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Ley Reformatoria Organic To The Organic Law Of Health, Law 67, To Include The Treatment Of Rare Diseases Or Orphan...

Original Language Title: Ley Orgánica Reformatoria a la Ley Orgánica de Salud, Ley 67, para incluir el Tratamiento de las Enfermedades Raras o Huérfanas ...

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4 -- Official Record No. 625 -- Tuesday, January 24, 2012

Pags.

electoral; contrary case will be the case-

swam or sanctioned with removal from office and suspension of political rights or participation for the period of one year ...................................................... 26

ECUADORIAN INSTITUTE OF

NORMALISATION: 2012-001 Available to the laboratories of trials, public and private services providing services

technicians, register via the INEN web page ................................................... 27

2012-002 Please note that the calibra-tion, public, and private laboratories that lend

technical services, are registered through the INEN web page ....................................... 27

SERVICE NATIONAL OF

CUSTOMS OFFICE OF ECUADOR:

DGN-604-2011 Delegate administrative powers to engineer Luis Villavicencio

Franco, National Director of Capital and Administrative Services ........................... 28

DGN-629 Derogase Resolution Nº DGN-0386 of July 7 of 2011, published in the

Official Registry No. 504 of August 2, 2011, as well as the Specific Manual for the Sanitary Process for Regulatory Faults and Contraventions ......... 30

SUPERINTENDENCE of

COMPANIES:

SC.ICI.CPAIRS.G. 11.015 Normar in the adoption for the first time of IFRS for

SMBs, the use of fair value or revaluation as a cost attributed, in the case of real estate ....................... 31

MUNICIPAL ORDINANCES:

- Macara Municipal Government: About

Disabilities ............................................ 32

-Municipal Decentralized Autonomous Government of the Urdaneta Canton: General regulations for determination, management, collection and information of special contrib improvements, for works executed in the canton ................ 38

-Municipal Government of Zamora: What

regulates the organization, operation and occupation of the posts and premises that make up the Market Centre Queen of the Swan ......................... 44

REPUBLIC OF ECUADOR

NATIONAL ASSEMBLY. SAN-2012-0050 Quito, January 12, 2012

Lord Engineer Hugo del Pozo Barrezueta Director of the Official Register City

Of my consideration: The National Assembly, in accordance with the powers conferred upon it by the Constitution of the Republic of Ecuador and the Organic Law of the Legislative Function, discussed and approved the project of ORGANIC REFORM LAW TO THE ORGANIC LAW OF HEALTH, LAW 67, TO INCLUDE THE TREATMENT OF RARE OR ORPHAN DISEASES CATASTROPHIC. In session of December 21, 2011, the plenary of the National Assembly met and gave a statement on the partial objection presented by the Constitutional President of the Republic. The text of the ORGANIC LAW REFORMING THE ORGANIC LAW OF HEALTH, LAW 67, was accompanied by article 138 of the Constitution of the Republic of Ecuador and Article 64 of the Organic Law of the Legislative Function, as provided for in Article 138 of the Constitution of the Republic of Ecuador. TO INCLUDE THE TREATMENT OF RARE OR ORPHAN AND CATASTROPHIC DISEASES , to be used in the Official Register. Intently, f.) Dr. Andrés Segovia S., Secretary General.

REPUBLIC OF ECUADOR

THE NATIONAL ASSEMBLY

CONSIDERING: That article 35 of the Constitution of the Republic states that those who suffer from Catastrophic or high-complexity diseases, will receive priority and specialized attention in the public and private fields; What, the Constitution of the Republic in its Article 50 states: " The State shall guarantee to every person suffering from Catastrophic or high complexity diseases the right to specialised care and free at all levels, in a timely and preferential manner. "; What, Article 361 of the Constitution states that the state will exercise the rectory of the national health issue through the national health authority, and this will be the

Registry No. 625 -- Tuesday, January 24, 2012 -- 5

responsible for formulating national policies, normalizing, controlling and regulating all health-related activities, as well as the operation of the entities of the sector;

What, article 4 of the Organic Law of Health establishes that the Ministry of Public Health is the national health authority;

That, article 6 of the Organic Law of Health establishes the responsibilities of the Ministry of Public Health, without any responsibility for regulating the matter

That, there is no legal standard that develops the constitutional precept concerning the subject of catastrophic diseases; that, there are diseases with a prevalence of less than 1 for each 10,000 people and that these types of diseases are high cost and of great economic impact for families and that are considered rare or orphan; and, In exercise of their constitutional and legal faculties, it issues the following:

Organic Reform to the Organic Law of Health, Law 67, to include the Atation of the

Rare or Huerfane and Catastrophic Diseases. Art. 1.- After Article 6 (5), include a numeral that reads as follows: " 5-A.-Dictar, regulate and control the correct application of the regulations for the attention of pathologies considered as catastrophic diseases, as well as, to direct the effective implementation of the programmes of care for them. " Art. 2.- Add to Title II of the Organic Health Law, Law 67, after Chapter III a Chapter that reads as follows:

" CHAPTER III-A

OF CATASTROPHIC AND RARE DISEASES OR ORPHANS

Article ... (1).-The State (a) it shall recognize in the national interest the catastrophic and rare or orphan diseases; and, through the national health authority, shall implement the actions necessary for the health care of the and the sick who suffer them, with the to improve their quality and life expectancy, under the principles of availability, accessibility, quality and warmth; and, quality standards, in the promotion, prevention, diagnosis, treatment, rehabilitation, empowerment and healing. People suffering from these diseases will be considered in conditions of double vulnerability. Article ... (2).-They are obligations of the national health authority:

(a) Issue protocols for the attention of these diseases, with the participation of the scientific sciences, the same ones that will establish the guidelines, criteria and procedures of diagnosis and treatment of patients suffering from rare or orphan diseases;

b) Promote, coordinate and develop, together with

national and international public and private specialised agencies; research for the study of rare or orphan diseases and catastrophic aim to favor early diagnosis and treatment in favor of better quality and life expectancy;

In cases where the National System of

Health is unable to issue the definitive diagnosis of a disease, the national health authority will implement all actions so that these cases are investigated in international health institutions in order to obtain the corresponding diagnosis and treatment.

c) Control and regulate, in coordination with the

competent agencies, insurance companies and pre-paid medical service providers as regards the offer of hedges for diseases considered rare or orphan.

Insurance companies and private companies of

health and pre-paid medicine, in the framework of the policies defined by the national health authority and this Law, shall be obliged to comply with the coverage committed in the respective insurance contracts without being able to refuse such cover on the pretext of subsequent appearance. of diseases considered to be catastrophic and rare or orphan.

d) Control that health service providers

maintain the active search for cases related to rare or orphan and catastrophic diseases, in accordance with the Epidemiological Surveillance System that includes the registration of patients who suffer from these types of diseases.

e) Implement the necessary measures to facilitate and

allow the acquisition of medicines and special supplies for the care of diseases considered rare or orphan in a timely manner, permanent and free for the attention of people suffering from rare or orphan diseases.

f) Establish, jointly with the organizations

of patients and scientists, actions to disseminate and promote knowledge of rare and orphan diseases.

Article ... (3).-The national health authority will create It will implement a topic of registration and information of patients suffering from rare or orphan diseases and will require the reports that must be sent by all the health service providers of the sectors. public and private with respect to patients who are diagnosed or those who do not the final diagnosis can be made.

6 -- Official Registration No. 625 -- Tuesday, January 24, 2012

The agency in charge of migration policy and diplomatic institutions will coordinate with the national health authority and the ministry in charge of the economic and social inclusion, the implementation of the registration of foreign residents suffering from rare or orphan diseases, in order to provide timely care in the country of residence and to be the case in the national territory.

Article ... (4).-The national health authority will promote actions aimed at training, at undergraduate, postgraduate and continuing education, for all staff and health professionals, in order to disseminate scientific knowledge of rare or orphan diseases.

Article ... (5).-The Health Authority national rules governing the production and importation of medicinal products and special inputs to treat diseases considered rare or orphan; and, shall, through the regulations it issues for the purpose, provide sufficient and necessary supplies of such products. medicines for patients according to their needs. The National Health Authority shall promote the mechanisms that enable patients suffering from these diseases, access to medicines and special inputs for their treatment. " Art. 3.- Include in Article 144, after the words: "specialized not available in the country," the words: "for people suffering from catastrophic, rare or orphan diseases,". Art. 4.- In Article 259, after the definition of: "Donor", add the following definitions: " Catastrophic disease.-It is the one that meets the following characteristics: a) That implies a high risk for the life of the

person;

b) That is a chronic disease and therefore your attention is not emergent; and,

c) Your treatment may be scheduled or the average value of your monthly treatment is greater than that determined in the Ministerial Agreement of the Health Authority. '

Rare and Huerfane diseases: Rare or orphan diseases, including those of genetic origin, are those potentially fatal, or debilitating long-term, low-prevalence and high-complexity diseases. Art. 5.- Agreguese following the General Disposition First of the Organic Law of Health, Law 67 the following: PRIMERA-A.-The ministry in charge of the economic and social inclusion will implement the programs of care and social protection families that have among their members patients suffering from diseases considered rare or orphan and catastrophic through the implementation of policies for inclusion and social cohesion, equality and comprehensive protection in coordination with the National Health Authority.

Art. 6.- In the Organic Law of Health, Law 67, replace the words "TRANSITIONAL PROVISION" by: "TRANSITIONAL PROVISIONS" and add the following provisions: FIRST.-Once the Organic Reform Law has been published to the Organic Law of Health to Include Treatment of Rare or Huerfane and Catastrophic Diseases, the Ministry of Public Health will issue and update the list of diseases considered rare or orphan, at least every year taking into account the diseases. considered rare or ultra rare by the World Health Organization/Organization Panamericana de la Salud. Within one hundred and eighty days, the Ministry of Public Health will dictate the agreements, resolutions and other technical norms for the effective implementation of the Organic Law Reform to the Organic Law of Health to Include the Treatment of Rare or Huerfane and Catastrophic Diseases.

SECOND.-Once the Organic Reform Law has been published to the Organic Health Law to include the Treatment of Rare or Huerfane and Catastrophic Diseases, all programs of care for catasrophic diseases that are running in any public dependency, they will pass depend on the Ministry of Public Health, who will be responsible for continuing with its execution.

THIRD.-Once the Organic Reform Law has been published to the Organic Law of Health to include the Treatment of Rare or Huerfanas Diseases and Catastrophic, the Ministry of Finance will proceed to carry out the corresponding budget classification, within the General Budget of the State, so that the Ministry of Public Health will have the necessary funds and can fulfill the obligations determined in this Act.

Art. Final.- This Law shall enter into force with its publication in the Official Register. Given and signed at the headquarters of the National Assembly, located in the Metropolitan District of Quito, Pichincha Province, twenty-one days from December, two thousand eleven. f) FERNANDO CORDERO CAVE President f) DR. ANDRES SEGOVIA S. Secretary General CERTIFIED that the National Assembly discussed and approved the ORGANIC REFORM LAW TO THE ORGANIC LAW OF HEALTH, LAW 67, TO INCLUDE THE TREATMENT OF RARE OR ORPHAN AND CATASTROPHIC DISEASES , in the first debate on 7 and 12 July 2011, in the second debate on 7 November 2011, and on the partial objection of the President of the Republic on 21 December 2011. Quito, January 12, 2012 f.) Dr. Andres Segovia S., Secretary General.