The Spanish Supreme Court recognizes the right to decide about Umbilical Cord Blood Storage in Public Healthcare

For many years in Spain families giving birth in a public health hospital could not opt for the conservation of their baby's umbilical cord blood in a family bank (with few exceptions). That restricted the access to cord blood banking for app 50% of the population,. This has caused a comparative disadvantage for these families. Moreover, for private banks like ours, it has limited the existing market.

Spanish Law 9/2014 stipulates that the extraction of human cells or tissues can be used for various purposes, namely:

• Allogeneic use: Cells are extracted from one person and applied to another.
• Autologous use: Cells are extracted and applied to the same person.
• Eventual autologous use: Cells are obtained for the purpose of being preserved for potential future use in the same person, without a medical indication at the time of collection and initiation of preservation.

Following a request made by a user of the Extremadura Regional Health Service (SES) in 2021, whose delivery was scheduled at the public hospital of Badajoz, the following question arose: the patient wished, at her own expense, for the umbilical cord blood to be extracted during childbirth for subsequent storage in a private bank with which she had signed a contract. To this end, she requested that the SES formalize a collaboration agreement that would allow the transfer of the blood to the private bank for conservation.

The administrative resolution denied the request, arguing that while public health should promote the extraction and storage of stem cells for use in other patients (allogeneic use), the storage of umbilical cord blood for potential future use by the same individual (eventual autologous use) is not a public health priority. The resolution states that "reserving this blood for a hypothetical and improbable personal use would deny a sick patient current help that they could obtain if such storage were done in public banks and would therefore violate, in full, the principles of altruism, solidarity, and equity in donation that underpin the health system." The resolution also argues that the number of transplants for autologous use is significantly lower than the number of allogeneic transplants.

The patient filed an administrative lawsuit before the Court of Mérida, which dismissed her claim. She subsequently appealed to the Higher Court of Justice of Extremadura, which, in its ruling No. 74/2021 of April 22nd, recognized the patient's right to be given the umbilical cord blood obtained during childbirth. The Junta de Extremadura appealed this ruling to the Supreme Court, and its appeal has been dismissed, confirming the ruling of the Higher Court of Justice of Extremadura.

Therefore, the Supreme Court's ruling dismisses the appeal filed by the Junta de Extremadura and recognizes the patient's right to have the public hospital sign a protocol ensuring the technical adequacy of the method used from the collection to the conservation of the umbilical cord blood, if she chooses to conserve it in an external private establishment.

So, the Supreme Court ruled in February 2024 that women giving birth in public healthcare have the right to decide the fate of their baby's stem cells at the time of birth.

The Supreme Court affirmed the right of families, including public healthcare users, to conserve umbilical cord blood and the stem cells it contains for potential future use by the same person (eventual autologous use). To exercise this right and conserve their cells in an external center, the regulation requires the signing of an agreement or protocol between the extraction center and the recipient of the blood.

The Supreme Court's ruling states that "Regional Governments, in the legitimate exercise of their powers in health matters and respecting the common services established by the national system, must preserve the right of users of the public health service to decide on the fate of the umbilical cord, thus enabling the viability of the legitimate option granted to the patient to obtain and conserve the stem cells existing in the umbilical cord blood for eventual autologous use. Therefore, it cannot prevent users of a public hospital from being deprived of exercising the right recognized in Article 7.2 of Royal Decree-Law 9/2014, of July 4th, by refusing to sign the necessary protocol that would allow the patient to conserve their stem cells in an authorized external private center."

It further adds that "Refusing to sign this protocol makes it impossible to exercise a right recognized to the patient" and that this refusal "introduces a factor of distortion and discrimination that conditions the exercise of this right for people with greater economic capacity to the detriment of public healthcare users with fewer economic resources."

As of today, eight months after the ruling, Famicord group Spanish banks have already carried out dozens of collections in public hospitals in areas where we were previously unable to operate. However, the process is not fully established. Users who wish to contract our services in these hospitals must face certain bureaucratic hurdles. Currently, we must request permits from the competent health authority for each service, which is far from being a reality established throughout the public health service. Nevertheless, all communities are responding favourably, and opportunities are beginning to emerge to generate a framework agreement that regulates this activity and facilitates procedures for all these families.

The Supreme Court judgment appeared in the main media

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