Colombia has taken a significant step in response to a pricing dispute with GSK’s ViiV Healthcare regarding the HIV medication dolutegravir. Colombian authorities announced their intention on Tuesday to issue a compulsory license for the drug, known as Tivicay when used alone or as Dovato in combination with other therapies.
The purpose of this compulsory license is to enable the Colombian government to procure more affordable generic versions of dolutegravir through the Pan American Health Organization. Compulsory licensing allows national authorities to grant a third party the license to produce a patented product, essentially permitting the production of a generic version before the original patent expires, as explained by the National Institutes of Health (NIH).
Historically, this policy was developed and has been used to enhance access to essential medications in low-income countries, especially during public health crises.
ViiV Healthcare has yet to respond to the situation following requests for comment. However, a company spokesperson informed Stat that ViiV is aware of the Ministry of Health’s resolution. They are actively exploring potential responses and engaging with the Colombian government to seek a potential resolution.
This dispute over dolutegravir pricing in Colombia is reminiscent of a previous standoff between Colombia and Novartis concerning the Swiss pharmaceutical company’s leukemia medication, Gleevec. In 2016, Colombia had expressed intentions to reduce the price of Gleevec (imatinib) by approximately 45%, citing “public interest” as the reason for improving access to the drug. Reports had earlier suggested that Colombia was considering the issuance of a compulsory license to achieve cost savings.
In the recent decision regarding dolutegravir, Colombian officials once again invoked the “public interest” argument to justify their actions. This move underscores the ongoing challenges and discussions surrounding access to essential medications and their pricing in the global pharmaceutical landscape.