Decision Makers and Decision-Making Processes Diagram
*Note: for acronyms please refer to the list of decision makers and influencers
In 2010, population in Mexico is estimated to be 107.9 million inhabitants, with a 6%/GDP health spending. Currently, the country is undergoing a major demographic and epidemiologic transition. The urban and the aging population are both increasing at high rates and chronic diseases (such as obesity, diabetes and cardiovascular conditions) is facing a rising prevalence.
The Ministry of Health is the regulatory body for all issues related to public health (institutions, policies, surveillance, budget). In addition, there are private and public health & social security institutions, with different affiliation rules and scope of provided services.
Health services are provided as follows:
Social security institutions cover almost half of the population, providing them with social security and complete health coverage at no cost. Only a very small percentage of the population has access to private health insurance, yielding a high dependency on out-of-pocket expenditure for drugs and devices. Seguro Popular (SP) is a health insurance mechanism aiming to achieve universal health coverage by 2012, including only a limited but growing number of covered procedures and pathologies.
Public health institutions buy most of their “health products” (devices, drugs, diagnostics..etc) by means of public bid tenders, which are price-oriented. Servicios Integrales (integral services, SIs) provide institutions of complete kits or trays for many procedures, such as hemodialysis, minimally invasive abdominal procedures, etc., which are also acquired via tenders.
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DECISION-MAKERS AND INFLUENCERS
Secretaría de Salud (SSA): the Ministry of Health; it is the regulating entity regarding all public health matters. Divided in several dependencies. SSA also funds open-population hospitals (SSA-dependent), national institutes for specialized medicine (cardiology, oncology, etc.) and the Instituto Nacional de Salud Pública (National Institute of Public Health).
Consejo de Salubridad General (CSG): the General Health Council; in charge of emitting all mandatory health regulations.
Comisión Interinstitucional del Cuadro Básico de Insumos del Sector Salud: the National Formulary commission; it is in charge of granting the Cuadro Básico (CB) code.
Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris): dependency in charge of control and surveillance of all health centers, sanitary code grants and quality & advertising control of all health-related products and services.
Instituto Mexicano del Seguro Social (IMSS): The Mexican Institute of Social Security, which is the biggest health institution in Latin America, covering almost 45 million people. It provides social security and health services at no cost. Only legal, signed-in employees (and their direct family) have access to the services. Funds come from Federal budget and employees & employers fees.
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado (ISSSTE): The social security and health provider institution for bureaucracy at the Federal level, covering nearly 10 million people. Health services are provided at no cost.
Seguro Popular (SP): Created in 2003, it is a public, voluntary-affiliation insurance system created to provide health services to uncovered population. It is based on annual, family-based, income-dependant fees, with only a limited (but increasing year-to-year) number of procedures and pathologies included in the coverage. Funds come from Federal & state budget and from individual affiliation fees. It has got a separate catastrophic health expenses fund. Services are provided using IMSS’s and ISSSTE’s infrastructure nationwide.
Secretaría de la Defensa Nacional (Sedena): The Army. It offers health and social security services to enrolled population and direct families.
Secretaría de Marina (Semar): The Navy. It offers health and social security services to enrolled population and direct families.
Petróleos Mexicanos (Pemex): The national, State-owned oil firm. It offers complete health coverage and social security to its employees and direct families. It has got the highest per capita health expenditure among public health services providers.
IMSS Oportunidades: Social development program backed up by IMSS to support rural population welfare; it offers basic health and orientation services to families.
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Regulatory Pathway/Market Approval Process
For any medical devices to be marketed in Mexico it must first acquire a sanitary registration. The ministry of Health “Secretaría de Salud” (SSA), (by means of Cofepris) is responsible for sanitary registry grant. Information on safety and efficacy must be provided for approval. Once the code is granted, all marketing and commercial activity can be started.
However, in order to sell it to public health institutions, the product must be submitted to the CSG in order to receive a CB code, which is the National Formulary list. The CB code consists of a 10-digit code and a generic description of the technology, thus any brand whose characteristics match the description may use the code for commercial activities with the public health sector.
There are four (4) catalogues in which all drugs and medical devices & inputs fall: drugs, medical equipment, healing inputs and diagnostic auxiliaries. The submission dossier, along with the sanitary registry and a complete description of the technology, must include a complete health economic evaluation: there is a detailed guideline to conduct these assessments making this a formal health technology assessment. The guideline is available at: (http://www.csg.salud.gob.mx/descargas/pdfs/cuadro_basico/GUxA_EVAL_ECON25082008_2_ech.pdf). The price used to perform the evaluation is considered a reference price for future commercial activity.
The process includes a revision of the dossier by the Cuadro Básico authorities, a concise review and evaluation of the technology and the dossier by a committee of each and all of the most important public health institutions (IMSS, ISSSTE, SSA-dependent hospitals, Sedena, Semar) and the formal statement of the CSG towards the submitted product after a multi-institution voting process. If the code is granted, the producer must then submit the technology to each individual public institution’s formulary mostly through public bid tenders, which are price-oriented. If the code is denied, the producer is notified and explained why the submission did not succeed, and may resubmit. The process can take some months until its resolution. It is worth noting that the formulary of all public health institutions can only include technologies with a CB code, being the former the same throughout the institutions.
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Reimbursement and Coverage/Payment Flow Map and Procurement Process
When any of the public health institutions decide to buy or acquire any kind of inputs, the basis and conditions of the bid are posted online. Before the former takes place, a comment meeting is held. The bid is price-oriented, so whoever’s position is the least costly is the winner. In some cases only national products are subject to compete; if there are no positions, the bid is declared empty and entry conditions (which do not include clinical and/or technical requirements) are relaxed. Contracts are mostly multiannual.
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The complete updated sanitary registry is to be included. As well, the dossier must include data on safety, efficacy and effectiveness for both the current gold standard and the proposed technology. Although evidence-based medicine (EBM) principles are considered, locally-produced evidence is warmly welcomed. For the HTA, a complete economic evaluation comparing the current, standard treatment with the proposed technology is mandatory, including sensitivity analysis. Prices should be expressed in inflation-adjusted local currency (Mexican pesos, MXP).
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CB: Cuadro Básico “Basic Description”
Cofepris: Comisión Federal para Protección contra Riesgos Sanitarios “Federal Commission for the Protection against Health Risks”.
CSG: Consejo de Salubridad General “General Council on Health”
EBM: Evidence-based medicine.
GDP: Gross domestic product.
HTA: Health technology assessment
IMSS: Instituto Mexicano del Seguro Social “Mexican Social Security Institute”
ISSSTE: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado “Institute for Social Security Services for State Workers”
MXP: Mexican pesos.
Sedena: Secretaría de la Defensa Nacional “Secretariat of National Defense”
Semar: Secretaría de Marina “Mexican Navy”
SP: Seguro Popular “People’s Insurance”
SSA: Secretaría de Salud “Ministry of Health”