Bill C-51 Takes an Election Break
This should be the last Bill C-51 article for a while, perhaps until next year. Now that the 39th Parliament has been dissolved, all House and Senate bills that did not received Royal Assent have died on the Order Paper, including Bill C-51. The death toll amounts to 412 of the 462 bills that were introduced in this session of Parliament. That sounds like a large amount of legislation to abandon, but 90 percent of the terminated bills were private members bills, which do not typically make it into law. Bill C-51 was a House government bill, and in that category, 33 of 62 introduced bills died. So what will become of Bill C-51 now?
The next Government will start from scratch, even if the Conservatives are returned to power. All bills for the upcoming Parliament must be introduced at the First Reading stage, even if they pre-existed in the previous Parliament further along in the legislative process. So C-51 will not resume where it left off, but will it be re-introduced at all when Parliament opens again?
In the last Parliament, C-51 was introduced at First Reading on 8 April and was debated over the course of four days in the House (30 April, 1 May, 9 June and 10 June). The House then went into summer recess before a vote could be called on the Bill at Second Reading to send it to committee, so C-51 has not lost much ground if it has to start at First Reading again.
Of course, since bills are numbered sequentially by order of introduction in a session of Parliament, C-51 will be assigned another number in the new Parliament (unless it again happens to be the 51st House government bill introduced in the session). That means that StopC51 will have to reserve another domain name and do some rebranding for their propaganda website. I wonder if they will conclude that the renumbering is a conspiratorial plot by Health Canada, inspired by Big Pharma, to slip the Bill through covertly.
There seems little doubt that, for the following reasons, C-51 will be re-introduced in some form:
The Long-term Natural Health Product (NHP) Strategy. Although C-51 addresses more than NHPs, the Bill does represent the next logical step in a decade-long strategy to ensure Canadians have informed access to safe, quality NHPs. That strategy began with the House Standing Committee on Health report, Natural Health Products: A New Vision, in November 1998 and has been followed consistently by both Liberal and Conservative governments since then. Further amplification of the strategy has been well advertised in Health Canada’s Blueprint for Renewal: Transforming Canada’s Approach to Regulating Health Products and Food and their Food and Consumer Product Safety Action Plan. The strategy calls for the regulation, inspection and enforcement of NHPs regarding their safety, quality and effectiveness. In 2004, the regulation requirement was met when the NHP Regulations came into force after much consultation with the NHP industry. C-51 is now addressing the inspection and enforcement requirements by amending the respective sections of the Food and Drugs Act. If the Bill comes as a surprise to StopC51, then they either have not been paying attention for the last decade or are demonstrating wilful ignorance. In any case, both the Liberals and Conservatives have supported this NHP strategy during their government terms, and so it stands to reason that they will continue to advance it, whichever party forms the next government.
Need for C-51. C-51 is intended to update the Food and Drugs Act and other acts to improve Health Canada’s ability to oversee the safety, quality and, where applicable, effectiveness of drugs, NHPs, food, cosmetics and medical devices. It should not come as a surprise that legislations require periodic updating. The need for C-51 to update the Food and Drugs Act is particularly evident given that the Act currently limits fines to only $5K and product recalls to being voluntary. Neither of these enforcement provisions is much of a deterrent to irresponsible health product manufacturers. The Bill also closes some legal loopholes that have hindered inspectors in the past, such as the authority to transit through private property in order to conduct an inspection at a licensed site. Critics of C-51 typically point out that NHPs are inherently safe and so do not require “draconian” powers of enforcement, as if all NHP manufacturers and distributors are so saintly that they would never cut corners to maximize profits. Such critics would do well to review Health Canada’s webpage on Advisories, Warnings and Recalls under the categories of Ayurvedic Medicine, Chinese Medicine, Dietary Supplements, Herbal Medicines, Impotence Products, Natural Health Products, Sexual Enhancement Products, Sleep Supplements, and Weight Loss Products. Whether the Liberals or Conservatives come to power, the next government will need to address the existing deficiencies in product safety enforcement. The provisions of C-51 address these deficiencies.
Support for C-51. A review of the House debates on C-51 indicates that the Conservatives, Liberals and Bloq Quebecois all support the Bill in principle. Although the NDP opposes the Bill and each of the other parties, including the Conservatives, have individual critics, the official Liberal, Conservative and Bloq speakers expressed a desire to send the Bill to committee for review. In fact, it is likely that C-51 would have been passed at Second Reading and sent to committee this fall if the election had not been called, even in the face of StopC51’s fear-inspired write-in campaign. The next government, whether Liberal or Conservative, will realize that they have sufficient support to follow through with C-51.
StopC51’s campaign did have one lasting effect. Last spring, they had spread so much misinformation about C-51 that Health Canada had to organize a series of cross-country consultations with stakeholders. From the letter of invitation, Health Canada wrote:
“Since the tabling of Bill C-51, some natural health product stakeholders have raised questions and expressed concerns regarding the potential impact of Bill C-51 on the regulation and accessibility of natural health products in Canada. Health Canada is committed to engaging stakeholders in this very important initiative. To this end, Health Canada is holding a series of regional meetings with natural health product stakeholders. The purpose of the meeting is to share with you the intent of the Bill, discuss its provisions and seek your valuable feedback.”
Meetings were held in Vancouver, Kelowna, Edmonton, Calgary, Toronto and Montreal between 20-27 May. Close to 300 stakeholder groups were invited to attend. Reportedly, the consultations helped clear up the myths being disseminated by StopC51. However, Health Canada heard from the stakeholders their desire to be reassured about the intent and limitations of some of the provisions of C-51, and so in June, Health Canada proposed a number of amendments to the Bill. These amendments clarify the intent and limits implied in the language of C-51 and reiterate provisions that already exist in the NHP Regulations, thus promoting them into legislative provisions. The amendments establish that:
- NHPs are a sub-category of therapeutic products.
- The type and amount of information required for product licensing is relative to the risks and benefits of the product.
- Traditional and historical evidence can be used for product licensing.
- An Expert Advisory Committee comprising members with product-based consumer, patient/caregiver, scientific/academic, practitioner/clinical and industry experience will be formed and consulted.
- Inspectors will be limited to taking some actions only when they reasonably believe that a contravention of the Act has occurred or when they believe the action will prevent injury to health.
In the end, the amendments do not change how NHPs will be regulated, but hopefully, the wording of the amendments will inoculate stakeholders against StopC51’s fear mongering. In all likelihood, these amendments will be made to the Bill prior to its re-introduction in the next session of Parliament.
With the election scheduled for 14 October, there will not be much time left at the end of the year for the new government to organize itself and then get down to routine House business, if in fact Parliament is recalled this year at all. Most probably, Bill C-51 (or whatever its new number will be) will be on holiday until the spring of 2009.