Compulsory Framework Redefines Demand Planning and Inventory Management in Health Sector
- Sheyla Cuenca
- Sep 16
- 3 min read
On 10 September 2025, the Ministry of Public Health published in the Official Gazette Ministerial Agreement No. 00003-2025, which approves the Manual for the Estimation and Programming of Needs for Medicines and Medical Devices. This regulation, mandatory for all institutions within the National Health System, redefines the way procurement is planned and executed in the public health sector.
Beyond a new administrative procedure, this Manual establishes technical, epidemiological, logistical, and budgetary criteria that transform how needs are calculated, purchases are scheduled, and inventories are managed within the public health system. For companies, it implies adapting planning strategies, participation in procurement processes, and stock management under a stricter regulatory framework with greater traceability requirements.
Key Aspects of the Manual
1. Objectives
Regulate the process of estimating and programming needs for medicines and medical devices.
Define the technical competencies of those responsible.
Provide quantification methodologies based on historical consumption, epidemiological profile, and population data.
Guide purchase programming according to the available budget.
2. Scope
The Manual applies to all entities of the National Health System. Compliance is mandatory for the Comprehensive Public Health Network.
3. Selection of Medicines and Devices
Selection is carried out by the Pharmacotherapy Committees of each establishment, according to the level of care, complexity, and epidemiological profile.
For medicines, selection must be based on the current National Basic Medicines List and on authorisations granted by the National Health Authority.
For medical devices, the official list of essential devices must be followed, and specialised professionals must be involved.
In cases of referral and counter-referral, the inclusion of new medicines must be reported to the Ministry of Public Health within a maximum of thirty days.
For national programmes such as HIV, tuberculosis, and malaria, planning follows specific Standard Operating Procedures.
4. Needs Estimation
Estimation must be based on at least twenty-four months of information, correcting missing or atypical data. Three main methods are provided:
Historical consumption: projects usage trends for each medicine or device using tools such as Adjusted Average Monthly Consumption, simple linear regression, and the breakeven point relative to the average.
Epidemiological profile or morbidity: uses clinical case statistics and therapeutic guidelines to calculate future demand.
Population or demographic method: uses surveys and demographic projections to estimate needs.
5. Purchase Programming
Programming adjusts estimates by considering existing stocks, products in transit, safety stock, replenishment times, and the available budget.
6. Purchase Prioritisation
The Manual introduces two main tools:
ABC Analysis (Cost-Based Analysis): classifies products by economic impact.
Class A: 10%–20% of items account for around 70%–80% of total purchase value.
Class B: 20%–30% of items have intermediate incidence.
Class C: 50%–60% of items represent only about 5% of expenditure.
This analysis focuses management efforts on products of greatest economic relevance.
VEN System (Vital, Essential, and Non-essential): classifies products according to clinical importance, prioritising the acquisition of vital and essential products over non-essential ones.
Conclusions
Ministerial Agreement No. 00003-2025, published in the Official Gazette on 10 September 2025, approved and mandated the compulsory application of the Manual for the Estimation and Programming of Needs for Medicines and Medical Devices across all institutions of the National Health System.
This instrument, both technical and regulatory in nature, redefines procurement planning by establishing procedures based on technical, epidemiological, logistical, and budgetary criteria. Its implementation seeks to ensure continuous and safe supply, reduce the risks of shortages and overstocking, and optimise resource use.
For the pharmaceutical and medical device industries, the Manual becomes an essential frame of reference that directly impacts demand planning, inventory management, and participation in public procurement processes, with strategic implications for their operations in Ecuador’s health system.
