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Addressing the Challenges of HIV Drug Supply

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From Will Stephens, Vice President, Global Access & Partnerships, Janssen Global Services, LLC

Recently, I attended the Clinton Health Access Initiative’s (CHAI) 2nd Antiretroviral (ARV) Supplier Summit in Kerala, India. Over the course of three days, CHAI brought together innovator pharmaceutical companies and generic drug manufacturers as well as civil society representatives to explore the trends and challenges of broadening HIV drug delivery.

A key theme of the summit was sustainability and suppliers’ capacity to meet the rapidly growing needs for HIV drugs. In 2005, 1.3 million people with HIV were receiving ARV treatment in low and middle-income countries; in 2009, 5.2 million were on treatment. By 2015, an estimated 15 million people will be targeted for ARV treatment.

As we heard throughout the summit, this is a challenging time for those of us working to broaden access to these medicines in resource-limited settings. The demand for safe and effective HIV drugs is increasing, while funding for HIV programs is flat or decreasing. Companies – both innovator and generic – are under constant pressure to produce safer, more effective, more convenient HIV medicines ever more cheaply.

It was clear from summit discussions that having more generic companies manufacturing HIV drugs may not always expand access and/or lower prices; and in fact, it’s likely to drive high quality, higher-priced generic manufacturers out of the market. Furthermore, as generic companies compete for smaller market shares and their profits are squeezed, some are exploring more profitable opportunities outside of HIV. With all these challenges, advocates fear that there may be HIV drug shortages in the future and that universal treatment goals will not be met.

Summit attendees also reiterated that ensuring a robust HIV drug supply is more than just manufacturing cheap generic drugs. Those elements we believe to be critical to our access efforts – affordability, medical education, timely registrations, strengthening supply chain, ensuring quality drug products, and monitoring the safety & effectiveness of our products – are considered essential to ensuring effective HIV drug access by many HIV stakeholders.

Our licensing agreements with generic manufacturers play a key role in achieving that. But the agreements are only the beginning. Our end goal is – and must always be – delivering safe, affordable and quality products to patients in need. We continue to work with our generic partners for the long-term – providing technical support as they prepare regulatory dossiers and collaborating with them to address product awareness and/or medical information needs in order to facilitate faster access to our HIV medicines.

As last week’s meeting showed, the access environment is constantly changing and new challenges must be met. Providing effective and sustainable access to HIV medicines is a cornerstone of our commitment to healthcare around the world. Today, I am confident that our efforts and agreements with generic manufacturers, as well as potentially other similar mechanisms to generic licensing, are capable of addressing the ever-changing access needs of patients in resource-limited countries and that we can deliver on this promise for the long-term.

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