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We need companies to apply access approaches more systematically, consistently and at a larger scale 

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The recently released ‘2021 Access to Medicine Index’ assesses pharma companies in 106 low- and middle-income countries, including India, on their actions to improve equitable access to products on the market and to make new products available. It covers 82 diseases, conditions and pathogens, including common killers, such as HIV and AIDS, TB and malaria, lower respiratory tract infections, diarrhoeal diseases, maternal health conditions and cancers. Claudia Martinez, Lead for the Access to Medicine Index shares more insights from this year’s report and recommends steps to mitigate the gaps in R&D and access strategies identified, in an interaction with Lakshmipriya Nair

 

The Access to Medicine Index points out that despite the COVID-19 pandemic, pharma companies still not targeting all priority pathogens with epidemic potential through R&D? Can you elaborate why they do not get the focus they deserve? Why is the industry, on a global level, shying away from making the required investments?

Investment into infectious diseases offers limited commercial prospects for pharma companies compared to other disease areas, such as oncology. The sustained supply of products like vaccines and antibiotics requires high investment and risk, yet the price is low. As a result, over the last years, several companies have shifted resources away for infectious diseases to focus on more profitable areas. Governments and international organisations have stepped up to fill the gap, yet R&D investment in infectious diseases outside HIV/AIDS, malaria and tuberculosis, still lags behind. Solving this issue will require a rethink of the commercial model and incentives underpinning this market.

 

The Access to Medicine Index finds that “the industry’s response to COVID-19 has been vigorous in some regards, but revealed little preparedness for the next pandemic.” What are the measures that can be implemented to circumvent this problem and prepare the world better for the next pandemic?

Action is needed in multiple areas. Firstly, companies do not need to wait for an epidemic or new strain to emerge before starting R&D against EIDs. They can share IP, (e.g., with CEPI – Coalition for Epidemic Preparedness Innovations), repurpose existing medicines, look at vector control products, and develop rapid diagnostics or new adjuvants (to boost immune responses).

 

It is also crucial that companies manage their intellectual property rights responsibly. As the pandemic accelerated, companies began sharing intellectual property assets, such as compound libraries, with research groups working on COVID-19. Companies should share IP assets for other EIDs so that these can be put to full use preparing for the next pandemic (e.g., unpublished clinical trial data, pre-clinical compounds matched with specific targets, or innovative but unpublished processes). When it comes to patents, companies should either proactively engage in voluntary licensing to enable generic manufacturers to boost supply, or publicly waive patent rights. Several licensing decisions relating to COVID-19 have been announced (e.g., Serum Institute of India is producing AstraZeneca’s COVID-19 vaccine under licence).

 

Finally, more needs to be done to build supply chain resilience. A limited number of companies demonstrated the ability to react to and anticipate supply disruptions. Specialist teams dedicated to ensuring continuous supply in LMICs and LICs should become standard in pharma companies’ toolkits against pandemics, as well as actions to improve local availability through capacity building initiatives with local manufacturers.

 

A 10-year analysis of Index trends published in 2019 found there had been an increase in access and affordability strategies by pharma companies, but progress is still only gradual. What can be done to accelerate this progress? Where are the gaps in the existing strategies?

Companies’ access strategies are heavily focused on patient assistance programmes and equitable pricing strategies, such as income-tailored pricing. We need companies to apply access approaches more systematically, consistently and at a larger scale – both in terms of the number of patients reached and their geographic scope. The Index reports that people living in low-income countries (LICs) (As defined by the World Bank) are being consistently overlooked by companies when it comes to access strategies and that this is the case across all products, including healthcare professional-administered and the self-administered products. To address this, companies should look at implementing price reductions or segmentation aimed at affordability, especially in LICs. They should look at improving transparency in terms of patients reached so access gaps can be identified and filled.

 

Can you cite some examples of great access strategies by pharma companies, governments? How can they be enlarged, replicated in scale and scope?

Below are some selected examples of companies’ access strategies:

  • Novartis is the only company applying access strategies across the three product categories assessed by the Index: products procured at the supranational level, healthcare-administered and self-administered products. For instance, Novartis (Through its generic division, Sandoz) is increasing access to three important tuberculosis (TB) medicines (pyrazinamide/ethambutol/rifampicin/isoniazid [Rimstar 4-FDC], rifampicin/isoniazid [Rimactazid] and clofazimine [Lamprene]) via supranational agreements with the Global Drug Facility. An interesting example of a healthcare administered product would be Novartis’ work its in-country partner Cipla in India to launch an emerging market branded version of omalizumab (Xolair), a treatment for asthma to serve different income strata, in parallel to the original brand to improve affordability.
  • Takeda’s patient assistance programme (PAP), initiated in 2017, considers all population segments in upper-middle-income countries (UMIC), low- and middle-income countries (LMIC) and low-income countries (LIC) to ensure broad affordability of its health products. The company first focused on brentuximab vedotin (Adcetris), an oncology medicine for lymphoma, with Thailand offering an inclusive, comprehensive example of Takeda’s intra-country pricing approach.

More systematic application of these approaches is critical to ensure that access strategies are replicated and scaled up. This is also enabled by the sharing of best practice examples by different companies.

 

Can you elaborate on the role of stakeholders, funders and governments to usher a systematic change in the way research is done and shared?

When governments put money on the table to incentivise R&D into infectious diseases, conditions should be attached to ensure any successful product is also made available to people living in low- and middle-income countries, with equity of access being an underlying principle. Similarly, investors should also be aware of when pharmaceutical companies make strategic decisions to leave the infectious disease space and see that as a material risk.

 

What role is Access to Medicine Foundation ready to play in bringing about this transition? 

The Access to Medicine Foundation plays a unique role in driving this change. Integral to our approach is to build consensus on where pharma companies can and should be taking action to improve access to medicine. Every two years, we translate the stakeholder consensus into clear metrics for measuring company behaviour, which we publish in our methodology reports. Our research ranks the companies on access to medicine to stimulate competition and encourage companies to address priority health targets and topics. We engage directly with companies on what our research means for their specific organisation, portfolio and pipeline, just as we reach out to investors and policy-makers to facilitate the uptake of best practices and the development of new approaches to long-standing barriers to access. 

 

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