Government Briefs: Response to the Report of the Standing Committee on Health Natural Health Products: A new vision

December 3, 1998

The Canadian Pharmacists Association wishes to congratulate the committee on a fairly balanced report in view of the overall number of representations that stemmed from one side of the industry and the very few representations from health care providers and the Canadian public.

We would like however to reiterate some of the concerns already put forth in our brief in responding to the recommendations put forward by the Standing Committee.

An initial overall comment warranted by the lack of definitions in the recommendations pertains to what the committee means by NHP stakeholders. In the absence of a clear definition, a number of the recommendations have to be questioned, 5, 11, 31, 41. This is especially necessary in view of other terms used which may or may not be covered by the term NHP stakeholders such as: NHP industry stakeholders, practitioners, health practitioners, the broader/general public.

For clarity, we will be addressing the recommendations as they appear in the report.

Expertise and Regulatory Structure

Recommendation 3

As stated in our brief, the Canadian Pharmacists Association believes that Option 3 of the proposed structures would be the most advantageous for Health Canada. NHP would benefit from the scientific know-how that already rests with the TPP instead of setting up a costly parallel structure.

Recommendation 5

This is an unprecedented recommendation that could open the door to many representations by other groups dealing with the federal government to insist on similar treatment. It could for example open the door for the Pharmaceutical Manufacturers to have purview over the hiring of personnel that would be in a position to judge their submissions. This leads to a situation where the NHP stakeholders could be judge and party. We believe that the advisory Committee could establish criteria and guidelines for the profile of the people that should be hired by the NHP but that the final decision rests solely with Health Canada.

Recommendation 9

There is a lack of clarity as to which pool of experts Health Canada would draw from for this Advisory Committee. Would traditional experts with knowledge in herbal products be selected, i.e., pharmacology, etc.? What would be the consultation process for the establishment of this advisory committee and for the new regulatory environment?

Recommendation 10

In this area in particular, it would be important to rely on existing facilities and expertise rather than set up a new structure at major cost to government.

Recommendation 11

See comment under 5.

Quality/Good Manufacturing Practices

The Canadian Pharmacists Association wholeheartedly agrees with the recommendations in this section.

Efficacy

Recommendation 20

The CPhA has some concerns about the qualification of "reasonable evidence" instead of "evidence" by itself, which has a universally recognized meaning. Either there is evidence or not and the word "reasonable" in this context seems to be used to open the door to not much evidence at a level that can be expected for these types of products.

Recommendation 21

We wish to reiterate what we submitted in our brief to the committee in opposition to this recommendation.

"Claims of efficacy leading to increased use have contributed to the current need to review herbal products and evaluate their inclusion in the arsenal of remedies available to all. As with all other remedies being assessed in Canada, there is a move toward evidence-based decision making, and herbal products should be subjected to the same rules as required for other therapeutic products, particularly if they are to be considered for inclusion on drug benefit lists as requested by many people using them.

To attempt a scientific validation of the efficacy of herbal products, the following factors need to be considered:

• existence (or lack) of phytochemical data;
• in vivo and in vitro animal study data;
• existence (or lack) of clinical data (Many will argue that clinical trials require considerable resources, often far beyond the budget of herbal product manufacturers, one could consider long-term records of use through peer- reviewed literature and a good risk assessment process as a means to replace actual clinical trials, as described in the presentation of the Advisory Panel on Herbal Remedies);
• formulated product versus the crude extract, since a formulated product containing, for example, an aqueous plant extract, equivalent to the same weight of a crude aqueous plant extract, may not necessarily be bioequivalent.

Documented clinical data do not exist for most herbal products; however, there is no reason why those products should not be available for minor conditions, provided that they are consistent with traditional uses that based on known pharmacological and toxicological data, appear rational, that the herbal ingredients are of suitable quality and safety, and that the appropriate warnings and contraindications appear on the label. However, these products could not make therapeutic claims unless they were evidence based.

The Canadian Pharmacists Association recommends that therapeutic claims of efficacy for herbal products be substantiated by available clinical data. We further recommend that Health Canada regulate and monitor the types of claims and advertising made by herbal product manufacturers."

Recommendation 23

CPhA supports the move to more complete information appearing on the label, including the source of the clinical data available to substantiate the claim.

Product Licensing

Recommendation 26

The product licensing system timelines should not arbitrarily be set. It should be based on the information available for the individual product and normal back and forth exchange of information between the manufacturer and HPB.

Recommendation 27

As indicated in our brief to the committee, the Canadian Pharmacists Association jointly with the Canadian Medical Association are in the process of developing monographs for the Canadian market. A similar endeavour by HPB would only serve to duplicate what is already being done.

Recommendation 28

As with other therapeutic products on the market, the manufacturer should be required to submit a monograph for new products it wishes to introduce in Canada. The monograph should be an integral part of the application for a license.

Recommendation 30

The term practitioner needs to be defined for this recommendation to be fully explanatory.

Recommendation 31

As we understand it, this would mean that the products would be submitted to the DIN system or a similar system chosen to re-place it.

Labelling

Recommendation 33

Though CPhA fully agrees that there is a need for greater information on the label, the "relevant information needed to make informed choices" requirement could lead to fairly big labels. We hope that provisions as to what should appear on the label will be subject to broad consultation on the matter with all stakeholders involved in the distribution of those products.

Recommendation 36

Review of these sections is currently being done through the HPB Renewal Process, this specific endeavour could therefore amount to a duplication of efforts.

Cost Recovery

The Canadian Pharmacists Association agrees that in a spirit of fairness the cost recovery rules should apply to all programs of HPB and should be determined once a full understanding of additional costs to the department for the creation of this new direction are known.

Informed Choice

Recommendation 44

As front line distributors of products and information on NHPs, we hope that pharmacists are included under "practitioner groups" and that they will be consulted in an ongoing fashion as the process unfolds.

Recommendation 45

The Canadian Pharmacists Association is pleased to see the importance given one of its recommendations pertaining to the need to study interactions of herbal products with conventional medications. We hope that contraindications with other medications will also appear on labels and in herbal product monographs.

Aboriginal Healers

Though this section only applies to aboriginal healers, it should be extended to practitioners of traditional Chines medicine where compounding also takes place. We would however caution HPB not to exempt all preparations of this nature since a number of them are done with products that are prohibited in Canada because of their provenance.

Plant Conservation

The CPhA would like to recommend that not only plants be protected but that special attention also be placed on products from animal sources, i.e. ground rhinoceros horns, elephant tusks, etc.

Conclusion

The Canadian Pharmacists Association wishes to recommend that Option 3 of the diagrams for the structure of the proposed NHP Directorate be adopted instead of Option 2. We believe that the federal government should maximize the use of the structures and services that are already in place, thus reducing the tax burden for all Canadians.

We hope that the above comments will be useful in assessing which of the Committee’s recommendations should go forward and which should be submitted to additional consultation. We also hope that definitions will clarify the term stakeholders as used in the recommendations.