S05 E02

Keeping It Legal:
A Look at Life Sciences Laws and Regulations

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Adrienne Blanchard
Founder
Blanchard Law

In the second episode of our fifth season, our host Peter Brenders talks with Adrienne Blanchard, Founder of Blanchard Law, about the differences between US and Canadian healthcare laws, life sciences regulations, and rules around DTC advertising.

LIONA LOKETIS:

From the Chronicle Podcast System, this is the NPC Podcast of the National Pharmaceutical Congress, for July 28, 2021. The NPC Podcast was created to discuss and consider the purpose, process and people of the pharma industry during the year of Covid. And today we’re continuing the healthcare conversation by answering questions from listeners, just like you.

This program is presented in cooperation with Impres, Canada’s next generation commercial partner. The industry is rapidly evolving and Impres is designed to help you evolve with it. Learn more about Impres tailored best-in-class solutions at www.impres.com.

Our guest today is Adrienne Blanchard of Blanchard Law in Ottawa. She’ll be speaking about IP issues in pharma with your host, Peter Brenders. But first, here is Mitch Shannon, the CEO of Chronicle Companies.

Mitch, do you happen to know any appropriate lawyer jokes? 

MITCH SHANNON (MS):

Liona, I’ll need to refer that question to our legal office. That’s just how complicated the landscape has become when you wade into matters of intellectual property, life sciences regulations and commercial law.

Our guest today spent three years with the federal government developing IP policy. She now runs her own firm where she negotiates distribution arrangements, licenses and matters pertaining to clinical trials.

Here’s Adrienne Blanchard in conversation with Peter.

PETER BRENDERS (PB):

 

Welcome to the NPC Podcast. I'm Peter Brenders, your host. In our continuing look at the purpose, process, and people in pharma in Canada, this episode takes a look at the law. In particular, we're going to dive in on some misconceptions companies have about Canadian pharma law, especially when compared to other countries like the United States, for example. 

 

To help us explore this topic, we're delighted to have one of Canada's foremost experts join us today from Ottawa. Adrienne Blanchard is a long standing lawyer in life sciences, food, and consumer products with an emphasis on IP regulatory and commercial matters. She's published a long list of articles and is ranked an expert leading practitioner in biotech and IP, the who's who legal Life Sciences Canada, as a global elite thought leader, and most recently in best lawyers in Canada biotechnology law. In her almost three decades, Adrienne has worked for national and boutique law firms, as well as having worked for the federal government and developing policy and supporting the legislative agenda. Today, she represents clients in various matters before regulatory bodies, including Health Canada, the Patent and Medicine Prices Review Board, and the Canadian Food Inspection Agency. 

 

Welcome to the NPC Podcast, Adrienne. 

 

Adrienne Blanchard (AB):

 

Thanks for the introduction, Peter, and thanks for the invitation to be here today. 

 

PB:

 

We're delighted to have you with us today. As our leaders well know, protection of consumer safety in pharma is paramount. And as a result, we know the pharma industry is one of the most heavily regulated industries, from the earliest stages of development and testing to ultimate market authorization and sale. So I understand there are some rules, though, on who can do what, who can say what, and how drugs are made available and sold in Canada. Maybe you can tell us a little bit about the laws that guide the industry in our country.

 

AB:

 

Well, in Canada, we have a mix of laws, but also industry and professional codes of ethics and voluntary agencies. So at the federal level, we have the food and drugs act and its associated regulations. The key provisions there obviously govern the product approvals, product safety, the requirement to report regarding adverse events, and also provisions around the prohibition on false advertising. But there's really no legislation that prescribes how companies can and can't promote their drugs. There is if companies do want assistance to know that their advertising is aboveboard, there is a voluntary advertising preclearance agency, the PAAB, the pharmaceutical advertising advisory board, and they will pre-clear advertisements that are made by companies to healthcare professionals. But unlike the US, it's not necessary to provide copies of advertising to the regulator, either before or after dissemination. 

 

PAAB's review is really aimed at ensuring that companies, whatever they say, complies with the rule against false and misleading advertising. And they review claims to ensure the claims are in scope of what the market authorization says. And also to ensure that any claims of product comparisons are supported.

 

PB:

 

There's laws that guide us in terms of how we sell but at the end of the day, it's really up to companies to implement these. And then, as you said, there's, there's some other agencies that are voluntary, companies can go to if they want to, which is quite different than what we hear in the US where you must get pre-approval on some of these aspects. 

 

So the laws in Canada then are different. I'm hearing that but what about sort of interactions with the stakeholders, with healthcare practitioners? Are there rules governing those?

 

AB:

 

There are rules, they're not laws, they're ethical codes of healthcare professionals. 

 

PB:

 

Their own rules, not the rules in the company. It's the rules of the professionals themselves?

 

AB:

 

There are rules of the professionals themselves. And there are also industry codes. But those are voluntary codes through industry, trade associations, and they govern the manner in which companies can speak with various stakeholders, which includes healthcare professionals, patient groups, and other consultants.

 

PB:

 

The Canadian laws help us set a framework and then companies themselves can set their own sort of standards of how they want to work. So companies bringing drugs to Canada then often operate sort of, I guess, probably their mindset from where they've started from usually in the US approach. And I'm aware that you're helping companies navigate these Canadian laws. So maybe you can take us through some examples of where you've seen what mistakes or incorrect assumptions are companies making about Canada?

 

AB:

 

Well, there are quite a few differences between the Canadian environment and the US environment, for example, the US has limitations. They have an anti-kickback statute, which is a criminal statute limiting the activities between companies and physicians in terms of not being able to provide anything of value or services or items that are payable by the federal health care program. So we don't have that law. We don't have those laws that are attached to companies as they do in the US although we do have some professional codes that govern health care professionals for obvious prohibitions like not accepting gifts from pharmaceutical companies. But they are not criminal statutes. And they are not as restrictive as I understand it as the anti-kickback laws are in the US.

 

PB:

 

So you talked a little bit about advertising at the start there in terms of false advertising. So do we have prohibitions on advertising here in Canada?

 

AB:

 

We have prohibitions against direct-to-consumer advertising. Companies can advertise obviously to healthcare professionals. But direct-to-consumer advertising is quite limited. Under the regulations, you can only advertise quantity, price, and drug name directly to consumers. So that's a significant difference from US.

 

PB:

 

So in the US, they're also talking about the indication this drug is used for x, for example, but in Canada, we can't connect the two.

 

AB:

 

Exactly, exactly. But that doesn't mean that all communications between companies and patients or consumers is prohibited. So not every communication is an advertisement. For example, there are obviously corporate statements that can mention product names, clinical trial recruitment can be done. So there are opportunities to deal with patients and the like, simply not direct to consumer advertising.

 

PB:

 

Okay, so let's talk about sort of selling your product in Canada and whether you're selling to HCPs, health care practitioners, you're selling to pharmacies. Differences, similarities from the US, what would those look like?

 

AB:

 

One of the main differences that often surprises US companies is that it is possible to provide discounts to the trade, so discounts to pharmacies in most of the provinces all there are restrictions in Quebec and Ontario.

 

PB:

 

You're listening to the NPC Podcast, I'm Peter Brenders, your host. 

 

What about sort of engaging HCPs directly in different ways? I mean, is it broader, more narrow than the US?

 

AB:

 

My understanding is that there are more ways to engage with HCPs in Canada, and a lot of it stems from that law that I spoke about earlier, the anti-kickback legislation. In the US, it is possible for companies to engage a healthcare professional to do a speaker program based on their product to other health care professionals, other doctors. In that case, from a legal perspective, the health care professional is considered to be an agent of the company. In Canada, we do have speaker programs, but they're really scientific exchange programs, companies can support them, can fund them. 

 

But at the end of the day, the health care professional maintains responsibility for the content of that presentation. They are not the agent of the company, the presentations have to be balanced. And mention several different treatments, not just focused on a company's product, the company that has funded the activity. So there's a significant difference there that often surprises US companies.

 

PB:

 

In those type of learning activities, then so where docs will be talking, it'll be their slides, will be their presentation, their responsibility to develop their balance. But often, when docs sort of approach companies and say, Hey, can you give me some information on your product or other areas? Are companies allowed to give them that information?

 

AB:

 

The practice in Canada is yes, not that they be provided proactively. So there's the difference between the US and Canada. In the US, for these programs, the companies want to give the slides, their slides to the doctor and dictate what the doctor says more or less, or have control over it because they are their agent. So in Canada, the practice is to provide the materials reactively, and not to dictate at the end of the day, what the healthcare professional says. And that's really more an issue that arises from the professional codes of the doctors.

 

PB:

 

I mean, just trying to think technically then, so if you're providing docs, docs ask you for some information, you're providing it to them, you almost have to give it to them in a form that they can edit it to help reflect what they want to say, as opposed to - Hey, here is some branded materials. Doctor, you need to show this at a meeting.

 

AB:

 

Yes, exactly. So that is not the way it would be done in Canada, it would be here some information for you. And your speaker agreement, obviously would set that out as well that the doctor at the end of the day has overall responsibility for the content of the presentation.

 

PB:

 

Okay, well, let's come back to some of the differences. I see companies as they think about how they want to support healthcare providers. And you're talking about sort of doing talks, ongoing learning and educational initiatives as company comes to market. They want to bring in a new treatment out there. They need to let the community know what works, what doesn't, what the efficacy, what the safety, all those issues that are out there. 

 

But I wonder if companies trip themselves up on that very nature in terms of what they typically do in other markets versus that aren't tailored to Canada, so are companies sort of setting rules for themselves in Canada that might hamstring themselves?

 

AB:

 

I do see from time to time differences where a company has a global code of conduct. And it is more restrictive than what the company could do in Canada. So for example, one of the big differences that we see is that we don't have this distinction, this clear distinction that's required, as it is in the US, between commercial and scientific, the roles within a company. So oftentimes, the global Code of Conduct will say, that has to be maintained, these silos. I think it arises mostly from the law in the US, but we don't have that in Canada. 

 

So, the global Code of Conduct could be more restrictive than what could be done locally. And also, the trade association code of ethics as well, may be more restrictive than what might be permitted at law. Prescribing activities, such as how many members of the company can be at a stakeholder meeting, for example, those things are not in Canadian law, though they are in industry code.

 

PB:

 

So what I'm hearing from you, and maybe correct me on this one is that Canadian laws are kind of the same. They don't differentiate within a company who can do what, it is simply what the company can do or not do. Is that fair?

 

AB:

 

Well, that's true. Well, the law speaks to persons. But when you're speaking about a company and employees of a company, the company is the person from a legal perspective. So that's correct. A lot of the detail around promotion is driven by codes and not by legislation.

 

PB:

 

So you talked about sort of advertising and talked about promotion. But does that extend to like, who can give out what, who can approve what type of grants. Companies must request grants all the time, grants and sponsorships? Who can approve these? So again, does the law differentiate in terms of who has, who should approve these things or not.

 

AB:

 

We don't have that in Canada, I understand it is in the US, again, very clear that there is a distinction and certain grants have to be approved by medical and certain grants should be approved by commercial. We don't have that distinction in Canada, and even the industry code does not get down to that level of governing internal company affairs when it comes to granting. There are a lot of rules in the codes around franchising, and what types of grants are appropriate in terms of dealings between companies and healthcare professionals. But they do not dictate the way in grants are approved internally.

 

PB:

 

You're listening to Adrienne Blanchard on the NPC Podcast. 

 

Let's extend that to sort of other interactions beyond just the physician, healthcare practitioner. You kind of alluded to this at the beginning earlier in talking about sort of other stakeholders. Companies can talk to patients, companies are interested in working with other health professionals, nurses, pharmacists, and that one, so interactions with these other individuals. Allowed, not allowed, or is it just speak to what those interactions entail?

 

AB:

 

Exactly. And again, going back to what the law says, the key provision of the Food and Drugs Act is a prohibition against false advertising, false misleading and deceptive advertising as to the character or merit of a product. So that is the line, the detail of that is not in legislation. So it is the actions of the company and how they conduct themselves is really going to be measured by that prohibition, are they saying something that is false, misleading or deceptive, or not.

 

PB:

 

So that makes it quite actually easy. If you think about it for a company, it's like, you know, do the right thing. Don't mispromote, don't sort of misrepresent what you're trying to do. And if you're a company that's out there, like so many of the pharma industry is, it's that patient centricity trying to help the patient, it's just a matter of doing the right thing. It's not all about sort of selling that product as if you want to be a partner and system, the system will allow you to be a partner. So is that kind of what we're hearing?

 

AB:

 

And your dealings obviously have to respect the rule against direct-to-consumer advertising. So dealing with patient groups, so long it is it is not advertising. But partnerships are obviously allowable, getting feedback from patient groups is allowable. Not every communication between a company and the individual patient or consumer is considered advertising. There's a lot of flexibility in terms of what companies can do and still be within the law.

 

PB:

 

So okay, so clearly, Canada is not the US, and you know what companies can engage and sell here in ways unlike the US, but as I heard from you, too, the US can do certain things that we can't do here and DTC was one of those you talked about. 

 

So what do you see? I mean, you've been so close to the regulatory environment for so long and you understand sort of this environment and it's changing in the coming years or it always evolves. Do you have any insight, or if you were forced to guess? Are we going to become more like the US or we're going to become stay as our own? What might change in the Canadian regulatory environment down the road?

 

AB:

 

I would have to say I don't see a lot of the US system being adopted into Canada. We have seen Canada take some policies of the EU, for example, on clinical trial transparency. The EU publishes and allows access to some clinical trial information after a product is approved, and Canada a few years instituted a similar policy. Canada is also proposing some changes to its privacy law that are similar to the EU privacy law. I think where there are best practices out there, Canada is open to adopting them, but it will always be driven by unique to Canada interests.

 

PB:

 

I think you already told us, Adrienne, that DTC advertising, not a thing that's allowed in Canada or it's very limited, whereas in the US, they're permitted to actually talk about the drug and that therapeutic indication. So what could we see here?

 

AB:

 

That's right, we don't see a lot of television advertising around prescription drugs. But reminder ads are still permitted. And back to my earlier point, not all communications are considered prohibited. 

 

So reminder ads, you may recall, a number of years ago, there were a series of ads on TV that ran around the product Viagra. They featured happy men, and the distinctive blue diamond pill that didn't have any markings, there was no mention of the use of the drug. There was just a statement that flashed that said, Viagra: Ask Your Doctor. 

 

That was considered to be a reminder ad, it was controversial, much talked about. But it was permissible because it didn't contravene the rule that when you're direct to advertising directly to consumers, you are limited in what you can say to the drug name, the price and the quantity and those ads did not contravene that rule. So there is some scope to work within the regulations, to advertise in ways that are not considered advertising, if I can say.

 

PB:

 

So we're not talking about the drug. We're not talking about the indication per se. What about companies that just want to talk about disease? I want to talk about a rare disease. I want to talk about something that no one knows about. And you think about a lot of rare diseases out there are poorly known because they're rare. Patients are struggling with these diseases and companies have an interest to study these diseases and find treatments for that one. Are there prohibitions or limitations on companies from talking about these various rare diseases?

 

AB:

 

Actually, those would be considered disease awareness programs or information, not considered advertising. Speaking about a disease, writing publications about a disease, even publications that mentioned several different products that could treat that disease - that is not considered to be advertising either. That is patient disease awareness and permissible.

 

PB:

 

We've been speaking with legal expert Adrian Blanchard on the NPC podcast. Thank you for listening.

 

MS:

Thanks to Adrienne and Peter. You can find Adrienne at blanchardlaw.ca. 

Or if you have comments or follow-up questions about today’s conversation, why not message us via Twitter @2021NPC. Otherwise, you can also send us an email to health@chronicle.org or phone our comment line at 647-873-6995. 

If you liked today's podcast, go ahead and share it with your colleagues. Find it at Apple iTunes, Google Podcasts, Stitcher, Spotify, or wherever you get your podcasts.

The NPC Podcast is presented in cooperation with Impres, Canada's next generation commercial partner. Visit them at www.impres.com.

This is Mitch Shannon of Chronicle Companies. Podcast Producer is Jeremy Visser in Toronto. He is assisted by Aria Empakeris in Vancouver. The announcer was Liona Loketis. The musical theme is performed without compromise  by the NPC Podcast Orchestra under the direction of Maestro Fielding Millbrook. 

Happy Simcoe Day to our Ontario listeners. Stay safe and we’ll talk again next week.