Taipei Times, the president of the private bank HealthBanks Biotech, Chang Shiu-kang, said that while the birthrate in Taiwan has decreased from 15.18% in 1996 to 9.56% in 2004, only 5% of births currently store cord blood. Thus, the market has much room for growth. Taiwan's current market for private cord blood storage is estimated between NT$700 million and NT$800 million annually, and is expected to grow to NT$1.5 billion in the next three years.
Meanwhile, Taiwan is also served by public cord blood banks. The California-based company Stemcyte operates the StemCyte Taiwan National Cord Blood Center. Stemcyte is a participating member of the United States National Marrow Donor Program (NMDP). In Sept 2004, the NMDP announced that Stemcyte's Taiwan cord blood would be added to the NMDP registry.
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Thailand: In October 2004, the US-based charity The Max Foundation sponsored a charity bike ride called the "Tour de Thailand". The Max Foundation claims that the fundraiser will be used to establish a cord blood donor bank in Thailand. Funds from the ride will be overseen by the British Community in Thailand Foundation for the Needy (BCTFN).
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AUSTRALIA
Australia:
A national program of collecting cord blood donations for the public was started in 1995 and includes the Sydney Cord Blood Bank (SCBB) as well as collecting hospitals and banks in Melbourne and Brisbane. They collect anonymous cord blood donations for use by any patients, in Australia or overseas, needing a stem cell transplant. The cord blood units are listed at the Australian Bone Marrow Donor Registry (ABMDR) and the information is available worldwide through the website of the Bone Marrow Donors World Wide (BMDW)
The Sydney Morning Herald reported on 21 Sep 2002 that the federal Health Minister launched the $20 million National Cord Blood Collection Network, a formal alliance of state banks planned in the 2000 budget. The aim is to collect 20,000 donations from the general population and 2000 from the Aboriginal one by 2005, which will provide adequate tissue matching for 95% of Australians in need.
Teenagers and Young Adults (TYAs) with cancer are more likely to survive in Australia than in the USA. This was the result of a research study presented at the 4th International Conference on Teenage and Young Adult Cancer Medicine on Friday, 31 March 2006. The study author,Prof. Archie Bleyer of the Cancer Treatment Center, St Charles Medical Center, Bend, Oregon, attributes the higher survival in Australia to the fact that all Australians have national health insurance.
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A national program of collecting cord blood donations for the public was started in 1995 and includes the Sydney Cord Blood Bank (SCBB) as well as collecting hospitals and banks in Melbourne and Brisbane. They collect anonymous cord blood donations for use by any patients, in Australia or overseas, needing a stem cell transplant. The cord blood units are listed at the Australian Bone Marrow Donor Registry (ABMDR) and the information is available worldwide through the website of the Bone Marrow Donors World Wide (BMDW)
The Sydney Morning Herald reported on 21 Sep 2002 that the federal Health Minister launched the $20 million National Cord Blood Collection Network, a formal alliance of state banks planned in the 2000 budget. The aim is to collect 20,000 donations from the general population and 2000 from the Aboriginal one by 2005, which will provide adequate tissue matching for 95% of Australians in need.
Teenagers and Young Adults (TYAs) with cancer are more likely to survive in Australia than in the USA. This was the result of a research study presented at the 4th International Conference on Teenage and Young Adult Cancer Medicine on Friday, 31 March 2006. The study author,Prof. Archie Bleyer of the Cancer Treatment Center, St Charles Medical Center, Bend, Oregon, attributes the higher survival in Australia to the fact that all Australians have national health insurance.
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next step...
EUROPE
European Union:
In the European Union, there is a principle of non-commerciality of body material, transmitted in an EU directive (a directive has legal force in all EU countries) that forbids MAKING A PROFIT with body material. Thus, a clinic would be forbidden from re-selling cord blood at a profit. It is, however, permissible for blood banks to charge fees for blood products which allow them to recoup their operating expenses. Those operating expenses can include the costs of recruiting donors and conducting relevent research to improve their work. Many of these practices are similar to the United Sates, with the sole distinction being that a blood bank cannot be a for-profit commercial company. For example, when a US patient receives a blood transfusion in a hospital, the blood bank providing the unit charges the hospital for their expenses, and the hospital in turn charges the patient's medical insurance.
The legal philosophy behind the EU directives is the concept that one does not OWN one's body, one merely has authority over it. The legal difference between ownership and authority prevents people from selling their blood, or a kidney, or any other part. You cannot sell something that you do not own.
With respect to the non-commerciality of body material, Treaty ETS 186 of the Council of Europe, titled "Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin" gives more information. Article 21 is the "Prohibition of financial gain" and Article 22 is the "Prohibition of organ and tissue trafficking". The Council of Europe is a larger club than the European Union; their treaty will have legal force for those countries who sign and ratify the protocol.
On 31 March 2004, the governing body of the European Union issued an "EU-Directive on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells". The draft directive (version date 28 May 2003; 55 page pdf download) had annexes at the end which required standards comparable to GMP conditions (Good Manufacturing Procedures). The final published directive (11 page pdf file) omits the annexes, and thus the standards are more lax. However, member states can continue to impose higher standards if they wish (example: Germany requires GMP conditions).
More information about regulations and policy in both the UK and EU can be found at the website of the Cardiff Centre for Ethics, Law and Society: www.ccels.cardiff.ac.uk.
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France:
In France, where modern cord blood transplantation began in 1988 (Reference: Gluckman, Eliane et al. 1989 NEJM 321:1174-8), private cord blood banking is illegal, because cord blood is considered a national resource.
However, at the end of 2004, there were only 3000 public cord blood samples banked in France, because the French government puts higher priority on bone marrow registries than cord blood banking. Only 3 hospitals collect cord blood donations in France. As a result of the low national inventory, there are two prices for a cord blood transplant in France: a national price of 7,000 Euro per sample and an international price of 17,000 Euro per sample. Clearly, the development of a bigger national inventory would make the French health care system independent of costly cord blood imports.
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Germany & Austria:
In Germany, the Federal Medical Association (Bundesärztekammer) imposes "Guidelines for the transplantation of cord blood" (Richtlinien zur Transplantation von Stammzellen aus Nabelschnurblut). The complete text of the guidelines can be found here (23 page pdf file). Private cord blood banking is allowed in Germany, and the Guidelines apply to both public and private cord blood banking within Germany. However, it is the prevailing opinion of the German Medical Association that: "Für die Bevorratung von autologen CB-Präparaten ist zur Zeit keine medizinische Indikation bekannt, sie ist daher zum gegenwärtigen Zeitpunkt nicht notwendig." (Translation: At present there is no indication known for the stockpiling of autologous CB-samples, hence it is at present not neccessary).
The private German bank VITA34 maintains a web site listing all public donation centers in Germany: www.nabelschnurblut.de. Donation to a public bank is offered at about 70 of the 1000 birth hospitals in Germany. Between both public and private banks, only 2% of the cord blood is saved from 715,000 births per year in Germany.
Because the federal guidelines apply to all cord blood banks, any private banks which operate within Germany are strictly regulated. This web site is available as Parents Guide translation for Germany . Private banks within Germany must obey Standard Operating Procedures and maintain GMP-conditions in order to receive manufacturing authorization (Herstellungserlaubnis) in accordance with German Drug Law (Arzneimittelgesetz). Compliance is supervised by the responsible regional councils in collaboration with the Paul-Ehrlich-Institute. The Guidelines explicitly state how the cord blood must be shipped (within 24 hours at 22 degree C ± 4 degree C) and the required tests on cord blood.
However, there is one "loophole" in the German regulations: Parents are allowed to ship cord blood out of the country, and the high standards imposed by German law do not apply to any cord blood that is shipped out and processed abroad. Parents who use banks elsewhere on the continent will not have the same level of protection until the European Union finishes drafting the EU Proposed Tissue Directive (version date 28 May 2003; 55 page pdf download) which will be issued in early 2004.
In Austria, the situation is very similar to Germany. The Austrian "Guidelines for the transplantation of stem cells. Part III: cord blood stem cells - collection, storage, manipulation and use" (Richtlinien zur Transplantation von Stammzellen Teil III: Nabelschnurstammzellen (Cord Blood, CB) - Gewinnung, Lagerung, Manipulation und Anwendung) are similar to the German Guidelines. The Austrian authors write: "Eine Plazentarestblutbank kann ein autologes, allogenes oder kombiniertes Programm betreiben." (Translation: A placental blood bank can practice an autologous, allogeneic, or combined program.) The complete text can be found here. (18 page pdf file)
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Italy:
Italy has a network of public cord blood banks that is maintained by their equivalent of the US National Marrow Donor Program (NMDP). It is called GRACE, which stands for "Gruppo per la Raccolta e Amplificazione delle Cellule Ematopoietiche" (Translation: Group for the Collection and Expansion of Hematopoietic Cells).
On 3 February 2003, the Ministry of Health (Ministero della salute) published in the official government announcements (Gazzetta Ufficiale 27) the following ordinances regarding cord blood:
"Le banche per la conservazione delle cellule staminali potranno essere attivate solo nelle strutture pubbliche. Ma dovranno essere autorizzate dalle regioni. E’ quanto dispone un’ordinanza del Ministero della salute, pubblicata nella Gazzetta Ufficiale 27 del 3 febbraio 2003. Resta confermato, inoltre, il divieto di istituire banche per la conservazione del sangue da cordone ombelicale presso strutture private. Confermata anche la disciplina sull’importazione ed esportazione di cellule staminali da cordone ombelicale, che continuerà ad essere assoggettata all’autorizzazione preventiva da parte del Ministero della salute. Il provvedimento si è reso necessario perché l'impiego di cellule staminali da cordone ombelicale in campo terapeutico è in parte ancora oggetto di studio. E quindi, il Ministero ha ritenuto opportuno esercitare una più stretta attività di controllo e vigilanza nell’ attesa dei necessari adeguamenti della normativa vigente ai più recenti risultati della ricerca scientifica."
The Ordinances from the Ministry of Health are only valid for one year. The most recent was written on 7 April 2005 and published in the official government announcements: Gazzetta Ufficiale N. 107 del 10 Maggio 2005 (10 May 2005). It repeats the same concepts of the precedent ones (private banking in Italy is still forbidden), but “Article.4” specifically explains that exportation of cord blood is allowed and describes the exact procedure to accomplish this. Download 3 page pdf of Gazzetta Ufficiale N. 107
In addition to anonymous public banking, Italy also has a family banking program for parents who already have a child with a transplantable disease. This is just like the Sibling Donor Cord Blood Program in the United States. These families are offered "dedicated storage" where the blood is reserved for them alone in the event that the older child requires a transplant. At the 2005 meeting of the European Bone Marrow Transplant Group, it was reported that the program has thus far banked 84 cords and released 24 for transplants.
Reference: Bergamaschi P, Perotti L, Bellotti A, et al. 2005; "Dedicated cord blood for related allotransplants: a single bank experience." Bone Marrow Transplantation vol.65(supplement 2):S120, abstract P497.
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Netherlands:
With respect to the legal situation on autologous cord blood banking in The Netherlands, legislation will be in force by the end of 2003. In Feb 2003 the Dutch Parliament passed a law on "Safety and Quality of Body Material". One of the main points of the law is that any health care professional (doctor, nurse, etc.) who in their profession receives any body material (from an amputated limb to cord blood), is obliged to offer that to an "organ bank", which will decide whether the material is useful and can be stored, or has to be destroyed as "medical waste".
The law on the "Safety and Quality of Body Material" will also regulate cord blood banks, for autologous as well as allogeneic use, when standards will be made public at the end of this year. Although the Law has passed Parliament, it will not go into force until one or more Royal Decrees are issued, and those will be issued after Standards have been set under which such an organ bank will have to operate.
A multidisciplinary group was commissioned by The Federation of Medical Scientific Societies in The Netherlands, called "De Stichting Federatie van Medisch Wetenschappelijke Verenigingen in Nederland" (FMWV: www.fmwv.nl) to prepare a "Code for Proper Secondary Use of Human Tissue in The Netherlands". The group inlcuded researchers, lawyers, clinicians and patient representatives. The code was released in 2002 and is binding for all members of medical and biomedical research societies in the Netherlands. An English Version of the Code is available at the website of the FMWV (55 page pdf; 744 kB). The code recognizes that data derived from body material is often more important than the material itself, and must be stored in code (ie: encrypted), with a prohibition against linkage between data and donor.
An opinion survey of expectant parents in The Netherlands has shown that 93% of all pregnant woman in the Netherlands (and their partners) think that there should be a personal cell bank (for cord blood) in The Netherlands. There is none at the moment. Some of the respondents would not make use of such a bank themselves, but wish others to have that opportunity, since only 72% said that they would make use of a personal cell bank for the cord blood of their child, if money is not an issue. About the same percentages said that they would use a personal cell bank for their child if it would be government funded (via taxes, meaning that everyone in society would contribute), or when the personal cell bank would be funded via an extra premium for their health care insurance. However, when they were confronted with the option to pay directly out of their own pocket (an estimated EURO 1.800, up front, for 99 years), only 20% wanted to do that. Furthermore, 60% were willing to donate a fraction of the cord blood for research purposes that would generate revenues to reduce the banking fee. These results were independant of income, age, geography (people living in cities compared to living in rural areas) and whether the coming child would be a first born, or not.
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Poland: Poland has several public cord blood banks, which have not been very active in recent years due to a lack of funding. Several private cord blood banks have formed as well. Operating expenses are low in Poland, as compared to other EU countries, which makes it a very attractive location for new bio-tech companies.
Poland does not have specific regulations for cord blood, but treats cord blood under their regulations regarding "organs for transplantation". This law forbids any institution except the National Transfusion Service from reselling a blood product. The full text of the Polish law for transplantation is on-line, in Polish. Poland also complies with EU regulations.
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Russian Federation: In April 2003, the Moscow government announced (Kommersant 4/15/03) the presumption of consent for organ donation. Cadavers have been harvested without family notification. The government is allowed to confiscate placentas for their new public cord blood bank, which uses a BioArchive freezer (Thermogenesis press release of 2/18/2003).
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United Kingdom:
In Britain, the first cord blood transplant of an adult took place in 2002. The UK's largest stem cell registry is The Anthony Nolan Trust, started by Shirley Nolan to seek a matched donor for her son. As of Nov 2004, the Guardian reported that the NHS service which collects cord blood donations for the public good is only operating routinely in three hospitals in north London. The head of the national Cord Blood Bank, Sue Armitage, says the bank has accumulated an inventory of 7,000 cord blood units since they opened in 1996 and have released 80 for transplant. Armitage says her service is proposing to bank another 20,000 units from selected hospitals with large maternity units, in hopes of building a bigger national service.
The UK Department of Health has decided to regulate tissue banks, and these regulations apply to cord blood banks as well (unlike the USA, where "blood" and "tissue" are regulated separately). The Department of Health Code of Practice for Tissue Banks (33 page pdf) was published in 2000, but will be compulsory after March 2004. The Guidance on the Microbiological Safety of Human Organs, Tissue and Cells used for Transplantation is also available through the UK Dept of Health website. The Code of Practice is also known as MHRA accreditation, where MHRA is the Medicines and Healthcare products Regulatory Agency of the UK Department of Health.
There is an on-line list of MHRA accredited facilities.
Only tissue banks accredited by the MHRA or Code of Practice will be allowed to supply tissues for transplant at National Health Service (NHS) hospitals. In plain English, this means that parents who bank cord blood with banks that do not comply with the Code of Practice are wasting their money, because they will not be able to use those cells in the UK. This holds true regardless of whether the tissue bank operates in the UK or elsewhere; British citizens seeking transplant at NHS hospitals will not be able to use cord blood unless it was processed and stored according to the Code of Practice. The Department of Health Code of Practice paves the way for adoption of the new EU Tissues and Cells Directive (see the section on European Union) which is likely to also come into force in 2005.
On 5 Oct 2003, the Sunday Herald reported that the Scottish National Blood Transfusion Service (SNBTS) secured £750,000 of government funding to open a national cord blood bank. According to Dr. Rachel Green, clinical director of the West of Scotland Blood Transfusion Service, storage of 1000 cord blood samples will cost £250,000. They hope to store the blood from 3000 umbilical cords in three years. "There will still be people who store for private purposes, just as people use private health care. People are taking more and more responsibility for their own health.... One of the things we are looking at is having a public bank in addition to a private bank. We would ask people if they would like to store for their own use or to donate for the use of everyone else. We would like to do a joint programme.” A follow-up report in The Herald 11 April 2005 indicates that the program will soon start operations.
On 16 Nov 2004, the Guardian reported that the willingness of doctors and midwives to participate in cord blood collection is extremely variable. Shamshad Ahmed, director of the UK private bank Smart Cells International, says: "We do find situations where there's a hospital in one area that's happy to do this collection but five miles down the road, there's a complete ban."
The Royal College of Obstetricians and Gynaecologists (RCOG) have issued guidelines which recommend that cord blood not be collected until after delivery of the placenta.
More information about regulations and policy in both the UK and EU can be found at the website of the Cardiff Centre for Ethics, Law and Society: www.ccels.cardiff.ac.uk. (Despite the similarity, the Cardiff Centre, "CCELS", bears no relation to the Nasdaq symbol of the private bank Cryo-Cell International, "CCEL".)
Healthcare in the UK is also undergoing an information revolution: over the next decade, the NHS National Programme for IT (NPfIT), will connect over 30,000 physicians in England to almost 300 hospitals via broadband internet, allowing electronic access to healthcare records, prescription information and research into illnesses. Patients will also have access to their health care information, transforming the way the NHS works. The Government has billed NPfIT as "the biggest change to healthcare since the creation of the NHS in 1948", and this is not an overstatement. The program will cost £6 billion (as of April 2005 that is US$16 billion). However, the project is already running into major snags and almost every component of the new system is behind deadline. Newspaper reports and surveyed physicians are critical of the project.
For those UK cord blood banks which are set up as "limited" corporations, financial information is available from the website of Companies House. The main functions of Companies House are to:
The history of Companies House is as follows: The United Kingdom has enjoyed a system of company registration since 1844. Today, company registration matters are dealt with in law, by the Companies Act 1985 and the updating legislation contained in the Companies Act 1989. All limited companies in the UK are registered at Companies House, an Executive Agency of the Department of Trade and Industry. There are more than 1.8 million limited companies registered in Great Britain, and more than 300,000 new companies are incorporated each year.
On the separate topic of embryonic stem cell research: In the 2002 fiscal year, the US National Institutes of Health (NIH) spent about $11 million on embryonic stem cell grants. By contrast, Britain, whose government has embraced stem cell research, spent $41.5 million in stem cell research grants in 2002, including the start-up of a government-run stem cell bank that plans to store cell lines for research use.
Also a separate but parallel topic: organ donation. Physicians in the British Medical Association (BMA) are officially backing a plan for presumed consent for organ donation (this link requires free registration). As of Feb 2004, legislation mandating this plan is being debated in Parliament. There is a critical organ shortage in the U.K., where 7,278 people were on the transplant waiting list in late December 2003. According to the BMA, research suggests that around 90% of the population has expressed a desire to be an organ donor after death, but only 19% are in the U.K.'s National Health Service (NHS) Organ Donor Register. In the proposed plan, this register would only record the names of those who OPT OUT of organ donation. In Belgium, which has already adopted a similar plan, only 2% of the population has opted out.
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In the European Union, there is a principle of non-commerciality of body material, transmitted in an EU directive (a directive has legal force in all EU countries) that forbids MAKING A PROFIT with body material. Thus, a clinic would be forbidden from re-selling cord blood at a profit. It is, however, permissible for blood banks to charge fees for blood products which allow them to recoup their operating expenses. Those operating expenses can include the costs of recruiting donors and conducting relevent research to improve their work. Many of these practices are similar to the United Sates, with the sole distinction being that a blood bank cannot be a for-profit commercial company. For example, when a US patient receives a blood transfusion in a hospital, the blood bank providing the unit charges the hospital for their expenses, and the hospital in turn charges the patient's medical insurance.
The legal philosophy behind the EU directives is the concept that one does not OWN one's body, one merely has authority over it. The legal difference between ownership and authority prevents people from selling their blood, or a kidney, or any other part. You cannot sell something that you do not own.
With respect to the non-commerciality of body material, Treaty ETS 186 of the Council of Europe, titled "Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin" gives more information. Article 21 is the "Prohibition of financial gain" and Article 22 is the "Prohibition of organ and tissue trafficking". The Council of Europe is a larger club than the European Union; their treaty will have legal force for those countries who sign and ratify the protocol.
On 31 March 2004, the governing body of the European Union issued an "EU-Directive on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells". The draft directive (version date 28 May 2003; 55 page pdf download) had annexes at the end which required standards comparable to GMP conditions (Good Manufacturing Procedures). The final published directive (11 page pdf file) omits the annexes, and thus the standards are more lax. However, member states can continue to impose higher standards if they wish (example: Germany requires GMP conditions).
More information about regulations and policy in both the UK and EU can be found at the website of the Cardiff Centre for Ethics, Law and Society: www.ccels.cardiff.ac.uk.
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France:
In France, where modern cord blood transplantation began in 1988 (Reference: Gluckman, Eliane et al. 1989 NEJM 321:1174-8), private cord blood banking is illegal, because cord blood is considered a national resource.
However, at the end of 2004, there were only 3000 public cord blood samples banked in France, because the French government puts higher priority on bone marrow registries than cord blood banking. Only 3 hospitals collect cord blood donations in France. As a result of the low national inventory, there are two prices for a cord blood transplant in France: a national price of 7,000 Euro per sample and an international price of 17,000 Euro per sample. Clearly, the development of a bigger national inventory would make the French health care system independent of costly cord blood imports.
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Germany & Austria:
In Germany, the Federal Medical Association (Bundesärztekammer) imposes "Guidelines for the transplantation of cord blood" (Richtlinien zur Transplantation von Stammzellen aus Nabelschnurblut). The complete text of the guidelines can be found here (23 page pdf file). Private cord blood banking is allowed in Germany, and the Guidelines apply to both public and private cord blood banking within Germany. However, it is the prevailing opinion of the German Medical Association that: "Für die Bevorratung von autologen CB-Präparaten ist zur Zeit keine medizinische Indikation bekannt, sie ist daher zum gegenwärtigen Zeitpunkt nicht notwendig." (Translation: At present there is no indication known for the stockpiling of autologous CB-samples, hence it is at present not neccessary).
The private German bank VITA34 maintains a web site listing all public donation centers in Germany: www.nabelschnurblut.de. Donation to a public bank is offered at about 70 of the 1000 birth hospitals in Germany. Between both public and private banks, only 2% of the cord blood is saved from 715,000 births per year in Germany.
Because the federal guidelines apply to all cord blood banks, any private banks which operate within Germany are strictly regulated. This web site is available as Parents Guide translation for Germany . Private banks within Germany must obey Standard Operating Procedures and maintain GMP-conditions in order to receive manufacturing authorization (Herstellungserlaubnis) in accordance with German Drug Law (Arzneimittelgesetz). Compliance is supervised by the responsible regional councils in collaboration with the Paul-Ehrlich-Institute. The Guidelines explicitly state how the cord blood must be shipped (within 24 hours at 22 degree C ± 4 degree C) and the required tests on cord blood.
However, there is one "loophole" in the German regulations: Parents are allowed to ship cord blood out of the country, and the high standards imposed by German law do not apply to any cord blood that is shipped out and processed abroad. Parents who use banks elsewhere on the continent will not have the same level of protection until the European Union finishes drafting the EU Proposed Tissue Directive (version date 28 May 2003; 55 page pdf download) which will be issued in early 2004.
In Austria, the situation is very similar to Germany. The Austrian "Guidelines for the transplantation of stem cells. Part III: cord blood stem cells - collection, storage, manipulation and use" (Richtlinien zur Transplantation von Stammzellen Teil III: Nabelschnurstammzellen (Cord Blood, CB) - Gewinnung, Lagerung, Manipulation und Anwendung) are similar to the German Guidelines. The Austrian authors write: "Eine Plazentarestblutbank kann ein autologes, allogenes oder kombiniertes Programm betreiben." (Translation: A placental blood bank can practice an autologous, allogeneic, or combined program.) The complete text can be found here. (18 page pdf file)
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Italy:
Italy has a network of public cord blood banks that is maintained by their equivalent of the US National Marrow Donor Program (NMDP). It is called GRACE, which stands for "Gruppo per la Raccolta e Amplificazione delle Cellule Ematopoietiche" (Translation: Group for the Collection and Expansion of Hematopoietic Cells).
On 3 February 2003, the Ministry of Health (Ministero della salute) published in the official government announcements (Gazzetta Ufficiale 27) the following ordinances regarding cord blood:
- Cord blood banking is only authorized as a public conservation structure.
- Each bank is also subject to approval by the regional government where it is located.
- Private banking is forbidden.
- The import or export of cord blood must be authorized by the Ministry of health.
- These provisions are believed necessary because therapies using stem cells from umbilical cord blood are still under study.
"Le banche per la conservazione delle cellule staminali potranno essere attivate solo nelle strutture pubbliche. Ma dovranno essere autorizzate dalle regioni. E’ quanto dispone un’ordinanza del Ministero della salute, pubblicata nella Gazzetta Ufficiale 27 del 3 febbraio 2003. Resta confermato, inoltre, il divieto di istituire banche per la conservazione del sangue da cordone ombelicale presso strutture private. Confermata anche la disciplina sull’importazione ed esportazione di cellule staminali da cordone ombelicale, che continuerà ad essere assoggettata all’autorizzazione preventiva da parte del Ministero della salute. Il provvedimento si è reso necessario perché l'impiego di cellule staminali da cordone ombelicale in campo terapeutico è in parte ancora oggetto di studio. E quindi, il Ministero ha ritenuto opportuno esercitare una più stretta attività di controllo e vigilanza nell’ attesa dei necessari adeguamenti della normativa vigente ai più recenti risultati della ricerca scientifica."
The Ordinances from the Ministry of Health are only valid for one year. The most recent was written on 7 April 2005 and published in the official government announcements: Gazzetta Ufficiale N. 107 del 10 Maggio 2005 (10 May 2005). It repeats the same concepts of the precedent ones (private banking in Italy is still forbidden), but “Article.4” specifically explains that exportation of cord blood is allowed and describes the exact procedure to accomplish this. Download 3 page pdf of Gazzetta Ufficiale N. 107
In addition to anonymous public banking, Italy also has a family banking program for parents who already have a child with a transplantable disease. This is just like the Sibling Donor Cord Blood Program in the United States. These families are offered "dedicated storage" where the blood is reserved for them alone in the event that the older child requires a transplant. At the 2005 meeting of the European Bone Marrow Transplant Group, it was reported that the program has thus far banked 84 cords and released 24 for transplants.
Reference: Bergamaschi P, Perotti L, Bellotti A, et al. 2005; "Dedicated cord blood for related allotransplants: a single bank experience." Bone Marrow Transplantation vol.65(supplement 2):S120, abstract P497.
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Netherlands:
With respect to the legal situation on autologous cord blood banking in The Netherlands, legislation will be in force by the end of 2003. In Feb 2003 the Dutch Parliament passed a law on "Safety and Quality of Body Material". One of the main points of the law is that any health care professional (doctor, nurse, etc.) who in their profession receives any body material (from an amputated limb to cord blood), is obliged to offer that to an "organ bank", which will decide whether the material is useful and can be stored, or has to be destroyed as "medical waste".
The law on the "Safety and Quality of Body Material" will also regulate cord blood banks, for autologous as well as allogeneic use, when standards will be made public at the end of this year. Although the Law has passed Parliament, it will not go into force until one or more Royal Decrees are issued, and those will be issued after Standards have been set under which such an organ bank will have to operate.
A multidisciplinary group was commissioned by The Federation of Medical Scientific Societies in The Netherlands, called "De Stichting Federatie van Medisch Wetenschappelijke Verenigingen in Nederland" (FMWV: www.fmwv.nl) to prepare a "Code for Proper Secondary Use of Human Tissue in The Netherlands". The group inlcuded researchers, lawyers, clinicians and patient representatives. The code was released in 2002 and is binding for all members of medical and biomedical research societies in the Netherlands. An English Version of the Code is available at the website of the FMWV (55 page pdf; 744 kB). The code recognizes that data derived from body material is often more important than the material itself, and must be stored in code (ie: encrypted), with a prohibition against linkage between data and donor.
An opinion survey of expectant parents in The Netherlands has shown that 93% of all pregnant woman in the Netherlands (and their partners) think that there should be a personal cell bank (for cord blood) in The Netherlands. There is none at the moment. Some of the respondents would not make use of such a bank themselves, but wish others to have that opportunity, since only 72% said that they would make use of a personal cell bank for the cord blood of their child, if money is not an issue. About the same percentages said that they would use a personal cell bank for their child if it would be government funded (via taxes, meaning that everyone in society would contribute), or when the personal cell bank would be funded via an extra premium for their health care insurance. However, when they were confronted with the option to pay directly out of their own pocket (an estimated EURO 1.800, up front, for 99 years), only 20% wanted to do that. Furthermore, 60% were willing to donate a fraction of the cord blood for research purposes that would generate revenues to reduce the banking fee. These results were independant of income, age, geography (people living in cities compared to living in rural areas) and whether the coming child would be a first born, or not.
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Poland: Poland has several public cord blood banks, which have not been very active in recent years due to a lack of funding. Several private cord blood banks have formed as well. Operating expenses are low in Poland, as compared to other EU countries, which makes it a very attractive location for new bio-tech companies.
Poland does not have specific regulations for cord blood, but treats cord blood under their regulations regarding "organs for transplantation". This law forbids any institution except the National Transfusion Service from reselling a blood product. The full text of the Polish law for transplantation is on-line, in Polish. Poland also complies with EU regulations.
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Russian Federation: In April 2003, the Moscow government announced (Kommersant 4/15/03) the presumption of consent for organ donation. Cadavers have been harvested without family notification. The government is allowed to confiscate placentas for their new public cord blood bank, which uses a BioArchive freezer (Thermogenesis press release of 2/18/2003).
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United Kingdom:
In Britain, the first cord blood transplant of an adult took place in 2002. The UK's largest stem cell registry is The Anthony Nolan Trust, started by Shirley Nolan to seek a matched donor for her son. As of Nov 2004, the Guardian reported that the NHS service which collects cord blood donations for the public good is only operating routinely in three hospitals in north London. The head of the national Cord Blood Bank, Sue Armitage, says the bank has accumulated an inventory of 7,000 cord blood units since they opened in 1996 and have released 80 for transplant. Armitage says her service is proposing to bank another 20,000 units from selected hospitals with large maternity units, in hopes of building a bigger national service.
The UK Department of Health has decided to regulate tissue banks, and these regulations apply to cord blood banks as well (unlike the USA, where "blood" and "tissue" are regulated separately). The Department of Health Code of Practice for Tissue Banks (33 page pdf) was published in 2000, but will be compulsory after March 2004. The Guidance on the Microbiological Safety of Human Organs, Tissue and Cells used for Transplantation is also available through the UK Dept of Health website. The Code of Practice is also known as MHRA accreditation, where MHRA is the Medicines and Healthcare products Regulatory Agency of the UK Department of Health.
There is an on-line list of MHRA accredited facilities.
Only tissue banks accredited by the MHRA or Code of Practice will be allowed to supply tissues for transplant at National Health Service (NHS) hospitals. In plain English, this means that parents who bank cord blood with banks that do not comply with the Code of Practice are wasting their money, because they will not be able to use those cells in the UK. This holds true regardless of whether the tissue bank operates in the UK or elsewhere; British citizens seeking transplant at NHS hospitals will not be able to use cord blood unless it was processed and stored according to the Code of Practice. The Department of Health Code of Practice paves the way for adoption of the new EU Tissues and Cells Directive (see the section on European Union) which is likely to also come into force in 2005.
On 5 Oct 2003, the Sunday Herald reported that the Scottish National Blood Transfusion Service (SNBTS) secured £750,000 of government funding to open a national cord blood bank. According to Dr. Rachel Green, clinical director of the West of Scotland Blood Transfusion Service, storage of 1000 cord blood samples will cost £250,000. They hope to store the blood from 3000 umbilical cords in three years. "There will still be people who store for private purposes, just as people use private health care. People are taking more and more responsibility for their own health.... One of the things we are looking at is having a public bank in addition to a private bank. We would ask people if they would like to store for their own use or to donate for the use of everyone else. We would like to do a joint programme.” A follow-up report in The Herald 11 April 2005 indicates that the program will soon start operations.
On 16 Nov 2004, the Guardian reported that the willingness of doctors and midwives to participate in cord blood collection is extremely variable. Shamshad Ahmed, director of the UK private bank Smart Cells International, says: "We do find situations where there's a hospital in one area that's happy to do this collection but five miles down the road, there's a complete ban."
The Royal College of Obstetricians and Gynaecologists (RCOG) have issued guidelines which recommend that cord blood not be collected until after delivery of the placenta.
More information about regulations and policy in both the UK and EU can be found at the website of the Cardiff Centre for Ethics, Law and Society: www.ccels.cardiff.ac.uk. (Despite the similarity, the Cardiff Centre, "CCELS", bears no relation to the Nasdaq symbol of the private bank Cryo-Cell International, "CCEL".)
Healthcare in the UK is also undergoing an information revolution: over the next decade, the NHS National Programme for IT (NPfIT), will connect over 30,000 physicians in England to almost 300 hospitals via broadband internet, allowing electronic access to healthcare records, prescription information and research into illnesses. Patients will also have access to their health care information, transforming the way the NHS works. The Government has billed NPfIT as "the biggest change to healthcare since the creation of the NHS in 1948", and this is not an overstatement. The program will cost £6 billion (as of April 2005 that is US$16 billion). However, the project is already running into major snags and almost every component of the new system is behind deadline. Newspaper reports and surveyed physicians are critical of the project.
For those UK cord blood banks which are set up as "limited" corporations, financial information is available from the website of Companies House. The main functions of Companies House are to:
- incorporate and dissolve limited companies;
- examine and store company information delivered under the Companies Act and related legislation;
- make this information available to the public.
The history of Companies House is as follows: The United Kingdom has enjoyed a system of company registration since 1844. Today, company registration matters are dealt with in law, by the Companies Act 1985 and the updating legislation contained in the Companies Act 1989. All limited companies in the UK are registered at Companies House, an Executive Agency of the Department of Trade and Industry. There are more than 1.8 million limited companies registered in Great Britain, and more than 300,000 new companies are incorporated each year.
On the separate topic of embryonic stem cell research: In the 2002 fiscal year, the US National Institutes of Health (NIH) spent about $11 million on embryonic stem cell grants. By contrast, Britain, whose government has embraced stem cell research, spent $41.5 million in stem cell research grants in 2002, including the start-up of a government-run stem cell bank that plans to store cell lines for research use.
Also a separate but parallel topic: organ donation. Physicians in the British Medical Association (BMA) are officially backing a plan for presumed consent for organ donation (this link requires free registration). As of Feb 2004, legislation mandating this plan is being debated in Parliament. There is a critical organ shortage in the U.K., where 7,278 people were on the transplant waiting list in late December 2003. According to the BMA, research suggests that around 90% of the population has expressed a desire to be an organ donor after death, but only 19% are in the U.K.'s National Health Service (NHS) Organ Donor Register. In the proposed plan, this register would only record the names of those who OPT OUT of organ donation. In Belgium, which has already adopted a similar plan, only 2% of the population has opted out.
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Last modified: 22.May 2008
Copyright 2000 - 2008 Frances Verter
Copyright 2000 - 2008 Frances Verter