Our Goals

Relaxing the “Drop Dead Date” - Complacency Reigns

Many in the industry are understandably relieved with the publicity that Health Canada will not start its strict compliance plan against unlicensed natural health products until 2011.

The industry has also been thrown another concession, a review of a handful of the Schedule F (i.e. prescription drugs).

It is frightening that these are seen as “positive” developments. They are “positive” in the sense that the industry is being granted a few concessions. What is frightening, however, is how grateful and complacent the natural health community becomes when Health Canada slows its drive to re-shape the NHP industry into something that only the larger companies want.

The natural health community has become so afraid of Health Canada that a slowing of the “inevitable” death of the natural health product industry as we knew it becomes a cause of relief.

The reality is that:

  • we are going to lose 75-80% of our natural health products;
  • the “types” of products will change. Many multi-ingredient products will not remain;
  • innovation into multi-ingredient products will be stifled;
  • our children will not have access to the types of products we enjoyed;
  • many quality firms will not survive;
  • many will be terrorized by Health Canada enforcement action when full compliance is a reality;
  • eventually we will face cost recovery.

What is perhaps most troubling is that Canadians who rely on NHPs that will be lost are going to suffer health consequences. This is an ethical crisis that we face. We know that the natural health community is more than a marketplace or a business environment: it is a place where many find healing and relief. We also know that by rendering the majority of NHPs illegal, that many will suffer health consequences. Most of us are standing by and watching as this happens.

The over-regulation of the NHP industry is not an accident. It is not a mistake. It is not due to any misunderstanding of the meaning of the NHP Regulations. The death of the NHP industry as we knew it is the inevitable result of the Regulations as they are currently written. Doing nothing, or trying to achieve minor concessions can only lead to the result we are all witnessing happen.

The NHPPA is not willing to celebrate minor concessions while NHPs continue to be relentlessly driven from the shelves.

The natural health community is facing a crisis of belief. Many believe they have to settle for the truncated industry that Health Canada will allow. Many believe that we cannot have a vibrant industry that celebrates innovation and common sense. Many believe that putting vulnerable Canadians at risk as vital health products are taken away cannot be stopped. Many believe that Canadians cannot have the freedom to access natural health products that they previously enjoyed. The NHPPA does not subscribe to any of these beliefs.

In its short history the NHPPA has demonstrated the power of positive action and belief.

The NHPPA does not believe that the natural health community needs to settle for the bleak future Health Canada is offering. The NHPPA does not believe that we can ethically pass this challenge by accepting complacency and fear. Indeed, complacency and fear are necessary for Health Canada to succeed.

The public supports this industry and is passionate and motivated about protecting access to natural health products. We do not have to settle. We can re-focus and move forward.

The NHPPA is calling on the entire natural health community to shake off complacency and fear, and work towards ensuring we have a vibrant and growing future.

Natural Health Products Protection Association

December 2009


TABLE OF CONTENTS:

Mission Statement

The Natural Health Products Protection Association is federally incorporated as a non-profit organization with the sole object of:

Protecting access to Natural Health Products and Dietary Supplements.

By limiting its purpose to protecting access to Natural Health Products and Dietary Supplements, the NHPPA will focus on identifying and responding to threats facing the Natural Health Product and Dietary Supplement industry. In essence, the NHPPA will act as an industry watchdog.

Regulatory Goals

The NHPPA Advisory Board has given the NHPPA the immediate goal of obtaining a regulatory environment where:

  1. NHPs are presumed to be safe. A NHP cannot be taken off of the market unless the Government can prove that it is unsafe;
  2. there are different claims structures so that:
    a) manufacturers do not have to make claims;

    b) manufacturers can make limited claims, such as structure function claims with a low evidence threshold, and

    c) manufacturers can make specific health claims if they can meet a higher evidence threshold;

  3. NHPs are not regulated as drugs. They are either regulated as food or as a third category separate from drugs and food;
  4. there are Good Manufacturing Processes that are appropriate for the low risk profile of NHPs, and
  5. there is a conflict resolution mechanism to settle disputes between the Government and industry members.

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The Need for the NHPPA

The purpose of the NHPPA will be to provide expertise in identifying threats to the natural health product industry, and through multi-lateral discussion arriving at solutions to address those threats. In providing legal, political and strategic expertise on threats to the industry, the NHPPA hopes to be an asset to both individual stakeholders in the industry, as well as to existing organizations.

The need for an industry watchdog like the NHPPA was recently demonstrated with the release of Bill C-51 on April 8, 2008. The NHPPA released a Discussion Paper the following day which has alerted stakeholders to the threats posed by the Bill. The NHPPA has provided a leadership role in educating stakeholders on the issues presented by the Bill.

The NHPPA has also played a leading role in identifying the issues in Bill C-52, the Consumer Protection Act.

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Approach to Protecting access to Natural Health Products and Dietary Supplements.

Education - to bring about meaningful change there has to first be an appreciation that change is needed. We plan on conducting public education campaigns, working with the media to create public awareness, and working to educate all levels of Government concerning individual and industry stakeholder concerns.

Unity - to bring about meaningful change the stakeholders will need to work together. We plan on working with other stakeholders and groups to bring about a broad consensus and encourage co-ordinated actions.

Communication - the goals for regulatory change need to be clearly and professionally communicated to Members of Parliament. In pursuing regular meetings with Members of Parliament, we also plan on encouraging the creation of a cross-party Natural Health Product Caucus to make our issues less partisan.

Political Encouragement - representative government only works when the voters clearly communicate their wishes to their representatives. We will be facilitating this communication through various avenues to encourage voter participation and education.

Summary

In any industry issues change over time. The NHPPA views itself as a permanent member of the Natural Health Product and Dietary Supplement sector with a view to ongoing regulatory analysis and issue-based stakeholder consensus building.

Current Activities

Background:

There is currently a pressing need to bring about regulatory change at the federal level. At the same time, there are a number of divisions between stakeholders and various stakeholder groups. Because the NHPPA’s mandate is so focussed, the NHPPA can act as a bridge between the various stakeholder groups without encroaching upon their activities.
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The Immediate Threat to the Natural Health Products Industry

At this point almost 60% of product license applications have been either refused or withdrawn. These are primarily license applications for single ingredient products. The NHPPA expects that the percentage of license refusals will increase as the NHPD starts considering multi-ingredient products. In short, the industry will remain largely illegal, or the majority of NHPs will have to be taken off of the market.

Innovation on new products is grinding to a halt. Small and medium sized manufacturers are being driven out of business.

Eventually cost recovery for the NHPD will put further strain on the industry and consumer access to Natural Health Products.

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Bill C-51

On April 8, 2008, the Minister of Health introduced Bill C-51 into the House of Commons. The Bill passed first reading.

Bill C-51 changes the legal landscape for the natural health product industry. For the first time, manufacturers, retailers, distributors and natural health practitioners face personal bankruptcy if they cross Health Canada. Directors and officers of corporations are not protected as the the Bill makes them personally liable and hence subject to personal bankruptcy for any breach of the Act and Regulations by the corporation.

Bill C-51 provides Health Canada with unprecedented powers such as the power to seize and detain product, equipment and property for any reason and for any length of time. Health Canada is also given the power to destroy seized property without Court supervision.

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Other Threats facing the Natural Health Product Industry

Although the Natural Health Product industry is facing an immediate threat with the imposition of the drug-style NHP Regulations, there are other threats lurking in the background. These threats include:

  • international treaties Canada and the United States are participating in such as CODEX;
  • the imposition of ever stricter standards upon the industry by Health Canada and the Food and Drug Administration in the United States;
  • the seizure of products at the border between the United States and Canada. Currently, the main problem is U.S. products entering Canada. However, with the imposition of stricter standards on dietary supplements by the F.D.A., there is a real risk that the F.D.A. will adopt the Health Canada approach of stopping products at the border;
  • the imposition of ever-widening intellectual property right agreements and treaties that will affect the Natural Health Product industry.

Stakeholders are currently not being kept up to date on these issues. The NHPPA is well placed to keep its stakeholders informed on all issues that threaten their interests.

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2010 Goals

Within the next 12 months our goals are to:

  • establish a reliable funding base to enable us to implement our plan;
  • invite stakeholders to become associates to support the NHPPA and to participate in bringing about regulatory change;
  • establish positive relationships with key stakeholder groups to build a consensus and to form a working group to co-ordinate activities;
  • conduct public education campaigns in 10 major Canadian cities;
  • continued participation in radio and TV talk shows as part of a co-ordinated education campaign;
  • conduct local and media campaigns to educate the public and to support educational and/or political rallies;
  • continue to foster working relationships with key MPs in Ottawa;
  • work towards the creation of a cross-party National Health Products caucus;
  • co-ordinate and track letter writing campaigns and a petition drive to generate political will for change.

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