Backgrounder The Impact of Bill C-51 on the Natural Health Products Regulatory Regime ISSUE: There are misconceptions that the proposed Bill C-51 will significantly impact the manner in which natural health products are regulated in Canada. More specifically some stakeholders feel that the Bill targets natural health products with increased fines and enforcement actions and additional regulatory hurdles before products are licenced. BACKGROUND: On April 8, 2008 the Government of Canada tabled Bill C-51 - An Act to Amend the Food and Drugs Act - into the House of Commons. The proposed amendments to the Food and Drugs Act will: a)
Help modernize the regulation of health products and food;
Provide new tools to more quickly and effectively protect Canadians; and
Provide better information that allows Canadians to play a more active role in their own health and safety.
A regulatory framework specific to natural health products has been in place since January 1, 2004. The Natural Health Products Regulations establish pre-market requirements for the safety, efficacy and quality of the products and require a site licence as evidence of compliance with good manufacturing practices in sites where these products are manufactured, packaged, or labelled. CURRENT STATUS: Regulatory Framework for Natural Health Products in Canada The fundamental basis for the NHP Regulations is solid. It is the result of extensive consultations (1997 – 2004) with stakeholders from across the spectrum (industry, consumers, patient groups, academics). The NHP framework provides Canadians access to products that are safe, effective and of high quality in a manner that is commensurate with the level of risk. The 2007 Natural Health Product Regulatory Review re-affirmed stakeholder support for the regulations and identified ‘regulation proportional to risk’ as the issue of greatest concern to stakeholders. (87 % supported the Regulations with some modifications; 5% indicated their products fit better under other Regulations; 4% indicated the Regulations should not apply to either high or low risk NHPs; 2% think the Regulations do not meet the original intent; 2% think the Regulations are not based in science). Backgrounder
NHPD is moving forward with a new Risk-Based Approach (RBA) which will further address regulation proportional to risk through a combination of operational, policy and regulatory modifications. Impact on the Regulation of Natural Health Products
Bill C-51 is not focussed on NHPs and will not affect the manner in which these products are regulated in Canada. The Act is not intended to alter how NHPs are currently approved for market release, their availability /access to the consumer; or to increase enforcement against the NHP industry. Bill C-51 is intended to allow for the flexibility of individual product lines (such as NHPs) to continue to be regulated proportional to their risk and accounting for their unique product profiles. Impact on the Regulation of Natural Health Products - Access There is misconception that this Bill will remove the majority of natural health products from the market. This is incorrect as the Bill specifically recognizes that different product classes have different standards of evidence. The standards of evidence for NHPs, which allow for a full range of evidence from traditional use to full clinical trials, will remain unchanged. Furthermore, under Bill C-51 the benefits of having specific NHP regulations will continue. Some examples of products which were granted licenses and market access under the NHP Regulations and which were previously not approved include: melatonin (for sleep), glucosamine sulfate (for joint pain) and 5HTP (for reducing pain, headaches and aiding in sleep). Impact on the Regulation of Natural Health Products - Definitions
Bill C-51 will also not move the review of natural health products into a more drug-like framework. The term “therapeutic product” is an umbrella definition intended to capture products sold for therapeutic purposes, that is, NHPs, drugs, veterinary drugs, medical devices, cells, tissues and organs, blood and vaccines. The new definition does not change the designation of an NHP nor the separate regulatory framework for NHPs. Concerns regarding the Bill affecting the practitioner or caregiver / patient relationship, are unfounded. The definition of sale and distribution will not impact the practitioner / patient relationship with regard to the practices of compounding or the caregiver / patient relationship. The relationship between practitioner and patient, specifically with regard to the activity of compounding, falls under provincial / territorial jurisdiction, relating to the definition of “practice of medicine”. Impact on the Regulation of Natural Health Products -Compliance & Enforcement
Bill C-51 does not specifically target NHPs for compliance and enforcement action and recognizes that compliance and enforcement activities must be commensurate to the level of risk. In addition, compliance and enforcement activities will continue to be guided by the Backgrounder Compliance Policy for Natural Health Products and the Health Products and Food Branch Policy Branch’s Policy 001. This policy sets out a risk-based approach to compliance activities in which those products posing the highest risk to the health and safety of Canadians will be subject to compliance action first. These new powers bring Canada up to par with other international regulators. It is accepted that most companies, including NHP companies, do comply with requests for product recalls. However, without this Bill, if companies choose not to recall, Canada will remain unable to require them to recall their products even in situations when there are clear health and safety concerns. Increased Fines & Penalties While fines under the new Bill have increased, the highest fines are intended to be applied for the most severe contraventions. The highest penalties are reserved for wilful or reckless behaviour, where there is never an intent to follow the law (such as with many counterfeit products). The Sentencing Criteria, which direct the courts towards what should be considered higher risk offences. A minor contravention would not be treated in the same manner as an incident that has significant impacts on the health and safety of Canadians. Prosecution is not always the best, or first intended, recourse. Compliance under the NHP Regulations Under the NHP Regulations and with the application of the Compliance Policy, Health Canada has addressed a number of health and safety issues, as was found with adulterated products such as benzodiazepines in sleep aids and drugs such as sildenafil in products for erectile dysfunction. There have been substitution problems as found with diethylene glycol in fluoridated toothpaste, and incorrect plants being used in Black Cohosh products (for relief of the symptoms of menopause). Also, where good manufacturing practices have not been respected there have been safety issues around bacterial contamination, and heavy metals, including arsenic and lead. Unacceptable amounts of containments can pose a significant risk to health. Infants and children are particularly vulnerable. CONCLUSION: Stakeholder concerns that the intent and application of Bill C-51 will substantially alter the present regulatory regime for NHPs are unfounded. Bill C-51 is not focussed on NHPs and will not affect the manner in which these products are regulated in Canada. The modernization of the Act does not disproportionately target NHP products or industry.
P-eksamen Oppgave 1 Totalt 17% 5 % Beskriv forskjellen på åpent og lukket brudd. 12 % Gjør rede for symptomer på brudd. Oppgave 2 Totalt 15% 2 % Leukemi inndeles i 2 hovedformer. Nevn hvilke. 13 % Velg en av de to hovedformene. Beskriv symptomer og tegn. Oppgave 3 Totalt 30% Beskriv komplikasjoner som kan oppstå 1.postoperative døgn. Gjør rede for hvordan disse komp
Eureka Orienteers Newsletter: July 2006 . president: mark valentine, secretary: jenni jamieson victorian selectors: geoff lawford, (foot O). anitra dowling, MTBO. Coming Events: Eureka Club Series #2 (+ AR Vic Champs) Blackfellows Flat 5km W of Ballan MEL 77 13 Aug Sun Social event TK Carroll’s Spring North of Ballan MEL EUREKA NEWS: Remember this date: Sun October 22nd. Lon