Medellin, Colombia – It was pitch black when Ariel Villan awoke one night last December, startled by noises at the door of the home he shares with his husband on the coast of Santa Marta, Colombia.

He held his breath and froze, thinking someone had broken in to rob them. But the sound was not real. It was yet another hallucination.

Villan, 45, was taking efavirenz, an HIV treatment linked to side effects like abnormal dreams, suicidal ideation and insomnia. His anxiety and paranoia had become so severe that he regularly had panic attacks and lucid dreams.

In an interview, he told Al Jazeera the symptoms plunged him into a deep depression.

“I told my doctor, ‘Look, I’m not going to continue with a treatment that’s making me feel bad,’” he said. “I’m depressed. I have suicidal thoughts.”

All of that changed after January when he switched to taking the antiretroviral drug dolutegravir to treat his HIV infection.

“I started to recuperate everything I had lost, which was my will,” Villan said. “The will to brush my teeth, to go out and buy a pastry … Now I go jogging to the beach every day at 6am.”

The World Health Organization considers dolutegravir a preferred first-line treatment for HIV, given its limited side effects and rapid efficacy. Patients reach a low enough level of virus in their system that they won’t transmit HIV during sex.

But there’s a problem: The active ingredient in the medication is currently under patent.

In April, however, the Colombian government took a historic step. It issued its first-ever compulsory licence, a legal mechanism that allows it to co-opt the drugmaker’s patent in the name of public interest.

That decision is expected to clear the way for Colombia’s health programmes to buy generic doses of the drug at a much lower cost.

But bypassing the patent has enmeshed Colombia in an ongoing lawsuit with the pharmaceutical company ViiV Healthcare, which has openly protested the compulsory licence.

The company argues that Colombia’s new policy “weakens the intellectual property system” that finances the “costly research and development necessary to drive advances in HIV treatment and care”.

Colombia is “a shining example of a country that has taken a little bit of risk”, said Brook Baker, a health policy analyst and law professor emeritus at Northeastern University.

He pointed out that governments that move to issue compulsory licences can risk retaliation from drug companies or the countries where those businesses are based.

That is what happened when Colombia pushed to cut the price of a key leukaemia drug in 2016.

The government ultimately backed down under pressure from lobbyists in the United States, where the drug’s patent-holder was located.

Officials feared the fight for a lower-cost drug might cause the US to rescind the $450m in funding it offered to support Colombia’s historic peace deal with the FARC, an armed rebel group.

But advocates have argued that the need for affordable, effective HIV treatment in Colombia is dire. The country has the third highest number of people living with HIV in Latin America, with about 230,000 cases as of 2023.

In Latin America as a whole, HIV cases have been on the rise, increasing by 8 percent from 2010 to 2022, according to a United Nations report.

Ordinarily, the price of medications like dolutegravir is high. The brand-name version, Tivicay, costs about $1,150 in Colombia for a one-year supply, versus approximately $45 for the generic.

In other words, with the generic medication, Colombia can treat nearly 26 people for the price of one.

There is also evidence that access to generic HIV medication can help stem new infections.

Sub-Saharan Africa, for instance, has the world’s highest levels of HIV infection, but rates of infection have decreased by nearly 50 percent from 2010 to 2022 in part because of international investment and accessible medications.

Generics are accessible there because drugmakers often grant voluntary licences to countries in the region, allowing them to make or purchase off-brand versions of the medicines.

But drugmakers do not typically grant licences for top treatments like dolutegravir in countries like Colombia and Brazil, which both have high HIV rates but are considered upper-middle-income.

And agreements forged under the World Trade Organization require all member states to respect copyright patents, even when it comes to life-saving treatments.

Issuing a compulsory licence to circumvent patent restrictions is “relatively unusual”, said Suerie Moon, global health expert and professor at the Geneva Graduate Institute.

But, she added, Colombia’s move is not unprecedented.

The World Trade Organization’s agreements include carve-outs for efforts to protect public health, including the right to announce compulsory licences for necessary medications.

Several nations, including the US, used that flexibility during the COVID-19 pandemic to distribute vaccines.

When pushing for a lower-priced option, compulsory licences are “one of the strongest tools that a government has in a negotiation with a (drug) company”, Moon explained.

She believes those licences are unlikely to threaten the business model for pharmaceutical companies, given how rarely the licences are used and how profitable the industry is.

“You have seen constant and rapid innovation in the HIV field. Why? Because there’s still plenty of money to be made,” Moon explained.

When the Colombian government announced the compulsory licence for dolutegravir in April, many healthcare nonprofits cheered the move.

For instance, Doctors Without Borders — also known as Medecins Sans Frontieres, or MSF — called it a “precedent for the region”.

In a press release, the nonprofit explained that dolutegravir is one of its first-choice treatments for all of its HIV/AIDS programmes. But Carmenza Galvez, the coordinator for MSF’s Colombia programme, said her team had been unable to use the medication because of “prohibitive costs”.

Now that the compulsory licence is in place, Galvez said the programme planned to incorporate the drug into its treatment for sexual violence survivors.

Experts also point to its benefits for other vulnerable populations in Colombia, such as the country’s large Venezuelan migrant and refugee population, estimated at more than 2.8 million people.

Heriberto Mejia Mercado, an advocate with the LGBTQ rights group Caribe Afirmativo in Barranquilla, works to donate medicines to Venezuelans who do not have legal status in Colombia and therefore can’t access healthcare.

Venezuelans accounted for one in four people living with HIV in Colombia last year. The Colombian government cited the group as a motivation to issue the dolutegravir licence.

Mejia Mercado explained that dolutegravir is especially critical for people who haven’t taken medication consistently, perhaps because they were on the move.

Generally, migrants “have gone a long time without receiving medication”, Mejia Mercado said.

Dolutegravir, he added, “would replace the regimen they were receiving five months or two years ago in their home country”.

Of course, dolutegravir is not a silver bullet to treat HIV, cautioned Gustavo Campillo, president of the RASA Foundation, which helps people in Medellin access treatment and health insurance.

The treatment doesn’t work for everyone, Campillo explained, and each patient’s drug regimen is a unique “medical judgment” offered by their doctor.

Dr Juan Carlos Catano, an infectious disease specialist who treats HIV in Medellin, told Al Jazeera that patients also cannot take dolutegravir on its own.

It is typically part of a regimen that includes four other pills.

Still, he has seen a marked improvement among patients who switched to regimens that include dolutegravir.

“When someone switches from one of those old regimens to dolutegravir, they say, ‘I started living again,’” Catano explained. “All the side effects from the old regimen went away.”

He added that the steep cost of the drug, even when covered by insurance, can mean dolutegravir isn’t prescribed as often as older regimens.

“If dolutegravir could match the price of those old treatments, they could be given dolutegravir instead of the others, which are more toxic,” Catano said.

Yet, the introduction of dolutegravir into more health programmes depends on two things: how many generic doses the Colombian government buys — and how quickly.

“It takes some time for generics to be registered,” said Luz Marina Umbasia, director of the Global Humanitarian Progress Corporation in Colombia.

Umbasia explained that the purchasing process typically takes at least six months, although her organisation has encouraged the Colombian government to buy doses “as soon as possible”.

That will allow patients access over the near term, while the drug is still under patent. The rights that ViiV Healthcare holds for dolutegravir in Colombia are set to expire in 2026.

Some advocates, however, doubt Colombia’s ability to coordinate a quick and efficient dolutegravir purchase. They cited a shortage of hepatitis C medicine last year that resulted from delays in price negotiations and supply acquisition.

“We don’t have a good experience with the Colombian government,” said Nestor Alvarez Lara, a pharmacist and president of the advocacy group High Cost Patients.

He called on the Colombian government to undertake a “very well-planned” rollout of the generic dolutegravir to avoid the same dilemmas.

“You have to buy in large quantities,” he said. “There’s a great deal of distrust that, at some point, you might have three months’ supply and then run out of medication.”

In a statement to Al Jazeera, the Colombian Ministry of Health and Social Protection said the government is finalising a negotiation to buy a “continuous supply” of dolutegravir through the Pan American Health Organization (PAHO).

They expect it to become available in the last three months of 2024. Officials plan to start by purchasing more than 800,000 bottles, guaranteeing a year of treatment for about 67,000 people.

Villan considers himself lucky to have switched over to dolutegravir. He only learned it was an option because his husband switched his medications last year, and Villan saw his mental state transform.

“I met my husband again,” Villan said.

Villan added that he has helped friends get dolutegravir when their health insurance ran out. He hopes the new licence will broaden access and eliminate the uncertainty they face.

“You have to be on continuous treatment for it to be effective,” he said. “Having that confidence, that consistency … we can live a completely undetectable life.”