Embedding access-to-medicine thinking in the strategic approaches of companies
At the Access to Medicine Foundation, we have demonstrated our ability to trigger progress from companies to improve access to medicine in low- and middle-income countries (LMICs) across all our research publications, including each iteration of the Index and Benchmark.
While there is still much more work to be done by companies within healthcare sectors, for example in expanding equitable pricing strategies and R&D for emerging infectious diseases and antimicrobial resistance (AMR), our publications have triggered and tracked substantial changes and clear longitudinal global health progress across a variety of areas measured through our research. For example, the 2021 Access to Medicine Index findings demonstrated a marked shift in the industry and significant progress over the previous decade with bringing access to medicine into the mainstream.
In 2022, all pharmaceutical companies included in the Index set targets and goals related to access-to-medicine initiatives, embedding this practice in their company ethos and approach to access. This accomplishment demonstrates an improvement since 2016, when 17 companies were doing so, and a considerable improvement since 2010 when only 8 companies had clearly defined access-related goals. Since we started measuring progress on this core access starting point, company progress improved from a minority to the majority and then to all companies following suit, demonstrating that, as Margaret Chan, Former Director General of the World Health Organization has said, ‘’What gets measured, gets done.’’
Encouraging a systemic approach to planning ahead for access while projects are still in the R&D pipeline
Another area where we have seen significant progress in recent years is in access planning. In 2014, the Access to Medicine Foundation began calling for companies to plan ahead for access while projects are still in the development phase (Phase II and onwards).
Access planning encourages companies to develop concrete plans to make successfully approved products available and affordable to people living in LMICs at the same time as they become available in high-income countries. These plans may include commitments to filing for registration with regulatory authorities in LMICs to ensure early availability, as well as equitable pricing strategies, non-exclusive voluntary licenses with generic manufacturers, and other measures to ensure supply can meet global demand.
For new antibiotics and antifungals, it is also important to combine access plans with stewardship plans, to help ensure that innovative new products required in the fight against drug-resistant infections reach those most in need, while simultaneously protecting such critical products from developing resistance. This can be achieved through advance planning for resistance surveillance, appropriate prescribing measures, and supply chain strengthening to prevent shortages and stockout that can contribute to resistance. The COVID-19 pandemic has shed new light on the importance of access planning and maintaining that companies don't see access in LMICs as an afterthought.
Over the years, we have utilised its three-part model for change that includes building consensus, stimulating competition and sharing best practice, to mobilise our wide array of stakeholders and identify key change-making moments to encourage companies to improve their performance in access planning.
For example, in 2019, the Access to Medicine Foundation hosted an interactive workshop, called an “Amsterdam Session,” capitalising on our convening power to bring experts from pharmaceutical companies, NGOs, governments and investors together to identify steps companies can take to ramp up progress on access planning during R&D. During the session, pharma company representatives presented their respective approaches to systematically developing effective access plans during development and the run up to a product's first global launch.
Furthermore, the Access to Medicine Foundation collaborated with a working group of experts, including CARBX, GARDP, the Wellcome Trust, and the US and UK governments, to develop the first ever comprehensive Stewardship and Access Plan (SAP) Development Guide. The tool sets out the practical and early actions that pharma companies and product developers can take to ensure swifter access to new antibacterial products at affordable prices, while ensuring responsible use. Following the launch of the tool, the Antimicrobial Resistance (AMR) Benchmark, published in 2021, saw a roughly 60% increase from the previous Benchmark in projects in the pipeline with Stewardship and Access Plans attached to them - clear and tangible progress.
The AMR Benchmark has closely examined this area since the first report in 2018, when only a handful (7%) of antibiotics in late-stage clinical development had both access and stewardship plans in place. By 2021, this had risen to 90% of late-stage R&D projects for medicines, setting a clear precedent and demonstrating a marked shift in the thinking of companies in how they approach access and stewardship.
Additionally, the 2022 Index found that fifteen companies, up from up from eight in 2021 and one in 2018, are taking the lead in developing structured approaches for pairing each R&D project with a plan to achieve this aim soon after the first global launch.
In September 2020, Patrice Matchaba, Group Head, Global Health & Corporate Responsibility at Novartis, publicly re-committed to developing access plans stating that: “Our current goal is that 100% of all launch products must have an access plan […] and once we’ve completed that, the holy grail is to look at access at end of Phase II.” The 2021 Index found evidence of access planning in place for Novartis’ R&D projects in late-stage development, a clear improvement from 2018. The 2019 Novartis in Society Report publicly recognises that Novartis looks at the opportunities included in its Company Report Card in the Access to Medicine Index to prioritise actions to improve access to medicine.
In 2020, the Foundation commissioned an external evaluator to conduct an independent evaluation of the progress of the Foundation in advancing access to medicine in LMICs. This evaluation focused on assessing the influence of the Foundation on the pharmaceutical sector, progress and impacts on the ground achieved by pharmaceutical companies’ actions, as well as exploring the mechanisms through which the Foundation influences companies to achieve positive change. This evaluation also assessed the value for money (VfM) of the Foundation to current and prospective funders. In essence, the evaluation was carried out in order to confirm or dismiss the validity of the Foundation’s Theory of Change and effectiveness of our mechanisms of influence.
This independent evaluation provided insights into the Foundation’s reputation and influence within the pharmaceutical industry, reporting that: “For the development of its Access Principles, Novartis sought input from the Foundation. Other companies, such as Takeda, have also indicated that the Foundation’s engagement has been important in helping to generate internal support for access planning during R&D and for articulating strategies on how to do this."
The evaluation also states that "the Foundation’s contribution to driving company’s attention for early access planning will have tangible long-term impacts for people in LMICs.”
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