AUGUST 11, 2020

Cystic Fibrosis of the Pancreas or Mucoviscidosis Law.



Healthcare & Life Sciences Department Report | Cystic Fibrosis of the Pancreas or Mucoviscidosis Law

Dear Sir or Madam,

By means of Decree No. 662/2020, published in the Official Gazette on August 11th, 2020, the Executive Power enacted Law No. 27,553, on “Cystic Fibrosis of the Pancreas or Mucoviscidosis”, which was approved by the National Congress on July 23rd (the “Law”).

The Law declares the fight against Cystic Fibrosis of the Pancreas or Mucoviscidosis disease (the “Disease”) of national interest and aims to establish the legal regime of protection, health care, work, education, rehabilitation, social security, and prevention in order for the people who suffer from the Disease to achieve their development and social, economic and cultural inclusion in accordance with the provisions of the National Constitution.

Without a doubt, the most resonant point of the Law and that has been criticized even by the Minister of Health himself, is the one that establishes that health insurance entities and the public sector must cover a hundred percent (100 %) of all the medical care benefits and treatments that are indicated by the doctors and that the people suffering from the Disease need, as well as the inclusion in the Mandatory Medical Program of all the procedures and practices established in the Law.

In addition, and anticipating what could be the responses of the health insurance entities and the public sector at the time of having to cover these treatments, the Law clarifies that such coverage must be given “in the conditions and amounts necessary as prescribed by the doctor, being forbidden its substitution and/or modification by the healthcare organization, prepaid medicine company and the public health sector”.

The Law, which will be applied throughout the territory of the Argentine Republic, is of public order for which it is established that the enforcement authority must enter into the necessary agreements with the provincial jurisdictions and the Autonomous City of Buenos Aires, in order to guarantee the implementation of this Law throughout the national territory.

It is established that the Law must be regulated within ninety (90) days as of its publication, but it is expressly provided that criteria and coverage forms that restrict the rights acknowledged by the Law may not be introduced in this regulation.

In this regard, we hereby provide you with this executive summary with the most relevant remarks of the Law:

• The Executive Power will establish the enforcement authority of the Law, which must coordinate with the provinces the fulfillment of the Law, being in charge of the provincial health authorities the execution of the Law, for which purpose they may dictate the complementary regulations necessary to such end.

• The enforcement authority will be in charge of, among others: (i) establishing standards for the provision of medicines and supplies that will be reviewed and updated at least every two years in order to promote an improvement in the quality of life of patients; (ii) carrying out national informational campaigns to detect, disseminate and raise awareness of the disease, as well as educational and training programs; (iii) creating a single national drug bank for the treatment of patients suffering from the Disease for the distribution of medicines, which will also be able to manage the purchase of drugs produced abroad in the case of specific treatments that require it.

• The National Ministry of Health must grant the Unique Certificate of Disability (Certificado Único de Discapacidad) to the person diagnosed with the disease and establish a direct support relationship with scientific entities, civil associations, and NGOs that carry out activities inherent to the purpose of the Law at the national and international level.

• The competent authority must coordinate the immediate referral of the person diagnosed with the Disease to the multidisciplinary centers specialized in the pathology.

• The Disease will not be a cause of disability to work in any area and the ignorance of this right will be considered a discriminatory act according to Law No. 23,529 and its amendments.

• Neonatal screening will be implemented as a mandatory practice in all public or private clinics, institutions, or hospitals. If the diagnosis is confirmed in a person, their siblings or direct descendants should be included in the screening.

• The expenses demanded the Law enforcement will be met with the items allocated annually by the General Budget of the Public Administration.

Without a doubt, a regulation will be necessary to make this Law operational and to clarify certain aspects of it.

Should you require any further information on this matter, please do not hesitate to contact us.

Ana Andrés