Some members of the pharmaceutical industry have argued throughout the COVID-19 pandemic that intellectual property is not the primary cause for global vaccine inequity.
*This article was originally published on The Hill Times on November 2, 2022.
Advocates for reducing intellectual property rules to promote access to medicines see a report issued by the House Foreign Affairs Committee last week as having many positive elements, while members of the pharmaceutical industry and related groups expressed mixed reactions, ranging from openness despite their disagreement with a key recommendation to questioning the premise of the study itself.
The report has “a lot of things that are positive” but “would have been even better if we’d done them two years ago,” said Adam Houston, a medical policy and advocacy officer for Médecins Sans Frontières (MSF) Canada. “If many of these things had been the starting point, they would have had more impact.”
However, Houston said his focus now shifts to monitoring whether some of the recommendations that his organization views as positive will be implemented. The most immediate one deals with the World Trade Organization (WTO) and its Agreement on Trade-Released Aspects of Intellectual Property (TRIPS)—the creation and development of which is described in detail in Part 1 of this series about the relationship between health equity and intellectual property.
Recommendation 9 of the report tabled in the House of Commons on Oct. 24 calls on the federal government to “advocate for an extension” of a June 2022 agreement that was reached to temporarily waive TRIPS and suspend intellectual property (IP) rights related to the COVID vaccine. This was done in an effort to improve access to vaccines in low-income countries, which have experienced significantly lower rates of vaccination. When the compromise waiver was reached, it set a six-month window for a review, at which time WTO members are to consider an expansion of the waiver to cover COVID diagnostics and therapeutics.
However, Houston notes that Standing Order 109 of the House of Commons, cited by Liberal MP and Foreign Affairs Committee chair Ali Ehsassi (Willowdale, ON) when he tabled the report, does not require the government to deliver a response for 120 days. This means the window for reviewing the TRIPS waiver closes before the government is required to table its response to the committee.
While advocates of the waiver say they are largely pleased with the report, the recommendation about TRIPS, as well as the strong focus on IP during the committee’s study, has drawn criticism from some members of the pharmaceutical industry, who have argued throughout the pandemic that IP is not the primary cause for global vaccine inequity. Rather, they point to issues such as logistics and vaccine hesitancy in low-income countries.
“We start from the premise that—to the extent that there’s current access limitations with respect to either COVID-19 vaccines, or diagnostics or therapeutics—these are related to issues around global policy and procurement and regulatory [issues] as opposed to intellectual property,” said Declan Hamill of Innovative Medicines Canada, which represents Canada’s pharmaceutical industry.
“The central premise [of the report] is that intellectual property is the barrier to greater vaccine access,” said Hamill, who serves as the organization’s vice president of policy, regulatory, and legal affairs. “Therefore, our concern would be that there’s a lot of emphasis on intellectual property on this issue, and less attention paid to other issues that we believe are at least as important, if not more important, in terms of improving vaccine equity.”
BIOTECanada, which represents Canada’s biotechnology industry, also raised concerns about the recommendation to expand the TRIPS waiver, while taking a more favourable view of other aspects of the report.
“I think when you look at the TRIPS waiver, the issue that the industry has with that is it’s one of those things that feels like it’s going to help, but in fact, I don’t think would have,” said Andrew Casey, president of BIOTECanada.
Casey argued that vaccine shortages came not from the industry’s lack of ability to manufacture the vaccine, but from shortages of the many component parts needed to go into producing each dose. He noted, for example, that the Pfizer-BioNTech vaccine contained 280 component parts.
He said BIOTECanada sees it as a complex problem to be addressed on many levels, and for that reason, his organization was “really impressed” with other aspects of the report.
“It took a fairly comprehensive look at the problem and the challenge,” he said. “And rather than trying to find a simplistic solution, it sort of recognized that it was a fairly complex series of issues that need to be addressed, rather than one specific thing.”
BIOTECanada is particularly pleased with some of the report’s recommendations around investing in the healthcare systems in low-income countries.
Casey said his organization is also open to recommendation 10 in the report, which calls for a review of Canada’s Access to Medicines Regime (CAMR). This regime—as described in Part 2 of this series—is something the Canadian government pointed to as a reason not to delay supporting a TRIPS waiver, though it has not made use of the provisions under CAMR during the pandemic.
“I think the system clearly wasn’t working as well as we wanted,” said Casey. “So I think taking a look at it to find out if there’s a better way, or a way to improve it, makes good sense.”
Houston said that MSF, which has long been critical of CAMR as being too administratively burdensome to be effective, would likely also be willing to participate in a review of the regime. However, he said given that his organization has observed long-standing issues with CAMR, it may also be time to look beyond it and towards broader changes.
“I do think we’d participate if something came up. And if there is momentum to do this, obviously, we’d rather have a better mechanism than what we have,” he said. “But I wouldn’t want to put all the eggs in the basket.”
He noted there are “some real questions of diminishing returns here,” and questioned, “how much time do we spend tinkering with this … versus saying, maybe the end goal of access to medicines is better met in some other way.”
Houston said that for MSF, recommendation 8 in the report stands out.
It calls for the federal government to “ensure that its agreements to provide research and development funding include clauses that allow intellectual property resulting from that funding—including vaccines, therapeutics, and diagnostics—to be easily licensed to manufacturers serving low- and middle-income countries.”
Houston said having these “strings attached” to publicly funded research could make a significant impact.
The future of health equity and IP
Many of the advocates and researchers interviewed for this series say the events of the pandemic have opened up a broader conversation about the intersection between health equity and intellectual property beyond the current pandemic.
“None of these issues here are purely about COVID,” said Houston, noting that there are many other global issues involving access to medicines, such as tuberculosis. “We don’t need temporary changes around COVID. We need systemic changes, to get drugs and vaccines to the people who need them.”
While he said he is disappointed with the inequities that have existed around COVID vaccines, he sees some pandemic-related events as a jumping-off point to move forward.
“We’ve seen what we can do when we do have these massive levels of investment,” he said. “There are an incredible number of COVID-19 vaccines that have been approved around the world in a very short period of time, and even more candidates out there. So, that really shows that if we invest in this sort of [research and development], we can really do incredible things.”
He said intellectual property will remain part of the picture in terms of access to medicines, but there are new approaches that can be taken within that framework. He said he wants to see “some strings attached, so that public funding for public health has public benefits.”
“Intellectual property, at the very least, it’s not going anywhere tomorrow,” said Houston. “Public investment should yield public dividends. So if we’re saying there should be IP, well, who should own that IP? Maybe the [public] investors should have more control over that IP.”
Jeremy de Beer, a University of Ottawa law professor who studies intellectual property, innovation, and global trade and development, said he wants to see a future where there’s a shift in the relationship between innovation and intellectual property.
“I reject the premise that intellectual property protection is inevitably necessary to incentivize innovation and that it has to be at the expense of access,” said de Beer.
While one of the central arguments against a TRIPS waiver hinged on the idea that waiving IP would be a disincentive to innovation, de Beer said there are other models of science which a more relaxed IP framework would encourage.
“The fundamental assumption behind intellectual property rights is that a winner-take-all race to be the first to apply for a patent is the best incentive,” he said. “We know that in many situations that’s not the case, and that collaboration rather than competition, openness as opposed to exclusivity, is the key to generating transformational change, breakthrough innovations.”
He added that many factors in the innovation landscape have changed since the TRIPS agreement was signed in 1994, and that these changes support a more open approach to science. In particular, he pointed to technological changes that facilitate working together through “asynchronous collaboration,” as well as increased labour mobility that sees people moving to new firms more often.
De Beer advocates for “embracing open science, and opening our minds to possibilities beyond the proprietary models that dominated the discussion in the late 20th century.”
“It’s not about throwing the baby out with the bathwater,” he said. “It’s just understanding the enormous potential of open science and open innovation, and what role intellectual property can and cannot play in that framework. We have so many more policy tools at our disposal than we had when the TRIPS Agreement was created. We have to embrace that and use those tools.”
However, Richard Owens, a senior fellow with the Macdonald-Laurier Institute and a lawyer specializing in intellectual property and technology, disagreed that lower IP barriers would foster innovation, saying the argument comes down to a philosophical difference around the role of property.
“There’s a lot of ideology opposing property. Property is one of the greatest inventions as a concept in history,” said Owens. “Nothing provides us with better environmental protection, scientific benefits, and individual dignity.”
He argued that relaxing patents would decrease openness, on the grounds that patents provide protection for scientists to reveal their innovations.
Without patents, “what we would have is a system whereby inventors were forced to secret their inventions, not document them … [and not disclose] them to other scientists or anybody else,” he said, rather than “try to profit from them for the good of everybody.”
Dr. Srinivas Murthy, a physician and associate professor at the University of British Columbia medical school, challenged that view on two grounds.
“Intellectual property has only been sort of present over the past, say, 50 years within the drug development industry, and before that there were much more open approaches and there was huge development within the space,” he said, pointing to insulin and polio vaccines as examples of medical technologies developed earlier in the 20th century.
Murthy, who is also co-chair of the World Health Organization’s clinical research committee on COVID-19, said the scientists working for drug companies may have motivations that are not driven by the financial incentives associated with IP.
“I’m not convinced … the scientists out there—even at these drug companies who are doing great, great work—that the only reason they’re doing all of their science is so that their companies can make money,” he said. “These scientists are doing this because they want to see their products out there, and it’s only the companies and the shareholders who are putting those IP barriers in place.”
“So I’m not convinced—either from history or just morally—that we need intellectual property to develop high-quality products.”
As the conversation on the international stage shifts towards a pandemic treaty, Murthy said he would like to see a plan for how to rapidly scale up innovation and production of medical supplies in parts of the world in ways that are not contingent on profit. But more than anything, he said he’d like for it to have reliable enforcement mechanisms.
“Enforcing things in the pandemic treaty is going to be 99 per cent of the work there,” he said. “We’ve seen in some climate treaties that countries can write things and agree to things, but not necessarily do things. And so I think, regardless of what’s written down in the pandemic treaty, making sure that we keep our countries accountable is going to be the first and most important thing.”