Access to Covid-19 therapies: Pharma's take

Thomas Cueni (IFPMA)

Despite 30 years of experience in the pharma industry, Thomas Cueni admits that, at the beginning, he did not fully appreciate that the new coronavirus, which first emerged in Wuhan, China, had the potential to trigger a global crisis. His experiences with SARS in 2003 and MERS in 2012 suggested the outbreak would remain geographically limited.

A trip to Japan in mid-February changed his mind. The country was in the midst of the quarantine of the Diamond Princess cruise ship, where hundreds of people became ill with Covid-19.

Thomas Cueni is director general of the IFPMA (the International Federation of Pharmaceutical Manufacturers and Associations), a Geneva-based organization that brings together 37 of the world’s largest pharmaceutical companies.

“Collaboration as never before”

Despite historical under-investment in research against infectious diseases, the industry has mobilized tremendous resources in the quest for treatments and a vaccine, displaying "collaboration as never before."

As a result, no less than 150 therapeutic agents and more than 120 vaccine candidates are in development. Researchers are also exploring if a number of drugs developed for other diseases can be repurposed. Cueni says this wealth of potential therapies is, above all, a clear demonstration that the pharma innovation system works. And it is the reason why "patents are more of an asset than a hindrance in the face of Covid-19."

The issue of patents for Covid-19 therapies has been at the centre of attention, including at the World Health Assembly’s annual meeting, which took place Monday and Tuesday. Patents typically give a company a 20-year monopoly on its product - although in health emergencies, companies are legally entitled to issue “compulsory licenses” for products they deem to be critical for public health, using “flexibilities” in negotiated World Trade Organization rules.

In Covid-19 times, normal business models can’t apply

Although Cueni acknowledges that emergencies can sometimes justify such an exceptional measure, he is against its systematic use. And he is against the political use of this threat, which has already been brandished by several countries. Pharma's argument is that it will weaken the patent system and ultimately discourage companies from investing in research - including for the next pandemic.

But he also agrees that in the face of Covid "the pharmaceutical industry cannot apply its normal business model". For pharma, the solution then lies in “voluntary licences” that companies can agree to issue on their patented products to expand production and reduce prices.

Thomas Cueni cites the case of Gilead Sciences, which has set up a network of partners to produce remdesivir, in Brazil, India and elsewhere. The experiemental drug, appears to speed recovery of some seriously ill Covid-19 patients, in initial trials.

Medicines Patent Pool offers a third way

In the same vein, IFPMA supports the extension of the Medicines Patent Pool mechanism to the Covid-19 arena. initially created by the UN’s UNITAID, MPP has a track record of successfully negotiating voluntary licenses for vital HIV, TB and Hepatitis C treatments, sometimes reducing their cost by a factor of 300. Initially created by the UN’s UNITAID, MPP has already offered to act as a coordinating mechanism for voluntary licensing of treatments that might emerge from Covid-19 research - in coordination with WHO. The fact that the IFPMA is officially in favour of it is no small matter.

The question of vaccines remains. Cueni expects that there will be "about ten valid vaccines, two or three of which will hopefully be available by the spring of 2021". But the challenge of producing vaccines on a global scale is not, he says, an intellectual property issue. "Patents have little impact on the price of a vaccine. What matters is quality control," he says. Quality control employs 50 times as many people as in drug production, he contends, due to the high standards that have to be met.

Joining the Access to Covid-19 Tools Accelerator (ACT)

On April 24, the IFPMA also joined the WHO's Access to Covid-19 (ACT) Accelerator initiative, which is committed to equitable, global and affordable access to Covid diagnostics, therapies and vaccines. "We don't want to repeat the situation in 2009 during the H1N1 flu epidemic, when rich countries bought up all the vaccine stocks,” says Cueni.

Ultimately, ensuring global access to Covid-19 therapies will require massive scale up of production - and only the biopharmaceutical industry has that capacity, he adds.

At the same time, he confirms that "collaboration is key and we don't have all of the answers yet. As for equitable distribution of a future vaccine, he says “we have to define clear priorities, beginning, without a doubt, with the vaccination of health care workers, vulnerable populations, and taking into account regional differences in the pandemic's spread."

For more about IFPMA’s take, see also a Q&A with Cueni here:

Health Policy Watch-Pharma under the microscope in the Covid-19 crisis