APHC/CHPA Submission to the House of Commons Standing Committee on Health – Bill C-420
Submission to the House of Commons Standing Committee on Health Concerning Bill C-420, An Act to Amend the Food and Drugs Act
L’Assocation Pharmaceutique Homéopathique du Canada/ The Canadian Homeopathic Pharmaceutical Association
April, 2005
APHC/CHPA Submission to the House of Commons Standing Committee on Health – Bill C-420
Table of Contents Section Title
Page Number
Summary of APHC/CHPA Recommendations Regarding C-420
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1.
Introduction to the CHPA
1
2.
Homeopathy and Homeopathic Medicines
2
3.
Overview of Regulation of Homeopathic Medicines in Canada, 1989 to 2004
3
4.
Regulation of Homeopathic Medicines as Natural Health Products
4
5.
Consequences of Bill C-420 as Written
6
6.
The Importance of Rescinding Schedule A Prohibitions
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Appendices A:
Member Companies of APHC/CHPA
B:
1990 Health Canada Information Letter 775 – Homeopathic Preparations
C:
Evolution of the Regulatory Framework for Homeopathic Medicines
D:
1996 Guidance Document - Good Manufacturing Practices for Homeopathic Medicines
E:
1997 Guidance Document - Labelling Standard for Homeopathic Medicines
F:
1998 Guidance Document - Indications for Use – Multi-ingredient Low Dilution Homeopathic Preparations
G:
CHPA Letter to the Hon. Anne McClellan, September 24, 2002
H:
CHPA Position Statement (2003) Concerning Regulation of Homeopathic Medicines as Drug Products
I:
Letter From Health Products and Food Branch to CHPA, April 5, 2004
APHC/CHPA Submission to the House of Commons Standing Committee on Health – Bill C-420
Summary of APHC/CHPA Recommendations Regarding C-420 If passed and proclaimed as approved at second reading, Bill C-420, an Act to amend the Food and Drugs Act, would present significant adverse consequences for manufacturers and importer/distributors of homeopathic medicines and would immediately eliminate availability of these pharmaceutical (drug) products to Canadian consumers and health care practitioners. Recommendation 1: The Canadian Homeopathic Pharmaceutical Association (CHPA) recommends the removal of Sections 1. (1) and 1.(2) from Bill C-420 Rationale:
Homeopathic medicines have been defined as drug products in Canada’s regulatory framework, including the current Natural Health Products Regulations, since 1990. Sections 1.(1) and 1.(2) of Bill C-420 as written will alter this drug status by incorporating all natural health products, including homeopathic medicines currently captured within the regulatory definition of “natural health products” into the proposed definition of “food”. Homeopathic medicines are not foods and cannot comply with Canada’s food regulations. As a consequence, until such time as other legislative and regulatory amendments restored drug status for homeopathic medicines, all homeopathic medicines would be non-compliant with Canadian regulation and therefore subject to being removed from the Canadian market through regulatory intervention. Were this to occur, Canadian consumers would be denied access to these safe, effective and affordable alternative medicines.
Recommendation 2: The Canadian Homeopathic Pharmaceutical Association (CHPA) recommends the retention of Sections 2 and 3 of Bill C-420 Rationale:
Section 3, Schedule A provisions of the Food and Drugs Act have long posed a prohibition of responsible use of health claims in labelling and advertising for foods and for OTC drug products, including homeopathic medicines. The internationally accepted evidence of efficacy supporting indications for use and health claims for homeopathic medicines resides in their history of use and published traditional references such as Materia medicas. Although many of these traditional references are recognized by Health Canada and referenced in Health Canada guidance documents, Schedule A remains an impediment to responsible and informative health claims. S-1
APHC/CHPA Submission to the House of Commons Standing Committee on Health – Bill C-420
An external advisory committee convened by Health Canada has reviewed Schedule A and submitted recommendations to remove the impediments presented by Schedule A. Recommendation 3: CHPA requests that the Standing Committee on Health recommend to the Minister of Health that notwithstanding the future of Bill C-420, the Minister exercise the authority provided under Section 30 of the Food and Drugs Act to remove the Schedule A prohibitions. Rationale:
Whereas the vast majority of non-government organizations in the natural health products and pharmaceutical industries and whereas the majority of advisory bodies asked to examine Schedule A have recommended that Schedule A be rescinded, it would be appropriate for the Minister of Health to undertake the necessary regulatory amendments using existing authority provided under Section 30(j) and (m) of the Food and Drugs Act.
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APHC/CHPA Submission to the House of Commons Standing Committee on Health – Bill C-420
1.
Introduction to the CHPA
The Canadian Homeopathic Pharmaceutical Association (CHPA) is Canada’s federally chartered, national industry association representing the public policy and regulatory interests of manufacturers and importer/distributors of homeopathic medicines. To qualify for membership, an individual or company must hold a valid Health Canada product license for a homeopathic medicine (DIN or DIN-HM). CHPA has 13 member companies who hold the vast majority of valid product licenses and account for the vast majority of sales of these products in Canada. A list of CHPA members is appended (Appendix I). The association’s office is located in Ottawa. CHPA has been recognized for many years by Health Products and Food Branch (HPFB) as the industry body that represents Canada’s homeopathic pharmaceutical industry. CHPA’s technical committee and board of directors have been engaged in consultations with HPFB on the regulation of homeopathic medicines since 1990. Members of CHPA’s board of directors are active in the recognition and regulation of homeopathic medicines at the international level. Two CHPA board members are members of the HPUS Homeopathic Pharmacopoeia Convention of the United States, one of four pharmacopoeias recognized by Health Canada. Staff members of affiliated companies are also active in the further development of the homeopathic pharmacopoeias of France, Germany and the European Union. As a consequence of this involvement, CHPA has the capacity to monitor the regulation of homeopathic medicines in the US and EU member states whose regulatory agencies have formal (mutual recognition agreements) and informal working relationships. It is with the benefit of this capacity and knowledge of regulatory frameworks in other jurisdictions that CHPA has played an active role in the development of the Natural Health Product Regulations and related guidance documents as they affect homeopathic medicines. CHPA is represented on the Management Advisory Committee of the Natural Health Products Directorate.
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APHC/CHPA Submission to the House of Commons Standing Committee on Health – Bill C-420
2.
Homeopathy and Homeopathic Medicines
Homeopathy was developed approximately 200 years ago and has been widely adopted in health care in Europe, Asia, South America and North America. Homeopathy is based on the theory of similars, the concept that a substance that can cause certain symptoms of diseases, indications and health disorders can also alleviate the same when administered in extremely diluted form. Internationally recognized pharmacopoeias (compendia of ingredients and drug preparations) specify ingredients and methods of manufacture for thousands of homeopathic medicines. The most widely accepted pharmacopoeias are those of the United States (Homeopathic Pharmacopoeia of the United States), France (la Pharmacopée française) and Germany (HAB). These three are recognized by Health Canada and referenced in Health Canada guidance documents. Health Canada also recognizes the harmonized EU pharmacopoeia still under development as it will incorporate those of France and Germany. The pharmacopoeias are “living documents” in that they are continuously being updated through a peer review process such as that of the Homeopathic Pharmaceutical Convention of the United States and the counterparts of this organization in France and Germany. Homeopathic medicines are manufactured from pharmaceutical quality source (active) ingredients of botanical, mineral and animal origin. While many homeopathic medicines are manufactured from single source ingredients, there are also many multi-ingredient formulations that are approved and available to consumers throughout Canada. Over 5000 Health Canada product licenses (Drug Identification Numbers) have been issued for homeopathic medicines. All of these products are OTC (over the counter, nonprescription) medications that are distributed and sold through pharmacies and natural health product retail establishments for self-care. Homeopathic medicines are also available to Canadians through their health care practitioners.
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APHC/CHPA Submission to the House of Commons Standing Committee on Health – Bill C-420
3.
Overview of Regulation of Homeopathic Medicines in Canada, 1990 to 2004
Health Canada has considered homeopathic medicines to be drug products since 1990 with the publication of the department’s Information Letter 775 (please refer to Appendix B). With the publication of IL775, all homeopathic medicines became subject to product licensing requirements. Publication of IL775 triggered a dialogue between Health Canada and manufacturers and importer/distributors of homeopathic medicines that led to development of policies outlined in guidance documents published by the Therapeutic Products Directorate between 1996 and 1998. These documents largely completed a regulatory framework for homeopathic medicines whereby the majority of products and formulations became compliant and eligible for product licenses (DINs). A chronology of events illustrating the evolution of the regulatory framework is appended (Appendix C). The three guidance documents are: 1996 Good Manufacturing Practices – Supplementary Guidelines for Homeopathic Preparations (please refer to Appendix D) 1997 Labelling Standard for Homeopathic Preparations (please refer to Appendix E) 1998 Indications for Use – multi-ingredient low dilution homeopathic preparations (please refer to Appendix F) One of the most significant milestones in the implementation of the regulatory framework was the compliance project that was jointly managed by TPD and CHPA in 1997/1998. This project facilitated the submission of applications for product licenses and the issuance of over 4700 DINs for homeopathic medicines by end of 1998, bringing the vast majority of the homeopathic medicines on the Canadian market into compliance as drug products. It should be noted that despite the completion and implementation of the aforementioned guidance documents, many homeopathic medicines approved and available in the US and EU remained ineligible for product licenses in Canada under the existing drug regulations. Homeopathic medicines manufactured from source ingredients listed in Schedule D and Schedule F and the list of Prohibited Substances of the Drug Regulations were not eligible for product licenses. Most, but not all of these restrictions are being addressed through the coming into force and implementation of the Natural Health Product Regulations beginning in January of 2004.
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APHC/CHPA Submission to the House of Commons Standing Committee on Health – Bill C-420
4.
Regulation of Homeopathic Medicines as Natural Health Products
Prior to the development of the Natural Health Product Regulations, neither CHPA nor Health Canada contemplated regulating homeopathic medicines as anything other than “drug products”. In fact, when the definition of natural health products was being contemplated, CHPA recommended to the then House of Commons Standing Committee on Health and to the Minister of Health that homeopathic medicines not be included in the proposed category of “natural health products”. When this advice was not taken and homeopathic medicines were identified in Health Canada’s consultation documents as being included in the proposed natural health products category, CHPA again requested that homeopathic medicines be removed. These efforts continued through 2002 and into 2003, as documented in a CHPA letter to the Hon. Anne McLellan (please refer to Appendix G) and CHPA’s 2003 position statement (Appendix H). We ask the current members of the Standing Committee on Health to note that CHPA’s rationale for continuing to regulate homeopathic medicines as “drug products” (pharmaceuticals) was clear and consistent. The key points of this rationale were and remain: •
Homeopathic medicines are defined and regulated as drug products (pharmaceuticals) in all major countries of manufacture, including Canada, the United States and the EU
•
Homeopathic medicines are recognized as drug products by pharmacists and health care practitioners in all industrialized countries
•
Unlike the majority of “natural health products” captured by the current regulatory definition (Natural Health Product Regulations), homeopathic medicines were already compliant with and licensed under, the existing Canadian drug regulatory framework. There was no need or apparent demonstrable societal benefit of re-regulating homeopathic medicines as “natural health products”.
It was only during the latter stages of development and drafting of the Natural Health Product Regulations that it became clear to CHPA that: •
the then-proposed Natural Health Product Regulations would continue to classify homeopathic medicines as “drug products”
•
the then-proposed Natural Health Product Regulations had the potential to improve consumer and practitioner access to homeopathic medicines and
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APHC/CHPA Submission to the House of Commons Standing Committee on Health – Bill C-420
•
Health Canada was prepared to assign additional qualified human resources to better regulate a broader range of homeopathic medicines than had been permitted for distribution under the existing Drug Regulations.
It was only then that CHPA ceased efforts to have homeopathic medicines remain subject to the drug regulations. As of April, 2005, NHPD has established a unit responsible for homeopathic medicines. This is a measure that had been called for by CHPA and health care practitioners for years. Health Products and Food Branch has also confirmed NHPD’s responsibility for regulation of the majority of homeopathic medicines, including those manufactured from Schedule D and Schedule F source ingredients (please refer to Appendix I). This effectively achieved CHPA’s request of having all homeopathic medicines regulated by a single office within Health Canada. As of April 2005, NHPD has concluded administrative arrangements within Health Products and Food Branch to put this single office responsibility into practice. In summary, the Natural Health Products Regulations and related administrative arrangements within the Health Products and Food Branch have served to confirm the status of homeopathic medicines as pharmaceutical (drug) products and to provide a more complete regulatory framework for homeopathic medicines. This more complete framework is of benefit to all stakeholders (manufacturers, importer/distributors, consumers, health care practitioners and Health Canada).
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APHC/CHPA Submission to the House of Commons Standing Committee on Health – Bill C-420
5.
Consequences of Bill C-420 For Homeopathic Medicines
As drafted and now under review by the Standing Committee on Health, Bill C-420 proposed to redefine all products now included in the regulatory definition of “natural health products” as foods. If this is done, none of the over 5000 homeopathic medicines approved, licensed and widely used in Canada, could comply with Canada’s food regulations. As a consequence, all homeopathic medicines currently available to Canadian consumers would become non-compliant and as such, subject to removal from the Canadian market at Health Canada’s entire discretion. Additional consequential legislative and regulatory amendments would be required to restore compliance and ensure continuing access for these products to the Canadian market. We submit that this risk of losing current access to market for homeopathic medicines has not been understood or taken into account by either the proponents of C-420 or its sponsoring Member of Parliament who believe that certain dietary supplements should be regulated as food products. As a consequence, CHPA has no alternative but to request that C-420 be amended to remove Section 1(1) and Section 1(2).
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APHC/CHPA Submission to the House of Commons Standing Committee on Health – Bill C-420
6. The Importance of Rescinding Schedule A Prohibitions Section 3, Schedule A of the Food and Drugs Act has presented an insurmountable impediment to health claims for foods and drug products for decades, even where the health claims and the supporting science and post-market experience are internationally accepted. As a consequence, manufacturers and others have been prevented from communicating potential health benefits to consumers and health care practitioners through responsible labelling and advertising statements. Numerous organizations (including CHPA), various advisory committees and the Standing Committee on Health have recommended that Schedule A be extensively amended or completely rescinded. CHPA notes that Sections 2 and 3 of Bill C-420 would achieve this, if enacted. CHPA is therefore prepared to support passage of Bill C-420 if amended to remove Section 1.(1) and 1.(2) of the Bill. Given the societal and industry consensus that Schedule A is not longer appropriate, CHPA would welcome a clear recommendation from the Standing Committee on Health to the Minister of Health to effectively rescind Schedule A using existing provisions of the Food and Drugs Act that empower the Minister to remove references to diseases and disease states by regulatory amendment through the usual regulatory process.
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