PS 1 - Assessment and Management of Environmental and Social Risks and Impacts
Policies and practices for the regulation of Pharmaceuticals and Pesticides: Ascendis’s South African operations are subject to the statutory requirements of the South African Government. The registration, importation, manufacture and distribution of pharmaceuticals requires strict compliance to the Medicines and Related Substances Act (MRSA), 101 of 1965, and associated General Regulations (2013), for which a Medical Controls Council (MCC) Good Manufacturing Principles (GMP) license is issued. The MRSA regulations prescribe how pharmaceuticals must be registered, repackaged, monitored, stored, destroyed, labelled, advertised, and dispensed. All medicines for human use are subject to this law, including complementary and biological medicines. The company is MCC - GMP accredited which indicates that a recognized Quality Management System is in place, manufacturing processes are clearly defined and controlled, and all critical processes are validated to ensure consistency and compliance with the MRSA specifications and in accordance with the GMP Guidelines specified by the MCC (other countries have different administrative organizations that have their own GMP guidelines). The South African GMP Guidelines are based upon the WHO version of GMP, and this is enforced by the national Department of Health. Inspections are performed at each manufacturing site by inspectors appointed by the Department of Health every 2-3 years in order to ensure compliance with GMP as well as compliance with each registration dossier.
Access to, and the formulation of, pesticides is regulated by the Department of Agriculture, Forestry and Fisheries (DAFF) under the Pesticide Management Policy (2010) and the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act (1947), in partnership with other government departments that administer the MRSA, Hazardous Substances Act (1973); the Foodstuffs, Cosmetics and Disinfectants Act (1972); and the Occupational Health and Safety Act No. 85 of 1993. DAFF frequently conducts unannounced/random inspections of both manufacturing facilities and distribution points.
The manufacturing operations of Farmalider (and the companies proposed for acquisition, Scitec and Remedica) are governed by the applicable EU legislation and the company is compliant in this regard. Taking this in account, for the purposes of this document the following sections largely provide insight into Ascendis’s South African operations. The gaps identified in each section and subsequent ESAP items, will however apply to all the company operations, as well as any future developments/acquisitions.
Environmental, Health and Safety Policy: Ascendis has an Occupational Health and Safety (OHS) Policy and an OHS management system in place at operations in South Africa, which includes the Group ‘Health & Safety Key Items’, and an OHS Manual which contains the Safety Standards
. It is the responsibility of Human Resources to maintain the policy document and other Group-level OHS control arrangements. The Chief Executive Officer (CEO) is the Board member with specific responsibility for OHS. All manufacturing or repackaging sites of the company have an identified Health & Safety Coordinator, whose job function includes the coordination of health and safety control arrangements at that location. There is no specific reference to environmental responsibility in the policy, thus Ascendis will develop an overarching corporate policy that defines its Environmental, Health and Safety (EHS) objectives and principles and will apply this to guide the activities of all operations from an EHS perspective (ESAP #1).
Identification of Risks and Impacts: As mentioned, the Group applies the Good Manufacturing Practice (GMP) approach to its operations within the relevant statutory framework, and these are audited annually by SGS. The GMP is a quality management system which is designed to ensure the efficient and effective production of products, but does not include the identification of environmental risks / impacts and monitoring parameters beyond good house-keeping. Since the company growth is predominantly via acquisitions, the company will develop and implement an Environmental and Social Due Diligence (E&SDD) process that is applied prior to acquisitions or establishment of any new business, to identify the E&S risks while taking local legislation and the Performance Standards into account. Thereafter, the company will define measures directed at addressing E&S risks and material gaps against a time based plan. These actions are defined in the attached ESAP (ESAP #2).
E&S Management Programs: During the site visits of the South African operations it was clear that facilities were well managed with strict GMP administrative procedures that currently meet local legislative requirements. However, no formal environmental management system is in place, although some basic environmental monitoring is undertaken (as described in PS:3). Environmental issues are predominantly dealt with on a site-specific basis, and not via a conventional (corporate-wide) environmental management system. For example, the sports nutrition factory is in the final stages of implementing a HACCP (Hazard Analysis & Critical Control Points) system, which identifies food safety risks, prevent food safety hazards and addresses legal compliance, and which requires regular environmental monitoring. In Spain, the activities of Farmalíder are carried out following the European Good Manufacturing Practices, whose compliance is verified periodically by the Spanish Agency for Medicines and Medicinal Devices. The company has also implemented an environmental, health and safety system which is regularly updated to ensure that workplace/occupational risks are minimized, and environmental impacts are appropriately managed. Remedica’s four production facilities are EU c
ertified, and approved by the health authorities of the U.K., Germany, Denmark and Australia, among others, who have confirmed that the company’s Quality System meets the requirements of Good Manufacturing Practice. The entire Quality Control System is regularly audited by Quality Assurance to ensure that it continuously meets the increasing demands of the various regulatory agencies that randomly inspect Remedica’s premises.
Scitec has 700 product formulations registered with the European Food Safety Authority (EFSA),is certified by GMP, HACCP and EUROCERT ISO 9001 & 22000, and the facilities are registered with the Food and Drug Administration to allow trading into the US market. An in-house Quality Control Team monitors the quality of all products from raw materials to finished goods, with multiple QA/QC tests throughout the entire manufacturing process. Every product is engraved with a Unique Product Tracking Code (UPTC) for traceability from the plant to consumer.
Rapid expansion of the company and an increase in product diversity has introduced some complexity over time, and this is likely to continue; thus, it has been agreed that the company will develop a corporate approach to E&S management to ensure a consistent approach to this aspect within all activities across the Group. The approach will be to consolidate and enhance all existing policies and practices into an integrated environmental, social, and occupational, health and safety (OHS) system with mitigation measures, monitoring parameters and implementation responsibilities. A risk assessment process which includes the identification of environmental, labor, occupational health and safety (OH&S) and community-related risks and impacts, will form a core basis of the ESMS. Risks and impacts may be identified from regulations, permit conditions, review against the World Bank Group (EHS) Guidelines, and recognized international industry codes of conduct, such as the Food and Agriculture Organization of the United Nations (FAO) Code of Conduct on the storage and distribution of Pesticides, as well as the Global Manufacturing Practices under the Medicine Control Council of South Africa. Monitoring parameters and thresholds will be consistent with those referenced by national requirements and the World Bank Group’s General EHS and sector-specific Guidelines. Overall, the resulting E&S management system (ESMS) will be aligned with the requirements of Performance Standard 1 and other recognized international standards such as ISO 14001 and OHSAS 18001. Thereafter, this will become the corporate standard to be employed consistently across all Group operations, as well as all future businesses as articulated in ESAP #3. Ascendis will undertake annual EHS assurance audits against the EHS Policy to confirm the adequacy of the ESMS for all operations, and based on the findings, will address gaps/deficiencies.
Supply Chain: Ascendis is highly diversified and receives products from di
fferent countries. As part of the overall ESMS, Ascendis will develop a specific management procedure for its supply chain, which will include the development and implementation of a Supplier’s Code of Conduct which will be mainstreamed into contractual agreements with major suppliers, and reviewed over time as needed. The focus of the Supplier’s Code of Conduct will be on fair labor practice, environmental management and product quality (ESAP #4).
Organizational Capacity: Ascendis has a very strong management team with significant experience in the manufacturing and distribution of various consumer products. Ascendis does, not however have dedicated corporate Environmental, Health and Safety (EHS) capacity, although each site has a Health and Safety (H&S) officer that reports to the General Manager. Thus, the company commits to appoint an appropriately qualified person who will oversee the corporate development and implementation of the EHS Policy and integrated Environmental and Social Management System (ESMS) across the Group and for each new acquisition / development. In addition, the job description for the site level H&S officers will be enhanced to define specific Environmental and Social (E&S) roles and responsibilities. The individual responsible at the corporate level for EHS will also coordinate reporting on such efforts to the Board, compile the EHS input into the Annual Report as well as ensure implementation of the conditions of the ESAP (ESAP #5).
Monitoring and Review / Reporting: As mentioned, each site operated by Ascendis has an H&S officer who ensures compliance to local regulations and currently reports any incidents of non-compliance to the relevant General Manager. As per the ESMS, in future specific EHS key performance indicators will be monitored and reported upon, as follows: compliance with legal and regulatory requirements, including the ESMS progress and certification where applicable, energy and water consumption and efficiency; GHG emissions; solid and hazardous waste management and disposal, effluent discharges, compliance with national OHS requirements, including accident rates (lost-time accidents); customers and community complaints, supplier performance and community engagement activities, ESAP #6. Implementation will be supported by the provision of resources (qualified and competent staff, capital and operating budgets), be integrated throughout operations, and include training, to accomplish the program and its requirements, as well as measures related to the evaluation and monitoring of priority risks and impacts, and furthermore be extended to include contractors working on projects. During construction/renovation of projects, contractors will be required to provide regular EHS monitoring reports to the proposed EHS Manager, who will ensure adherence to local regulations and the policies of the company.
For the South African operations a Group Health and Safety Committee has recently been const
ituted which meets quarterly at the Head Office in Johannesburg. (comprised of H&S representatives, 4 fire marshals, first aiders level 1-3, facilities manager, 1 employee elected representative, i.e. 11 people, and there are subsidiary level committees in accordance with the South Africa Occupational Health and Safety Act). The Terms of Reference of this Committee will be expanded to include environmental aspects, and monitoring data on EHS will be reported to the Committee. Currently any material non-compliances, serious social or environmental incidents and/or accidents that may impact upon the businesses’ reputation or productivity are reported to the Board Social and Ethics Committee, and this will remain the approach in future.
Emergency Preparedness and Response: The South African operations of Ascendis have basic procedures in place for fire prevention, but no emergency response and evacuation policies or procedures for unforeseen events such as armed robberies, social unrest etc. The company will therefore implement a comprehensive Life and Fire Safety and Emergency Preparedness Policy and Plan for their premises, in cooperation with stakeholders on neighboring sites, and ensure training for all employees and security personnel in both emergency and LFS procedures (ESAP #7). As an integral part of the ESDD associated with each new acquisition (ESAP#2), the company will perform a review of the Life and Fire status of all facilities of the target business. The ESDD process will attempt to assess the level of compliance by the target business with local building fire, and legal/insurance requirements, as well as with internationally recognized LFS standards. Depending on the findings, Ascendis may draw up an LFS plan to implement relevant corrective measures on the facilities. In addition, greenfield projects shall comply with the WBG LFS requirements articulated in section 3.3 of the General EHS Guidelines.