Eileen McMahon has written a series of columns for the The Chronicle of Healthcare Marketing, answering questions submitted by readers.
"How can you manage issues arising from regulations and legal requirements in different jurisdictions. At a recent meeting of our global brand team, certain concepts emerged that would never be encouraged here in Canada."
We are faced with this issue daily. Laws are federal (national) or provincial (state) and vary from country to country. For example, in the United States, direct-to-consumer advertising of prescription drugs is permissible, whereas in Canada, it is prohibited (except for name, price and quantity).
Regulations and legal requirements are bridged by (i) understanding the objectives of the organization, and (ii) giving the organization options for achieving those objectives. Typically, options will range from no- or low-risk options to options that involve risk (e.g., complaints by competitors or reviews or inquiries by a governmental agency). The organization’s decision maker then makes business decisions based on the level of risk that the company is willing or authorized to assume.
"I have just heard a radio ad on a U.S. station for a product that claims to be 'Better Than Viagra.' It sounded as though it could be compounded in a rapid-melt or possibly topical-delivery system. How can this be legally advertised to consumers?"
As mentioned in the example used in the preceding question, in the United States, prescription drugs can be advertised directly to consumers, provided that the advertising is accurate and not misleading, and meets other legal requirements. In Canada, although direct-to-consumer advertising of prescription drugs is generally prohibited, other activities that are not regarded as advertising (e.g., publishing information on educational or patient support programs that meet the requirements of applicable policy documents of Health Canada). Furthermore, Health Canada recognizes that Canadians are already exposed to advertising that spills over from the United States and that would be illegal if originating in Canada. So if you were listening to the advertisement on a U.S. radio station while residing in Canada, Health Canada’s position is that it has no jurisdiction over U.S. advertising.
"My company markets medical devices in the United States and Canada. I have heard that a recently released report criticized the way that medical devices are reviewed and approved in the United States. Will this report change the U.S. approval process? Does this report have any implications for Canada?"
The report focused on the 510(k) process, under which companies that wish to sell medical devices in the United States are allowed to show that their devices are safe and effective by comparing them to devices already marketed in the United States (known as predicate devices). The report found that the 510(k) process is deeply flawed and does not ensure that devices are safe and effective, and made available to patients in a timely manner. Nonetheless, it is unlikely that the 510(k) process will be scrapped. The FDA swiftly rejected the report’s conclusions. Furthermore, the report has no impact on Canada’s process for approving medical devices, which is governed by Canada’s Medical Devices Regulations. Certain corporations and industry organizations have criticized the Canadian review process for being even more flawed than the U.S. process, noting that devices approved years ago by regulatory agencies in Europe, Australia and the United States are still undergoing review by Health Canada. In many cases, review times in Canada take two to three times longer than Health Canada’s stated targets.
"The lawyers at my company seem to need to have a say (or control of) almost everything we do in marketing – what we say in social media, the funding we want to give to research, the pitch we make to physicians, and even the way we use our brand. It’s a bit tiresome. Why do our lawyers need to do this?"
Well, there are several reasons. First, your in-house lawyers want to ensure that your company is complying with applicable laws: laws that set out what you may and may not say when you market your product; privacy laws that govern the information you collect from patients and physicians and the way you can use that information; and laws regarding misleading advertising that govern how aggressively you can pitch your product. In addition to all these laws, there can be pressure from your U.S. head office to ensure that your marketing practices and codes of conduct in Canada conform to those in the United States (where stiff penalties are imposed for violating laws in these areas). And if funds flow from a company to government officials, the U.S. foreign corrupt practices legislation can rear its head in Canada. So, although your in-house lawyers’ involvement can be tiresome, they are doing their job to keep your company out of trouble.
"Why can the advertising of some products make aggressive marketing claims and others can’t? For example, a TV ad for exercise equipment promises that you can 'lose 10 lbs in 5 days'; an orange juice carton states that its contents 'prevent bone loss'; a shake supplement calls itself the 'Perfect Food'; a vitamin supplement says that it 'eases the pain of osteoarthritis'; another one promises to 'help fight premature lines and wrinkles.' Prescription drugs, however, have few claims but lots of warnings. Why can't pharmaceutical companies also make whatever claims they want, as long as they are accurate?"
Some products are regulated more stringently than others. Different laws govern different products: claims for foods are governed by food regulations; claims for supplements are governed by the natural health product regulations; and claims for over-the-counter and prescription drugs are governed by drug regulations. Claims made to consumers regarding drugs have the most stringent laws (e.g., advertising to consumers of prescription drugs is prohibited in Canada, except for publicizing the name, price and quantity of the drug). Further, U.S. laws differ from Canadian laws. So if the product or the publication that you are reviewing comes from the United States, different claims are allowed on their products. U.S. advertising that “spills over” into Canada is generally governed by U.S. rather than Canadian laws. Some of the examples that you give may, in fact, be contrary to law (e.g., the product that promises speedy weight loss may be contrary to the Competition Act’s misleading advertising provisions and may also violate other laws). Most times, the government enforces laws on the basis of complaints made by consumers, healthcare professionals or competitors. If no complaints are made, illegal advertisements may run for some time before being pulled.
For all these reasons, you will see different claims on different products. Some are legal claims; some are not.
"I'm a sales rep for a drug company. When I'm explaining my products to doctors, can I be more aggressive than the 'approved marketing materials' for our products? For example, can I discuss off-label uses for the products?"
To promote a prescription drug for a use that is not approved for the product is contrary to law. However, responding to an unsolicited enquiry about the prescription drug is fine. Many companies require that enquiries regarding off-label uses of products be directed to their medical department to ensure that the responses are not regarded as promoting off-label uses. By doing this, sales reps limit their discussions to indications that are approved for the prescription drug. In addition, many companies have codes of conduct regarding how their sales reps market products, including how the sales reps should respond if they get these kinds of questions from doctors.
"There has been a lot of press recently about the regulation of energy drinks such as Monster and Red Bull, and about their changing status from NHP to food. I’m confused. If energy drinks become foods, doesn’t this make them less regulated rather than more regulated?"
NHPs (natural health products) are drugs. So you’d be correct in thinking that NHPs would be more strictly regulated than foods. However, Health Canada is proposing to impose certain additional requirements for energy drinks once they are regulated as foods. Like other foods, energy drinks will need to meet the nutrition, ingredient and allergen labelling requirements applicable to all foods. Labels will also be required to show the total caffeine content and to state "high source of caffeine" and "do not mix with alcohol." There will also be a maximum limit of 100 mg of caffeine per 250 ml and an absolute maximum of 180 mg for a single serving. (That’s about the amount of caffeine in a medium cup of coffee.) Other changes are proposed as well.
"Does this mean that Tim Hortons and Starbucks is going to need to check ID, before selling people their coffee?"
The proposed change in regulation will apply to energy drinks only, not coffee or other caffeinated beverages (like pop).
"We're getting lots of flak from physicians about the shortages of drugs. Is this a legal issue?"
The drug supply in Canada (and other countries) is complex, involving legal, business and operational issues. From a legal perspective, considerations include (i) agreements between the companies that sell the drugs and their suppliers of medicinal and non-medicinal ingredients and the supply obligations under those agreements; (ii) agreements between the companies that sell the drugs and their suppliers of finished products and the supply obligations under those agreements; (iii) regulatory compliance issues (e.g., manufacturing site changes prompting supply issues); (iv) patent litigation and a company’s ability to sell the drug, in view of the litigation; (v) the suppliers’ compliance with laws on shipping, warehousing and distributing drugs – how much of a drug can be stockpiled and how can the shelf life of the drugs be managed to comply with those laws; (vi) pricing of drugs and the impact of supply shortage on driving up the price of drugs, or the impact of the "leakage" of drugs from one country to another (e.g., drugs priced at $x can be diverted to another country in which the drugs are sold at $x+); (vii) competition or antitrust issues if the supply of drugs is controlled; (viii) product liability or contractual issues, if patients who need the drug are harmed by the lack of supply.
The answers provided in this column are based on limited information and do not constitute legal advice or the opinions or position of Torys LLP.
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This publication is a general discussion of certain legal and related developments and should not be relied upon as legal advice. If you require legal advice, we would be pleased to discuss the issues in this publication with you, in the context of your particular circumstances.
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