Build trust with society

We aim to increase access to our medicines for underserved populations around the world, and follow high standards of ethical behavior wherever we operate. In 2022, we pledged investment for research into new medicines for neglected tropical diseases while advancing partnerships to enhance cardiovascular and cancer care for patients across the world.

Access to medicines

Despite recent medical advances, billions of people around the world still lack access to the medicines and healthcare services they need.

Many of the most acute issues are in low- and middle-income countries (LMICs), which face the dual burden of infectious and non-communicable diseases (NCDs), as well as fragile and under-resourced health systems. But the COVID-19 pandemic also exposed deep health inequities in higher-income countries, where barriers to access are often linked to structural health system issues as well as demographic, social and economic challenges.

At Novartis, we not only discover and develop new medicines, but also aim to make them available to as many people as possible. We have been committed to increasing access to medicines for decades. Over the years, we have moved from a donations-based approach to one that employs a combination of access models for more sustainable social impact. In 2022, our access programs and initiatives reached 54.6 million patients worldwide.

Our targets

To reinforce our commitment to access, we have set key targets covering both our strategic innovative therapies and our global health priorities (see "Novartis global health priorities").

In 2022, we achieved a 26% increase in patients reached with our strategic innovative therapies in LMICs compared with the previous year, representing an increase of 119% since 2019. Patients reached through our global health programs declined by 5% from the prior year, driven by increased availability of generic alternatives due to the easing of COVID-19-related supply disruptions in the wider industry. However, we remain on track to meet our target as the latest figure represents an increase of 107% from 2019.

Novartis Access Principles

We systematically integrate access strategies into how we research, develop and deliver our new medicines globally.

Our approach

To achieve our targets, we work to improve access for patients across the lifecycle of our medicines. We are guided by the Novartis Access Principles, which commit us to systematically integrate access strategies in how we research, develop and deliver our new medicines.

These strategies include innovative approaches to affordability, such as sustainable business models and value-based pricing, as well as efforts to adapt medicines for different patient groups or for diverse environments. While affordability and availability remain key issues, the ability of health systems to effectively use innovative medicines is another critical barrier to access.

In 2022, we pledged additional funding for research into new medicines for neglected tropical diseases. We became the first pharmaceutical company to contribute an innovative medicine to the ATOM Coalition to treat chronic myeloid leukemia (see "Research and development"). We also expanded our 20-year collaboration with the Max Foundation to drive access to our innovative breast cancer treatment, in addition to chronic myeloid leukemia, and we launched key partnerships with health systems in both high-income countries and LMICs.

Novartis global health priorities

Our work on global health is aligned with our overall efforts to expand access to our medicines. We follow an integrated approach for the elimination or control of four diseases where there has been market failure and little investment in research and development:

Sickle cell disease (SCD)

Every day, an estimated 1 000 children are born in Africa with SCD. Of those, more than half die before their fifth birthday due to preventable complications from the illness. The Novartis Africa Sickle Cell Disease program is a holistic approach to diagnose, treat and manage the disease in sub-Saharan Africa (SSA). We are engaging with eight countries in SSA. This includes full partnership agreements with three countries, with more planned over the next several years. See "Integrated access in action: sickle cell disease (SCD) in Africa" for details of our integrated approach to tackling SCD.

Malaria

According to the WHO, there were an estimated 619 000 malaria deaths globally in 2021, despite it being a preventable and treatable disease. Novartis has been involved in the fight against malaria for decades. Since 1999, we have delivered more than one billion treatments of artemisinin-based combination therapy (ACT) to endemic countries, of which over 90% were supplied on a zero-profit basis. We are developing a new optimized dose of ACT for use in infants of less than five kilograms. In 2022, we announced our decision to proceed to Phase III clinical trials in 2023 for our lead malaria pipeline program (see "Our approach to clinical trials").

Chagas disease

Chagas disease causes around 12 000 deaths a year. The disease is endemic in 21 countries, mostly in Latin America. Fewer than 1% of the six million people infected receive proper antiparasitic treatment. Starting as a parasitic disease, Chagas disease can lead to chronic heart disorders in up to 30% of patients. We are conducting a Phase IV study in patients with the cardiac form of Chagas disease in collaboration with the Brazilian Clinical Research Institute, and working to strengthen health care systems in Brazil, Mexico, and Bolivia. Novartis is also a member of the Global Chagas Disease Coalition.

Leprosy

Currently, an estimated 2-3 million people live with leprosy. Over the past 30 years, great strides have been made in treating the disease through multidrug therapy (MDT). Since 2000, Novartis donations of MDT packs have treated over 7.5 million people. In 2020, we renewed our pledge to continue donations for another five years. We are also working with the WHO on a process to reliably replenish the stocks of medicines used to treat leprosy.

Research and development

We assess our R&D work against the needs of underserved populations and integrate access considerations and evidence needs for LMICs early into the development process. We begin anticipating potential access barriers and enablers for our investigational medicines at the end of Phase II development. To further improve access, we do not file or enforce patents in low-income countries.

In 2022, we pledged to invest USD 250 million for research into new medicines for malaria and neglected tropical diseases such as Chagas disease and leishmaniasis. See "Bringing our medicines to patients" for more information on our R&D pipeline.

Beyond our investigational therapies, we also adapt existing medicines for different patient groups or for diverse environments. In 2022, we launched a pediatric friendly formulation of hydroxyurea, a treatment for sickle cell disease, in Ghana, with plans to expand to Kenya, Tanzania and Uganda.

Affordability and availability

We use a combination of approaches to make our medicines affordable for patients across the income pyramid.

In high-income and upper-middle income countries, we seek to price our medicines based on the value they deliver to patients, health systems and society. We believe this approach incentivizes health systems to focus on interventions that deliver the most effective, efficient and sustainable outcomes. For more information on our position on value-based pricing, please see our corporate website.

We expanded our 20-year collaboration with the Max Foundation to include donations of our Kisqali and Femara medicines for breast cancer

In LMICs, we implement tiered pricing for launches of our strategic innovative therapies, taking income levels, local affordability barriers and economic realities into consideration. This approach supports governments in responding to unmet medical needs in a way that is sustainable for our business. All our medicine launches in 2022 included a tiered pricing strategy for LMICs.

Additionally, we have support programs to help patients facing financial hardship or other barriers to access, as well as to support education on disease awareness and adherence to medication. These include Novartis Patient Assistance in the US and Novartis Oncology Access for patients across Asia and the Middle East. Overall, we have around 800 active patient support programs in 80 countries.

To drive access in SSA, we launched a dedicated unit in 2019 to focus on reaching more patients in the region across several therapeutic areas through sustainable business models. We deliver our portfolio of medicines across the income pyramid in SSA and have established an ecosystem of local partners to drive impact and reach more patients across income levels.

Our Novartis Access program, an innovative business model to increase access to on- and off-patent medicines for noncommunicable diseases (NCDs) in countries across Africa, Latin America and Asia, evolved in 2022. The aim of this was to address the complexity of health system barriers that, along with a lack of access to high-quality and affordable medicines, contribute to poor health outcomes. To further drive impact and integrate the approach into our core business, we increased the flexibility of the product offering, broadened distribution to additional channels, and took steps to address health system needs that may inhibit access to these medicines.

At the same time, we continued to expand our emerging market brands (EMB) program, adding 29 new EMBs including for Leqvio, Piqray and Kesimpta. We also continue to narrow or eliminate the time lag between launches in Europe and in other countries. For instance, during 2022 we launched an EMB of our lung cancer treatment Tabrecta in Malaysia two months before the first EU launch in Germany.

Through our donation programs, we help broaden access to patients in LMICs with serious or life-threatening illnesses and those affected by natural disasters and extreme poverty. In 2022, we expanded our 20-year collaboration with the Max Foundation to include donations of our Kisqali and Femara medicines for breast cancer – a leading cause of cancer-related deaths among women in LMICs. The expanded program, known as CancerPathtoCare™, will also continue to support patients with chronic myeloid leukemia and other rare cancers through donations of our Glivec, Tasigna and Scemblix medicines.

For over 30 years, Novartis has been working with partners around the world to eliminate leprosy. Since 2000, through the WHO, Novartis has donated more than 70 million blister packs of multidrug therapy (MDT) valued at approximately USD 124 million, helping to treat more than 7.5 million leprosy patients worldwide. Our agreement with the WHO also covers donations of triclabendazole for the treatment of fascioliasis, a disease caused by parasites known as liver fluke. Novartis has been donating the medicine to the WHO since 2005.

Health system strengthening

Barriers to access are complex: while affordability and availability remain key issues, the ability of health systems to effectively use innovative medicines is another barrier. We work closely with governments and civil society to strengthen health systems and lower barriers to healthcare delivery.

We follow a systematic, enterprise-wide approach. Health system strengthening (HSS) is being integrated throughout our core business planning processes, and all Novartis launches have a global HSS strategy for local adaptation.

Current projects include reducing delays in breast cancer diagnosis due to COVID-19 backlogs through clinic optimization in Portugal and helping to establish heart failure clinics in 14 LMICs to reduce the high re-admission rates many patients face following heart failure. Our Avoidable Blindness program executed partnerships across four countries in Sub-Saharan Africa, focusing on strengthening policy, primary care integration and referral networks – all critical elements of equitable access to eye health services.

We supported key partnerships during the year. These included the Collaborative on Strategic Public Private Partnerships for Cardiovascular Health with Harvard University and the World Economic Forum to strengthen the capacity of health systems to detect, treat and ultimately prevent atherosclerotic cardiovascular disease (ASCVD), which accounts for over 85% of all cardiovascular disease deaths. In the US, we expanded our Beacon of Hope program, which funds research at historically Black medical colleges into how to tackle disparities endemic in the US health system (see "Taking action on health equity in the US").

The data table below covers HSS activities in LMICs managed by the Novartis Global Health organization. In 2022, we increased the number of people reached despite fewer points of service provision and standalone awareness events, due primarily to our focus on maximizing the efficiency of these activities. The ongoing impact of the COVID-19 pandemic in some countries also limited the number of community engagements during the year.

Act4Biosimilars

In May, our Sandoz division founded and sponsored a new global initiative called Act4Biosimilars to increase access to biologics. Bringing together patient advocates, healthcare professionals and industry leaders, Act4Biosimilars is aimed at increasing global adoption of biosimilars by at least 30% in more than 30 countries by 2030. Biosimilars tend to cost much less than branded medicines, which makes them more affordable for those on low incomes. Sandoz already systematically considers access when pricing generics and biosimilars, typically entering a market at below the reference price. Sandoz medicines reached approximately 450 million patients worldwide in 2022.

Fighting antimicrobial resistance

The WHO has declared antimicrobial resistance (AMR) – when antibiotics and other antimicrobial medicines become ineffective and infections become increasingly difficult or impossible to treat – a major public health threat. AMR causes nearly 1.3 million deaths a year, as many as HIV and malaria combined, according to the Global Research on Antimicrobial Resistance report published in 2022.

Novartis supports the global scientific consensus that overuse, underuse and misuse of antimicrobial medicines all contribute to the spread of AMR, and that a balanced approach is needed. Our approach to tackling AMR focuses on four areas:

• Prevention responsible manufacturing to prevent antibiotics entering the environment
• Access strengthening access to high-quality, affordable antibiotics
• Responsible use ensuring prescription of the right antibiotic at the right dose for the right duration
• Innovation investing in the development of new, more effective antibiotics through the AMR Action Fund

In 2022, Sandoz announced an additional EUR 50 million investment to support increased manufacturing capacity for finished dosage form penicillin at the Kundl, Austria, manufacturing site. Sandoz also extended its collaboration agreement with Ares Genetics to develop a digital platform for development and life-cycle management of antibiotics until 2025. In addition, Novartis is part of the AMR Action Fund, which plans to invest more than USD 1 billion in the clinical development of new antibiotics.

Sandoz announced an additional EUR 50 million investment to support increased manufacturing capacity for finished dosage form penicillin

Novartis is partnering with the Ecumenical Pharmaceutical Network (EPN) to support faith-based organizations in SSA combat AMR through prevention, education and awareness. See our corporate website for more information about our work on AMR.

Maintaining high ethical standards

Our industry faces ethical questions and decisions every day on issues such as patient care, data use, and access to medicines. To guide us in these decisions, we have a comprehensive Code of Ethics – developed together with our employees and experts in behavioral science – that applies to all employees, as well as a suite of internal policies and controls. We also provide online tools, such as the Ethical Decision Explorer, to help employees navigate ethical dilemmas, in addition to training on ethics to employees at all levels of the company. In 2022, 98% of employees completed training on our Code of Ethics.

In addition, our ethical standards are built into our relations with business partners via our Third Party Code and we have programs in place to combat falsified medicines and monitor potential adverse effects of our medicines (see "Protecting patient health and safety").

We also work through industry codes, including PhRMA’s Code on Interactions with Health Care Professionals and the IFPMA’s Code on Pharmaceutical Marketing Practices, as well through as regional and local industry associations. The UN Convention Against Corruption and the OECD’s Convention on Combating Bribery of Foreign Public Officers inform our policies and programs. We are a signatory to the UN Global Compact and we are working to implement the UN Guiding Principles on Business and Human Rights. You can read more about our approach to ethics, risk and compliance here.

Encouraging employees to speak up

The Novartis SpeakUp Office, our grievance mechanism, enables employees and external parties to raise concerns about potential misconduct while being protected against retaliation.

In 2022, a total of 2 569 complaints of alleged misconduct, resulting in 2 400 cases with 2 871 allegations, were received and handled. Of the total cases, 385 (16%) were classified as central matters (higher-risk cases) warranting further investigation. Lower-risk matters are addressed or investigated locally. The investigated central matter allegations resulted in 116 dismissals or resignations, and in 62 written warnings. Other remedial actions such as training, coaching and implementing new controls were also used when deemed appropriate.

The increase in cases from the prior year was primarily due to matters related to data security as a result of enhanced protective measures and monitoring systems the company put in place. These measures included a campaign on data loss prevention to support regular mandatory trainings on information management, data privacy and data use. The increase in reported cases indicates that our SpeakUp program and related awareness activities are having an impact in encouraging people to raise their concerns.

Measuring our ethical climate

In 2022, we conducted our second global ethics survey to gather data on ethical behavior and the ethical climate across our company. We received more than 33 000 responses. We use insights from the survey to drive conversations at the global and local levels and take action where needed. For example, in 2022 we further clarified our commitment to protect employees who speak up from disciplinary action in a new standalone policy on non-retaliation, which was created in consultation with our human rights and employee relations teams. We intend to continue running the global ethics survey in 2023.