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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CONSIDERING: That article 35 of the Constitution of the Republic establishes that those who suffer catastrophic diseases or high complexity, will receive attention priority and specialized in the fields of public and private; That the Constitution in its article 50 provides that: "The State shall guarantee to every person that suffer catastrophic diseases or high complexity the right to free and specialized care at all levels, timely and preferential."; That, the article 361 of the Constitution establishes that the State shall exercise the rectory of the if theme national of health through it authority health national, yque this will be it record official No. 625-Tuesday 24 of January of the 2012-5 responsible of formulate them political national, regulate, control and regular all them activities related with it health, as well as , the operation of the entities of the sector;

That, article 4 of law of health establishes that the Ministry of public health is the national health authority;

That, article 6 of law of health establishes the responsibilities of the Ministry of public health, without it has been considered no responsibility governing considered catastrophic diseases concerning matter;

That there is no legal standard that develops the constitutional precept concerning the matter of catastrophic diseases; That, there are diseases with a prevalence lower of 1 for each 10,000 people and that this type of diseases are of high cost and of great impact economic for them families and that are considered rare or orphan; and, in exercise of its constitutional and legal powers, issued the following: reform law to the organic health law, law 67, to include the Tr treatment of rare diseases or orphan and catastrophic. Article 1.-then of paragraph 5 of article 6 included a paragraph which read as follows: "5-A-dictate, regulate and control the correct application of the rules for the care of diseases considered as catastrophic diseases as well, directing the effective implementation of programmes of care of them." Article 2.-Add in title II of the organic health law, law 67, after chapter III a chapter that says the following: "chapter III-A of CATASTROPHIC ILLNESSES and rare or orphan article..." (1) the Ecuadorian State shall recognize national interest to catastrophic and rare diseases or orphan; and, through the authority health n international, will implement the necessary actions for the health care of the patients who suffer from them, in order to improve its quality and life expectancy, under the principles of availability, accessibility, quality and warmth; and quality standards in promotion, prevention, diagnosis, treatment, rehabilitation, empowerment and healing. People who suffer from these diseases will be considered under conditions of double vulnerability. Article... ((2).-obligations of the national health authority: to) broadcast protocols for the attention of these diseases, with the participation of the scientific ociedades, which establish guidelines, criteria and procedures of diagnosis and treatment of the patients who suffer from rare diseases or orphan;

(b) promote, coordinate directed, jointly with agencies specialized national e international public and private, research for the study of them diseases rare or orphan and catastrophic with the purpose of favouring Diagnostics and treatments early toward of a best quality and expectation of life;

In those cases in which the national health system it is impossible 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 with the purpose of obtaining a diagnosis and appropriate treatment.

(c) control and regulate, in coordination with relevant agencies, to the insurance companies and providers of medical services pre paid in relation to the offer of coverage for diseases considered rare or orphan.

Insurance companies and private health and medicine companies pre paid, within the framework of the policies defined by this law, and national health authority will be required to comply with coverage involved in the respective insurance contracts unless they can deny coverage on the pretext of the subsequent appearance of diseases considered rare and catastrophic or orphan.

d) control the providers of health services to maintain the active search for cases involving rare diseases or orphan and catastrophic, in accordance with the system of epidemiological surveillance that includes the registry of patients who suffer from such diseases.

(e) implement them measures necessary that facilitate and allow the acquisition of drugs and inputs special for the care of diseases considered rare or orphan in form timely, permanent and free for the attention of them people that suffer from diseases rare or orphan.

f) establish, in conjunction with patient organizations and scientific, actions to disseminate and promote awareness of rare diseases and orphan.

Article... (3) the national health authority will create and implement an if subject of registration and information for patients who suffer from rare diseases or orphan and will require reports that obligatorily must send all the institutions providing health services in the public and private sectors with respect to patients who are diagnosed or those n which you may not broadcast the final diagnosis.

6 registro Oficial Nº 625 - Tuesday, January 24, 2012 the agency responsible for immigration policy and diplomatic institutions will coordinate with the national health authority and the Ministry responsible for economic and social inclusion, the implementation of the register of persons residents abroad who suffer from rare diseases or orphan, in order to provide prompt disposition in the country of residence and if applicable in the national territory.

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

Article... (5) the national health authority will regulate the production and import of medicines and special supplies to treat diseases considered rare or orphan; and it will seek through the regulations issued for this purpose, the necessary and sufficient provision of such medicines to patients according to their needs. The national health authority will promote the mechanisms that allow the patients suffer these diseases, access to medicines and supplies special treatment." Article 3.-included in article 144, after the words: "specialized not available n the country,", the words: "for people who suffer catastrophic, rare diseases or orphan,". Article 4.-in article 259, after the definition of: "Donor", add the following definitions: "(Enfermedad Catastrófica.-Es aquella que cumple con las siguientes características: a) that involves a high risk for the life of the person;"

(b) that it is a disease that is chronic and thus their attendance not be emerging; (y, c) that your treatment can be programmed or that the average value of your monthly treatment is higher than that determined in the Ministerial Agreement of the sanitary authority. "

Rare and orphan diseases: rare diseases or orphan, including origin genetically, are potentially fatal or debilitating diseases in the long term, low-prevalence and high complexity. Article 5.-added below the first General provision of the organic law of health, law 67 the following: PRIMERA-A-the Ministry in charge of the branch of social and economic inclusion run attention and social protection programmes to families who are members to patients suffering from diseases considered rare or orphan and catastrophic by policies of social inclusion and cohesion equal and comprehensive protection in coordination with the national health authority.

Article 6.-the law of health law. 67, replace the words "Transitional provision" by: "Transitional provisions" and added the following provisions: first-once posted to the organic law of the health reform law to include the treatment of rare diseases or orphan and catastrophic, the Ministry of public health will issue and update the list of diseases considered rare or orphan at least every os years taking into account the diseases considered rare or ultra rare by the world Organization of the Pan American Health Organization of health. Within the period of 180 days, the Ministry of public health, will dictate the agreements, resolutions and other technical standards for the effective application of the reform law to the law of health to include the treatment of rare diseases or orphan and catastrophic.


SECOND.-Once posted to the organic law of the health reform law to include the treatment of rare diseases or orphan and catastrophic, all programs of care for disease catasroficas running any public reporting, will be dependent on the Ministry of public health, who will continue with its execution.

THIRD.-one time posted the law reform to the organic health law to include the treatment of rare diseases or orphan and catastrophic, the Ministry of Finance shall make the corresponding r classification budget, within the General budget of the State, the Ministry of public health have necessary funds and to fulfil the obligations determined by this law.

Art. End: the present law shall enter into force with its publication in the Official Gazette. Given and signed at the headquarters of the National Assembly, located in the Metropolitan District of Quito, Pichincha province, to twenty-one days of the month of December of two thousand eleven. ((f) FERNANDO CORDERO CUEVA f President) DR. ANDRES SEGOVIA S. Secretary General certificated the National Assembly discussed and approved the law organic reform to the organic health law, law 67, to include the treatment of the diseases rare or orphan and CATASTROPHIC, in first debate 7 and July 12, 2011, in second debate on 7 November 2011 and is delivered on the part of the President of the Republic on 21 December objection of (2011 Quito, 12 of January of 2012 f.) Dr. Andres Segovia S., Secretary General.

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