When it comes to evidence-based decision-making in health, clinical trials are the standard for determining if a drug is safe and effective. However, up to half of the information from these trials is never made available to doctors or patients.
Enacting pharmaceutical transparency: A call to action
Evidence for Democracy has formally endorsed the international All Trials campaign, and previously published about the need for transparency in clinical trials. All Trials demands that all clinical trials worldwide be registered, and their results reported. Matthew Herder introduces a new tool that physicians, researchers, civil society groups, investigative journalists and others can use to gain access to unpublished pharmaceutical safety and effectiveness data.
Matthew Herder is Associate Professor, Health Law Institute, Faculties of Medicine and Law, Dalhousie University. He is also a member of Evidence for Democracy's Network of Experts. Twitter:@cmrherder
Disclaimer: This blog and the template letter are not intended to provide legal advice.
Enacting Pharmaceutical Transparency – Who, What, How, When & Why
This is a call to action—a call that physicians, biomedical researchers, civil society, journalists and others have long made concerning the need to improve the level of transparency in pharmaceutical research and regulation. It’s important to echo that call now, not only because it’s right—transparency is vital to evidence-based medicine and patient safety—but because a new mechanism in Canadian law has the potential to open up a great deal of hidden information about pharmaceutical interventions.
Only one physician researcher appears to have taken advantage of this mechanism since Canada passed Vanessa’s Law in 2014. That has to change. It’s not enough for governments to enact laws and policies that require greater pharmaceutical transparency. Real people and institutions—physicians, other health care providers, biomedical researchers, civil society organisations, investigative journalists and others—have to enact transparency too.
To aid in this process, I have developed a tool—a template letter—that is free to download and use as a means of gaining access to unpublished pharmaceutical safety and effectiveness data. The tool and the terms it contains are based upon best research practices, research ethics norms, and the European Medicines Agency (EMA) policy on publication clinical data.
Who can use this letter?
Any “person who carries out functions relating to the protection or promotion of human health or the safety of the public” can use this letter. You don’t have to be a Canadian resident or citizen. As long as you fulfil that function, i.e. protect/promote human health or public safety, and the reason why you are asking for the information is to “related to the protection or promotion of human health or the safety of the public”, you can use this letter and you are eligible to receive information from the Canadian regulator (Health Canada) about pharmaceutical interventions.
What can you ask for?
The legal provision that this letter takes advantage of gives the Canadian Minister of Health the power to disclose “confidential business information”. While many argue that drug safety and effectiveness information should not be categorized as confidential business information, the scope of that term in Canadian law is broad and the regulator has taken the position that unpublished safety and effectiveness data falls within it. So until that changes, it is critical to take advantage of Vanessa’s Law, which gives the Minister of Health the power to make confidential business information available to persons who protect/promote human health or public safety. Canada gets most of the drugs that go through the US Food and Drug Administration or the EMA. Health Canada thus has a valuable store of information in its possession.
How can you ask for it?
The letter is a template. You need to fill out who you are, why you are a person who protects/promotes human health or public safety, why you want the information, and what information you want.
The letter also contains a set of terms under which the information will be shared. I drafted these terms based on my understanding of best research practices, norms of research ethics, and relevant policies, most notably, the EMA’s publication of clinical data policy. I also solicited feedback from a number of colleagues about these terms. I welcome further input and/or encourage others who intend to use the template letter to refine these terms as they see fit provided they commit to make their findings publicly available.
My objective was to create a user-friendly tool. The terms that Health Canada required one physician researcher to sign onto are problematic. They limit the physician’s ability to share the information for the purpose of carrying out and reporting his research. In contrast, the set of terms embedded in the template letter are designed to give those who make requests for information the flexibility they need to use, share and analyze information in order to fulfill the law’s fundamental purpose, i.e. protect/promote human health or public safety.
When can you use the letter?
Now! The law is in effect and can be used by the Canadian Minister of Health whenever she sees fit. All you have to do is fill out the letter and mail it.
Why should you do so?
As I highlight in a new commentary in the Canadian Medical Association Journal, the level of transparency in the realm of pharmaceuticals has long been subject to social influence. The medical profession was once instrumental in curbing secrecy in the patent medicine trade. However, as pharmaceutical science and industry grew more sophisticated and premarket regulation was introduced through the twentieth century, the secrecy that physicians once fought to curb in the patent medicine marketplace was slowly but steadily replaced with expectations of confidentiality between pharmaceutical companies and pharmaceutical regulators. I hope this template letter will be a useful tool to help physicians, researchers, civil society, journalists and others to enact change anew.