Bayer Pharmaceutical Division: Patient Access Charter

BAYER’S VISION AND PURPOSE

Guided by our purpose “Science for a better life”, Bayer delivers breakthrough innovations in health care and agriculture. We contribute to a world in which diseases are not only treated but effectively prevented or cured, in which people can take better care of their own health needs, and in which enough products are produced while respecting our planet’s natural resources. That's because at Bayer, we believe that growth and sustainability should go hand in hand. In short, we are working to make our vision “Health for all, hunger for none” a reality.

 

Sustainability is one of the Bayer’s corporate strategic pillars and an integral part of our divisional business strategies, operations and compensation system. We make a positive contribution to society and the environment. Our ambitious targets for 2030, are fully in line with the United Nations’ Sustainable Development Goals and the climate targets of the Paris Agreement.

 

Our product portfolio, global market position, and commitment to innovation enable us to continue to make a significant positive contribution in solving some of the major challenges of our time. We are aware of the responsibility this carries and strive to proactively deliver on it. We also recognize that our impact is measured not only by what we have to offer but also by how we engage with society and communities around the world.

 

That is why we continuously aim to further elevate our efforts in transparency and in strengthening public trust in science. Underpinning our conduct are our Bayer Societal Engagement (BASE) Principles, which guide us and form the basis for our activities.

 

We have created a strong governance framework for our sustainability goals: Bayer’s CEO Werner Baumann is also the Chief Sustainability Officer. Since 2021, we have been including measurable sustainability targets in the long-term compensation of our management and Board of Management. Specifically, 20% of their long-term incentives are linked to success in meeting our access and sustainability goals.

 

Additionally, an independent Sustainability Council with nine internationally recognized experts advises our Board of Management and other functions within Bayer in all sustainability matters. It was founded in May 2020.

ACCESS TO MEDICINE STRATEGY

Living up against our vision “health for all”, requires having clear patient access goals. Aiming to provide access to as many patients as possible, we have established ambitious and auditable targets aligned to the UN’s SDGs:

 

// Enabling 100 million women in LMIC to gain access to modern contraception by 2030.
By doing so, we want to improve women’s health, rights and economic status as a step towards increasing Gender Equality (SDG #5).

 

// Broaden access to our pharmaceutical products in LMIC..
Enabling worldwide patient access to our medicines is one of our key goals at Bayer (SDG #3). With this in mind, we have changed the way we price our pharmaceutical products internationally and implement programs that reduce the out-of-pocket burden at an individual level.

 

These targets are designed to kick off a broader patient access agenda along the entire value chain of the company.

 

Our Access-to Medicine strategy is built on four cornerstones:

  • Empowering women, globally: Access to quality healthcare and gender equality are key indicators for social and economic prosperity. For over 50 years, Bayer has been supporting education programs and rights-based family planning in more than 130 countries, particularly with access to modern contraception. As a global market leader in women’s health,  Bayer is stepping up with the goal to help provide 100 million women in low- and middle-income countries with affordable modern contraceptives by 2030.
  • Inclusive and sustainable growth:  We are transforming our business by introducing flexible, tailored approaches to reduce the burden of cost on patients by working to expand reimbursed access through our Equitable Pricing Strategy. Tailored Patient Affordability Programs (PAPs) help patients overcome financial obstacles to access the treatments they need. We believe in inclusive growth approaches from which many patients worldwide will benefit.
  • Health system strengthening and capacity building:  Improving access to healthcare requires more than just making products available. In close collaboration with local and global partners, Bayer supports programs which are in line with our access goal, without pursuing commercial intentions. By bringing our knowledge, capabilities, resources, and networks in line with local needs, we can make a difference in achieving the United Nations SDGs (see text box on partnerships).
  • Product development with a structured access planning approach: Access Planning is an integral part of the product development and commercialization process. It is critical that development programs consider patient access early on, always with the aim for rapid and sustainable access to innovative medicine globally. Bayer has developed a new structured access planning approach, which is designed to help find the best possible strategies for all pipeline products, particularly for low- and middle-income countries with a high burden of disease.

While patient access has no geographical limitations in principle, we need to ensure that we don’t miss patients in low-and-middle-income countries (LMICs), as well as underprivileged populations in high-income countries. From a product scope perspective, the beforementioned cornerstones apply to Bayer’s full portfolio. As a research- based company, Bayer’s focus will be on our innovative products to be made available to all patients benefitting from them.

OUR ACCESS COMMITMENTS

The following commitments on patient access are there to help activating our access-to-medicine strategy.  

  1. Bayer aims to prepare a holistic patient access plan for all pipeline assets no later than in phase II. The patient access plan will consider the global health perspective, assess the burden of disease in LMICs and identify local access strategies.
  2. Bayer is committed to making our developed drug products available in all countries where we conduct clinical studies.
  3. Bayer believes clinical study participants, who have experienced a clinical benefit, should be granted continued and cost-free access, to bridge the period until the drug is available on the market.[1]
  4. As part of the access planning, the time span of the launch of a new drug globally and the first filing for registration in a low-middle income country should not exceed 12 months.
  5. Bayer does not file for or enforce patents in the low-income countries (LICs) for human pharmaceutical products or vector control products.1,[2] Moreover, Bayer joined the Patent Information Initiative for Medicines (Pat-INFORMED), which provides basic patent information about approved Bayer products and makes them publicly available.
  6. Bayer has implemented multiple commitments promoting transparency beyond regulatory requirements.[3] Related to patient access, Bayer has set up processes for providing factual summaries of clinical trial results in plain language in order to help inform patients about the clinical trials in which they participate. The lay-friendly summaries are understandable for the non-research audience and are published usually within 12 months after the end of the trial, or within 12 months of the termination date of the trial or of the development project. [4] We will continue on this path, striving to advance transparency in the future.
  7. In our engagement for Neglected Tropical Diseases (NTDs) we focus on eliminating African sleeping sickness (HAT) and taeniasis, as well as controlling Chagas disease in Latin America. In this context we remain committed to manufacturing and donating essential medicines as long as needed, in order to achieve the goals highlighted by the WHO roadmap 2030.[5]
  8. We are applying equitable pricing principles to ensure affordability in LMICs. For all newly launched brands, and nine of our legacy global brands, the national income level is considered in the pricing strategy.
  9. By 2030, we are committed to help provide 100 million women in low- and middle-income countries with access to modern contraception. Following the increasing demand for long-acting, reversible contraceptives (LARCs) in LMICs, Bayer is committed to ensure supply chain security for its low cost / high quality product portfolio of implants and hormonal IUDs, provided to the UN and other family planning programs.[6],[7],[8]
  10. In order to support access to medicines beyond product delivery, Bayer engages in partnership programs, which are aimed at capacity building and health system strengthening in LMIC. Such partnerships follow the principals of local governance, impact generation, transparency and sustainability. We report regularly on the progress of our major partnerships. 
 

[2] The foregoing policy will apply as long as a country remains an LIC, according to the World Bank classification, and as long as the country’s government does not enact policies which warrant a change in filing or enforcement strategy.

[5] This is also part of Bayer’s commitments reflected in the Kigali Declaration 2022.

[8] Bayer made the announcement that it would help provide 100 million women in LMICs with modern contraception by 2030 at the Nairobi Summit (nairobisummiticpd.org).

OUR PARTNERSHIPS

To help us realize our goals, we work together with a wide range of private and public organizations to understand their perspective, to define our targets and to make an impact at scale. Here a few examples:

 

FAMILY PLANNING

We provide a broad range of contraceptives at preferential prices to the United States Agency for International Development (USAID), the United Nations Population Fund (UNFPA) and NGOs in the broader network of family planning to help provide women with more family planning options. As a major donor to The Challenge Initiative (TCI), hosted by the Bill and Melinda Gates Institute at Johns Hopkins University, Bayer is supporting best practice approaches, to increase women’s access to family planning resources in deprived urban environments. Additionally, a collaborative pilot with the German Red Cross (GRC) explores how to address sexual rights and reproductive health issues in humanitarian response.

 

NTDs

We have partnered with the World Health Organization (WHO) to eradicate or control neglected tropical diseases such as the African Sleeping Sickness, Chagas disease or Taeniasis. In collaboration with the Drugs for Neglected diseases initiative (DNDi), we also have a new component in phase II for the treatment of river blindness.

 

NCDs

With our implementing partner GIZ/IS (German Agency for International Cooperation) we have launched the Ghana Heart initiative, aiming to increase the effectiveness of cardiovascular treatment in Ghana. This is done in close collaboration with the leading teaching hospitals in Accra and Kumasi, the Ghana Health Service, the Ghana Ministry of Health, the Ghanaian cardiology association, and multiple other local stakeholders.

TRACKING THE PROGRESS

Bayer aims to provide transparent and in-depth insights into both its sustainability and access strategy, as well as its sustainability performance. The annual Bayer Sustainability Report supplements the nonfinancial statement pursuant to the CSR Directive Implementation Act (CSR-RUG), which is published in the combined management report of the Bayer Annual Report.

 

Additional key targets, goals, KPIs and achievements related to progress can be found in the following table:

Access Activity

Goals

KPI

Achievements in 2021

SDGs

Provide modern contraceptives through public and private channels in low- and middle-income countries (LMICs) with Bayer presence. Additionally, provide modern contraceptives at low cost to UNFPA and USAID, as well as other NGOs, also for LMICs. This includes our continued partnerships with, for example, The Challenge Initiative (TCI) and our cooperation program on family planning with UNFPA in Egypt.

Read more

Help provide 100 million women in low- and middle-income countries with modern contraception by 2030, in line with the UN Sustainable Development Goals.

 

# of women reached with modern contraceptive.

 

 

TCI:

# of cities engaged, population footprint.

 

Contraceptive uptake: annual family planning client volume, # of additional users of modern contraceptives since July 2020.

 

UNFPA Egypt: # of women reached with modern contraceptive.

 

2021 status: 41 million women.

27 million in Europe/Middle East/Africa

7 million in Latin America

7 million in Asia/Pacific

 

 

 

TCI:

111 cities with an overall population footprint of 123 million.

 

Contraceptive uptake: 2.83 million family planning clients per year, of which about 820,000 are additional users.

 

UNFPA Egypt: 35,000 women reached with modern contraceptives.

Bayer and other pharmaceutical companies founded in 2017 “Access Accelerated. Moving Noncommunicable diseases (NCDs) Care Forward” an initiative aimed at improving access, prevention, and care for patients with NCDs in LMICs.

 

Cardio-Vascular: The Ghana Heart Initiative (GHI) aims to improve the prevention, diagnosis and management of cardiovascular diseases (CVDs).

 

Oncology: Initiate health care systems strengthening projects in low- and middle-income countries.

Read more

Sustainably improve local prevention, management, and treatment standards of cardiovascular and other non-communicable diseases.

GHI:

# of health professionals trained

 

# of health facilities reached/trained

 

 

 

 

Oncology:

# of patient supported

GHI:

>1800 health professionals trained

 

>180 health facilities improved (training/equipment)

 

Oncology: Liver Cancer Program with MOH Egypt started in 2021 –

72 screening centers set up; 119 patients received access to treatment so far

Make a difference in the lives of patients suffering from Neglected Tropical Diseases (NTDs). Manufacture and donate essential medicines as long as we need to achieve health for all.

Read more

Sustainable elimination of some of the most devastating Neglected Tropical Diseases (NTDs) as public health problems in some of the most underserved regions of the world by 2030.

Output: products distributed by WHO to countries.

 

Impact: number of patients treated.

The reports from WHO for 2021 will be available in Q2/2022 due to the data collection and verification process at WHO.

Contribute to the World Federation of Hemophilia (WFH) Humanitarian Aid Program, supporting people with hemophilia in low to middle income countries across the globe to access the care they need.

Read more

Reaching as many as 5,000 people with hemophilia A per year across all types of treatment: on demand, prophylaxis, and surgery.

# of patients treated

8,594 patients treated in 2021.

Facilitate access to everyday health care for 100 million people in underserved regions or social strata.

Read more

By 2030, expand access to everyday health for 100 million people in underserved communities around the world.

# of people reached

2021: 46 million (+ 13 million in India).

Support female entrepreneurs with groundbreaking ideas,  through the Women Empowerment Award to

recognize and celebrate their role as game changers driving sustainability and social impact through entrepreneurial innovation.

Read more

Empower women as key change makers and help female entrepreneurs generate social impact in Sub-Saharan Africa.

# of applications

400 applications from across Sub-Saharan Africa. .

As a signatory to the United Nations Women’s Empowerment Principles, we pursue an inclusive approach to ensure that gender parity and equality principles are integrated into our talent management and development processes.

Read more

Increase the

proportion of women in top management to 33% by 2025, and 50% by 2030.

Proportion of

women in top management, the highest management level in the Bayer Group below the Board of Management.

Proportion of

women in top management by the end of 2021: 27% women (2020: 23%) and 73% men (2020: 77%).

Mitigate climate change and limiting global warming to 1.5 degrees Celsius in line with the Paris Agreement. Ensure a net zero future by 2050 for the pharmaceutical business.

Read more

Make our own sites climate-neutral in our Group targets to be met by 2030.

% reduction in greenhouse gas (GHG) emissions

Compared to 2020, we succeeded in reducing our own Scope 1 and Scope 2 emissions by 11.5%, or around 410,000 metric tons.