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Angie Drakulich was editorial director of Pharmaceutical Technology.
GSK Works in Developing Nations to Improve Everything from Research to Roads.
GlaxoSmithKline (GSK) has been leading several industry efforts during the past decade to improve healthcare among developing-country populations. In 2001, the company dedicated a research and development (R&D) facility in Tres Cantos, Spain, to developing new treatments to combat diseases in the developing world. GSK now operates an open laboratory at the facility, which offers researchers from around the world a place to collaborate on new medicines for neglected diseases.
Pricing and partnerships
GSK also offers preferential pricing as well as not-for-profit pricing of its antiretrovirals (ARVs) to developing nations which helps to improve access to the needed drugs. The program reaches 69 of the world's poorest countries. In addition, approximately 75% of the company's manufactured vaccines are sold to developing countries on a tiered-pricing plan.
GSK has established community investment activities and partnerships that foster healthcare practices in places such as sub-Saharan Africa, Asia, and South America, and has launched several partnerships aimed at finding solutions for global healthcare problems.
"Developing countries face multiple issues on a systemic basis that negatively affect health outcomes for their citizens," says Jon Pender, vice-president for intellectual property and access at GSK, about the company's global healthcare efforts. "Fundamentally, poverty both makes people sicker and makes it harder to tackle healthcare challenges. Many people living in poverty do not have enough food or clean water. In this context, a healthcare system may exist only in name or only in isolated pockets within a country. For example, Africa suffers 24% of the global disease burden yet has only 3% of the world's health workers and 1% of the world's health budget with which to tackle it. There is no way you can get those numbers to add up to adequate healthcare provision. Together, the public and private sectors and civil society have helped to galvanize more resources for global health and reduce the barriers to access to medicines. GSK sees itself as a part of this movement and is specifically addressing issues where our talents and resources can be deployed to maximum benefit."
A major challenge with regard to developing and delivering needed medicines to developing countries and neglected populations has to do with the long-standing reality of the economics behind R&D, adds Pender. He points out that developing a new medicine or vaccine typically takes 10 to 12 years and costs around $1 billion, including the costs of failures. Traditionally, the lack of a viable commercial return on this investment for diseases that are not prevalent in industrialized markets meant that little research was conducted on these diseases. Today, however, more attention is being paid to previously neglected diseases, such as tuberculosis (TB) and malaria, and new approaches that share the risks and costs of R&D are being pursued, he says. Through product-development partnerships with organizations, such as the PATH Malaria Vaccine Initiative (MVI) and the TB Alliance, the pharmaceutical industry is developing new tools to combat theses diseases.
The past two years have been particularly important for GSK in this regard. In addition to establishing the open research laboratory in Spain, in 2010, GSK made available to the public more than 13,000 potential malaria targets to help scientists globally focus on finding a malaria treatment. The company is also working with PATH–MVI and the Bill & Melinda Gates Foundation to develop a vaccine against malaria. The vaccine is in Phase III clinical trials at 11 sites across seven countries in Africa.
The company also established an R&D unit focused on developing late-stage products and formulations for diseases that affect populations in the emerging markets. Other pharma companies are involved, including Amgen, which is working with GSK to make its osteoporosis medicine, denosumab, available in developing countries. Gilead is partnering with GSK to make its drug for hepatitis B, tenofivir, available in China. India's Dr. Reddy's and GSK worked together to move two new cardiovascular branded generic drugs for developing-country populations into development. The R&D unit, meanwhile, has four ongoing late-stage projects in respiratory disease, urology, dermatology, and cardiovascular disease. These projects involve working with regions and countries to understand fully the local needs and to tailor clinical trials to those needs.
The registration of new medicines in many of these targeted countries, however, can be costly, complex, and time-consuming, says Pender. "Too often, regulatory authorities do not have sufficient capacity to deal effectively with numerous and complex product registrations. A possible solution would be the creation of a harmonized registration system that several countries with the same disease priorities can adhere to."
In an attempt to improve this situation, GSK established a dedicated Developing Countries and Market Access operating unit in July 2010. One of the unit's goals is to increase patient access to key medicines and vaccines.
The recently created Advance Market Commitment (AMC), pioneered by the Global Alliance for Vaccines and Immunization (GAVI), offers another financing mechanism to ensure more sustainability in vaccine manufacturing and supply for the developing world. Recently, GSK agreed to supply up to 300 million doses of its pneumococcal vaccine for a period of 10 years to countries that are part of GAVI as part of the first global AMC for the pharmaceutical industry. Pfizer has made a similar commitment for its vaccine.
Another challenge faced by the healthcare industry globally is the infrastructure that exists in many developing countries, including poor distribution networks and a lack hospitals, clinics, and healthcare professionals. Political issues often compound these barriers, meaning that even when there is funding, there is little action, says Pender. "In middle-income countries, the health system may be more developed, but wide ranges in income mean that many poor people at the lower rungs of the income ladder are not able to access healthcare," he adds. The needs to strengthen health systems and reduce inequities are becoming more visible, and much more can be done to increase access to life-saving services, says Pender.
In the least developed countries (LDCs), the challenge of improving healthcare and access to medicines is even more difficult. Earlier this year, therefore, GSK formed a partnership with AMREF, CARE International UK, and Save the Children to help reinvest 20% of the company's profits made in LDCs back into projects that strengthen the healthcare infrastructure in those countries. The money will go toward programs that improve health outcomes by supporting frontline health workers who operate in these countries.
Since 2009, GSK also has committed to significantly reducing its prices for patented medicines in the LDCs. The company's goal is to reduce prices to no more than 25% of their price in the United Kingdom.
Going forward, GSK plans to continue and add to these global healthcare efforts. "All these initiatives commit us to continuing to work closely with the global community and to ensuring the necessary resources and political will are in place to make partnerships work," says Pender. "Partnerships that combine the resources and expertise of companies, governments, international agencies, academic institutions, NGOs and communities, are a central component to our global health approach. From GSK's perspective as a global company, we believe this is not only the right thing to do but makes good business sense. By working with others to find logical and sustainable solutions for the long-term, we can achieve more for patients than we can alone," he adds.