The hepatitis C virus (HCV) was identified and described in mid-1989, but until the year 1990 there was no provision for adequate technical means to prevent its transmission through blood and blood products. the form of a HCV antibody detection test which began to be applied on a compulsory basis in all blood or plasma units taken from blood banks, in accordance with the provisions of the Order of the Ministry of Health and Consumer Affairs of 3 of October 1990.

Therefore, in these circumstances, people affected by haemophilia or other congenital coagulopathies were exposed to the risk of hepatitis C as a result of the periodic treatments to be received. with coagulation factor concentrates.

Because of this situation there are a number of people, belonging to this group, who were infected and developed hepatitis C disease, as a result of treatments received in the system. public health, at a time when the state of science did not allow adequate measures to prevent this transmission.

The damage to these cases in people affected by hemophilia or other congenital coagulopathies is particularly burdensome, not only because of the high number of people affected, more than 60%, but also because of the added effects. which involves hepatitis C in patients who have previously had a chronic process such as the one mentioned.

In response to this situation, Law 55/1999, of 29 December, of Tax, Administrative and Social Order, in its Article 80, provided that these persons would be entitled to social assistance, for which they entrusted the The government will draw up the relevant census of the affected population, as well as the preparation of a draft law setting out the conditions and the amount of aid to which the persons included in the aforementioned census could access.

For the preparation of this census, a Gestora Commission was created, regulated by the Order of the Ministry of Health and Consumer Affairs of 21 March 2000, in which representatives of the affected communities were integrated. and the General Administration of the State, as well as specialists in the field. On the basis of the provisions of Article 80.2 of that Law 55/1999, by the Order of the Ministry of Health and Consumer Affairs of 18 January 2000, the Technical Committee to be set up was set up to determine the medical criteria for the inclusion of the potential affected in the said census.

In addition, through the Order of the Ministry of Health and Consumer Affairs of 25 May 2000, two files were created and regulated with personal data, managed by the Ministry of Health and Consumer Affairs, and referred to the census. and the definitive census of the persons concerned, thereby guaranteeing the due confidentiality of these, as provided for in Article 80.1 of Law 55/1999, in line with Article 5.1 of the Organic Law 15/1999 of 13 December 1999, of Protection of Personal Data. Likewise, in compliance with the latter, the interested parties were informed of the existence of these files, providing them with precise information so that they could make the exercise of the rights of access, rectification, cancellation and opposition.

The provisional census, prepared from the data provided by the public health centers, as set out in Article 80.2 of Law 55/1999, was approved on July 19, 2000 by the Gestora Commission. Once published and notified to interested parties, a period of two months was established in order to allow those persons not included, upon presentation of the required documentary contributions, to be incorporated.

Finally, the definitive census of people with hemophilia and other congenital coagulopathies who have developed hepatitis C as a consequence of having received treatment with coagulation factor concentrates in the system. public health, was approved on 21 November 2000 by the Gestora Commission and published with the required confidentiality.

Subsequently, in compliance with the provisions of Article 80.4 of the aforementioned Law 55/1999, it was carried out by Law 14/2002 of 5 June, establishing social aid for persons with hemophilia or other congenital coagulopathies that have developed hepatitis C as a consequence of having received treatment with coagulation factor concentrates in the field of the public health system, and other tax rules, to regulate conditions and the amount of the social aid to which the persons covered by the said census can access; which was set at € 18,030.36.

Moreover, in the first provision of Law 14/2002 of 5 June, it is envisaged that, by way of regulatory development, the possibility of the persons who may be entitled to receive the aid provided for in this Regulation should be regulated. not included in the final census provided for in Article 80 of Law 55/1999 of 29 December 1999, but which, in accordance with objective and duly accredited circumstances, satisfy the conditions required.

The objectives of this royal decree are to regulate the procedure for applying for inclusion in the census and the granting of social aid within the deadlines set in the law.

An Evaluation Commission is created, which will have the functions of raising the inclusion proposals in the census of those with hemophilia or other congenital coagulopathy that meets the required requirements. It will also be responsible for formulating proposals for the resolution of requests for social assistance.

This royal decree develops the provisions of article 3.2 and the additional provision of Law 14/2002 of June 5, and in its preparation have been heard the sectors affected and consulted the autonomous communities and the cities of Ceuta and Melilla.

In its virtue, on the proposal of the Minister of Health and Consumer Affairs, with the approval of the Minister of Public Administrations, in agreement with the Council of State and after deliberation of the Council of Ministers at its meeting of the 28th of March 2003,

DISPONGO:

Article 1. Entitlement to the right.

They are beneficiaries of the social aid regulated in this royal decree:

a) People with hemophilia or other congenital coagulopathies who, having developed hepatitis C as a consequence of having received treatments with coagulation factor concentrates in the system public health, be included in the final census provided for in Article 80 of Law 55/1999 of 29 December 1999, of fiscal, administrative and social measures.

b) People with haemophilia or other congenital coagulopathies who, having developed hepatitis C as a consequence of having received treatment with coagulation factor concentrates in the health system In the light of the objective circumstances duly accredited, they do not appear in the final census provided for in Article 80 of Law 55/1999 of 29 December 2000, adopted by the Management Committee for the Development of the census, and be included in it for meeting the requirements laid down in Article 6 of this Royal decree.

(c) In the case of the death of the persons referred to in the preceding paragraphs, the children of the age and the disabled may receive the social assistance in equal parts, in the absence of them, the spouse not legally separated or, where appropriate, the person who had been living with the deceased on a permanent basis with a similar affectivity relationship during at least the two years prior to the date of death; in the absence of the foregoing, the parents of the deceased.

Article 2. Social aid.

1. The beneficiaries referred to in the previous Article shall be entitled to the receipt, for one time, of a social aid of EUR 18,030.36, which shall be compatible with that of any public pension, in accordance with the provisions of the Law. 14/2002, dated June 5.

2. Social assistance shall be exempt from the income tax of natural persons, in accordance with the provisions of Article 7 (s) of Law 40/1998 of 9 December 1998 on the Income Tax of Physical Persons and other rules Tax, as amended by the final provision of Law 14/2002, of 5 June.

3. In order to access social assistance, the waiver of all types of claims for contamination by the hepatitis C virus against any of the public health authorities and health centres linked to the disease will be necessary. National Health System, or their respective staff.

4. Social assistance may not be granted to those who have obtained a conviction against any of the public health authorities and health centres linked to the National Health System for the spread of the hepatitis virus. C.

Article 3. Application for social assistance.

1. Persons who consider themselves to be beneficiaries of social assistance may apply for their grant within four months from the entry into force of this royal decree in the case of Article 1 (1) and from the date of entry into force of this Regulation. in the census in the case of paragraph 2 of that Article.

2. The request for assistance shall be addressed to the Minister for Health and Consumer Affairs and his presentation may be made in any of the forms set out in Article 38.4 of Law No 30/1992 of 26 November 1992 on the Legal Regime of Administrations Public and the Common Administrative Procedure.

3. The application for social assistance may be made in accordance with the model set out in Annex I to this royal decree and shall be accompanied, in the case of closure, by the documentation specified in Annex II.

Article 4. Processing of social aid.

1. The processing of applications for social assistance to the Subdirectorate General for Health Promotion and Epidemiology, which will perform the functions of the Secretariat of the Evaluation Committee referred to in Article 7 of this royal decree, shall be carried out. The General Secretariat of Health shall be assigned the human and material resources necessary for the performance of its functions. In any case, the confidentiality of the data collected and the respect of the privacy of the affected persons and their families must be guaranteed.

2. The functions of the secretariat shall be as follows:

(a) Custodian and manage the centralised record and file of all existing data, as well as the data files of a confidential nature created by the Order of the Ministry of Health and Consumer Affairs of 25 May 2000, concerning the provisional and definitive census of persons with haemophilia or other congenital coagulopathies who have developed hepatitis C as a result of receiving treatment with coagulation concentrates in the field of the health system public, complying with the requirements of the Organic Law 15/1999, of December 13, Protection of Personal Data.

b) To issue, through the Secretary and with the President's approval, the certifications of the agreements adopted by the Evaluation Commission.

c) Elevate the Minister of Health and Consumer with the draft resolutions adopted by the Evaluation Committee.

d) Communicate the autonomous communities and the cities of Ceuta and Melilla, for the purpose of completing the requirements of paragraphs 5, 6 and 7 of Article 3 of Law 14/2002 of 5 June, all previous resignations of the beneficiaries, as well as the decisions to grant social aid.

Article 5. Resolution and payment of social aid.

1. The Minister for Health and Consumer Affairs will decide on applications for the granting of social assistance, subject to a report and on a proposal from the Evaluation Committee. The maximum period for the notification of the decision to the applicant shall be six months.

Applications whose resolution is not notified within six months shall be deemed to be dismissed.

2. The decision shall terminate the administrative procedure and the administrative procedure may be brought against it.

3. It is for the Ministry of Health and Consumer Affairs to pay, where appropriate, for social assistance.

Article 6. Request for inclusion in the census.

1. People with haemophilia or other congenital coagulopathies who, having developed hepatitis C as a consequence of having received treatments with coagulation factor concentrates in the field of the public health system, were not On 21 November 2000, in the census provided for in Article 80 of Law 55/1999, of 29 December 2000, they may apply to the Deputy Secretary for Health and Consumer Affairs for their inclusion in the census, in accordance with the additional provision First of Law 14/2002, of June 5.

2. The application may be made using the model set out in Annex III to this royal decree, and the documentation required in Annex II, paragraph 2.1, shall be accompanied, in the case of closure, by supporting the following meeting: requirements:

a) Being hemophilic or having a congenital coagulopathy.

b) Having received treatment with coagulation factor concentrates in the field of the public health system.

c) Haber developed hepatitis C, crediting it by, at least, the following two means:

1. The presence of anti-HCV antibodies with HCV-positive RNA-HCV.

2. ° High transaminases three times in a prolonged period, exceeding six months, and at least three determinations are likely.

3. The time limit for the submission of the application shall be four months from the date on which it is known to have developed hepatitis C with the criteria laid down in the previous paragraph.

4. The Under-Secretary for Health and Consumer Affairs will decide on the application for inclusion in the census, after a report from the Evaluation Committee. The maximum period for the notification of the decision to the applicant shall be three months.

The resolution shall terminate the administrative route and may be brought against the administrative-administrative appeal.

Article 7. Evaluation Committee.

1. A Committee on Evaluation, which will be responsible for the study and assessment of applications and the adoption of the motions for resolutions to be adopted in the procedures carried out by the Commission, is hereby set up within the Ministry of Health and Consumer Affairs. the Subdirectorate General of Health Promotion and Epidemiology to which this royal decree refers. In particular, you will have the following functions:

a) Establish your own call regime and the character and periodicity of your meetings.

b) Access the centralized log and file of all existing data from applicants.

c) Access the data files of a confidential character.

d) To study the applications for inclusion in the census referred to in Article 6 of this royal decree and to elevate the Undersecretary of Health and Consumer, through the Secretariat, to the motions for resolutions.

e) Report requests for social assistance and prepare proposals for the resolution of social aid.

f) Report on how many petitions and complaints could be submitted and prepare the corresponding motions for resolutions.

g) Communicating the Autonomous Communities and the cities of Ceuta and Melilla, through the Secretariat, the prior resignations of the interested parties and the granting of the social aid decisions referred to in the Article 4.2.d).

2. The Evaluation Committee shall be composed of the following members:

(a) The President, who shall be the Secretary-General of Health or the person to whom he delegates.

b) Four representatives of the Ministry of Health and Consumer Affairs appointed by the Secretary General of Health, on a proposal from the Director General of Public Health, one of whom will be the Secretary of the Commission.

c) Two vowels appointed by the Minister of Health and Consumer Affairs among those proposed by the associations of hemophiliacs affected by national implementation.

d) Two representatives from the autonomous communities and the cities of Ceuta and Melilla, designated by the Minister of Health and Consumer Affairs among those proposed by those communities and cities with Autonomy Statute.

e) Three advisory vowels, licensed in Medicine and Surgery, specialists in the field, appointed by the Secretary General of Health.

3. All members of the Evaluation Committee shall act with a voice and vote. The vote of the President shall be qualified in case of a tie.

4. The Commission of Evaluation shall adjust its operation to the provisions of the bodies governed by Law No 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations and the Common Administrative Procedure.

Single additional disposition. No increase in public spending.

The creation and operation of the Evaluation Committee provided for in Article 7 of this royal decree will not increase public spending.

Single end disposition. Entry into force.

This royal decree will enter into force on the day following its publication in the "Official State Gazette".

Dado en Madrid, a 28 de marzo de 2003.

JOHN CARLOS R.

The Minister of Health and Consumer Affairs,

ANA MARIA PASTOR JULIAN

ANNEX I

Social Help Request Model

ANNEX II

Form to be completed and documentation that is attached (in closed) to the social help request

Documentation attached to the form:

1. Censates:

(a) Photocopy of the certification of inclusion in the definitive census provided for in Article 80 of Law 55/1999 of 29 December, of fiscal, administrative and social measures, of hemophiliacs or other persons congenital coagulopathies that have developed hepatitis C as a consequence of having received treatments with coagulation factor concentrates in the field of the public health system.

(b) Written prior to the exercise of all types of claims for contamination by the hepatitis C virus against any of the public health administrations and healthcare facilities linked to the System National of Health, or their respective staff.

(c) Written not to have obtained a conviction against any of the public health administrations and health centers linked to the National Health System for the spread of the hepatitis C virus.

2. Uncensored:

2.1 Inclusion in the census.

a) Model of application in Annex III.

b) Certification of the corresponding service of the public health center (Annex IV) or supporting documentation of gathering all the requirements required in Article 6 of this royal decree for the inclusion in the census of persons haemophiliacs or congenital coagulopathy that have developed hepatitis C as a consequence of having received concentrates of coagulation factors in the field of the public health system.

2.2 Social help.

They will accompany the form and the documentation required under section 2.1, the following steps of resignation:

(a) Written as a prior waiver of the exercise of all types of claims for hepatitis C virus contamination against any of the public health administrations and healthcare facilities linked to the System National of Health, or their respective staff.

b) Written not to have obtained a conviction against any of the public health administrations and health centers linked to the National Health System for the spread of the hepatitis C virus.

ANNEX III

Census include request request model

ANNEX IV

Public Health Center Certificate Model