Lead Author: Michael Seiders
Organization: Bristol-Myers Squibb Company
A Holistic View of Barriers to Patient Access to Medicines:
Sustainable Development Goal (SDG) 3.8 calls upon the world to “achieve universal health coverage (UHC), and provide access to safe and effective medicines and vaccines for all.” Although great progress has been made regarding access to medicines over the last few decades, the World Health Organization (WHO) estimates that over 2 billion people still do not have access to even the most essential medicines. Despite the ongoing development of transformational new medicines and expanding availability of generic drugs, for many, even basic healthcare services are beyond their reach. Weak systems and incoherent policies exacerbate inequalities rather than resolving them, making poverty both a primary determinant and ongoing consequence of poor access to healthcare.
Access to medicines is a highly complex issue. It is often argued that the price of medicines and the protection of intellectual property (IP) rights are barriers to access to medicines. However, the reality is that the most immediate systemic access obstacles for billions of people are more basic and localized such as a lack of health care funding and infrastructure/capacity; limited numbers of local health care practitioners ; long regulatory delays ; poor public health education; local government imposed taxes and trade barriers ; unstable political environments and a lack of electricity and available clean water.
Nearly three-fourths of the world’s poor live in countries now classified as middle-income countries (MICs) with the access issue compounded by large income disparities across the population. Many governments are considering options for UHC; however, even in growing economies, governments face uncertainties in the ability to finance sustainable expanded coverage. Furthermore, many large multilateral and bilateral funders are increasingly focusing limited resources to the lowest income countries, creating a dynamic in which some lower income people living in MICs may have less access to medicines than some people in lower-income countries.
Due to the lack of viable insurance systems in many low-and-middle-income countries (LMICs), total out-of-pocket spending can represent 90% of private health spending in these countries, as compared with only 15% in high-income countries. As a result, 150 million people each year in LMICs suffer financial hardship. The WHO opines that UHC will be very difficult to achieve if out-of-pocket expenditures as a percentage of total health spending is 30% or above.
Industry Efforts to Respond to Global Access Challenges:
In response to access challenges, pharmaceutical companies, both individually and collectively, and NGOs such as PEPFAR , the Global Fund to Fight AIDS and the Gates Foundation have donated product and tens of billions of dollars, all in a collective effort to increase access to medicines and health care across geographies. Such organizations have also established philanthropic programs aimed at addressing fundamental health care infrastructure and capacity issues in developing countries. Some companies, including BMS, are engaged in voluntary licensing of IP to generic manufacturers in another effort to increase access to medicines in developing countries. Yet even with all these mechanisms in place, major gaps in access to medicines remain.
Intellectual Property’s Role in Facilitating Innovation:
Any genuine commitment to improving access to medicines must meet short and long-term objectives - supplying the medicines of today and tomorrow to patients while continuing to enable and encourage an innovative ecosystem necessary to foster the development of new medicines. IP is a critical and proven facilitator of innovation and an enabler of both short and longer-term access to medicines. For a product to be accessible, it must first be available.
The vast majority of important medicines owe their existence to the R&D activities of the biopharmaceutical industry. In fact, 91% of drugs are developed by the private sector with no direct government role. Industry has developed more than 550 medicines in the last 15 years for some of the world’s most critical and emerging health needs, including antibiotics, vaccines, and recent transformational medicines for cancer, cardiovascular disease, viral infections and diabetes. During the past 5 years, 182 novel drugs to treat major public health concerns have been approved by the US Food and Drug Administration (FDA). (SDG 9)
That spirit of innovation continues to this day with 45 FDA approved new medicines in 2015 alone. Industry continues to be instrumental in exploratory research, as well as translating research into patient-ready life-saving and life-enhancing medicines for those in need. The development and discovery of new medicines, including those which may address or be modified to address the unmet medical needs of local populations, is a byproduct of strong IP protection. IP protection is by its nature time-limited, but the benefits of access to the patients are not; they are much longer-term. Appendix I contains examples of innovative biopharmaceutical success stories (SDGs 1, 3 and 9) and the transformational impact on the lives of millions patients.
Strong Intellectual Property Protection Benefits Developing Countries:
The mutually reinforcing nature of robust IP law and the existence of the generic drug industry is often overlooked. The generic business model relies for its cost-savings on an R&D cycle funded and conducted by innovators, without which there would be no medicines to copy. Stronger IP regimes actually promote the dissemination of new medicines. Thus, the IP-based incentives that drive the innovation cycle are just as critical to the future of generic medicines as they are to innovative medicines. (SDGs 1, 3 and 9)
• Strong IP protection results in faster launch and faster access to new medicines in developing countries and results in the introduction of many medicines that would not otherwise be available in those countries at all (in either brand or generic form).
• Innovator launch of a medicine in a developing country, driven by IP, “materially improves access to that medicine [by a factor of 7, on average] compared with instances or time periods when a generic provider” launches.
• Patient compliance and health outcomes improve when IP acts as an incentive for innovators to develop a local market, as compared with generic launches.
• Recent studies have shown that developing countries that adopt strategies that impair IPRs tend to pay more for drugs than those that respect IPRs, undermining the access objectives. In a review of HIV/AIDS antiretroviral medicine purchases reported to the WHO and the Global Fund, researchers determined that countries that used compulsory licensing to manufacture or import generic antiretroviral medicines paid more than those who negotiated for the best branded or generic deal. The typical premium paid by countries with a compulsory license program was 83 percent.
Considerable Barriers Limit Access Even When No Intellectual Property Applies:
Several notable examples:
• 95% of essential medicines, as defined by the WHO, are off patent, but still one third of the world’s population does not have reliable access to them and, in parts of Africa and Asia, that is true for half the population.
• Despite all the current mechanisms in place to facilitate no-or-low costs access to non-patented HIV medicines, only 15.8 million of the estimated 36.9 million people living with HIV globally (about 43%) were accessing treatment in 2014.
• Despite the wide availability of no-or-very low cost non-patented HIV medicines, in at least 14 African countries, 80% or more of people who were estimated to be eligible for treatment under the WHO guidelines were not receiving antiretroviral therapy as of 2013.
• First-line treatments for killer diseases like malaria and TB are available as generic products at very low cost, and yet many people are denied access to them.
• Despite the availability of free medicines for Onchocerciasis or River Blindness, since 1987, the US Center for Disease Control currently estimates around 37 million cases still exist; 99% of which are in Africa,
• According to the WHO, an estimated 649 million people, or about 50% of the population in India do not have regular access to the hundreds of non-patented drugs on India’s EML. Despite its large domestic generic drug industry, India’s investment in health as a percentage of its GDP has averaged around 4% for the last decade. India’s current level of 4.5% is one of the lowest figures in the world ranking it below such countries as Haiti and Ethiopia.
BMS Efforts to Address the Unmet Medical Needs of Patients:
Recognizing the differences in access challenges among countries, BMS is pursuing solutions adapted to regional or local country situations. Creating and ensuring strong and functional health systems is absolutely essential to improving access to medicines. From delivering innovative patient solutions, to strengthening healthcare infrastructure and increasing disease awareness, to improving affordability and developing patient assistance programs, we are engaged with a wide range of stakeholders to understand local challenges and work together in developing long-term and sustainable patient access solutions. Above all, access to medicine is a shared responsibility, across many stakeholders and BMS is committed to seeking collaborative solutions with governments, NGOs and other relevant stakeholders in achieving better health outcomes, The following examples highlight current BMS initiatives that could be scaled to achieve greater impact on health outcomes, improve policy coherence and public health and advance human rights.
The Bristol-Myers Squibb Foundation:
The mission of the Bristol-Myers Squibb Foundation is to promote health equity and improve the health outcomes of populations disproportionately affected by serious diseases and conditions by strengthening community-based health care worker capacity, integrating medical care and community-based supportive services, and mobilizing communities in the fight against disease. The Foundation engages partners to develop, execute, evaluate and promote innovative programs to help patients with HIV and comorbid diseases such as cervical and breast cancers, tuberculosis and mental health disorders in sub-Saharan Africa; hepatitis B and C in China and India and type 2 diabetes in China and India. (SDGs 1 and 3). The Foundation also is working to build cancer nursing capacity in Central and Eastern Europe. BMS Foundation Programs are outlined in Appendix B with specific patient, public policy and sustainability metrics listed in Appendix C.
BMS Non-Foundation Activities: HIV/AIDS, Hepatitis C and Cancer:
BMS is very active in in advancing access to medicines for patients in need from a corporate standpoint as well. Over the last 15 years, BMS has engaged in several groundbreaking initiatives in HIV, HCV and Cancer.
Our HIV Global Access Program, established in 2000, has helped increase access to our antiretroviral (ARV) medicines for HIV many patients around the world. The program is built around three pillars: Pricing Policy; Patent Policy and Partnerships.
In HCV, recognizing the disproportionate burden of disease in developing nations, BMS has executed a strategy aimed at increasing access to our HCV medicine, Daklinza (daclatasvir), in LMIC. Building on our experiences in HIV, we have implemented a multipronged approach with: Tiered Pricing; Voluntary Licensing with the Medicines Patent Pool (MPP) and Collaborations. Dr. Margaret Chan, WHO Director-General recently commented on the daclatasvir/MPP agreement: “This agreement could change the lives of millions of people with Hepatitis C. It’s a vital step towards ensuring essential treatments are available to all who need them, both rich and poor.”
In Cancer, we are working with PAHO in the Americas to improve the quality and effectiveness of national breast and cervical cancer programs and the quality and completeness of national cancer registries in the region.
BMS specific company HIV, Hepatitis C and Cancer programs are explained in greater detail in Appendix D.
Focusing on the unmet medical needs of patients, BMS has embraced a holistic approach, implementing innovative programs designed to enable access to medicines by overcoming structural barriers and policy incoherence in collaboration with governments and multilateral organizations. Similarly in our access efforts, we are improving affordability and accessibility of medicines for countless patients, strengthening local economies and training thousands of health care workers on the ground.
Maintaining and expanding access to quality health care is a shared responsibility that requires bringing together complementary capabilities and stakeholders to drive system-wide changes. Continued innovation is needed to address current and future unmet medical and healthcare needs. As a founding signatory to the Business for Social Responsibility Guiding Principles on Access to Healthcare , BMS embraces the important role we play and accepts its responsibility in striving to address and solve global health challenges.
The United Nations High Level Panel should consider access solutions based on accurate assessments, solicit input of all relevant stakeholders and address access barriers in a holistic way. Mechanisms proposing to increase limitations or exceptions to IP protection will erode incentives to innovate and dilute desired policy goals by undermining the very foundations that underpin patient access to medicines. Removing IP protections will do nothing to address many of the access barriers cited in this submission. It is not a strategy that will enable greater access to medicines for more people; rather, we believe it will ultimately have the opposite effect for patients.
Bristol-Myers Squibb appreciates this opportunity to comment.
Appendix, Bibliography, References
Appendix A: Biopharmaceutical Innovation Success Stories:
Atrial Fibrillation (AF): AF is the most common cardiac arrhythmia (irregular heart beat). The majority of AF patients have non-valvular atrial fibrillation (NVAF) and the risk of stroke is five times higher in this patient population. For decades, the standard of care for NVAF required routine blood testing and frequent dose adjustments. While a risk of bleeding is associated with all oral anticoagulants, novel oral anticoagulants (NOACs) that now exist offer potential advantages over previous treatments, including fewer drug interactions and fixed doses, without the need for routine blood testing.
Cancer: Thanks to medical innovation, people with cancer are living longer with added societal benefits. Fifteen years ago, the average life expectancy for Chronic Myeloid Leukemia was five years, today it is largely a chronic disease. In the U.S., between 1990 and 2013, the 43 million life-years saved from cancer have generated about $4.7 trillion in added income. In another study, medicines specifically account for 50 percent to 60 percent of increases in survival rates since 1975. Advances in science are leading to innovations in cancer treatments that are fundamentally different than traditional therapy such as radiation and chemotherapy. Immuno-Oncology agents are groundbreaking modalities designed to use the body’s own immune system to fight cancer, and are being studied for their potential to improve quality and length of survival in multiple tumor types. Prior to the availability of IO treatment options, 25% of melanoma patients survived 1 year. This increased to 74% with IO therapy.
Hepatitis C (HCV): As recently as 1989, the virus behind this disease was not well understood, only being referred to as non-A, non-B Hepatitis. Until 2013, the standard of care offered comparatively limited efficacy, had harsh side effects and was inconvenient for patients. With the very recent advent of Direct Acting Antiviral (DAA) therapy, cure rates are now approaching 100 percent even in many difficult to treat patient types.
HIV/AIDS: Patients diagnosed with AIDS in 1990 could expect to live only months, during which time they would be likely to contract a number of other infections. In the 30-plus years since the discovery of the HIV virus, more than 30 medicines have been approved to treat HIV infection. Over time, medicines have improved in tolerability, efficacy and convenience. Today, a patient who receives HIV antiretroviral therapy may expect to have a lifespan approaching that of someone who does not have HIV.
Rheumatoid Arthritis (RA): As late as the 1990s, the most often used agents against this incapacitating disease were gold salts with debilitating side effects, limited efficacy and slow onset of action. Today, thanks to earlier diagnosis and innovative treatments, bone abnormalities in patients with RA are much less frequent. In addition to being able to better manage the symptoms of the disease, newer biologic medicines and disease modifying anti-rheumatic drugs (DMARDs) allow physicians to directly target the disease, slow the progression of joint damage and even possibly put the disease into remission.
Appendix B: Bristol-Myers Squibb Foundation Programs in Developing and Emerging Markets:
• SECURE THE FUTURE: The Bristol-Myers Squibb Foundation’s landmark program continues to provide community-based care and support to people living with HIV/AIDS. The Foundation has committed more than $180 million to more than 250 projects throughout the region since it was launched in 1999. Its Technical Assistance Programme is a unique south-south skills transfer initiative active in South Africa, Swaziland, Lesotho, Ethiopia, Kenya, Tanzania and Zimbabwe to strengthen community-based services and health care worker training for adolescents and the elderly living with HIV and for HIV patients who suffer co-morbidities, including female cancers and tuberculosis.
SECURE THE FUTURE supports the ENGAGE-TB Approach of the World Health Organization’s Global TB Programme by funding pilot programmes in five countries in sub-Saharan Africa to strengthen community-based care for patients with tuberculosis (TB), the leading killer of people living with HIV. BMS SECURE THE FUTURE partners are linked here.
Working with the Baylor International Pediatrics AIDS Initiative at the Baylor College of Medicine and with governments in sub-Saharan Africa, the Foundation helped establish five Children’s Clinical Centers of Excellence in Botswana, Lesotho, Swaziland, Uganda and Tanzania, a network of eight satellite clinics and a Pediatric AIDS Corps of pediatricians and specialists. More than 275,000 children are receiving care through this network with almost 36 percent of the children now in adolescents and teen years.
Now operating as a technical assistance and skills transfer program, STF focuses on harnessing and strengthening community-based resources and building capacity to improve the effectiveness and sustainability of community outreach programs.
The Foundation also is collaborating with prestigious partners such as the World Health Organization, UNAIDS, the President's Emergency Program on AIDS Relief and the Pink Ribbon Red Ribbon initiative of the George W. Bush Institute among others to leverage the legacy and infrastructure of SECURE THE FUTURE in Africa to help HIV patients who are co-infected with tuberculosis or who may be at risk of developing cervical or breast cancers.
• Delivering Hope: Since 2002, Delivering Hope™ initiative has been helping communities and health care workers in China and India effectively raise awareness about the dangers of hepatitis B and hepatitis C, inform health policy and national programs, build the capacity of health care providers and communities to address these diseases, and promote disease prevention in the hardest-hit and greatest at-risk populations.
Delivering Hope has awarded more than US $15 million to 50 projects in Asia since 2002. In China alone, more than 8 million people who are at high risk of hepatitis infection have benefitted from Delivering Hope programs over the past decade. Partners for the program are linked here.
To extend the impact of these projects into the future, in 2013 the Foundation established three Centers of Excellence to more broadly share successful, innovative and evidence-based practices and more comprehensively address viral hepatitis among vulnerable populations in China and India. One Center of Excellence is located at the China Foundation for Hepatitis Prevention and Control (CFHPC). The others are in India at the Liver Foundation of West Bengal (UFWB) and at the Hope Initiative in Uttar Pradesh. These Centers will scale up and replicate evidence-based community interventions developed by previous Foundation-funded projects and also inform public policy in liver and metabolic diseases.
• Together on Diabetes: More than 92 million people in China – about 9% of the population – were living with type 2 diabetes in 2012, the most of any country. That figure is projected to grow to about 130 million, or 12% of the population, by 2030. India, which has 63 million people diagnosed with type 2 diabetes (9%), ranks second only to the U.S. in terms of prevalence. By 2030, India will have more than 101 million people living with type 2 diabetes.
Together on Diabetes is building on the work of the Foundation’s Delivering Hope™ initiative to address hepatitis B and C in Asia. Together on Diabetes has funded nine projects in China and India to reduce diabetes-related health disparities by strengthening community-based health care worker capacity and integrating medical care and community-based supportive services. BMS Partners on Together on Diabetes are linked here.
• Bridging Cancer Care: iEach year, more than 14 million people are diagnosed with cancer and 8 million people worldwide die from cancer. About six in 10 cancer deaths occur in less developed regions and disparities in cancer persist among the poor, racial minorities and vulnerable people. The Bristol-Myers Squibb Foundation is working to change that for people living with lung, skin and cervical cancers.
The Bristol-Myers Squibb Foundation supports innovative, community-based programs that address the needs for cancer care and patient support among disparity populations in the United States, Central and Eastern Europe and sub-Saharan Africa. Over the years, the Foundation and its partners around the world have:
o Increased the skills and capacity of oncology nurses in Central and Eastern Europe (CEE)
o Established Centers of Excellence for nursing practice, smoking cessation and palliative care in the CEE region. BMS Bridging Cancer Care partners are linked here.
o Partnered with the George W. Bush Institute, Susan G. Komen, UNAIDS, USAID/PEPFAR and others in the Pink Ribbon Red Ribbon coalition to address cervical and breast cancers among women living with HIV in Africa.
Appendix C: Data Metrics on Specific Bristol-Myers Squibb Foundation Programs:
Secure The Future:
• Patients: SECURE THE FUTURE has reached over 185,000 disproportionately affected populations and diagnosed over 1,400 patients with targeted diseases;
• Projects: Funded 57 projects, including 16 in 2015, with over 211 separate partnerships;
• Policy: 68% of projects have contributed to overall health equity. 63% of projects have resulted in changes in health policy and 95% of projects have resulted in changing established standards of care;
• Training: Trained over 185,000 healthcare workers and established 5 project that resulted in improved community support structures. 79% of projects offer healthcare worker skills enhancement;
• Sustainability: 91% of all SECURE THE FUTURE projects have been sustained and 45% have been replicated.
• Patients: Delivering Hope has reached nearly 90,000 disproportionately affected populations and diagnosed over 1,600 patients with targeted diseases;
• Projects: Funded 14 projects, including 1 in 2015, with over 339 separate partnerships;
• Policy: 93% of projects have contributed to overall health equity. 57% of projects have resulted in changes in health policy and 89% of projects have resulted in changing established standards of care;
• Training: Trained over 91,000 healthcare workers and established 1 project that resulted in improved community support structures. 86% of projects offer healthcare worker skills enhancement;
• Sustainability: 90% of all Delivering Hope projects have been sustained and 83% have been replicated.
Together on Diabetes:
• Patients: Together on Diabetes has reached nearly 92,000 disproportionately affected populations and diagnosed over 99,000 patients with targeted diseases;
• Projects: Funded 9 projects with over 111 separate partnerships;
• Policy: 100% of projects have contributed to overall health equity. 80% of projects have resulted in changes in health policy and 100% of projects have resulted in changing established standards of care;
• Training: Trained nearly 18,000 healthcare workers and established 9 projects that resulted in improved community support structures. 78% of projects offer healthcare worker skills enhancement;
• Sustainability: 100% of all Together on Diabetes projects have been sustained and 83% have been replicated.
Bridging Cancer Care:
• Patients: Bridging Cancer Care has reached nearly 50,000 disproportionately affected populations and diagnosed 142 patients with targeted diseases through screening;
• Projects: Funded 20 projects, including 1 new project in 2015, with over 161 separate partnerships;
• Policy: 77% of projects have contributed to overall health equity. 25% of projects have resulted in changes in health policy and 83% of projects have resulted in changing established standards of care;
• Training: Trained over 9,400 healthcare workers and established 11 projects that resulted in improved community support structures. 100% of projects offer healthcare worker skills enhancement;
• Sustainability: 100% of all Bridging Cancer Care projects have been sustained and 58% have been replicated.
Appendix D: Specific Information Regarding BMS Programs to Enhance Patient Access in HIV, Hepatitis C and Cancer:
HIV: Established in 2000, the BMS Global HIV Access Program has helped increase access to our antiretroviral (ARV) medicines for HIV patients around the world. The program is built around three pillars:
• Pricing Policy: In sub-Saharan Africa and low-income countries, areas hit the hardest by the AIDS pandemic, Bristol-Myers Squibb maintains a pricing policy that reflects no profit to BMS on our ARVs [Zerit (stavudine), Videx (didanosine), and Reyataz (atazanavir)]. In other middle income countries, the company has instituted tiered pricing that takes into consideration factors including affordability and government commitment to care.
• Patent Policy: BMS maintains a HIV medicines patent policy that reflects our commitment to access through generic manufacturer participation in many developing countries. Since 2001, BMS has entered into over a dozen royalty-free licensing agreements with generic manufacturers to encourage them to manufacture and supply these important medicines to developing countries. At present, there are more than 15 generic formulations of BMS-developed ARVs with WHO Pre-Qualification status.
In 2013, BMS entered into a License and Technology Transfer Agreement with the United Nations-backed and UNITAID funded Medicines Patent Pool (MPP) for atazanavir. This agreement was the first entered into by the MPP for a WHO preferred 2nd-line treatment. The 110-country territory of this agreement covers 88.5% of people living with HIV/AIDS in the developing world. Of significance, BMS has opted not to collect any royalties on the sale of licensed product. The agreement also allows for the creation of fixed-dose combinations by the licensee. The number of patients receiving licensed atazanavir has grown by 900%, and encouragingly, the WHO forecasts substantially increased use of atazanavir in the developing world over the next 5+ years.
• Partnerships: A health threat of the enormity of HIV is not one that can be solved by any single stakeholder or sector of society. As such, the cornerstone of our access approach is to work collaboratively with partners who share in a commitment to the fight against HIV/AIDS. In 2000, BMS was one of the five founding industry members of the Accelerating Access Initiative (AAI). The non-industry partners of the AAI are the WHO, United Nations Population Fund, United Nations Children’s Fund, World Bank, and the UNAIDS Secretariat. Individually and collectively, members of AAI worked to address affordability constraints and increase access to HIV/AIDS care and treatment in developing countries. Through collaborative efforts such as the AAI and others, the number of people with access to treatment in low- and middle-income countries has increased from figures measured in the thousands in 2000 to over 15 million people in 2015. These figures provide evidence to the power of multi-stakeholder collaboration but also highlight the existence other access challenges, beyond affordable medicines.
Hepatitis C: The World Health Organization estimates Hepatitis C to be a disease that globally impacts as many as 185 million patients as well as their families and the communities they live in. Over 80% of patients infected with the Hepatitis C virus live in LMIC. Recognizing the disproportionate burden of disease in developing nations, BMS has executed a strategy aimed at increasing access to our Hepatitis C medicine, Daklinza (daclatasvir), in LMIC. Building on our experiences in HIV, we have implemented a multipronged approach:
• Tiered Pricing: BMS has implemented a tiered pricing approach to Daklinza which takes into consideration a country’s economic development and burden of disease, as well as government commitment to holistically address Hepatitis C. The lowest pricing tier applies to all low-income and least developed countries.
• Medicines Patent Pool / Voluntary Licensing: In addition, our access-enabling strategy includes voluntary licensing of our daclatasvir patents and know-how in 112 countries where nearly two-thirds of all patients living with hepatitis C in LMICs reside. In November 2015, building on the previous success of the collaboration with the Medicines Patent Pool, BMS entered into a voluntary License and Technology Transfer Agreement for daclatasvir with the MPP. This agreement represents the first entry of the MPP into Hepatitis C. The royalty-free agreement also allows for the creation of fixed dose combinations and provides sub-licensees with BMS know-how to facilitate rapid availability of licensed product in the territory. The significance of this collaboration and the resulting agreement was noted by Dr. Margaret Chan, WHO Director-General who said “This agreement could change the lives of millions of people with hepatitis C. It’s a vital step towards ensuring essential treatments are available to all who need them, both rich and poor.” (SDGs 1 and 3).
• Collaborations: BMS believes that a collation approach that brings together multiple stakeholders to the table to discuss and act on the best path forward is needed to enable broad access to HCV treatment. Consistent with this belief, BMS is working with civil society, NGOs and governments on multiple fronts to address barriers to access.
Cancer: The Women’s Cancer Initiative in the Americas works to improve the quality and effectiveness of national breast and cervical cancer programs and the quality and completeness of national cancer registries in the region. The PAHO Foundation with support from the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and its members, with an additional contributions from BMS, and in collaboration with the Pan American Health Organization (PAHO), coordinates the Women’s Cancer Initiative in Latin American and Caribbean (LAC), where breast and cervical cancer are leading causes of preventable and premature death among women.
Citations and References:
i. The 2030 Agenda for Sustainable Development recognizes the importance of “the role of the diverse private sector, ranging from microenterprise to cooperatives to multinational corporations” to achieve the SDGs, and calls for a “revitalized global partnership” that includes the private sector.
ii. Bristol-Myers: Big Spending Has Big Rewards, The Wall street Journal, by Charlie Grant, November 30, 2015.
iv. A 2009 survey of 36 countries found that 15 common generic medicines listed on the WHO Essential Medicines List (EML) are frequently unavailable in either the public or private sectors, with regional availability ranging from 29% in Africa to 54% in the Americas.
v. The American Cancer Society. Examples include: On average, in Africa only one physician exists for every 50,000 patients, while the physician-patient ratio in the United States is closer to 1 in 300. Moreover, 6 of 10 African cancer patients would benefit from radiation therapy in the course of their cancer treatment. But 20 countries in Africa do not have a single radiation treatment facility. And even when such facilities are available, coverage is often woefully inadequate. For example, Ethiopia, a country of some 90 million people, is served by a single radiation treatment center located in the capital city of Addis Ababa.
vi. Bate R, Putze E, Naoshy S, McPherson A, & Mooney L, (2010) “Drug Registration—A Necessary But Not Sufficient Condition for Good Quality Drugs—A Preliminary Analysis of 12 Countries,” Africa Fighting Malaria Working Paper, Washington, DC. China has long registration timelines: up to 3 years for original medicines, 18 months for imported generics, and even longer for vaccines.
viii.India collects more pharmaceutical taxes than it spends on medicines, adding to the current level of policy incoherence. Broad analysis for 2011 indicates total annual Government expenditure on drugs in India around $1.15B in comparison to the $1.22B it receives in taxation of pharmaceuticals. Includes domestic tax (VAT and excise duty) and import taxes; based on broad analysis of 2011 data representative at national level; state level data not investigated. Source: Indian Department of Pharmaceuticals Annual Report 2012; High Level Expert Group (HLEG) Report on Universal Healthcare Coverage for India 2011, Instituted by Planning Commission of India.
x. George J. Schieber et al., “Financing Global Health: Mission Unaccomplished,” Health Affairs 26, no. 4 (July 1, 2007): 921–34, doi:10.1377/hlthaff.26.4.921.
xi. O’Neill K et al. (2015) “Out-of-pocket expenses incurred by patients obtaining free breast cancer care in Haiti”, The Lancet, Volume 385, Special Issue, S48. This study of patients obtaining free breast cancer care in Haiti found that out-of-pocket non-medical costs forced 52% of participants into debt and 20% to sell possessions. Even with free treatment, out-of-pocket expenses accounted for more than 91% of annual earnings at the patients’ income level. This financial burden can represent an overwhelming obstacle to treatment for many patients.
xiii. Van Minh H et al. (2014) “Progress towards achieving universal health coverage in ASEAN”, Global Health Action, [S.l.], 7
xiv. PEPFAR (Presidents Emergency Program For AIDS Relief). http://www.pepfar.gov/
xv. In 2014-15, Partnership for Quality Medicines Donations (PQMD) members donated more than $2 billion to over 150 countries. http://www.pqmd.org/assets/PDFs/updated%20pqmd_annual%20report_2011-12%20updated%200513.pdf
xvi. For a listing of current industry-wide programs, please see the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) website http://partnerships.ifpma.org/partnerships/by-type.
xvii. Sampat B, Lichtenberg F. What are the respective roles of the public and private sectors in pharmaceutical innovation? Health Affairs. 2011;30(2):332‐339.
xviii. US Food and Drug Administration, “Summary of NDA Approvals and Receipts, 1938-present,” http://www.fda.gov/aboutfda/whatwedo/history/productregulation/summaryofndaapprovalsreceipts1938tothepresent/default.htm
xix. Pharmaceutical Research and Manufacturers of America (PhRMA), “Medicines in Development,” http://www.phrma.org/innovation/meds-in-development
xx. US Food and Drug Administration, “Novel drug approvals for 2015,” http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm430302.htm
xxi. Nature Reviews Drug Discovery, “The importance of new companies for drug discovery: origins of a decade of new drugs,” http://www.nature.com/nrd/journal/v9/n11/full/nrd3251.html
xxii. See. e.g., Angeli F, “With the help of a foreign ally: biopharmaceutical innovation in India after TRIPS”, Health Policy & Planning 2014.
xxiii. Patents and the Global Diffusion of New Drugs, Iain M. Cockburn, Jean O. Lanjouw, and Mark Schankerman, American Economic Review 2016, 106(1): 136–164
xxiv. See, e.g. Ernst R. Berndt and Iain M. Cockburn, “The Hidden Cost Of Low Prices: Limited Access To New Drugs In India,” 2014; Cockburn, Iain M., Jean O. Lanjouw, and Mark Schankerman. 2016. "Patents and the Global Diffusion of New Drugs." American Econ. Review, 106(1): 136-64; Margaret Kyle and Yi Qian, “Intellectual Property Rights and Access to Innovation: Evidence from TRIPS,” National Bureau of Economic Research, Dec. 2014, http://www.nber.org/papers/w20799; Margaret Kyle, WIPO 23rd SCP http://www.wipo.int/webcasting/en/index.jsp (Wed 2 morning session, 15:50).
xxv. Ibid.; see also Ryan, M. Pharmaceutical Foreign Direct Investment, Technology Transfer, Health Competitiveness, and the Jordan-United States Free Trade Agreement, George Washington University Law School, Creative and Innovative Economy Center (May 2007).
xxvi. Charles River Associates, “The role of the innovative industry in ‘developing’ the market for new medicines in Emerging Markets: A case study approach,” April 2013.
xxviii. Amir Attaran, Opinion: Negotiation is best way to make drugs affordable, Financial Times (April 6, 2015), available at http://www.ft.com/cms/s/0/fd8453aa-cd85-11e4-9144-00144feab7de.html#axzz40rA60VNF.
xxx. World Health Organization and Health Action International (Global), Measuring Medicine Prices, Availability, Affordability, and Price Components (Geneva: 2008).
xxxi. USAID, AIDS By the Numbers,
xxxii. Médecins Sans Frontières (MSF) estimates the average price of ARVs per patient, per year is $67. Access to Medicines is a Global Struggle, The Pharmaceutical Journal, October 2, 2014.
xxxiv. Laing, R., “The patent status of medicines on the WHO model list of essential medicines,” https://www.wto.org/english/tratop_e/trips_e/techsymp_feb11_e/laing_18.2.11_e.pdf
xxxv. Attaran, A., “How Do Patents And Economic Policies Affect Access To Essential Medicines In Developing Countries?,” Health Affairs, http://content.healthaffairs.org/content/23/3/155.full (2004)
xxxvi. Center for Disease Control, http://www.cdc.gov/globalhealth/ntd/diseases/oncho_burden.html
xxxvii. India’s population in 2016 is 1.31 billion. http://www.indiaonlinepages.com/population/india-current-population.html
xxxviii. World Health Organization, The World Medicines Situation: Access to Essential Medicines, 2013
xxxix. World Bank and OECD, 2006-2016.
xl. World Bank and OECD, 2016.
xli. Link to Business for Social Responsibility Guiding Principles on Access to Health Care
xlii. Five Facts About Innovative Cancer Medicines, PhRMA, May 2014 http://www.phrma.org/catalyst/five-facts-about-the-value-of-innovative-cancer-medicines.
xliv. F.R. Lichtenberg, current estimates based on “Has Medical Innovation Reduced Cancer Mortality”, Columbia University and National Bureau of Economic Research, Revised 12 April 2013.
xlv. PhRMA: Since 2004 cancer innovations were largely responsible for a 40 percent increase in living cancer survivors, from 9.8 million to 13.6 million. The new therapies also saved $188 billion on hospitalizations.
xlvi. F.R. Lichtenberg, "The Expanding Pharmaceutical Arsenal in the War on Cancer", National Bureau of Economic Research Working Paper No. 10328 (Cambridge, MA: NBER, February 2004).
xlvii. Meta-Analysis of Phase II Cooperative Group Trials in Metastatic Stage IV Melanoma to Determine Progression-Free and Overall Survival Benchmarks for Future Phase II Trials, Edward L. Korn, Journal of Clinical Oncology 26:527-534, 200.
xlviii. Robert C, et al. Nivolumab in Previously Untreated Melanoma without BRAF Mutation. New England Journal of Medicine 2015;372:320-30. DOI: 10.1056/NEJMoa1412082.
xlix. May Margaret T. et. al, Impact on Life Expectancy of HIV-1 Positive Individuals of CD4R Cell Count and Viral Load Response to Antiretroviral Therapy, AIDS. 28(8):1193-1202, 2014.
l. The Washington Post, June 20, 2014, A Mississippi infant’s case opens a new door on studying a cure for HIV, June 20, 2014. Dr. Anthony F. Fauci directs the National Institute of Allergy and Infectious Diseases at the National Institutes of Health. http://www.washingtonpost.com/opinions/anthony-fauci-a-mississippi-infants-case-opens-a-new-door-on-studying-a-cure-for-hiv/2014/06/20/a5faf5b2-f7e8-11e3-a3a5-42be35962a52_story.html
li. Hopkins Arthritis.org