Companies use a mix of tools to address availability and affordability, yet good practices extend to only a few products and diseases. Companies do not consistently include poor populations in registration, pricing and licensing actions.
This chapter analyses pharmaceutical product deployment: how pharmaceutical companies ensure their products reach the people who need them. As a first step, companies must register their products in countries where they are needed. They can then use three main product-deployment tools: equitable pricing, responsible IP management and product donations. These three tools are considered by stakeholders to have the biggest potential impact on supply and affordability. The Index evaluates how pharmaceutical companies approach registration and use these three tools. It assesses how companies are tailoring them to reach the people in greatest need for improved access to specific products. For this analysis, the Index has identified priority countries* for each disease in scope: countries with a particular need for access to products for the disease in question.
Registration is limited, particularly where the need for better access is greatest.
Most companies (18) have filed to register some of their newest products in some low- and middle-income countries (LICs; MICs). Across the industry, however, most (125, or 78%) of the companies’ 160 newest products are registered in less than half of the corresponding priority countries*. Looking only at the newest products, companies file for registration in only 25% of the priority countries they could potentially have reached.
Little evidence of needs-based pricing
Almost all companies (19) use equitable pricing for products in scope (Astellas is the exception). GSK leads, with equitable pricing for more than 60 products. However, the extent of equitable pricing hovers around one third of the 850 products on the market for high-burden diseases. Further, only 5% of products (44) are covered by needs-based pricing: strategies that set different prices for different population segments within a country (intra-country equitable pricing); take multiple socio-economic factors into account when assessing affordability; and apply in at least one priority country.
There are more products with equitable pricing strategies than in 2014. Yet, these still respresent a third of all 850 products on the market, and their use of price differentiation within countries remains static. Such strategies are particularly important where inequality is high (e.g., in many large middle-income countries), Only 44 (5%) products out of 850 have a strategy that meet the key criteria looked at by the Index and applies in even one priority country*.
*Priority countries are disease-specific sets of countries with a particular need for access to the products in question.
Voluntary licensing expands into hepatitis C
While companies remain cautious in their use of voluntary licensing, there is movement. Since 2014, companies have licensed products for a diseases other than HIV/AIDS for the first time: hepatitis C. However, middle-income countries (MICs) with large populations in need are often excluded from licence scopes. 13 companies now publicly disclose patent filing/enforcement policies. Three companies have independently published information about their patents, the first to do so.
Since 2014, more compounds have been covered by voluntary licence agreements. For the first time, this includes products for a disease other than HIV/AIDS: hepatitis C.
Donation programmes are being tailored to local needs
Companies continue to engage in product donations, with most programmes addressing neglected tropical diseases (NTDs) and communicable diseases. Programmes for communicable diseases are becoming increasingly tailored toward local needs, while programmes for NTDs have the most specific public-health-related targets, such as control, elimination or eradication. There is little data on the impact of structured donation programmes outside of the NTD space.