Health Canada is set to provide new guidelines by March on how to differentiate messages that promote drugs from those that are non-promotional. The process was started in 2019 and then put on hold, presumably because of the pandemic. In mid-January, work began again, with expectations that a new document will be finalized by early spring. It contains some significant wins for those critical of how drugs are promoted by companies.
But, having a good definition of what is and is not promotion is just the first step. What also needs to happen is action. Right now, that is sorely lacking. Once the guidance document is finalized, let’s start fixing the way that we enforce rules about promotion. Because all evidence suggests that allowing the industry to self-regulate some forms of promotion and having Health Canada outsource regulation of other types to outside bodies isn’t working.
Perhaps, the biggest and most fundamental change is Health Canada finally recognizing that the relationship between drug companies and patient groups – such as the Arthritis Society Canada that advocate for people with the same type of illness – is not always healthy. Many patient groups are funded by drug companies, but that information is difficult to find and most of these groups don’t have policies that explain how they handle these relationships.
Now, under this new standard, if patient groups are involved in clinical trials and don’t disclose funding they receive from the company paying for the trial, that will be considered promotion. If patient groups unduly call a new medication a “breakthrough,” that could be considered promotion.
But having decided that something is promotion under this new definition, what then happens? Well, aside from telling patient groups to stop, it doesn’t appear that Health Canada has any other options. There are no provisions in the new standard for fining groups or for making groups issue corrections.
Health Canada has never truly exercised the power it has under the Food and Drugs Act to regulate promotion, except in two areas. One is direct-to-consumer advertising (DTCA) of prescription drugs. This is when an ad both names the drug and tells people for what the drug is used. It’s illegal to do this in Canada. The new standard will make it easier to call out DTCA, but once again what will Health Canada do to the companies involved?
To find out, look at what Health Canada currently does. There is no explanation on its website about what any company did that was wrong, except to say that there was a complaint. There is no explanation about what action Health Canada took, except to say something such as: “Compliance letter sent to request correction of non-compliance.” There’s no indication of follow-up, fine or other punishment for breaking the law.
The new standard will also potentially make it easier to spot illegal promotion of over-the-counter (OTC) drugs such as cough and cold remedies, or drugs for constipation. This is the other type of advertising that Health Canada directly regulated a few decades ago.
For ads shown on TV at that time, it reviewed the scripts to make sure they were accurate. But back in the mid 1990s, it turned this function over to what it calls advertising preclearance agencies. These are organizations, such as Ad Standards and MIJO, which are supposed to enforce Health Canada’s rules about advertising over-the-counter drugs and natural health products, respectively.
How effective these organizations are in controlling the messages about OTC drugs that we see on TV is an open question. If you view an ad, try and spot what it is required to say about the safety of the product. The only safety information that ASC and MIJO require is a statement such as: “Talk to your doctor or pharmacist to make sure this medicine is right for you.”
When these OTC products are advertised on TV, sometimes this message is not on long enough to even read it fully. Sometimes the print is too small to read and sometimes the colour of the type means that it can’t be seen against the background. The new standard about defining promotion isn’t likely to change what’s on TV screens.
Changes to Health Canada’s guidance document won’t affect promotion to doctors at all. Another of these advertising preclearance agencies is the Pharmaceutical Advertising Advisory Board (PAAB). The pharmaceutical industry set up the PAAB back in the mid-1970s to avoid having the federal government do the regulating. Changing the rules by which the PAAB operates requires a two-thirds majority vote by its board, but of the 13 organizations represented on it, five directly benefit from advertising.
The PAAB prescreens all ads for prescription drugs that appear in Canadian medical publications or in electronic advertising, in brochures that sales representatives leave behind in doctors’ offices, and any other type of communication between drug companies and doctors.
Compliance with the PAAB code is voluntary, although Innovative Medicines Canada (IMC), the lobby group for the major drug companies operating in Canada, has made compliance with it compulsory for its members. If an ad violates the PAAB’s code, all that happens is that the ad is withdrawn if it’s still being used. Health Canada endorses what the PAAB does and has representation on its board as an observer.
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If the PAAB and the company doing the advertising can’t reach an agreement, the complaint can be escalated to Health Canada. That happens once or twice a year, but there is no information about what happens next. The new document is silent on all of this.
Finally, there are all the other ways that drug companies promote their products to doctors. These include visits by sales representatives, sponsoring continuing medical education courses, paying the travel and accommodation costs for doctors going to international meetings, setting up displays at medical conferences, and paying doctors to be speakers for companies. These are regulated by the IMC itself and complaints are reviewed by a board made up primarily of IMC members.
Health Canada doesn’t oversee any of these activities. Health Canada’s position is “[w]hile it is the responsibility of Health Canada to administer the Food and Drugs Act and related Regulations, it is the responsibility of market authorization holders (manufacturers and distributors) to ensure that their advertising complies with the relevant legislation and regulations.” New guidelines won’t change this approach.
In a study I lead a few years ago, we compared the quality of ads under three different forms of regulation – direct industry control, the PAAB and direct government control as is done in the United States. The U.S. model, while it has its own problems, came out well ahead of the others.
One of the major problems is that U.S. regulation is under-resourced and understaffed. As of 2016, the Food and Drug Administration’s office of prescription drug promotion with a staff of slightly more than 70 people received nearly 100,000 promotional material submissions related to prescription medications annually.
While abolishing IMC’s self-regulation and the PAAB is not possible, setting up an independent body through legislation may be an alternative. Working as a Crown corporation, it would have the legal authority to regulate all forms of promotion for prescription and OTC products, thereby rendering the IMC self-regulation and the PAAB irrelevant.
This new Crown corporation would have to be free from financial ties to the industry. Organizations that would have representatives on its board would also have to be free from any financial conflict of interest.
There would have to be stable funding for the organization for it to function effectively. Here, there are a number of possibilities, including a model followed in Italy to finance independent drug research – a tax on the money that drug companies spend on promotion.
External regulation won’t get at internal company decisions that result in deceptive promotion. That’s why legislation such as the False Claims Act in the United States exists. It encourages whistleblowers to come forth. Under this legislation, if the government successfully prosecutes a company, the whistleblower gets a percentage of the fine.
Finally, continuing medical education and other forms of objective information about therapeutics is needed. Doctors shouldn’t feel the need to turn to drug companies for information in the first place.
The new guidelines need to include meaningful regulation that makes it clear what is promotion. Beyond the guidelines, there also needs to be meaningful consequences for not meeting the regulations.