ViiV HEALTHCARE STATEMENT ON PROPOSED COMPULSORY LICENCE FOR DOLUTEGRAVIR IN COLOMBIA

ViiV Healthcare is committed to enabling access to our medicines to benefit people living with HIV, regardless of income or where they live.

As part of our broader access strategy, voluntary license agreements aim to accelerate access to innovative antiretrovirals like dolutegravir in support of our mission to leave no person living with HIV behind.

Our adult voluntary licence for dolutegravir applies to all Lower Middle-Income, Low Income, Least Developed and sub-Saharan African countries as defined by the World Bank.

In countries like Colombia, which is defined by the World Bank as an upper middle-income country, we operate a flexible pricing policy, which considers a number of factors including but not limited to the government’s ability to pay (based on Gross National Income – GNI – per capita) and the public health need in terms of the burden of the HIV epidemic, local affordability, domestic healthcare system funding, purchasing patterns and volumes. The price that is offered to governments is reflective of this policy.

Towards the end of 2023, the Ministry of Health in Colombia issued a resolution declaring access to dolutegravir a matter of public interest and its intent to pursue a compulsory licence, which comprised the start of an administrative process. The compulsory licence has not been issued to-date but is now with the Colombian Patent Office to continue that process to a conclusion.

We do not consider that compulsory licences are an effective means to support sustainable access or increase access to innovative medicines. The use of compulsory licences weakens the intellectual property system relied on by the life sciences sector to conduct the innovative and costly research and development necessary to drive advances in HIV treatment and care. As well as discouraging innovation, compulsory licensing seeks to push the costs of developing new medicines onto other countries,

We have made submissions opposing the grant of the compulsory licence throughout the process, and we will continue to oppose going forward, using appropriate legal means.

ViiV Healthcare believes in the importance of dialogue and is actively seeking to engage the Colombian government to understand its situation in more detail, in particular the effects of the Venezuelan migrant crisis on the Colombian healthcare system, and to find a solution. 

We will continue to provide consistent supply of dolutegravir in Colombia, as we have been doing since the medicine was introduced. Our supply will be in line with demand in Colombia, ensuring that patients have access to the medication they need.

As a company 100% dedicated to HIV, we remain committed to continue making our medicines more widely available and live our mission of leaving no person living with HIV behind.

Media contacts

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OR call +44 7823 523 755

For US-specific media enquiries,email: Audrey Abernathy

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Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellowcard in the Google Play or Apple App store. By reporting side effects, you can help provide more information on the safety of this medicine.

If you are from outside the UK, you can report adverse events to GSK/ViiV by selecting your region and market, here.