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Guest Commentary

There is a better way — moving beyond the patents vs access debate: A Guest commentary

Gilead’s strategy for access to HIV, HCV drugs in low-income countries holds lessons for COVID-19 vaccines

Ex-Gilead execs Clifford Samuel and Claudio Lilienfeld propose a middle ground in the IP waiver debate based on Gilead’s solutions to getting HIV and HCV therapies to patients in low-income countries.

May 9, 2021 | 4:52 PM GMT

The debate about whether to suspend patent rights for COVID vaccines doesn’t need to be an “us vs. them” battle that pits access against innovation. Drawing on our previous work for Gilead, we propose a scenario that can create a win for patients, companies and countries.

We are currently in the throes of the latest iteration of a global debate about patent rights that has reared its head regularly over the past decades, a debate in which people take sides stridently and viscerally. Yet, in a surprising move, the Biden administration announced this week that it is willing to negotiate an arrangement via the World Trade Organization in Geneva to make such a thing possible.

Emblematic of the struggle to find a solution, a May 3 opinion piece from The Washington Post Editorial Board took a stab at finding a middle ground in the all-too-often binary debate about access to medicines, yet chose a title that tilted heavily to one side and buried a passing reference to what we think should be the path forward: voluntary licensing.

The two polar positions can be boiled down to this: (a) pharmaceutical companies are parasites profiting off the lives of the poor and bankrupting governments all over the world vs. (b) stripping away intellectual property protections (and profits) will discourage innovation and leave us without the lifesaving medicines and advancements we need.

Voluntary licensing sits between these two extremes and has already been implemented in a few cases with demonstrably positive impact, including transforming the HIV/AIDS pandemic from a death sentence in many parts of the world to a chronic disease.

This era, with tectonic shifts caused by the global COVID pandemic, is ripe for a more nuanced approach that can steer us away from a status quo that this quote from Gandhi illustrates rather succinctly: “An eye for an eye will leave the world blind.”

Gilead Sciences Inc. (NASDAQ:GILD) had more than once been caught in fraught situations similar to the COVID vaccine makers, and it came up with a collaborative solution in partnership with the U.S. government, international organizations, and civil society advocates, exactly what the current moment demands.

The arc of history summons us to take action to get life-saving medicines including vaccines into the hands of people with the least ability to access them. The Gilead solution, first launched in 2006 and continuously honed thereafter, combines several elements: (1) first and foremost, licensing agreements with (primarily Indian) manufacturers of generic medicines to allow these companies to sell their licensed generics in 116 countries (across Africa, South and Southeast Asia, and Latin America and the Caribbean, and beyond); (2) the transfer of technology and know-how; and (3) collaboration with governments and international agencies to not only facilitate the access, but also to re-enforce quality. On the latter, for example, Gilead would reduce its already nominal royalties if the manufacturer sought and received a tentative FDA approval or WHO prequalification, each of which ensure the maintenance of a globally recognized quality standard. The 116 countries were determined based on GNI per capita and disease burden, to help identify the low- and lower middle-income countries most in need and severity of disease in them. Gilead established a dedicated business unit to manage all of these efforts.

Furthermore, Gilead recognized that low-cost medicines were only one component of the broader challenge of ensuring access to effective healthcare. It worked with local governments and NGOs, as well as donor agencies, to bolster the ability to address the diseases. Programs included studies of disease burden across the various geographies, support for medical education and training, and help to secure diagnostic capabilities. In parallel, the firm conducted an intensive advocacy campaign to raise awareness with governments who might otherwise not have known that Gilead-licensed generics were available at a fraction of the brand-name price.

Yes, that meant that Gilead was, in a sense, supporting efforts to help the Indian generic manufacturers compete against Gilead’s own products. And, this was all done while Gilead’s patents were alive and well, with the company sharing its intellectual property rights in order to expand access. This demonstrated that granting patents and expanding access to medicines could be two peas in the same pod, rather than two gladiators fighting in a Roman arena. Meanwhile, Gilead remained among the most profitable companies. Win-win-win. Not winner take all.

Gilead began using this licensing model in the mid-2000s with its then breakthrough HIV and HBV treatments, and subsequently replicated this model as soon as FDA, in December 2013, approved its transformational cure for HCV, Sovaldi sofosbuvir. In parallel with the FDA approval process for Sovaldi, the company’s executives went to India to begin discussions that led to new licensing agreements being completed within months of the drug’s launch in the U.S. More recently, the company used the licensing approach again to enable wider access to the experimental COVID treatment Veklury remdesivir.

As a result of Gilead’s licensing, tech transfer and advocacy effort, prices in the developing world dropped from $20/month to $4/month for Gilead’s sanctioned generic HIV medicines, and $60 for a curative course of generic HCV medicines. The numbers of people treated with Gilead’s HIV medicines went from a few tens of thousands to more than 18 million people every day across the world. Several million people have been cured of hepatitis C as a result of this program.

Note that our work focused on access to medicines in low- and lower middle-income countries, and in this piece, we are reflecting on the lessons learned from that experience and not addressing drug pricing in high-income countries, nor are we commenting on the strategies currently being deployed for distribution of COVID vaccines. What we are offering is food for thought: a menu of options based on Gilead’s multifaceted approach. The Gilead model is not one size fits all. It is an additional approach that should be considered more frequently, and built upon or adapted.

We believe this is a moment to capitalize on the Biden/Harris administration’s broader efforts to bring people together. Leading innovator biopharma companies, working with governments and civil society, should seize this opportunity to replicate, improve and expand upon already time-tested efforts such as Gilead’s now 15-year-old approach to generic licensing. A handy resource could be prior work assessing the voluntary licensing model, including case studies authored by the Harvard School of Business, which has used the case in its classes.

This should happen now in the context of COVID vaccines and treatments, but it can and should cover the broadest spectrum of diseases and therapies. Innovators are poised to make dramatic inroads into diseases ranging from Alzheimer’s to cancer, and licensing and other innovative approaches to access can ensure that the poorest of the poor benefit along with the more well off. Governments, perhaps led by the Biden administration, should springboard off the newly announced efforts of the WTO to expand access to COVID vaccines to create a broader set of principles that can be applied to virtually any major public health need.

Clifford M. Samuel recently served as SVP for global patient solutions at Gilead, overseeing all operations across low-, lower middle-, and middle-income countries. Claudio Lilienfeld was an adviser to Samuel and served as senior director for international government affairs at Gilead. Both are now independent consultants.

Signed commentaries do not necessarily reflect the views of BioCentury.

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