Medicine for All: The Role of the Pharmaceutical Industry in Providing Access to Medicine in LMICs

In the inaugural event of the Global Cancer Movement, initiated by OncoDaily, Moy Bracken, Research Unit Manager at the Access to Medicine Foundation, delves into critical strategies for improving access to oncology medicines, especially in low and middle-income countries (LMICs). The virtual event highlights the importance of addressing global disparities in cancer treatment and exploring solutions to ensure equitable access to life-saving therapies.

My name is Moy Bracken, and I’m here representing the Access to Medicine Foundation, and today I want to talk to you about the pharmaceutical industry’s role in providing sustainable access pathways for oncology medicines. So as we know, cancer is a leading cause of death worldwide, but access to life-saving treatments remains a challenge, and this is particularly felt in low- and middle-income countries. And I think traditionally what we’ve seen from some of the global health models, it’s been focusing on diseases of high public health importance, such as HIV, malaria, and TB.

But the growing burden of NCDs in low- and middle-income countries, which includes cancer, there is an increased recognition for the need to expand the access to oncology medicines within these regions, and it very much aligns with one of your pillars at OncoDaily for equitable access to cancer treatments. So just maybe some background on the prevalence of cancer. It’s rising in low- and middle-income countries, driven by a number of factors, including aging populations and exposure to risk factors, for example, tobacco, and by 2040, 70% of global cancer deaths are expected to occur in low- and middle-income countries.

And of course, one of the biggest drivers as well in these disparities and poor patient outcomes is lack of access to oncology medicines. So at the same time, we do see the pharmaceutical companies that are increasingly prioritizing developing oncology medicines in their portfolios, and in 2022, 18% of global pharmaceutical revenue was for oncology medicines. At the Access to Medicine Foundation, it’s our mission to mobilize the pharmaceutical industry to improve equitable access in these underserved regions, and today I want to talk about some of the barriers to accessing oncology medicines and the pathways that the industry can engage in to bridge this gap.

Next slide, please. So just an overview of the organization, for those of you who are not familiar with us, we are a non-profit research organization based in Amsterdam with the primary mandate to reduce health disparities in low- and middle-income countries. And the mechanism we do this by is by mobiling the companies that manufacture these life-saving drugs to improve access.

We do so by publishing research reports, which use data-driven insights to stimulate access to medicine. And next slide, please. And we do so through our research reports, but also a number of different mechanisms.

So we do build multi-stakeholder consensus on the responsibility of the industry alongside other global health factors, including governments and private foundations. And we offer practical guidance to companies and provide clear standards for external accountability. We also create opportunities for companies on how they can improve access to key products.

And we share best practices from the industry throughout our research reports. And finally, we engage in strategic change-making, speaking at conferences through policy shaping, also mobilizing investors and activating a wide community of stakeholders to engage with the private sector on these key opportunities to scale up access to medicine. And our research reports are available for free for everybody on our website.

So I do encourage you to check them out. And we get our data from both public sources and also from the pharmaceutical industry themselves. Next slide, please.

And I’m sorry. And our key stakeholders, as I mentioned, include governments, international organizations and companies. And one thing I wanted to mention is we engage heavily with the pharmaceutical industries, encouraging them to improve access to the key products.

But we cannot bridge the gap in access without the investment decisions of shareholders in these companies. So at the Access to Medicine Foundation, we have over 100 institutional investors who are signatories to our work. And they use our insights, rankings and practice to engage differently with the industry.

Next slide, please. So I’m sure you’re all familiar with the different barriers to access, which really are universal regardless of where you live. But this slide just illustrates the multilevel barriers that people face in low and middle income countries.

For many people in low and middle income countries, medicine affordability is one of the most significant hurdles to access. And there are many ways in which the pharmaceutical industry can intervene, including equitable pricing models that are tailored to the realities of these countries and working collaboratively on different models such as licensing and inclusive business models. And I’m going to expand upon those later.

Also, at the health system level, they can engage in capacity building initiatives like training and supply chain improvements and addressing patient level barriers to ensure that they are working with communities and that treatments are not only available, but also accessible and acceptable. Next slide, please. And so, as I mentioned, we’re a research organization and we work across different sectors.

But one of our most well-known research reports is the Access to Medicine Index. It was just published last month and it’s available on our website. And it benchmarks the top 20 pharmaceutical companies by market cap on a number of different performance indicators related to access to medicine in low and middle income countries.

We have 81 different diseases that we look at and we look at the products these companies make for those diseases included in that disease scope or 19 different subtypes of cancer. We also contain actionable recommendations for companies to improve on access in low and middle income countries. Next slide, please.

So this slide is just a really an overview of how the pharmaceutical industry can really start during the clinical trial stage to think about how they can overcome access barriers to patients all the way up to the last mile. So it’s really crucial that they maintain access provisions throughout R&D. Also, we heard people speaking earlier about improving diversity in clinical trials and also the global landscape of clinical trials, something which I will expand upon later as well.

Developing plans for access when products are still in product development, as well as engaging in mechanisms to facilitate registration in low and middle income countries, which helps to ensure that products are quality assured and available. Once a product is on the market, there’s a number of different access strategies that can be implemented, and these really need to be tailored to the local context and consider the ability to pay of the payers within these countries. And later on in my presentation, I’m going to talk about two of the more sustainable approaches that we see that the pharmaceutical industry can adopt to increase access to oncology medicines.

And then finally, a cross-cutting theme, which I’ll reference throughout the presentation, is partnerships and collaboration. It’s really key that the industry engages with partners that are working towards the same goal to reduce health inequities in oncology, access to oncology medicines. And one good example of that is the Access to Oncology Medicines Coalition, which is a global initiative led by the Union for International Cancer Control, and that works with 40 partners along the whole ecosystem from diagnostics to pricing to access for oncology medicines.

And now I just wanted to walk you through some of the main findings from the pipeline to patient access that we have in our most recent report. You can go to the next slide, please. Yes, so as I mentioned, considering patient access at the early stages of clinical trials is essential to ensure that innovative cancer medicines are not only scientifically validated, but also affordable and equitably available.

So through our research, we did analyze 685 trials that companies are carrying out for different diseases within the scope of our index. And we found that less of less than half of these are carried out in any of the countries we analyze. So for reference, we have 113 countries within our scope, which comprises of 80 percent of the world’s population.

And less than half of these trials were carried out in any of the countries that we look at. And the number is, in fact, lower for oncology trials at 38 percent, despite having 80 percent of the world’s population. And I guess the disparity in the global landscape of clinical trials does have significant implications for access for a number of different reasons.

So we find that companies prioritize access planning where they’re carrying out clinical trials. Therefore, if they’re not carrying out a clinical trial somewhere, it’s going to lead to delays access or reduced access or no access in the future for those patients. In addition to this, clinical trials offer patients potentially lifesaving access to investigational medicines.

But of course, if trials are not carried out in those countries, patients living in those countries do not have that opportunity. And finally, the resulting lack of research data from populations in these countries limits the understanding of how diverse patient populations respond to new therapies. And I guess this is extremely pertinent with the move we see towards precision and therapies.

So really addressing this disparity does require action from the industry, along with other stakeholders, including building clinical trial capacity in low and middle income countries and fostering partnerships to improve the infrastructure. And I mean, as a starting point, they can they can engage in expanding the global reach of the clinical trials to countries that already have that infrastructure in place, because we are talking about a very wide range and cohort of countries that have different system readiness. Next slide, please.

And so, as I mentioned, planning for access during R&D is crucial to ensure timely access to medicine, and we know that pharmaceutical companies are heavily prioritizing R&D in oncology. And to put this into context, we did analyze over 800 R&D pipeline developments from 20 different companies across 81 diseases, and almost half of these were for oncology. So we see major companies like Pfizer, Aviv, Merck expanding their oncology pipelines.

But as these therapies advance, if there is not equitable access to them once they reach the market, it really means that global disparities in patient outcomes are going to become even greater. So one way which we push the industry to improve access to new, innovative therapies is to engage in access planning and access planning is a strategic process that companies can use to ensure patients can access new medicines. So it really involves identifying barriers to access that patients might face, including affordability, availability and planning for regulatory approval proactively and looking at barriers and how you can overcome them.

And really, these should be started early on in the development phase during clinical trials. And over the years, we have noticed a trend in companies mainstreaming policies for access planning within their R&D practices. However, we don’t see the implementation of those policies wide scale.

And although 62 percent of the trials that we analysed did have access plans in place, the plans are very limited and really only focus on a very small cohort of countries. And for pipeline assets for cancer, they are actually less likely to have access plans in place for other compared to other therapeutic areas. So 44 percent of the cancer trials we looked at had an access plan in place for any LMIC compared to 72 percent for communicable diseases.

And I think one of maybe of the explanatory factors for that is that a lot of the communicable disease developments are developed in conjunction with public health partners who fund the development and they incorporate provisions for access early on in development. So it really does indicate that the pharmaceutical industry is investing heavily in oncology. Their access plans in this therapeutic area are lagging behind, which only serves to drive global inequities in access to oncology medicine.

Next slide, please. So this slide just gives an overview of the different types of access strategies that companies use for products that are already on the market. So as part of our analysis, we analyzed 140 products made by these companies, 40 percent of them were for different types of cancer, which speaks to how the industry really is prioritizing oncology medicines.

And companies can use a wide range of different strategies based on the economic and health care context of each region. And effective implementation does require understanding of local challenges as well as leveraging partnerships to ensure medicine reach those that need the most. So in upper middle income countries, we see that companies are engaging in public reimbursement mechanisms with governments, having innovative pricing models and differential pricing.

However, obviously, this is only an avenue that companies can engage in if the public health infrastructure is there to reimburse the products. Other strategies we’ve seen include second brand strategies where companies introduce lower cost version of branded products. And this is an effective strategy to improve affordability while also maintaining the quality assurance of recognized branded products.

And for oncology, we do see strategies in upper middle income countries and lower middle income countries to support out of pocket payments and alleviate financial burden for patients. For example, patient assistance programs. And on the other side, we see donations as an avenue to reach the most vulnerable patients in the lowest income groups, particularly if there’s not a viable market to sustain sustainable access.

And but two of the main models that I wanted to talk to you about today, mostly because of positive trends we’ve seen in them and also their potential for scalability for oncology medicines are inclusive business models and voluntary licensing. And next slide, please. So what is voluntary licensing? It is an agreement between a patent holder, which in this case is the pharmaceutical company who owns the patent rights to the innovative medicine.

And in this agreement, they permit generic manufacturers to produce, distribute or sell the medicine under specific terms and conditions. And really, these agreements offer several potential benefits. If the innovative pharmaceutical company does not intend to launch the product in the low and middle income countries for both the public health perspective, but also from the perspective of commercial sustainability and increased generic competition lowers the cost of drugs, which facilitates access for patients in low income groups.

And by making generic versions available before the patent expires, patients are more likely to receive timely access to treatments. If you are waiting for a patent to expire, this could result in years of delays, whereas with the licensing mechanism, patients can access generic medicines when this product is still on patent. And when also reducing the price for patients, licensing also allows pharmaceutical companies to retain a share of revenue because many companies charge royalties on the sales from the generic companies.

So this maintains an incentive for the companies and also for ongoing innovation. And the model has been used very successfully for antiretroviral drugs and hepatitis C and other infectious diseases. And we did see an upsurge in some of these agreements in our previous publication in 2022 for COVID pandemic therapeutics.

However, despite the successes, it really remains an underutilized tool in therapeutic areas such as oncology and really more initiatives are needed to scale its impact for a broader range of cancer medicines. Two years ago, during our current period of analysis, we did see the first agreement of its kind for a cancer drug, nilotinib, which is manufactured by Novartis. And this agreement was agreed through an intermediary, a UN-backed public health organization called the Medicines Patent Pool, who are based in Geneva.

And it really did signify a shift within the narrative around voluntary licensing, which up until then had been only utilized for infectious diseases. And it also set a precedent for expanding voluntary license beyond infectious diseases into other noncommunicable diseases. That being said, since that license has been issued, there hasn’t been any other move from pharmaceutical companies to follow suit, despite the cautious optimism that we had two years ago.

And the Medicines Patent Pool has actually published a report on which oncology medicines should be prioritized for licensing. They include Pembrolizumab from Merck and Trastuzumab from Roche. And they have done studies to show that expanded access to generic versions of these medicines would have a significant public health impact in low and middle income countries.

Next slide, please. And the last mechanism I wanted to talk to you about was inclusive business models. And so an inclusive business model is a strategy that integrates underserved populations, particularly in low and middle income countries, into the value chain as customers, suppliers or distributors in ways that are both commercially sustainable for companies and socially impactful.

So historically, most of the medicines reaching very low income groups were through donation programs from companies or corporate social responsibility initiatives or also through the donor driven model, which we’ve seen you successfully for vaccines and HIV. And of course, these strategies were very successful in addressing some critical health care gaps. But really, we are advocating for more comprehensive, tailored and inclusive approaches to successfully address chronic issues in the long term.

So these models vary in type and in implementation, but a key and key to all of them is they focus on partnerships to tackle access barriers. And they really have long term plans for scalability to include other therapeutic areas and other countries. And different from licensing, these inclusive business models include a large number of products that pharmaceutical companies make within their scope, whereas licensing really only refers to one medicine.

So this year in our index, we identified five companies in particular that had launched inclusive business models with comprehensive approaches to facilitate access. And these models are all at different stages of implementation. And there is certainly room for scalability.

But we see this as a positive trend towards maintaining sustainable access in low and middle income countries. Four out of these models supply oncology medicines indicated for a range of different cancer types, including colorectal cancer, leukemia and breast cancer. And collectively, they cover over 102 countries, including all low income countries.

And as I mentioned, there are different stages of implementation. So really, I feel we are yet to see the true outcome of some of these initiatives. And we did find that only one company is comprehensively reporting on the outcomes, including patients reached during this model.

However, we do see it as a positive shift because we see the potential for scalability of these models to more disease areas, including oncology. And because they are revenue generating for the company, it means that they are more sustainable approaches rather than the donor driven models that we have previously seen relied on in low income contexts. And I really would encourage other companies to follow suit.

And we think it’s imperative that companies consider sustainable access as a part of their core value to impact patient outcomes in low and middle income countries. And I think we’re almost at time, but I just wanted to finish on the last slide, which gives an overview of some of the global media outreach that we’ve had for our most recent publication. And we firmly believe that those working in the public health space and in health care can help amplify the message to push the industry to improve access to low and middle income countries.

We really feel that improving access to oncology medicine is not just a business imperative for companies. It should be a moral responsibility. And by prioritizing access, the pharmaceutical industry can transform lives and achieve sustainable growth in underserved markets.

Thank you very much.