Legislation In Donation And Organ Transplantation

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Legislation in donation and organ transplantation


On the legal part, the legislation on organ transplants is all in Royal Decree 1723/2012. This consists of 34 articles structured in 9 chapters, 10 provisions of different types and 3 annexes.The different chapters talk about the general provisions of transplantation, respect and protection of the donor and the receiver, of obtaining organs, their assignment, transport and exchange, of organ transplantation, of their warm and security, of the authoritiesand the coordination of activities related to the obtaining and transplantation of organs, of the information systems;and of the inspection, supervision and precautionary measures and the infractions and sanctions.

In Chapter 1, which talks about the general provisions, articles from one to three are commented;The purpose of the law, which is to regulate the activities related to the obtaining and use of human organs, the scope of the law and finally some of the definitions to clarify what means hospital coordination of transportation.

Chapter 2 is article 4 and article 5. The first talks about the fundamental principles that govern the obtaining and clinical use of human organs, and the second on the laws of confidentiality and protection of patient personal data.

Chapter 3 is about article 9 that explains, in sections 1, 2, 4 and 5 what are the requirements to obtain the organs of deceased donors. The same chapter includes article 11 that indicates the characteristics that a center must meet to be authorized to obtain organs.

Chapter 5, separated in article 17 and 18, indicates the requirements that have to be met to be able to transport human organs and those that have to meet the transport centers to be sanitaryly authorized.

Chapter 6 talks about the quality and safety of organs. It is divided into article 21 that explains the characterization that donors and human organs must have, article 22 on the traceability of human organs, article 13 indicating the system of notification and management of serious adverse reactions and events,Article 24 indicated that training must have the health personnel, and finally article 25 on the Quality and Security Program.

Chapter 7 goes on the authorities and the coordination of activities related to obtaining or organ transplantation. It is constituted by article 28 on the regional, sectoral and hospital units of transplant coordination;and article 29 indicating that it is the Permanent Commission of Transplants of the Interterritorial Council of the National Health System. We also have article 31, included in Chapter 8, is responsible for explaining information systems.

And finally chapter 9 on inspection, supervision and precautionary measures of infractions and sanctions. In this article 33 we can see that it is divided between the very serious infractions, the serious infractions and the slight infractions. Then we have all the annexes on the diagnostic and certification protocols of death for the extraction of organs of deceased donors.


Organ transplant: the transplant, according to the Generalitat of Catalonia, is about the replacement of a sick organ by a healthy organ of a corpse donor. The organs that can be transplanted are the kidneys, the liver, the heart, the lungs, the pancreas and the intestine. Each transplant implies a different procedure and care. We will talk about the functions and diseases that cause the need for a transplant, the waiting list and transport of each of the organs.


The kidney is a vital organ that carries as a function to filter the blood of toxic substances, maintains the internal balance of the body and manufactures substances that stimulate the production of red blood cells. In Catalonia, chronic renal failure, which is what is called when the kidneys do not work well or have stopped working, it is the most frequently caused by arterial hypertension and diabetes.

When there is renal failure, it is essential to move on to a treatment that replaces the kidney function. The first step is dialysis, but if the patient’s condition is good and the advantages of treatment exceeds the risks of an operation, a transplant can be practiced. The transplant is an advantage since they stop depending on the dialysis machine and avoid the complications that arise when used for a long period of time.

Currently the waiting list for renal transplantation according to the Generalitat of Catalonia is around 1.100 patients. These constitute two waiting lists, the transplantation from living donor and from donor corpse. You can be in the two waiting lists at the same time.

In the kidney transplantation the criteria that are followed to decide who is the following is based on the time of permanence on the waiting list and for the donor/receiver compatibility that is the blood group, the HLA (human leukocyte antigen),The weight, size and age. When a donation is produced and the extraction of the organ, an analysis of this is analyzed to be able to choose the most suitable receiver following the criteria established above. Thanks to the existence of dialysis, the kidney is an organ that has no urgency 0 (it is the one that implies a high risk and dying in the next 24-48 hours if there is no transplant).

The transplant consists of medical compatibility tests called CrossMatch that are made between donor and receiver cells to prevent hyperagudos rejections. If there is compatibility, a last dialysis session is carried out before submitting to the operation. Generally during the operation the kidney is implanted without extracting the other kidneys.


The liver is a vital organ located in the abdominal cavity that participates in digestive functions, metabolic, protein function, processing and subsequent elimination of substances produced by both the organism itself and external and immune. Hepatic diseases can be acute, which are mainly those of viral origin such as hepatitis A and B or caused by medications, toxic or other causes;and chronic liver diseases caused by viral origin such as hepatitis B and C or alcohol consumption or by problems and bile ducts. Chronic liver diseases can progress to liver cirrhosis, contracting the risk of developing liver cancer.

The transplant is reserved only for those diseases that are already acute or chronic, there is no other therapeutic alternative. Normally these are chronic diseases in the phase of decompensated liver cirrhosis and that already shows symptoms of liver failure. Even so, the appearance of a terminal phase, either in acute or chronic disease, entails a high risk of death and an urgent transplant is always necessary.

At the moment the waiting list of Catalonia is according to the Generalitat of around 160 patients, being able to be helped by a donation of both living donor and donor corpse. These are ordered according to their clinical severity from more to less according to their risk of death using the MELD system (Model for End-Stage Liver Disease). This system calculates a score from the bilirubin variables (pigment formed by the degradation of hemoglobin), creatinine (organic compound generated from the degradation of creatine) and inr (way of standardizing the changes obtained through timeof prothrombin) that allows an estimate of the risk of death to three months of patients. 


The heart is the main organ of the circulatory system, which drives blood through the body’s blood vessels. The inability to pump the blood constitutes the heart failure or insufficiency that causes a rapid deterioration of the physical capacity and quality of life of the person who suffers it. In terms of heart problems, myocardial infarction is one of the most frequent diseases in our society, caused by fat plaques associated with thrombosis that causes a vessel occlusion that prevents blood from reaching a part of the heart muscle, whichcauses me to stop working properly and the cells of that part of the muscle die. In addition, on the other hand, the progressive dilation of the heart can also evolve into irreversible heart failure.

According to the Generalitat of Catalonia, current. The criteria established for the award of organs and tissues are followed, these being compatibility, the patient’s clinical situation and the time of permanence in the list.

The heart transplant is to replace the patient’s sick organ with the healthy corpse donor. This operation is necessary in patients who have a terminal phase heart disease that has evolved towards heart failure and no longer responds to usual medications, since when that treatment fails the transplant is the only option that remains to preserve an acceptable quality of life.

In the most serious cases of heart failure, the heart works at a third of its usual performance, which can cause injuries in other organs, so it is important that for the transplantation to succeed the rest of the organs are in good condition.


The lungs are the vital organs that perform the exchange of gases in the blood so that oxygen limps and eliminates carbon dioxide, eliminating a large number of germs that reach daily l’ inner. If the amount of germs in the body is large, the lung may not be able to eliminate them what causes infections. In addition, if this is deteriorated, for example due to tobacco, this increases the risk of infection.

Chronic obstructive pulmonary disease, emphysema and chronic bronchitis can cause chronic respiratory failure. Also other diseases such as pulmonary fibrosis bronchoectasia, cystic fibrosis or pulmonary hypertension may indicate the need for a transplant. All paintings evolve to irreversible respiratory failure that appears progressively until in the most advanced phases they force the patient to use an oxygen treatment to continue breathing.

The Generalitat of Catalonia indicates that, at the moment in the lung transplant waiting list there are about 50 patients. The criteria established for the award of organs and tissues are followed, these being compatibility, the patient’s clinical situation and the time of permanence in the list that are applicable for all organs from donors corpse. In spite of that, in lung transplants some isolated cases can be prioritized that the medical team considers that the patient is at a vital risk situation.


The pancreas is the organ that secret insulin by cells that are located in the pancreatic islets. This organ does the exocrine function (necessary in digestion) and endocrine function (the secret insulin). The best known function, that of insulin, allows glucose between easily in cells, for which it is its main source of energy. The pancreas can have two types of diseases, type I diabetes mellitus, which is a disease of autoimmune origin that causes the destruction of insulin secretory cells and entails that it has to depend absolutely in an injected insulin treatment. It is caused by genetic and environmental factors is not well known and usually appears during the first decades of life, so it is usually called youth diabetes.

Type II diabetes mellitus, which is attributed to genetic or environmental factors such as inadequate or obesity modify the function of pancreas cells or the ability they have to use glucose. This usually appears in adult patients and unlike type I, does not make them dependent on insulas since they can control it with a good diet and/or oral antidiabetics.

The Generalitat of Catalonia reports that the waiting list for pancreatic transplants is 30 patients. The criteria established for the award of organs and tissues are followed, these being compatibility, the patient’s clinical situation and the time of permanence in the list that are applicable for all organs from donors corpse.

The pancreas is not considered a vital organ since patients can survive perfectly with insulin administration, transplant is a way for the patient to have a better quality of life but is not necessary to survive most times. Renal complication is one of the complications of diabetes so normally pancreas transplantation is done as well as the kidney. 


When there is a donation, the organ is awarded according to the order to the most serious, since these diseases having a high risk of death receive the national emergency priority 0. In addition, children’s patients have a state priority program through the PELD system. The intervention consists of carrying out the sick liver and subsequently implement the new donated organ, joining the ducts previously sectioned in the extraction. In addition, the gallbladder of the transplanted organ is removed to avoid future problems.

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