Is the industry doing more to improve access to medicine?
The analysis presented here is based on the comparison of the 2021 Index main findings with the 2018 Index and the 10-year analysis report to assess progress made by the industry. Although the methodology has been updated with a new robust framework since 2018, viable comparisons have been drawn in the core technical areas assessed by the Index to drive action in the industry.
Pharmaceutical companies align business with access to medicine
The 2021 Index findings show that five new companies have updated their business rationale and adopted an inclusive business model, aimed to be inclusive of underserved populations. A total of 15 business models have been newly launched by seven companies, while six existing inclusive business models have been scaled up to include additional countries in scope since 2018.
The increasing number of companies implementing new inclusive business models and scaling up the existing ones suggests there is more commitment to considering the vulnerability of different patient groups which may face additional barriers to access within countries in scope of the Index. The scale-up in the last 4 years indicates that local strategies have been successful, sustainable in the long term and adaptable to different contexts. Since 2018, the number of companies decoupling sales agents’ rewards from sales volume targets only has risen from nine to 12. Since 2018, Astellas, Bayer and Johnson & Johnson newly demon-strate policies to mitigate unethical behaviour by decoupling incentives for sales agents from sales volume targets only.
Progress in R&D since 2018
The analysis showed that most of the R&D projects assessed in the 2021 analysis target diseases which are considered priority for global health by WHO and Policy Cures Research. Since 2018, the number of R&D projects targeting priority diseases has increased from 38% to 66%. The longitudinal analysis also showed that the number of R&D projects targeting maternal and neonatal health conditions has increased from 9 to 10 since 2018.
With regard to the health products newly introduced to the market, the Index 10-year analysis showed that at least 171 new health products had been approved since 2010. In the last two years, another 78 health products have been marketed, making the total number of new product approvals to at least 249 since 2008. However, most of the newly approved products still target the more profitable non-communicable diseases over communicable diseases. The 2021 analysis showed that only two recently approved products target NTDs
Inconsistent uptake of voluntary licensing
According to the 10-year analysis report, the number of companies entering into voluntary licensing or non-assert agreements remained equal to seven. The number of licensed compounds had increased from 18 to a maximum of 22 between 2016 and 2018, with new compounds for hepatitis C treatment (3) and HIV (1) marketed and licensed.
This longitudinal analysis demonstrates that licensing has remained confined to a small group of companies and diseases. Nevertheless, it has the potential to be a more beneficial tool which can lead to expanding access to more products targeting a range of diseases and more countries in need and specifically non-communicable diseases.
Slight increase donation programme activity
The number of companies engaging in donation programmes for neglected tropical diseases (NTD) as well as the number of structured programmes have slightly increased in the last 12 years. This reveals an increment in adopting donation as a pro-access tool and the companies’ commitment to ensuring access to their donated products. Some existing donation programmes targeting the same disease and offering the same products have been merged into one single programme.
More companies disclose patent status
Disclosing patent status information is another way to improve access to medicine, specifically by facilitating increased supply as well as affordability. Transparency on the patent status (where patents are filed) gives greater certainty to international drug procurers and generic medicine manufacturers when planning the manufacture and/or supply of generic products.
Since 2014 the number of companies disclosing at least some information have constantly been increasing. According to the 2021 analysis, almost all the companies share patent status data for some of their products with stakeholders. Most of the data is shared through the online database Pat-INFORMED, while few companies self-publish patent information online.
Progress in health system strengthening, supply and R&D capacity building, leaving manufacturing behind
Health system strengthening, manufacturing and supply capacity building initiatives represent additional ways in which the pharmaceutical companies can improve access to medicine and address issues in health product availability and accessibility (e.g. appropriate prescription, efficient administration). The 2021 Index finds that companies have been engaging in more and better-quality health system strengthening initiatives compared to the 2018 Index analysis. In the last two years the companies have adopted a more sensitive and solid approach to ensure the quality of their initiatives and that they meet the health needs of specific patient populations and communities.
According to the 2021 Index findings, pharmaceutical companies have improved in the supply chain and R&D capacity building areas, as well. However, companies’ efforts remain focused on the same geographic regions and disease areas as in 2018, with most R&D capacity building initiatives focusing on communicable diseases in sub-Saharan Africa. In contrast to health system strengthening and supply chain strategies, the number and the quality of manufacturing capacity building initiatives has decreased in the last two years, suggesting an overall negative trend in this area. Although the number of companies implementing manufacturing initiatives is still 15 as in 2018, with technology transfers leading the local manufacturing strategies, the number of initiatives meeting the Good Practices Standards is lower.