Trying to transplant the transplanters

Efforts by DKMS, a privately run German company that recruits volunteer bone marrow patients, to make inroads into Spain have sparked a hostile response from the Spanish authorities. The National Transplant Organization (ONT) has presented a report to Spain's State Attorney's Office outlining a series of infractions of national legislation regarding bone transplants by DKMS.

For the moment, the move effectively prevents Spanish hospitals from working with DKMS by warning them that they do not have the necessary permits to extract bone marrow.

At the center of the row over how bone marrow transplants should be managed, ONT head Rafael Matesanz accuses DKMS of "trying to privatize the Spanish system." Matesanz says he is defending Spain's approach to bone marrow transplants, which he describes as "altruistic" and "free." The Spanish system, as in some other European countries - but not Germany - does not pay donors, nor charge recipients of donations.

In response, DKMS says it registered in Spain as a not-for-profit organization. DKMS, which was founded in Germany in 1991 and branched out into the United States in 2004, hit the headlines in Spain following the case of Hugo Pérez Santos, a 35-year-old from Avilés (Asturias) who had gone to Germany for a bone marrow transplant. The company launched a campaign to find potential donors in Spain, obtaining offers from 1,204 Spanish volunteers, who are now listed on the world donor registry as "belonging" to DKMS.

This means that from now on, if the ONT needed to use the bone marrow of any of these potential donors, it would have to pay DKMS 14,500 euros. The company receives its bone marrow material free of charge, which the ONT describes as "taking advantage of a very emotional moment" in response to a plea by a sick person for help to expand its donor portfolio. After donors are called up to donate their marrow for free, DKMS then charges recipients 14,500 euros to cover costs.

According to the Josep Carreras Foundation, set up by the opera singer who overcame bone cancer, and the only official registry in Spain approved to organize bone marrow transplants, DKMS's prices are 6,000 euros above the usual fees. The Foundation charges around 8,500 euros.

When contacted by EL PAÍS regarding its business model, DKMS said it is a health foundation and that its actions are legal.

"Due to the great number of requests that DKMS receives from Spanish patients, we consider it our obligation to continue to support them, especially since the law allows it," said the company. "DKMS's activities in Spain are in accordance with Spanish legislation and rules," the company said.

Matesanz accepts this, but accuses DKMS of being a front for international cosmetics company Coty. He adds that DKMS has contacted Spanish doctors saying it had permission from the ONT to operate in Spain. The German company has brought a suit against the ONT accusing it of damaging its reputation.

The ONT accuses DKMS of breaking the law, saying it has tried to find donors in Spain without previously alerting regional governments, which are responsible for health services; having sent samples to Germany, a practices it says could constitute tissue trafficking; collecting personal information from Spaniards without authorization from the Spanish Data Protection Agency; and taking advantage of high-profile cases to find new donors, in contravention of Spanish legislation, which says that donations must benefit specific individuals.

Matesanz says it is this last aspect that most threatens Spain's free transplant system, where not only are donors not paid or recipients charged, but they are not given the opportunity to choose the recipients of their donations, unless it is a relative. Other countries, such as Germany, function differently. There, the ONT chief accepts, DKMS's actions are "completely legal."

France and Brazil do not let DKMS operate on their territory, while Poland and the United States do.

Heder Murari Borba, the general coordinator of the Brazilian National Transplants System, has told EL PAÍS that "DKMS is a powerful private center with branches in many countries and acts like a company to find bone marrow transplant donors." Brazil refused DKMS permission to operate in 2008.

Evelyne Marry, the head of France's bone marrow donor registry, says her country has refused to allow DKMS to operate there. While refusing to accuse the organization of being profit driven, she admits "it is highly profitable."

The Josep Carreras Foundation says that DKMS's turnover is around 24 million euros a year.

Manuel Arias, the president of the Spanish Transplant Society, says he is concerned that companies like DKMS could pave the way for a system whereby those with the money can jump the waiting list for a bone marrow or organ transplant.

"The Spanish system is based on transparency, altruism, and non-payment," says Arias. "It is understandable that people are going to be concerned about somebody coming here and breaking that system up, especially when it has been shown that the system works. Spain is a transplant success story thanks to its approach," he says.

Arias points out that the country has consistently increased the number of donors, and now has 35 for every million inhabitants, twice the European Union average.

Indeed, Spain has probably the best organ transplant system in the world. Its healthcare is highly regarded ? it ranked seventh in the World Health Organization's top 10 in 2000 (the UK was 18th) ? and, like the NHS, it is free at the point of delivery. It has an excellent network of family doctors and a health center within 15 minutes of every home. But when it comes to transplants, Spain is way out in front.

Spain has about 5,500 people on the transplant waiting list, compared with about 8,000 in the UK. It has only two-thirds of the UK population, but the impressive part is the proportion of families who say yes to organ donation at the moment of death. In the UK, it is 60 percent. In Spain, it is up to 85 percent.

Matesanz says Spain's success is not about donor cards, registers or "presumed consent" but about the teams of transplant coordinators in every hospital. "The key is organization."

Alejandro Toledo, president of the Fight Against Kidney Diseases (Alcer) as well as of the General Alliance of Patients organizations, agrees. "When there is already a good system in place, changing it involves a great many risks. In this country we have managed to carry out transplants regardless of income levels, without any kind of factor interfering." His represents the majority of health experts and medics in Spain, who support the current legislation.

In the United States, the American Transplant Foundation (ATF) also defends the Spanish model, but its Outreach and External Affairs Coordinator, Kyle Pietari, says he has no problem with donors being rewarded in some way. "California has just approved legislation regarding payment for stem cell and tissue research, although not organs, and we are awaiting federal legislation. We think it is worth looking into the question of how to reward donors," he says, adding: "I think we would need to introduce tough regulation to make sure that no exploitation takes place."

At the same time, as the AFT's executive director Anastasia Darwish points out, access to the US healthcare system involves payment. For those with healthcare packages or who can afford their own insurance, "once you are on the transplant list, everybody is treated the same. You can't pay to jump the queue."

The dispute with DKMS needs to be seen within the context of Spain's legislation regarding stem cell research.

Prior to 2003, scientists in Spain were only allowed to use frozen embryos. In July 2003, the government passed a law authorizing stem cell research on embryos but imposed many restrictions. The necessary steps to put the law into effect were, however, not taken.

But this changed when it was decided that embryos available for research could also include any that are frozen within two weeks of conception. In 2006, the law was changed to allow parents who have children with incurable diseases to conceive a new embryo and utilize stem cells, thereby providing a tissue donor. This procedure would only be used after all other options had been exhausted, so it is not a primary means for treatment.

The new law allows research on embryos that have already been created for fertility treatments, and were then frozen as they were not needed. The embryos will have to be more than five years old. Parents who give their consent for the embryos to be used for research will sign an informed consent form granting permission for a specific research project. They will not be allowed to benefit financially and will have no rights to possible subsequent patents.

Matesanz describes the current situation regarding stem cell research as a legal loophole, and is unhappy that private stem cell banks are allowed to exist, even though they must hand over material to the state system if a recipient has been found for it.

Reaching that deal meant tough negotiating, and Matesanz says he does not like having to deal with companies that charge around 100 euros a year to store stem cells. The privately run banks store their material outside Spain so that they cannot be used in this country. Around 200 parents have so far used the private system, compared to the 51,000 using the state system. It is estimated that more than 30,000 Spanish couples keep umbilical cords in other countries.

Marcelo Palacios of the International Society of Bioethics, calls the current situation "cellular exile," and argues that the law in Spain should be changed. "The criteria for donation should always be altruism and non-payment," he says, adding: "We need to encourage people to donate umbilical cords on the basis that they will be used for everybody's benefit."

It can be a difficult scientific and ethical balance for policies to reflect the desire for progress in managing disease along with the importance of maintaining the collective moral views of a nation. Today, stem cell research is still fraught with debate, both within and between nations. The variation in policies throughout the world clearly demonstrates the exciting therapeutic potential coupled with ethical criticisms of stem cell research.