Regulatory Harmonization at its Finest: Adopting a Global System of Chemical Classification

Health Canada is currently contemplating a potentially major overhaul of the rules regarding the classification and labeling of workplace chemicals – even the pictograms are changing!  The purpose of the change is to implement the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in Canada.

This should (hopefully!) bring a sigh of relief from workers, employers and producers involved in the manufacture and use of workplace chemicals.

A little background: chemicals used in the workplace are often produced and sold around the world.  Different regulatory requirements mean that there are multiple standards, classifications and label requirements for the same chemicals in different jurisdictions.  These differences make it hard for countries to regulate the import and export of chemical products, increases costs to industry (the need to comply with multiple, different regimes isn’t fun or easy) and impact workers who need to understand the hazards of a chemical in order to work safely.

The GHS is an international system created by the United Nations aimed at implementing a consistent set of criteria for classification and labeling on a global level. (Interesting tidbit – Canada’s current system was one of four major existing systems used as the basis of the GHS: go us!)

The GHS system covers all hazardous chemicals, including chemicals used in the workplace, transport, consumer products, pesticides and pharmaceuticals.  The goal of the GHS is to harmonize the classification and labelling of chemicals and mixtures and the communication of health and safety information.  In addition to being safer for workers, GHS promotes regulatory efficiencies (a personal favourite of ours here at theregulationstation!), facilitates trade, improves compliance and reduces costs.

Aside from GHS just being a good idea, the implementation of the GHS is intended to achieve one of the Canada-United States Regulatory Cooperation Council commitments, i.e. to align and synchronize implementation of common classification and labelling requirements for workplace hazardous chemicals within the mandate of Health Canada and the United States Occupational Safety and Health Administration (OSHA).

Earlier this month, Health Canada launched a consultation process that sets the ball rolling on applying the GHS in Canada.  The comment period closes on September 15th.

While exciting, this is not new news – a plan to switch to a new system was first announced in 2011 as part of the Canada-United States Regulatory Cooperation Council commitment, intended to bolster trade between those two countries. However, as more and more countries get on board, these changes could have a much larger impact; 67 countries have already implemented the GHS.



When Will Medical Device Regulation Intersect With At-Home 3D Printing?

By Paul Banwatt

Recently it was reported that the FDA sent a letter to a mobile app developer, Biosense Technologies Private Ltd., informing them that their app product, the uChek Urine analyzer, potentially required FDA clearance as a medical device. The FDA is still planning to release final guidance on clearance requirements for the 40,000 medical apps that are out there. But what about 3D printed medical devices?

First, let’s ask: What’s a medical device according to the FDA?

  • an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
    • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
    • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
    • intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.” (emphasis added)

According to the FDA even a simple tongue depressor can be a medical device, so it seems to me at least likely that a 3D printed object such as a prosthetic, implant or, yes, tongue depressor could fall within this definition. And if such a printed object is labeled, promoted or used as such, then it may require FDA clearance. Here’s a 3D printable prosthetic finger available right now on Thingiverse that may or may not qualify as a medical device. So how and when will health agencies start to regulate individuals putting medical device designs on sites like Thingiverse, and people printing and using them at home?

This post first appeared at Law in the Making

Exciting Innovation in the Cosmetics Industry: Nutritopicals

[note to readers:  this post was originally posted on our affiliate site on January 24, 2013]

We recently stumbled across a really interesting interview on the Supply Side Cosmetics Insights website regarding the partnership between Skin Authority and the Dole Nutrition Institute.

The CEO of Skin Authority, Celeste Hilling spoke to Supply Side Cosmetics Insights about the partnership.  You can read the entire interview here.

In a nutshell, the two companies combined forces to create “a new category of product” – wait for it, nutritopicals (trademarked of course – LOVE IT!!!).

The two companies share a passion for extolling the virtues of vitamin D – which Hilling calls “one of the most important building blocks of health” – and they developed a product based on the powerhouse.

The VitaD Illuminating DUO is the first product in the nutritopicals category.  It incorporates a

  • spice powder made of Dole’s 100% vegan, whole-food, plant-based source of Vitamin D which can be sprinkled on anything you eat or drink (ie a food)



  • a topical elixir which provides full-spectrum vitamin D to the surface layers of the skin through daily application (ie a cosmetic).

Hilling explains that nutritopicals are about striking “a perfect balance between internal and external nutrition” and promises that there will be other products that will take nutrition from the table to the cosmetic counter.

Talk about a company thinking outside the box!  Stories like this make us believe in and get excited about future innovations in the food, cosmetic and natural health product industries!  Just think about all the possible combinations…

And of course, we get all jacked up thinking about how Health Canada will regulate all these new products, and how they will provide companies with some really great branding opportunities – nutraceutical, cosmeceuticals and now NUTRITOPICALS: c’mon, it’s brilliant!


New Database for Canadian Clinical Trials

Big changes are coming to how drug trials are conducted in Canada. Currently, drug companies can choose to only publish the findings of a drug study if the results are favourable.  As a result, it is estimated that the results from half of all clinical trials are never published.

Many find the idea of keeping such information under wraps a bit unsettling. And so it seems, does Health Canada. As reported here, Canada has finally joined a number of other countries in requiring researchers to register drug trials.

In the near future, the government of Canada will unveil a new website and database where Health Canada will host information about every drug trial being run in Canada after April 1, 2013. The move will bring Canadian practice closer to that of many other countries that already require trials to be registered.

Alright. Sounds good. Score one for transparency, right?

Well, not exactly.

While some people (ok, we’re guessing a lot of people) like the idea of publishing information on clinical trials authorized by Health Canada, the plan to launch the website is not without its challenges.

Perhaps the biggest potential problem is that seems like Health Canada is not going to put any pressure on companies listed on the database to actually put their study results into the database. So while the studies will be registered, we may not be able to find out very much about what actually happened. (This sounds a bit like bosses asking employees to write their own performance evaluation, but not ever reviewing the evaluations.)

The other problem is that the drug biz is global business (like most things these days).  So while the website is telling us all about what companies are doing in Canada, it is not going to have much to say about what companies are doing in other countries.

What to do?

On the one hand, regulators could tighten the rules and require more disclosure from pharmaceutical companies. Regulations could include mandatory disclosure of information on international databases. This is what many countries are already doing and is in line with the standards of World Health Organization. But tightening regulations on disclosure requires political will and such moves risk the political stigma of being “anti-business”. The reasoning is that tight regulations discourage companies from doing business in Canada.

As so many things do these days, it goes back to the delicate act of balancing government intervention and the will of the free market. As pointed out here: “Striking the right balance between over-regulation and under-regulation, too little open data and too much is a tricky task”.

For the time being it looks like the website database is going to be all that we get. It will be interesting to see how much information this project brings to the public. Health Canada states that feedback about the project will be taken into consideration because the Government of Canada is committed to transparency.

Perhaps then it falls to us to weigh in on where the balance lies.


The Regulatory Abyss of Drug Compounding

Over the past weeks, the most dreaded words in regulatory law – “jurisdictional grey area” (dun dun dun) – have made Canadian headlines.

This phrase has been targeted at a recent chemo scandal in which five Canadian hospitals administered weaker-than-prescribed drugs to patients.  The drugs at issue had been mixed by a drug compounding company in Mississauga, Ontario called Marchese Hospital Solutions.

To make matters worse, the Canadian chemo scandal follows closely on the heels of a meningitis outbreak in the US caused by the shipment of tainted drugs across the country.  Similar to Canada’s chemo scandal, the tainted drugs that caused the outbreak in the US had been mixed by a speciality compounding.

These two cases have highlighted the current lacuna in the oversight and regulation of compounding facilities in both Canada and the US.

As it turns out, Marchese had been operating without any federal or provincial oversight for a number of years.  Regrettably, this didn’t become an issue until watered-down drugs were administered to over 1,200 patients, resulting in over 100 deaths.

According to Marchese’s President, both Health Canada and the Ontario College of Pharmacists declined to regulate the company’s work.  Ontario Health Minister Deb Matthews has recently (and reluctantly) admitted that she has no idea how many companies like Marchese are currently operating without regulatory oversight.

Since the scandal was uncovered, no one has taken responsibility for the faux pas: Marchese, Health Canada, and the Ontario College of Pharmacists have all placed the blame squarely in the “jurisdictional grey area”.

So, what exactly is compounding, and why does its regulation appear to be akin to a game of regulatory tag (“Not it! Not it!”)?

In a nutshell, compounding is the combining or mixing of two or more ingredients, where at least one is an active ingredient, to create a final drug form for dosing.

Sounds simple, but things get complicated when we consider the divide in regulatory oversight of drug preparation:  Health Canada regulates drug manufacturing and provincial bodies regulate pharmacists and their activities.

Determining who is responsible for the oversight of compounding where it is not done in the manner of a traditional pharmacist (i.e. where there is no direct relationship with the patient) is unclear.

Health Canada has issued a Policy to help us figure out whether stirring up a drug cocktail will fall under either federal or provincial regulation, although it doesn’t seem to account for companies like Marchese who aren’t typical drug manufacturers or typical pharmacists.  

And to make matters worse, the onus seems to be on the company to determine what they do – and we all know how effective self regulation can be!  If the company doesn’t figure it out, it could simply sail off into the jurisdictional grey area and avoid regulatory oversight altogether (intentionally or otherwise).

In response to the Marchese incident, a legislative committee has been established to investigate what went wrong, and new legislation is being drafted to bridge the gap between drug manufacturing and drug compounding.

The FDA is also drafting new regulations in respect of drug compounding.  That agency is proposing that compounding activities be split between: “traditional compounding” (i.e. combining or mixing ingredients for an individual patient), which will be subject to State regulation; and “non-traditional compounding” (where more risk is involved), which will fall under federal oversight.

Hopefully these new measures will avoid future problems like the chemo and meningitis scandals. As with so many things, it’s deeply unfortunate that people had to die to shed light on an existing jurisdictional grey area.

The Times, they Are A Changin’ – The Dawn of a New Era for Canadian Medical Marijuana


Dear readers, you know me best as the regulatory lawyer obsessed with all things food, but truth is my regulatory geekiness reaches beyond just food.  And when a regulatory issue this new and hot comes along, it’s hard for me to not want to shout it from the rooftops (or in this case, from the blog).  Yes, dear reader, I’m a geek for all things regulatory, so please appease me as I write about a new development in Canadian regulatory law:  medical marijuana.

Marijuana is regulated under two different Acts and their respective Regulations:  The Controlled Drugs and Substances Act (as an illegal drug) and the Food and Drugs Act (inasmuch as it has medicinal properties).

According to Health Canada, scientific studies have not yet demonstrated conclusively that dried marijuana is safe and effective for medicinal use, and therefore, it hasn’t been approved as a drug under the Food and Drug Regulations (notably, a number of products containing cannabis have been approved, but not dried marijuana).

Nonetheless, since 1999 Canadians have been able to access dried marijuana for medical purposes through the “Marihuana Medical Access Program”.  In 2001, the Marihuana Medical Access Regulations (“MMAR”) were introduced, establishing a scheme by which seriously ill Canadians can obtain an authorization to possess dried marijuana for their own personal medical use.

Under the MMAR, people authorized to possess marijuana have three options for obtaining their supply:  they can produce it themselves under a license from Health Canada, they can designate an individual to produce it on their behalf under a license from Health Canada, or they can buy it directly from Health Canada, which contracts a private company (Prairie Plant Systems Inc) to produce and distribute marijuana for the Program.

The New Regime

On December 16, 2012, the Government announced big changes to the way Canadians access medical marijuana, motivated by concerns about abuse of the current system, putting the health and safety of Canadians at risk.

It appears from Health Canada’s announcement that the Program grew much larger and faster than was originally expected, resulting in unintended consequences ranging from significant costs to Canadian taxpayers (both administrative and as a result of the subsidized cost of marijuana purchased directly from Health Canada), grow operations catching fire (an average of 1 in 22 grow operations catch fire and under the old rules, licensed growers could grow medical marijuana in homes) and exploitation resulting in the flow of medical marijuana to the illegal market.

The new proposed scheme treats dried marijuana as much as possible like a medication by creating a licensing scheme for commercial production and distribution (can you hear my regulatory geek juices flowing!?!).  The proposed Regulations impose security requirements for the production site and key personnel of the licensed producer, standards for packaging, transportation and record keeping and do not permit grow operations in residential homes.

And in addition to these changes, HealthCanadais getting out of the marijuana biz:  HealthCanadawill no longer receive or process applications or issue licenses for individuals to possess medical marijuana.  Instead, people will be able to obtain any commercially available strain of marijuana with something similar to a prescription from an authorized health care practitioner.

Thus, the proposed new regulatory scheme returns HealthCanadato its traditional role of regulator, rather than producer and service provider.

As the new program rolls out, I’ll provide more information on this blog regarding the specific application requirements.  HealthCanadaisn’t yet accepting applications for licenses (and won’t until the new Regulations are promulgated) but parties interested in applying to become a licensed producer can work with HealthCanadanow to apply for an authorization to conduct certain R&D activities with marijuana.

It is expected the new Regulations will come into force in the Spring of 2013.  There will then be a transition period until March 31, 2014 during which the current system and the new system will operate concurrently.  The new system is expected to be fully operational by April 1, 2014.

I don’t know about you, but I’m pretty excited to see how this new regulatory regime will play out.  As with everything new, there are lots of criticism of the new scheme, primarily related to concerns about increased costs to users and restrictions on the strains of marijuana that will be commercial produced, and therefore available.

I’ll be watching developments closely and will continue to blog about them.