Unlocking Revenue and Saving Lives: A Two-Pronged Approach to Pharma Business in low to middle income countries
Clifford Samuel’s Bio
Clifford Samuel is a renowned figure in the biopharmaceutical industry, particularly for his contributions at Gilead Sciences. Working at the California-based company, Clifford spearheaded a business unit dedicated to providing life-saving medications to low and middle-income countries. Clifford’s responsibilities encompassed an impressive roster of regions, covering Central America, the Caribbean, South America, Africa, Southeast Asia, the Pacific, Eastern Europe, and Central Asia, spanning a total of 140 countries, including China. With unwavering determination, he executed differential business strategies which would meet local socio-economical needs to ensure that these vital medicines reached disadvantaged communities around the world.
Video Transcript (7 mins read)
Fabio D’Agostino:
Hi Everyone and welcome to this interview with Clifford Samuel. Clifford is a global health expert and he’s going to tell us how we can get more life science medicines and innovative drugs to low and middle income countries. So Clifford, I’ll let you introduce yourself.
Clifford Samuel:
Fabio, thank you very much for the opportunity. Hello, my name is Clifford Samuel. I spent 24 years at Gilead Sciences, and I recently completed a fellowship at Harvard Law School.
Fabio:
Thank you. So can you tell us a bit more about this 24 years at Gilead?
Clifford Samuel:
Yeah, so Fabio, at Gilead, I joined Gilead in 1996. I departed in 2020. And during my tenure at Gilead, I led Gilead’s Access to Medicine’s business unit. By the way, but just by reference, Gilead is a biopharmaceutical company here in San Francisco, California that research develops and commercialized medicines in areas of unmet medical need. This is HIV AIDS treatments and prevention medicines, viral hepatitis, Gilead also developed a cure for hepatitis C and most recently a treatment remdesivir for COVID. So I led Gilead’s access to medicines program where we, after much, hit and misses, the actual program started in 2003. We were pretty naive and ran into a bunch of criticisms about our access to medicine strategy. In 2007, the chairman and CEO, John Martin, met with my boss and colleague, Gregg Alton, and decided we needed to do something different. And that’s where… We separated the access to medicine strategy from the commercial business and created a business unit. And that’s what I led. I led Gilead’s business unit focused on access to medicines, getting its branded medicines into over 120 countries. And this geography spans Central America, Caribbean, South America, all of Africa, the South, South East Asia Pacific, Eastern Europe, Central Asia. Now, Fabio, with the brand, what we did was we executed a business strategy that Harvard Business School calls business at the base of the pyramid, where you tier the price of the brand and you make it available at reduced prices into these low-middle-income countries. But what we saw was we needed a catalyst. And that’s where the vision of John Martin came in, where he… agreed that we could execute a voluntary licensing strategy alongside the branded tiered pricing product in these markets. And voluntary licensing by definition, Fabio, is where an innovator or pharmaceutical company gives permission to a manufacturer, in this case Indian manufacturers, African, South East Asian manufacturers, the permission to create a generic version of the company’s patented medicine. And typically, this voluntary licensing involves the technology transfer and know-how of how to make that medicine. And that’s what I led Fabio at Gilead, the voluntary licensing strategy alongside a branded strategy in over 130 countries.
Fabio:
Thank you. And you mentioned Harvard and I think you recently completed a fellowship. So can you tell us a bit more about this fellowship and the work that included?
Clifford Samuel:
Yes, so Fabio, what I’ve recently completed in Harvard, it was a year-long fellowship. I received a grant to pursue this year-long fellowship. And how did this fellowship come about? A former colleague and I, Claudio Lilienfeld, he ran government affairs reporting to me at Gilead. When the COVID pandemic hit, we saw two familiar things that we saw during the HIV AIDS pandemic. The first was everyone was arguing over patent rights. And while this argument was happening, the medicines to treat COVID weren’t getting to patients in low-middle income countries who needed them. And what we saw was that this hyphenate debate over patent rights and the lack of access was solved through voluntary licensing and access to medicines during the HIV AIDS pandemic. So we got a grant and engaged Harvard Law School, our colleagues there along with Stanford Graduate School of Business and Hoover Institute. We spent a year engaging donor agencies, thought leaders and heads of state around the role of voluntary licensing, access to lifesaving medicines and local manufacturing. And so we had the first listening exercise at Harvard, the second at Stanford University, and the third was a readout of the final report at the Carnegie Endowment for International Peace. Now, what we captured in this final report are a set of principles and standards in a template of sorts calling out the various actors, the role of innovator farmer, the role of governments and the role of donor agencies and what’s necessary, what are the key conditions in executing and deploying a successful voluntary licensing strategy? Because at the end of the day, we believe that the next innovation of medicines, whether it’s in Alzheimer’s, oncology, infectious disease, these are large molecules, they are not going to get to patients in low middle income countries. unless there’s some collaboration and cooperation. And we fundamentally believe that pharma executing a business at the base of the pyramid strategy, this is a strategy championed by Harvard Business School, Kash Rangan, alongside voluntary licensing is the solution, Fabio.
Fabio:
Excellent, yeah, it has to be something sustainable
Clifford Samuel:
Absolutely.
Fabio:
and it makes sense. So now that you completed this fellowship, what’s next?
Clifford Samuel:
Yes, so the fellowship was truly an academic exercise capturing what are the core components to ensuring the successful deployment of voluntary licensing and what mechanisms should be in place. For example, you can’t have tech transfer without the know-how. The know-how is most critical in the technology transfer. Now phase two is where I’m seeking a grant to have a good two-year push on phase two of this exercise. Phase two is to go and sit with pharma companies, whether they are small startups that are in the Bay Area here, medium or large pharma, and explain to them that there are four to 5 billion people at the base of the pyramid in these low middle income countries, and that there’s a missed opportunity for pharma marketing to these 4 to 5 billion people. It’s something that my chairman, CEO John Martin, actually felt in the early days that not only was it the right thing to do to get these branded medicines to low middle income countries, but these were commercially viable, sustainably markets that if we cultivate them early, then we can find a way to navigate how the complexities of these markets and optimize revenues in these markets. So that’s the first conversation I want to have around the business, the missed business opportunity and voluntary licenses as an additional vehicle. So that’s the conversation with Pharma. And then I’m going to governments and have the conversation with governments about how do you get prepared to receive these technologies? Are your regulatory frameworks in place and strengthened? Your supply chain mechanisms? Are your doctors and ancillary healthcare providers trained and ready to prescribe these medicines? And then I’m going to donor agencies and saying, let’s talk about advanced purchase agreements or volumes agreements to assist what we’re seeing, which is… innovators coming together, working with governments, either through bilateral arrangements or through the medicines patent pool to ensure voluntary licensing is made available in low-middle income countries. And by the way, Fabio, Gilead was the first to sign on to the medicines patent pool in 2011, which has now been the conduit for how… COVID medicines got to many patients in low middle income countries. So this exercise that I’ve just completed at Harvard and what I intend to initiate in phase two is really in concert with the medicine’s patent pool, but also looking at possible bilateral arrangements as well.
Fabio:
Excellent. Well, this sounds extremely impactful. You elaborated on the voluntary license. Maybe you can tell us a bit more into why it’s important, but in particular, I’m curious to learn if there is anything we can, like the pharmaceutical industry, can learn from other countries that perhaps have already entered successfully 4 to 5 billion people in these low to middle income countries.
Clifford Samuel:
Yes, Fabio, it’s a really good question. And look, I would say that I’m from one of those countries. I’m from a small country in the Caribbean. And here’s an observation. And yes, it’s not pharma, it’s consumer goods, but Coca-Cola, batter, rickets, they’ve all, Unilever, they’ve all figured out how to market in these low-middle income countries. They’ve realized that you need different kind of, it’s not like North America, Japan, Australia, Europe marketing. It takes a different kind of strategy. The product offerings are different, the education and training mechanisms that are needed, but Unilever and Coca Cola, Bata, even cigarettes and alcohol companies have figured out how to market their products. in these low-middle-income countries and realize revenues. What I would submit is pharma needs its senior leaders to really incubate a separate business unit and focus on these geographies. It’s a long steady race. It’s not instant, but there are opportunities there, there are revenues to be realized there. And that’s the strategy that I’m taking to pharma. But I’m also taking a conversation to governments to say, you have to be prepared as well. Your regulatory frameworks and health systems should be strengthened. And that’s the message.
Fabio:
Excellent. So in terms of like take home message, what will be the take home message from this interview?
Clifford Samuel:
Yeah, so Fabio, my biggest concern is as, you know, being here in the Bay Area, the pharmaceutical biotech startup industry is poised to make significant advancements in the next decade in areas such as oncology, Alzheimer’s, cardiovascular and infectious diseases. Many of these medicines will be large molecules or platform technologies that are easily reverse engineered. And when that is the case, Fabio, the only way patients in low middle income countries will gain access to these medicines, because the technology and the know-how are in the hands of a few within these pharma and biotech companies, the only way these patients will gain access is through collaboration and cooperation. And the fastest and most seamless collaboration and cooperation is the voluntary licensing mechanism, Fabio. So my plea, my charge is to say, let’s start thinking more strategically about voluntary licensing as a framework, as a way of gaining access to medicines and also doing well and doing good while optimizing revenues, Fabio.
Fabio:
Excellent. Thank you so much Clifford for sharing your experience with us.
Clifford Samuel:
Thank you.
Fabio:
It’s been a pleasure and I’d like to invite everyone who is interested in developing a global health strategy in a sustainable way and still profitable way to reach out to Clifford and myself if you want to and we’d be happy to and delighted to work with you.
Clifford Samuel:
Thank you for the opportunity, Fabio. It’s a passion of mine, global health, and executing a business at the base of the pyramid through voluntary licensing. So thank you very much.
Fabio:
Thanks, bye bye.
Clifford Samuel:
Cheers.
Contact Clifford Samuel
Useful links
The BiGS Fix (Harvard Business School) https://www.hbs.edu/bigs/blog/post/big-pharma-has-a-model-to-make-profit-and-save-lives
Clifford Samuel’s Report about Voluntary Licensing (VL) https://globalaccessaction.org/vl