6 Economic sectors of relevance to Belgium
What are the laws, guidelines and initiatives for the economic sectors of relevance in Belgium?
Tool 6 provides additional guidelines and standard for economic sectors relevant to the Belgian economy. The information in Tool 6 can help organisations to identify and assess the human rights impacts of their activities and the economic sector to which they belong.
The sectors discussed in Tool 6 are construction, metals and minerals, pharmaceuticals, transport, arms trade and the diamond sector. For each of these sectors, the most important legislation, guidelines, industry initiatives, multi-stakeholder initiatives and certification schemes are presented.
In short, Tool 6 can help organisations to answer the following questions:
- How is an enterprise’s sector and operational context relevant to its responsibility to respect human rights? (Question 15 of the Interpretive Guide of the UNGP)
- Which human rights issues are most salient to your business? (Question 23 of the Interpretive Guide of the UNGP)
GOOD TO KNOW: The page "Why" of tool 6 presents the relevance of tool 6, how the sectors were selected and how Tool 6 fits into the greater scheme of the toolbox Business and Human Rights.
- Regulatory framework governing the construction sector
Construction organisations are facing increasingly high expectations around compliance with labour and human rights standards. These expectations come from public and private clients, civil society and national and international regulations.
This section discusses the international, European and national legislation by which construction organisations have to abide in order to respect human rights, including labour and environmental rights. The section also presents guidelines that aim to assist organisations with their human rights compliance.
The International Labour Organization (ILO) has developed important conventions in the last decades which are relevant to or specifically target the construction sector. In its National Action Plan (action point 26), Belgium commits to subscribe to a series of ILO conventions on health and safety at work.
This section only refers to the ILO conventions that have been ratified by Belgium. Because of the vast number of conventions, this tool will merely mention most important ones, and will only additionally explain the most relevant ones for the construction sector.
Occupational Health and Safety
The following Conventions are relevant to the construction sector:
- Occupational Safety and Health Convention (1981);
- Occupational Health Services Convention (1985);
- Safety and Health in Construction Convention (1988);
- Promotional Framework for Occupational Safety and Health Convention (2006). The Convention will take effect for Belgium on 31 May 2019.
- Asbestos Convention (1986). This Convention provides for measures to prevent, control, and protect workers against health hazards from occupational exposure to asbestos.
- Working Environment (Air Pollution, Noise and Vibration) Convention (1977);
- Chemicals Convention (1990). This Convention concerns safety in the use of chemicals at work.
- Convention concerning the Protection of Workers against Ionising Radiations (1960);
- Convention concerning Prevention and Control of Occupational Hazards caused by Carcinogenic Substances and Agents (1974);
- Convention concerning Benefits in the Case of Employment Injury (1964).
The following two codes of practice are specifically applicable to the construction sector:
The Safety in the use of synthetic vitreous fibre insulation wools (glass wool, rock wool, slag wool) (2001) code of practice defines major principles and approaches concerning safety requirements and precautions in the use of insulation wools. It provides practical control measures to minimize occupational exposure to fibres and dusts, prevent irritation and discomfort, and avert any long-term health risks.
The Safety and health in construction (1992) code of practice provides practical guidance on the legal, administrative, technical and educational framework for safety and health in construction, with a view to:
- preventing accidents, diseases and harmful effects on the health of workers;
- ensuring appropriate design and implementation of construction projects;
- providing means of analysis from the point of view of safety, health and working conditions, construction processes, activities, technologies and operations;
- taking appropriate measures for planning, control and enforcement.
- European Union
The European Union has numerous directives, regulations, guidelines and (certification) tools that are relevant to the construction sector. Some target the construction sector, while others do not solely focus on it, but have a direct impact on the sector. The most important ones are listed below:
Internal market and energy efficiency directives and regulations
The Construction Products Regulation No 305/2011 (2011) lays down harmonized conditions for marketing construction products in the EU. The regulation provides a common technical language to assess the performance of construction products. It ensures that reliable information is available to professionals, public authorities, and consumers, so that they can compare the performance of products from different manufacturers in different countries.
The objective of the regulation is to guarantee the quality and safety of construction - with particular attention to the protection of workers, consumers and the environment - through the compliance of construction products with minimum requirements. The minimum requirements for building materials are:
- Mechanical resistance and stability;
- Safety in case of fire;
- Hygiene, health and the environment;
- Safety and accessibility in use;
- Protection against noise;
- Energy economy and heat retention;
- Sustainable use of natural resources.
The following EU Directives are relevant to the construction sector:
- Directive 2005/36/EC on the recognition of professional qualifications;
- Directive 2006/123/EC on services in the internal market;
- Directive 2009/125/EC on establishing a framework for the setting of eco-design requirements for energy-using products;
- Directive 2009/28/EC on the promotion of the use of energy from renewable sources.
- Directive 2010/31/EU on the energy performance of buildings;
- Directive 2017/1369/EU on the indication by labelling and standard product information of the consumption of energy and other resources by energy-related products;
- Directive 2011/7/EU on combating late payment in commercial transactions;
- Directive 2012/27/EU on energy efficiency.
Occupational health, safety and environment directives and regulations
The EU has several directives relevant to the construction sector. These regulate the health and safety of workers at work. They focus, for instance, on the manual handling of loads, temporary or mobile construction sites, construction and demolition waste, and asbestos.
EU Regulation 1907/2006 on registration, evaluation, authorisation and restriction of chemicals (REACH) is relevant for construction products that use recovered substances, such as metals, aggregates and glass. The main objectives of the regulation are to ensure a high level of protection of human health and the environment from risks that can be posed by chemicals; the free circulation of substances on the internal market; and enhancing competitiveness and innovation.
EU Regulation 66/2010 on the EU Ecolabel helps identify products and services that have a reduced environmental impact throughout their life cycle, from the extraction of raw materials through to production, use and disposal.
EU Regulation 995/2010 prohibits the import of illegally harvested timber. Importers are obliged to have a due diligence system that determines the source of timber and its legality. Traders have the obligation to trace their direct suppliers, and where applicable, their clients.
Tools and guidelines
The Dangerous substances database CP-DS offers information on construction product regulations related to dangerous substances. It is designed to help interested parties identify relevant regulations.
The EU-LCI database provides a set of common values at EU level for the Lowest Concentration of Interest in indoor air.
The Guidelines for the waste audits before demolition and renovation works of buildings (2018) are intended for organisations that handle waste in demolition and re-use/recycling in the construction sector. The text includes best practice examples, recommended templates and a list of international, EU and national policy and framework conditions.
The EU Commission introduced the non-binding Construction and Demolition Waste Management Protocol (2016), which proposes the following actions:
- Improved waste identification;
- Source separation and collection;
- Improved waste logistics;
- Improved waste processing;
- Quality management;
- Appropriate policy and framework conditions.
The Level(s) Building sustainability performance is a voluntary reporting framework to improve the sustainability of buildings. Within the Level(s) framework, each indicator is designed to link the individual building’s impact with the priorities for sustainability at the European level.
The CE mark is a EU label. All EU countries must allow the selling of construction products bearing the CE mark. This means that public authorities cannot ask for any additional marks or certificates. Materials may only be CE marked if they meet the requirements of the Construction Products Regulation (2011) and the corresponding Harmonized Technical Standards. Manufacturers who plan to CE mark their products can consult the guide CE marking step-by-step (2015).
Belgium has numerous laws and guidelines that are relevant to the construction sector. Some target the construction sector, while others do not solely focus on it, but have a direct impact.
National legislation relevant to the construction sector covers the general well-being of employees, the prohibition of child labour and the prohibition of trafficking in and smuggling of human beings . Also relevant to the construction sector are the rules and regulations regarding the employment of foreign employees and the prohibition on employing people with an irregular migration status. Organisations or self-employed persons established in another country must declare their foreign employees or themselves to the social security authorities. This is the so-called Limosa declaration, which is mandatory in Belgium.
The Federal Public Service for Employment, Labour and Social Dialogue website gives more information on the relevant regulatory frameworks for organisations in the construction sector.
Social dumping is the practice of employers using cheaper labour than is usually available under Belgian law, for instance by hiring migrant workers. The following guidelines aim to combat social dumping:
- The Plan for Fair Competition (2015) contains 40 measures to combat social dumping and secondment fraud. One of them is visual identification for construction workers, the so-called contru-badge. The government, together with employers and trade unions from the construction sector, have signed the Plan.
- The Guidelines for the Construction sector (2017) formulate guidelines for both construction businesses and social partners. All social inspection services apply these guidelines in a uniform manner to create a level playing field for all actors in the construction sector.
- The Sociale Inlichtingen- en Opsporingsdienst (SIOD)/ Service d’information et de recherche sociale (SIRS) is a strategic body that develops a vision on social fraud prevention and translates this into concrete strategies. In this way, the SIOD/ SIRS contributes to the strategic plan and the annual action plans for social fraud prevention.
- Industry initiatives
This section gives a selection of industry initiatives that aim to assist organisations with their human rights compliance by providing guidelines and standards.
Building Responsibly is a global engineering and construction industry initiative established to promote the rights and welfare of workers in the construction sector. The initiative develops common approaches and standards, shares learning and tools, and engages workers and other stakeholders on the specific challenges that organisations face.
Building Responsibly developed ten principles to establish a common, global baseline for the treatment of workers in the engineering and construction industry. These are the Worker Welfare Principles:
- Workers are treated with dignity, respect and fairness; Workers are free from forced, trafficked and child labour; Recruitment practices are ethical, legal, voluntary and free from discrimination; Freedom to change employment is respected; Working conditions are safe and healthy; Living conditions are safe, clean and habitable; Access to documentation and mobility is unrestricted; Wage and benefit agreements are respected;
European Construction Industry Federation
The European Construction Industry Federation (FIEC) speaks for the European construction industry. With 31 national member federations, it represents construction organisations of all sizes, from all building and civil engineering specialties, and engaged in all kinds of working methods. The FIEC is the social partner representing employers in the European Sectoral Social Dialogue on Construction.
Confederatie Bouw / Confédération Construction
The Confederatie Bouw / Confédération Construction was founded in 1946 as an umbrella employers' organisation for the construction sector in Belgium. It represents more than 15.000 organisations in the construction sector: self-employed, SMEs and MNEs, active in all areas of construction. The Confederation defends the interests of the sector before the government, economic policymakers and construction partners.
Members of the Confederation receive information, advice, support with formalities and training. In the Charter of the Confederation against social dumping and secondment fraud (2016), the Confederation sets guidelines for its members to fight against social dumping.
- Worker representation is respected;
- Grievance mechanisms and access to remedy are readily available.
- Multi-stakeholder initiatives
This section gives a selection of multi-stakeholder initiatives that aim to assist organisations with their human rights compliance by providing guidelines and certification standards.
U.S. Green Building Council – LEED
LEED, or Leadership in Energy and Environmental Design, is a green building rating system. It is available for all types of buildings. It is a third-party green building certification program that sets globally recognized standards for the design, construction and operation of high-performance green buildings. LEED certification is an initiative of the US Green Building Council.
Mega-Sporting Events Platform for Human Rights
The Mega-Sporting Events Platform for Human Rights is a multi-stakeholder initiative that addresses human rights issues throughout the lifecycle of large sporting events with a focus on the construction of supporting infrastructure in the host countries.
Forest Stewardship Council
The Forest Stewardship Council (FSC) sets standards for responsibly managed forests, both environmentally and socially. FSC certification attests that organisations along the supply chain have met the best practice standards of FSC.
Infrastructure Transparency Initiative
The Infrastructure Transparency Initiative (CoST) is a multi-stakeholder initiative that aims to improve transparency and accountability in public infrastructure. CoST works to promote the disclosure, validation and interpretation of data from infrastructure projects.
- Expert centre
BRE - BREEAM
BRE is an expert centre that generates independent research. The research is used to create the products, standards and qualifications that help to ensure that constructions are safe, efficient, productive, sustainable and enjoyable places to be.
BREEAM is a sustainability assessment method for planning projects, infrastructure and buildings. BREEAM does this through third party certification of the assessment of an asset’s environmental, social and economic sustainability performance, using standards developed by BRE.
Metals and minerals
- Regulatory framework governing the metals and minerals sector
- International Labour Organisation
The ILO Safety and Health in Mines Convention (1995) ensures the health and safety of miners in the workplace. It is applicable to all mines. The responsible parties are the government and employers from states, including Belgium, that have ratified the Convention.
The ILO Code of Practice on Safety and health in coal mines (1986) provides guidelines for drafting safety and health regulations for the coalmining industry. It contains provisions on general safety and health measures, specific measures for work underground, road and shaft driving, coal-getting, transport, etc., and procedures for the control of dust, firedamp, fire and other hazards. The Code of Practice on Safety and health in underground coalmines (2009) sets out a national framework that specifies the roles of the competent authorities, employers, workers and their organisations. It also includes a methodology for identifying hazards and preventing and minimizing risks, as well as specific provisions for safe underground coalmining operations.
The ILO Code of Practice on Safety and health in opencast mines (revised in 2018) applies to any situation or operation involving occupational safety and health aspects in opencast mines. It requires the competent authorities responsible for safety, health and working conditions to pay attention to these situations.
The ILO Handbook on Safety and health in small-scale surface mines (2001) is targeted at all actors involved in open-pit small-scale mining. It sets out the basic requirements for protecting workers’ safety and health, and contains recommendations on good mining practices to be followed in this regard.
The OECD Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas (2016) provides detailed recommendations to help organisations respect human rights and avoid contributing to conflict through their mineral purchasing decisions and practices. The Guidance is for any organisation potentially sourcing minerals or metals from conflict-affected and high-risk areas. Conflict-affected and high-risk areas are identified by the presence of armed conflict, widespread violence or other risks of harm to people.
The Guidance is applicable to all minerals and global in scope. The objective is ultimately to promote responsible private sector engagement in post-conflict fragile states. Since its adoption in 2011, the Guidance has become the leading industry standard for organisations on mineral supply chain transparency and integrity.
Organisations are supposed to review their choice of suppliers and sourcing decisions and integrate into their management systems the following five-step framework for risk-based due diligence for responsible supply chains of minerals from conflict-affected and high-risk areas:
1. Establish strong management systems.
- Organisations should:
- Adopt a policy, incorporating the due diligence standards, for the supply chain of minerals originating from conflict-affected and high-risk areas.
- Structure internal management to support supply chain due diligence.
- Establish a system of controls and transparency over the mineral supply chain, including a chain of custody, a traceability system or the identification of upstream actors in the supply chain.
- Strengthen engagement with suppliers.
- Establish a grievance mechanism as an early-warning risk-awareness system.
2. Identify and assess risk in the supply chain. Organisations should identify risks in their supply chain and assess risks of adverse impacts. A supplement to the Guidance gives suggested measures for risk mitigation and indicators for measuring improvement.
3. Design and implement a strategy to respond to identified risks. Organisations should devise and adopt a strategy for risk management. They should implement this plan and monitor and track performance of risk mitigation efforts. Senior management should be informed of each step in this process.
4. Carry out independent third-party audits of due diligence at different positions in the supply chain. Such audits may be verified by an independent institutionalised mechanism.
5. Report publicly on mineral supply chain due diligence policies and practices. Public reporting is key to translating due diligence into actual change along supply chains, especially in producing areas.
The Guidance has two supplements: one focuses on gold and the other on tin, tantalum and tungsten (3T). They provide specific guidance according to the different positions in the mineral supply chain. Both supplements identify high-risk red flag locations of mineral origin or transit which trigger the due diligence standards in the Guidance.
For both 3T minerals and gold, the five-step framework explained above is applicable. For 3T, the Guidance includes specific recommendations for local mineral exporters, international concentrate traders and mineral re-processors, smelters/refiners, all upstream businesses (mineral supply chain from the mine to smelters/refiners) and all downstream businesses (minerals supply chain from smelters/refiners to retailers). For gold, the Guidance includes specific recommendations for medium and large-scale gold mining businesses and artisanal and small-scale mining corporations, local exporters, recyclers, international traders of mined gold and recyclable gold, refiners, bullion banks and all other downstream organisations (for instance, downstream users of gold and gold materials, and manufacturers of articles that contain gold).
Complementary tools to the Due Diligence Guidance for Responsible Supply Chains of Minerals are the Practical actions for companies to identify and address the worst forms of child labour in mineral supply chains (2017) and Sourcing Gold from Artisanal and Small-Scale Mining (2016), which calls on stakeholders to engage in the legalisation and formalisation of artisanal mining communities.
The Due Diligence Guidance for Meaningful Stakeholder Engagement in the Extractive Sector (2017) is an OECD Guidance that provides a practical framework for identifying and managing risks with regard to stakeholder engagement activities.
- Organisations should:
- European Union
The EU Regulation 2017/821 lays down supply chain due diligence obligations for EU importers of tin, tantalum and tungsten, their ores, and gold originating from conflict-affected and high-risk areas. The regulation is based on the OECD Guidance for responsible mineral supply chains.
This regulation aims to disrupt links between conflict, human rights abuses, and the global minerals trade, by requiring importers bringing ores, 3T and gold into the EU, from anywhere in the world, to do so responsibly. EU importers are required to apply the OECD five-step framework for risk-based supply chain due diligence as a tool to source responsibly from high-risk areas. EU importers include EU-based smelters, refiners, traders, banks, as well as manufacturers that import 3T and gold minerals and metals into the EU. Importers whose annual import volumes for each mineral or metal fall below specific volume thresholds are exempted from the mandatory requirements. Organisations that import 3T and gold as recycled or scrap material are within the scope of the regulation, but are subject to reduced due diligence requirements.
Organisations further downstream that bring 3T and gold into the EU—for example, in products or components—are not currently covered by the regulation. Nevertheless, the EU Commission and the EU member states expect all organisations in mineral supply chains to meet the due diligence standards of the UNGP and the OECD Guidelines.
The regulation requires businesses to address a range of supply chain risks linked to the extraction, trade, transport, and export of minerals. These risks include adverse impacts linked to tolerating, profiting from or contributing to serious human rights abuses.
While the majority of the requirements of the regulation will take full effect in January 2021, the EU Commission has encouraged all organisations to start carrying out due diligence on their supply chains before that date. The practices required by the regulation are not new to organisations or governments, as the EU already endorsed and committed to promote the OECD Guidance and UNGPs in 2011. The EU thus expects all organisations along mineral supply chains - not only those dealing with 3T and gold - to carry out supply chain due diligence in line with the OECD standards.
The US 2010 Dodd Frank Act Section 1502 has similarities with the EU regulation as it requires organisations to carry out a due diligence review of their supply chain, however, it focuses only on gold, tin, tungsten and tantalum coming from the Democratic Republic of Congo or an adjoining country.
- Industry initiatives
The industry initiatives discussed in this section aim to assist member organisations with responsible mineral sourcing issues in their supply chains by setting guidelines, conducting audits or monitoring supply chains. This list is not exhaustive.
- All mineral resources
The International Council on Mining and Minerals (ICMM) is an international organisation dedicated to a safe, fair and sustainable mining and metals industry. Membership of ICMM requires a commitment of member organisations to implementing and reporting on the 10 ICMM Principles. These principles include integration of ethical business practices and sustainable development into corporate strategy, and respect for human rights.
The Responsible Business Alliance (RBA) is an industry coalition dedicated to electronics supply chain responsibility. The Responsible Business Alliance, formerly the Electronic Industry Citizenship Coalition, is comprised of electronics, retail, auto and toy organisations that have committed to support the rights and well-being of workers and communities affected by the electronics supply chain. The members commit and are held accountable to the RBA Code of Conduct (2018), which is a set of standards on social, environmental and ethical issues in the electronics industry supply chain.
The Responsible Minerals Initiative (RMI) provides resources for businesses in a range of industries on responsible mineral sourcing in supply chains. These tools and resources include the Responsible Minerals Assurance Process), on making sourcing decisions that improve regulatory compliance and support responsible sourcing from conflict-affected and high-risk areas.
Responsible Cobalt Initiative
The Responsible Cobalt Initiative is a framework that enables business members to identify and address potential adverse impacts arising from their business activities and relationships. This includes calling on businesses to trace how their cobalt is extracted, transported, manufactured and sold. The Responsible Cobalt Initiate is based on the OECD Guidance. It was initiated by the Chinese Chamber of Commerce for Metals, Minerals & Chemicals Importers & Exporters, with support from the OECD.
- Tin and tantalum
The International Tin Supply Chain Initiative (ITSCI) is led by the tin and tantalum industry and implemented in cooperation with civil society and governments. It aims to institutionalize key aspects of supply chain due diligence according to the OECD Guidance. ITSCI monitors supply chains to allow tin metal users to source responsibly and avoid total disengagement from high-risk areas, while ensuring that miners continue to benefit from access to markets. ITSCI focuses on tin sourced from Burundi, the Democratic Republic of Congo, Rwanda and Uganda.
- Gold and associated silver, platinum and palladium
The London Bullion Market Association’s (LBMA) Responsible Sourcing Programme was set up to consolidate, strengthen, and formalise existing standards for refiners’ due diligence. The Responsible Gold, Silver, Platinum and Palladium Guidances are mandatory frameworks for all refiners wishing to sell on the London Bullion Market. The frameworks include measures to combat money laundering, terrorist financing and human rights abuses.
World Coal Association
The World Coal Association (WCA) is the global network for the coal industry. It works to demonstrate and gain acceptance for the fundamental role coal plays in achieving a sustainable, lower carbon energy future. The association focuses on improving environmental performance, protecting water resources, reducing emissions, health and safety, fairness in employment, human rights, community engagement, transparency and good governance.
- Multi-stakeholder initiatives
This section gives a selection of multi-stakeholder initiatives that aim to assist organisations with their human rights compliance by providing guidelines and sharing knowledge.
- Voluntary Principles
The Voluntary Principles (2000) are the only human rights guidelines designed specifically for the extractive sector. Participants in the Voluntary Principles Initiative — including governments, companies and NGOs — agree to proactively implement or assist in implementing the Voluntary Principles. The Principles are designed to guide organisations in maintaining the safety and security of their operations within an operating framework that encourages respect for human rights.
The Extractive Industries Transparency Initiative (EITI) is a global standard for the good governance of oil, gas and mineral resources. EITI members include governments, civil society, industry and institutional investors. The initiative promotes and facilitates revenue transparency by governments and businesses. Countries that sign up to EITI must publish the payments they have received from extractive industry businesses, and businesses must publish what they pay to governments. Belgium is a supporting state, not an implementing state.
- European Institute of Innovation and Technology Raw Materials
European Institute of Innovation and Technology (EIT) Raw Materials unites academic and research institutions, as well as businesses from EU countries. They collaborate on finding new, innovative solutions to secure the supplies of raw materials and improve the sector all along its value chain. EIT Raw Materials aims to enhance innovation in the raw materials sector by sharing knowledge, information and expertise. Entrepreneurs, start-ups and SMEs can receive funding and support through the large partner network and through collaboration activities.
The European Partnership for Responsible Minerals (EPRM) is a multi-stakeholder partnership which includes civil society, government and business members. The partnership aims to increase the proportion of responsibly produced minerals from conflict-affected and high-risk areas, and to support socially responsible extraction of minerals which contributes to local development. The EPRM focuses on tin, tantalum, tungsten and gold.
The EPRM enables supply chain actors to make progress in responsible mineral sourcing by supporting businesses (especially SMEs) in conducting due diligence, and by creating a platform for sharing knowledge, best practices and lessons learnt.
- Global Battery Alliance
The Global Battery Alliance is a public-private coalition that aims to catalyse, accelerate and scale up action towards an inclusive, innovative and sustainable battery value chain (including iron ore, lithium, cobalt, nickel). To achieve that goal, the Global Battery Alliance seeks to:
- Ensure the value chain’s social and environmental sustainability in line with the Sustainable Development Goals;
- Unlock innovation throughout the battery value chain;
- Support the development of policy principles to harness the battery value chain for global economic convergence and catch-up.
- Certification schemes
Sustainability schemes for mineral and metal resources address selected social, environmental and economic grievances. The coverage of the supply chain differs per scheme. Some target the mining and processing stage (for instance, the IRMA Certification and the Conflict-Free Gold Standard), the smelter and refinery level (for instance, the Responsible Minerals Assurance Process), or the upstream part of the supply chain (for instance, ITSCI and ICGLR). Others cover the entire supply chain (for instance, Fairmined, Fairtrade, Responsible Jewellery Council, Better Coal, CERA, and the Aluminium Stewardship Initiative). Fairtrade, Fairmined and the Responsible Jewellery Council award a product label at consumer level.
- All mineral resources
Standard for Responsible Mining – IRMA Certification
The Initiative for Responsible Mining Assurance (IRMA) aims to establish a multi-stakeholder and independently verified responsible mining assurance system that improves social and environmental performance. The certification will be based on the IRMA Standard for responsible mining (2018). This standard is designed to support the achievement of four overarching principles: business integrity, social responsibility, environmental responsibility, and planning and managing for positive legacies.
The CERA EU label is currently being developed. It aims to be a standardized certification scheme ensuring environmental, social and economic sustainability in extraction, processing, trading and manufacturing of all mineral raw materials, including fossil fuels. The CERA label guarantees traceability of certified materials by using a combination of traceability technologies, including proof of origin methods throughout the entire value chain.
CERA is initiated and funded by the European Institute of Innovation and Technology. The CERA team consists of universities and independent audit and consulting companies.
- Gold and/or associated silver and platinum
Conflict-Free Gold Standard
The World Gold Council developed the Conflict-Free Gold Standard (2012) based upon internationally recognized benchmarks such as the OECD Guidance. The Standard provides a common approach by which gold producers can assess and provide assurance that their gold has been extracted in a manner that does not cause, support or benefit unlawful armed conflict, or contribute to serious human rights abuses or breaches of international humanitarian law.
Fairtrade Gold is an independently certified and audited Fairtrade system for gold, silver and other precious metals from artisanal small-scale mining organisations. Fairtrade Gold comes from Fairtrade-certified mines that have met the Fairtrade Standards (2013). This includes conditions on ensuring that human rights, environmental protection, and health and safety requirements are upheld and maintained. Miners receive fair pay, as well as a Fairtrade Premium.
Fairmined is an assurance label that certifies gold from artisanal and small-scale mining organisations. The Fairmined Standard (2014) provides gold for businesses selling labelled products with strict traceability requirements. Fairmined is backed by a third party certification and audit system that ensures that artisanal and small-scale mining organisations meet world leading standards for responsible practices, delivering organisational and social development and environmental protection. The Fairmined initiative was created by the Alliance for Responsible Mining, a non-profit organisation.
- Diamonds and/or gold and platinum metals
Established in 2000 with the purpose of eradicating the trade in so-called ‘conflict diamonds’, also infamously labelled as ‘blood diamonds’, the Kimberley Process is a binding agreement. The practical instrument that is in force to operationalize this commitment is the Kimberley Process Certification Scheme (KPCS). It both safeguards the shipment of ‘rough diamonds’ and certifies them as conflict free. The Kimberley Process defines conflict diamonds as: “rough diamonds used to finance wars against governments” around the world.
The Kimberley Process Certification Scheme does not offer a guarantee against possible human rights violations by governments or the private sector, violations of international or domestic labour laws and standards, or violations of environmental laws and standards.
The Kimberley Process is structured as a tripartite organisation, composed of member states, the diamond industry, and civil society. While the member states (“participants”) are allowed to vote, the industry (represented by the World Diamond Council) and civil society (represented by the Civil Society Coalition) have the status of observers.
Under the terms of the Kimberley Process Certification Scheme, participants must:
- Satisfy ‘minimum requirements’ and establish national legislation, institutions and import/export controls;
- Commit to transparent practices and to the exchange of critical statistical data;
- Trade only with fellow members who also satisfy the fundamentals of the agreement;
- Certify shipments as conflict-free and provide the supporting certification.
Since Belgium is a Kimberley Process participant, the import and export of rough diamonds in Belgium is only allowed if a valid Kimberley Process certificate, issued by a competent national authority, accompanies the shipment.
In addition to the certification system, all Kimberley Process Certification Scheme participants have endorsed a System of Warranties (2018), which was introduced by the diamond sector in 2002 to comply with, support and strengthen the Kimberley Process Certification Scheme. The system offers sellers the option to attach a guarantee to their invoices to show that the goods meet Kimberley Process standards. This mechanism can also be used when selling polished diamonds. A jewellery manufacturer can use the guarantee to demonstrate that the purchased diamond was not involved in the financing of conflict and is in accordance with the resolutions of the United Nations. The seller thereby guarantees that the diamonds are conflict-free, based on personal knowledge and/or written guarantees provided by the supplier of these diamonds. The flow of warranties has to be audited and archived by the business.
In addition, and as part of the System of Warranties, diamond industry organisation have adopted a number of non-binding principles of self-regulation (2015). Non-respect of these principles can lead to expulsion from sectoral organisations, such as the diamond bourses and membership organisations. The principles include:
- trading only with organisations that include warranty declarations on their invoices;
- not buying diamonds from suspect sources or unknown suppliers, or which originate in countries that have not implemented the Kimberley Process Certification Scheme;
- not buying diamonds from any sources that, after a legally binding due process, have been found to violate government regulations restricting the trade in conflict diamonds;
- not buying diamonds in or from any region that is subject to an advisory by a governmental authority indicating that conflict diamonds are emanating from or available for sale there, unless diamonds have been exported from the region in compliance with the Kimberley Process Certification Scheme;
- not knowingly buying, selling, or assisting others to buy or sell conflict diamonds;
- ensuring that all employees in the organisation who buy or sell diamonds within the diamond trade are well-informed on trade standards and government regulations restricting the trade in conflict diamonds.
The Responsible Jewellery Council (RJC) is a standard-setting and certification organisation. The business members span the jewellery supply chain, from mining to retail. Members commit to and are independently audited in terms of the Responsible Jewellery Council Code of Practices for diamonds, gold and platinum group metals. Certification under the RJC code is compulsory for all RJC commercial members within two years of joining.
The RJC Chain of Custody Standard for the precious metals supply chain applies to gold and platinum group metals (platinum, palladium and rhodium). The Chain of Custody Standard (2017) requires organisations to have policy and risk management frameworks for conflict-sensitive sourcing practices, drawing on the OECD Guidance.
- 3T, gold and/or cobalt
International Conference of the Great Lakes Region Regional Certification Mechanism
The Regional Certification Mechanism is one of the six tools of the International Conference of the Great Lakes Region’s (ICGLR) regional initiative to fight against the illegal exploitation of natural resources. The mechanism focuses on tin, tantalum, tungsten and gold.
The purpose of the Regional Certification Mechanism is to provide for sustainable conflict-free mineral chains in and among ICGLR member states, with the aim of eliminating conflict financing. The mechanism comprises the following main elements:
- Mine site inspection and certification, with a focus on compliance with OECD due diligence recommendations;
- Mineral chain of custody tracking;
- Mineral export and certification;
- Mineral tracking database;
- Third-party audits;
- Independent mineral chain auditor.
Responsible Minerals Assurance Process
The Responsible Minerals Initiative provides a tool, the Responsible Minerals Assurance Process (formerly the Conflict-Free Smelter Program), which offers businesses and their suppliers an independent, third-party audit. This determines which smelters and refiners can be verified as having systems in place to responsibly source minerals in line with current global standards. The focus is on tantalum, tin, tungsten, gold, and cobalt smelters and refiners. The Conflict Minerals Reporting Template helps organisations to disclose and communicate about smelters in their supply chains.
ASI Performance Standard and Chain-of-Custody Standard
The Aluminium Stewardship Initiative (ASI) Performance Standard and the ASI Chain of Custody Standard have been developed to be applied to the global aluminium value chain. The Standards aim to enable the aluminium industry to demonstrate responsibility and provide independent and credible assurance of performance.
The Performance Standard (2017) defines environmental, social and governance principles and criteria, with the aim of addressing sustainability issues in the aluminium value chain. Implementation of the Code of Conduct Standard (2017) enables a link between verified practices in the successive steps of the supply chain under the Performance Standard, and the products produced by ASI Certified Entities.
Bettercoal was set up in response to businesses’ need for greater assurance that their coal comes from mines that take a responsible approach to protecting workers, communities, and their local environment. It assesses the performance of coal mining operations in terms of the Bettercoal Code through the Supplier Assessment Process. The Bettercoal Code (2018) sets out in detail the guidelines which mining organisations may refer to in order to define their own social, environmental and ethical policy.
- United Nations
At international level, several treaties have been signed which impose a total ban on the production, use, development, transfer or storage of chemical and biological weapons, anti-personnel mines and cluster bombs.
- Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on their Destruction (1993)
- Convention on the prohibition of the development, production and stockpiling of bacteriological (biological) and toxin weapons and on their destruction (1972)
- Convention on the Prohibition of the Use, Stockpiling, Production and Transfer of Anti-Personnel Mines and on their Destruction (1997)
- Convention on Cluster Munitions (2008)
- Arms Trade Treaty (2013)
The international Arms Trade Treaty provides States common rules for the export of arms to eradicate the illicit trade in arms.
The States which are party to these treaties must transpose them into national law.
The UN Security Council imposes restrictive measures, including arms embargos and financial restrictions, in the form of resolutions that are binding on member states. Sanctions can be directed at non-state actors, state actors, or both. They can be applied to the entire territory of a state, or to a certain region of a particular state.
The following countries and entities are subject to an arms embargo:
- Afghanistan (Taliban) (2000);
- Al Qaeda and ISIL (2002);
- Central African Republic (2013);
- Democratic Republic of the Congo (2003);
- Iraq (2004);
- Libya (2011);
- North Korea (2006);
- South Sudan (2018);
- Sudan (2004);
- Somalia (1992);
- Yemen (2015).
(Belgian) organisations are not allowed to directly or indirectly supply, sell or transfer arms or related materiel to these countries or entities. They may not provide any assistance, advice or training related to military activities, including financing and financial assistance.
- Economic Community of West African States (ECOWAS)
The ECOWAS Convention on Small Arms and Light Weapons, Their Ammunition and Other Related Materials (2006) sets a general prohibition on import, export, transit, transfer to organisation, and possession by civilians of small arms and light weapons and munitions. Exceptions are permitted following consultation of an ECOWAS member state with the ECOWAS Executive Secretariat. An ECOWAS exception certificate has to accompany an application to obtain an export licence in the country of export. Therefore, when a Belgian legal entity intends to transfer small arms and light weapons to an ECOWAS member state, an ECOWAS exception certificate needs to accompany the export application at the appropriate Belgian regional level.
- European Union
The European Union Common Position 2008/944/CFSP defines common rules for and governs export control of military technology and equipment. The export and transit of goods mentioned in the Common Military List of the European Union must be checked against the criteria included in the Common Position (Article 2). Its purpose is to prevent exports of those military goods when they could be used for undesirable purposes, such as domestic repression or the exacerbation or prolongation of tensions or armed conflicts. The Common Position is the minimum requirement. When converting it into national law, member states may adopt stricter rules.
The EU can take restrictive measures in the framework of the Common Foreign and Security Policy on the basis of Article 215 of the Treaty on the Functioning of the EU (2007). Sanctions can be applied to the entire territory of a state, or to a certain region of a particular state. The EU has the following arms embargo's in:
- Afghanistan (Taliban) (1996);
- Al Qaeda and ISIL (1996);
- Belarus (2011);
- Central African Republic (2013);
- China (1989);
- Democratic Republic of the Congo (1993);
- Iran (2007);
- Libya (2011);
- Myanmar (1991);
- Russia (2014);
- South Sudan (2011);
- Sudan (1994);
- Somalia (2002);
- Syria (2011);
- Yemen (2015);
- Venezuela (2017);
- Zimbabwe (2002).
EU organisations are not allowed to directly or indirectly supply, sell or transfer arms or related materiel to these countries or entities. They may not provide any assistance, advice or training related to military activities, including financing and financial assistance. Belgian flag vessels or aircraft may also not be used by these sanctioned countries. Sanctions can be directed at private organisations, state actors, or both.
Goods that could be used for the purpose of torture or other cruel, inhuman or degrading treatment or punishment are prohibited. Article 3 of the European Convention for the Protection of Human Rights and Fundamental Freedoms lays down an unconditional, comprehensive prohibition on torture and other cruel, inhuman or degrading treatment or punishment. Article 4 of the Charter of Fundamental Rights of the European Union states that no one shall be subjected to torture or to inhuman or degrading treatment or punishment. To enforce these fundamental rights, the EU:
- Prohibits export, import and technical assistance involving goods which have no practical use other than capital punishment or torture and other cruel, inhuman or degrading treatment or punishment (EU Regulation 1236/2005 Annex 2);
- Requires licences for the export, import and transit of goods that could be used for the purpose of torture or other cruel, inhuman or degrading treatment or punishment (EU Regulation 1236/2005 Annex 2).
The EU requires licences for dual-use items. These are products, including software and technology, which are used in civilian industries but also might have a military application, including the manufacture of weapons of mass destruction (nuclear, biological and chemical weapons, and long range rockets). EU Regulation 428/2009 sets up an EU community regime for the control of exports, transfer, brokering and transit of dual-use items.
Organisations require mandatory licences for:
- export and transit of dual-use items outside the EU;
- transfer of goods in Annexe IV of EU Regulation 428/2009 inside the EU.
The Flemish, Walloon and Brussels-Capital governments can require licences for certain goods that are not listed in Annexe IV of EU Regulation 428/2009.
The export, import and transit of arms and ammunition and related materiel in Belgium are regulated at the regional level (Flanders, Wallonia and Brussels). The federal government is responsible for (1) the import, export and transit of arms and ammunition and related materiel for the Belgian Army and the federal police; and (2) arms brokering regulations.
- Federal level
The Law of 18 September 2017 aims to prevent money laundering and the financing of terrorism, and to limit the use of cash. This law combats financing of illicit arms trade. The law demands that financial institutions, stockbroking firms, management corporations and investment corporations develop and apply effective policies, procedures and internal control measures.
A licence from the Minister of Justice is required for any Belgian, or any foreigner residing in or trading from Belgium, who wants to act as an arms broker / intermediary. This regulation is extraterritorial, meaning it applies to every Belgian residing anywhere. The goods do not have to pass through Belgium for this rule to be applicable.
The Royal Decree of 8 March (article 10) (1993) regulates the import, export, and transit of weapons, ammunition, and materiel for military or law enforcement use, as well as related technology. Maritime vessels have to submit a travel schedule to customs before leaving a Belgian port, whatever their flag. Every air vessel, whatever its nationality, also has to submit a travel schedule to customs, indicating all ports of destination.
The production, trade, stockpiling and transportation of the following is prohibited:
- blinding laser weapons;
- inert munitions and armour that contains depleted uranium or any other industrial uranium;
- antipersonnel mines;
- cluster munitions.
There is also a prohibition on financing any business registered under Belgian or foreign law which engages in the production, use, repair, sale, trade, distribution, import or export, stockpiling or transportation of:
- inert munitions and armour which contains depleted uranium or any other industrial uranium;
- antipersonnel mines;
- cluster munitions.
Organisations registered to trade in Flanders require mandatory licences for:
- all material destined to support military actions;
- law enforcement material;
- civilian firearms, parts and ammunition.
Organisations registered to trade in Flanders are required to obtain licences to transfer for the following within the EU:
- transfer of defence-related products, and other material appropriate for military use;
- transfer of law enforcement material;
- transfer of civilian firearms, parts and ammunition.
Organisations are obliged to have licences to obtain licences for the following outside the EU:
- import, export and transit of defence-related products and other material appropriate for military use;
- import, export and transit of law enforcement material;
- import, export and transit of civilian firearms, parts and ammunition.
Since 2003, the Flemish government has had the authority to adopt restrictive measures, for instance the imposition of an arms embargo. In 2006, the Flemish government imposed an arms embargo on Israeli military end-users and/or end-use: no export, or transit of goods that can enhance the military capability of the Israeli Defence Force is permitted. Thus, strategic goods can still be exported to Israel if the exporter can prove that (a) the goods are destined for re-export from Israel; and (b) that the end-use will take place outside of Israel.
Legal entities registered to trade in Wallonia require mandatory licences for:
- civilian arms;
- material appropriate for military use according to the Common Military List of the European Union (latest version adopted by the EU Council on 26 February 2018);
- law enforcement material.
This is regulated in Walloon Decree of 21 June 2012 relating to the import, export, transit and transfer of civilian arms and defence-related material.
Organisations registered to trade in Wallonia are required to have licences for the export of the following within the EU:
- transfer of defence-related material;
- transfer of law enforcement material;
- transfer of civilian arms.
Organisations are obliges to have licences for the following outside the EU:
- import, export and transit of defence-related material;
- import, export and transit of law enforcement material;
- import, export and transit of civilian firearms.
Organisations registered to trade in Brussels require mandatory licences for:
- the products, including software and technology, which are on the Common Military List of the European Union (latest version adopted by the EU Council on 26 February 2018);
- law enforcement material;
- civilian firearms.
Organisations registered to trade in Brussels are required to have licences for the transfer of the following within the EU:
- transfer of defence-related material;
- transfer of law enforcement material;
- transfer of civilian firearms.
Organisations are obliged to have licences for the following outside the EU:
- import, export and transit of defence-related material;
- import, export and transit of law enforcement material;
- import, export and transit of civilian firearms.
- Regulatory framework governing the pharmaceutical sector
- UN system
Various UN agencies have been promoting the right to access medicines. The main initiatives are listed here:
The Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health released this first report to encourage pharmaceutical companies to facilitate access to essential medicines in line with the Millennium Development Goals (MDGs). These referred to the duty of pharmaceutical companies “to provide access to affordable essential drugs in developing countries”. This is now a target of SDG 3, namely to “ensure healthy lives and promote well-being for all at all ages”.
The Report of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health (2013)
The Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health released a second report in which the challenges and good practices relating to the right to health (specifically access to medicines) were reiterated. This report also identified the key elements of these rights, namely availability, accessibility, acceptability and quality. For these purposes, the report further encourages local production of medicines, price regulations, medicines lists, procurement, distribution, rational and appropriate use and quality of medicines. The Special Rapporteur emphasised the need to take a right-to-health approach to market-oriented perspectives on access to medicines.
WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPA-PHI) (2008)
The World Health Organisation (WHO) launched this global strategy to encourage fair protection of intellectual property rights (IPR), in a way which is compatible with respect, protection and fulfilment of the right to access essential medicines, and which guarantees that everybody has the right to benefit from the results of research and development relevant to diseases that disproportionately affect poor populations. The strategy basically promotes research, innovation, technology transfer and local production of medical products, by aiming for a balanced protection of IPR and the improvement of public health policies.
The global strategy also aims at eliminating barriers to access by creating funding mechanisms for sustainable research and development, and by monitoring and evaluating the implementation of the strategy, including through reporting systems.
The WHO Essential Medicines and Health Products (EMP) Department released this practice guide to promote affordable access to quality, safe and effective medical products. It also sought to increase awareness of the utility of research and development, and the need to conduct this in a way that is compatible with the rights to health and equality.
Essential Medicines and Health Products Information Portal
This portal of the WHO aims at increasing awareness about the need to guarantee access to essential medicines and health products. It is supported by the US Agency for International Development (USAID)-funded Systems for Improved Access to Pharmaceutical Services (SIAPS) Program, implemented by Management Sciences for Health (MSH). This database provides access to sources covering several issues, such as the WHO Technical report series, Biological Standardization, Specifications for Pharmaceutical Preparations, Drug Dependence and The Selection and Use of Essential Medicines.
UN Global Compact: Human Rights, Access to Medicines, and the Pharmaceutical Industry (2011)
The UN Global Compact released this good practice note to promote responsible business in line with the UN goals. This report from the human rights working group (HRWG) addresses the need to guarantee access to medicines, particularly for the poorest populations.
- The World Trade Organisation (WTO)
This declaration sought to support the right of developing countries to use the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) (1994) in a manner compatible with their public health goals - such as universal access to medicines - by allowing states to apply exceptions to IPR protection when their public health needs are incompatible with the general TRIPS regime. This declaration sought to increase awareness about the need to prioritize the rights to health, life and equality in specific circumstances, such as in case of epidemics.
The OECD launched this project in light of the central role that the pharmaceutical sector plays in improving life expectancy and quality of life through the production of medicines. The project also highlights the inequality of access to essential medicines, and the lack of universal access at affordable prices. Therefore, the OECD considers it necessary to evaluate incentives at work in the pharmaceutical sector and the sustainability of pricing models, particularly for new medicines, and especially medicines for cancer or rare diseases.
This project also promotes international high-level dialogue among stakeholders on access to innovative pharmaceuticals and sustainability of pharmaceutical spending. The initiative was endorsed by OECD member states and health ministers at the G7 Health Ministerial meeting in Kobe. The ultimate aim is to find sustainable funding for research and development in the pharmaceutical sector to guarantee sustainable and equitable access to innovative medical treatments. The project also aims to conduct a prospective study to assess the sustainability of pharmaceutical spending, and to organise stakeholder consultations.
- The Council of Europe (CoE)
This reference work aims to promote and monitor the quality control of medicines in the member states of the CoE that have signed the CoE Convention on the Elaboration of a European Pharmacopoeia (1964). The website contains official standards for a legal and scientific framework for quality control of pharmaceutical products. They define the qualitative and quantitative composition and the tests to be carried out on medicines, raw materials for producinf medicines, and intermediates of synthesis. Pharmaceutical corporations need to comply with these standards to commercialise these products in the territory of the signatory states.
The Protocol to the Convention on the Elaboration of a European Pharmacopoeia (1989) defines the powers of the EU and its member states within the European Pharmacopoeia Commission.
The ultimate purpose of the European Pharmacopoeia is to promote public health and protect consumers by regulating and controlling the quality of medicines and their components. It also aims at making safe use of medicines compatible with the free movement of medicinal products within the jurisdiction of the CoE.
The website also includes a Guide for the Work of the European Pharmacopoeia, the Rules of Procedure of the European Pharmacopoeia Commission, the Code of Practice for the work of the European Pharmacopoeia and the List of Groups of Experts & Working Parties (2016).
Various agencies of the EU have competence to regulate and monitor health issues:
Firstly, the European Commission - Department (DG) Health and Food Safety (SANTE) Is competent for EU policy on food safety and public health in accordance with the Treaty on the Functioning of the European Union (168). However, the EU is not competent to define health policies, or the organisation and provision of health services and medical care. It has a complementary function to national policies on public health issues, which also relates to the activities of the pharmaceutical sector.
Secondly, the European Medicines Agency (EMA) is competent for “the scientific evaluation, supervision and safety monitoring of medicines in the EU.” The Code of Conduct aims to avoid conflict or competing interests between EMA officers and the regulated industries (pharmaceutical sector). This Code is in line with the EU Regulation that addresses financial or other interests in the pharmaceutical industry which could have an undue influence on its transparency and duty to act in the public interest. It also regulates EMA officers duties of confidentiality and discretion.
The European Pharmacopoeia of the CoE is also mandatory in all EU member states. In addition, the EU has a website with all pharmaceutical legislation for medicinal products for human use.
Thirdly, the Commission Expert Group on Safe and Timely Access to Medicines for Patients ("STAMP") has been created to advise the European Commission on implementing EU pharmaceutical legislation, as well as related programmes and policies. This expert group is also in charge of evaluating whether policies are able to implement the EU legal framework effectively, and guarantee safe and timely access to and availability of medicines for patients.
Good Manufacturing Practices (GMP - goede fabricagepraktijken of goede manier van produceren) van geneesmiddelen) (2018)
The Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) released these guidelines in French and English for the national industry. These guidelines seek to protect consumers and include the CoE and EU standards. This agency also publishes the national regulations for the information of stakeholders.
- Other initiatives
In this section, some initiatives from other actors are listed, as they can be useful for pharmaceutical corporations seeking to evaluate actual or potential human rights adverse impacts that their activities may cause.
This is the association of medicine sector organisations in the that are active in Belgium. It brings together more than 130 pharmaceutical companies. These corporations aim to research and develop new medicines. The website provides good practices and information on the regulatory framework - for instance, on the regulation regarding the transparency in the information provided by these corporation to the users (medical doctors). It also provides information on Mdeon, the deontological platform for health services providers, information on authorised marketing of medicines, and other useful information such as Betransparent.be and the Sunshine Act; the deontological code of pharma.be and other international deontological codes.
The Access to Medicine Foundation in the Netherlands aims at encouraging and guiding pharmaceutical corporations in providing access to medicines to vulnerable populations in poor countries. This foundation constructed an index with funding from the Bill & Melinda Gates Foundation and the UK and Dutch governments. The index has been designed to benchmark corporations to identify best practices and progress gaps. This way, the the pharmaceutical industry’s action on improving access to medicines, particularly in developing countries, is made explicit.
This NGO is a multi-stakeholder initiative comprising public health NGOs, patient groups, health professionals and disease groups. It has been created to advocate on health rights in Europe. Its main mission is to promote EU health-relevant policies, as well as other more focused campaigns such as universal access to medicines; trade for health; food, drink and agriculture; clean air; vulnerable populations such as Roma children, etc. The website provides several resources on these issues.
This institute has created the Pharmaceutical Human Rights Assessment for Pharmaceutical Corporations (HRAPC). The assessment is specific to this sector and focused on its particular human rights challenges. It mainly refers to indicators for assessing the human rights impact of clinical trials, marketing practices, and product safety, among other issues.
- Relevant issues for value chains in the pharmaceutical sector
Besides general guidelines on employment and environmental protection, this sector should pay particular attention to activities related to research and development. Three issues are mentioned here:
- Participation of vulnerable populations in clinical trials
The NGO SOMO launched the report Protection of Clinical Trial Participants in Countries Outside the EU (2011) to raise awareness about clinical trials for medicines used in the EU, as these have been increasingly offshored, particularly to low- and middle-income countries. Many participants hired are from vulnerable populations with limited access to health care and are not protected by national regulatory authorities and ethics committees.
Upon the request of the NGO Wemos and some parliamentarians, the European Parliament, approved an amendment in 2018 to request the European Medicines Agency to report on how it protects clinical trial participants, and how trials are conducted in line with ethical guidelines. The new element is that besides complying with the EMA duty to protect clinical trial participants, this agency must now report on this to the European Parliament.
The World Medical Association (WMA) Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects (last revision of 2013) also promotes ethical principles for medical research involving persons. This Declaration encourages its adoption by any medical research professionals. It is in line with the International Code of Medical Ethics. In general, researchers must promote and safeguard the health, well-being and rights of all patients, including persons involved in clinical trials. In addition, pharmaceutical corporations should be transparent and manage their supply chains responsibly. This includes voluntary participation in trials and the possibility to have access to the treatment after the trial.
The NGO SOMO also launched the report Putting Contract Research Organisations on the Radar (2011) to increase awareness on the actual and potential adverse human rights impacts in the value chains of pharmaceutical organisations when they offshore or outsource contract research organisations (CROs).
Besides these clinical trials, researchers should also be transparent about the funding and sponsors of the research conducted, as well as its results.
- Equitable use of genetic resources
The pharmaceutical sector should also be aware of the international protection of genetic resources, which includes strict regulation of their use for research and development, as well as related commercial use.
The Convention on Biological Diversity (CBD) (1992) recognises the sovereign rights of states over genetic resources found on their territory, and promotes their use with respect for the environment. The benefits from their use must be shared with the country where the resources were found. This mechanism is known as the principle of access and benefit sharing, or ABS.
The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization (in force since 2014) further regulates the use of these genetic resources and related traditional knowledge. It also regulates how ABS should be implemented by the state parties.
The EU also enacted a Regulation on Compliance Measures for Users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union. This regulation aims at increasing trust between states parties to the Nagoya Protocol and stakeholders - such as local communities - that can benefit from ABS of genetic resources. It also recognises the importance of genetic resources for research and development of new medicines, and for food security.
This EU regulation is also in line with the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) (2001), which also recognises the rights of farmers to the diversity of crops. It seeks to create a global system to provide farmers, plant breeders and scientists with access to plant genetic materials, and ensure that recipients share benefits with the countries where the genetic resources originate.
The United Nations University has further released a Survey of Model Contractual Clauses, Codes of Conduct, Guidelines, Best Practices and Standards to guide users in the ABS system.
The ABS Clearing-House (ABSCH) is an online platform of the CBD that informs stakeholders on the national implementation of the Nagoya Protocol ABS system and the clearing-house mechanism of the CBD. This is particularly relevant for the value chains of organisations working with genetic resources and their derivates. It also seeks to connect providers and users of genetic resources and associated traditional knowledge
- Regulatory framework
- International level
To prevent accidents affecting people and the environment, rules and regulations have been imposed on the transport, storage, and handling of dangerous goods. The United Nations has developed tools to harmonize these regulatory systems:
The UN Recommendations on the Transport of Dangerous Goods - Model Regulations and the Globally Harmonized System of Classification and Labelling of Chemicals. For each mode of transport, corresponding rules and regulations are developed based upon the UN Model Regulations.
The Globally Harmonized System of Classification and Labelling of Chemicals (GHS), administered by the United Nations Economic Commission for Europe (UNECE), classifies dangerous goods into nine categories according to the type of hazard, and accordingly proposes labels for easy identification. The category determines, among other things, which goods can be transported, the mode of transport, and the manner of packaging and the handling.
For safety reasons, the carriage of dangerous goods by road, rail and inland waterways is regulated by international treaties.
UNECE administers several regional agreements in relation to transport of dangerous goods by road (ADR), and inland waterways (ADN). In practice, any organisation worldwide can accede to the European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) and Waterways (ADN).
The Intergovernmental Organisation for International Carriage by Rail (OTIF) has developed uniform rules for the carriage of dangerous goods by rail, the carriage of persons and goods, and technical provisions for rolling stock. The Regulations concerning the International Carriage of Dangerous Goods by Rail are incorporated into the Convention concerning International Carriage by Rail. The Convention is applicable in Europe, the Maghreb and the Middle East.
The Convention on International Civil Aviation (1944) set up the International Civil Aviation Organisation, a specialized agency of the United Nations. The Convention sets out principles for safe and orderly international civil aviation. International air transport services may be established on the basis of equality of opportunity and must operate soundly and economically. Only civilian flights authorized by a state party or civilian flights consistent with the aims of the Convention are permitted. The Convention prohibits the carriage of “munitions of war or implements of war” in or above the territory of a state in an aircraft engaged in international navigation, except by permission of such state.
The Convention is supplemented by 18 annexes, a select number of which are relevant for human rights:
- Annex 2: Rules of the Air
- Annex 16: Environmental Protection, Part I, Aircraft Noise
- Annex 16: Environmental Protection, Part II, Aircraft Engine Emissions
- Annex 17: Security
- Annex 18: The Safe Transport of Dangerous Goods by Air. Annex 18 forms the foundation for the ICAO Technical Instructions for the Safe Transport of Dangerous Goods by Air. It aims to provide a level of safety such that dangerous goods can be carried without placing an aircraft, its occupants or the environment at risk.
Several core treaties regulate the interaction of states and organisations at sea, the obligations on organisations to prevent pollution of the marine environment, and the safety of seafarers and sailors.
The UN Convention on Law of the Sea (UNCLOS) defines the rights and responsibilities of states with respect to the ocean usage and sovereignty. Every vessel from any organisation has the duty to render assistance to any person found at sea in danger of being lost. This has implications for shipping corporations operating in waters with a high prevalence of boat refugees.
International Maritime Organisation
International collision regulations and global standards for seafarers, as well as international conventions and codes relating to search and rescue, the facilitation of international maritime traffic, and the carriage of dangerous goods, have been developed and adopted by the International Maritime Organization. This is a specialized agency of the UN and responsible for safety and security of shipping and the prevention of marine pollution by ships. IMO has also adopted a wide range of measures to prevent and control pollution caused by ships and to mitigate the effects of any damage that may occur as a result of maritime operations and accidents.
The two most important Conventions adopted by IMO are the International Convention for the Prevention of Pollution from Ships (MARPOL) (1973). This is the main international convention on prevention of pollution of the marine environment. The Convention includes regulations aimed at preventing and minimizing pollution from ships - both accidental and resulting from routine operations. Special Areas with strict controls on operational discharges are included in the annexes.
The International Convention for the Safety of Life at Sea (SOLAS) (1974) is one of the most important treaties concerning the safety of merchant ships. It regulates the safety of the crew and the passengers. It also includes the International Maritime Dangerous Goods Code (2004) that regulates the maritime carriage of dangerous goods. Since 2008, all cargo vessels over 300 tons, passenger ships and mobile offshore drilling units must install a Long-Range Identification and Tracking (LRIT) system. Vessels must also transmit their position to the flag state at least 4 times per day, and “on demand” as frequently as every 15 minutes. LRIT is complementary to the coastal ship tracking system known as the Automatic Identification System (AIS). AIS automatically transmits the position and identification of the vessel to coastal stations and nearby vessels to avoid collisions.
International Labour Organisation
The ILO has adopted many specific safety, security, environmental and labour rules for seafarers, inland navigation personnel, fishers, and dockworkers, as well as rules on working and resting times for truckers. The list below is a selection of ILO regulations ratified by Belgium.
ILO regulations protecting dockworkers:
ILO regulations protecting seafarers include general provisions that protect fundamental rights and set minimum standards:
- The Maritime Labour Convention (2006) sets out the fundamental rights of seafarers in relation to working conditions.
- Merchant Shipping (Minimum Standards) Convention, 1976
A number of more specific regulations address vulnerable groups and working conditions at sea:
- Protection of Young Seafarers Recommendation, 1976
- Access to employment: Recruitment and Placement of Seafarers Convention, 1996
General conditions of employment:
- Seafarers' Hours of Work and the Manning of Ships Convention, 1996
- Repatriation of Seafarers Convention (Revised), 1987
- Seafarers' Annual Leave with Pay Convention, 1976
Safety, health and welfare:
Security of employment:
- Continuity of Employment (Seafarers) Convention, 1976
- Social security: Social Security (Seafarers) Convention (Revised), 1987
The ILO has also developed codes of practice and guidelines. The following are relevant from a human rights perspective:
- Safety and Health in Ports (2016)
- Code of practice on safety and health in shipbuilding and ship repair (2018)
- Guidelines on flag State inspection of working and living conditions on board fishing vessels (2017)
- Guidelines for implementing the occupational safety and health provisions of the Maritime Labour Convention, 2006
- Security in ports (2004)
- Safety and health in ports (2003).
- European Union
This section discusses regulations in force within the European Union which apply to the following modes of transport: land (road, rail, inland waterways), air, and maritime (long sea shipping, short sea shipping). Inland waterways are defined as the waters on the landward side of the baselines of the territorial sea of the coastal state, and are therefore covered under the paragraphs related to ‘land’.
For road and rail transport within the EU, the EU provides binding regulations for organisations on working time, social rights, and protection of passengers’ rights. An overview of relevant regulations can be found in the "Where?" section.
The inland transport of dangerous goods is regulated by the Directive that lays down common rules for the safe and secure transport of dangerous goods within and between EU countries by road, rail or inland waterway. It also covers aspects such as loading and unloading, the transfer to and from another mode of transport, as well as the stops in the course of the transport process. It extends the application of international rules to national transport of dangerous goods.
For air transport, important issues are the safety of the aircraft, its passengers, and personnel (air safety); security threats from unlawful acts such as terrorism and crime (air security); and the right to privacy for passengers.
The basic regulations governing aviation safety and environmental protection are set out in the common rules found in Regulation relating to the design, production, maintenance and operation of aircrafts and their engines, propellers, and parts, as well as the provision of air traffic management and air navigation services.
This regulation is complemented by more specific regulations laying down technical specifications for airworthiness of aircraft and their components; environmental certifications (including levels of noise pollution, exhaust levels); rules and procedures for issuing, maintaining, amending, limiting, suspending or revoking licenses, privileges and responsibilities of the holders of the approvals; and licenses, rules and procedures for the maintenance of products, parts, etc.:
- Initial Airworthiness: Regulation lays down implementing rules for the airworthiness and environmental certification of aircraft and related products, parts and appliances, as well as for the certification of design and production organisations.
- Additional Airworthiness: Regulation contains additional airworthiness specifications for operations of large airplanes used in commercial air transport.
- Continuing Airworthiness: Regulation contains rules on the continuing airworthiness of aircraft and aeronautical products, parts and appliances, and on the approval of organisations and personnel involved in these tasks.
- Air Operations: Regulation lays down technical requirements and administrative procedures related to air operations.
- Third Country Operators: Regulation lays down technical requirements and administrative procedures related to air operations of third country operators.
The basic common rules for air security are set out in the Regulation on common rules in the field of civil aviation security. This regulation establishes common rules to protect civil aviation against acts of unlawful interference that jeopardise security. It applies to all airports, operators (including air carriers) and all entities operating from premises located inside or outside airports that provide goods and/or services to or through airports.
As consumers, all passengers are protected regardless of their mode of travel. Passenger rights for air travel are set out in the Regulation that sets out duties for air carriers and minimum rights for passengers when: (a) passengers are denied boarding against their will; (b) a flight is cancelled; or (c) a flight is delayed.
This regulation is complemented by Interpretative Guidelines. These establish common rules on compensation and assistance to passengers in the event of denied boarding, cancellation or long delay of flights, as well as on air carrier liability in the event of accidents.
For transport at sea, the main human rights issues are the safety of the ship, its passengers, and personnel (maritime safety); the risk of environmental damage resulting from pollution, impacting biodiversity and human livelihoods (environmental protection); and the employment and working conditions of maritime personnel.
The EU Directive establishing a vessel traffic monitoring and information system aims at enhancing the safety and efficiency of maritime traffic in the EU's waters and coasts. Masters, operators or agents of ships, as well as shippers or owners of dangerous or polluting goods carried on board such ships, must comply with the requirements under this Directive. One such measure is advance notification of the arrival of dangerous goods prior to their entry into the ports of member states.
The EU Regulation concerning the rights of passengers when traveling by sea and inland waterway defines the rights of passengers when traveling within the EU. The EU Regulation concerning the liability of carriers of passengers by sea in the event of accidents regulates the carriage of passengers and their luggage. The Directive establishing a Community vessel traffic monitoring and information system sets up a system to monitor Europe’s waters and coasts. It seeks to enhance maritime safety, port and maritime security, environmental protection and pollution preparedness.
The EU has adopted directives to stop ship-source pollution and to enhance protection of the marine environment from pollution by ships. The Directive on ship-source pollution and on the introduction of penalties for infringements applies to discharges of polluting substances from any ship, irrespective of its flag, whether in EU internal waters, the territorial sea of a member state, straits or the high sea. This directive addresses non-compliance with the MARPOL standards and introduces penalties for pollution offences. MARPOL standards limit the discharge of noxious liquid substances, in order to prevent pollution from engine room wastes, cleaning cargo areas and tanks, sewage, and other harmful substances.
The Directive on maritime safety and the prevention of pollution from ships aims to improve the implementation of EU legislation on maritime safety, on the prevention of pollution from ships, and on shipboard living and working conditions.
Employment and working conditions
The EU has adopted several directives to protect and ameliorate the working conditions of seafarers. The main ones are the Directive on seafarers' hours of work on board ships and the Council Directive on working time rules for seafarers, including hours, rest, paid leave and fitness for work.
The key human rights issues in this sector relate to working conditions and transport of dangerous goods. National legislation governs the accreditation conditions for road transport organisations. It sanctions organisations for violations of working standards and regulations on safe storage, transport of dangerous goods, and resting periods for drivers. An overview of the relevant national regulations can be found in the "Where?" section.
The main human rights issues for air transport are the safety of aircraft, passengers and crew, the working conditions of personnel, and passengers’ right to privacy. The Law of 27 June 1937 determines that the rules and regulations governing aerial navigation in Belgian airspace will be issued by royal decree. The law prohibits the unauthorized transport of arms, ammunition and explosives on board an aircraft or into an airport. The complementary decrees determine that only registered aircraft with valid air operating certificates may enter Belgian airspace. The decrees regulate which dangerous goods can be transported by air and how this may take place, as well as the liability of the carrier for carriage of persons and goods. An overview of the relevant national regulations can be found in the "Where?" section.
The main human rights issues for maritime transport are the safety of ships, passengers, and personnel, and the social, safety and working conditions of maritime personnel. An overview of the relevant national regulations can be found in the "Where?" section.
- Industry Initiatives
This section gives a selection of industry initiatives that aim to assist organisations with their human rights compliance in the transport sector by providing guidelines and standards.
- Clean Cargo Working Group
The Clean Cargo Working Group is part of 'Business for Social Responsibility', a non-profit organisation set up by multinationals. The Working Group is an initiative involving cargo carriers, freight forwarders, and major brands. It aims to reduce the environmental impact of global goods transportation and promotes sustainable shipping. The main focus of the Clean Cargo Working Group is on how to measure and report on carbon dioxide emissions by ocean carriers.
- Maritime Anti-Corruption Network
The Maritime Anti-Corruption Network commits its members to implementing seven anti-corruption principles as part of an overall compliance program. These principles are:
- Compliance program requirements
- Proportionate procedures
- Risk assessment
- Training and communication
- Monitoring and internal controls
- Reporting, discipline and incentives
- Due diligence
- International Transport Workers' Federation
The International Transport Workers' Federation (ITF) Flags of Convenience Campaign demands a genuine link between the flag a ship flies and the nationality or residence of its owners, managers and seafarers, in order to hold ship owners accountable for the protection of seafarers' rights.
- IMPA ACT
IMPA ACT is the responsible supply chain management and corporate social responsibility platform for the international shipping and marine industry, created by the International Marine Purchasing Association (IMPA). IMPA ACT members commit to the IMPA ACT Supplier Code of Conduct. The Supplier Code of Conduct is a set of social, environmental and economic principles that are based on internationally endorsed UN expectations for organisations. The Code of Conduct represents current best practice.
- World Ports Sustainability Program
The World Ports Sustainability Program (WPSP) is a commitment by major world ports to reduce greenhouse gas emissions. Ports do this by influencing the sustainability of supply chains, taking into account local circumstances and varying port management structures. The ports actively seek ships’ cooperation in support of measures to reduce emissions into the air from ships. One project within WPSP is the Environmental Ship Index (ESI). The Index identifies seagoing ships that perform better in reducing air emissions than what is required by the current standards of the International Maritime Organisation. To promote the use of greener ships, the Port of Antwerp rewards ships with a high ESI score with a reduction in tariffs.
The WPSP Charter (2018), aiming at reducing greenhouse gasses, endorses all 17 Sustainable Development Goals (SDGs) and commits to contributing to them. The states parties to the WPSP Charter commit to: establishing and maintaining a global library of best practices; providing a portal for projects and initiatives of international port-related organisations that have joined the program as partners; functioning as a think-tank and breeding ground for new collaborative projects; and reporting regularly about the sustainability performance of the global ports sector. The five core themes relating to the SDGs are resilient infrastructure, climate and energy, community outreach and port-city dialogue, safety and security, and governance and ethics.