HEAL Committee Report
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LIST OF RECOMMENDATIONS
1. Health Canada, in conjunction with a new separate NHP Expert Advisory Committee, set out an appropriate definition of NHPs and amend the Food and Drugs Act accordingly.
2. Health Canada, in conjunction with the new NHP Expert Advisory Committee, examine the status of bulk herbs for legislative purposes.
Expertise and Regulatory Structure
3. The Government give consideration to the advisability of creating a new regulatory authority for NHPs that reports directly to the Assistant Deputy Minister of the Health Protection Branch.
4. The structure for this new regulatory authority be established within the next six months and be permanently staffed by individuals with expertise and experience in the field of NHPs.
5. The selection of personnel be agreeable to both government and NHP stakeholders.
6. When necessary, working groups reflecting the various segments that make up the NHP category be set up to advise the new regulatory authority.
7. All relevant inspection personnel be provided with training specific to NHPs.
8. The necessary process to amend the Food and Drugs Act not delay in any way the implementation of the regulatory and administrative changes that can proceed at this time.
9. An Expert Advisory Committee be established immediately to assist Health Canada in the general and specific tasks necessary to design a new NHP regulatory environment.
10. This Expert Advisory Committee review the re-establishment options for an NHP section with research and laboratory capacities and report its findings to Health Canada.
11. The selection of members for the Expert Advisory Committee be agreeable to both NHP stakeholders and Health Canada.
12. The new regulatory authority assume primary responsibility for assessing safety of products.
13. General safety protocols be developed by the Expert Advisory Committee based on EAC judgements of reasonable evidence.
14. When necessary, this regulatory authority establish appropriate working groups to assess the safety of specific products.
Quality/Good Manufacturing Practices
15. Health Canada, in collaboration with the NHP industry, establish appropriate GMP guidelines reflective of the different nature of NHPs.
16. GMP standards for NHPs include specific quality control and testing for herbal products.
17. Manufacturers, packagers, importers and distributors of NHPs, whether located in Canada or abroad, be obliged to hold valid establishment licenses.
18. Inspection activities be performed consistently and on a regular basis by inspectors knowledgeable about the products.
19. NHPs be allowed to make health claims, including structure-function claims, risk-reduction claims and treatment claims.
20. Claims be assessed to ensure that there is reasonable evidence supporting the claim.
21. The evidence not be limited to double blind clinical trials but also include other types of evidence such as generally accepted and traditional references, professional consensus, other types of clinical trials and other clinical or scientific evidence.
22. The evidence required vary depending on the type of claim being made, with different evidence being required for structure-function claims and risk-reduction claims for minor self-limiting conditions than for therapeutic or treatment claims.
23. The label indicates clearly the type of evidence used to support the claim.
24. The new product licensing framework be based on a risk management approach that emphasizes the margin of safety associated with a particular product.
25. Health Canada, in conjunction with the Expert Advisory Committee, establish categories within the NHP class to determine what level of regulation is appropriate for a particular product.
26. A product licensing system based on monographs be used when they are available. Such a system should rely on a pre-market approval process and the regulator should have a short period of time (for example, 30 days) to review the application.
27. Health Canada, in conjunction with the Expert Advisory Committee, establish procedures to create new Canadian monographs based on work already accomplished in other countries.
28. Manufacturers of products that do not have monographs be required to provide evidence to Health Canada before a product is marketed. The level of evidence would be consistent with the margin of safety associated with the product.
29. The level of post-market monitoring be based on the margin of safety associated with the product and include an NHP adverse event reporting system for industry and an adverse reaction hotline for practitioners and the general public.
30. Certain lower safety products be made available to consumers with appropriate warnings and other lower safety products only be made available with practitioner intervention.
31. The new framework be phased in over a period of months to allow sufficient time for the stakeholders and the regulator to review the current DIN system and conform to the new regulations.
32. Health Canada consult with its new separate NHP Expert Advisory Committee to determine what information is to be included on the labelling, consisting of, at a minimum, the items recommended by the Advisory Panel on Natural Health Products.
33. NHP labelling provide consumers with all relevant information needed to make informed choices.
34. NHP labelling be standardized to provide clear and consistent product information.
Section 3 and Schedule A of the Food and Drugs Act
35. Health Canada immediately initiate a review of the diseases listed in Schedule A to ensure that only appropriate diseases are included and, where relevant, specific diseases be exempted by regulation from the broad terms found in Schedule A.
36. Health Canada, subsequently, conduct a study with the participation of representatives from consumer groups, the food, natural health products and pharmaceutical industries, and health practitioners to determine whether subsections 3(1) and (2) of the Food and Drugs Act or all of the diseases listed in Schedule A should be deleted.
Importation of Human-Use Drugs for Personal Use
37. When the new regulatory framework is implemented, the personal importation policy be reviewed by Health Canada and the Expert Advisory Committee to determine if it is still appropriate and to outline permissible changes.
38. Health Canada conduct a review analysing the impact of the overall cost recovery policy on the different segments of the NHP industry.
39. The NHP industry stakeholders be consulted in the establishment of the most appropriate fee structure and amount.
40. As a result of this review, the existing fee levels be re-examined if necessary.
41. As part of the immediate process for NHPs, Health Canada work with stakeholders to establish appropriate, accessible and effective appeal processes for relevant policies and possible inclusion into a revised regulatory and legislative framework.
42. Health Canada immediately utilise existing formats and forums for more open and transparent communication on NHPs with the broader public and practitioners.
43. Communication efforts include details about decisions and actions regarding NHP products (removal from market, change of status, etc.).
44. Relevant consumer, industry and practitioner groups be consulted on a regular basis about the nature of the required information.
45. The federal government research bodies, including Health Canada, begin immediately to encourage research on NHPs. This could include studies focusing on the interactions of herbal products with conventional medications as well as studies that explore different uses by various groups in Canada.
46. Health Canada undertake, through its various established avenues, the dissemination of the resulting information to health care professionals and consumers.
47. Health Canada inform its provincial and territorial counterparts of the regulatory changes with regard to NHPs and of the concerns raised by practitioners.
48. The new regulatory framework for NHPs be enforced in a regular and consistent manner and done in conjunction with education.
49. Sufficient resources be provided for enforcement activities.
50. If a product that is extemporaneously compounded for a particular person is not exempted from the regulatory framework, that such a product be exempted.
51. Health Canada work with Foreign Affairs and International Trade to ensure that existing International Agreements that currently protect biological diversity are not violated and that additional strategies are developed if needed to prevent depletion of these valuable health resources.
52. The interim enforcement policy regarding NHPs continue to be applied until the new framework is in place.
53. The Minister appoint, immediately, a transition team responsible for ensuring that the new framework is established quickly.