A series of public health catastrophes over the last decade or so—where critical safety information was withheld or downplayed by drug manufacturers, regulatory agencies, or both—has underscored the importance of transparency in the drug regulatory system. Without transparency patients are exposed to significant risks and, in many cases, suffer actual harm because neither they, nor their physicians, are fully aware of all the relevant safety and efficacy information. Law-makers and regulators in the United States and Europe have responded with a variety of measures to ensure greater transparency in the regulatory process. Canada, meanwhile, continues to lag behind these efforts.
Last November Health Canada invited me to attend a one-day consultation for “Phase II of the Summary Basis of Decision (SBD) project.” By all accounts, including Health Canada’s own internal evaluation, Phase I of the project has been an abject failure. SBD was supposed to make Health Canada’s decision-making more transparent—to tell us why a given drug was approved for sale in Canada; to spell out the evidence showing the drug is safe and effective. But by the time the SBD project was implemented in 2005 most of the information that it made available was already in the public domain. Officials at Health Canada were well aware of the SBD project’s shortcomings. Phase II, we were told, would expand the breadth of the information to be disclosed.
One of the ways in which Health Canada might expand the scope of project is to include not just information about products that it approves for sale, but also information about drugs, biologics, and medical devices that it rejects. In other words, Health Canada could disclose its “negative decisions” and the evidence behind them. When presented during the consultations in November, this option was met with strong pushback from industry. Such information is the property of the manufacturer, the representative of “Rx&D” essentially contended, and Health Canada isn’t free to disclose it. Where’s the section in the Food and Drugs Act that gives Health Canada the power to do that, he questioned. Joined by patient advocates, Health Canada officials stood its ground. They pointed out that one regulator, the European Medicines Agency, already discloses what it calls “negative opinions,” and similar information also emerges from the FDA’s public committee hearings in the United States. But by the end of day’s discussion it was not clear that disclosing negative decisions was going to be high on the agenda moving forward. Health Canada’s summary report of the consultations reflects a similar level of ambivalence towards posting negative decisions.
I think that’s a mistake for several reasons. Think first of the harms to patients that could result from not disclosing why a drug was not approved for a particular indication. Physicians might not exercise their discretion to prescribe a drug off label if they had the benefit of that information. Think second of the people who, by participating in research, were informed they would benefit others by generating new knowledge only to have that knowledge later shelved by a company for business reasons. But also think of the waste and inefficiency. Most applications for market approval never make it through the approval process. Knowing why the applications of others fail could help researchers and manufacturers to design better or different clinical trials. Instead they are left to repeat each other’s mistakes.
So why does Rx&D take the position that negative decisions are theirs to be kept in confidence by regulators like Health Canada? Because they can. Because the law lets them do so. And because that’s the approach they know.
Rx&D’s resistance to disclosing negative decisions is part of a bigger fight over transparency in the regulatory system. As I explained in a recent paper in CMAJ, there’s no Canadian court decision, law, trade agreement, or even a memorandum of understanding with another regulator that specifically says that clinical trials are the property of manufacturers. The same goes for negative decisions. The problem is that manufacturers have multiple channels and opportunities to assert ownership of that kind of information. If I file a request for information about a drug under the Access to Information Act, Health Canada will almost always check with the manufacturer of the drug before releasing any information. In a recent decision, the Supreme Court of Canada said this “procedural protection” was important. I think the decision was a step in the wrong direction. But it clearly preserves a space for manufacturers to oppose any move to disclose information under the access to information scheme. More broadly, in consultations like the ones I attended last November the importance of protecting “confidential business information” and “trade secrets” is always part of the company line. It’s reasonable to suspect that this familiar refrain complicates Health Canada’s efforts to engage in more proactive disclosure.
Though transparency initiatives in other countries are far from perfect, and important details have to be worked out, regulators elsewhere seem less accepting of industry’s proprietary claims. Health Canada should be more strident in its demands for transparency for several reasons. In addition to avoiding harms to patients, and respecting research participants’ contributions to knowledge creation, there’s something to be said against propping up a failing business model. I’m beginning to wonder whether the companies who assert that secrecy is integral to innovation are actually capable of the kinds of disruptive innovation that pharmaceutical and biotechnology development so urgently needs. Secrecy is the oldest trick in the trade. To encourage radical breakthrough models of innovation, improve regulatory science and decision-making and ultimately protect Canadians from harm, meaningful transparency is needed. Expanding the scope of the SBD project is just one part of that, and it is long overdue.
About the Contributor
Matthew Herder is an Assistant Professor at Dalhousie University in the Faculties of Medicine and Law, and a member of the Health Law Institute.