The scientific and technical progress of the last few years in the field of Medicine and Biology and, in particular, regarding the diagnosis of brain death, the preservation of organs and the practice of transplants, The Court of Justice of the European Court of Justice of the European Court of Justice of the European Court of Justice of the European Court of Justice of the European Court of Justice of the European Union organ transplantation.

Law 30/1979 states that the removal of organs or other anatomical pieces of deceased may be made after the death has been established. According to the death criteria of the Candanchu Opinion of the Spanish Society of Neurology in 1993, death can be secondary to processes that lead to complete and irreversible damage to brain functions. -brain death-or processes leading to cardiorespiratory arrest. However, Royal Decree 426/1980 regulates only the obtaining of viable organs for transplantation by death in the situation of brain death.

The current reality determines the validity of organs obtained by death in a cardiac arrest situation, provided that organ preservation procedures can be applied in the deceased person. This method of obtaining organs is validated by the clinical reality and widely accepted by organ transplant professionals, both nationally and internationally. This is confirmed at the Conference on Donors in Aystolia of the Netherlands in March 1995 and in the Spanish Consensus Paper on organ donation in asistolia, dated November 27, 1995.

In this regard, the non-law proposal adopted on 17 June 1997 calls on the Government to "proceed with the review and, where appropriate, update of the regulatory regulations for the transplants and, in particular, in the related aspects". to the criteria of brain death and the donation in asystole ". On the same terms, the Board of Elected Judges was stated at its meeting on March 6, 1997, which suggested "the regulatory modification of the death criteria, adapting it to the advances of the scientific community."

In these types of donations, and in order to maintain the viability of the organs, it is essential to perform early technical organ preservation, aimed at reducing the secondary damage to the ischemia suffered by the organs. organs in the time that elapses from the diagnosis of death to the extraction. Therefore, an effective mechanism should be used and sufficient agility to allow for the immediate authorisation of the courts to obtain the organs in cases where this is necessary.

On the other hand, Royal Decree 426/1980 limits the diagnosis of brain death to the technology available at the time of its approval, preventing the incorporation of new procedures, of proven efficacy and safety, for make such a diagnosis. Healthcare professionals, at the present time, have greater scientific knowledge and have new technological advances with which they can help to make the diagnosis of brain death.

Also, it is necessary to adapt to the current reality the provisions that regulate the requirements that the centers must gather to be authorized to carry out activities of extraction and transplantation of organs, to adapt the administrative procedures for the distribution of existing territorial competences, and provide for mechanisms for the evaluation and monitoring of these activities.

Law 30/1979 provides for the operation of specialized autonomous and state organizations and collaboration with international organizations that make possible the exchange and rapid circulation of organs for transplantation, with the to find the most suitable receiver. Technical and scientific progress and development in this field of the territorial health model provided for in Law 14/1986 of 25 April, General of Health, make it necessary to update these organizations adapted to the current distribution of territorial competences, in such a way as to facilitate coordination, the rapid exchange of information and an evaluation and monitoring of these activities.

This Royal Decree respects and promotes the principles of altruism, solidarity, gratuitousness, information, informed consent of the living donors, verification of the non-opposition of the deceased and therapeutic purpose provided for in Law 30/1979 of 27 October on the extraction and transplantation of organs, as well as the respect for confidentiality and secrecy in accordance with the provisions of Law 14/1986 of 25 April, General of Health, and in Organic Law 15/1999, of 13 December, for Personal Data Protection.

According to the advances in the matter of organ transplantation, the Royal Decree 63/1995, of 20 January, on the Management of Health Benefits of the National Health System, is updated.

In the preparation of this provision the contributions and suggestions of numerous experts, centers, entities, professional corporations and scientific societies and other entities related to the material.

The project has been discussed with the representatives of the Autonomous Communities, within the Standing Committee on Transplants of the Interterritorial Council of the National Health System and submitted to the plenary session of the Tip.

This Royal Decree, as soon as it determines essential and common aspects for the protection of the health and safety of persons, both donors and potential recipients, has the condition of basic regulation. (a) health, in accordance with the provisions of Article 2.1 and Article 40 (7), (8), (9) and (13) of Law 14/1986 of 25 April 1986, under Article 149.1.16.a of the Constitution, with the exception of Article 14, which is given to the protection of the State's exclusive competence in the field of external health.

In its virtue, on the proposal of the Ministers of Health and Consumer Affairs and of Public Administrations, in agreement with the Council of State and after deliberation of the Council of Ministers at its meeting on 30 December 1999,

D I S P O N G O:

CHAPTER I

Scope of the rule

Article 1. Scope of application.

This Royal Decree regulates the activities related to the collection and clinical use of human organs, including the donation, extraction, preparation, transport, distribution and activities of the transplant and their follow-up.

Article 2. General rules and principles.

1. In those activities, the rights referred to in Article 10 of Law 14/1986 of 25 April, General of Health, and the rules and principles laid down in Law 30/1979 of 27 October on Extraction and Transplanting of organs, specifically those of voluntary, altruism, gratuitousness, absence of profit and anonymity, so that it is not possible to obtain financial compensation or any other type for the donation of any part of the human body.

Also, equity in the selection and access to transplant of potential recipients will be guaranteed, and the necessary measures will be taken to minimize the possibility of disease transmission or other risks and to treat ensure the highest chances of success of the organ to transplant. Quality assessment and control systems shall be established.

Article 3. Definitions.

For the purposes of this Royal Decree, it shall be understood as:

1. Organ: that differentiable part of the human body made up of various tissues that maintains its structure, vascularization and ability to develop physiological functions with an important degree of autonomy and sufficiency.

In this sense, they are organs: the kidneys, the heart, the lungs, the liver, the pancreas, the intestine, and how many others with similar criteria can be extracted and transplanted according to scientific-technical advances.

2. Living donor: a living donor is considered to be a person who, in compliance with the requirements laid down in Article 9 of this Royal Decree, makes the donation in the life of those organs, or part thereof, the extraction of which is compatible with the life and the function of which can be compensated by the donor body in an appropriate and safe manner.

3. Deceased donor: the deceased person is considered deceased to that deceased person from whom it is intended to extract organs, which, in compliance with the requirements laid down in Article 10 of this Royal Decree, would not have expressly stated his opposition.

4. Diagnosis of death: the diagnosis and certification of the death of a person shall be based on the irreversible cessation of cardiorespiratory functions or brain functions, as provided for in Article 10.

5. Recipient: is that person who receives the transplant from an organ for therapeutic purposes.

6. Removal of organs: a process by which the organs of a living or deceased donor are obtained for subsequent transplantation into one or more recipients.

7. Organ transplantation: therapeutic use of human organs consisting of replacing a diseased organ, or its function, with a healthy organ from a living donor or a deceased donor.

8. Centre for the extraction of living donor organs: health centre which, in compliance with the requirements specified in Article 11 of this Royal Decree, has the corresponding authorisation for the development of the organ extraction activity in living donors.

9. Centre for the removal of organs from deceased donors: health centre which, in compliance with the requirements specified in Article 12 of this Royal Decree, has the corresponding authorisation for the development of the extraction activity organs in deceased donors.

10. Organ transplant centre: health centre which, in compliance with the requirements specified in Articles 15, 16, 17, 18 and Annex II of this Royal Decree, has the corresponding authorisation for the development of the activity of organ transplants.

CHAPTER II

Respect and protection for the donor and the recipient

Article 4. Objectives.

1. The extraction of human organs from living or deceased donors shall be carried out for therapeutic purposes, in other words, for the purpose of promoting the health or the conditions of life of the recipient without prejudice to the research which can be further performed.

2. In any case, the use of human organs must respect the fundamental rights of the person and the ethical postulates of biomedical research.

Article 5. Confidentiality.

1. No information shall be provided or disclosed to enable the identification of the donor and the recipient of human organs.

2. The family of the donor may not know the identity of the recipient, the recipient or his family members of the donor and, in general, any dissemination of information which may directly relate to the extraction and the subsequent graft or implementation. This limitation excludes those directly interested in the assumption of Article 9.

3. The information concerning donors and recipients of human organs shall be collected, treated and kept in the strictest confidence, in accordance with the provisions of Article 10.3 of Law 14/1986 of 25 April, General of Health, and the Law Organic 15/1999, of December 13, Personal Data Protection.

4. The duty of confidentiality shall not prevent the adoption of preventive measures where the existence of individual or collective health risks is suspected in the terms provided for in Articles 26 and 28 of the General Health Act or, where appropriate, in accordance with the provisions of the Organic Law 3/1986 of 14 April of Special Measures on Public Health.

Article 6. Education and training.

1. The health authorities shall promote the information and education of the population in relation to donation and transplantation, the benefits they provide for the persons in need, as well as the conditions, requirements and guarantees that this procedure assumes.

2. They will also promote the continuing training of healthcare professionals related to these activities.

Article 7. Promotion and advertising.

1. The promotion of the donation or procurement of human organs or tissues will always be carried out in a general way and by pointing out its voluntary, altruistic and selfless character.

2. The promotion and publicity of the centres and activities referred to in this Royal Decree shall be subject to inspection and inspection by the competent health authorities as provided for in Article 30.1 of Law 14/1986 of 25 January 1986. April, General Health.

The competent health administration of the corresponding Autonomous Community shall mean the center and the State General Administration when the promotion or advertising activities exceed that scope.

3. Advertising for the donation of organs or tissues for the benefit of individual persons, or of health centres or certain institutions, is prohibited.

Article 8. Gratuity of donations.

1. No gratification may be received for the donation of human organs by the donor, or any other natural or legal person.

2. The carrying out of medical procedures related to the removal shall in no case be burdensome for the living donor or for the family of the deceased.

3. It is prohibited to make any publicity about the need for an organ or tissue or about its availability, offering or seeking some kind of gratification or remuneration.

4. The recipient shall not be required to pay any price for the transplanted organ.

CHAPTER III

From obtaining, preserving, and processing organs

Article 9. Living organ donor: conditions and requirements.

1. The removal of organs from living donors for further transplantation in another person may be performed if the following conditions and requirements are met:

a) The donor must be older, enjoy full mental faculties, and a proper state of health.

(b) It must be an organ or part thereof, the extraction of which is compatible with life and the function of which can be compensated by the donor body in an appropriate and safe manner.

c) The donor must be informed in advance of the consequences of his decision, and must give his consent in an express, free, conscious and disinterested manner.

(d) The removal of organs from persons who, due to mental deficiencies, mental illness or any other cause, may not be able to grant their consent in the manner indicated. The removal of organs from minors, even with the consent of parents or guardians, cannot be performed.

e) The destination of the extracted organ will be your transplant to a given person for the purpose of substantially improving your life prognosis or living conditions.

2. The removal of organs from living donors shall be limited to situations in which great chances of successful transplantation may be expected and the free consent of the donor referred to in paragraph 1 (c) of this Article shall not be assessed. Article. A mandatory report of the Ethics Committee of the transplant hospital will be required.

In no case shall living donor organs be extracted or used when in any event it may be considered as an economic or other social or psychological conditioning.

3. The physical and mental health of the donor must be accredited by a doctor other than the one or those who are to carry out the removal and transplantation, who shall inform the risks inherent in the intervention, the foreseeable consequences of somatic or psychological order, the repercussions that you may have in your personal, family or professional life, as well as the benefits that the transplant is expected to achieve.

The above shall be accredited by a medical certificate which shall necessarily refer to the state of health, the information provided and the response and motivations freely expressed by the person concerned and, in his case, any indication of pressure external to it. The certificate shall include the nominal relationship of other professionals who may have collaborated in such tasks with the doctor who certifies.

4. In order to extract organs from a living donor, the person concerned must give in writing his express consent before the judge in charge of the Civil Registry of the locality concerned, following the explanations of the doctor to be carried out the removal and in the presence of the physician referred to in paragraph 3 of this Article, of the doctor responsible for the transplant and of the person to whom the conformity is to be given for the intervention, as indicated in the authorization document of the center.

The assignment document where the donor's conformity is manifested will be signed by the person concerned, the physician who has to execute the extraction and the other assistants. Any of them will be able to effectively oppose the donation if they are in doubt that the donor's consent has been expressed in an express, free, conscious and disinterested manner. Copy of the transfer document shall be provided to the data subject.

In no case will the removal of organs be performed without the prior signature of this document.

5. Between the signature of the transfer document of the organ and the removal of the organ must elapse at least twenty-four hours, the donor being able to revoke his consent at any time prior to the intervention without any formality. Such revocation may not give rise to any kind of compensation.

6. The removal of organs from living donors may only be carried out in the health centres expressly authorised by the health authority of the Autonomous Community concerned. The conditions and requirements to be met by those centres are those referred to in Article 11 of this Royal Decree.

7. By way of derogation from Article 8, the living donor shall be provided with health assistance for restoration.

Article 10. Removal of organs from deceased: conditions and requirements.

1. The procurement of organs from deceased donors for therapeutic purposes may be performed if the following conditions and requirements are met:

(a) That the deceased person, from whom it is intended to extract organs, has not expressly expressed his opposition to the removal of organs after his death. Such opposition, as well as their conformity if they wish to express, may refer to all types of organs or only to one of them, and any form in which it has been expressed shall be respected.

In the case of minors or incapacitated persons, the opposition may be made to be held by those who have been in the life of those who are legally represented, in accordance with the provisions of the legislation. civil.

(b) Provided that the removal of organs from deceased donors is intended to be carried out in an approved centre, the person to whom it is appropriate to give the conformity for the removal or in whom it delegates, as specified in the Article 11.3, the following relevant checks must be carried out:

1. Information about whether the person concerned made a patent for any of his or her family members or the professionals who have cared for him in the health center, through the annotations that they have been able to make in the Record book of Will Statements or in the medical history.

2. The examination of the documentation and personal belongings that the deceased carried with him.

Whenever circumstances do not prevent this, family members present in the health center should be provided with information on the need, nature and circumstances of the extraction, restoration, conservation or of mortuary healing.

2. The removal of deceased organs may only be carried out after verification and certification of the death carried out in the form, with the requirements and by qualified professionals, in accordance with the provisions of this Royal Decree and taking into account the protocols included in Annex I to this Royal Decree, the ethical requirements, scientific advances in the field and the generally accepted medical practice.

These professionals should be physicians with qualifications or expertise appropriate for this purpose, other than those physicians who have to intervene in the extraction or transplantation and will not be subject to the instructions from these.

The death of the individual may be certified after confirmation of the irreversible cessation of cardiorespiratory functions or the irreversible cessation of brain functions. It will be recorded as the time of death of the patient when the diagnosis of death was completed.

3. The irreversible cessation of cardiorespiratory functions shall be recognised by appropriate clinical examination after an appropriate period of observation. The clinical diagnostic criteria, observation periods, as well as confirmatory tests required in accordance with medical conditions, shall be in accordance with the protocols set out in Annex I to this Royal Decree.

In the case referred to in the preceding paragraph, and for the purposes of the certification of death and the removal of organs, the existence of a death certificate shall be required by a physician other than that which intervenes in the extraction or transplantation.

4. The irreversible cessation of brain functions, i.e. the observation of a known structural etiology and irreversible character, shall be recognised by appropriate clinical examination after an appropriate period of observation. The clinical diagnostic criteria, observation periods, as well as confirmatory tests required in accordance with medical conditions, shall be in accordance with the protocols set out in Annex I to this Royal Decree.

In the case referred to in the preceding paragraph, and for the purposes of the certification of death and the removal of organs, the existence of a medical certificate signed by three doctors, including a medical certificate, shall be required. neurologist or neurosurgeon and the Head of Service of the medical unit where you are admitted, or your replacement. In no case shall such facultative be part of the extractor or transplantation equipment of the organs to be removed.

5. In cases of accidental death, as well as when a judicial investigation is carried out, prior to the removal of organs, the consent of the appropriate judge must be sought, which, after the medical examiner's report, must be granted provided that the result of the instruction in criminal proceedings is not impeded.

(a) In the cases of death by cardiorespiratory arrest, the medical officer responsible for the extraction of the preservation techniques to ensure the viability of the organs, after communication to the Court of Instruction competent, so that, if deemed necessary, it can establish any limitation or positive indication for its practice.

Elapsed time established in the protocols referred to in Annex I from the communication without the Court having formulated any indication, the preservation techniques shall be initiated, previously extracting samples of biological liquids and any other sample that could be estimated in future in accordance with the protocols referred to in Annex I to this Royal Decree.

These protocols will also regulate the "chain of custody" of the samples deposited in the hospital, at the disposal of the investigating judge, who will determine their destination.

(b) The application for the removal of organs must be accompanied by the death certificate referred to in paragraphs 3 or 4 of this Article, in accordance with a medical report explaining the personal and admission to the hospital, and an accreditative sheet, signed by the person responsible for giving the conformity for the extraction, that the doctor or doctors who sign the death certificate are different from the one who will perform the extraction of organs and/or transplantation.

6. For the person responsible for giving the conformity for the extraction, or the person to whom the delegation is delegated, as determined for the authorisation of the centre in Article 11.3, a document shall be issued in which it is expressly stated. which:

(a) The checks on the will of the deceased, as set out in paragraph 1 of this Article, or on persons who have their legal representation, have been carried out.

(b) The information provided to the family members referred to in paragraph 1 of this Article has been provided, provided that the objective circumstances have not prevented it, including the latter situation if it occurs.

(c) Death has been checked and certified, as provided for in paragraphs 3 or 4, as appropriate, of this Article, and attached to the authorization document said medical certificate of death.

(d) In the death situations referred to in paragraph 5 of this Article, the appropriate judge's authorization is provided.

e) The hospital center where the extraction is to be performed is authorized for this and that authorization is in effect.

(f) The organs for which the extraction is not authorised shall be recorded, taking into account the restrictions which may have been imposed by the donor in accordance with paragraph 1 of this Article.

g) The name, surnames and professional qualifications of the doctors who have certified the death must be entered, and none of these doctors are part of the extractor or transplant team.

Article 11. Live donor organ extraction centres: general requirements and procedures for the granting, renewal and extinction of the authorisation of activities.

1. The removal of organs from living donors for further transplantation in another person may only be carried out in health centres expressly authorised by the competent health authority of the relevant Autonomous Community.

2. In order to be authorised, the centres where these activities are carried out must meet the following requirements:

(a) Be authorised as a centre for the removal of organs from deceased donors and as a transplant centre for the organ for which the authorisation for the extraction of a living donor is sought.

b) Dispose of sufficient medical and nursing staff and with proven experience for the correct assessment of the donor and the realization of the extraction.

c) Dispose of the necessary facilities and equipment to ensure the correct performance of the extractions.

d) Dispose of the necessary health services to ensure the proper preoperative study of the donor and the correct treatment of any complications that may arise in the donor.

e) having protocols to ensure the proper selection of the donor, the process of immediate and long-term extraction and post-operative monitoring to ensure the quality of the entire process.

3. Without prejudice to the specific rules in respect of each Autonomous Community, the procedure for granting, renewing and extinguishing the approval of the centres for the production of live donor shall be adjusted as follows: In Article 12 of this Royal Decree, on authorization to the centers of organ extraction of deceased donors.

The authorisation shall determine the person to whom, in addition to the person responsible for the medical unit in which the transplant is to be performed, it is appropriate to give the conformity for each intervention, after verification that the conditions and requirements set out in Article 9 of this Royal Decree.

Article 12. Removal centres of deceased donor organs: requirements and procedure for the granting, renewal and termination of the authorisation of activities.

1. The removal of organs from deceased donors may only be carried out in health centres which have been expressly authorised by the competent health authority of the relevant Autonomous Community.

2. In order to be authorised, the removal centres of deceased donor organs shall meet the following requirements:

a) Dispose of an organization and a functioning regime that allows to ensure the execution of the extraction operations in a satisfactory manner.

b) Dispose of a transplant hospital coordination unit that will be responsible for coordinating donation and extraction processes.

(c) Ensure the availability of medical personnel and technical means to verify death in the form referred to in Article 10 and in accordance with the protocols listed in Annex I to this Royal Decree.

d) Dispose of medical, nursing, and health services and technical means sufficient for the correct assessment and maintenance of the donor, according to the protocols included in Annex I of the actual present Decree.

e) Ensure the availability of an appropriate laboratory for the performance of those determinations that are considered at any time necessary and that allow adequate clinical evaluation of the donor.

f) Ensuring the availability of facilities, medical and nursing staff, as well as the material needed to ensure the correct execution of the extractions.

g) Dispose of a restricted and confidential access register, where the necessary data will be collected to identify the extractions performed, the organs obtained and the destination thereof, with the corresponding Alphanumeric keys ensuring anonymity and confidentiality as provided for in Article 5 (3) and (4) and allowing, where necessary, the proper monitoring of organs obtained from the same donor.

h) Keep a file of serums for a minimum period of ten years, in order to make, if necessary, biological controls.

i) Dispose of the appropriate personnel, facilities and services for the restoration of the body of the deceased person, once the extraction has been performed. You must also allow access or visitation of your family members and close associates if requested.

The authorisation shall be determined by the person responsible for giving the conformity for each intervention, in accordance with Article 10.

3. Without prejudice to the specific rules in respect of each Autonomous Community, the application for authorisation shall contain:

a) The name of the or those responsible for the donation and extraction process.

(b) Memory with the detailed description of the means available to the centre at its disposal, in accordance with the requirements of paragraph 2 of this Article.

4. Duration: authorization granted shall be valid for a period of validity, at the end of which it may be renewed after the health authority of the Autonomous Community has established that the conditions and requirements which gave rise to the granting of the same. In no case shall it be automatically extended.

5. Amendments: any substantial modification which takes place under the conditions, structure, responsibility or operation of the centre must be notified to the health authority of the Autonomous Community and may give rise to the revision of the the authorization and even, considering the transcendence of such modifications, could become the extinction of the same even if the period of validity has not expired.

6. The Autonomous Communities shall notify the Ministry of Health and Consumer Affairs of the decisions which they adopt with regard to the approval of centres for the removal of organs from deceased donors which are covered by this provision and which must be included in the in the General Register of Health Centres, Services and Facilities.

7. The organ extraction centres shall provide the competent authority of the Autonomous Community with all the information requested to them in relation to the authorised activity.

8. Extinction or suspension of authorization: The authorization of the centers to obtain human organs may be revoked or suspended as provided for in Article 37 of Law 14/1986 of 25 April, General of Health.

9. All health centres approved for the removal of organs shall take the necessary measures to ensure that all citizens entering and their family members have full knowledge of the regulation on donation and removal of organs for therapeutic purposes.

Article 13. Transport of human organs.

The transport of organs from the extractor centre to the transplantation centre shall be carried out under the appropriate conditions and means of transport, according to the characteristics of each organ, and shall be accompanied by the following: identification and documentation:

1. º An outer label in which it appears:

a) Organ: type of human organ.

b) The origin and destination of the organ: institutions involved with the name of the shipping and reception officials, their addresses and contact telephones.

c) Extractor hospital exit day and time.

2. The documentation that must accompany the shipment will be:

a) Report on the characteristics of the organ and preservation solutions.

b) Report on the characteristics of the donor and relationship of the tests or studies performed and their results.

Article 14. Entry or exit of human organs from Spain for transplantation.

The entry or exit of human organs from Spain for transplantation will be the subject of prior authorization by the Ministry of Health and Consumer Affairs. It is up to the National Transplant Organisation to exercise this competence, which will be governed by the following criteria:

1. Entry of human organs in Spain: the National Transplantation Organization will admit human organs whenever it is carried out through the connection with a legally recognized organ exchange organization in the country of origin. In addition, it must be noted that the body meets the ethical and health guarantees required in Spain and that the following circumstances are present:

a) The organ comes from a deceased donor.

b) Appropriate receiver exists in Spain.

(c) A report is available from the foreign extractor centre where studies have been carried out on the donor needed to demonstrate the validity of the organ and the absence of communicable disease liable to constitute a risk. for the receiver.

2. Departure of human organs from Spain: the National Transplantation Organization will admit the departure of human organs whenever it is carried out through the connection with a legally recognized organ exchange organization in the country of destination. In addition, the following circumstances should be noted:

a) The organ comes from a deceased donor.

b) There is no suitable receiver in Spain.

c) An appropriate receiver exists in the target country.

3. The powers of the State in this matter may, where appropriate, be the subject of a discharge in accordance with the terms laid down in Article 15 of Law No 30/1992, the Legal Regime of Public Administrations and the Administrative Procedure. Common.

CHAPTER IV

Organ Transplantation

Article 15. Requirements for authorizing human organ transplantation.

1. The transplantation of human organs may only be carried out in approved centers, with the prior written consent of the recipient or his legal representatives, as provided for in Article 10.6 of Law 14/1986, General of Health, and prior to information of the risks and benefits involved in the intervention, as well as of the studies that are technically appropriate for the type of transplant in question in each case.

2. The document setting out the informed consent of the recipient shall include: name of the health centre, the date of its authorisation to perform transplants and the name of the recipient and, where appropriate, the name of the representatives authorising the recipient. transplantation. The document will have to be signed by the doctor who informed the recipient and by himself or his representatives. The document will be archived in the patient's medical history and will be made available to the patient.

3. In the clinical history of the recipient, the necessary data will be collected to identify the donor, the organ and the hospital center from which the transplanted organ comes, with the corresponding alphanumeric keys that guarantee the anonymity and confidentiality, as provided for in Article 5 (3) and (4

.

4. The person responsible for the medical or surgical unit in which the transplant is to be carried out may only agree if there are reasonable prospects for substantially improving the vital prognosis or the living conditions of the recipient, and that the have performed between donor and recipient the studies which are technically appropriate for the type of transplantation in question.

Article 16. Procedure for granting, renewing and extinguishing the authorization of organ transplant centers.

1. Human organ transplantation shall be carried out in health centres which have been specifically authorised for each of its modalities by the competent health authority of the Autonomous Community concerned.

2. Without prejudice to the specific rules laid down in each Autonomous Community, the application for authorisation shall contain:

a) The type of transplant to perform.

b) The relationship of physicians responsible for the transplant team, as well as the documentation supporting their qualification.

c) Memory with the detailed description of the means available to the center, in accordance with the requirements required to perform the corresponding activity.

3. Duration: authorization granted shall be valid for a period of validity, at the end of which it may be renewed, subject to a finding by the health authority of the Autonomous Community that the conditions and requirements which gave rise to the granting of the same. In no case shall it be automatically extended.

4. Amendments: any substantial modification which takes place under the conditions, structure, responsibility or operation of the centre must be notified to the health authority of the Autonomous Community and may give rise to the revision of the the authorization and even, considering the transcendence of such modifications, could become the extinction of the same even if the period of validity has not expired.

5. The health authority of the Autonomous Community may, in the light of the results obtained in the transplants performed by the centre, reconsider the authorisations granted.

6. The Autonomous Communities shall notify the Ministry of Health and Consumer Affairs of the decisions which they adopt in relation to the transplantation centres of human organs which are governed by this provision and which must appear in the General Register of Health Centers, Services and Facilities.

7. Human organ transplantation centres shall provide the competent authority of the Autonomous Community with all the information requested to them in relation to the activity for which they have been authorised.

8. The different organ transplantation modalities that exist or may appear as a result of scientific-technical development may be contemplated in the following three situations:

(a) Modes expressly authorized, through the regulations, by the Ministry of Health and Consumer Affairs, in which the technical requirements and minimum conditions to be met by the centres and services that go to carry out them: the health authority of the Autonomous Community, which, after having verified compliance with those conditions and requirements, may, according to its own discretion, grant the authorization.

(b) Modes for which there is no express regulation by the Ministry of Health and Consumer Affairs or regulations of the Autonomous Community concerned: the health authority of the Autonomous Community that corresponds to allow a specific centre and service for its development on a provisional basis, and the decision taken must be communicated to the Ministry of Health and Consumer Affairs.

(c) Modes for which there is an express regulation by the Ministry of Health and Consumer Affairs in which its initiation is prohibited or its development is suspended: such prohibition or suspension shall be dictated by the Ministry of Health Health and Consumer Affairs, hearing or on a proposal from the entities or societies of a scientific nature that are relevant in each case, and in consideration of special circumstances of risk to patients.

The health authorities of the Autonomous Communities shall not grant or withdraw authorisations which they may have granted to the centres and services in those forms expressly prohibited or suspended.

9. Extinction or suspension of the authorisation: the authorisation of the centres to transplant human organs may be revoked or suspended as provided for in Article 37 of Law 14/1986 of 25 April, General of Health.

Article 17. Human organ transplant centers: minimum general requirements.

Transplantation of human organs may only be performed in healthcare facilities that have specific authorisation for their practice in accordance with the requirements set out in the previous article.

In order to be authorised, human organ transplant centres must meet the following minimum general requirements:

1. To be authorised as an extractor centre for deceased donor organs and to demonstrate sufficient activity to ensure the viability and quality of the transplant programme.

2. Have a health organization and a proper functioning system to perform the requested intervention.

3. Have the necessary health services to ensure the proper performance, monitoring and correct treatment of any complications that the practice of this transplant requires.

4. Have the appropriate medical and surgical unit with sufficient health personnel and with proven experience in the type of transplant in question.

5. Ensure the availability of specialists with proven expertise in the diagnosis and treatment of transplant complications to develop.

6. To have the necessary facilities and material to ensure an adequate transplantation process, both in the preoperative and in the intervention itself and the postoperative period.

7. To have a pathological anatomy service with the technical and human means necessary for the study of complications associated with transplantation and to be able to carry out the possible postmortem studies.

8. Have a microbiology laboratory where the controls of the infectious complications presented by the patients can be carried out.

9. Have a Transplant Commission and those protocols that ensure the adequate selection of the recipients, the transplantation process and the immediate and long-term post-operative follow-up that guarantee the quality of the entire procedure therapeutic.

10. Have a hospital coordination unit for transplants.

11. Have a register, restricted and confidential access, where they will consist of the transplants carried out with the precise data for the identification of the donors, in such a way as to allow in necessary the appropriate follow-up of the organs transplanted in the center.

12. To have an adequate register to evaluate the activity of the transplants performed in the center, as well as the results obtained.

13. To ensure the availability of an immunology laboratory and a histocompatibility unit with the necessary technical and human resources to ensure the correct performance of the immunological studies necessary for pre and post-transplant.

14. The medical and surgical units involved in the different types of transplants will, at all times, adapt to the scientific progress existing in the field and will follow updated diagnostic and therapeutic protocols according to the generally accepted medical practice.

Article 18. Human organ transplant centers: minimum specific requirements.

In addition to the general requirements set out in the previous article, human organ transplant centres must meet the minimum specific requirements set out in Annex II to this Royal Decree, for the modes that are detailed in it.

CHAPTER V

From interterritorial coordination of activities related to donation and transplantation

Article 19. National Transplant Organization.

1. The National Transplant Organisation, which is responsible for the exercise of the powers of the Ministry of Health and Consumer Affairs in the field of organ procurement and transplantation, is constituted as the operational technical unit which, following the principles of cooperation, effectiveness and solidarity, aims to coordinate the activities of donation, extraction, preservation, distribution, exchange and transplantation of organs and tissues in the whole of the Spanish healthcare system.

2. The National Transplant Organization is attached to the Ministry of Health and Consumer Affairs through the Department's Secretariat and will be headed by a National Coordinator, appointed by the Minister of Health and Consumer Affairs, with the rank of Deputy Director. general.

3. The Ministry of Health and Consumer Affairs shall assign to the National Transplant Organization the means necessary for the development of its activities, including support structures and organizations, which are endowed with the flexibility and autonomy that requires the most efficient exercise of its functions.

4. The National Transplant Organization will coordinate its activities with the existing coordination structures in the Autonomous Communities.

5. Without prejudice to the competences of the Autonomous Communities, the National Transplant Organisation shall carry out the following activities:

a) Coordination of the distribution and exchange of organs and tissues for transplantation.

b) Updating and managing national-wide waiting lists for organ and tissue transplants.

c) Coordination of the logistics of the transport of transplant and organ equipment and/or human tissues for transplantation.

d) Promotion of studies and research that can advance knowledge and technologies related to organ and tissue procurement and transplantation.

e) Collection, analysis, elaboration and dissemination of data on organ and tissue extraction and transplantation activity.

f) Development and maintenance of records of origin and destination of organs and tissues obtained for the purpose of transplantation.

g) Establishment of measures to ensure the quality and safety of organs and tissues obtained for transplantation.

h) Information, promotion and dissemination of organ and tissue donation and transplantation activities to health administrations, healthcare professionals, social agents and the general public.

i) Promotion of the continuing training of health personnel performing these activities.

j) Cooperation with similar international organizations and organizations in all actions that are agreed to be considered beneficial in the field of transplants.

k) Those other functions that may be assigned to you by the Interterritorial Council of the National Health System.

Article 20. Regional, sectoral and hospital units of transplants.

1. The Autonomous Communities shall establish units for the autonomic coordination of transplants, led by an autonomic coordinator, appointed by the competent authority in each case. These units will collaborate in the fulfilment of the general objectives set by the Permanent Transplant Commission of the Interterritorial Council of the National Health System.

It is up to the Autonomous Communities to provide the infrastructure and means to the autonomous units for the proper development of their functions.

2. In those Communities deemed necessary, sectoral coordination units may be established.

3. Hospital coordination units, with the necessary infrastructure and means, shall be established in all approved centres for the removal and transplantation of organs and tissues.

Article 21. Permanent Transplant Commission of the Interterritorial Council of the National Health System.

1. The Permanent Transplant Commission will be the National Health System's advisory committee on organ and tissue donation and transplantation. This Commission will depend on the Interterritorial Council of the National Health System, to which it will have to give specific account of its activities.

2. The Chair of the Permanent Transplant Commission of the Interterritorial Council will be appointed, on a proposal of the Permanent Commission of Transplants, by the Minister of Health and Consumer in his capacity as President of the Interterritorial Council of the National Health System, a body to ratify such appointment.

3. This Commission shall be composed of the national transplant coordinator and the regional transplant coordinators of each Autonomous Community.

CHAPTER VI

Of inspection, supervision and precautionary measures and of violations and sanctions

Article 22. Inspection, supervision of activities and precautionary measures.

1. The inspection and supervision of the transplant coordination units and centres involved in the procedures of the extractor and/or transplant activity correspond to the competent authority of the Autonomous Community. To this end, the units and centres shall provide all the information in the form and manner in which it is requested in relation to the activity for which they have been authorised.

2. If a performance or irregular situation is detected which could compromise the health and/or safety of patients, the preventive and precautionary measures referred to in Articles 5.4, 12 and 16 of this Royal Decree shall be adopted, and immediately notify the relevant Autonomous Coordination Unit and the National Transplant Organisation in order to take appropriate action.

Article 23. Infringements and penalties.

In the violations of the use of files containing personal data, the provisions of Title VII of the Organic Law 15/1999 of 13 December of the Protection of Personal Data, and in the other aspects, as laid down in general, in Chapter VI of Title I of Law 14/1986 of 25 April, General of Health.

Additional disposition first. Basic character.

Without prejudice to its possible impact in the field of personality rights, this Royal Decree is of a basic standard, in accordance with the provisions of Article 2.1 and paragraphs 7, 8, 9 and 13 of the Article 40 of Law 14/1986, of 25 April, General of Health, pursuant to Article 149.1.16.a of the Constitution, except for Article 14 which is issued under the exclusive competence of the State in the field of external health.

Additional provision second. Transplant benefits in the National Health System.

Paragraph 3.5.o j) (specialized care) of Annex I to Royal Decree 63/1995 of 20 January on the management of health benefits is amended as regards the performance of transplants from the National System of health, which will have the following wording:

"j) Transplants of organs, tissues and cells of human origin, in accordance with the legislation expressed in the field, and provided that they have proven therapeutic efficacy."

Additional provision third. Transport of potentially hazardous material.

In the transport of potentially infectious organs or in need of dangerous substances for conservation, the provisions contained in national and international regulations on the transport of dangerous goods.

Additional provision fourth. Assessment and accreditation of centres and services.

In the development of the provisions of article 19 of this Royal Decree and in the exercise of the powers laid down in article 70.2.d) of Law 14/1986, General of Health, the National Organization of Transplants -with the agreement of the Permanent Transplant Commission of the Interterritorial Council, and at the request of the different Health Administrations of the Autonomous Communities and Health Services, may act as a technical entity for the evaluation and accreditation of the centres and services authorised under the provisions of this Royal Decree.

Additional provision fifth. Removal of organs.

In order to provide the necessary resources for the formation of the National Transplant Organization, as provided for in this Royal Decree, the Subdirectorate General of Programs of the National Transplantation is deleted. General Secretary for Health Care at the Ministry of Health and Consumer Affairs.

Single transient arrangement. Survival of the authorization for human organ transplantation and extraction centers.

The centers that have granted the authorization for the currently existing modalities of development of extraction and transplantation of human organs will not need new authorization, according to the norms contained in the present Real Decree, until the end of the period of validity of your current authorization. In any event, at the request of the Centre or by order of the Autonomous Community, the authorisation procedure provided for in this text may be applied immediately.

Single repeal provision. Regulatory repeal.

As soon as they may be in force, the following provisions are repealed:

1. Royal Decree 426/1980, of 22 February, for which Law 30/1979, of 27 October, is developed on the extraction and transplantation of organs.

2. The Resolution of 27 June 1980, of the Secretariat of State for Health, implementing the Regulation of Law 30/1979 of 27 October on the removal and transplantation of organs.

3. Articles 1 to 15, inclusive, of the Resolution of 27 June 1980, of the Secretariat of State for Health, on the National Transplant Organisation and the laboratories of histocompatibility.

4. Order of 25 August 1980, from the Ministry of Health and Consumer Affairs, for the creation of the Transplant Advisory Commission.

5. Order of 29 November 1984, from the Ministry of Health and Consumer Affairs, determining the basic and common minimum criteria for the accreditation of centers for the practice of heart and heart transplants.

6. Order of 7 March 1986, from the Ministry of Health and Consumer Affairs, on the appointment of the transplant coordinator in Social Security hospitals.

Final disposition first. Exclusions.

Are excluded from the scope of this Royal Decree:

(a) Without prejudice to the provisions of Chapter V of this Royal Decree, the extraction and implantation of human tissues, which shall be governed by the provisions of Royal Decree 411/1996 of 1 March 1996 on the activities related to the use of human tissues. The umbilical cord and the hematopoietic progenitors obtained through it are not considered waste products and are also subject to the aforementioned Royal Decree 411/1996.

(b) The hemodonation, blood and human plasma, blood banks and medical devices, which are regulated by Royal Decree 1945/1985 of 9 October; Royal Decree 478/1993 of 2 April; Royal Decree 1845/1993 of 22 October, and other special provisions in the field.

(c) Human embryos and foetuses, their cells, tissues and organs, which are governed by the provisions of Law 42/1988 of 28 December 1988 on the donation and use of human embryos and foetuses or their cells, tissues or organs; and other special provisions in the field.

(d) The gametes, which are governed by the provisions of Law 35/1988 of 22 November on assisted reproduction techniques and other special provisions in the field.

e) The mere procurement of human substances, organs or tissues for the sole purpose of conducting clinical studies and analyses or other diagnostic or therapeutic purposes.

f) Hair, nails, placenta and other human waste products.

g) The realization of clinical autopsies, as established in Law 29/1980, of 21 June, which regulates the clinical autopsies, and in Royal Decree 2230/1982, of June 18, which develops it.

h) A person's donation/consent so that their corpse can be used for study, teaching or research.

Final disposition second. Public expenditure.

The constitution of the National Transplant Organization, as a management body, with a rank of Subdirectorate General, and the approval of its employment relationship, to be carried out jointly by the Ministries of Economy and Finance and Public Administrations, within the Executive Committee of the Inter-Ministerial Commission on Remuneration, will not lead to an increase in public spending.

Final disposition third. Updates to the diagnostic and death certification protocols for organ removal in deceased donors.

The Ministry of Health and Consumer Affairs will update the protocols for the diagnosis and certification of death for the removal of organs from deceased donors listed in Annex I to this Royal Decree, according to the progress of the Scientific and technical knowledge in the field, after the opinion of the Permanent Transplant Commission of the Interterritorial Council of the National Health System. These updates will be the subject of enactment and publication in the "Official State Gazette."

Final disposition fourth. Entry into force.

This Royal Decree shall enter into force on the day following that of its publication in the "Official Gazette of the State".

Given at Arrecife at December 30, 1999.

JOHN CARLOS R.

The First Vice President of the Government and Minister of the Presidency,

FRANCISCO ALVEZ-HELMETS FERNANDEZ

ANNEX I

Diagnostic protocols and death certification for the removal of organs from deceased donors

1. Diagnosis and certification of death.

A person's diagnosis and certification of death will be based on confirmation of irreversible cessation of cardiorespiratory functions (death by stop-cardiorespiratory) or brain function (death). (encephalic), as provided for in Article 10 of this Royal Decree.

2. Diagnostic criteria for brain death:

1. Diagnostic conditions: Coma of known and irreversible etiology. There should be clinical evidence or neuroimaging of destructive injury to the central nervous system compatible with the brain death situation.

2. Neurological clinical exploration:

1. The diagnosis of brain death always requires the realization of a neurological exploration that must be systematic, complete and extremely rigorous.

2. º Immediately before starting the neurological clinical examination, it is necessary to check whether the patient presents:

a) Hemodynamic stability.

b) Proper Oxigation and ventilation.

c) Body temperature < 32 ºC.

d) Absence of metabolic alterations, substances or central nervous system depressant drugs, which may cause coma.

e) Absence of neuromuscular blockers.

3. The three fundamental findings in neurological exploration are as follows:

a) Coma arreactive, without any motor or vegetative responses to the algesic stimulus produced in the territory of the cranial nerves; there must be no posturing or decortication postures.

b) Absence of troncoencephalic reflexes (reflexes, fotomotor, corneal, oculocephalic, oculovestibular, nausea, and tusigene) and cardiac response to the intravenous infusion of 0.04 mg/Kg of atropine sulfate (test of atropine).

c) Apnea, demonstrated by the "apnea test", by checking that there are no chest or abdominal respiratory movements during the time of disconnection of the respirator sufficient for the PC02 in arterial blood to be higher to 60 mm of Hg.

4. The presence of motor activity of spontaneous or induced spinal origin does not invalidate the diagnosis of brain death.

5. º Conditions that hinder the clinical diagnosis of brain death.

Certain clinical situations may hinder or complicate the clinical diagnosis of brain death by preventing neurological exploration from being performed in a complete or necessary safety. Such conditions are:

a) Patients with severe craniofacial massif damage or any other circumstance that prevents the exploration of troncoencephalic reflexes.

b) Intolerance to the apnea test.

c) Hypothermia (core temperature below 32 °C).

d) Intoxication or prior treatment with high doses of drugs or central nervous system depressants.

e) Children under one year of age.

3. Period of observation: The observation period should be assessed individually, taking into account the type and severity of the injury, as well as the instrumental tests performed.

Whenever the diagnosis is clinical only, it is recommended to repeat the neurological scan according to the following periods:

a) At six hours: in cases of known destructive injury.

b) At twenty-four hours: in cases of anoxic encephalopathy.

c) If drug or central nervous system depressants are suspected or present, the observation period should be prolonged, at the medical discretion, according to the average life of the drugs or substances present. and to the general biological conditions of the patient.

The observed observation periods may be shortened to medical criteria, according to the diagnostic support instrumental tests performed (see paragraph 4).

4. Diagnostic support instrumental tests: From a scientific point of view they are not mandatory, excluding the following situations:

1. Those referred to in paragraph 2.5.

2. Absence of demonstrable destructive brain injury due to clinical evidence or neuroimaging.

3. When the causal injury is primarily infratentorial.

However, in order to complement the diagnosis and shorten the observation period, it would be advisable to perform some instrumental test.

In the particular case that the etiology causing the coma is of an infratentorial location, the instrumental test to be performed must demonstrate the existence of irreversible lesion of the cerebral hemispheres (electroencephalogram or blood flow test).

1. The number and type of test diagnostic tests to be used must be assessed individually, taking into account the particular characteristics of each case and the diagnostic contributions of the techniques used. Diagnostic instrumental tests are of two types:

a) Tests that evaluate the neural function:

1. Electroencephalography.

2. Evoked Potentials.

b) Tests that assess brain blood flow:

1. Cerebral Arteriography of the 4 Vessels.

2. Cerebral Angiography by digital subtraction (arterial or venous).

3. Brain Angiogammagrafia with radiopharmaceuticals able to cross the intact blood-brain barrier.

4. Transcranial doppler sonography.

In the future, diagnostic support instrumental tests that credit absolute diagnostic assurance may be added.

2. Uncomplicated brain death diagnosis.

Before a known cause coma, and once excluded the existence of situations that could make it difficult to diagnose (paragraph 2.5.), a patient who presents a clinical examination of brain death and a test A conclusive diagnostic support instrument may be diagnosed with brain death, without having to wait for the observation period referred to in paragraph 3.

3. Diagnosis of brain death in special situations.

In those clinical conditions where there are circumstances that hinder or complicate clinical diagnosis (section 2.5), when there is no demonstrable brain-destructive injury due to clinical evidence or neuroimaging and where there is a causal injury that is primarily infratentorial, in addition to the neurological examination, at least one confirmatory diagnostic support test must be performed.

4. Children born, infants and children:

a) The clinical diagnosis of brain death in newborns, infants and children is based on the same criteria as in adults, although with some peculiarities. Neurological exploration in neonates and small infants should include the suction and search reflexes. In neonates, especially the preterm, clinical exploration must be repeated several times, as some of the trunk reflexes may not have developed or are emerging, which makes these reflexes very vulnerable.

b) The observation period varies with age and with instrumental tests performed:

1. Neonates Preterm: Although there are no internationally accepted recommendations, two clinical scans and two separate electroencephalograms should be performed for at least forty-eight hours. This observation period may be reduced if a diagnostic test is performed showing no cerebral blood flow.

2. A term of up to two months: two clinical scans and two separate electroencephalograms for at least forty-eight hours. This observation period may be reduced if a diagnostic test is performed showing no cerebral blood flow.

3. From two months to one year: two clinical scans and two separate electroencephalograms for at least twenty-four hours. The second clinical examination and the electroencephalogram may be omitted if demonstrated by a diagnostic test for the absence of cerebral blood flow.

4. Between one and two years: two separate clinical scans for twelve hours (in the presence of a destructive injury) or twenty-four hours (when the cause of the coma is ischemic anoxic encephalopathy). These observation periods can be reduced if we have an additional diagnostic test.

3. Diagnosis of death by cardiorespiratory arrest.

1. Diagnosis:

1. The diagnosis of death by cardiorespiratory criteria will be based on the unequivocal observation of the absence of a heartbeat, demonstrated by the absence of central pulse or by electrocardiographic tracing, and No spontaneous breathing, both for a period of not less than five minutes.

2. The irreversibility of the cessation of cardiorespiratory functions should be observed after the appropriate period of application of advanced cardiopulmonary resuscitation maneuvers. This period, as well as the maneuvers to be applied, will be adjusted depending on the age and circumstances that led to the cardiorespiratory arrest. At all times, the steps specified in the advanced cardiopulmonary resuscitation protocols periodically published by the competent scientific societies should be followed.

3. In cases of body temperature below 32 degrees the body must be reheated before the irreversibility of the stop can be established and therefore the diagnosis of death.

2. Feasibility and preservation maintenance maneuvers.

The team in charge of the preservation or extraction procedure will only initiate their actions when the medical team responsible for the cardiopulmonary resuscitation process has left the written record of death, specifying the time of death.

In cases where judicial authorization is required as specified in Article 10 of this Royal Decree, it shall proceed as follows:

(a) The blood flow maintenance maneuvers may be resumed to the organs and the appropriate communication to the court of instruction on the existence of a potential donor will be made.

(b) After the positive response of the court or after 15 minutes without a negative response, the removal of a blood sample of 20 cc and if possible of 20 cc urine and 20 cc of juices may be carried out. Gastric (according to the attached protocol of chain of custody), which will be made available to the Court of Instruction. The preservation maneuvers will be initiated later.

c) Once the corresponding judicial authorization has been obtained, as set out in Article 10 of this Royal Decree, the removal of organs may be carried out.

ANNEX II

Specific requirements of organ transplant centers

1. The specific requirements of organ transplant centres shall be as follows:

a) For the performance of renal transplants: having a nephrology unit, and urology and/or general and digestive surgery and/or vascular surgery with sufficient staff and with demonstrated experience to guarantee the correct performance of these transplants and the proper monitoring, diagnosis and treatment of any complications of these patients.

b) To perform cardiac transplants: to have a cardiology and cardiac surgery unit with sufficient staff and with demonstrated experience in cardiac surgery that requires extracorporeal circulation and the the availability of a hemodynamic unit with the necessary experience in invasive cardiology techniques to ensure the correct performance of these transplants and the proper follow-up and treatment of the possible complications of these patients.

c) For the performance of lung transplants: having a unit of pneumology and thoracic surgery with sufficient staff and demonstrated experience in lung surgery and the availability of performance tests respiratory necessary to ensure the correct performance of these transplants and the proper diagnosis and treatment of the possible complications of these patients.

d) For the performance of heart-lung transplants: the centers must meet the specified requirements for the completion of cardiac and pulmonary transplants.

e) To perform liver transplants: to have a gastroenterology-hepatology and general surgery and digestive unit with sufficient staff and demonstrated experience in hepatobiliary surgery to ensure the correct performance of these transplants and the proper monitoring, diagnosis and treatment of any complications of these patients.

f) For the performance of pancreatic transplants: have a unit of endocrinology and general and digestive surgery or urology with sufficient staff and with demonstrated experience in hepatobiliary-pancreatic surgery for ensure the correct performance of these transplants and the proper monitoring, diagnosis and treatment of any complications of these patients.

g) To perform intestinal transplants: have a gastroenterology and general surgery and digestive unit with sufficient staff and demonstrated experience in intestinal surgery to ensure the correct the performance of these transplants and the proper monitoring, diagnosis and treatment of any complications of these patients.

2. In order to perform any other multiple organ transplant, it is essential to be authorized as a transplant center for each organ to transplant.

3. For the case of child transplants, it is necessary to have a specific authorisation from the centre, taking into account the availability of appropriate means and the optional staff with sufficient experience to do so.