The NHPPA is seeking to bring about a long-term solution to the current regulatory threat. The NHPPA is concerned that if the industry pursues a solution that is only short-term, that the industry could exhaust itself seeking a short-term solution and then find itself under regulatory threat in a couple of years time. For example, if the industry fights to force Health Canada to impose the current NHP Regulations more reasonably, there is nothing to prevent Health Canada from resorting to its current approach to the Regulations once the political pressure has subsided.
It is not lost on the NHPPA that the 53 Recommendations of the Standing Committee on Health came out a decade ago in 1998. When the 53 Recommendations were released, most of the industry reasonably believed that their long political struggle for regulatory fairness was going to result in a third category for Natural Health Products. Arguably the industry is in a worse regulatory environment today than it was ten years ago when the 53 Recommendations were released.
The NHPPA Advisory Board has given the NHPPA the immediate goal of obtaining a regulatory environment where:
- NHPs are presumed to be safe. A NHP cannot be taken off of the market unless the Government can prove that it is unsafe;
- there are different claims structures so that:
- manufacturers do not have to make claims;
- manufacturers can make limited claims, such as structure function claims with a low evidence threshold, and
- manufacturers can make specific health claims if they can meet a higher evidence threshold;
- NHPs are not regulated as drugs. They are either regulated as food or as a third category separate from drugs and food;
- there are Good Manufacturing Processes that are appropriate for the low risk profile of NHPs, and
- there is a conflict resolution mechanism to settle disputes between the Government and industry members.
The NHPPA will involve its stakeholders in the decision making and direction of the organization by taking direction from an Advisory Board of stakeholders. There is currently an interim Advisory Board fulfilling this role. A final Advisory Board will be selected annually by those NHPPA stakeholders who join the NHPPA as Associates. All NHPPA Associates will also have the right to submit proposals and comments to both the Advisory Board and the NHPPA Board.
