Matthew Herder and Andrea MacGregor question whether the deals just announced by the federal government with two companies developing COVID-19 vaccines serve the public interest because details about these deals are not publicly available.
Capping off numerous agreements with makers of PPE, medical devices, and other goods to help combat COVID-19, Canada’s federal government just announced deals with two companies developing vaccines against SARS-CoV-2.
It’s not that the vaccines in question aren’t promising. The agreements involve a novel vaccine technology known as mRNA vaccination. The two vaccines in development, known as “BNT162”, (sponsored by the company Pfizer Canada), and “mRNA-1273”, (sponsored by the company Moderna, Inc.), aim to give the body the genetic instructions to ward off SARS-CoV-2 directly. Trials for both vaccines are underway, with encouraging preliminary results for mRNA-1273 having been reported from early testing. While an mRNA-based vaccine has never been developed before against any human pathogen, if it proves effective against SARS-CoV-2, it will be much faster to produce in mass quantities because it doesn’t need to be cultured and purified like older vaccine technologies.
The problem, rather, is that we have no idea whether the agreements the federal government has signed with Pfizer and Moderna contain clauses that protect the public investment and public interest in these technologies. Transparency of the data behind these vaccines is, for instance, critically important given how fast they are being developed. Do the agreements contain commitments to enhanced data transparency? We don’t know because the deals themselves aren’t transparent. Accessibility is also an essential factor in the vaccine’s value for the public. Do the agreements say anything about equitable or humanitarian access, that is, specify that vaccines will be allocated based, at least in part, upon need and vulnerability? We don’t know. Do they say anything about the price of the vaccines if and when they reach the market? Even though the public sector often contributes substantially to the development of vaccines — Moderna’s mRNA has reportedly been 100% funded by the US government — that contribution is rarely reflected in such agreements with, for example, a “reasonable pricing” or “affordability” clause. But we simply don’t know whether that kind of public interest protection is present or absent from these deals because these deals are absent from public view.
To be clear, this secrecy is standard practice. Deals between university researchers, government labs, or government agencies with industry are, as a rule, kept confidential. If you know where to look and a publicly traded company is involved, you can sometimes find these deals buried in financial filings with the US Securities and Exchange Commission. That’s where a problematic deal between the Public Health Agency of Canada (PHAC) and a US company for the development of an Ebola vaccine, years before the 2014-15 West African epidemic, was unearthed, which PHAC later posted on its website. But pharma’s preference is always to keep these deals hidden from public view in order to preserve its negotiating flexibility in other deals, limit competitors’ knowledge of its Research and Development plans, and, it would seem, pre-empt the very sorts of questions we raise above about the adequacy of the deals vis-à-vis the public interest.
Keen to show that they’ve procured (unproven) drugs or vaccines for their own domestic populations, Canadian, US, UK, and other governments have thus far been willing to acquiesce to industry’s core term of confidentiality. But if ever there was a moment to shift practice, it is now. Governments and philanthropic organizations have contributed billions to the development of a slew of COVID-19 vaccines, not to mention other interventions. That financial investment alone should be enough to dictate greater deal transparency.
And if the Canadian government actually follows through and the deals with Pfizer and Moderna lack the kinds of protections we envisage, all is not lost. The government had the foresight to add a new provision to the country’s patent laws as part of its COVID-19 response legislation, and that provision gives the Minister of Health the power to override a company’s patent(s) pertaining to a vaccine (or other invention) and authorize a third party to produce the vaccine in question. Pharma opposes this kind of “compulsory licensing” far more than transparency. Similar to past public health emergencies, the mere threat of invoking compulsory licensing could help the government to re-negotiate these deals with Pfizer and Moderna and add terms that favour the public interest.
The Prime Minister, along with other world leaders, has publicly stated that the development of a vaccine against COVID-19 “cannot be a race with one winner.” To make that commitment concrete — while also ensuring that the data behind the vaccine is open to scrutiny and, if it ultimately proves safe and effective, is priced affordably — public interest protections must be integrated into the deals the government makes with vaccine manufacturers. Only if the deals are made public, and steps are taken to correct any omissions, can we be confident that private corporate interests are not being prioritized over the public interest and global health.
Matthew Herder is the Director of the Health Law Institute in the Faculties of Law and Medicine at Dalhousie University and a member of the “Transparency 2020” research team, which has filed numerous access to information requests since the start of COVID-19 in an effort to secure agreements between the federal government and various private sector partners. @cmrherder
Andrea MacGregor is a third year law student at the Schulich School of Law, Dalhousie University, and a member of the “Transparency 2020” research team, which so far, has received no documentation from the federal government.
Competing interests: Matthew Herder is a member of the Patented Medicine Prices Review Board, Canada’s national drug price regulator, and receives honoraria from the Board for his service. He also holds funding from the Canadian Institutes of Health Research and is a member of the Canadian Center for Vaccinology (CCfV) at Dalhousie University, which is running a clinical trial for a COVID-19 vaccine. He has, however, had no involvement in that trial whatsoever, or any of CCfV’s work related to the pandemic.