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Responsibility for our products Audited

Our success and our future are founded on innovative products that address people’s needs and enable them to lead a better life. Through our products, we are helping to overcome global challenges such as climate change and access to health. At the same time, we are also helping our customers achieve their own sustainability goals.

The safety of our products is at the core of our corporate responsibility. As long as used properly, our products should pose no danger to customers or the environment, nor should our pharmaceuticals have a negative benefit-risk evaluation. We therefore examine safety across the entire life cycle of our products and continuously take steps to minimize risks. We make our products safer to use by providing patients and customers with extensive informational material so that they can use the products in a responsible, safe and proper manner.

Safety of our chemical products

There are numerous regulations intended to ensure that chemicals pose no danger to humans or the environment. Compliance with these regulatory requirements is an important part of our work. With our Group-wide Product Safety Chemicals policy, we have introduced global processes for defining, steering and implementing product safety, and have established the corresponding management structures.

Our policies and regulations incorporate all relevant national and international chemical regulations, including the EU chemicals regulation REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) and the Globally Harmonised System of Classification and Labeling of Chemicals (GHS). We are committed to transparency; for instance, in line with the Global Product Strategy, an international initiative of the chemical industry, we provide our customers with product safety summaries for hazardous materials.

Merck has successfully completed the second phase of REACH implementation. All substances we produce or import in quantities ranging from 100 to 1,000 metric tons per year – around 70 different substances – were fully registered with the European Chemicals Agency (ECHA) by June 1, 2013. The next step, part of the third phase, is for us to register all substances produced or imported in quantities ranging from one to 100 metric tons by 2018. We have already started this process and are right on schedule with our activities.

Safety of our drugs

In everything we do, our number one priority is our patients’ safety. Ultimate responsibility for drug safety matters at Merck Serono is borne by our Medical Safety and Ethics Board (MSEB), which is chaired by the Global Chief Medical Officer. Merck Serono Global Drug Safety is responsible for continuously, systematically monitoring the safety of our drugs (pharmacovigilance). This unit processes safety information from various sources such as clinical trials, adverse reaction reports and scientific literature in order to provide patients with the latest risk-benefit evaluations during the entire life cycle of a drug. Through our Pharma Code for Conducting Pharmaceutical Business and Pharmaceutical Operations, we set standards for responsible marketing activities in order to ensure that patients and professional health care providers have access to relevant information and that patients receive effective treatment.

Quality of our products

Our goal is to provide customers and patients with high-quality brand-name products. Through our quality vision – “Quality is embedded in everything we do!” – we remind our employees of their responsibility – across all divisions, all Group functions and all levels of the company.

Sustainable products

We strive to continuously enhance the sustainability footprint of our products and are working to offer our customers products that enable them to reduce the impact of their own activities, as well as to achieve their own sustainability goals. One example of this is the Green3 concept. Through this program, the Performance Materials division is helping to promote environmentally preferable, energy-efficient, safe technologies and materials. We are developing innovative materials for energy-efficient liquid crystal and OLED displays and are thus helping our customers to reduce their own environmental impacts. Thanks to liquid crystals from Merck, displays consume approximately 20% less energy in comparison with the preceding generation of technology.

We have expanded the Green3 concept to include cosmetic products from our Performance Materials division. We are working to sustainably procure and produce cosmetic ingredients as well as optimize the related production processes. In dialogue with our customers from the cosmetics industry, we also develop proposals for cosmetic formulations that meet strict sustainability criteria as well as address the current trend towards more natural cosmetics. Several of our products have recently been certified by ECOCERT, an independent organization that represents high international standards for environmentally sustainable products.

As part of the Design for Sustainability program, the Merck Millipore division has developed a number of tools to drive sustainability across the product development process. One example is a scorecard that identifies key health and environmental impacts in certain life cycle stages as well as opportunities to make improvements. The Design for Sustainability program is especially aimed at reducing our customers’ own environmental impact, including their carbon footprint and water use.

In addition to this, Merck fosters its employees’ ideas for new businesses through its Innospire program. In view of the globally rising levels of energy consumption as well as the increasing scarcity of water, in 2013 we focused on energy conservation, energy efficiency, and energy conversion, as well as water treatment, water quality analyses, and efficient water consumption. These topics were of particular importance in our Performance Materials and Merck Millipore divisions. Merck employees were called upon to submit suggestions for new materials and systems, as well as for new business models. During the 2013 run of the Innospire program, 300 ideas were submitted, some of which pertained to the above-mentioned topics.

Access to health

Promoting access to health – not only to medicines – for underserved populations across the world is a priority for Merck. Our Access to Health (A2H) initiative leverages core competencies across all Merck divisions to provide comprehensive health solutions to underserved populations and patients in low- and middle-income countries. Merck is committed to the UN Millennium Development Goals (MDGs) and to working with partners to achieve them. Our robust approach to addressing the complex challenge of providing access is comprised of four components, known as the 4As for Access: Availability, Affordability, Awareness and Accessibility.

Availability

Availability includes efforts to reduce barriers to health care solutions and to tackle unmet needs in therapeutic areas that disproportionately affect the poor in low- and middle-income countries. Merck is a signatory to the London Declaration on Neglected Tropical Diseases (NTDs), which aims to expand access for the 1.4 billion people affected by NTDs. Within the scope of this unprecedented multi-stakeholder effort, Merck pledged to increase its praziquantel donation tenfold and to develop a pediatric formulation to treat schistosomiasis, a worm disease that often is contracted via contaminated water and is endemic in Africa, Asia and Latin America.

Affordability

Affordability entails offering our products at prices that poor populations can also afford through programs such as innovative pricing, intellectual property initiatives and donations. Through the Merck Praziquantel Donation Program, which is one of our lighthouse projects, Merck donates Cesol® 600 tablets, which contain the active ingredient praziquantel, to the World Health Organization (WHO) to fight schistosomiasis in Africa. At the end of 2011, Merck pledged to continue its efforts until the disease is eliminated in Africa, contributing up to 250 million tablets annually in the medium term. The WHO partnership has made it possible to treat around 38 million African children. Manufacturing plants in developing countries allow Merck to improve the affordability of their products by selling them in local markets at lower prices.

Awareness

Awareness focuses on the education of health care professionals, technicians and patients to promote high-quality disease prevention, screening and treatment. Interpol, the world’s largest international police organization, estimates that up to 30% of all medicines in developing countries are either counterfeit or of substandard quality. This is especially true in Africa and Asia, since they have little in the way of effective governmental drug inspection centers. The Minilab™ developed by the Global Pharma Health Fund (GPHF), which is exclusively financed by Merck, is an important element of our efforts to combat counterfeit medicines and ensures patient safety. The Minilab™ detects counterfeit medicines quickly, easily and inexpensively by using reference samples to test the identity and concentration of 70 active ingredients, ranging from antimalarial drugs and antibiotics to analgesics and antipyretics. To date, the GPHF has supplied 642 Minilabs to more than 80 countries. Merck also collaborates with Interpol and other biopharmaceutical companies to raise awareness about the harmful effects of counterfeit medicines.

Through our three-year Capacity Advancement Program (CAP), Merck is promoting awareness among health workers. In Kenya, we collaborate with the University of Nairobi on the Diabetes Community Awareness and Medical Education Program in a campaign to improve the early diagnosis of diabetes. The campaign has already reached 1,000 people in Kenya, providing patients with free screenings and medical check-ups. We run and sponsor pharmacovigilance training programs in collaboration with local health authorities to ensure that patients get best-quality health solutions, regardless of their location.

Accessibility

To strengthen supply chain and delivery as well as contribute to addressing the so-called “last mile” challenge, we are engaged with various global health stakeholders in discussions around collective and tailored solutions. To raise awareness about thyroid disorders, Merck runs screening programs in Africa, Asia and Latin America. We also use our ThyroMobil® to provide onsite screening and education about iodine deficiency. In Algeria, Merck supports local production through the transfer of manufacturing technology for the production of metformin and bisoprolol. As part of its commitment to improving access to health care for underserved populations, Merck has also constructed the rural pharmacy – an innovative pharmacy specifically designed for rural parts of Africa that will be piloted in Ghana. The pharmacy is a 40-foot shipping container which can be transported to rural communities pre-equipped and with minimal assembly required. Since people living in rural areas often travel great distances to access health care services, the pharmacy will improve accessibility by bringing health solutions directly to them.

Merck aims to establish itself as a health partner of choice in low- and middle-income countries and actively support them as they continue to develop.

Supplier management

For its business activities Merck needs raw materials, packaging materials, technical products, components, and services. Our basic expectations for suppliers and service providers include their compliance with fundamental environmental and social standards, derived primarily from the Core Labor Standards of the International Labour Organisation and the UN Global Compact. We have also signed the Code of Conduct of the German Association Materials Management, Purchasing and Logistics e.V. (BME), which is intended to combat corruption, violations of antitrust law, and child labor, among other issues.

In 2013, we instituted the Merck Responsible Sourcing Principles, which codify the requirements that we expect our suppliers to meet with regard to environmental, social and compliance standards. We have integrated these principles into our general terms and conditions and, depending on the potential risk, verify compliance with the Responsible Sourcing Principles by subjecting our suppliers to sustainability audits.