In the good old days legislative change meant governments would roll up their sleeves and get down to business. In truth, however, Canadian governments were never that proficient at the legislative process. And in today’s complex world, making or changing legislation can get downright torturous. It consumes so much effort and resources from government that compounded with tighter budgets and more demands, the current system is no longer sustainable.
Take for example a process that should be rather simple, like extending the use of an existing food additive to a food not currently listed in the Food and Drug Regulations (FDR). To this Health Canada can employ an Interim Marketing Authorization (IMA). An IMA has effect once published in Canada Gazette I, but Health Canada must then formalize the legislative process within two years. Given the demands on the ministry, it’s not surprising they are unable to keep pace.
The way laws and regulations are made differ. Making changes to Acts has always been the most challenging as this involves parliamentary time, a precious commodity. In the most recent federal budget bill, Bill C-38, the government has included a multitude of clauses that will change more than 70 Canadian laws, including some significant changes to the Food and Drugs Act (FDA). This latest budget bill, which is more akin to those in the U.S., departs from the usual simple bills of the past. Politics aside, and without advocating that this is perhaps the best approach forward, the underlying pressure to make parliament more proficient and responsive in the legislative process appears to bear some influence here as well.
There are only a few changes to the FDA. These changes, however, have a significant potential to reduce Health Canada’s bogged down regulatory process, and will hopefully free already tight resources for the ministry to work on other projects. Bill C-38 would amend the FDA to give Health Canada the authority to issue Marketing Authorizations (MAs) for a broad base of subjects that would otherwise be in conflict with current prohibitions in the FDA or the FDR. For example, MAs could be issued for health claims, use of food additives, and vitamins and minerals in food. The scope of MAs is broader than that for IMAs, which MAs replace. Regulations defining the MA application process, eligibility criteria and amendment procedures will need to be made.
The other significant change to the FDA is the proposed expansion of the concept of incorporation by reference. This is not new to the FDR, as the standards for many food additives, such as those in the Food Chemical Codex, are already referenced in the FDR. Other legislation, such as the Federal Organic Products Regulations, 2009, makes significant and strategic use of incorporation by reference. In the case of the organic regulations the actual standards for organics are not defined in the regulations, but are incorporated by reference. This allows changes and amendments to be made that would otherwise need to go through a very lengthy process even for simple changes or corrections. In the case of the FDA, the broader scope of incorporation by reference will allow Health Canada to reference within the FDR basically any document of its choice. This will allow Health Canada to remove sections within the current FDR and set these up as documents that are incorporated by reference. For example, the food additive tables currently in Division 16 of the FDR could then exist outside the FDR where they can be updated and amended in a more expeditious manner. The same could apply to health claims, and even the addition of vitamins and minerals to foods.
The process of submitting applications for health claims, food additives or for the use of vitamins and minerals in foods is not going to be any easier. The changes coming are geared to lightening the load for Health Canada. Industry’s benefit is indirect, in that with more of the ministry working on submissions, the time frame for their review should be reduced. The time savings of not having to wait for legislative change is an added bonus. The old idiom “doing more with less” is out; “doing better by doing less” is in. Let’s just hope it is better.
Gary Gnirss is a partner and president of Legal Suites Inc., specializing in regulatory software and services. Contact him at [email protected]