The Medicines Patent Pool (MPP) has signed sublicense agreements with 11 manufacturers across multiple regions to expand access to generic baloxavir marboxil, a single-dose antiviral treatment for influenza that was originally developed by Swiss pharmaceutical company Roche. 

The announcement, made the night before last Friday’s UN High-Level Meeting on Pandemic Prevention, Preparedness and Response, reignited calls for partnership to strengthen geographically diverse manufacturing capacity during what has been referred to as an era of ‘peacetime’ for flu before the next pandemic. 

“Rather than waiting for that crisis to come again, and we’ve seen it with COVID, let’s prepare in what we call peacetime, and this is peacetime for flu, and that is really critical because when the pandemic hits, we need to collectively respond with steam and scale,” said Tamara Schudel, Roche’s vice president and head of global policy.

Schudel and other global health leaders, civil society representatives, and pharmaceutical manufacturers welcomed news of the agreement at an event on the sidelines of the 81st session of the UN General Assembly hosted by MPP with support from Roche. 

The event, “Advancing pandemic preparedness through voluntary licensing, technology transfer, and local production,” was moderated by Health Policy Watch editor-in-chief Elaine Ruth Fletcher. It focused on how practical access arrangements, technology transfer and regional manufacturing can help strengthen pandemic preparedness before the next crisis.

Enabling proactive preparedness 

The agreements follow an initial voluntary licensing agreement made in May 2026 between MPP and Roche to expand access to baloxavir by allowing generic manufacturers to develop, manufacture and supply affordable generic versions of the treatment in 129 countries, subject to local regulatory authorization. 

The 11 manufacturers include four manufacturers with a global presence – Laurus Labs and MSN in India, and Desano and Guilin Pharma (Fosun) in China – alongside seven regional manufacturers with Biolab in Brazil, Kimia Farma in Indonesia, Hovid in Malaysia, Fidson in Nigeria, QCIL in Uganda, Lekhim in Ukraine and Stellapharm in Vietnam. 

The manufacturers celebrated the agreements and their significance as an important next step in expanding access to baloxavir and pandemic preparedness.

“We know pandemics won’t and can’t wait, and we should be ready at any time,” Biolab CEO Fabio Amorosino said. 

“[The sublicense agreements] enable proactive preparedness versus a reactive response. When licensing, manufacturing pathways, and supply arrangements are established in advance, we can respond much faster when demand arises,” said Kundal Reddy Bairy of MSN Pharmaceuticals. 

Innovative treatment benefits patients and public health 

The agreements are timely as influenza has been identified as the pathogen with the most pandemic potential.  Baloxavir has also proven to be effective against strains that are resistant to other classes of antiviral medicines, thus creating a more resilient defense against the evolving threat of influenza. 

“This is a single dose, which means it is going to be much easier on the healthcare workforce,” said Schudel. “It will also help ensure patient adherence. You don’t have to worry about a full package or a week. You take one pill, you’re done. 

“It also rapidly lowers the viral shedding, and that’s very critical from a public health perspective because it curbs the transmission. If you need to manage a local outbreak, that is absolutely critical.” 

MPP executive director Charles Gore said baloxavir can be used seasonally, giving manufacturers incentives to develop the antiviral: “With a lot of the other pathogens, there may not be a market. There may not be an incentive to develop fully. Nonetheless, that should not stop them licensing now, so that’s in place for the next pandemic.”

Ensuring access 

Expanding access to treatments such as baloxavir shouldn’t be thought of only when there is an outbreak or pandemic, but instead be incorporated into a government’s health system and preparedness agenda well before the next pandemic strikes.

“Access shouldn’t be an afterthought,” said Unitaid deputy executive director Tenu Avafia. “When there is an outbreak or an epidemic or pandemic, that’s not the optimal time to start discussions and to negotiate voluntary licenses. That’s not the best time to start looking at regulatory pathways to shape the market, to address procurement and supply chain challenges. The best time to do it is before the pandemic breaks.”

“The whole issue of access has to be built in, baked right into the preparedness agenda,” said Bruce Aylward, Assistant Director General for Promotion, Disease Prevention, and Care at the World Health Organization.

James Anderson, chair of the INTREPID Alliance, a consortium of pharmaceutical companies dedicated to accelerating the pipeline of antiviral treatments, used the ongoing Bundibugyo Ebola outbreak in DRC as an example of how the typical supply-demand market approach does not apply to pandemics or outbreaks. 

“The standard economics market-driven approach doesn’t work in pandemics, when you have an unpredictable, periodic outbreak. We only have to look at Bundibugyo. How can you be investing for something that the last time it could have been used was 12 years ago? The standard economics do not work [in this case], so we do need to fix that.” 

Currently, Anderson noted, of the 14 priority viruses with pandemic potential that INTREPID evaluated in their latest landscape analysis, three of viral families have nothing in the pipeline, in either the preclinical stage or in the clinical stage. Another six viral families have nothing in the development stage, meaning there will be no products available in the next three to five years. 

He called for sustained R&D investment and funding to move these viruses through the research pipeline. 

African investment

Speakers also called for more investment in African manufacturing to expand access, building on the momentum and regional transformation on the continent with the establishment of institutions such as the African Medicines Agency and the Africa CDC. 

“We will have to move forward by investing in African institutions,” said the Swiss Development Corporation’s Erika Placella. “We have to support governance, and we have to support capacity building and technology transfer, but all this will happen in Africa for Africa.” 

This aligns with high-level discussions made during the UN General Assembly pushing towards ‘practical sovereignty’ and a move away from foreign aid dependence. 

Kenya is one country in Africa that is moving from policy to action and is investing in local manufacturing opportunities for vaccines and other therapeutics by strengthening its healthcare system. 

A Kenyan Ministry of Health official, representing Dr Consolata Oggot, said his country is close to achieving WHO Maturity Level 3 status, which demonstrates a country’s ability to effectively regulate medical products and ensure their safety, quality, and efficacy.

This is important for Kenya to be “able to manufacture not only vaccines, but other pills as well”, he said. “All this licensing requires resources to build capacity through the healthcare system. Therefore, political goodwill is very important. We are happy to build on partnerships that exist, and partners that can provide financing are key to supporting our initiatives.” 

Moving with accountability 

While part of the problem of access to treatments is technical, there are also social and political challenges that need to be addressed, noted Resilience Action Network Africa (RANA) Executive Director Aggrey Aluso. 

Aluso referred to the ongoing Ebola outbreak in DRC as an example, pointing to how misinformation had undermined the public health measures needed to combat the spread of disease. 

He also notes that the word ‘generics’ is stigmatised when associated with medicine in Africa. 

To overcome these challenges, Aluso called for the “deliberate” involvement of communities to incentivize both manufacturers and the community, with manufacturers using innovative ways to engage the community and build awareness of therapeutics and vaccines.  

“We need to move with speed, but that speed needs to be accompanied by an enforceable and accountable mechanism that also incorporates the interest of the public, accountability, and equity,” said Aluso.