IFC’s appraisal considered the environmental and social management planning process and documentation for the Project and gaps, if any, between these and IFC’s requirements. Where necessary, corrective measures, intended to close these gaps within a reasonable period of time, are summarized in the paragraphs that follow and (if applicable) in an agreed Environmental and Social Action Plan (ESAP). Through implementation of these measures, the Project is expected to be designed and operated in accordance with Performance Standards objectives.
PS1: Assessment and Management of Environmental and Social Risks and Impacts
Policy, Environmental and Social Assessment and Management System: CM has developed and implements a quality policy which includes limited elements of environmental and occupational health and safety management. The policy covers all CM operation, however, is currently only implemented at the production plant. CM will revise this policy to include E&S aspects to align the latter with IFC PS requirements and ensure implementation across all operations (ESAP#1). The production plant is certified to ISO 13485:2016 standard requirement which a quality management system specific for medical devices manufacturers. Under this management system, a site-specific Health, Safety and Environmental (HSE) procedure for the production facility has been developed. The HSE procedure incorporates roles and responsibilities for its implementation, the process for waste management, management of occupational health and safety (OHS) including training requirement, use of Personal Protective Equipment (PPEs), permit to work, accident reporting and OHS Key Performance Indicators (KPIs).
As part of this investment, CM will develop a company-wide ESMS that will cover all its operations including the activities at the headquarters and warehouses, and equipment distribution. The company-wide ESMS will include plans related to: E&S risk identification and assessment, contractor management, emergency planning and response, stakeholder engagement and communication, OHS management, resource efficiency, solid waste management, hazardous materials management, pollution prevention and spill response, traffic and transport management, (including community safety), security management, auditing and monitoring of E&S risk and impacts, management review and reporting to the Board of Directors (ESAP#1).
Identification of Risks and Impacts: In line with national legislation requirements, CM undertook an Environmental and Social Impact Assessment (ESIA) for the production facility in 2021, prior to the start of construction and consequently obtained the required environmental permit for construction and operation. As for the construction of the headquarter, a stand-alone ESIA was not legally required. The E&S risk and impacts were evaluated under the Diamniadio City ESIA, which already accounts for such activities. Both ESIA covered both construction and operation phases and included the following amongst others: (i) environmental and social scoping; (ii) baseline studies; (iii) assessment of potential significant impacts due to construction and operational activities and identification of the mitigation measures; (iv) monitoring program for construction and operational phase of the project; (iv) stakeholder consultations; (v) E&S Management Plan (ESMP) with associated framework management plans including stakeholder engagement with grievance redressal mechanism, occupational health and safety and emergency preparedness and response. Furthermore, as part of the company-wide ESMS development, CM will establish an E&S risk identification and assessment procedure and regularly audit its operation to identify E&S risks related to its activities.
Management Programs: The production facility’s ESIA included a framework ESMP, covering construction and operation phases as outlined in previous section. The site-specific EHS procedure was developed based on the outcomes of the ESIA for the production facility and further plans will be developed as part of the ESMS. For the construction of the headquarters, Sonerco, a sister company of CM and part of the COSEMAD group, was contracted as the project management company. The construction works were subcontracted to various contractors. Sonerco conducts ad-hoc HSE audits and regular meetings with these subcontractors, ensuring compliance with COSEMAD’s contractor’s charter for good conduct which emphasizes environmental protection and occupational health and safety.
Furthermore, CM utilizes Sonerco's services for minor construction projects at distribution sites such as hospitals, primarily to house oxygen central units. Going forward, CM will develop and implement a contractor management plan including requirement for contractors to develop (i) an HSE plan including organization structure, training and capacity building of its own staff and sub-contractor staff; (ii) labor and working conditions requirement (ii) emergency preparedness and response system; (iii) monitoring, review and reporting; (iv) stakeholder engagement; and (v) grievance redressal mechanism including Gender-based violence and harassment aspects.
E&S organizational structure: CM has a quality, health, safety and Environment (QHSE) officer, who oversees QHSE compliance, monitoring, reporting, training, resource management, and pollution control at the production facility. The QHSE officer is assisted by two team members focused on the quality management system implementation and monitoring. CM’s QHSE manager will report to the COSEMAD Director of QHSE, who was under recruitment at the time of the appraisal. COSEMAD has established a QHSE function, including an organizational chart with clearly defined roles and responsibilities and reporting lines for staff managing the quality and HSE issues. As part of this investment, CM will recruit or designate an E&S officer responsible for overseeing E&S risk related activities for headquarters, distribution, warehousing, and contractors (ESAP#2).
E&S Training. The company has established an annual training plan for the production facility, which includes training on quality management, best practices, firefighting, first aid, general occupational health and safety. Going forward, as part of its ESMS development (ESAP#1), CM will upgrade the current training plan to cover E&S risk related to all activities and based on the E&S audits to be undertaken as part of the ESMS development and implementation.
Emergency Preparedness and Response: CM has in place documented emergency preparedness and response plans for production facility, and one for the construction phase of the headquarter. No emergency drills have been carried out for these sites. The company will develop and implement site-specifics emergency preparedness and response plan for the operational phase of the headquarter and the warehouses, identifying potential emergency situations and accidents; potential impact on the environment and outlines the necessary response actions and responsibilities (ESAP#3). The plan will include measures to prevent or mitigate accidents, fire outbreaks, electrical shocks, spillage and pollution prevention and other potential hazards like climate risk.
E&S Monitoring & Review: Currently environmental monitoring is undertaken for the production facility only. Intake Water quality and wastewater effluent quality are regularly tested and compared against national legislations. Electricity consumption is monitored for internal benchmarking. Going forward, the company will establish a robust E&S monitoring program, encompassing all its activities. As part of its PS1-compliant ESMS (ESAP#1), CM will develop an E&S monitoring and reporting procedure which will specify Key Performance Indicators (KPIs) and associated benchmark, including occupational health and safety (OHS) leading and lagging indicators (incident records, near miss, hazard reporting and other workplace monitoring data), resource (water and energy) usage and efficiency, pollution prevention and control (air emissions, noise, effluents, solid/hazardous waste management) and contractor E&S performance .
Supply Chain and Distribution Network: CM’s main suppliers are medical equipment manufacturers, and medical grade inorganic chemical manufacturers. Most of this materials/equipment are produced in controlled and automated facilities requiring high degree of quality, child and forced labor risk in the supply chain is very low. In Senegal and Mali, all the distribution and maintenance activities are carried out by the direct employees of CM, while in other countries, CM partners with other medical distributors. The major contextual risk within the distribution network are road safety and Gender based violence and harassment (GBVH), which network is discussed under PS4 section below.
PS2: Labor and Working Conditions
At the time of the appraisal, CM had a workforce of 133 direct employees, with roughly 37% female. The production facility has around 14 employees and uses casual workers (max 20) as and when required. When the plant will be fully operational, around 25 employees are expected to be employed and greatly reduce the number of casual workers. The remaining employees are based in the headquarter, with around 10 employees based in the warehouses. In addition, there are roughly 20 contract workers hired directly by the Company through a third-party contractor mainly for security and housekeeping services. Out of 133 employees, six are based in Mali and one in Cote d’ivoire. For the other countries, CM is not physically present, and the equipment distribution is done via distribution partners.
HR Policy/Procedures, Working Conditions and Terms of Employment: CM relies on COSMAD manual of procedures for certain Human Resources (HR) processes such as recruitment, payment of salaries and annual leaves. CM further relies on the national collective conventions for commerce and interprofessional on various matters. The national collective conventions for interprofessional describes the working conditions and terms of employment, including wages, workhours, rest periods, right to adhesions to unions and overtime. Each worker receives a written contract detailing wages, duration, and adherence to company regulations, and to refer to these conventions for any employment related undefined matter. Going forward, CM will develop a HR manual aligned with IFC PS 2 requirement and will carry out training for all its employees on their labor rights and obligations (ESAP#4). The HR manual will include policies and procedures on non-discrimination, equal opportunity, prohibition of harassment including sexual harassment, freedom of association, retrenchment, prohibition of child and forced labor, and workers' grievance mechanisms. The manual will also include policies and procedures for recruitment and hiring, training and career progression, compensation and benefits (working hours, overtime payment rate, insurance, leave policies), occupational health and safety, workplace conduct, disciplinary procedures and termination. CM also has a documented internal regulation as required by the national labor code and is applicable to all employees. This regulation provides details on hours of work, leaves, disciplinary action and workplace hygiene. Awareness of this regulation is carried out for all employees during the induction training. The internal regulation will be updated to align with the HR manual.
In terms of working hours, all employees are required to work 40 hours per week as per statutory requirement. The production plant currently operates 8 hours per day but is expected to operate 24 hours at full production capacity. The company currently maintains a database of trained casual workers (OSH and quality) for the production facility who are engaged on an as-needed basis and compensated daily. The company plans to transition to three 8-hour shifts per day, which will involve hiring additional employees. This change is expected to result in a reduction in the number of casual workers employed. Generally, employees at the headquarter and warehouses work from 9am to 6 pm with 2 hours break time. Overtime is typically not required, but it may be necessary for technicians and drivers to work more than 8 hours, particularly for maintenance and delivery tasks. Technicians and drivers are also required to travel outside of Dakar for interventions in medical facilities. CM provides hotel accommodation and a per-diem for employees intervening outside of Dakar. As part of its HR manual, CM will develop overtime and travel policies in line with national legislation and PS2.
Non-discrimination and Equal Opportunity and Worker’s Grievance Mechanism: CM does not currently have a documented policy on non-discrimination, equal opportunities, harassment including sexual harassment. As per ESAP#4, CM will develop and implement HR policies, in line with IFS PSs, including explicit statements to ensure non-discrimination, equal opportunity and fair treatment during recruitment and selection in its human resource manual.
No documented grievance mechanism is in place. However, the company reportedly implements an open-door policy, where employees can report any grievances to HR manager or/and their supervisor. Going forward, the company will formalize its grievance mechanism allowing access to all workers, including third-party workers, indicating (i) available channels to submit grievances (including separate channels for grievances related to gender-based violence and sexual harassment, and for confidential and anonymous complaints); (ii) roles and responsibilities for treating and responding to grievances; (iii) timelines for taking action; and (iv) system to log, track and report grievances and their status in accordance with IFC PS2 requirements (ESAP#5). The mechanism will also include a differentiated procedure and management of GBV and sexual harassment related grievances. The company will sensitize its workforce and disseminate information on online platforms and notice boards with additional specialised training provided to staff managing GBV and sexual harassment grievances.
Workers Engaged by Third Parties: CM engages contractors mainly for construction activities, cleaning and security. The company does not currently exercise oversight on third party workers. Going forward, CM will develop a contractor management plan (as part of ESAP#1), which will include monitoring contractor compliance with its EHS policies and various statutory requirements including for minimum wages, social security related benefits and leave provisions, non-deployment of child and forced labor, alignment of working hours and overtime payment with statutory requirements, OHS guidelines for the workers.
Occupational Health and Safety: Under the production site specific EHS plan, CM details the various aspects of OHS such as use of personal protective equipments, annual medical check-up, OHS risk assessment, permit to work, and accident investigation and reporting for the production facility. All employees have been provided with PPEs and training related to chemical handling, first aid and fire safety. No major workplace accident has been reported by CM for the past three years. No risk and hazard identification has been carried out for other activities at the headquarter and warehouse. Going forward, CM will undertake a detailed OHS risk audit for production facility, headquarter, the warehouses and other associated activities, such as maintenance and transportation, including exposure to radioactivity (ESAP#6). The OHS risk audit will be the basis for CM to create an OHS Management Plan (ESAP#1). This plan will outline specific procedures, training needs, permit-to-work systems, and methods for managing, reporting, and investigating accidents and incidents. The OHS Management Plan will apply to both direct workers and contractors, ensuring compliance with PS requirements, WBG EHS Guidelines, and Good International Industry Practices (GIIP) for the sector. The OHS Management Plan will further include heat stress management protocols, including but not limited to adjusted work schedules during high temperatures, provision of drinking water, the provision of shaded/cooled breaks, and training for all workers For construction activities, contractors are required to sign and abide by the COSEMAD contract’ charter for good conduct, which includes the commitment to provide a safe working environment for the workers and compliance with national legislation. Sonerco teams carries ad-hoc monitoring on contractors. Under its contractor management plan, CM will establish an appropriate contractor supervision and monitoring system, including OHS aspects.
Risk management related to exposure of radioactivity, during maintenance works of MRIs and similar equipments is dictated by the regulation promulgated by the Authority for Radiological Protection and Nuclear Safety (ARSN). The ARSN provides training and dosimeter for such employees and requires the employers to keep records accordingly. At the time of the appraisal, only 2 CM technicians were qualified and equipped with dosimeters for such interventions. As part of its ESMS, CM will develop a radioactive material management plan which will include managing exposure risk of employees.
PS3: Resource Efficiency and Pollution Prevention
Energy Consumption and GHG emissions: The Project’s main energy sources are grid electricity and diesel for transportation and backup generators. The Project emissions are estimated to remain below 25,000 tons of carbon equivalent per year. As part of its ESMS, CM will develop and implement a resource efficiency management plan to monitor, manage and establish target for resource efficiency.
Water and Wastewater management: The headquarters will use bottled drinking water and tap water for other purposes from the municipal supply. The headquarters will dispose of sanitary wastewater via on-site septic tanks. Water for production is sourced from an existing borehole and treated with an RO plant before use. The production process produces no effluent, but the RO plant generates a small amount that is rejected into the municipal sewerage network. The RO effluent quality is assessed every quarter against national effluent discharge limits, and measures are implemented if exceedances occur. Wastewater from the laboratory is treated as hazardous waste (see below). Water and wastewater quantities are not currently monitored. CM will develop a water and wastewater management procedure under its ESMS.
Dust and Noise Emissions: The CM facilities do not produce significant air or noise emissions during normal operation except by back-up generators when power is off. However, these risks may arise during construction activities. Given the advanced stage of headquarters construction, it is expected that dust emissions will be limited. Noise emissions during construction are managed by limiting construction activities between 7am to 5pm. Furthermore, no sensitive receptors were observed in the vicinity of the headquarter. CM will ensure that these risks are monitored and managed under its contractor management plan.
Solid Waste management: Both the production facility and headquarters generate minimal solid waste, primarily from offices and kitchens. The production plant produces small amounts of rejected HDPE bottles, which are recycled to produce new bottles. The site specific EHS plan ensures maximum recycling of waste. Construction waste produced is currently stored on site and sent to other construction sites for backfilling. Going forward, as part of its contractor management plan, CM will require its contractor to put in place a formal waste management plan, ensure sorting and proper disposal of each type of waste.
Hazardous material and waste management: Raw material used at the production facility consists of concentrated acetic and citric acids which are used in the dialysis kit component production. These materials are stored in dedicated temperature-controlled rooms and under restricted access with appropriate signage. The hazardous waste generated from the production plant includes small quantities of chemical containers/bags and laboratory wastewater which is stored temporarily on the site in dedicated containers and then disposed of by companies licensed by the environmental authority. Management of hazardous materials and waste is detailed in the EHS plan.
Another hazardous waste produced from CM supplied equipment is radioactive waste from MRI and other equipment. As discussed above, radioactive materials including waste are regulated by ARSN. Radioactive waste from equipment is returned to the equipment manufacturer under the supervision of ARSN. The equipment supplier is also responsible for providing appropriate training for the equipment operators. Under its radioactive material management plan, CM will detail the steps to ensure radioactive waste is properly returned to the main manufacturer and will provide guidance as needed to its customers.
PS4: Community Health, Safety and Security
Life and Fire Safety: Fire protection systems have been provided at the production facility, which include portable fire extinguishers, fire hydrant systems (with dedicated fire water storage), fire alarms, automatic sprinklers, smoke detectors, emergency exits and marking of evacuation routes. No fire incident has been reported so far at the production facility. The headquarter will have similar fire protections systems. For the warehouse, the fire protection system currently includes only fire extinguishers. CM will ensure that Life and fire safety aspects are covered in the detail OHS audit as per ESAP#5.
Road and Transportation Safety: Equipment deliveries, and maintenance interventions are needed outside of Dakar, which may require long journeys (normally less than 24 hours). Most of the transportation is done by CM fleet, however on certain occasions CM may hire third-party transportation services if needed. The current fleet of CM consists of around 20 vehicles including 5 trucks, and another 20 COSEMAD vehicles are assigned to work exclusively for CM. All CM and COSEMAD vehicles are equipped with In-Vehicle monitoring system, however, it is currently utilized mostly for GPS tracking. The number of vehicles used by CM is not expected to increase as part of this investment. CM and COSEMAD ensures all their drivers have proper driving license and experience prior to recruitment, which also includes a driving test.
CM will develop a Road safety and Transportation Management and Monitoring Plan. The plan will include, as a minimum: i) driver, vehicle and journey management policies and procedures, such as the prohibition of substance abuse, journey management and vehicle maintenance among others; ii) training requirement for drivers in particular related defensive driving, iii) appropriate use of IVMS for monitoring driver behavior and incidents; iv) monitoring leading and lagging indicators, including incident investigation and reporting . The company will ensure that the requirement of the Road safety and Transportation management plan is implemented by any third-party transportation service provider, contracted by CM.
Community based gender-based violence: Drivers and technicians are required to undertake deliveries, installation and maintenance tasks mainly in hospitals and medical facilities. Given the nature of their work, these employees are likely to interact with community members, such as patients, children or hospital employees, or members of the public along transportation routes. To avoid any risk of GBVH and child abuse, CM will develop and implement a sexual harassment and child safeguarding policy that will apply to all its employees, and contractors. This policy will include the (i) company’s commitment towards a zero tolerance for any form of sexual harassment and child abuse, (ii) requirement for all incidents and allegations to be treated seriously and promptly investigated, and (iii) grievance mechanism system for reporting such incidents, including anonymous means (ESAP#7).
Use of Security forces: Two to three security guards are employed per shift for each site, through security service provider. For each site and shift, one of the security guards is armed. Going forward, CM will undertake a security risk assessment that will form the basis to develop a Security Management and Monitoring Plan aligned with the requirements of PS4 and the Voluntary Principles on Security and Human Rights. This includes prescriptions for guard selection, rules of engagement (including minimum force), training, equipment, facilities, working conditions, and grievance management (ESAP#8).