Some 33 Members of the European Parliament released an open letter Friday urging top leadership in the European Commission (EC) to prohibit exclusive licensing for COVID-19 products developed with European Union (EU) grants, and demanding transparency in the research and development pipeline to ensure affordability commitments are met. 

In a separate letter signed by 37 NGOs and over 50 experts in health and patent law, public health and medicine, called on the World Health Organization and all Member States to get behind Costa Rica’s initiative to “pool” COVID-19 patent rights for essential drugs, vaccines, and technologies. The letter was posted by Knowledge Ecology International, a global patent watchdog group.

Those campaigns come right in the wake of the World Health Organization Director-General Dr Tedros Adhanom Ghebreyesus’ Twitter endorsement of Costa Rica’s call to create the “pooled rights” initiative.  

“We cannot allow patients to be refused care because of financial constraints or shortages resulting from manufacturing or supply constraints,” said the Members of the European Parliament in the letter addressed to EC President Ursula Von Der Leyen; EU Commissioner for Innovation, Research, Culture, and Youth, Mariya Gabriel; and EU Health and Food Safety Commissioner, Stella Kyriakides. 

Although the European Commission invests more than double of any private sector partner in EU-funded COVID-19 research, most of the calls for proposals so far do not seem to require companies or organizations to commit to affordability and access clauses, the MPs stated in their letter. Thus, it is even more important to enforce public oversight on the R&D process and bar exclusive licensing, they noted.

For new products, companies should be required to commit to non-exclusive licensing on any developed health technology as a precondition for receiving EU funding, said the MPs.  Granting exclusive licenses on new products could result in subsequent shortages, as only “one or very few companies” would be “allowed to produce an extremely timely medicine that is required in huge quantities worldwide,” the MPs stated.  

“From this moment forward, we require new medical tools to be immediately available once authorised for use, at an affordable price and in high enough quantities to meet global demand.”

Responding to the calls, Thomas Cueni, director-general of the International Federation of Pharmaceutical Manufacturers and Associations warned that pooling patent rights would not likely enhance the global battle against the virus. 

“While voluntary pooling of intellectual property and other assets can be a tool to stimulate R&D and facilitate access under certain conditions, its effects to address the current pandemic will likely be very limited,” warned Cueni in a statement. “Tools already exist for governments to access the medicines they need, and they are already being used in a number of cases. 

“In addition, there are established organizations in place –  such as the Medicines Patent Pool, a UN-backed initiative that uses a voluntary licensing and ‘pooled’ patent model to grant licenses to generics manufacturers – who have the expertise in licensing and managing an established pool of intellectual property assets,” Cueni added.

As one such example, AbbVie Pharmaceuticals recently announced that it would offer through the Medicines Patent Pool licenses for its lopinavir/ritonavir drug combination without patent restrictions, after the HIV treatment was identified by the World Health Organization as one of the drug combinations to be tested in a multi-country trial against COVID-19.

“Given the gravity and urgency of the COVID-19 pandemic, the biopharmaceutical industry has not wasted any time or spared any effort in using its skills, technology and resources to bring safe and effective treatments, vaccines and diagnostic to patients around the world as a matter of utmost urgency,” added Cueni, pointing to a list of IFPMA commitments on the emergency.

Civil Society Advocates Propose “Phased” Development of COVID-19 Patent Pool

However, the proposed pool of patent rights for COVID-19 technologies would, in fact, build on the successes of the Medicines Patent Pool in expanding affordable access to medicines for HIV/AIDS, tuberculosis, and hepatitis C, said Brook Baker, senior policy analyst at the Global Access Project, and a signatory on the KEI letter.

“Simply put, no exclusive rights should stand in the way of governments’ and the global community’s response to the COVID-19 pandemic,” Baker wrote in an opinion to Health Policy Watch on Costa Rica’s call to pool rights to drug development.

To build agreement around the roll-out of a COVID-19 patent pool, the KEI letter also proposes a phased approach. An initial “phase-one” agreement would establish the minimum legal basis to permit such licensing in the future, and create a process for working out the details. Hammering out which technologies to share, the terms of authorization, and possible remuneration for the pooled licenses could be done at a later date, the KEI signatories suggest. 

However, the pool for COVID-19 products should go beyond medicines patents, per se, to address regulatory test data, research data, cell lines, basic science innovations, and other intellectual property, the signatories, including some 37 NGOs and 50 experts.

Inputs to such a pool could come from governments that fund research and development or buy innovative products, as well as from universities, research institutes, charities, private companies and individuals who control rights, the letter suggests.

In parallel moves, two other large NGOs, Médecins Sans Frontières and the Treatment Action Group released separate public statements Friday calling for national governments to prepare to override patent protections as well as to take other measures, such as enacting price controls, to ensure availability of COVID-19 medicines, vaccines, and other medical tools. 

TAG threw its weight behind the MSF call, earlier in the week, for a US $5 price tag on a rapid COVID-19 test that can be used on the GeneXpert TB platform, which has thousands of diagnostics instruments in Africa, Latin America and South-East Asia.

“We know too well from our work around the world what it means to not be able to treat people in our care because a needed drug is just too expensive or simply not available,” said Dr Márcio da Fonseca, Infectious Disease Advisor at MSF’s Access Campaign in the statement.

South Africa, one of the first middle-income countries to embrace the Cepheid COVID-19 test, announced that it will begin using the new GeneXpert COVID-19 tests to leverage the large network of over 180 machines in the country to ramp up rapid testing, as total confirmed cases in the country crossed the 1000 cases threshold. The first test cartridges will be available for use in April.

First Patient in WHO’s COVID-19 SOLIDARITY Trial Enrolled in Norway

At the University of Oslo Hospital in Norway, the first patient was enrolled Friday in WHO’s massive multi-country SOLIDARITY trial to collect data on potential COVID-19 treatments. This followed on an announcement by Prime Minister Erna Solberg of a 2.2 billion NOK (US$ 211) additional investment into the Coalition for Epidemic Preparedness Innovations (CEPI) COVID-19 vaccine development efforts. That was in addition to a 1.6 billion NOK (US$ 153.6 million) investment in the Oslo-based CEPI vaccine efforts.

“We are in a global quest for knowledge unlike anything we’ve ever seen,” said Noweigian Minister of Health Bent Høie in a press briefing. “We can save lives, protect healthcare professionals and all others from getting the disease.”  

The Norwegian SOLIDARITY trial patient will be the first to take part in this WHO-organized global effort to test four potential COVID-19 treatments under a simplified protocol, so that even low-resourced healthcare facilities could participate. The drugs to be tested include Gilead’s experimental drug remdesivir; the lopinavir/ritonavir originally developed by AbbVie Inc. for HIV/AIDs along with beta interferon; as well as the anti-malarials chloroquine or hydroxychloroquine with azithromycin. Another arm of the trial is also starting on Friday in Spain.

The SOLIDARITY Trial began as global case counts surpassed half a million, and total deaths surged over 26,000.

“These are tragic numbers,” said Dr Tedros.

Some countries are already administering the medications ad-hoc on a compassionate use basis, as well as stockpiling for future mass use. But WHO’s Dr Tedros has cautioned against widespread use of such treatments without strong evidence – following media reports of people self-medicating with the substances or ones similarly named. One man in the United States, for instance, died after ingesting chloroquine phosphate, a chemical used in aquarium cleaning, following US President Donald Trump’s endorsement of chloroquine as a treatment for COVID-19, according to the Associated Press.

“We call on individuals and countries to refrain from using therapeutics that have not been demonstrated to be effective in the treatment of COVID-19,” said Dr Tedros. “The history of medicine is strewn with examples of drugs that worked on paper, or in a test tube, but didn’t work in humans or were actually harmful.” 

In one example, he said that “during the most recent Ebola epidemic, for example, some medicines that were thought to be effective were found not to be as effective as other medicines when they were compared during a clinical trial.

“We must follow the evidence. There are no short-cuts.”

Contrary to WHO’s cautious approach, a prominent bioethicist suggested a radical approach to fast-tracking vaccine development – purposefully infecting young healthy volunteers with the virus and seeing whether the vaccine protects against infection. In a preprint paper, Director of the Center for Population–Level Bioethics (CPLB) at Rutgers University Nir Eyal suggested that despite placing participants at risk of “severe disease and death”, such a ‘human challenge’ study design could “subtract many months” from the vaccine licensure process, reducing the global burden of coronavirus morbidity and mortality.

Image Credits: NIAID.