Some progress, but Big Pharma not moving fast enough to deliver access

The Access to Medicine Foundation has a message for the pharmaceutical industry: While the effort to get their products to people in low- and middle-income countries has accelerated, companies are not moving fast enough. With the latest version of the Access to Medicine Index, released today, the foundation continues a biennial tradition of ranking 20 of the world’s leading pharmaceutical companies based on how they prioritize access issues; target research and development toward diseases that disproportionately affect LMICs; and actually ensure that drugs and products reach the people who need them. While some companies have accelerated their efforts, including Novartis, which shot to the top of the rankings after finishing fourth in 2022, the overall takeaway is “we expected the pace of industry progress to be higher,” Jayasree Iyer, CEO of the Access to Medicine Foundation, told Devex. Compared to the 2022 report, “the pace was not where it needs to be.” The good news is that access is squarely on the agenda. Indeed, 17 of the 20 companies have elevated access to a direct board-level issue. Astellas, Daiichi Sankyo, and Merck & Co. offered evidence of only indirect board-level responsibility. But, for the most part, the multinationals have steadily been expanding the availability of their products in LMICs, often in the form of inclusive business models. In particular, Bristol Myers Squibb, Novartis, Novo Nordisk, Pfizer, and Sanofi have models in place that collectively cover 102 nations, including all low-income countries. The index praises the models for taking into account issues such as health system capacity and supply chain constraints and for prioritizing treatments for noncommunicable diseases, which have historically been overlooked. Lutz Hegemann, who is the president of global health and sustainability at Novartis, told Devex that expanding access to innovative medicines has been a goal for the company for more than a decade. Novartis was one of the first to launch an access framework and has pushed to reduce the lag time between the introduction of new products in high-income countries and the rest of the world. Hegemann said that the index has played a role in spurring improved access, primarily by giving the company insights into the steps its rivals are taking. “It’s inspiring to look across the sector,” he said. “We have had situations where we have said, this works well in this company. Can we potentially adopt it to create greater impact?” However, across the board, access strategies still remain disproportionately skewed toward upper-middle-income countries. Of the products the index assessed, there is no access strategy in low-income countries for 61%. That is a slight improvement over 2022 when the rate stood at 65%. The other problem is that it’s not clear how well companies are executing the strategies they do have in place to reach LMICs. That’s because there is a lack of information about whether products are actually reaching patients. Of the five models that the index highlights, only Sanofi offers clear figures on how many patients are being reached. AbbVie, which came in last in the overall rankings, was also the only company not to share any information on how it measures patient reach. “We need a stronger push for the companies to deliver on their models,” Iyer said. “As a global society, we have to do our part to make sure that becomes a reality.” Another key challenge is that companies do not appear to be prioritizing research and development into vaccines and treatments for the diseases that disproportionately affect LMICs. In the 2022 index, there were 367 projects in the pipeline that would have an outsized benefit in LMICs, versus 253 in the 2024 edition. That doesn’t mean there aren’t any promising candidates, though. There could soon be both a maternal vaccine from Pfizer and treatment from AstraZeneca/Sanofi for respiratory syncytial virus, which kills 100,000 children each year, almost all of them in the global south. GlaxoSmithKline is pursuing a new tuberculosis treatment. Novartis has two malaria products under development, including a treatment that does not rely on artemisinin. Currently the backbone of standard treatment, there are rising concerns about resistance to artemisinin, spurring a search for other options. Hegemann said Novartis is committed to making both malaria products widely available as soon as they are approved. He said the company would pursue a “not-for-profit approach and to work together with our partners to ensure that the medicines get to the patients.” To help make those and other new products available as quickly as possible, the index flagged key steps the industry broadly could take. That includes issuing voluntary licenses for products. These agreements, in conjunction with technology transfers, can ease local, affordable production of products. But in the period that the foundation monitored, only two voluntary licenses were issued. Gilead announced that it would issue voluntary licenses for the HIV prevention tool lenacapavir in the period outside the foundation’s analysis. Another issue that the foundation raised in this year’s index is the shortage of clinical trials for new products in LMICs. Only 43% of the 685 clinical trials the foundation analyzed were conducted outside of wealthier countries. “If a company is serious about access, then you do need to make sure that diverse populations around the world are part of your clinical studies, and you’re designing a product that is going to be useful for different populations around the world,” Iyer said. In addition, running a clinical trial can jump-start the registration processes for the product so that, if it is ultimately approved for use by local regulators, it can shorten the time it takes to get the product on the shelves. This could help shore up a key gap in Africa in particular, where many companies aren’t even bothering to register all of their products. The index found that 43% of the new, innovative medicines and other products that received regulatory approval over the past five years were not registered anywhere on the African continent. Iyer said that the issue of access is more important than ever following Donald Trump’s reelection as president of the United States. She said there is a risk that any instability created around questions of drug pricing or delivery in the U.S., for instance, could distract pharmaceutical companies from global health. “A lot of companies will also have to deal with the rise of misinformation and communication forces on top of that, when they should be keeping their eye on the ball when it comes to access and the gaps there,” she said.