Across the globe, approximately 400 million people lack access to effective and affordable healthcare, especially in low- to middle-income countries. However, according to the World Health Organization (WHO), these regions bear approximately 90% of the world’s disease burden. In cooperation with strong partners, we’re working to tackle this complex challenge by researching innovative solutions, developing new approaches and improving existing programs to help people at the point of care. To achieve this, health solutions must be affordable and accessible. Beyond these efforts, we’re also raising awareness for diseases and teaching people how to manage them. The Access to Medicine Index has recognized the progress we’ve made on improving access to health (A2H). In 2016, we were ranked fourth, moving us two places higher than 2014.
Our strategic approach
We endeavor to improve access to high-quality health solutions for underserved populations and communities in low- to middle-income countries. This goal forms the heart of our A2H approach. Indeed, Stefan Oschmann, Executive Board Chairman and CEO, focused on accelerating access to health in such regions during his presidency of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) from 2014 to the end of 2016.
At the World Economic Forum held in Davos, Switzerland in January 2017, we joined forces with 21 other leading pharmaceutical companies to announce Access Accelerated, a global initiative that seeks to improve both treatment and prevention of non-communicable diseases in low- and middle-income countries.
To improve access to health solutions, we're leveraging the expertise from all our businesses. We’re aware that individual companies and organizations can only do so much to improve access to health, which is why we closely collaborate with a wide range of partners.
Our A2H strategy focuses on the 4 As:
- Availability: We research, develop and refine health solutions that address unmet needs and are tailored to local environments.
- Accessibility: We promote initiatives that strengthen supply chains and develop localized health solutions in order to deliver and reach out efficiently at the point of care.
- Affordability: We seek to provide assistance to those who are unable to pay for the health solutions they need. Further information can be found under Prices of medicines and Community.
- Awareness: We contribute to raising awareness by empowering health workers, communities and patients so that they can make informed decisions.
Our A2H Charter defines our guidelines for the following topics:
- Our approach
- Pharmaceutical product donations and philanthropic activities
- Fake medicines
- R&D for neglected tropical diseases and priority communicable diseases
- Pharmaceutical product pricing
- Intellectual property rights
Effectively managing our A2H programs
Our Access to Health (A2H) unit investigates the factors that make it more difficult for underserved populations to receive healthcare, working with various partners to develop ways to lower these barriers. Our A2H team is backed by a steering committee featuring representatives from our Healthcare and Life Science business sectors as well as representatives from our subsidiaries. In this way, we ensure that our programs support our business strategy, can be implemented locally and have the desired effect.
We are currently developing quantitative and qualitative performance indicators to evaluate the efficacy of our programs. Using these indicators, we will assess our strengths and identify areas where we need to improve.
Beyond these efforts, we are also involved in industry-wide initiatives and are working with other companies to develop new approaches to assessing the efficacy of our A2H activities. For instance, in 2016 we endorsed the Business for Social Responsibility's (BSR) Guiding Principles on Access to Healthcare. As a member of the BSR Healthcare Working Group, we contributed to and led the development of the working paper entitled Advancing Access to Healthcare Metrics, which aims to help pharmaceutical and medical device companies improve their performance measurement and reporting on access to healthcare.
Sharing and protecting intellectual property
A great deal of time and money is required to develop new drugs, without a guarantee of success. It can take 10 to 15 years for an effective health solution to be market-ready. Pharmaceutical companies therefore need a solid, transparent and reliable legal framework to protect their intellectual property rights and enforce their patents, which provide a sufficient period of time to compensate for R&D costs.
Responsible treatment of intellectual property does not pose a barrier to health. It guarantees safety and high quality for patients worldwide. Most medicines that address the highest burden of disease in developing countries are not protected by patents. For example, 95% of the 2013 WHO Essential List of Medicines are off-patent.
We provide 45 medicines that are listed on the WHO Essential Medicines List and/or classified as first-line treatments, such as bisoprolol/amlodipine, metformin (Glucophage®), and praziquantel.
Our approach to intellectual property is set out in our Charter on Access to Health in Developing Countries – Rights to Intellectual Property.
In most developing countries, Merck KGaA, Darmstadt, Germany neither files nor enforces patents. In markets where we do register product patents, we are committed to sharing data with researchers and to improving public access to clinical study data. We provide transparent information on our patents and patent applications via publicly accessible databases. We furthermore approve voluntary licensing agreements of all kinds, including non-exclusive voluntary licenses and legally binding non-assertion covenants or clauses that aim to improve access to health. We also support TRIPS, an international agreement administered by the World Trade Organization (WTO) that addresses trade-related aspects of intellectual property rights, as well TRIPS addenda such as the 2001 Doha Declaration (Special Declaration on the TRIPS Agreement and Public Health). The Doha Declaration extends the deadline for least-developed countries to apply TRIPS provisions on pharmaceutical patents until at least 2033 as per a decision taken by the WTO’s council on November 6, 2015. We were in favor of extending this deadline until 2033 and therefore supported this move. Moreover, we support the concept of patent pools. However, we believe that these should be structured to improve access to medicines and should therefore prevent anticompetitive effects as well as geographic limitations. We consider joining patent pools when they are relevant to our portfolio and meet our efficacy, quality and safety requirements.
We share our knowledge and intellectual property and accelerate early discovery for infectious diseases. We are one of over 100 members of the WIPO Re:Search open innovation platform, which is sponsored by the World Intellectual Property Foundation (WIPO). In 2015, we initiated our first partnership as part of this platform, collaborating with the University of Buea in Cameroon. Our common goal is to repurpose compounds from our library to develop a treatment for onchocerciasis, a disease also known as river blindness. In early 2016, the collaboration received the Pathfinder Award, a grant from the UK-based Wellcome Trust to fund research on this condition.
Our transparent approach to intellectual property was also recognized in the 2016 Access to Medicine Index.
Partnerships and dialogue are key instruments to improving access to health. Our partners include multilateral organizations, government agencies, and NGOs, as well as academic institutions, health industry associations, companies, and experts from the private sector.
Through our Access Dialogues, we have created a platform that allows public- and private-sector stakeholders to exchange information and share best practices. This platform provides a way for participants to collaborate on improving access to health. These dialogues are part of our A2H efforts and commitments around awareness and aim to help stakeholders make well-informed health decisions.
In this vein, we hosted the Innovative Intellectual Property and Access Dialogue in 2015. At this event, we joined forces with leading experts on intellectual property and global health to discuss challenges and potential developments for our intellectual property strategy.
In addition to this gathering, dialogues on challenges in the local supply chain were held in 2015 and 2016 in conjunction with the Accessibility Platform, a multi-stakeholder initiative seeking to ensure that medicines are delivered safely, quickly and efficiently. Further information on the Accessibility Platform can be found under Supply chain.
High ranking in the Access to Medicine Index
Every two years, the Dutch Access to Medicine Foundation assesses the performance and achievements of pharmaceutical companies in terms of their efforts to improve access to medicine in developing countries. The foundation then ranks these companies in their Access to Medicine Index. In 2016, we came in fourth place. The foundation recognized us in particular for aligning our strategy and objectives more closely with the UN Sustainable Development Goals. The following initiatives were singled out as best practices:
- Our transparent approach to intellectual property and sharing of intellectual property through research partnerships.
- Our leading role in raising health awareness, such as our thyroid disorder campaigns in Indonesia and the Philippines.
- The many years we've devoted to detecting counterfeit medicines using the GPHF Minilab®.
- The expansion of our Su-Swastha program in rural India, aimed at supplying high-quality health products at affordable prices and establishing the required infrastructure.
- Our support for the network of vaccine manufacturers in developing countries.
- Our Virtual Plant Team platform, which we're using to ensure globally harmonized quality standards in local production facilities.
- Our continuous and holistic efforts in the fight against schistosomiasis, including our Praziquantel Donation Program in partnership with WHO.
Discourse to improve healthcare
Our Chairman of the Executive Board and CEO, Stefan Oschmann, took part in various events in the 2015-2016 period. For instance, at an event hosted in September 2015 to mark the 70th General Assembly of the United Nations, he gave a speech on the role of private industry in global healthcare. Oschmann also spoke on this topic in May 2015 at an event held on the occasion of the 68th World Health Assembly (WHA) of WHO. Moreover, in March 2015 he attended the Independent Expert Group (IEG) on Emergency Preparedness as an industry representative. This gathering was convened by Bill Gates at the request of Angela Merkel, Chancellor of Germany and G7 President.
Discussions at a global level
In the 2015-2016 period, we also participated numerous other events, including the following:
- Building the Path to Universal Health Coverage: Innovative Financing in Access to Medicines, a round table hosted in September 2015 by UNITAID, Norwegian Church Aid and the Medicines Patent Pool (MPP) in Oslo, Norway.
- Munich Security Conference on global security and foreign policy, held in February 2016: forum on current crises and future challenges to international health security.
- Geneva Health Forum (GHF) in April 2016: Event sponsor and organizer of the round table on “Empowerment: Providing tools to make informed health decisions for chronic diseases aligned with the WHO 2030 Health Workforce Strategy”.
- Supply Chain Conference hosted by the German Association for Supply Chain Management, Procurement and Logistics (BME) in February 2016; the topic was: “Accessibility Platform: Uniting Stakeholders for Optimal Global Health Impact”.
- Event on the occasion of the 69th WHO World Health Assembly in May 2016; the topic was “Strengthening local supply chains through multi-stakeholder initiatives to eliminate barriers to access”.
Activities at the local level
In 2015 and 2016, we also engaged stakeholders at a local level. Below are several examples:
- Continuation of our three-year Indonesia Free Anemia campaign: Raising awareness for the causes and treatment of anemia through social media.
- Together against malnutrition: We are supporting the Beyond Zero initiative of the Kenyan government. Our aim is to improve healthcare for mothers and their children.
- Various activities in China: Raising awareness for thyroid disorders through education programs, continuing education for physicians, and research projects. Collaboration with the National Health & Family Planning Commission as well as medical institutions such as the Chinese Medical Association.