On-patent products: how do pharmaceutical companies use pricing, licensing and donations to improve access to key medicines?
Low- and middle-income countries are home to the majority of the world’s poorest people. Whether medicines, vaccines and other products reach the people who need them in these countries depends on the choices companies make when making them available. Pharmaceutical companies have three main tools available to improve access to specific products: pricing, licensing and donations.
• Equitable pricing strategies: where companies take affordability into account when determining prices for different population segments.
• Voluntary licensing agreements: which give generic medicine manufacturers permission to develop and manufacture versions of on-patent products under transparent and access-friendly terms that can support affordability.
• Product donations programmes: which align with international guidelines and respond to specific, local need for greater access.
Which products need access initiatives?
The Index has analysed how companies are applying pricing, licensing and donations for specific groups of products – products that are critical targets for access initiatives. To define these groups, the Index uses four criteria: being on-patent, being a first-line therapy, being an 'essential medicine' as defined by the World Health Organization, and targeting a disease in scope.
Out of 1,036 products, 729 target a disease in scope and meet at least one of the other criteria of being a critical target for access initiatives:
Why these criteria?
Companies have considerable influence over the affordability, accessibility and availability of patented products. First-line therapies are generally needed in higher volumes, as they are the treatments doctors turn to first after diagnosis. Medicines on the WHO EML are considered essential for all healthcare systems.
Products on all three lists are critical targets for access
The 20 companies have 53 products that meet all criteria – these are deemed critical targets for access initiatives. They are mainly medicines for HIV/AIDS or hepatitis C, and vaccines, including the measles-mumps-rubella- varicella vaccine. The remaining products are varied, including essentials such as inhalable medicines for people with asthma.
Figure: Venn diagram of products on patent, on the WHO EML and considered first-line
Which products have access initiatives?
Almost three quarters of products on all three lists (37) have at least one company access initiative...
Figure: Proportion of first-line, EML, on-patent products covered by access initiatives.
...This is higher than the coverage of products that meet only two of the criteria: being first-line and on the EML. Just over half of first-line products on the EML are covered by an access initiative (240).
Figure: Proportion of first-line, EML products covered by access initiatives.
Which type of initiative is used most often?
The Index also dived into the different types of access initiatives that the companies are using, starting with the 53 products that qualify as critical targets for access initiatives. The Index compared the coverage of different access initiatives (pricing, licensing and donations) across products for diseases in different categories.
Most access initiatives involve pricing.
In all disease areas examined, there are more pricing initiatives than other types. Two products stand out for their comparatively broad-based access initiatives: emtricitabine/tenofovir disoproxil fumarate (Truvada®) for HIV/AIDS and sofosbuvir (Sovaldi®), a treatment for hepatitis C. Both are marketed by Gilead. The medicines have stratified pricing schemes applying in all countries considered a priority, and are licensed for local generic-version manufacture in more than 100 countries. There is a donation programme for emtricitabine/tenofovir disoproxil fumarate (Truvada®) in Kenya. However, it should be noted that the affordability of sofosbuvir (Sovaldi®) has been called into question, particularly for poorer populations in wealthier countries
Do companies use different types of initiatives for different types of disease?
The charts below show how products for different types of disease are covered with different types of access initiatives.
• Non-communicable diseases: Also known as non-infectious diseases. These include chronic or 'lifestyle' diseases such as heart disease and diabetes.
• Communicable diseases: Also known as infectious diseases. These include several viruses, such as meningitis, malaria, HIV/AIDS and hepatitis, as well as bacterial infections, including several that cause diarrhoea.
• Neglected Tropical Diseases: A WHO-defined set of infectious diseases that disproportionately affect people living in low- and middle-income countries, including hookworm and trachoma (river blindness).
• Maternal & neonatal health conditions: This includes contraceptives as well as products to support safe pregnancy and childbirth. Many hundreds of thousands of mothers and babies continue to die during or shortly after childbirth.
Most pricing strategies in this analysis have scope for expanding: most are applied in fewer than five of the countries where greater affordability is a priority.
Figure: Coverage of on-patent, first-line, EML products with access initiatives, by disease category
Looking more broadly, the charts below show the proportion of first-line treatments on the WHO EML that are covered with different types of access initiatives. There are 438 of these products in this analysis. Once again, most initiatives involve pricing. Donations are mostly used for products for Neglected Tropical Diseases, a set of infectious diseases that disproportionately affect people living in low- and middle-income countries. Voluntary licences have only been granted for products targeting two communicable diseases: HIV/AIDS or hepatitis C.
Figure: Coverage of first-line, EML products with access initiatives, by disease category