After waiting more than 200 days to receive a decision from the Health Research Ethics Board (HREB) on its Newfoundland and Labrador Genome Pilot Project research application, Sequence Bio is going on the offensive.
The St. John’s-based biotechnology company filed an application in Newfoundland and Labrador Supreme Court seeking an order declaring that the board, as appointed by the Heath Research Ethics Authority (HREA), is lawfully obligated to decide on a research application within 30 days of receiving it, as set out in provincial legislation.
“This is not a Sequence Bio issue, this is a Newfoundland and Labrador issue,” CEO Chris Gardner told The Telegram after a brief court appearance Thursday morning. “We deserve better. We deserve more research that’s happening here and that’s the bigger story.
“We’re confident that the courts are going to see that this is significant, not just for us but for all research and that the interpretation of this does warrant their involvement.”
The original application sought an order of mandamus, a judicial command to a government body to do or desist from doing a specific act that it is obligated in law to do. The day after the initial application was filed, the HREB clinical trial subcommittee rendered its decision.
“They served us a letter that was frivolous, that many of the clauses actually violated best practices and they essentially used that as a failure to approve,” says Gardner, noting it has already been brought to the appeals board and, should that fall through, Sequence Bio will take the decision to the courts.
Gardner says their actions are not about discrediting the regulator, but about creating an environment where research into the diseases affecting so many people in this province can thrive so as to improve health care delivery and outcomes.
“Regardless of your stance on any particular researcher’s research that they’re doing, I think we would all agree that a properly functioning regulator is good for all of us. It’s good for patient outcomes, it’s good for creating knowledge in this province, it’s good for keeping jobs in this province.”
Sequence Bio may be the first organization to challenge the regulator, but it isn’t the first to be affected by decision delays. Since the early days of getting the company off the ground, Sequence officials have heard “horror stories” from other researchers too afraid to speak up against the HREA and HREB out of fear of reprisal or blacklisting.
“What we’ve seen, since we’ve put a flag in the sand, is more individuals and more researchers willing to speak up,” says Gardner.
And Sequence Bio is giving them the forum in which to do so by establishing a website called itsaboutTimenl.ca where other researchers can share their stories.
“If you’re a researcher and you’ve had your research unlawfully declined or it went with them and they didn’t process it in the appropriate time, reach out to us, we can help,” Gardner said.
For those who think change can’t be effected, Gardner says Sequence Bio proved it can. The company played a part in getting Bill S-201 — an amendment to the national Human Rights Act to include genetics as a protected provision — passed into law.
“Here we have an HREA Act that is not good enough. It was written in 2011, it’s failed, it’s time for it to be better. I’m convinced we’re going to be able to do it,” he says.
Asked if he was worried about the long-term relationship with the HREA and HREB being negatively affected by the court action, Gardner said they couldn’t sit idle waiting for things to change.
“Ultimately, we’re doing the right thing, so if that damages our relationship with certain individuals at the HREB, well, they shouldn’t be there to begin with because they’re not doing the right thing.”
But that may be a moot point. Gardner says Sequence Bio is considering launching the genome project in New Brunswick.
“If Newfoundland and Labrador is simply closed for good research, we have to look elsewhere,” he says. “We have every confidence that this, in another jurisdiction, would fly through.”
With them will go close to 100 high-paying jobs and an estimated economic impact of $150 million that would have resulted from project approval.
When contacted by The Telegram, the HREA stated it would not comment on any matter still before the courts.
Both sides are due back in court on May 15 to set a hearing date.