The pharmaceutical industry is regularly chastised for failing to do enough to ensure that people in low and middle-income countries have access to its medicines. Yet the real picture is actually more nuanced, according to a newly released report that finds some — but not all — drug makers are making headway.
Some companies, for instance, are partnering to develop needed medicines. Others are pledging to waive or abandon patent rights and granting licenses so that generic versions of their drugs become available.
At the same time, the report finds that much more can be done.
“There is a social contract between pharmaceutical companies and the people who need their products. Our research suggests that many people in the industry are committed to fulfilling this contract. But progress is slower than many of us would like,” wrote Jayasree Iyer, executive director of the Access to Medicine Foundation, a nonprofit based in the Netherlands.
On the bright side, Iyer told us that, “overall, there’s no area where the industry, as a whole, is doing less. And there are several areas where they are doing more.” For instance, most drug makers have a detailed access-to-medicine strategy. But, she added “there are some areas where we need to move the conversation forward — affordability for more products and stopping the occurrence of misconduct.”
The foundation analyzed policies and practices meant to ease access to medicines for 50 different diseases in 107 countries. To assess performance, the foundation examined pricing; patents and licensing; R&D, quality manufacturing and safety monitoring; product donations and philanthropic activities; and public policy, which included anti-competitive marketing, lobbying, and corruption.
The foundation then took its findings and compiled an index that ranked the top 20 pharmaceutical companies on their efforts to improve access to medicine in low- and middle-income countries. Funding, by the way, came from the Bill & Melinda Gates Foundation, the UK government and the Dutch Ministry of Foreign Affairs.
So what did the foundation conclude? Here are some key findings:
In a statement, Glaxo chief executive Andrew Witty said the “fundamental changes we have made to our business model enable us to make our products as available and affordable as possible while generating the returns we need to sustain our business and invest in research.”
Significantly, the report found progress is “static” in some areas. There were no signs of improvement in a key measure of affordability — the proportion of drugs covered by pricing plans that consider the ability of people to pay for medicines. Only 5 percent of 850 drugs had pricing strategies that met key criteria set by the index, notably achieving affordability for different population groups within countries.
Over the past four years, the number of companies using equitable pricing strategies increased from 16 in 2012, to 18 in 2014, to 19 in 2016. Ischemic heart disease replaced HIV/AIDS as the disease with the most products with equitable pricing. Gilead Sciences (GILD) had the highest proportion of products — 50 percent — with equitable pricing strategies that target priority countries
The foundation also identified what it called 84 product gaps —where there is an “urgent need, but low commercial incentive to engage in R&D” — concerning the 50 diseases covered in the index. Drug makers developed 151 medicines for 31 of these gaps, but only six companies account for the bulk of this activity, the report found. Leading the pack was Glaxo, followed by AbbVie (ABBV).
The foundation also examined product registration, which refers to filing an application to market a drug in a particular country. Such registrations ensure that medicines reach the people who need them. However, the analysis found that registration is “limited, particularly where the need for better access is greatest.”
As for drugs being developed, the report counted 420 R&D projects that address specific needs of people in low and middle-income countries, up from 93 in 2014. The pipeline focuses heavily on five diseases —lower respiratory infections, diabetes, malaria, viral hepatitis and HIV/AIDS — that cause relatively large burdens and either have large commercial markets or are high priorities.
The report also sought to identify the extent to which drug makers are transparent about their policy positions; political contributions; marketing activities and memberships in associations and the associated financial support provided and board seats held. But the foundation concluded that “transparency remains low in all areas.”
Iyer noted that Gilead was not very transparent when it came to ensuring clinical trials are conducted ethically and sharing trial data, as well as sharing sales information and pricing strategies for certain drugs in specific countries.
This is a lengthy report and there is much to read, so please look here.