The group production plants do not store hazardous chemicals in quantities that would pose a risk to the surrounding communities.  The plants’ areas are enclosed with access regulated by gates and unarmed private security guards. IFC’s appraisal concluded that the level of security risks and impacts on nearby communities at existing plants is low.  Therefore, PS4 is not applicable to the project.  Requirements for security risk assessment and, if relevant, development of security management plans for future plants will be covered by the group’s corporate management system under PS1 requirements.  MS-Pharma development model is primarily driven by mergers and acquisition of existing production facilities; when construction of new facilities is required, the group purchases the land on the open private market with no expropriation or involuntary resettlement (PS5) necessary.  Furthermore, because of its nature, the project will have no impacts related to Biodiversity Conservation and Sustainable Management of Living Natural Resources (PS6) Indigenous Peoples (PS7), or Cultural Heritage (PS8) as facilities are located in industrial, urbanized areas.  Should future development trigger any of the above PSs, the group will develop specific plans, procedures, and standards to comply with IFC’s Performance Standards.

Environmental and Social Assessment and Management System

MS-Pharma facilities are certified under Good Manufacturing Practice (GMP), system for ensuring that products are consistently produced and controlled according to quality standards, from several authorities.  The UNP plant holds GMP certifications from 26 national authorities, including Jordan, all MENA countries, and EU while the MSI plant is certified by Jordan and Saudi Arabia with plans to be certified by EU and US.  The El Kendi plant is certified in Algeria, Sudan, and Libya with plans to obtain certifications from other MENA countries. The MS Pharma Injectable plant in Turkey follows GMP provisions in accordance with WHO and EU GMP regulations. All tasks are established and documented for each technical and other personnel working in the plant.

MS-Pharma does not have an Environmental and Safety management system (ESMS) at the corporate level.  Jordan operational facilities  work under a framework EHS manual covering general provisions on safety (e.g. risk classification, personal protective equipment (PPE), training, fire prevention, injuries reporting, etc.) and environment (e.g., waste disposal, treatment of wastewater, cross contamination prevention).  The El Kendi plant does not have an ESMS but implements (GMP and standard operating procedures, mainly covering product quality, engineering and maintenance, quality assurance and control, research and development operations, validation, and warehousing. MS Pharma Injectable plant in Turkey does not have an ESMS but as part of its GMP and ISO 9001 certifications have environmental and social programs, mainly covering, safety, environmental monitoring plan, accident/incident reporting procedure, firefighting equipments procedure, workplace measurements (noise, vibration, lighting and air quality) procedure, industrial waste management and plan, waste treatment unit operation instruction, hazardous and nonhazardous wastes management plan. The group is in the process of reviewing the EHS manual for UNP and MSI to achieve ISO 14001 and OHSAS 18001 certification (planned for 2016 for UNP) and is in the early stages of developing an ESMS for El Kendi.  As outlined in the ESAP (item #1), the group will develop a robust corporate ESMS framework, including overarching Environmental and Social Policies and procedures, in line with ISO 14001, OHSAS 18000 standards and IFC PSs provisions and requirements, and will ensure that individual operational facilities are aligned with this framework.  Given MS-Pharma plans to expand its operations in other countries, the group will ensure its corporate ESMS will be up to date with the group development and, if relevant, will include new relevant plans and procedures (e.g., land acquisition plans, chance find procedures, biodiversity management plans, etc.). 

MS-Pharma complies with all host country requirements regarding its operations, including requirements to undertake social and/or environmental impact assessments of new developments (e.g. El Kendi expansion, UNP, Saudi Arabia plant) where applicable.  As noted, the group strategy is to achieve growth by mergers and acquisition of existing companies/facilities rather than constructing new plants.  New facilities construction included in the group short term plans is located either in industrial areas promoted by local government agencies or in mix zones (urban and light industry) and will likely not be required to develop an environmental and social impact assessment (ESIA); however, if required, MS-Pharma will develop such a study according with national requirements and IFC PSs  As listed in ESAP (item #2), the group will develop a standard procedure and terms of reference for any such ESIA.  Furthermore, MS-Pharma will establish EHS and social principles, based on IFC PSs and applicable World Bank Group (WBG) EHS Guidelines (General, Pharmaceuticals and Biotechnology Manufacturing), to assess risks and potential impacts during the due diligence phase on prospective acquisitions and/or new plant development and, if relevant, develop an action plan to bridge identified gaps.

Currently, unarmed security guards directly hired by the plants provide security at each operational site except in MS Pharma Injectable plant in Turkey were the security operations are outsourced to external security provider company; their main function is to regulate entrance and access to the facilities.  For future acquisition, as outlined in ESAP item # 1 and 2, MS-Pharma will carry out a security risk assessment and, if necessary, develop a detailed security management plan in line with recognized international principles: Voluntary Principles on Security and Human Rights.

Organizational Capacity and Competency

At the corporate level, the group has appointed EHS  dedicated to oversee EHS and Occupational Health and Safety (OHS) issues and each production facility does have dedicated personnel to oversee EHS/OHS matters. At UNP and MSI plants, EHS/OHS functions are grouped under the quality department and are coordinated by one supervisor, holding a national certification.  At the UNP plant, the supervisor receives input from each of the main four divisions by a designated representative holding a relevant certification.  In El Kendi EHS matters are overseen by four officers and one supervisor that reports to the manager. MS Pharma Injectable plant in Turkey, all EHS/OHS issues are outsourced and managed by two consulting companies, EKO TREND in charge of all the environmental and social issues, and PAROLA OSGB in charge of all OSH related issues. Two specialists (environmental and HS) visit the plant once per week, and they are reporting to the in-house quality assurance manager. The recently appointed EHS coordinator at MS-Pharma is providing  EHS/OHS support and guidance for the group development and will ensure individual operational plants and/or activities in each country of operations are aligned and compliant with corporate principles, procedures, and standards outlined in the newly developed ESMS.

MS-Pharma has a corporate HR team consisting of one director and three additional people that oversee activities at operational sites.  In addition, each site has its own HR team, structured according to the size of operations (e.g., at MSI and at MS Pharma Injectable plant in Turkey one person is responsible for HR while UNP there are six people in the team and El Kendi has two).  Corporate social responsibility falls under the strategic planning department with its own department head in Jordan while at El Kendi is under the strategy and communication department that reports directly to the corporate team.

Management Programs

MS-Pharma is in the process of  formalizing  management program at the corporate level to oversee individual plants, contractors, and primary suppliers’ performance and to develop improvement measures and actions that address identified EHS/OHS issues.  As outlined in ESAP item #1, MS-Pharma will develop and formalize, as part of its corporate ESMS, specific procedures and standards for individual plants EHS performance, auditing of contractors and main suppliers, and improvement measures.  Furthermore, the group, as indicated in the ESAP (item #3) will conduct a gap analysis at each production plant, existing or to be acquired, and develop a detailed action plan, including required measures and deadlines, to bridge identified gaps.

Emergency Preparedness and Response

In accordance with local regulations, MS-Pharma maintains fire safety equipment at its facilities based on the nature of the risk involved.  The fire system at visited facilities include portable fire extinguishers, fire hydrant system with dedicated fire water storage (UNP, El Kendi, MS Pharma Injectable plant in Turkeys), and sprinklers. Smoke detectors and alarm systems were observed to be installed at the visited facilities. However, at the UNP plant in Jordan a Civil Defense audit has identified the sprinkler system in need to be updated according to new local regulations.  As outlined in the ESAP (item #3), MS-Pharma will carry out an assessment of all its facilities emergency preparedness and response plans to identify gaps with local standards and PS1 requirements and, if necessary, develop an action plan to bridge identified gaps.  On-site emergency response plans have been developed in Jordan.  Accordingly, potential hazardous areas have been identified and evacuation routes and assembly points are determined.  The plans identify emergency scenarios (e. g., fire, electric shocks, bodily harm, chemical spills, etc.), identified required actions, responsibilities and drills schedule.  However, the UNP plans are partially incomplete as some of the required information (e.g., contact numbers, team qualifications, etc.) is not reported in the relevant documents.  Furthermore, no formal emergency plans have been developed at the El Kendi. At MS Pharma Injectable plant in Turkey, a dedicated emergency response plan is in place containing the scope of fire and chemical spill either hazardous or non-hazardous. The emergency response plan, drills and trainings are supervised OHS specialist who work as an outsource consultant (Parolagrup) www.parolagrup.com. Some minor improvements are needed at the Laurus plant, regarding the provision of spill kits and secondary containments and the review of emergency exits which will be addressed as part of the gap analysis of facilities under ESAP item #3. The company, as part of its ESMS as outlined in ESAP item #1, will develop corporate procedures and standards, in line with local and PS1 requirements, covering emergency procedures at all its plants and will ensure that operational sites are compliant with such provisions.

Monitoring and Review

Operational sites have their own monitoring and reporting program in place in accordance with local regulatory requirements and GMP standards.  The program covers regulated emission, production areas parameters (e.g., temperature, humidity, differential pressure, noise at workstations, etc.), and waste parameters and falls under the responsibility of the plant quality control manager.  In Jordan, internal audits are conducted by each department general safety, emergency preparedness and firefighting issues.  The information is reported to the quality assurance manager that then reports to the plant general manager.  External audits are carried out periodically by third party certification bodies and regulatory authorities as part of required certification/compliance protocols.  In Algeria, internal audit follow GMP practices; EHS/OHS issues are reported to be audited internally but no formal procedure or reporting has been established. MS Pharma Injectable plant in Turkey monitors parameters of relative humidity, pressure and temperature constantly through the building management system and TSP (total suspended particles) regularly as per GMP requirements.  A motion detection system were also installed in the plant for energy consumption reduction program. Noise and illumination measurements are done annually and found compliant as per Turkish regulations. A hearing protection program will be in place to cover all MS pharma affiliates. As indicated in the ESAP, MS-Pharma corporate ESMS (ESAP Item #1) will include a monitoring and review procedures and plans to ensure its operations are compliant with both local regulations and WBG’s EHS guideline values.  The plan will cover benchmarks and specific key performance indicators, internal monitoring procedures, schedule, and standards, reporting procedures and review mechanisms to correct identified gaps. Monitoring thresholds will be consistent with those referenced in the applicable WBG EHS Guidelines (General, Pharmaceuticals and Biotechnology Manufacturing).

MS-Pharma currently employs a total of about 1977 people.  The El Kendi plant has about 1,000 employees, followed by UNP with 630, MS Pharma Injectable plant in Turkeyplant with 77 and MSI with 67.  At the corporate level, MS-Pharma employs 45 people.  One third of the workforce is composed by females, mainly employed as officers and senior operators.  Very few temporary or casual workers (about 60 at UNP) are hired, through third party providers, to work in the secondary packaging section or cleaning crew.

Human Resources Policies and Procedures

Local law in Jordan reflects seven of the eight International Labor Organization’s core labor standards but for freedom of association while Algeria is signatory of all eight.  Some of these standards are included in MS-Pharma Code of Conduct that is currently being finalized.  The document outlines a general framework covering all MS-Pharma staff and includes such elements as equal employment opportunity, non-discrimination and anti-harassment practices, integrity and business dealings, and anti bribery and corruption.  Once finalized it will be provided to, and acknowledged by, all employees.  Other relevant provisions and policies, have been developed as stand-alone documents (e.g. retrenchment, whistleblowers) or will be included in the HR manual being developed (minimum employment age of 18, freedom of association), or described in the HR procedures.  All facilities and/or entities under the group are required operate under these provisions.  These policies and procedures are consistent with local labor law and PS2 provisions; however, MS-Pharma will review these documents against PS 2 requirements and, if necessary, bridge any identified gaps.

Working Conditions and Terms of Employment

All workers have a signed contract that spells out terms of employment (e.g., salary, benefits vacation, etc.) and includes reference to relevant labor laws (overtime, various benefits).  In addition, MS-Pharma HR procedures provide additional details on many of the workers’ rights, benefits, and requirements while under contract with the group. 

The majority of workers holds open-end contracts with few term contracts in force.  Workers termination is regulated by local labor law and internal HR procedures that outline causes for termination.  In general, MS-Pharma implements full termination benefits, as specified by labor regulations, even in case where could not be applied.

MS-Pharma and its controlled companies provide statutory benefits to its employees.  Additional benefits like bonuses, payment of two extra monthly salaries, transport arrangements or allowances, free on-site canteen, additional medical insurance or preferred insurance rates, are available to employees depending on location. 

Workers’ Organization and Grievance Mechanism

Unions are present in Jordan and Algeria has one main worker union with about 2 million members.  As outlined above, the group recognizes workers’ freedom of associations and right to collective bargaining, and they are including such wording in their revised policies.  There is no evidence of tension or efforts to discourage workers’ organization at the group’s level. However, employees have not formed any company union and, in the case of Jordan and MS Pharma Injectable plant in Turkey, have not joined the pharmaceutical union.  MS-Pharma has an open door policy and has developed an internal grievance mechanism covering both employees and contracted workers in all its facilities except MS Pharma Injectable plant in Turkeywhich is in its initial stage of implementing the corporate program. The grievance process, which is included in the HR procedures and is compliant with PS2 requirements, is based on confidentiality and fairness.  The procedure covers the way grievances can be submitted to HR, how they are logged, processed and resolved, and outlines steps available to appeal any decision all the way up to the company CEO.  MS-Pharma will ensure that the procedure includes clear deadline for each step of the procedure, ensure that the process is fully documented, including responses and feedback to the interested party, and consider setting up a committee to deal with appeals before they reach the CEO.

Retrenchment

MS-Pharma has a good history of retaining its employees as it considers it a core value for growth and quality.  However, the group recognizes that future mergers and acquisition may require some retrenchment of existing workers.  Therefore, as outlined in the ESAP (item #5) MS-Pharma will finalize a retrenchment policy, in line with PS2 requirements, where responsibilities, alternatives, consultation and criteria for termination, re-hiring and severance benefits are outlined.

Occupational Health and Safety

Every new hire in Jordan and MS Pharma Injectable plant in Turkey goes through a company induction covering mainly technical training and including some EHS elements like safety procedures, waste disposal, PPE, and handling of chemicals.  Refreshers are provided by the quality assurance department once per year. Additional training is provided for specific tasks.  UNP is currently assessing the training program and broadening its scope.  In El Kendi there is no formal induction of new hires and training of workers, although the EHS department is reported to provide ad-hoc training for employees on a regular basis.  As outlined in the ESAP (item #1), the ESMS will include a detailed training plan and matrix to cover both technical and EHS/OHS relevant themes.  Regular health checkups are conducted based on local statutory requirements. At MS Pharma Injectable plant in Turkey, a medical emergency room is present, regularly visited by a doctor and nurse. Production plants follow GMP provisions and detailed Standard Operating Procedures (SOPs) are available for each technical task at production plants. These SOP are derived from a risk assessment, reviewed annually, of general tasks associated with each plant department/operative unit and include the identification, level, and mitigation of risks.  However, MS-Pharma has not conducted detailed job safety analysis to inform EHS/OHS mitigating measures and PPE provisions.  This is particularly important as facilities use a number of chemicals, solvents, and final products that could have health impacts (e.g. methanol, methylene chloride, isotretinoin, etc.).  As indicated in the ESAP (item #1), the group will develop a framework plan under which used substances/solvents are analyzed with respect to their EHS/OHS impacts (e.g., eliminating selected solvent from the process, solvent management plan) and job safety analysis for each relevant activity is conducted (to inform relevant PPE, signage, workers’ restrictions, etc.), and permit to work implemented where required.  As outlined in the ESAP (item # 3), the group will conduct a gap analysis at each plant and develop a time bound action plans to bridge any identified gaps.

PPE requirements vary according to the work area and may include hard hats, face masks, coats, gloves, safety glasses, shoes covers, or special coverall to guarantee sterile working environments.  OHS signage is occasionally present at some plants (UNP and MS Pharma Injectable plant in Turkey) but missing at others (El Kendi); furthermore, implementation of PPE has been observed to be relaxed at all visited sites.  As outlined in the ESAP (item #3), facilities will review PPE provisions, signage, and auditing measures to improve PPE usage at each plant and to develop a safety culture within the workplace.

In the past three years, no fatalities, significant accidents or environmental incidents have been reported at production plants and overall data showed some improvements in the total number of accidents recorded during the past two years. 

Critical air parameters levels detection, along with alarms and adequate firefighting systems (e.g., smoke detectors, automatic sprinklers, and extinguishers), were present at the production plants visited; however, local authorities (e.g. Civil Defense) have issued recommendation for specific improvements in the UNP facility.  The group will implement local firefighting requirements from the local authorities. The use of partitioned workplace areas with differential air pressure was also observed and high efficiency particulate air filters are present as per GMP protocols. 

Supply Chain

MS Pharma has centralized certain supply chain functions, such as the procurement or certain raw materials that are common across the different manufacturing plants. MS-Pharma is also  in the process of centralizing contractors and suppliers’ management and will include in its ESMS (ESAP item #1) relevant plans, procedures, and requirements for the proper management of contractors and suppliers according to GMP and IFC provisions.

Overall, MS-Pharma develops an average of 50 products per year and is currently developing over 365 new generic medicines.  Depending on the type of medicine, production can result in the generation of hazardous and non-hazardous waste streams.  Each facility complies with host country environmental requirements as well as a number of GMP standards. 

Air Emissions and Ambient Air Quality

Plants monitor key air emission parameters according to GMP requirements and, if present, local regulations.  Particulate emissions from sensitive production areas (e.g. production of cephalosporins) are controlled through high efficiency particulate air filters that are collected and disposed of by licensed contractors according to local requirements.  Aluminum filters are also used for individual air handling units and are regularly cleaned, maintained and/or replaced.  Research and development laboratories are provided with fume hoods. In the MS Pharma Injectable plant in Turkeythe air emission measurements are carried out by the licensed 3rd party (Aritsan) and cover the areas such as QC, production… etc. The plant received compliance report as per national regulations in Turkey valid until 2017. As indicated in the ESAP (item #1), MS-Pharma will develop and implement, under its ESMS, a monitoring program that will ensure compliance with air emission standards outlined in Table 1, Air Emissions Levels, of the WBG EHS Guidelines for Pharmaceutical and Biotechnology Manufacturing.

GHG Emissions

Energy at all MS-Pharma plants is procured from the national grid.  Diesel generators are present at sites as back up and are use in the rare cases of power failures.  Therefore, GHG emissions for the group are dominated by electricity consumption with a very small contribution from diesel consumption and are estimated at approximately 3,000 tons of CO₂e per annum. The project is not expected to produce GHG emissions in exceedance of IFC’s threshold of 25,000 tons per annum of CO₂e.

Water and Wastewater

Water is supplied by on-site groundwater wells at UNP and MS Pharma Injectable plant in Turkey, and the municipality at MSI and El Kendi. Water for production undergoes on site purification within a closed loop system. Drinking water is supplied in bottles by third party vendors.  Wastewater at UNP and MS Pharma Injectable plant in Turkeyis collected in enclosed septic tanks that are regularly analyzed by the teams, emptied by a licensed contractor and transported to the municipality waste water treatment facility.  The UNP plant plans to build a new, onsite waste water treatment system and use treated water for irrigation.  At the MSI, wastewater is treated by the industrial park wastewater treatment plant that is regularly audited by local authorities.  The El Kendi and the MS Pharma Injectable plant in Turkey discharge their effluent to a dedicated municipal sewer line after it has been treated at the on-site plant to meet local requirements.  Effluents are tested weekly according to local regulations (temperature, pH, conductivity, suspended matter, COD, BOD, phosphate, total nitrogen, NO₃, NO₂, ammonia).  As outlined in ESAP item #1, the group ESMS will develop and implement effluent standards according to local and site-specific requirements or, where discharge occurs to surface waters, as outlined in Table 2, Effluent Levels, of the WBG EHS Guidelines for Pharmaceutical and Biotechnology Manufacturing.

Solid Waste and Hazardous Material Management

MS-Pharma plants in Jordan have a waste reduction policy and waste disposal procedures in place.  Systems are in place to segregate paper, plastic, and metal for recycling and to recycle uncontaminated solvents in the laboratories.  The company is also developing plans to reduce waste in production and investing in new machinery with automated systems and controls to reduce rejected product. The MS Pharma Injectable plant in Turkeyhas a waste management plan for both hazardous and non-hazardous waste. Waste is handled by certified 3rd party contractor (Ekolojik Enerji A.S.Corlu Subesi) www.ekolojikenerji.com.tr. Medical waste is handled by Atik Cevre Teknolojileri Ins.San. ve Tic A.S.-Tekirdag Subesi www.atikcevre.com.tr in regular intervals. El Kendi follows GMP practices but does not have a formalized waste management policy and/or procedures. Cardboard and papers, as well as plastic wrapping and scrap metal, are segregated on site and then recycled by a third party.  Rejected and/or expired product, is collected and disposed by authorized third party contractor under the supervision of local authorities. 

Plants keep a list of hazardous materials used in production, which are handled and stored according to respective material safety data sheets and GMP requirements. 

In Jordan, standard operating procedures are in place to collect and temporarily store the small quantities of hazardous waste (e.g. spent solvents and organics) before they are collected and disposed by a licensed and authorized contractor; however, comprehensive plant-specific waste management plans have not been developed.  As indicated in the ESAP (item #1), MS-Pharma will develop and implement, under its ESMS, waste management plans in accordance with PS1 and PS3 provisions.

Although not formally structured and/or developed, the group has identified and is actively engaged with relevant stakeholders in each region of operations.  The group has identified three main groups of stakeholders: regulatory agencies; distributors, pharmacists and doctors; and end users of medical products.  Engagement with authorities is an on-going activity and covers both regulatory requirements and cooperation for product development, information sharing, and wide educational programs developed in association with relevant Ministry and/or local authority.  In Jordan, MS-Pharma has established a dedicated number, active during extended working hours, for pharmacists, doctors, and regulatory agencies to deal with technical questions.  End users and the public at large have the opportunity to log in grievances via a form, available at doctors’ offices and pharmacies that sell MS-Pharma products, or can reach the company directly by requesting the contact information available at each point of sale or doctor office.  In addition, contact information is available on the company website. While in general the same approach is followed in Algeria, where doctor and pharmacies are provided with a form to log in grievances and company information is available on the website, the overall system will need to be strengthen to facilitate grievance submission from all stakeholders, including the general public.

MS-Pharma recognizes corporate social responsibility (CSR) as an essential part of the company identity and therefore supports, through various activities, targeted initiatives for identified internal and external stakeholders.  Activities include blood drives, breast cancer awareness day, donation of unused company assets (e.g. information technology material, laptop, etc.), sponsorship of “back to school kits” for the most needy children, and provide scholarship and internship opportunities.  The group also collaborates with local patients associations to provide direct and indirect support for educational events, free medical days and products distribution.  Finally, MS-Parma partners with local authorities for training (Jordan) or promoting the use of locally produced medicines (Algeria) as well as working in collaboration with local municipalities to identify and promote activities that reach local communities.  Plans for 2016 include the creation of a CSR club within the company to promote direct participation of employees to CSR activities, sponsor a regional MENA workshop, in collaboration with Jordan FDA, for the promotion of generic drugs, and the creation of emergency centers, managed and/or sponsored by the company, for people living in the area near production plants.

As outlined in the ESAP (item #6), the company will formalize its external grievance mechanism and CSR activities by developing a corporate stakeholder engagement plan and procedures for its external grievance mechanism in accordance IFC PS 1 The plan will provide the necessary framework to guide PH-Pharma subsidiaries in different countries and, where relevant, provide guideline for the development of specific plans and procedures tailored to country needs and requirements.

Contact Person: Hasan Jibreel

Company Name: MS Pharma

Address: 7^th Circle – Zaharan Streen, Zahran Plaza Bldg - F2,

Aman 11844, Jordan

Email: hasan.jibreel@mspharma.com          

Phone: 00962 79 8338364

Website: www.mspharma.com