Summary.
The bill amends Articles 6 and 7 of Law 28 of 2014. It directs the Executive Branch (Órgano Ejecutivo) to create an intersectoral commission for the prevention, diagnosis, comprehensive care, research and treatment of rare, infrequent and orphan diseases. The commission would include representatives, each with an alternate, of the Ministry of Health (Ministerio de Salud), which would chair it; the Social Security Fund (Caja de Seguro Social); the Ministry of Economy and Finance (Ministerio de Economía y Finanzas); the National Disability Secretariat (Secretaría Nacional de Discapacidad); and patients or organized groups. A pharmaceutical industry representative and a geneticist would also participate, each with speaking rights only. The Ministry of Health would appoint the patient representatives and geneticist; the Ministry of Commerce and Industries (Ministerio de Comercio e Industrias) would appoint the pharmaceutical representative from a shortlist of three.
The commission would adopt its own rules and establish standards for determining diagnoses and treatments. It could form partnerships with national and international nongovernmental bodies and participate in collaborative projects to exchange scientific information, train health personnel, develop public education programs, and obtain diagnostic methods and treatments. Its duties would also include promoting biotechnology and pharmacogenomic research to produce treatments domestically, subject to quality and biosafety controls; developing funding programs through cooperation and agreements with public and private entities; updating the official disease list on referrals from the advisory body; and allocating a budget to the national program. It would meet in ordinary session at least two (2) times a year, between June and July and between January and February. Its chair or a majority of its members could convene extraordinary meetings.
The bill creates the National Care Program for Persons with Rare, Infrequent and Orphan Diseases to support prevention, diagnosis, comprehensive care and research, including appropriate treatment in each case. The Ministry of Health would regulate the program. An advisory body attached to it would, following the treating physician’s diagnosis, assess the information, issue an opinion or diagnosis, identify appropriate treatment and, where applicable, validate the disease classification. It would refer newly identified diseases to the commission for inclusion on the list.
The advisory body would consist of three (3) specialist physicians and a pharmacist, with alternates, appointed by the Ministry of Health for a term of no more than five (5) years. It would consult the treating physician and specialists in the relevant conditions. It would adopt internal rules, review cases and prescribed treatments at least once a month, and hold extraordinary meetings when needed. Decisions would require all members to be present and majority approval. The body would also provide technical assistance to the commission, follow up on suspected or diagnosed cases, retain copies of clinical records and provide them to the commission on request. It could seek a socioeconomic assessment from a Ministry of Health social worker, call in other specialists, report newly identified diseases and establish diagnostic and treatment protocols.
The Ministry of Health would recognize new diseases meeting the legal procedures and issue updated lists as their inclusion is approved. The Executive Branch would regulate immediate publication of those lists. The bill reiterates its amendments to Law 28 of 2014, orders preparation of a consolidated text and adjustment of the regulations. Acting through the Ministry of Health, the Executive Branch would issue implementing regulations within no more than sixty (60) days of promulgation; the law would take effect the following day. The provisions concern those public institutions, patients and health personnel, and the pharmaceutical and biotechnology sectors.
What it proposes.
- Social protection for people with rare, infrequent and orphan diseases.
- The structure and duties of an intersectoral commission and national program.
- Case and treatment assessment and updates to the official disease list.
Who it would affect.
- People with rare, infrequent and orphan diseases.
- Participating public institutions and health personnel.
- Patients or organized groups.
- The pharmaceutical industry.
Key points.
- Reorganizes the intersectoral commission and adds patient and pharmaceutical industry representatives and a geneticist; the latter two have speaking rights only.Art. 1
- Expands the commission’s duties concerning diagnosis, treatment, collaboration, research, funding, the official list and the program’s budget.Art. 2
- Requires at least two (2) ordinary meetings each year and allows extraordinary meetings called by the chair or a majority of members.Art. 3
- Creates a national program to support prevention, diagnosis, comprehensive care, research and patient treatment.Art. 4
- Creates an advisory body to assess each case after the treating physician’s diagnosis, identify treatment and refer new diseases for the official list.Arts. 5-6
- Sets meeting and decision rules and assigns the advisory body duties involving follow-up, clinical records, socioeconomic assessment and protocols.Arts. 7-8
- Provides for recognition and publication of new diseases, a consolidated text, revised regulations and entry into force the day after promulgation.Arts. 9-13