After a year of anticipation, the United Nations on Wednesday released a lengthy report that urges governments to take various steps to ensure greater access to needed medicines. And the list contains several proposals that have previously caused struggles with the pharmaceutical industry, suggesting the agency effort may be difficult to actually implement.
The report comes amid rising anxiety that too many people in a growing number of countries are unable to afford medications, whether these are the newest salves or older remedies. At the same time, the panel also addresses an equally compelling concern that not enough is being done to develop drugs to treat diseases that predominantly afflict poor populations.
“Our hope is to boost R&D for neglected diseases — or better said for neglected patients — and to encourage governments to control prices and quality of the needed products,” Ruth Dreifuss, a former president of the Swiss Confederation and one of two cochairs of the UN panel, wrote us. “The right to health is everybody’s right.”
Among the recommendations: the UN panel suggested countries should pursue compulsory licenses, which allow countries to sidestep patents and arrange for an alternative version of a medicine to become available. Despite long-running disputes over access, though, governments have shied away from pursuing licenses over concerns about repercussions.
A recent high-profile example is playing out in Colombia, where the government made plans to issue a license and sidestep a patent for a Novartis (NVS) cancer drug. The move prompted US Senate staffers and US trade officials to threaten the Colombian government by withholding support for peace talks with rebels and a trade agreement.
Consumer and patient advocacy groups largely praised the UN report. Doctors Without Borders, for instance, called it a “landmark report.” But some complained that the panel did not go far enough in some ways. Beyond encouraging governments to issue these licenses, Health GAP said the UN should have “condemned trade agreements and national laws” that do not make clear that countries have the right to issue a compulsory license.
The panel also suggested countries should amend patent laws so that companies can only obtain patents when “genuine innovation” has occurred. Patient advocates argue that the pharmaceutical industry unfairly tries to extend monopolies on their medicines by filing applications for patents that, in reality, represent minimal or modest changes.
The panel also said countries should require drug makers to disclose certain costs — such as R&D, production, and marketing. The goal is to spur more transparency from drug companies, which have long argued that higher costs justify higher prices. This thinking has also prompted lawmakers in several states in the United States to introduce bills with such requirements, although only Vermont has passed a law.
Another recommendation is for companies that receive public funds to publish their research findings. On a similar note, the panel suggested that drug makers should make publicly available all anonymous patient data from completed and discontinued clinical trials. The report recommended data sharing and data access should be a condition for public grants for R&D.
Here are some of the reactions:
“The most important recommendations from the UN experts is to delink the cost of R&D from the prices of drugs,” said Jamie Love of Knowledge Ecology International. “You cannot rely upon high drug prices to finance R&D without harming patients and creating unequal access. Policy coherence means making innovation and access happen at the same time. Delinkage is key to policy coherence.”
“Governments mustn’t allow the report to become yet another exercise that describes the current failures of the medical innovation system without contributing concrete steps to address those failures. Responsibility now clearly falls on them at the highest political levels to act by putting in place innovative and practical solutions,” said Dr. Bernard Pecoul of Drugs for Neglected Diseases Initiative.
The US Department of State released a statement saying it was “deeply disappointed,” because the report “detracts from, rather than advances” increasing access to medicines while supporting development of new treatments. “As the United States made clear in its submission to the Panel in February 2016, the narrowly-focused mandate of the Panel was flawed and unlikely to lead to outcomes that adequately address this complex issue.”
“It is equally regrettable that the panel worked under the presumption of ‘policy incoherence’ between intellectual property rights, international trade liberalization, and human rights, while failing to properly recognize the important role that these systems play in incentivizing drug development and expanding access to medicines around the world. Intellectual property rights and trade are essential to medical innovation, which is fundamental to promoting global health.”
The Pharmaceutical Research & Manufacturers of America was not pleased, though. The industry trade group called the report a “a missed opportunity to address the wide array of barriers to access that far too many people face every day.”
The panel “should have provided the opportunity for an informed, balanced, and inclusive dialogue that can make a difference to the lives of people who do not have adequate access to treatments for these and other reasons. However, the panel’s report acknowledges that it was limited in its mandate and unable to look at all the factors influencing access to medicines,” PhRMA added.
“As a consequence, the final report focuses narrowly on solutions which fail to recognize and address the complexity of biopharmaceutical research and development and the significant work already taking place to advance access to care. As such, neither this report nor its recommendations can be a sound basis for further consideration or action by the UN system.”