By Gregg Alton
Recent reports on the issue of access to medicines in developing countries are a clear reminder that biopharmaceutical companies — including Gilead Sciences — have an obligation to think about how all patients across the world can benefit from new medical advances as early as possible, regardless of economic circumstance. This is just as important as the cutting-edge science that leads to new medicines. There is no one-size-fits-all access solution — every country needs to be approached on its own terms.
In developing countries, generic licensing — where patent holders grant licenses that allow another drug company to manufacture a generic version of their drug — has helped transform treatment access, providing high-quality, low-cost drugs to resource-poor countries and communities. Of the 15 million people living with HIV in developing countries receiving treatment today, 10 million receive therapies developed by Gilead; the vast majority of these are in generic form, supplied as a result of Gilead’s licensing agreements. The company’s breakthrough hepatitis C medicines, first approved just three years ago, are already available generically in many developing countries too. The 2016 Access to Medicine Index recently recognized Gilead’s approach to patents and licensing as the best in the industry.
Yet generic licensing is only one part of the solution to a highly complex challenge. Tiered or differential pricing is used regularly in the pharmaceutical industry. The idea is simple enough: setting prices for countries according to their economic situation, as determined by their varying level of national income. However, Gilead looks not only at the purchasing power, but also considers other factors such as disease burden, treatment needs, and health-care infrastructure to help shape the company’s thinking. Some of the prices Gilead has set result in little or no profit to the company. For example, the company’s HIV medicines are available at not-for-profit pricing in 124 developing countries, and Gilead offers its hepatitis C medicines at a flat price to governments in 105 countries. This gives countries the ability to plan programmatically and financially, to encourage treatment scale-up.
Even though the approaches just described may address the cost of medicines, multiple additional factors are barriers to access. In many middle- and low-income countries, health systems have suffered from decades of under-investment, a high proportion of people having to pay for health-care out of their own pocket, leaving the most vulnerable populations unable to access life-saving treatments even when those medicines are available at low cost. In fact, figures from the World Health Organization show that in 47 low-income countries, out-of-pocket payments represent more than half of total health expenditures. Some countries also do not have enough trained health workers, or lack robust regulatory systems to quickly approve and regulate the use of new drugs. That’s why companies like Gilead must work with governments, non-profit organizations, and communities to build the programs, capacity, and expertise needed to overcome the complex barriers to access.
A comprehensive access approach must embrace a diverse range of strategies: pilot projects to validate innovative delivery models; dedicated and transparent drug registration policies; training for nurses, doctors, and community health workers; supply chain management; and partnerships to reach vulnerable populations most in need or at risk, are all needed. For example, Gilead supports the U.S. government’s DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe women) initiative to give adolescent girls and young women in Africa access to medication to reduce their risk of HIV infection.
No one who works in this field is naïve about the scope of the challenge — after all, despite enormous progress 20 million people living with HIV still don’t receive life-saving medicines. Access to medicine is not an exact science, and while there is no single or simple answer to the global access question, progress is possible. Innovator pharmaceutical companies, ministries of health and finance, health-care professionals, non-profits, generic manufacturers, researchers, and community organizations all have important roles to play. With greater collaboration and a focus on the real-world barriers that prevent people from receiving care, the full potential of biomedical innovation can be unlocked for all those in need.
To learn more about how Gilead is driving global access to medicines, click here.
Gregg Alton is Executive Vice President, Commercial and Access Operations ALA, Corporate and Medical Affairs at Gilead Sciences.