Royal Decree 1030/2006 of 15 September establishing the portfolio of common services of the National Health System and the procedure for updating it, regulates in its annexes the contents of each of the portfolios of public health services, primary care, specialized care, emergency care, pharmaceutical, orthoprosthetic, dietetic products, and sanitary transport, in accordance with the provisions of Law 16/2003 of 28 May, of the cohesion and quality of the National Health System.

Article 6 of the royal decree states that, by order of the current Ministry of Health, Social Services and Equality, prior to the agreement of the Interterritorial Council of the National Health System, the content of the different sections of the common service portfolio listed in its Annexes.

Article 7 of the royal decree states that the portfolio of common services of the National Health System, contained in its annexes, will be updated by order of the current Ministry of Health, Social Services and Equality, Prior agreement of the Interterritorial Council of the National Health System and Article 8 indicates that the proposals for the update of the portfolio will be raised to the Commission of benefits, assurance and financing, and that the definitive approval of These proposals shall correspond to the Ministry of Health, Social Services and Agreement of the Interterritorial Council of the National Health System.

As a result of these forecasts, Order SCO3422/2007, of 21 November, for which the procedure for updating the portfolio of common services of the National Health System is developed, has been applied for update that portfolio on different occasions through the corresponding ministerial orders.

Royal Decree-Law 16/2012 of 20 April, of urgent measures to ensure the sustainability of the National Health System and improve the quality and safety of its benefits, marked a substantial change in the common portfolio of National Health System services by modifying Article 8 of Law 16/2003 of 28 May, differentiating a basic common portfolio of care services, a supplementary common portfolio and a common portfolio of ancillary services.

The Interterritorial Council of the National Health System created on February 29, 2012 a working group on the development of the basic portfolio of services of the National Health System, with the objective of reviewing the common portfolio of services to identify and prioritise benefits, the content of which should be detailed, clarified or specified. This Working Group identified a number of areas that I consider it necessary to study for this purpose and, among others, prioritized activities to detect diseases in the presymptomatic phase by screening, genetics and human reproduction. assisted.

The prioritized areas are included within the basic common portfolio of health care services of the National Health System. For their approach, expert groups were set up to detail and update the corresponding section of the service portfolio referred to in Royal Decree 1030/2006 of 15 September. These groups have participated in professionals appointed by the Autonomous Communities and the Ministry of Health, Social Services and Equality, the scientific societies involved in each area and the Spanish Network of Evaluation Agencies. Health Technologies and National Health System Benefits that provide information based on the scientific evidence available on those cases where there are doubts about effectiveness or safety.

As a result of the work of these expert groups, the proposals for the completion of the common services portfolio have been elaborated, detailing the corresponding section of the portfolio, so that the conditions of use or criteria for the proper use of the services included, identify those that are obsolete and, where appropriate, are detected for inclusion those others that are not currently included, have demonstrated safety, efficiency and efficiency. The Group's final proposals have been drawn up taking into account the content of the assessment reports provided by the Spanish Network of Agencies.

These proposals were raised by the Commission on Benefits, Assurance and Financing to the National Health System's Interterritorial Council at its meetings on 20 December 2012 and 23 July 2013.

This order is intended to make the implementation and updating of the Annexes to Royal Decree 1030/2006 of 15 September, in the sections corresponding to activities to detect the diseases in phase, effective. presymptomatic by screening, genetics, as well as assisted human reproduction, in order to achieve the reach of the different areas, homogenizing and updating their indications in the light of the scientific evidence available and contributing to maintain cohesion in the National Health System.

In this way, the basic common portfolio of services of the National Health System will guarantee more effective and safe benefits and greater equity in access for all citizens, avoiding differences between the benefits to be received by users in each of the autonomous communities, thus achieving greater homogeneity and rationalisation of health expenditure.

The detection of pre-presytomatic diseases by screening is part of the disease prevention activities listed in Annex I to Royal Decree 1030/2006 of 15 September on a portfolio of common public health services and in several paragraphs of Annex II and III corresponding to the portfolio of common primary and specialised services, respectively. For this area, it was decided to start the work in two groups one on neonatal screening and one on cancer screening. In both cases, the proposals drawn up by these groups include those who have sufficient scientific evidence of the health benefits and of the cost effectiveness studies that support their inclusion in the portfolio. services. In the case of neonatal cribates of endocrine-metabolic diseases, it is emphasized the importance of having an information system that allows at the autonomic and state level to carry out a correct monitoring and evaluation of these programs. population and a quality management system that allows the screening processes to be addressed in a homogeneous way in all autonomous communities. In the population of cancer, and without prejudice to the evaluations carried out by the autonomous communities, a state-level assessment of these benefits will be carried out in the National Health System as a whole. All this, within the framework of the provisions of article 20 of Law 33/2011, of 4 October, General of Public Health. Another fundamental aspect is that the implementation of activities to detect diseases in the presymptomatic phase by screening for their population character and their impact is carried out in a progressive, rational and efficient manner.

On the other hand, Annex III to Royal Decree 1030/2006 of 15 September concerning specialised care and within the laboratory section 5.2.9, contains as paragraph 5.2.9.3 that of genetics but without detailing the content of this portfolio or to establish any type of requirements or concreteness, except for the general criteria governing the entire portfolio of services. In addition, in paragraph 5.3.7 concerning family planning, the genetic advice is collected in risk groups. Genetic diseases and disorders are very numerous and low prevalence in the majority of cases, which together with the high number and the continuous evolution of genetic analysis, has made in this order been chosen by to define the fundamental aspects of the genetic portfolio by defining the genetic advice and the groups of pathologies for which the genetic advice is to be given, as well as the types of genetic analysis and the criteria for the indication of each one of them.

Finally, assisted human reproduction is provided for in paragraph 5.3.8 of Annex III to Royal Decree 1030/2006 of 15 September for cases where there is a diagnosis of sterility or an established clinical indication, according to the programs of each health service and specifically citing the techniques it includes. This order incorporates the proposal of the Group of Experts, clarifying the criteria for the indication of the techniques of assisted human reproduction in the framework of the National Health System, and updates the techniques according to the evidence available science.

This order has been consulted to the Autonomous Communities and the cities of Ceuta and Melilla, to the National Institute of Health Management (INGESA), having been informed by the Public Health Commission regarding the cribados (a) the National Health System and the Interterritorial Council of the National System of Health and the Interterritorial Council of the National System of Health and the Interterritorial Council of the National System of Health. Health. It has also been submitted to the Spanish Data Protection Agency, the National Disability Council and the various sectors affected.

This order is made in use of the privileges conferred by the final provision of Royal Decree 1030/2006, dated September 15.

In its virtue, with the prior approval of the Minister of Finance and Public Administrations, according to the State Council, I have:

Single item. Amendment of Royal Decree 1030/2006 of 15 September establishing the portfolio of common services of the National Health System and the procedure for updating it.

Royal Decree 1030/2006 of 15 September establishing the common service portfolio of the National Health System and the procedure for updating it is amended as follows:

One. Paragraph 3.3 of Annex I is amended as follows:

" 3.3 Cross-cutting programs for the protection of health risks, prevention of diseases, deficiencies and injuries, and education and health promotion, aimed at the different stages of life and prevention communicable and non-communicable diseases, injuries, accidents and disabilities, including activities to detect in presymptomatic phase the screening diseases listed below:

3.3.1 The diseases that form part of the population program for neonatal screening of endocrine-metabolic diseases in the basic common health care system of the National Health System are:

3.3.1.1 Congenital hypothyroidism.

3.3.1.2 Fenilketonuria.

3.3.1.3 Cystic Fibrosis.

3.3.1.4 Medium chain acyl-coenzyme A-dehydrogenase (MCADD) deficiency.

3.3.1.5 Deficiency of 3-hydroxy-acyl-coenzyme A-long-chain dehydrogenase (LCHADD).

3.3.1.6 Glutaric acid type I (GA-I).

3.3.1.7 Anemia falciform.

The implementation of the population program for neonatal screening of endocrine-metabolic diseases in the basic common portfolio of health care services of the National Health System will be accompanied by the development of the Ministry of Health, Social Services and Equality of a system of information that allows in the autonomous and state levels to carry out a correct monitoring and evaluation of these population programs. The Ministry of Health, Social Services and Equality shall draw up an annual technical report on the evaluation of the screening programme to be made available to the citizen and the administrations on its website. It will also establish agreed protocols within the framework of the Interterritorial Council of the National Health System that will allow to address in all autonomous communities, in a homogeneous manner and according to quality criteria, the processes of screening.

3.3.2 Cancer screening programs that are part of the National Health System's basic common portfolio of care services are:

3.3.2.1 Population screening for breast cancer. In general, the following criteria will be met:

a) Target population: women aged between 50 and 69 years.

b) Screening test: mammography.

c) Interval between scans: 2 years.

3.3.2.2 Population screening for colorectal cancer. In general terms, it will be done according to the following bases:

a) Target population: men and women aged between 50 and 69 years.

b) Screening test: blood hidden in stool.

c) Interval between scans: 2 years.

3.3.2.3 Cervix cancer screening. In general, the following criteria shall be applied:

a) Target population: women aged between 25 and 65 years.

b) Screening test: cervical cytology.

c) Interval between recommended scans: 3 to 5 years.

3.3.2.4 According to the principle of evaluation established in Article 3 of Law 33/2011, of 4 October, General Public Health, and without prejudice to the evaluations carried out at the regional level, will be carried out a state-level assessment of these benefits in the whole of the National Health System, within the time limit to be determined by the Commission on benefits, insurance and funding.

3.3.2.5 The Autonomous Communities, the National Institute of Health Management (INGESA) and the mutual societies of officials will ensure in the cancers subjected to population screening the assessment of the individual risk in the who meet criteria of high personal risk or risk of family or hereditary cancer and if confirmed, monitoring them through specific action protocols. "

Two. Annex II is amended as follows:

1. Paragraph 6.1.6.a is amended as follows:

" 6.1.6.a Early detection of metabolopathies. In the case of neonatal screening for endocrine-metabolic diseases, it shall be performed in accordance with paragraph 3.3.1 of Annex I. '

2. Paragraph 6.3.1 is amended as follows:

" 6.3.1 Detection of risk groups and early diagnosis of gynecological and breast cancer in a coordinated and protocolized manner with specialized care, according to the organization of the corresponding health service. In the case of breast and cervical cancer screening, the criteria set out in paragraphs 3.3.2.1 and 3.3.2.3 of Annex I shall be taken into account. '

3. In paragraph 6.4, a new paragraph 6.4.6 is added with the following wording:

"6.4.6 Early detection of colorectal cancer in a coordinated and protocolised manner with specialised care, according to the criteria set out in section 3.3.2.2 of Annex I."

Three. Annex III is amended as follows:

1. Paragraph 5.2.9.3 is amended as follows:

" 5.2.9.3 Genetics. The genetic analysis shall be carried out in accordance with paragraph 5.3.10. '

2. Paragraph 5.3.7.1 is amended as follows:

"5.3.7.1 Genetic Council in Risk Groups as set out in paragraph 5.3.10."

3. Paragraph 5.3.8 is amended as follows:

" 5.3.8 Assisted human reproduction (RHA) treatments will be performed with therapeutic or preventive purposes and in certain special situations.

5.3.8.1 Assisted human reproduction treatments will be intended to help achieve pregnancy in those who are unable to achieve it naturally, not susceptible to treatment exclusively pharmacological, or after the failure of them. These procedures may also be used to prevent serious genetic diseases or disorders in the offspring and when an embryo with the same immunological characteristics as a sibling is required to affect a process. serious pathological condition, which is not susceptible to other therapeutic use. In order to be carried out in the field of the National Health System, they shall meet the general criteria for access to the RHA treatments referred to in paragraph 5.3.8.2 and, where appropriate, the specific criteria of each technique.

a) RHA treatments for therapeutic purposes: They will be applied to people who have undergone a sterility study and who are in one of the following situations:

1. The existence of a documented disorder of reproductive capacity, found after the corresponding diagnostic protocol and not susceptible to medical treatment or after the evident ineffectiveness of it.

2. No absence of pregnancy after a minimum of 12 months of sexual intercourse with vaginal intercourse without the use of contraceptive methods.

(b) RHA treatments with a preventive purpose: Iran to prevent the transmission of serious genetic diseases or disorders, or the transmission or generation of diseases of other serious origin, of early onset, susceptible to post-natal curative treatment according to current scientific knowledge, and which are avoidable through the application of these techniques.

c) RHA treatments in special situations: They will be performed for the following purposes:

1. Embryo Selection, with destination for third-party treatment.

2. The preservation of gametes or preembryos for the use of a delayed autologous use by medical indication to preserve fertility in situations associated with special pathological processes, as referred to in paragraph 5.3.8.3.d.

5.3.8.2 General criteria for access to treatment of RHA: They are applicable to all RHA techniques performed in the National Health System, except those aspects that are included in the specific criteria of each one of them that will prevail over the generals.

(a) Assisted human reproductive treatments shall be applied in the field of the National Health System to persons who meet the following criteria or situations of inclusion:

1. Women will be over the age of 18 and under the age of 40, and men over the age of 18 and under 55 at the time of the start of the sterility study.

2. º Persons without any child, prior and healthy. In case of couples, without any common, prior and healthy children.

3. The woman shall not present any type of pathology in which the pregnancy may present a serious and uncontrollable risk to her, both for her health and for her possible offspring.

(b) Assisted human reproduction treatments shall not be applied in the field of the National Health System to persons who present any of the following exclusion criteria or situations:

1. Prior Voluntary Sterilization.

2. Existence of documented medical contraindication for sterility treatment.

3. Existence of documented medical contraindication for gestation.

4. Existence of documented medical situation that seriously interferes with the development of the offspring.

5. º Impossibility to comply with treatment for health-related or other family-related or social-related reasons.

6. The existence of a documented situation concerning any other circumstance that may seriously interfere with the development of the offspring submitted for consideration by a committee of care ethics or similar organ.

(c) In cases where donated gametes or preembryos are used, the donor must be registered in the national donor register and the relevant information referred to in Article 21 of the Law 14/2006 of 26 May on techniques for assisted human reproduction.

5.3.8.3 Specific access criteria for each of the RHA techniques.

a) Artificial insemination.

1. Artificial Insemination with mate semen: Specific access criteria for this technique:

i) Existence of recognized therapeutic indication.

ii) Age of the woman at the time of treatment less than 38 years.

iii) Maximum number of cycles: four.

2. Artificial Insemination with donor gamete: Its realization will be conditioned by the availability of gametes in the center that indicates it, either through the center's own bank or an accredited gamete bank. Specific access criteria for this technique:

i) Existence of therapeutic indication.

ii) Age of the woman at the time of indication of treatment less than 40 years.

iii) Maximum number of cycles: six.

(b) In vitro fertilization: In vitro fertilisation, or by means of micromanipulation techniques, and the treatment and conservation techniques of gametes and preembryos derived therefrom are included.

1. In vitro Fecundation with own gametes: Specific access criteria for this technique:

i) Age of woman at the time of indication of treatment less than 40 years.

ii) Absence of evidence of ovarian bad reserve.

iii) Maximum treatment cycle limit: Three cycles with ovarian stimulation. This limit may be reduced according to the prognosis, and in particular the result of the previous treatments.

2. º Fecundation in vitro with donated gametes: Its performance will be conditioned by the availability of gametes in the public center that indicates it, either through the center's own bank or an accredited gamete bank.

i) With donated sperm: Specific access criteria for this technique:

-Age of woman at the time of indication of treatment less than 40 years.

-Absence of evidence of ovarian bad reserve.

-Primary or secondary sterility diagnosis without healthy child.

-Maximum treatment cycle limit: Three cycles with ovarian stimulation. This limit may be reduced according to the prognosis, and in particular the result of the previous treatments.

ii) With donated oocytes: Specific access criteria for this technique:

-Age of woman at the time of indication of treatment: less than 40 years.

-Preterm clinical ovarian failure established before 36 years, spontaneous or yatrogenic.

-Woman's genetic disorder only preventable by oocyte substitution.

-Unreachable or unreachable Omula for oocyte extraction.

-Maximum limit of treatment cycles: Three cycles with received oocyte reception. This limit may be reduced according to the prognosis, and in particular the result of the previous treatments.

c) Preembryo cryopreservation and transfer: cryopreserved preembryos may be transferred for their own use or may be donated. In the case of cryopreserved preembryos for own use, the specific criterion for women with primary or secondary sterility to be less than 50 years of age at the time of transfer and in the case of cryopreserved preembryos shall be applied. To be donated, the general criteria for access to RHA treatments will apply.

d) Cryopreservation of gametes or preembryos for deferred own use to preserve fertility in situations associated with special pathological processes: Specific criteria:

1. It will be performed in patients with possible risk of loss of their reproductive capacity associated with exposure to gametotoxic treatments or pathological processes with proven risk of premature ovarian failure or risk accredited primary testicular failure.

2. The transfer of cryopreserved gametes or preembryos shall be carried out in women under 50 years of age, provided that they do not present any type of pathology in which the pregnancy may lead to a serious and uncontrollable pregnancy. risk, both for your health and for your potential offspring.

3. º. It will be performed exclusively by medical indication, not including when it is only at the patient's own request for deferred use.

e) Seminal washing techniques to prevent the transmission of chronic viral diseases: Seminal washing may be applied to men who are seropositive to the hepatitis C virus or to HIV both in the care of sterile couples serodiscordant with chronic viral infection, as in the prevention of transmission of chronic viral infections in couples without sterility diagnosis.

In the case of seroconcordant couples, only the washing will be necessary, not requiring the subsequent study of the presence of viral particles.

For the application of treatments and techniques of assisted human reproduction, the general criteria and, where appropriate, the specific criteria described in the relevant paragraphs of these cases must be met. techniques.

f) Preimplantation genetic diagnosis (DGP): Includes:

1. DGP for the purpose of preventing the transmission of diseases or disorders of serious chromosomal or genetic origin, of early onset and not susceptible to curative treatment in accordance with scientific knowledge in order to carry out the embryo selection of the non-affected preembryos for transfer.

i) The situations that can give place to DGP for preventive purposes are:

-Monogenic diseases susceptible to preimplantation genetic diagnosis.

-Maternal or paternal structural or numerical chromosomal failure.

ii) The DGP will be performed for this purpose when the following specific criteria are met:

-there is a high risk of recurrence of the disease present in the family,

-the genetic disorder generates serious health problems, that is, that the disease of genetic base compromises the hope and/or quality of life for producing congenital anomalies, intellectual, sensory or motor disability, not susceptible to curative treatment according to current scientific knowledge.

-genetic diagnosis is possible and reliable, and includes a report of genetic advice specifying the genetic status of the partner or family consulting in relation to the disease and the identification of the gene involved, the responsible mutation and the certainty of the phenotype/genotype ratio.

-it is possible to perform an in vitro fertilization/intracytoplasmic sperm injection (FIV-ICSI) procedure with an adequate response after controlled ovarian stimulation.

-the specific criteria for IVF with own gametes.

iii) It will be necessary, in addition to the above criteria, for an express authorisation from the relevant health authority, following a favourable report from the National Commission of Assisted Human Reproduction, where appropriate, established in Article 12 (b) of Law 14/2006 of 26 May.

2. DGP for therapeutic purposes to third parties: DGP in combination with the determination of HLA (human leukocyte antigen) histocompatibility antigens of in vitro preembryos for the selection of the HLA embryo. compatible.

The specific criteria for accessing this technique are:

i) Women aged less than 40 years at the time of indication of treatment with an ovarian reserve sufficient for the purpose of the treatment being pursued.

(ii) Existence of a recognized indication, i.e., the previous child of disease that requires treatment with hematopoietic precursors from a histocompatible sibling.

iii) The express authorisation of the corresponding health authority, following a favourable report of the National Commission of Assisted Human Reproduction, as set out in Article 12.b of Law 14/2006 of 26 May.

iv) Maximum limit of treatment cycles: Three cycles with ovarian stimulation and three additional cycles after clinical assessment by the optional specialist or, where appropriate, by the National Commission of Assisted Human Reproduction of the results obtained in the initial three cycles. This limit may be reduced according to the prognosis, and in particular the result of the previous treatments.

5.3.8.4 In the treatment of RHA, the tests to be carried out in the field of such treatment to the other member of the partner, will be provided by the administration corresponding to the one in which the woman is insured. the RHA technique is to be performed. The pharmacological treatments associated with the RHA technique to which the other member of the partner is to be submitted are excluded from the provisions of this paragraph. '

4. In paragraph 5.3, a new paragraph 5.3.10 is added with the following wording:

" 5.3.10 Attention to patients and family members in the area of genetics that will comprise genetic advice and genetic analysis.

5.3.10.1 Care for patients and family members in the area of genetics in the National Health System will include:

(a) The diagnosis of genetic diseases or disorders, by integrating personal and family clinical information and that obtained after the genetic studies have been carried out.

(b) The transmission of information, in a clear and comprehensible manner, on the risk of recurrence of the disease or disorder, the consequences for the patient and his/her offspring and the possibilities of pre and postnatal prevention.

c) The referral of patients and family members to the various specialized professionals and support groups needed for the proper management of each situation.

5.3.10.2 The process of genetic advice and genetic testing for health purposes must be carried out by qualified personnel and must be carried out in accredited centres that meet the quality requirements that they are regulated in accordance with Article 56 of Law 14/2007 of 3 July of Biomedical Research. The competent regional or regional authority shall also credit institutions, public or private, which may carry out genetic analysis.

5.3.10.3 The genetic advice is the procedure to inform a person about the possible consequences for him or his offspring of the results of a genetic analysis or screening and its advantages and risks and, in its case, to advise it in relation to possible alternatives derived from the analysis. This procedure shall take place both before and after a genetic test or screening and even in the absence thereof.

a) The genetic advice will aim to help the person or family understand and adapt to the medical, psychological, family and social consequences of a particular disease or genetic disorder. This process, which includes the intervention of one or more professionals, will consist of:

1. Interpret personal or family medical records that allow you to assess the risk of occurrence or recurrence of a genetic disease or disorder.

2. Report on the type of inheritance, genetic analysis and its consequences, the possibility of prevention or treatment and the availability and accessibility of resources.

3. To offer appropriate advice, respecting the principle of autonomy of people for decision-making.

4. To request the informed consent prior to the performance of any genetic analysis, after explaining its validity and clinical usefulness, its benefits and the consequences derived from it.

(b) The genetic advice shall be indicated, at least, to the diagnosis, diagnostic suspicion or family history of:

1. º chromosomal anomalies or genomic imbalances that cause or can cause birth defects, severe learning difficulties, or infertility problems.

2. Children's and adult's hereditary diseases.

3. Hereditary and family cancers.

4. Congenital and development failures.

5. Intellectual disability with suspected genetic basis.

6. Fertility Disorders with suspected genetic base.

5.3.10.4 The genetic analysis is the procedure for detecting the presence, absence or variants of one or more segments of genetic material, which includes indirect tests to detect a gene product or a gene. specific metabolite that is indicative primarily of a particular genetic change.

(a) The indication of genetic analysis must be systematically linked to the genetic advice, respecting, at all times, the free autonomy of the individual and requiring his express and written consent, once he has been It is therefore necessary to inform the Commission of the objectives, possibilities and limitations of the analysis, as well as the possible impact of its results on an individual and family level, by taking the necessary measures to ensure access to information. as their understanding. People who have the judicially complementary capacity and the minors will participate, attended to their circumstances, with the necessary support and according to their age and abilities, in the decision-making throughout the process, as indicated in the Article 4 of Law 14/2007 of 3 July.

b) In performing genetic analysis:

1. The protection of people's rights and the treatment of genetic data of a personal nature will be ensured.

2. The criteria of relevance, quality, equity and accessibility will be carried out.

3. Only predictive tests of genetic diseases can be made or that allow the subject to be identified as a carrier of a gene responsible for a disease, or to detect a genetic predisposition or susceptibility to a disease. disease, for medical or medical research purposes and with genetic advice, when indicated, or in the case of the study of inter-individual differences in the response to drugs and genetic-environmental interactions or for the a study of the molecular basis of diseases.

4. In the case of persons with disabilities, information and documentation to be provided and communication and interaction with patients in the process of genetic advice will meet the accessibility requirements. universal and design for all.

c) Genetic analyses included in the common health system's common portfolio of services must meet the following requirements:

1. Having analytical and clinical validity based on scientific evidence.

2. Being of clinical utility: Constituir an essential element for the diagnosis, prognosis, selection and follow-up of treatments, as well as for making reproductive decisions, provided that the benefit/risk balance is favourable.

3. º Haber was previously valued in relation to the ethical, social, legal, organizational and economic implications of its inclusion in public health care.

d) Genetic analyses are classified according to their impact on health without considering the type of tissue in which they are performed and interchangeably of whether they are constitutional or somatic genetic alterations. They can be done in healthy, sick, carrier, or at risk for the disease.

e) Only those genetic analyses that, in compliance with the requirements of analytical and clinical validity, clinical utility and health impact, will be included in the basic common portfolio of health services of the National Health System. above, correspond to one of the following types of studies and meet the following criteria:

1. ° Diagnostic Genetic Analysis: They are performed on people with signs or symptoms of disease and serve to confirm or rule out a particular disease or genetic base disorder. The following indication criteria must be met for completion:

i) The person has signs or symptoms suggestive of a genetic disease or disorder that can be diagnosed by genetic analysis.

(ii) The genetic diagnosis of the disease meets at least one of the following requirements:

-implies a clear benefit in the clinical management (diagnosis, treatment, or follow-up) of the patient or their family members.

-prevents other inappropriate diagnostic or therapeutic procedures from being performed.

-provides key information for the reproductive decision-making of the individual or his or her family members that may compromise their offspring.

2. Pre-Symptomatic Genetic Analysis: They are performed in asymptomatic people and are used to determine if they present a high risk of developing a certain disease, usually of late onset. The following indication criteria must be met for completion:

i) The person belongs to a high-risk family or population group in which the presence of a genetic disease or disorder has been identified, the genetic alteration of which has been previously characterized and may be identified by a genetic analysis.

ii) In addition, at least one of the following requirements is met:

-Genetic analysis allows for early diagnosis and early treatment, which results in the decrease in morbidity and mortality in the disease, in anticipation of a better therapeutic response or in avoiding toxicities for side effects.

-The genetic diagnosis of the disease allows for reproductive decisions of the individual or of his or her family members that may compromise their offspring.

iii) In the case of minors, the presymptomatic genetic study in diseases appearing in adulthood should be deferred until the person has the maturity and competence necessary to understand nature and implications of their decision, unless effective preventive measures are in place in children. In diseases that appear in childhood and which can be prevented or treated properly, it should be as close as possible to the date on which these preventive and/or therapeutic measures should be initiated.

3. Genetic Analysis of Carriers: They are performed in people with high risk of disease transmission to their offspring, although in general they have little or no consequence for the health of this person, and they serve for determine whether the person is carrying an inherited genetic alteration. The following indication criteria must be met for completion:

i) The person, due to his or her personal or family history, presents an elevated risk of being a carrier of a particular disease or genetic disorder whose genetic alteration is known and which can be identified by the corresponding genetic analysis.

ii) The genetic diagnosis allows the making of reproductive decisions of the person or their family members that can compromise their offspring.

(iii) In the case of minors, the genetic study of carriers will not be carried out until the minor reaches the maturity and competence necessary to understand the nature of its decision and its implications and, in turn, capable of give your consent.

4. Genetic analysis for prenatal diagnosis: These are performed in case of fetuses with a high risk of suffering a certain disease or genetic disorder related to their health: chromosomal or molecular anomaly, when they are the following indication criteria:

i) The fetus is at high risk for severe genetic disease or disorder, or its parents belong to a family in which the presence of a serious disease or genetic disorder has been described.

ii) The genetic disease or disorder has a known genetic alteration and can be identified by the corresponding genetic analysis.

iii) Genetic analysis should contribute to the clinical management of gestation or newborn or reproductive decision-making.

5. º Analysis for Preimplantation Genetic Diagnosis (DGP): They are performed at:

(i) Preembryos at high risk for serious genetic diseases or disorders, of early onset and not susceptible to curative treatment in accordance with current scientific knowledge, and will be used for identify the non-affected preembryos to be transferred by assisted human reproduction techniques.

(ii) Combination with the determination of the histocompatibility antigens of the in vitro preembryos for therapeutic purposes for third parties, after a favourable report of the National Commission of Assisted Human Reproduction (CNRHA).

For the performance of the pre-implantation genetic diagnostic tests, the indication criteria as set out in paragraph 5.3.8.4. shall be met.

6. Pharmacogenetic and pharmacogenomic analysis: They are performed in people who need to be treated with certain medications included in the pharmaceutical delivery of the National Health System and are used to determine the therapeutic strategy, assess response to treatment or avoid potential adverse effects in a given individual. "

Additional disposition first. Information system for the neonatal screening program in the National Health System.

The Ministry of Health, Social Services and Equality will implement the information system of the neonatal screening program in the National Health System within the maximum period of six months from the entry into force of this order.

Additional provision second. Implantation of population screening for colorectal cancer.

The implantation of the population screening for colorectal cancer will be done progressively so that within five years from the entry into force of this order all the autonomous communities, the INGESA and the Mutuality General of Civil Servants of the State (MUFACE), Social Institute of the Armed Forces (ISFAS) and General Judicial Mutuality (MUGEJU) (hereinafter, mutual civil servants) have initiated this program and in ten years the coverage understood as invitation to participate, close to 100%.

Additional provision third. Implantation of neonatal population screening.

The implantation of neonatal population screening will be done progressively so that within one year from the entry into force of this order all the autonomous communities, the INGESA and the mutual societies of officials will have implemented this program.

Additional provision fourth. Deadline for adaptation to the forecasts of this order.

The Autonomous Communities, INGESA and the mutual societies of officials shall have a period of nine months to adapt their respective portfolios to the provisions of this order.

Additional provision fifth. No increase in public spending.

The measures included in this order will be met with the ordinary budget allocations and will not be able to increase the amount of appropriations or salaries or other personnel costs for the public sector.

Final disposition first. Competence title.

This order is dictated by the provisions of article 149.1.16. of the Spanish Constitution, which attributes to the State exclusive competence in the field of bases and general coordination of health.

Final disposition second. Entry into force.

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

Madrid, October 31, 2014. -Minister of Health, Social Services and Equality, Ana Mato Adrover.