Majority of key on-patent products have access initiatives, but these are limited in reach
From the 20 companies evaluated, the Index has identified 53 products that are critical candidates for companies’ access initiatives. The Index uses four criteria: being on-patent, being a firstline therapy, and being designated as an essential medicine by the World Health Organization, as well as targeting a disease in scope. The 53 products 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. The Index found that 37 of the products (70%) are covered by at least one such initiative. Yet most of these are limited in scale and reach.
Most initiatives limited in scope
Patents give their owners control over a product’s price as well as where and in what volumes it is available. The decisions pharmaceutical companies take have a larger impact on public health when patents cover first-line therapies on the WHO Model List of Essential Medicines (EML). First-line therapies are generally needed in higher volumes, as they are the treatments doctors turn to in the first instance, while products on the WHO EML are considered essential for all healthcare systems.
The Index conducted a specific analysis to investigate what companies are doing to facilitate affordability and supply to these products, examining pricing, licensing and donation programmes. It found that 37 of the products (70%) are covered by at least one such initiative. Yet most of these are limited in scale and reach.
Most of the initiatives involve using different prices for different populations. Per disease, the Index has identified 13 countries on average as priority targets for pricing strategies.* Most pricing strategies in this analysis are applied in fewer than five of the countries where greater affordability is a priority.
Figure: 53 products are critical candidates for companies' access initiatives
Drivers for action
Many products with access initiatives are for diseases targeted by donors and other global health actors, such as HIV/AIDS and hepatitis C or neglected tropical diseases, or are vaccines that are the focus of large international programmes to improve immunisation coverage. Two such 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.
There are also companies applying initiatives for diseases not widely prioritised by the global health community. For example, AstraZeneca has a particularly nuanced access strategy for its cholesterol-lowering drug, rosuvastatin (Crestor®). Its strategy can take account of individual people’s ability to pay in Brazil. The strategy segments the population into several groups, with the poorest paying the least. Another example is GSK’s salbutamol sulfate (Ventolin®), used in inhalers for asthma and chronic obstructive pulmonary disorder. This product is covered by particularly flexible pricing strategies in 11 out of 16 priority countries. The strategy is global and allows GSK to apply a single, locally adjusted price across specific country markets, taking account of locally relevant factors (such as disease burden, healthcare system and funding). GSK and Gilead account for more than half (23 out of 37) of the products with access strategies.
Figure: Which companies control the 53 products?
There are 16 on-patent first-line therapies that are on the EML and that currently have no pricing, voluntary licensing or structured donation programmes in place. These products include contraceptive methods and devices such as drosperinone/ethinylestradiol (Yasmin®) , as well as a palliative treatment for advanced prostate cancer, leuprolide acetate (Eligard®). Companies are urged to develop and implement access initiatives for these products, starting with countries where greater access is deemed a priority. Companies can also evaluate opportunities to expand access initiatives already in place for products in this group to additional countries, so that more people can benefit, recognising that, as patent owners, they are in a strong position to influence who gains access to these important products.
*Priority countries are disease-specific subsets of countries with a particular need for access to relevant products.