Industry makes progress on access strategies and voluntary licensing for products, but overall picture mixed

Each product in a pharmaceutical company's portfolio should have an access strategy to ensure it is widely available and affordable in low- and middle-income countries (LMICs). Equitable pricing and non-exclusive voluntary licensing (NEVL) are two important mechanisms that companies can use as part of an access strategy to increase access to a product. Furthermore, patent transparency is an important tool to ensure generic manufacturers can quickly enter the market once the original patents on a health product expire.

This section shows how companies have developed their access strategies since the 2021 Index. It also looks at how companies have progressed in NEVL and patent transparency over past Indexes.

More products now covered by access strategies

Since the previous Index, there has been a significant increase in the number of products in scope that are now covered by an access strategy. Access strategies can include, for example, pricing strategies, non-pricing initiatives (e.g., patient assistance programmes, non-exclusive voluntary licensing, donations) or a combination of pricing strategies with non-pricing initiatives.

It is important that companies put access strategies in place for both self-administered products and healthcare practitioner (HCP)-administered products. However, as in the 2021 Index, HCP-administered products continue to be covered by fewer access strategies compared to self-administered products in upper-middle income and lower-middle income countries. Access strategies are also far less likely to be used to expand access to products in low-income countries, compared to upper-middle income countries and lower-middle income countries.

Compared with the 2021 Index, data analysed in the 2022 Index shows an increase in the number of companies engaging in supranational agreements.

AstraZeneca now supplies products via supranational agreements, and in countries not eligible for international procurement processes. The company, along with Pfizer, also has access strategies that include the same terms as supranational agreements. As the figure shows, this has slightly increased the proportion of the products in scope that are covered by these access strategies. Data analysed in the 2022 Index shows progress in the percentage of products covered by an access strategy in countries outside supranational agreements. A smaller percentage of products are not covered by access strategies in non-eligible countries.

Increase in voluntary licensing is mainly related to COVID- 19 products

Engaging in NEVLs is one way that research-based pharmaceutical companies can ensure that key healthcare products, or the compounds vital to making those products, reach more people who need them – particularly those living in LMICs. When companies offer NEVLs, this can facilitate the entrance of generic manufacturers to market, making medicines more affordable and accessible.

AstraZeneca, Eli Lilly and Novartis have entered into new licensing agreements since the previous Index. There are now 27 licenced compounds, which include three new NEVLs for COVID-19 treatments and one private voluntary licence for a COVID-19 vaccine (in addition to the COVID-19 product already covered by a licence in the 2021 Index). Although more companies are getting involved in licensing agreements, the transparency, quality and breadth of these licences vary.

Number of companies disclosing patent status for some of their products remains high

When companies publicly disclose patent status data about their products – i.e., sharing information about where patents are filed – this transparency can bring significant benefits in terms of access to medicine. In particular, it provides greater certainty to generic medicine manufacturers and international drug procurers when planning the manufacture and/or supply of generic products, thereby facilitating increased supply and affordability.

Of the 20 companies, 19 publicly disclose information on the status of patents related to at least some of the products in their portfolio, the same number as the 2021 Index. Most of the data is shared through the online database Pat-INFORMED – an initiative coordinated between the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and the World Intellectual Property Organization (WIPO) – while a few companies self-publish patent information online.

Progress in capacity building in R&D and manufacturing, but stagnation in health systems strengthening

Capacity building initiatives focused on health systems strengthening, manufacturing, supply chain and R&D represent additional ways in which pharmaceutical companies can improve access to medicine and address issues in health product availability and accessibility (e.g., appropriate prescription, efficient administration).

Overall improvement in proportion of initiatives meeting all Good Practice Standards

For almost all fields of capacity building, improvement has been seen in the percentage of initiatives included that meet all Good Practice Standards (GPS); overall, 21 additional initiatives meet all GPS compared with the previous Index. The most significant improvement was seen in R&D capacity building, with an increase of 34 percentage points. Supply and manufacturing had smaller increases of 18 and 26 percentage points, respectively. For R&D capacity building, 11 more initiatives were included compared with the previous Index. In both supply chain and manufacturing capacity building, 13 new initiatives were included for analysis.

However, the number of high-quality capacity building initiatives focused on health systems strengthening has stayed relatively stable. In the 2021 Index, analysis showed that health systems strengthening initiatives were improving in terms of quality and quantity. In the 2022 Index, while seven new initiatives have been included for analysis, only two more initiatives meet all GPS, thereby reducing the overall percentage of health systems strengthening initiatives that meet all GPS.

Progress in outcome measurement focused on R&D capacity building

Measuring and sharing outcomes can provide valuable insights that can improve ongoing projects and inform future activities. Because of this, measuring capacity building outcomes is one of the GPS for manufacturing, supply and R&D capacity building, and publicly disclosing outcomes is a GPS for health systems strengthening. Outcome measurements across capacity building can include changes in patient health outcomes, quantity of donated equipment, evidence of patient reach or decreased stockouts in pharmacies.

Since the last Index, companies have especially done more to measure outcomes of R&D capacity building. Improvement in outcome measurement was also seen in supply chain capacity building initiatives, but no improvement was seen in measuring outcomes of manufacturing capacity building initiatives.

The Index measures whether companies both measure and publicly disclose outcomes of health systems strengthening initiatives. In the 2022 Index, only a marginal improvement in public disclosure of outcomes was seen across health systems strengthening initiatives.

Five-fold increase in scaled-up inclusive business models since 2021 Index

Since 2014, when inclusive business models were first assessed in the Index, ten more companies are engaged in inclusive business models, with 16 companies currently engaged in 51 inclusive business models.

This change reflects companies’ efforts to address unmet health needs of vulnerable groups who may face additional barriers to access. The number of inclusive business models that have scaled up has increased five-fold since 2021, whereas the number of piloted inclusive business models has stayed relatively consistent.

Scale-up can involve expanding to new countries, increasing the number of patients served, or expanding the diseases covered.

The full version of the Special Report is available via our Resource Centre.