Concerned about access to treatments for the fast-spreading coronavirus, Chile’s lower house of Congress passed nearly unanimously a resolution that would permit the government to issue compulsory licenses for any medicines, vaccines, or diagnostics for combating the pandemic.
The resolution supported by the Chamber of Deputies would also have the Chilean health ministry ask the World Health Organization to collect information on R&D costs directly associated with products used for preventing, detecting, and treating COVID19, including public and private investments. The vote, by the way, was 127 in support, but none against, with eight abstentions (see English translation here).
“This is an important step towards strengthening available legal tools for access to technologies that are useful for fighting this pandemic in Chile,” said Luis Villarroel, who heads Corporacion Innovarte, an advocacy group that fought for the resolution, in a statement. He argued that improving transparency into R&D costs should allow a better understanding of the roles played by government and industry.
Added Chilean congressman Giorgio Jackson: “Hopefully, all governments do it.”
The Chilean Pharmaceutical Chamber and the Industrial Association of Pharmaceutical Labs could not be reached for comment, although an industry source noted that the resolution is not binding on the government.
The move comes against a backdrop of mounting angst over the rising cost of medicines, which has prompted a growing number of countries to consider the use of compulsory licenses, a move that has been debated in Chile, for instance, for more than a year.
A country may grant such a license to a public agency or a generic drug maker, allowing it to copy a patented medicine without the consent of the brand-name company that owns the patent. This right was memorialized in a section of a World Trade Organization agreement known as the Trade-Related Aspects of Intellectual Property Rights, or TRIPS (here is a primer).
A year ago, another industry group, Our Health Latin America, argued that initial legislative efforts in Chile to support compulsory licensing “undermined innovation.”
The issue may take on an added urgency now, though, in the wake of Covid-19 amid concerns that a therapy or vaccine might be priced out of reach for any number of people.
The notion rose to the top of many radar screens late last month when U.S. Secretary for Human and Health Services Alex Azar initially testified before Congress and refused to commit to ensuring that any product that is research with taxpayer funds would be accessible to Americans. He subsequently backtracked, but by then a debate emerged over access to medical products in a time of a pandemic.
Whether the Chilean government adopts the resolution remains to be seen, but some believe the move may spark similar efforts elsewhere.
“This is the first of what will likely be many actions on compulsory licensing relating to this pandemic, if patented inventions are deemed useful,” predicted Jamie Love, who heads Knowledge Ecology International, an advocacy group that tracks access to medicine and patent issues, and first reported the vote.
The Chilean resolution also references a controversial resolution that was adopted last May by the World Health Assembly in a bid to improve access to medicines. That resolution, which was vehicle for cash-strapped governments to control their drug spending, was designed, in part, to provide greater transparency into R&D costs. However, the final wording limited access to such information.
The issue is of concern due to the role that R&D costs play in the larger discussion about drug pricing. The pharmaceutical industry regularly argues that many medicines, especially those that are used to treat cancers and rare diseases, require substantial outlays that must be recovered to not only cover costs, but provide incentives to conduct further research.
As we noted at the time, patient advocacy groups and a growing number of lawmakers have been asking the pharmaceutical industry to open its books in order to better understand the relationship between costs and pricing. Drug makers, however, have been consistently unwilling to do so, arguing that it is extremely difficult to assign costs to a specific product.