The Biden administration must disclose the costs of clinical trials

Forcing pharmaceutical corporations to share the costs of all clinical trials could play a key role in expanding access to medicines everywhere

Lebanon - COVID-19 Vaccination

Lebanon 2021 © Mohamad Cheblak/MSF

Pharmaceutical companies must be forced to share the costs of future clinical trials on a government website

Pharmaceutical corporations justify charging high prices for medicines, vaccines, and tests by saying that it costs billions to bring a drug to market. But there’s no way to know how truthful these claims are because companies don’t disclose how much they actually spend on research and development (R&D). This leaves the public and treatment providers like Doctors Without Borders/Médecins Sans Frontières (MSF) in the dark. We don’t know whether the prices we are paying are fair—and we have less leverage to advocate for lower ones if they aren’t.

Each and every day in more than 90 countries, our teams on the ground treat people who are directly and disproportionately affected by the high prices that pharmaceutical corporations charge for medicines, vaccines, and tests to treat, prevent, and diagnose a variety of illnesses. High prices prevent people in the communities in which we work from accessing the medical tools they need. And those are only the products that already exist; companies also often neglect to invest in developing new medical tools because they don’t see enough opportunity for profit.

Transparency of R&D costs is even more important given that the US government spends tens of billions of dollars annually to fund the R&D of new medical products. Instead, pharmaceutical corporations keep R&D costs a closely held secret.

Clinical trials are widely regarded as the most expensive part of bringing a drug to market. Making these costs public would put us all in a better position to demand fair prices.

Coalition demands Biden administration acts on R&D cost transparency

Read the letter

You have a right to know

Public, taxpayer funding not only makes most early R&D possible—including R&D conducted at universities and in federal labs. It also plays a major role in late-stage development of new medicines, vaccines, and diagnostics, including clinical trials. Yet drug companies have shown little regard for the public that’s footing the bill. They refuse to disclose in any detail how they’re using this government support, if these funds play a role in a product’s final price, and how much they themselves are contributing.

The most widely cited estimates of the average cost of developing a drug are based on industry-funded studies with methodology that has been widely challenged. In fact, recent studies suggest that prices of drugs in the US generate much more than companies spend on their R&D, meaning that companies are just trying to make as much money as possible without much concern for consumers. In fact, pharmaceutical corporations are likely reaping huge profits at the expense of taxpayers twice—first through the public funding they are given to carry out R&D, and then again from people paying often excessively high prices at the pharmacy.

Take a couple of the leading COVID-19 vaccines: Moderna received more than a billion dollars from the US government to create a COVID-19 vaccine—one that is expected to have made the company up to $18 billion last year alone. Pfizer-BioNTech’s vaccine was also built on publicly-funded research—supported by the German government—and is anticipated to bring in $36 billion for that same time period, the largest sales for any vaccine or medicine ever.

Even as Pfizer-BioNTech and Moderna benefit from government support, the public has no idea how much it cost these companies to develop COVID-19 vaccines. If this information was public, governments, global health agencies, and treatment providers like MSF would be in a better position to negotiate affordable and fair prices and wider global access—and protect many more people. Instead, we have been left in a situation in which the companies are tightly controlling global supply, protecting their profits, and failing to meet global needs as less than 12 percent of vaccines administered so far have been in low-income countries.

Vaccines are readily available and—for the time being—free at the point of care for people in the US, but taxpayer dollars are footing the bill. If flu shot pricing is any indication, "post-pandemic" pricing will increase the financial burdens on purchasers and continue to restrict access to COVID-19 vaccines, medicines, and tests in the US and abroad.

What the Biden administration can do about it

If pharmaceutical corporations insist that they must charge high prices in order to recoup the cost of R&D, then the public has a right to know what that R&D actually costs. Making R&D costs—especially the cost of clinical trials—public knowledge would bring much-needed accountability to an industry that has been allowed to control access and dictate what the public pays for lifesaving medical tools.

One simple, crucial step the US government can take toward lowering drug prices and creating an R&D system better aligned with people’s health needs is disclosing the costs of future clinical trials on ClinicalTrials.gov, a public website where drug developers are already legally bound to disclose trial results—or in a separate repository linked to ClinicalTrials.gov.

Some lawmakers in Congress have already highlighted the need for public access to R&D cost information. Now it’s time to take action and put people's health before pharmaceutical profits.

Francis Collins, the director of the National Institutes of Health—which is the government entity that dispenses most public R&D funding to research institutions, public laboratories, and pharmaceutical companies—has stepped down after more than ten years as the agency’s director. The Biden administration and Congress should ensure whoever steps into this role is committed to publicly disclosing the costs of clinical trials.

We can’t afford to operate blindly anymore. We need this information to negotiate and advocate for fair prices for lifesaving medicines, vaccines, and diagnostics across the world.