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General Provisions On Organ Transplants, Tissues And Cells


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image start infoleg site The Ministry of Justice and Human Rights

Act 27447

General Provisions.

The Senate and Chamber of Deputies of the Argentine Nation, meeting in Congress, etc.


Law on Transplantation of Organs, Tissues and Cells

Chapter I

General Provisions

Article 1-Object. This law aims to regulate the activities related to the obtaining and use of organs, tissues and cells of human origin, throughout the territory of the Argentine Republic, including research, promotion, donation, extraction, preparation, distribution, transplantation and monitoring.

Article 2-Scope of application.

1. This law applies to the practices currently being carried out and to the new techniques which the implementing authority recognises, in accordance with the provisions of the rules.

2. The implant of organs, tissues and cells must be performed when the other means and resources available have been exhausted, insufficient or inconvenient or the best therapeutic alternative for the patient's health, according to the scientific evidence.

3. The characteristics of the cells covered by this law should be determined in the regulations.

4. Excluded:

(a) the naturally renewable or separable tissues and cells of the body, as detailed in the regulations;

(b) blood and blood components for transfusion purposes covered by the specific legislation;

(c) germ cells and tissues for the purpose of assisted human reproduction;

d) Cells to be used in basic research.

Art. 3 °-Principles. This law is part of the following principles:

1. Respect for human dignity in all its dimensions.

2. Respect for the autonomy of the will as an ethical and legal basis for all medical intervention.

3. Solidarity and distributive justice in the allocation of organs, tissues and cells.

4. Equity in access to transplant treatments.

5. Extraordinary human body, organs, tissues and cells.

6. The integral care of the transplanted patient.

7. The observance of ethical principles in the development and promotion of all research activities linked to transplantation, based on scientific advances.

8. Self-sufficiency, understood as the development of policies and strategies to maximize the availability of organs, tissues and cells, in order to ensure the progressive decrease in waiting lists.

9. Volunteering, altruism and gratuitousness in donation.

Chapter II

Of the Rights of Persons Linked to the Transplantation of Organs, Tissues and Cells

Art. 4 °-Rights of donors and recipients of organs, tissue and cells.

a) Right to privacy, privacy and confidentiality. In the treatments regulated by this law, the privacy of the persons involved and the confidentiality of the information and personal data are respected. The competent authority may not disclose the identity of donors and recipients. Except for cases where the individual, in public, free and voluntary form, manifests as a giver or a recipient.

b) Right to integrity. Practices linked to transplantation should not pose risks or burdens to human beings that are disproportionate to their potential benefits. The importance of the likely benefits of the practice must be greater than the risks or costs to the human being.

(c) Right to information. The persons involved in the practices regulated by this law must be informed in a clear and adapted manner to their cultural level about the risks, the consequences evolution and possible complications of the medical procedures to be carried out.

(d) the right to equal and equal treatment. Donors and recipients are entitled to equal treatment without discrimination.

(e) the right to comprehensive coverage of treatment and follow-up in the terms of the rules in force.

(f) the right to priority transfer by air or land, together with an accompanying person, of persons who are required to be transferred for transplantation in the terms of the regulation.

Chapter III

Of the Professionals

Article 5-Requirements. The medical acts referred to the donation and transplantation process referred to in this law must be performed by physicians or teams of registered health professionals and authorized to the effect by the respective authority of comptroller (a) in accordance with the requirements laid down in this respect by the INCUCAI. The authority of the court or tribunal is liable for any damages arising from the registration of persons who have not complied with such fees.

Health team professionals should provide all the information in the form and manner in which they are requested in relation to the activity for which they have been authorized.

Art. 6 °-The teams of health professionals must be in charge of a chief medical officer to whom he will eventually replace a deputy chief medical officer, according to the norms that to this effect dictate the INCUCAI, being its members jointly responsible for the compliance with this law.

Art. 7 °-The authorization of heads, subchiefs and professionals of the health team must be granted by the corresponding judicial health authority, which must inform the national health authority in order to maintain the system integrity.

Article 8-Obligation to notify. Medical professionals who perform dialysis treatments or who indicate to a patient the performance of a transplant must register these circumstances in accordance with the rules that the National Central National Institute may dictate. Coordinator of Ablation and Implant (INCAÇAI).

Chapter IV

Of the Services and Establishments

Article 9-Requirements. The medical acts referred to in this law must be carried out in the field of medical establishments authorized by the respective authority of judicial comptroller, in accordance with the rules that the INCAÇAI dictates.

For the purposes indicated, laboratories are considered to be included for the classification of antigens in the major complex of histocompatibility of donors and receptors, tissue and cell banks for transplantation.

The authority of the court or tribunal is jointly and severally liable for the damage arising from the registration of establishments which have not complied with those expressed.

Establishments enabled under this law must have a permanent training regime for personnel affected by the transplant activity, which provides for specific training at all stages of the process. donation-transplant.

The establishments must 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.

Art. 10.-Vigence of registration. The validity of the registration referred to in the previous article cannot be greater than two (2) years. Its renewal can only be carried out after inspection of the establishment by the authority of judicial comptroller and accreditation by the authority of the same to continue counting with the retreads mentioned in the previous article. Successive renewals shall be valid for equal periods. The authority of the court is jointly and severally liable for the damages resulting from the renewal of registration of establishments without the requirements of this article being met.

Art. 11. Liability. The institutions in which doctors or health teams develop their transplanted activity are responsible for the scope of this standard.

Art. 12. Registration. Establishments which have been authorised to carry out transplanting treatments must register the medical acts referred to in this law which are carried out in their field, in accordance with the rules laid down for that purpose by the INNCOI.

Art. 13.-Alterations. The services or establishments authorized for the purposes of this law, cannot produce modifications or alterations that imply diminishing, restricting or changing the conditions accredited to the purposes of the habilitation.

Chapter V

Services of Attorney

Art. 14. The establishments that meet the characteristics defined in the regulations, must have services for the donation of organs and tissues, which will guarantee the correct detection, evaluation and treatment of the donor.

Art. 15. Public, private and social security establishments should promote the permanent training of staff affected by the donation process, for which they can carry out cooperation and technical assistance agreements. with national, provincial or municipal health authorities.

Article 16. Procurination Services. The services referred to above must, as a minimum, count on a specialised professional who performs or coordinates the following functions:

a) Detection, evaluation and treatment of potential donors.

b) Provide families with complete and accurate information on organ and/or tissue donation, and their health and social relevance.

(c) Ensure the development of the donation-transplantation process in the framework of the existing rules and programmes.

d) Generate promotion, dissemination and training actions within the institution.

Chapter VI

From the Prior Medical Information to Donors and Recipients

Article 17.-The heads and deputy heads of the teams, as well as the professionals referred to in Article 6, must provide the living donors and the recipients of the health information, precise, complete and appropriate on the procedure the expected benefits, risks, inconvenience and foreseeable adverse effects, in a whole according to the current regulations.

Art. 18.-Incapacity of the patient. In the case of a recipient in a situation of incapacity or restricted capacity, the information must be provided to the patient in the presence of his legal representative or curator.

Art. 19. Informed consent in transplants with living donor. Donors and recipients, or in their case the legal representative, must provide free and voluntary informed consent in a whole according to the current regulations. In the event that they do not object, the information must be provided to their family group.

Art. 20.-Registration. From the information provided and the informed consent must be recorded in the clinical histories of the donor and recipient, in the form and modality arranged in the regulations.

Chapter VII

Of the Acts of Disposition of Organ, Tissue and Cells Coming from Persons

Art. 21.-Enabling condition. The removal of organs, tissues and cells for the purpose of transplantation between persons concerned in accordance with the provisions of the following Articles is permitted only where it is considered that, reasonably, it does not cause serious harm to the health of the donor and there are prospects for success in preserving life or improving the health of the recipient.

Art. 22.-Limitation. The ablation of organs and tissues in life for transplantation purposes will only be allowed for a capable person over eighteen (18) years, who can only authorize it in the event that the recipient is his or her consanguineal relative or the fourth grade, or their spouse, or a person with whom they maintain a convivencial union, in accordance with the rules in force. In all cases, the favourable opinion of the professionals in charge of the transplanting is indispensable.

Art. 23.-Cross-donation. In the event that a donor/recipient couple does not meet the conditions of compatibility required to carry out a kidney transplant, cross-donation with another couple is permitted under the same conditions. The donor and recipient of each donor must be related to each other in accordance with the links set out in the previous article. The INCACAI must dictate the rules for the operation of a Cross-Kidney Donation Register, in which the requirements for the development of the activity described will be established. The regulations may incorporate other practices according to scientific medical progress.

Article 24-Deadline. In the cases provided for in this Title, the intervention may be carried out only after the period of 40-eight (48) hours from the supply of the information to donors and recipients, or, where appropriate, to legal representatives, under the conditions laid down in this law.

Art. 25.-Respect of the documentation and registration. All actions must be documented and recorded in accordance with the rules that the INCUCAL will dictate to this effect.

Art. 26.-Hematopoietic Progenitor Cell Donor (CPH). In the scenario of implantation of CPH, any person capable of more than eighteen (18) years may be able to be a donor without the kinship limitations set out in Article 22 of this Law. Children under eighteen (18) years prior to the authorization of their legal representative, may be donors only when they bind the recipient a kinship of those mentioned in the aforementioned precept.

Art. 27. Revocation of consent. In all cases, the consent provided for the ablation or for implantation can be revoked until the very moment of the surgical intervention, while the ability to express his will, without any responsibility, is preserved. Likewise, the retraction of the giver generates no obligation of any kind.

Art. 28. In no case shall the expenses associated with the ablation and/or the implant and subsequent medical treatment be borne by the giver or his successors. Such expenditure must be covered by the institutions responsible for the social or health coverage of the recipient, or if the recipient does not have it.

Art. 29. The inassists in which the giver incurs, on the occasion of ablation, his work and/or studies, as well as the situation in excess thereof, are governed by the provisions on the protection of diseases and accidents establish the legal orders, collective agreements or statutes governing the activity of the giver, always taking into question that provision which is more favourable to him.

Art. 30. When, for therapeutic reasons, it is essential to abate living organs or tissues that may be implanted in another person, the provisions governing bodies from corpses apply. The rules of procedure shall determine the specific cases referred to in this paragraph. When a block cardiopulmonary transplant is performed from a cadaveric giver, the comptroller's authority may have the heart of the receiver for assignment in the terms provided for in this law.

Chapter VIII

Of the Acts of Disposition of Organ and/or Tissue to the Finances of the Donation

Art. 31. Requirements for donation. Demonstration. Every capable person, greater than eighteen (18) years can express:

a) Manifest your negative or affirmative will to the donation of the organs and tissues of your own body.

(b) to restrict in a specific way its affirmative determination to grant to certain organs and tissues.

c) To condition the purpose of the affirmative will of donation to some or some of the intended purposes in this law, implant in living human beings or for purposes of study or investigation.

Such expression of will must be expressed in writing, through the channels provided for in Article 32, and may also be revoked in writing at any time.

If the affirmative determination of donation is not restricted or the purpose of the donation is not conditioned, all organs and tissues, and both ends, are understood.

Art. 32.-Channels enabled. The channels enabled to receive the expressions of will provided for in the preceding article are as follows:

(a) National Central National Institute for Coordinating And Implementing (INNCAI).

b) National Register of Persons (RENAAPER).

c) Records of the Civil State and Capacity of Persons.

(d) Judicial Health Authorities, through the provincial agencies and public, private, or social security establishments authorized for this purpose.

e) Correo Oficial de la República Argentina Sociedad Anonima.

The INCAÇAÍ must coordinate with each of the institutions enabled the actions to record immediately the manifestations of will received, which in no case can have any cost for the declarant.

Regulations may establish other forms and modalities that facilitate expressions of their will.

Art. 33. Requirements for obtaining deceased donor organs and/or tissues.

The ablation of organs and/or tissues can be performed on any person capable of greater than eighteen (18) years, who has not left the express record of his opposition to the removal of his organs or tissues after his death.

If the will of the deceased is not registered, as provided for in Articles 31 and 32, the professional in charge of the donation process must verify the decision as determined by the regulations.

Art. 34.-Minors. In the event of the death of minors of eighteen (18) years, the authorization to obtain the organs and tissues must be carried out by both parents or by the one who is present, or the legal representative of the child.

The opposition of one of the parents eliminates the possibility of carrying out the extraction in the body of the child.

In the absence of the above mentioned persons, intervention should be given to the Ministry of Pupil who can authorize ablation.

Art. 35.-Supposed of violent death. In the event of a violent death, prior to the ablation of the organs and tissues, the authorization of the judge who understands in the case must be required, which must be provided with the prior intervention of the medical examiner, the police or the person who complies with the law. function, who should inform you if it does not affect the autopsian exam.

Within the four (4) hours of the death, the judge must inform the INCAÇAI or the relevant provincial body, the authorization conferred, through a judicial decision founded, with specification of the organs or tissues They may be ablected in accordance with the opinion of the coroner. The refusal of the intervener must be justified in accordance with the requirements of this law.

The INCUCAI, or the relevant provincial body, must inform the intervener judge, the conclusions of the donation-transplant process.

Art. 36. Certification of death. The death of a person may be certified after confirmation of the irreversible cessation of circulatory or brain functions. Both should be recognised by appropriate clinical examination after an appropriate period of observation.

Art. 37.-The clinical diagnostic criteria, observation periods and diagnostic tests required according to medical conditions, for the determination of the cessation of brain functions, should be adjusted to the established by the Ministry of Health of the Nation with the advice of the INCUCAI.

In the case of the preceding paragraph, the death certificate must be signed by two (2) doctors, including at least one (1) neurologist or neurosurgeon. None of them should be the doctor or team member who performs ablation or organ implants of the deceased.

The time of death of the patient is the one in which the diagnosis of death was completed.

Art. 38.-Aesthetic restoration. The establishment in which the ablation is carried out is obliged to:

(a) Arbitor all means at its disposal in order to restore the aesthetic of the corpse without any charge to the successors of the deceased.

(b) to carry out all the operations authorized within the shortest possible period of time for the successors of the deceased to have been requested to return the body.

(c) To confer at all times the body of the donor a dignified and respectful treatment.

Art. 39.-Notification. Any doctor who certifies the death of a person must initiate the donation process, in accordance with the rules that the INCUCAI dictates.

Chapter IX

Of the Bans

Art. 40.-Bans. The carrying out of any kind of extraction shall be prohibited in the following cases:

(a) Where the requirements and provisions of this Law have not been met.

(b) Where it is intended to be practised on the body of a woman of gestational age, without prior verification of the absence of the current pregnancy.

(c) Where the intervener is the person who has attended and treated the deceased during his last illness or who is diagnosed with his death.

(d) When the principles of voluntarism, altruism or gratuitousness are not respected.

Also prohibited: Any consideration or other benefit for the donation of organs, tissues or cells or intermediation for profit and the realization of any activity linked to this law without respecting the principle of confidentiality.

Chapter X

Of the Media

Art. 41.-Recommendations. The INCUCAI should make recommendations to the media on the responsible approach to news related to donation and transplantation, which will include among other issues, the following:

a) Respect for the confidentiality of the identity of donors and recipients.

b) The promotion of the donation, highlighting its solidarity, altruistic and selfless character, transmitting truthful and scientific information.

Art. 42. The advertising of orders for organs, tissues and cells for certain persons, as well as misleading advertising on therapeutic treatments that do not have scientific evidence, nor the proper authorization by part of the competent authority. Cases in which the individual or his family members, in public, free and voluntary form, manifest themselves are exempted from this prohibition.

Art. 43. Failure by the media to comply with the provisions of the preceding Articles should give rise to the intervention of the competent enforcement authority in order to assess the application of the sanctions which may be imposed. reciprocate.

Chapter XI

Of the Peñas

Art. 44. It shall be repressed with imprisonment of six (6) months to five (5) years and special disablement of two (2) to ten (10) years if the author is a health professional or a person who carries out health collaboration activities:

(a) The person who directly or indirectly provides or offers the benefit of heritage content or not, to a possible giver or third party, to obtain organs, tissues or cells.

(b) the person who, by himself or by an interposite, receives or requires for himself or for third parties any benefit of patrimonial content or not, or shall accept a direct or indirect promise for himself or for third parties, in order to obtain organs or tissues which are not their own.

(c) The purpose of the purpose of profit is to mediate in the procurement of organs or tissues, from persons or bodies.

Art. 45.-It shall be repressed with imprisonment of two (2) to six (6) years and special disablement of two (2) to ten (10) years, if the author is a professional of the art of curing or a person engaged in activities of collaboration of the art of curing who improperly extracted organs or tissue from dead bodies.

Art. 46. It shall be repressed with imprisonment or imprisonment of four (4) years to life for which the organs or tissues of living humans shall be removed, without complying with the requirements and formalities required in Article 22.

Art. 47.-It shall be repressed with a fine, according to the values determined by the regulations, and/or special disablement from six (6) months to two (2) years:

(a) The public officer who does not comply with the obligation imposed by Article 32.

(b) The doctor who does not comply with the obligation imposed by Article 8 °.

(c) He who does not comply with the provisions of Article 25.

Art. 48. It shall be subject to a fine, in accordance with the values determined by the rules, and special disablement of one (1) to three (3) years, the doctor who does not comply with the obligations laid down in Article 39. In case of reoffending the disablement will be five (5) years to life.

Article 49. Where it is established that the authors of the conduct under this Title have received sums of money or property in return for such actions, they shall also be liable to pay as a fine, the equivalent of double the amount of the perceived value.

Article 50.-When the authors of the conduct awarded in this title are public officials linked to the area of health, the respective penalties will be increased by one third in half. Where such conduct is carried out in the usual manner, penalties shall be increased by one third.

Chapter XII

Of the Administrative Sanctions and Procedures

Article 51-Infringements of an administrative nature to any of the activities or rules which are regulated in this order, in which private establishments or services are incurred, shall be liable to the following cumulative according to the severity of each case:

(a) Receipt.

(b) Fine, in accordance with the values laid down by the rules.

(c) Suspension of the entitlement to the service or establishment, for a term of up to five (5) years.

(d) temporary or permanent closure, partial or total, of the establishment in breach.

(e) Suspension or disablement of professionals or teams of professionals in the exercise of the activity referred to in Article 3 for a period of up to five (5) years.

(f) Disablement of up to five (5) years for the exercise of the profession to doctors and other professionals of the art of curing that practice any of the acts provided for in this law, without the authorization of the health authority.

In case of extreme gravity or reiteration, the disablement may be final.

Article 52-The penalties provided for in the preceding article are prescribed at two (2) years and the same is interrupted by the administrative or judicial acts or by the commission of any other infringement.

Art. 53. The administrative violations of this law and its regulations must be sanctioned by the judicial health authority, prior to summary, with a trial and defense hearing of the alleged offenders.

Art. 54. The failure to pay the fines applied makes it necessary for them to be charged through fiscal mediation, constituting sufficient executive title the authenticated testimony of the final conviction.

Art. 55. The proceeds of the fines imposed by this law on the judicial health authority must be entered into the Solidarity Fund for Transplants.

Chapter XIII

From the National Central Institute for the Coordinating and Implant Coordination (INCAÇAI)

Art. 56.-The National Central Institute for the Coordination of Public Law and Implant (INNCAI) works in the field of the Ministry of Health, as a state entity governed by public law, with legal status and institutional, financial and administration, is empowered to execute one hundred percent (100%) of the genuine revenue it receives.

Art. 57.-These are the functions of the National Central Institute for the Coordination of Discharge And Implante (INCAÇAI):

1. Promote the quality, safety and traceability of organ, tissue and cell donation and transplantation processes in the Republic of Argentina;

2. Promote and promote the donation and transplantation of organs, tissues and cells within the framework of the principles and rights set out in Articles 3 and 4;

3. Coordinate the necessary logistics and operability to ensure the proper functioning of the national donation and transplantation system;

4. With the advice of the Federal Transplant Commission (COFETRA), the technical standards to be used for the production and use of organs, tissues and cells for transplantation;

5. With the advice of the Federal Transplant Commission (COFETRA), the rules for the enabling of transplant establishments, laboratories for the establishment of HLA for donors and recipients, tissue and cell banks for purposes for the transplantation; and for the authorization of professionals and teams to carry out the practices in the framework of this law;

6. To enforce compliance with this law and its regulations and other complementary rules, and to collaborate in the implementation of laws related to the subject, recommending to the provincial governments to adapt their legislation and action to the compliance with these purposes;

7. Intervening the judicial bodies that incur acts or omissions that mean the non-compliance with the provisions of this law;

8. Coordinate with the respective jurisdictions the conduct of inspections aimed at verifying that the establishments in which the activities covered by this law are carried out conform to it and its regulations;

9. To propose, with the advice of the Federal Health Council (COFESA), the rules for the intervention by the courts, until the final decision of the implementing authority or the competent judge, of the services or establishments in which the exercise of acts or omissions relating to the subject-matter of this law is presumed to be in danger to the health or life of persons;

10. Promote continuous training in the donation and transplantation of organs, tissues and cells;

11. To promote, evaluate and develop scientific research on the donation and transplantation of tissues and cells;

12. To evaluate publications and documentation and to intervene in the authorization of investigations that are carried out with own resources linked to the subject;

13. To lay down rules on the detection, selection and maintenance of deceased donors, ablation, conditioning and transport of organs and tissues;

14. Advise and assist the health authorities and provincial bodies in the field, in the exercise of the police power and any other matter they require;

15. To collaborate with the provincial agencies in the planning and development of continuous training in the field of organ, tissue and cell donation and transplantation;

16. periodically provide information regarding its activity to the Ministry of Health of the Nation and carry out periodic related publications on the subject of the Institute;

17. Coordinate the distribution of organs and tissues at the national level, as well as the reception and dispatch of the same at international level and the actions that are carried out for the maintenance of the following records:

a) Registration of expressions of will;

(b) Registration of donors of CPH;

(c) The registration of the destination of each of the organs or tissues that have been softened with the hierarchy of confidential records under medical secrecy.

18. To direct actions to keep the waiting list of potential recipients of organs and tissues in the national order updated, coordinating their action with provincial bodies of similar nature;

19. Understand activities aimed at the treatment of potential deceased donors and monitor the correct determination of the diagnosis of death, ablation and conditioning of organs, coordinating their action with the provincial bodies;

20. To carry out the activities inherent in the follow-up of transplant patients, for the purposes of comptroller and statisticians;

21. To direct actions to keep the records created by this law in the national order up to date;

22. Propose rules and provide technical assistance to the relevant bodies in the field of this law;

23. Acquire, build, lease, manage and dispose of goods, accept inheritances, legacies and donations, be on trial as an actor or defendant, hire services, works and supplies and in general carry out all acts necessary to the achievement of objectives, in accordance with the provisions in force;

24. Propose to the entities in charge of social security and the respective authorities of comptroller the modifications or inclusions that it considers appropriate in its subject, providing the information requested by that entity;

25. To provide technical and financial assistance, through subsidies, loans or grants, to the transplant treatments carried out in national, provincial or municipal public establishments. Also to promote and directly assist the creation and development of regional and/or provincial ablation and/or organ implants;

26. To conclude agreements with private entities for their participation in the system;

27. To advise the Executive Branch in all matters concerning campaigns of mass dissemination and awareness of the population with respect to the problems of transplants;

28. Carry out international health relations in the field of donation and transplantation, and technical cooperation with international organizations, non-governmental organizations, and government agencies;

29. Develop and administer the national information system in which the donation and transplantation activity carried out in the field of the Argentine Republic is recorded;

30. To take any action necessary for the fulfilment of its purposes in accordance with this law and its regulations.

Art. 58.-The National Central National Institute of Coordination and Implant Coordinator (INCAÇAI) must be in charge of a (1) directory composed of one (1) president, one (1) vice president and one (1) director, appointed by the national executive branch of compliance with the following provisions:

(a) The President must be appointed on a proposal from the Ministry of Health;

b) The Vice President should be appointed to the proposal of the Federal Health Council (COFESA);

c) The director must be designated prior open competition of titles and background with outstanding track record, whose evaluation will be carried out by the Ministry of Health;

d) The board members last four (4) years in their duties and can be re-elected for one more period. They must have full-time dedication and cannot participate in a property in any institute, entity or institution linked to the object of this law.

The Ombudsman shall, through the relevant area, appoint an ad honorem officer in charge of all investigations and advice which, either on his own initiative or at the request of a party, has as its object the operation of the INCAÇAI.

Art. 59.-Corresponds to the directory:

(a) to give its rules of procedure;

(b) Approve the organic-functional structure of the Institute, the annual budget of expenditure, the calculation of resources and investment accounts, and draw up the memory and balance sheet at the end of each financial year. In the expenditure budget, no more than 10% (10%) may be allocated for administrative expenditure;

(c) allocate the resources of the Solidarity Fund for Transplants, dictating the rules for the granting of subsidies, loans and grants, of which at least twenty percent (20%) will have to be allocated to training;

(d) To fix the remuneration of the board members; to designate, promote, sanction and remove the staff of the Institute, and to set their salaries, stimulating the exclusive dedication;

(e) to recruit staff for extraordinary or special tasks which cannot be carried out with their permanent plant resources, laying down working conditions and their remuneration;

f) Delegate functions to the president, for a given time.

Art. 60.-Corresponds to the President:

(a) Represent the National Central Institute for the Coordination of Binding And Implante (INCAÇAI) in all its acts;

(b) To convene and preside over the meetings of the Board, in which it shall have a voice and vote, which shall prevail in the event of a tie;

(c) invite representatives of interested sectors to participate, with a voice but without a vote, when addressing specific issues in their area of action;

(d) Convening and chairing the meetings of the Advisory Councils;

(e) Adopt all measures which, under the jurisdiction of the Board, do not allow for delay, subject to consideration by the Board in the first session;

f) Delegate functions to other members of the board, with the agreement of the latter;

g) Fulfill and enforce the resolutions of the directory.

Art. 61. In the field of INCAÇAÍ two (2) Advisory Councils, of an honorary nature, are to be operated as determined by the rules of this Law:

a) One (1) patient advisory board made up of patients belonging to the organisations representing people transplanted and waiting to be transplanted;

b) One (1) advisory board composed of representatives of scientific associations and societies, universities and other research and research centres.

In addition, the Federal Transplant Commission (COFETRA) can act as an advisory body, consisting of those responsible for each of the Provincial Ablation and Implant Agencies.

Art. 62.-Create the Solidarity Fund for Transplants, which integrates with the following resources:

(a) the contribution of the national State, by means of the appropriations allocated to it by the budget of the Nation;

(b) the proceeds of the fines resulting from the application of the administrative and criminal penalties provided for in this Law;

(c) The fund arising from accrediting:

1. The production of the sale of disused goods, those of his own production, the publications he carries out, interest, income or other fruits of the goods he manages.

2. Legacies, inheritances, donations, contributions of the national State or the provinces, of official, private or third party entities, according to the modalities established by the regulations, with a view to solving their operation.

3. Transfers of the balances of the cumulative fund and of those of its allocated annual budget, not used in the financial year.

Art. 63. The resources of the INCUCAI must be deposited in a special account to their order created for these purposes and destined primarily to assist the development of the services to be carried out for the transplantological treatment in national, provincial or municipal public establishments, in order to assist patients without social coverage, as well as to promote the procurement of organs and tissues necessary for the purposes of this law. The judicial health authorities must provide for the creation of organ transplant services in public institutions of adequate complexity in their respective programmatic areas.

Chapter XIV

Of the Preventive Measures and Inspection Activities

Art. 64. The judicial health authority is authorized to verify compliance with this law and its regulatory provisions, by means of inspections and requests for reports. For such purposes, their authorized officials have access to the establishments or services, whether or not authorized, in which the exercise of the activities provided for by this law is exercised or presumed, they may proceed to the abduction of evidence and provide for the provision of services or establishments.

Article 65.-Without prejudice to the sanction which is ultimately in accordance with the provisions of Article 35, the judicial health authority may adopt the following preventive measures:

(a) If acts or omissions are incurred which constitute damage or danger to the health of the persons, the total or partial closure of the establishments or services involved may be carried out or the medical acts referred to in this Article shall be suspended; this law. These measures may not be longer than one hundred and eighty (180) days;

(b) to close the services or establishments operating without the relevant authorisation;

(c) Suspension of the advertising in breach.

Art. 66. For the purposes of Articles 64 and 65 of this Law, the judicial health authority may require, if necessary, the assistance of the public force, and request search warrants from the federal courts or tribunals. Competent authorities.

Chapter XV

Of the Special Judicial Procedure

Art. 67. Any civil action aimed at obtaining a judicial decision on non-property matters relating to the ablation and implantation of organs or tissues is a matter of jurisdiction of the federal or provincial courts in the civil domicile of the actor. The following special procedure should be used in the federal order:

(a) The claim must be signed by the actor, accompanied by all the evidence to prove the legitimacy of the order. No third party representation is allowed and the actor's appearance must always be personal, without prejudice to the legal sponsorship;

(b) The application is received, the judge must convene a personal hearing which must be held within a period of not more than three (3) days of the filing of that hearing;

c) The hearing must be taken personally by the judge and in it must be present the actor, the tax agent, the adviser of minors in his case, a medical expert, a psychiatrist and a social worker, those who must be appointed prior to the judge. In addition, the presence of other experts, advisors or specialists that the judge deems appropriate can be arranged. Failure to comply with these essential requirements results in the nullity of the hearing;

(d) The conduct of the hearing must be carried out by a circumstantial act, and in the course of the hearing, the experts, the tax agent, and the child adviser may, in their case, formulate all kinds of questions and require the explanations of the actor who consider appropriate and necessary;

(e) The experts must submit their report to the judge within forty-eight (48) hours after the hearing, and the hearing may also, within the same period, seek any additional information which it considers appropriate;

(f) In a row, the tax agent and the adviser to minors, if any, should be given the right to take account of all who have to raise their opinion within 24 hours;

(g) The judge must sentence within forty-eight (48) hours after the procedural procedure of the preceding paragraph;

(h) In the case of extreme urgency, duly accredited, the judge may establish by resolution established deadlines less than those referred to in this Article, enabling working days and hours;

(i) the failure to comply with the formalities and requirements laid down in this Article shall result in the nullity of all acts;

(j) The resolution to be passed may be appable in relation to suspensory effect. The appeal must be instituted in a manner founded within forty-eight (48) hours, and the judge must raise the cause to the superior in the term of twenty-four (24) hours of receipt thereof. The court must resolve the appeal within three (3) days. The tax agent may appeal only where the judge has ruled in the opposite direction to the judgment;

k) This procedure is exempt from the payment of seals, fees, taxes or rights of any kind.

Art. 68. The failure of the judge, the tax agent or the child adviser, if any, to the obligations set out in the previous article, is considered to be a serious misconduct and a poor performance of his duties.

Art. 69.-Invite the provincial governments to sanction in their respective jurisdictions similar rules to those of this chapter.

Chapter XVI

From the Tracking of Transplanted Patients

Art. 70. The Ministry of Health must ensure the provision of necessary medicinal products and therapeutic procedures that arise as a result of transplants performed in persons without coverage and lack of resources as established by the Ministry of Health. Regulation of the law.

Article 71-Law 24193.

Art. 72.-Regulations. This law shall be regulated within 90 days of its publication in the Official Gazette.

Art. 73.-Accession. I invited the provinces and the Autonomous City of Buenos Aires to adhere to the corresponding provisions of this law.

Art. 74.-Commune to the national executive branch.



MARTA G. MICHELETTI-EMILIO MONZO-Eugenio Inchausti-Juan P. Tunessi

e. 26/07/2018 N ° 54077/18 v. 26/07/2018