From Will Stephens, Vice President, Global Access and Partnerships Program, Janssen
For additional perspectives on our approach to access to medicines and the Medicines Patent Pool, please click here.
Anyone familiar with our Company knows that our responsibility and commitment are always focused on the needs of patients.
This is more than a belief; it’s a way of life for my Global Access & Partnerships team. For people living with HIV in resource-limited countries, we work diligently to increase access and affordability for our HIV medicines. We license our HIV medicines to generic companies to ensure they will be broadly available, and we operate our Global Access program on a not-for-profit basis. We have a comprehensive effort to improve the health of women and children in the developing world, part of which is helping to ensure that no child is born with HIV. We are also working on a portfolio of child-friendly formulations of our HIV medicines so that kids living with HIV will have more treatment options.
And our greatest responsibility is ensuring we meet the needs of HIV patients today and for the future.
Earlier this year, we responded to a formal invitation from the Medicines Patent Pool (MPP) to begin negotiations to grant licenses to the patents for our HIV medicines. We expressed confidence that our direct agreements with quality generic manufacturers were providing the best route to expand access to patients in need. After thorough deliberation and discussion, we continue to believe that this is the best approach to providing access to our HIV drugs today, so we have decided not to enter into negotiations with the MPP. Let me tell you why.
Our access efforts are working. Through our nine licensing agreements with generic manufacturers we are effectively and responsibly meeting the needs for our HIV medicines in resource-limited countries; five of these agreements include the rights to develop fixed-dose combinations. And we are collaborating with researchers to study further how our medicines can be used best to help patients in developing countries and providing medical education to ensure our medicines are used appropriately in these settings.
Some have suggested that sharing our IP with the MPP will immediately save the lives of tens of thousands or even millions of people living with HIV. But sadly, that is not the case. Our HIV medicines are not included in the World Health Organization (WHO) guidelines for HIV treatment in resource-limited settings. In these settings, providing HIV medicines for patients new to treatment (“first-line”) remains the top public health priority today; outside of the Americas, 97% of people receiving HIV treatment are on first-line. In resource-limited countries our HIV medicines are indicated for treatment-experienced patients (“third-line”). Treatment of 3rd-line patients is generally limited to a small number of “centers of excellence” where physicians have the specialist knowledge and access to HIV drug resistance testing needed to ensure the appropriate use of HIV drug combinations. These drugs are often the last option for patients. We remain concerned that the model put forth by the MPP could foster more widespread use of inappropriate combinations of these drugs of “last resort” that could adversely impact the future of HIV treatment globally.
Over the course of the last year, I’ve been asked a few questions about how the patent pool and intellectual property (IP) affect access to medicines. I believe a few key issues are sometimes overlooked in this debate. First, it’s important to remember that the MPP is just one potential mechanism to share the IP, or patents, of HIV medicines – and that the MPP does not directly provide or manufacture HIV medicines for resource-limited countries.
Secondly, our intellectual property is not a barrier to access. We already proactively license our IP to responsible generic manufacturers, innovator pharmaceutical companies, and product development partnerships. But HIV drug access requires more than just intellectual property and reduced prices - it also requires registration of our medicines with local health authorities, supply capability, quality products and safety monitoring. Our licensing agreements help provide these essential elements.
Effective HIV drug access requires a commitment to ensure that quality, affordable and safe medicines, used properly and safely. That is at the heart of our access efforts.
Over my past 30 years with the Company I have seen firsthand our impact in improving the lives of patients. This has never been more apparent than in our work to address HIV.