As more countries seek to control their health care spending, the Italian government is asking the World Health Assembly to adopt a resolution that would require drug makers to disclose their R&D and production costs, as well as prices charged for medicines and vaccines.
In explaining the rationale for such a move, Italian health minister Giulia Grillo wrote to World Health Organization Director-General Tedros Ghebreyesus that “international action is required to improve transparency” in order to widen access to pharmaceuticals.
Specifically, the resolution would provide the WHO with a mandate to collect and analyze data on clinical trial outcomes; analyze the patent landscape; and provide a forum for countries to share information on prices, R&D and marketing costs, R&D subsidies, and public sector investments. As part of the effort, the WHO would be encouraged to create a web-based tool so data can be compared.
At the same time, individual countries — or member states — would be urged to require drug makers to provide similar information, and withhold product registration if companies fail to comply. Countries would also be encouraged to avoid adopting measures in any trade agreements that “limit transparency” into pricing and costs, among other things.
In effect, the proposal would set an international standard and, for this reason, is likely to be widely debated, given that the pharmaceutical industry has resisted similar efforts elsewhere. The resolution is expected to be discussed at the World Health Assembly in May, according to a source. A spokeswoman for the International Federal of Pharmaceutical Manufacturers and Associations declined to comment.
The proposal comes amid intensifying efforts by a growing number of cash-strapped countries to contain the rising cost of medicines. Recently, more government officials or lawmakers — from Malaysia to El Salvador to the U.K. — have explored compulsory licenses, which are granted to a generic drug maker to copy a patented medicine without the consent of the company that owns the patent.
But anxiety over prescription drug prices is no longer confined to mostly poorer nations. Over the past few years, the issue has become a flashpoint in the U.S., where the Trump administration and Congress have floated various proposals and pieces of legislation. And in the name of transparency, some congressional lawmakers have proposed bills to require drug makers to report price hikes.
A few states, however, have already pursued some form of transparency aggressively. California, for instance, enacted a law that requires drug makers to provide information about planned price hikes. Other states — such as Vermont, Nevada, Maine, and Oregon — have passed laws that require companies to justify price hikes, although Nevada also seeks information about costs and Maine lawmakers plan to do so.
Published on StatNews
Imagem from AFP