A potentially game-changing antiviral treatment for COVID-19 that can be administered orally early on, and potentially head off much more serious cases, is set to be licensed for generic production in most low- and middle-income countries (LMICs), in an unprecedented breakthrough in access to a new COVID treatment.  

The historic deal, reached between the pharma company Merck Sharp & Dohme (Merck) and the Medicines Patent Pool paves the way for MPP to sign contracts with generic drug manufacturers to produce and sell the treatment, molnupiravir  at discounted prices to more than105 countries worldwide, once the drug has been approved by the US Food and Drug Administration and the World Health Organization. 

The agreement is the first time in the pandemic that a major pharma company has agreed to such an open-ended license for generic production of a newly developed drug. The drug,  currently awaiting US FDA emergency review, reduced risks of hospitalization or death by about 50% among patients with mild or moderate COVID, according to the company reports of the results of its Phase III trial.  

The deal also represents a major coup for the Geneva-based MPP, a non-profit organization with a long track record of negotiating with big pharma innovators for broader generic production of costly new drugs for treating hepatitis, HIV, and other diseases. 

Until now, however, MPP had not been able to enter fully into the COVID medicines access fray – with pharma producers reluctant to negotiate with the non-profit over broad-based licenses for the generic production of COVID vaccines and drugs.  Other new COVID drug treatments, such as the newly-approved monoclonal antibody cocktail REGEN-COV, remain expensive and hard to access in most LMICs. They are also more difficult to use  – as they need to be administered intravenously.

Charles Gore, MPP Executive Director, said of the breakthrough, “This transparent, public health-driven agreement is MPP’s first voluntary licence for a COVID-19 medical technology, and we hope that MSD’s agreement with MPP will be a strong encouragement to others.”

The MPP is all the more meaningful as the new drug will be the first major COVID medication that can be administered orally to non-hospitalized patients, said WHO in a statement.

‘Best agreement any company has made’    

The announcement was roundly hailed by WHO and other UN-affiliated agencies managing the UN-supported ACT-Accelerator initiative to broaden access to vaccines and drugs.  A number of medicines access advocates who have bitterly criticized pharma for failing to issue more voluntary license deals for for other cutting edge vaccines and treatments, issued particularly warm statements about the Merck deal. 

Said Jamie Love, of Knowledge Ecology International, “The license between the MPP and Merck for the manufacture and sale of molnupiravir is the best agreement any company has made for licensing its intellectual property during the COVID-19 pandemic.

“The 69-page license agreement is fully transparent, unlike the agreements with CEPI, COVAX, Operation Warp Speed, the Gates Foundation, the Wellcome Trust, other companies or most governments,” added Love referring to the other international and UN-supported initiatives on COVID drug and vaccine access.

“The license makes it possible for any generic manufacture located anywhere the world to supply molnupiravir in the licensed territory, and provides a pathway for supplying to countries outside the licensed territory, when patents are not in place or subject to compulsory licenses.

“The licensed area is large enough (more than half the world’s population) to induce efficient generic entry and economies of scale,” he added – while noting that the 18% population coverage in LAC is weakest – although a separate Merck deal with Brazil is reportedly underway. 

Concluded Love: “Given the objectives of scaling up production of molnupiravir at the lowest prices for the lowest income countries, the agreement is an impressive achievement for the Medicines Patent Pool and Merck deserves credit for being the first company to make a deal with the Medicines Patent Pool.”

MSF calls out shortcomings of contract 

Even so, some civil society stakeholders, and notably Médecins Sans Frontières (MSF) said that the licensing arrangement “does not go far enough” expressing “disappointment with the limitations of this license, as its territory excludes nearly half of the world population and important upper-middle-income countries (UMICs) with robust manufacturing capacity, such as in Brazil and China.” 

Yuanqiong Hu, Senior Legal and Policy Advisor, MSF Access Campaign added that: “After more than a year of secrecy of companies’ bilateral deals in a pandemic, it is a welcomed step forward to have the first fully published voluntary license from MPP covering COVID19 medical tool. 

“However, a closer look reveals its limitations for increasing access to one of the first promising antiviral drugs for COVID-19. It’s disappointing…. Middle-income countries excluded from the license had 30 million COVID-19 infections in the first half of 2021, 50% of all infections in low- and middle-income countries.

Medicines, Law and Policy, while generally positive, also called out a clause that would allow MPP terminate a sublicence agreement with a manufacturer of the new drug, in the case of a patent challenge – a clause reportedly included at the request of the drugs initial developers at DRIVE, a subsidiary of Emory University and Ridgeback Pharmaceuticals.

Emory University has in fact waved royalties on the sale of the drug in low- and middle-income countries for as long as the WHO-declared international public health emergency continues.

However the termination of sublicence clause also has provoked protests by students, who say that it could restrict or undermine the flexibility of the generic licensing agreement.

Merith Basey, Executive Director for Universities Allied for Essential Medicines, a student-led movement that aims to change universities’ licensing practices told us: “Emory University has betrayed its mission to serve humanity by stifling global access to a potentially life-saving COVID treatment. Molnupiravir was developed on Emory’s campus with massive amounts of tax-payer funding, yet this license includes a stipulation demanding a no-patent challenge. We call on the institution to remove the clause and favor people over profit in the midst of a global pandemic that has killed over 5 million people so far.”

Image Credits: Merck , Merck .