Quality and safety rules for donating and using human cells and tissues

Automatic summary, not yet reviewed

1. The rule covers the donation, procurement, evaluation, processing, preservation, storage, distribution, clinical use and clinical research of human cells and tissues intended to be applied to people. Blood and blood products, and organs, are excluded.
2. Donation is always voluntary and altruistic: neither the donor nor any other person or entity may receive payment for it. A living donor may only receive limited compensation for expenses and inconveniences, and recipients pay nothing.
3. To donate while alive, a person must be of legal age, have full legal capacity and good health, and sign a written informed consent, which can be withdrawn before the cells or tissues are removed. For deceased donors, removal is possible if they did not state opposition while alive.
4. Cells and tissues may only be obtained, processed, stored, distributed and applied in centers and units authorized by the health authority. Authorizations are specific to each activity and tissue type, last between two and four years, and are never renewed automatically.
5. Importing and exporting tissues and cells requires authorization from the Ministry of Health, based on a report from the National Transplant Organization. Imports are only authorized if there is a proven benefit and no national availability, and exports only if there is sufficient availability and a medical reason.
6. A traceability system tracks every cell or tissue from donor to recipient, with a single mandatory code. Information is kept for at least 30 years, and a haemovigilance-style system reports serious adverse effects and reactions.
7. Regional governments inspect tissue establishments periodically, with no more than two years between inspections. Violations are penalized as health offenses.
8. The rule also applies to situations and procedures that started before it took effect, except for unfavorable sanctions. It enters into force the same day it is published in the Official State Gazette.

Who it affects

• Living donors and families of deceased donors: They must know that donation is free and altruistic, that they must give written consent, and that they can withdraw it before the cells or tissues are removed.
• Patients receiving cell or tissue transplants: They receive cells and tissues without paying anything, with guarantees of quality, safety and traceability.
• Tissue establishments, banks, and procurement and application centers: They need specific health authorization for each activity, must meet detailed technical requirements, undergo inspections and report adverse events.
• Regional governments and the National Transplant Organization: They authorize, inspect and sanction centers, and manage the records and information on donations.
• Companies and entities that import or export tissues: Every import or export of tissues requires prior authorization from the Ministry of Health with equivalent health guarantees.

Words worth knowing

Trazabilidad (traceability)

The ability to follow the trail of a cell or tissue at every step, from donor to recipient, identifying all people and centers involved.

Uso autólogo (autologous use)

When cells or tissues are removed from a person and later applied to that same person.

Uso alogénico (allogeneic use)

When cells or tissues are removed from one person and applied to a different one.

Establecimiento de tejidos (tissue establishment)

A tissue bank or hospital unit where cells and tissues are processed, preserved, stored and distributed.

Biovigilancia (biovigilance)

A system for reporting, recording and communicating serious adverse effects and reactions related to cells and tissues.

It summarizes the law as published in the BOE. It is written by artificial intelligence and may contain mistakes: the official text is what counts. Read the official text · How we make summaries