Good practice in making products affordable and available is limited
The Index analyses how pharmaceutical companies deploy medicines, diagnostics and vaccines once they have emerged from the pipeline. It finds that companies generally do not systematically target populations with the highest needs in their registration, pricing and licensing actions.
Products being registered in one quarter of high-need countries
A product can only be sold in a country once it has been registered. For every disease it covers, the Index has developed a priority country list and examines to what extent companies try to register their newest products in them. It found that companies have tried to register their newest products in only a quarter of these countries.
However, some companies are showing good practice in the area of needs-responsive product registration. For example, Novartis and Novo Nordisk have filed to register most of their newest products where they are needed*; Gilead commits to filing for registration of new products in low- and lower-middle-income countries (LICs; LMICs) within 12 months of gaining regulatory approval, and also publishes when and where products are registered.
Limited needs-based pricing
Companies are considering affordability for more products than they did in 2014, but the proportion of the industry portfolio covered by such equitable pricing schemes remains the same.
Only 5% of products are covered by pricing strategies that meet the key criteria set by the Index – i.e., achieving affordability for different population groups within countries; with reference to multiple socio-economic factors – and apply in at least one country with a particular need for access*. Three companies – GSK, AstraZeneca and Sanofi – are responsible for most of this activity.
*Priority countries are disease-specific: for each disease in its scope, the 2016 Index has identified countries with (a) high burdens of the disease and high inequality; and (b) low-income levels.
Licensing expands but excludes key middle-income countries
Since 2014, seven companies have published new or expanded pledges to waive or abandon patent rights in certain countries or regions. A total of 16 now have such pledges. These vary in breadth and scope, with some covering more countries and regions. Three companies now voluntarily publish details of their patent portfolios, which supports the supply of generic medicines. This compares with none doing so in 2014. More HIV/AIDS products are covered by voluntary licences, and, for the first time, such licences are being used, by Bristol-Myers Squibb and Gilead, to expand access to products for a second disease: hepatitis C.
These steps are promising. However, large middle-income countries (MICs) such as Mexico, Ukraine and Thailand are often excluded from licences. MICs are home to the majority of the world’s poor.
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