The 2022 Access to Medicine Index finds that, since the COVID-19 pandemic hit, more pharmaceutical companies stepped up to make some of their products more widely accessible in low- and middle-income countries (LMICs).
If COVID-19 is to be a turning point in global health, the challenge now is for companies to expand access to more of their products – and in a greater number of countries – to reach people across LMICs.
As the world emerges from the worst of the COVID-19 crisis, pharmaceutical companies are now at an important juncture, where lessons learned from the pandemic can prove pivotal in finding solutions to bridge long-standing gaps in access to medicine in LMICs.
The 2022 Access to Medicine Index, published today, shows that more companies have stepped up and moved in the right direction – including some companies that were previously less likely to take action.
For the first time, all 20 companies in scope report an access-to-medicine strategy, with 19 integrating this into their overall corporate strategy.
The Index also finds examples of companies that are increasing access and strengthening delivery of their products in LMICs, with GSK, Pfizer and Takeda standing out for their strong equitable access strategies across different country income classifications.
Additionally, more companies have engaged in voluntary licensing agreements, making their on-patent products available for generic manufacturing.
This can increase regional availability, supply and affordability of new and innovative medicines that would otherwise not reach people living in many LMICs.
However, much of this progress is disproportionate, with low-income countries still widely overlooked in comparison to middle-income countries.
Pfizer and Sanofi do report ambitious new commitments in these countries. If such commitments are successfully translated into action going forward, more people with the greatest need stand to benefit.
“Pharmaceutical companies have responded to the inequity in access to medicine laid bare by COVID-19 – including committing to addressing this in many countries.
If they can deliver on these ambitions and reach patients quickly and broadly, it will be a breakthrough in solving persistent gaps in global health equity,” says Jayasree K. Iyer, CEO, Access to Medicine Foundation.
Planning for equitable access needs be comprehensive, beyond product launch
To ensure people in LMICs have access to new and innovative medicines and vaccines as soon as possible after they are launched, companies ideally need to have an access plan in place for products in the pipeline from at least Phase II of R&D (‘late-stage’).
Six companies – Astellas, Boehringer Ingelheim, Johnson & Johnson, Merck, Novartis, and Takeda – now have access plans in place for all of their late-stage R&D projects, marking the first time any of the 20 companies have reached this milestone.
While this progress is encouraging, only 15% of access plans across the companies in scope include one of the 27 low-income countries, with the 26 upper-middle income countries far more likely to be considered in companies’ access plans for an R&D project.
Some companies have access plans that are more comprehensive and include low-income countries.
For example, Novartis includes five low-income countries in clinical trials for cipargamin (KAE609), for the treatment of severe malaria; in line with its post-trial access policy, the company commits to registering the medicine in those countries once approved.
Takeda’s access plan for its dengue vaccine QDENGA® (TAK-003) considers burden of disease in terms of it plans to file for registration, as well as innovative equitable pricing models and methods to ensure sustainable cold chain supply.
The vaccine received its first market approval in August 2022, and European Medicines Agency (EMA) approval is pending.
While the industry-wide improvement in planning for access during the R&D stage is encouraging, companies need to consider the sustainable and affordable supply of the new and innovative medicines they launch.
Here, entering into voluntary licensing agreements can play a crucial role by allowing for the introduction of low-cost generic medicines – particularly if companies do not intend to launch their own branded products in particular LMICs.
One of the key findings of the 2022 Index is that companies are increasingly engaging in non-exclusive voluntary licences (NEVLs), whereby multiple generic manufacturers are authorised by the patent holder (pharmaceutical company) to develop and manufacture generic versions of patented medicines, often in different countries.
During the period of analysis, six companies entered into new licensing agreements, three of them for the first time: AstraZeneca, Eli Lilly and Novartis. While much of this trend is driven by companies engaging in voluntary licensing for COVID-19 products, it opens the door for more companies to consider entering licences for a wider range of medicines, including novel therapies and products for non-communicable diseases (NCDs).
Novartis’ NEVL for a leukaemia medicine with the Medicines Patent Pool – the first such agreement covering an NCD – is significant. Going forward, more companies need to engage in NEVLs, covering a wider range of diseases and countries, earlier in products’ lifecycles, and with access-oriented clauses.
“The 2022 Index finds that industry-wide improvement in planning for access and expanding access strategies still overlooks low-income countries. Companies must consider the depths of their plans, strength of their supply chains, and equity of their pricing strategies to reach the most vulnerable populations,” says James Hazel, Research Programme Manager for the 2022 Index, Access to Medicine Foundation.
AstraZeneca rises to the top three, Merck joins the top five
The Access to Medicine Index ranks 20 of the world’s leading research-based pharmaceutical companies on their actions to improve access to medicine in 108 LMICs.
Although GSK retains the number one spot this year, it is followed closely by Johnson & Johnson and AstraZeneca, the latter having newly joined the top three.
GSK leads by engaging in R&D to develop treatments for diseases that disproportionally affect people living in LMICs and by applying tailored access strategies across product categories, including licensing.
AstraZeneca takes the top spot in the area of Product Delivery by excelling in its approach to patent transparency and technology transfers.
For the first time, Bayer has joined the top ten, improving its performance in R&D – with the broad geographic reach of its R&D plans highlighted as a best practice in the 2022 Index.
Merck joins the top five. It excels in R&D access planning, with access plans in place for all late-stage R&D projects, in addition to performing strongly in its approach to patent transparency.
R&D for emerging infectious diseases that could trigger next global health crisis
Successive editions of the Index show that prior to the COVID-19 pandemic, pharmaceutical companies were largely not engaging in R&D for emerging infectious diseases (EIDs), including coronaviruses that had already been identified as having pandemic potential.
Unfortunately, the 2022 Index finds that the pipeline for R&D projects covering EIDs (excluding COVID-19 and other coronaviral diseases) has remained mainly empty.
Only five of the 20 companies in scope – Bayer, Johnson & Johnson, Merck, MSD and Takeda – are active in this area, and they target a small number of EIDs that are seen as being able to trigger the next pandemic or serious epidemic.
Despite this stark picture, there have been significant successes in R&D for EIDs. Johnson & Johnson’s two-shot Ebola regimen (Zabdeno® & Mvabea®) was approved, and Bayer’s vector control product (Fludora® Co-Max), used to control adult mosquitos that potentially carry diseases such as Chikungunya and Zika, received World Health Organization prequalification, with the company also providing evidence that it plans to register the product in several countries in scope of the Index.
As the risk of EIDs increases globally through climate change, urbanisation, globalisation and migration, more companies will need to invest in R&D across a wider scope of these diseases and engage in access planning in tandem with developing products. Over and above the global risk, many people living in LMICs already face the threats of EIDs – with recent outbreaks of Ebola, Marburg virus and Lassa Fever illustrating the urgent need for vaccines and treatments.
* 2022 Access to Medicine Index period of analysis: 1 June 2020 – 31 May 2022