To coincide with the United Nations High-Level Meeting on Noncommunicable Diseases (NCDs), the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) issued a report of independent policy research, conducted by RAND Health, which identified the most significant obstacles to stemming the rise of NCDs in developing countries. The key finding of the research shows that effective treatments for NCDs exist and are likely to be available in generic form, but in many instances, these drugs fail to reach many people in the developing world. The study identified four key areas in improving access to NCD treatments: innovative ways to improve NCD medicine adherence; overcoming barriers to availability in poor and remote areas, where markups, taxes, and duties along the supply chain and counterfeit drugs are a problem; improving access to primary care; and removing regulatory restrictions that hamper medicine availability in developing countries.
“Fifity percent of NCDs are avoidable, therefore, prevention measures, including lifestyle modifications, doing more physical exercise, stopping smoking and a healthy diet, are some of the most cost-effective and efficient ways to tackle the magnitude of NCDs across the developing world,” said IFPMA Director General Eduardo Pisani, in a Sept. 19, 2011, IFPMA press release. “But we know that while prevention is imperative and cost-effective, its impact can only be felt over the longer term. We also need to know how best to improve access to treatments that patients in developing countries need more urgently. The launch of the first in the series of IFPMA reports illustrates how the research-based pharmaceutical industry is committed to this challenge and how we want to understand what areas require particular focus,” he said.
As in many global health initiatives, a multistakeholder approach, including participation from industry, the public sector, public and private partnerships, and nongovernmental organizations (NGOs) is considered a crucial way to address the problem of NCDs in the developing world. “The increasing burden of NCDs in low- and middle-income countries poses an economic, social, and moral stumbling block to global health and prosperity,” said IFPMA President and AstraZeneca CEO David Brennan, in the IFPMA press release. “This underscores the importance of partnership to understand what the most significant problems are and to work together to solve them.”
According to data from IFPMA, research-based pharmaceutical companies are engaged in 213 health partnerships, of which approximately 25% deal directly with NCDs or help strengthen the primary care to deliver treatments. A recent partnership for NCDs was announced in September 2011, when the World Health Professions Alliance (WHPA) announced an NCD Health Improvement Card and toolkit, sponsored by IFPMA. WHPA is an international organization representing healthcare professionals, such as dentists, nurses, pharmacists, physical therapists, and physicians. WHPA represents more than 26 million healthcare professionals in 130 countries, and the NCD toolkit will be shared with them to help encourage patients to identify and prevent risky behaviors.
Priority for policy research
The RAND report identifies four key areas in which the pharmaceutical industry can be participate in addressing the problem of NCDs in the developing world: realizing product improvement beyond the chemical compound, enhancing supply-chain efficiency and integrity, achieving gains from regulatory harmonization, and improving access to primary care.
The RAND research showed that a large array of drugs for NCD treatment has been developed and are likely to exist in generic form, so that the most immediate gains in health can be achieved by improving access to existing medicines as opposed to developing new compounds. The four major NCDs are cardiovascular disease, chronic respiratory disease, diabetes, and cancer. In reviewing the availability of noncancer NCD drugs on the World Health Organization’s (WHO) Essential Medicines List, the report concluded that first-line treatments for noncancer NCDs and palliative care are likely to be available in generic form in developing counties. Development needs still exist for second- and third-line medicines for refractory cases, to reduce side effects in the treatment of noncancer NCDs, for palliative care, and for the first-line treatments for many cancers. Given the availability of NCD treatments, however, the report points to the importance of strategies to improve access and adherence to treatments, such as through packaging (e.g., blister packaging to facilitate patient compliance and administration), pricing, and patient education. The viability of fixed-dose combination products for NCD treatments is another area that can be further explored as a means to reduce dosing and consolidate treatment although the report points to certain challenges in developing fixed-dose combinations for NCDs, such as development, manufacturing, and regulatory challenges.
Supply-chain efficiency and integrity are two major concerns in tackling the problem of NCDs in the developing world. The availability of medical treatment and drugs in poor and remote areas is limited and made more difficult through large markups in the supply chain and further compromised through counterfeit drugs. Although consumer goods, such as beverages, shampoos, and mobile-phone cards, often are available in remote areas, drugs are not available due to segmentation for the supply chains for medicines. Particularly in low-income countries that depend on donor assistance, supply chains are commonly segmented horizontally and vertically. Horizontal segmentation refers to instances where international donors coordinate the delivery of medicines to the point of entry and leave the distribution to local organizations, which can result in variable and unpredictable distribution of supplies. Vertical segmentation refers to separate supply chains that are maintained by different donor organizations or by different disease states, which can create highly fragmented and inefficient supply chains. Other problems in the supply chain include problems for distribution to rural or remote areas and weak supply-chain management. Problems in supply-chain management are caused by a lack of standardized information systems, inefficient inventory accounting and management practices, a lack of trained supply-chain managers, limited tracking and tracing mechanisms, poor storage facilities and conditions, and stock theft. These problems contribute to increased transportation and inventory costs, a lack of reliable data to forecast future demand, significant imbalances between local demand and supply, increased waste and vulnerability to breaches of supply-chain integrity. Counterfeit drugs are part of those breaches in supply-chain integrity, and according to WHO estimates, 25% of drugs are counterfeited in developing countries.
The RAND research points to the importance of improving supply-chain integrity and recommends the evaluation of public-sector solutions with a private-sector approach for supply-chain security and verification of product authenticity. For example, the adoption of efficient purchasing and supply-chain management practices from private industry has the promise of improving NCD drug distribution. Public-private partnership models are another possibility. The report points to Tanzania’s accredited drug-dispensing outlets as an example. These are privately operated outlets that are organized to dispense a limited set of prescription drugs to underserved communities, and which operate with very little capital and by which the government provides incentives and training to outlet owners. The adoption of radio frequency identification (RFID) and bar coding for tracking and tracing drugs is another tool, but would require international or at least regionally accepted standards for implementing the technology.
The report also points to regulatory obstacles in developing countries that impede access to NCD treatments. The report points to uncertain timelines and variable requirements for product registration, GMP inspections, labeling, and product identification codes, which can increase cost, sometimes to the point to which it makes product registration prohibitively difficult in a given country. For example, a recent analysis by WHO found that none of the 26 assessed sub-Saharan countries had adequate and sustained funding for operation of their national medical regulatory authorities. These authorities lacked qualified staff, especially with respect to marketing authorization and inspections, and the capacity to assess the application for an innovator medicine was highly limited.
The report points to the benefit in greater harmonization of regulatory requirements as a means to increase product availability. The report suggested quantifying the benefits of regulatory harmonization to promote a data-driven dialogue with national authorities and to promote the use of existing activities, such as the WHO Certificate of Pharmaceutical Product (CPP) scheme, the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), and the International Conference on Harmonization (ICH) Global Cooperation Group (GCG) scheme. The WHO CPP scheme allows countries to rely on the registration by another recognized competent regulatory authority in evaluating the quality, safety, and efficacy of a drug product. This process is advantageous for developing countries, where national drug authorities may not have the capacity to do their own evaluations. PIC/S consists of the national regulatory authorities of nearly 40 countries and seeks to develop and promote harmonized GMP standards by providing guidance documents, training, assessing inspectorates, and facilitating cooperation.
Improving access to primary care is an important way to tackle the problem of NCDs. The RAND report highlighted that in the absence of a primary-care system, NCDs go unnoticed until complications arise, adequate treatment is not initiated, treatment effect is not consistently monitored, and terminally ill patients do not receive palliative care. A recent World Health Survey conducted by WHO in 70 countries showed that only 50.6% of respondents with a chronic condition in high-income countries reported having access to treatment, and these percentages are even lower for people in less economically strong countries, with only 32% of respondents having access to treatments in low-income countries and 37.5% in lower-middle-income countries. According to World Bank data, low-income countries have on average 0.18 physicians and 0.53 nurses for every 1000 people compared with one physician and 1.69 nurses per 1000 people in lower-middle income countries. In terms of affordability, according to WHO’s 2010 NCD country-capacity survey, only 25% to 35% of low-income and lower-middle income countries have insurance schemes, be they public or private, that cover NCD-related services and treatments, compared with 85% of high-income countries. At the same time, improving access to primary care is a complex challenge, which requires fundamental issues, such as resourcing, governance, and capacity building. As initial steps, the report proposes a survey of innovative approaches for delivering effective and efficient primary care in developing countries and an assessment of those approaches that can be scaled up in a given country or area.
“We are confident that further research into these priority areas can yield actionable guidance on how to improve access to NCD medicines in the developing world and that the research-based pharmaceutical industry is committed to executing this program,” concludes the report. The report is part of the process of a multistakeholder approach to participate in the problem of NCDs in the developing world.