Executive Summary
Naturopathic doctors are the general practitioners who have the training and licensed authority to specialize in natural medicine. Patient safety and therapeutic benefit are paramount in determining the most effective treatment protocol for their patients. Naturopathic doctors have extensive academic and clinical training with respect to the therapeutic use, contra-indications, possible adverse reactions, and toxicities of natural remedies.
The Canadian Naturopathic Association (CNA) is a non-profit association representing the interests of naturopathic doctors and promoting naturopathic medicine throughout Canada. Its membership consists of naturopathic doctors, naturopathic medical students, suppliers of natural remedies for professional use, and the provincial naturopathic associations. The Canadian Naturopathic Association is advocating for reform of the current regulation of botanical medicines, homeopathic preparations and nutritional supplements under the Food and Drug Act.
It is important to note here that the Canadian Naturopathic Association stands behind the regulation of natural health products to ensure patient and public safety, and behind good manufacturing practices to ensure quality assurance of products. However, current regulation cannot guarantee these principles. Current regulation is too lax in the case of treating natural health products without health claims as "foods" and too restrictive in treating those with health claims similar to pharmaceutical "drugs".
In Canada, federal regulation restricts naturopathic doctors' prescription rights to many of the natural remedies they are trained to use. They are not and have not been consulted in regulatory decisions that effect their access to the natural health products they need for effective patient care.
In this document, the Canadian Naturopathic Association will present an overview of the practice of naturopathic medicine, the safety and clinical effectiveness of the natural medicines that naturopathic practitioners prescribe, and the cost-effectiveness of health promotion and disease prevention. This brief will detail the problems with the current regulation of natural health products and the negative effects that the current regulation of natural health products has on naturopathic doctors in delivering effective patient health care. The Canadian Naturopathic Association will also put forward recommendations for change.
(See Summary of Recommendations to the Standing Committee on Health.)
Return to Table of ContentsNaturopathic Medicine is a distinct system of primary health care that uses natural methods and substances to support and stimulate the body's self-healing processes. It provides a complete, individualized and coordinated approach to health care integrating modern scientific knowledge with traditional and natural forms of medicine. Naturopathic Medicine is the art and science of disease diagnosis, treatment and prevention using natural therapies including:
Naturopathic doctors are the general practitioners who have the training and licensed authority to specialize in natural medicine. They are trained to diagnose the underlying causes of disease and to maximize the body's innate ability to heal by using the least invasive methods possible. They specialize in the composition, application and prescription of natural medicines as well as nutritional therapy and lifestyle change. In order to treat the whole person and to individualize treatment, naturopathic doctors select and integrate the natural therapies appropriate to the individual patient.
The practice of naturopathic medicine respects the six naturopathic principles:
Doctors of naturopathic medicine are also trained to recognize conditions which require conventional medical treatment such as surgery or prescription drugs. In these cases, patients are referred to the appropriate practitioners or to local hospitals. Naturopathic doctors may work in conjunction with conventional medical doctors utilizing a combined medical treatment for the benefit of the patient.
The Education and Training of Naturopathic DoctorsNaturopathic doctors have at least seven years of post-secondary education. They must complete a three year full-time university program with the specific science courses required as a prerequisite to any medical school, in order to be accepted at an accredited Naturopathic Medical College. In Canada, naturopathic medical education is a four year full-time program which includes extensive supervised clinical training.
The Canadian College of Naturopathic Medicine (CCNM) is one of four naturopathic institutions in North America officially recognized for the quality of their programs by the Council on Naturopathic Medical Education. CCNM offers Canada's only four-year, full- time post-graduate program training naturopathic doctors in basic medical sciences including pharmacology and pharmacognosy, physical and clinical diagnosis, naturopathic principles and therapeutics. Students receive more than 4,000 hours of classroom and clinical training. The College houses a highly respected teaching clinic where senior students treat patients under the direction of registered naturopathic doctors. Application rates for the College's programs have grown nine-fold since 1991. There are currently 337 students in attendance at the College. The CCNM's library is regarded as Canada's finest natural medicine resource centre.Upon completion of the four year program, graduates must successfully complete international naturopathic physicians licensing examinations (NPLEX). The interest in naturopathic medicine as a career option is growing tremendously. CCNM estimates that by the year 2004, seven years from now, the number of naturopathic doctors in Canada who will have passed NPLEX and qualify to be licensed in any regulated province or state, will have tripled.
Provincial Regulation of Naturopathic PracticeNaturopathic practice is currently regulated under provincial law and through a licensing board in four provinces in Canada. Laws regulating naturopathic practice were enacted in Ontario in 1925, British Columbia in 1936, Manitoba in 1943, and Saskatchewan in 1952. After passing NPLEX, naturopathic doctors in regulated provinces must also pass provincial examinations in order to practice naturopathic medicine in those provinces.
The Canadian Naturopathic Association is the national association and there are seven provincial associations representing the interests of naturopathic doctors and promoting naturopathic medicine across the country. The Alberta Association of Naturopathic Practitioners, the Nova Scotia Naturopathic Association, and the Quebec Professional Association of Naturopathic Physicians are currently working towards regulation in their respective provinces.
Return to Table of ContentsThe cost of health care is increasing in an economic environment which restricts government and corporate spending. In this climate, the cost-effective benefits of naturopathic health care cannot be overlooked.
Doctors of naturopathic medicine focus on treating the underlying causes of illness and successfully manage and treat many disease conditions without the costly use of prescription drugs or surgery. Traditional systems of healing are often far more successful in treating many types of conditions for which conventional medicine has failed. This is particularly true for chronic and degenerative conditions. Naturopathic practitioners see an estimated nine patients with chronic illness compared to one patient with acute illness.
Stress and stress-related illness is increasing dramatically in today's society. Stress management, nutritional therapy and lifestyle counselling are all part of a naturopathic practitioner's program for treating the whole person. Naturopathic doctors also focus on health maintenance and health promotion. They involve patients in their own health program enabling the patients to make effective, educated self-care decisions which can prevent future health problems and the outlay of health care dollars.
More and more corporations are investigating and incorporating comprehensive wellness programs to decrease employee health care costs, reduce employee absenteeism, and increase employee productivity, job satisfaction and well-being. As recognized experts in treatment, prevention and health promotion, naturopathic doctors will continue to play a crucial role.
Return to Table of ContentsNaturopathic doctors prescribe natural remedies as part of a treatment protocol to enhance health, and prevent and treat disease.
Natural remedies include but are not limited to vitamins, minerals, enzymes, co-enzymes, herbs or botanicals, homeopathic preparations, amino acids, etc. from both plant and animal sources. They are also referred to as natural health products, natural medicines or natural therapeutics.
Naturopathic doctors believe that the disease process starts because of deficiencies and the body's inability to heal itself. They prescribe natural medicines to help protect the body from deficiencies created by modern diets characterized by processed and "fast" foods. Natural remedies can offset the damaging effects of free radicals caused by preservatives, pesticides, and metabolic processes. Deficiencies in the nutrients required for good health also result from environmental factors including minerally depleted soils, fertilizer use and air and water pollution. These deficiencies also increase the body's need for essential nutrients and reduce the body's ability to absorb them.
Natural therapeutics are used by naturopathic doctors in conjunction with nutrition and diet, stress management, and exercise. They are suitable for the prevention and treatment of disease within a holistic model of health and contain only elements, molecules and substances found in nature. They include substances drawn from many different healing disciplines such as western herbal, native American, traditional Chinese and ayurvedic medicines.
Return to Table of ContentsLicensed naturopathic doctors must ensure that patient treatment protocols are safe and effective. Their knowledge and clinical experience with respect to therapeutic indications, contra-indications, possible adverse reactions and toxicities uniquely equips naturopathic doctors to prescribe natural remedies for their patients. They appraise the safety and effectiveness of the natural medicines they use through literature review and by monitoring therapeutic benefit, appropriate laboratory testing, and patient outcomes in the clinical setting. Guarantees of identification, purity, quality, and safety of the natural medicines they prescribe to their patients is critical.
For the most part, natural medicines are inherently low-risk products. Health Canada statistics published in May 1997 show the total number of poisonings from vitamins, minerals and herbs in 1995 to be none compared to 2,737 from pharmaceuticals, prescription and over-the counter drugs. Natural health products are safe when used for the appropriate indications and in correct doses. A small number of natural substances are more toxic and doses need to be controlled precisely. These should only be used under the prescription and guidance of a naturopathic doctor. In general, the actions of natural health products can be more gentle than pharmaceutical drugs and tend to support the body's natural mechanisms.
For most natural medicines, the required dosage for a specific purpose is usually defined within a therapeutic range and the level at which toxicity occurs is many times higher that the therapeutic range This makes natural medicines in general much safer than pharmaceutical drugs where the range between the effective dosage and the toxic dosage is often very small. For homeopathic remedies, dilution to infinite proportions during their preparation is an important safeguard against toxicity and unwanted side effects.
It should be noted that there exists a body of knowledge concerning the use and safety of natural health products and traditional medicines which is totally separate and distinct from the study of pharmaceutical drugs,. Herbal and homeopathic pharmacopoeias have been developed and published in many countries including the United States, Britain, Germany, India and China. Based on empirical observations accumulated over centuries of human use, they document in detail how various natural medicines are used and their effects.
To date, the clinical effectiveness of natural remedies has largely been documented by individual case (anecdotal) reports and patient outcome studies. It is interesting to note that recent research philosophies have begun to recognize the validity of "anecdotal" research and are focusing on outcomes studies. Currently the Canadian College of Naturopathic Medicine is conducting a patient outcome study in collaboration with Bastyr University and the Southwest College of Naturopathic Medicine and Health Sciences in the United States using a database of 10,000 naturopathic patients.
Clinical trials or laboratory testing have also been completed on many natural substances confirming the effectiveness of many botanical and nutritional therapies. However, where scientific research is conducted in the absence of naturopathic or complementary medical theory and when qualified naturopathic or complementary medical practitioners are not included in the studies, the experimental designs are very often inadequate. Thus the outcomes are often not valid, producing controversy and contradicting other available evidence. For example, this can occur when the dosage regimens used are not based on what would be customary for a naturopathic doctor to prescribe.
Naturopathic practitioners are kept abreast of current research and clinical studies through peer reviewed scientific journals of many disciplines and through continuing education seminars at naturopathic medical conventions, including pharmacology and pharmacognosy.
Return to Table of ContentsThe Problems With the Current Regulation of Natural Health Products and Recommendations for Change
It is essential that the therapeutic substances naturopathic doctors prescribe to their patients be accessible, of high quality and safe. To this end, the Canadian Naturopathic Association supports appropriate regulation of natural health products.
Naturopathic doctors use their education, training, and expertise in the use of natural medicines and nutritional supplements to clinically evaluate these substances for the benefit of their patients. They seek out high quality natural products formulated for professional use. Naturopathic doctors are negatively impacted by the current regulation of botanical and homeopathic medicines and dietary supplements because their access as professionals has been limited.
Return to Table of Contents"Practitioner" Status
In their education and clinical training, naturopathic doctors learn to prescribe a comprehensive range of natural medicines, parenteral therapies, and nutritional supplements for effective patient treatment. As documented previously, their education and training is extensive and similar to that of conventional medical doctors, yet they are not considered "practitioners" under the current Food and Drug Act. They are restricted from prescribing a number of remedies that are within their scope of practice and that they are trained to prescribe because these are listed in Schedule I, II, IV, and Schedules D, and F, and in the Controlled Drugs and Substances Act. However, conventional medical doctors are allowed to prescribe these restricted and controlled natural substances without appropriate academic and clinical training in their use.
The definition of "practitioner" under the Food and Drug Regulations means a person authorized by the law of a province of Canada to treat patients with any drug listed or described in Schedule F to the regulations. Naturopathic doctors are licensed to practice currently in four provinces, each with different provincial acts and none which allow them to prescribe controlled or restricted "drugs". The provincial pharmacy regulatory authorities determine where drugs are sold and whether they require a regulated environment of sale and professional intervention. Their drug schedules are linked to the federal schedules that control and restrict drugs making a circular restriction that is irrational.
Naturopathic doctors are not able to prescribe those substances that appear on the provincial drug schedules that indicate a prescription is the condition of sale, and/or are only available from a pharmacist. These include some botanical medicines, homeopathic preparations, amino acids, naturally occurring hormones, enzymes, minerals, vitamins, and trace minerals.
Naturopathic doctors are also restricted from access for their patients to the Special Access Programme (formerly known as the Emergency Drug Release Programme) of the Therapeutic Products Directorate. Patients must now be referred to a medical doctor at cost to the health care system for medicines that can be appropriately prescribed and monitored by naturopathic doctors. In communication with the Director, Bureau of Pharmaceutical Assessment, it was indicated to the CNA that any proposal to include naturopathic doctors under this program would be referred by SAP to the Standing Committee and should be brought to the attention of the Committee.
Recommendations: The Canadian Naturopathic Association recommends that:Establishment Licensing Initiative Restrictions
An essential part of a naturopathic doctor's practice is access to specific natural medicines and nutritional supplements to be used in patient treatment. The success of the treatment is dependent on the use of the specific, high quality substances that are prescribed. Many naturopathic doctors maintain extensive in-office dispensaries to ensure that the natural medicines they prescribe will be readily available to their patients. Patients always have the option to choose where to purchase their medicines and alternative sources such as specialized pharmacies may be available in larger centres.
However, for many patients of naturopathic doctors throughout Canada, there is no easy access to the prescribed therapeutic substances outside of the doctor's office. A significant number of these remedies are not available over-the-counter in health stores or pharmacies. Some must be compounded by the naturopathic doctor to meet individual patient needs. Some packaged products with particular and specific formulas/combinations and/or superior quality are not available in Canada and must be imported by the practitioner.
Should the proposed Establishment Licensing Initiatives be implemented, naturopathic doctors will be treated as importers when they import the natural medicines they have found to be the most effective for patient treatment. These initiatives will require naturopathic doctors to put in place the same systems and procedures as commercial importers at a cost that naturopathic practitioners and their patients cannot afford.
Naturopathic doctors prescribe specific substances and provide them to their patients. They are not in the retail business of selling to the general public or marketing natural health products through their dispensaries. The primary role of a naturopathic doctor is that of health care provider. Implementation of the proposed Establishment Licensing Initiatives will, in effect, prevent naturopathic doctors from using the most effective treatment protocol they have chosen for their patients, by curtailing access.
Other Cost Recovery Effects
Naturopathic doctors rely on a relatively small number of suppliers to provide them with the high quality products they require to treat their patients.
The increased costs to this sector of manufacturers and distributors through the implementation of the proposed cost recovery and establishment licensing initiatives threaten to be prohibitive. These increased costs are associated with the range of products and whether they are manufactured and distributed, or distributed only. Small companies will pay similar costs to large companies due to same inspection processes. It is anticipated by the natural health products industry that the result will be significant increases to the purchase cost of natural medicines. The industry also fears company closures.
These situations endanger the availability of the remedies to naturopathic doctors and their patients and will particularly effect the accessibility of rarely prescribed substances, particularly homeopathics. In general, increased costs will limit Canadians' access to these products, and their ability to take responsibility for their own health and to implement the recommended treatment plan from their naturopathic practitioner.
Recommendations: The Canadian Naturopathic Association recommends that:
The Canadian Naturopathic Association has been discussing regulatory problems with the Therapeutic Products Programme (TPP) staff for many years with few satisfactory results. Only recently has the TPP staff begun to put in place a communication and consultation process with representatives from a wide range of stakeholders from the natural health products profession and industry.
Although naturopathic doctors are qualified health professionals and trained in the effective and safe use of natural medicines, they have not been adequately consulted in the regulatory process. The Canadian Naturopathic Association questions why this valuable and accessible resource has not been utilized more fully.
TPP Committees
It is unclear what impact naturopathic doctors have, if any, on the decisions made by TPP staff regarding the regulation of natural health products.
Currently the expertise of naturopathic doctors is utilized on three Therapeutic Products Programme committees:
On the Senior Advisory Committee on Management and the Expert Advisory Committee on Complementary Medicine there are only two representatives from the natural health products profession/industry. We question the wisdom, effectiveness, and good faith of having only one member of the Expert Advisory Committee on Complementary Medicine educated and trained in complementary medicine. This becomes more alarming when taking into account the mandate of the Committee: "To provide the Therapeutic Products Programme with timely collective expert advice porn scientists and practitioners on scientific questions of benefit and risk management with respect to the use of complementary medicines by Canadians for prescribed and self-medication use."
Committee members' expenses to attend meetings are largely covered by the TPP budget. At a time of implementing a program of cost recovery, it appears financially irresponsible to pay for consultants who don't have the expertise to be able to assist the TPP staff and not to include a broader representation from those such as naturopathic doctors who do have such expertise.
The Advisory Panel on Herbal Remedies was created through Health Minister David Dingwall's office and was initially accountable to his staff Shortly after its inception it became accountable to the Therapeutic Products Programme staff. The Canadian Naturopathic Association along with other organizations wrote to the Health Minister to complain of this change.
Two situations have occurred that again question the ability of TPP staff to effectively utilize the experience of "experts" in complementary medicine in an advisory and consultation capacity. After the announcement by Health Minister Allan Rock of the formation of the Standing Committee on Health, the name of the Advisory Panel was changed to the Advisory Panel on Natural Health Products and its mandate expanded to include "issues relating to the appropriate regulatory framework" for all natural health products, not just herbal remedies. However, membership in the Panel was not expanded to include expertise in the broader areas of responsibility.
Panel members met over seven months both in person and by phone. They developed a draft Regulatory Framework for Natural Health Products which they considered to be a "work-in- progress" but complete enough to be presented to the Standing Committee on Health. The expense to both the individual members/organizations and the Therapeutic Products Programme to produce a workable regulatory model has been significant. When the report was prepared by the TPP staff prior to presentation, it was received back from the staff by the Panel members so significantly altered as to be unrecognizable. It is unacceptable to the Canadian Naturopathic Association to have its members' expertise, time, and commitment wasted and devalued by not including their input in this and other TPP Committees.
TPP Decisions To Ban and Restrict Products
Some natural health products are restricted or illegal for sale in Canada but available in other countries. Others are pulled off the shelves with no reasonable explanation given. As an example, last summer, the Health Protection Branch pulled several brands of natural progesterone cream off the shelves. After much public uproar and media attention to this situation, an investigation of this decision occurred.
Naturopathic doctors are the experts in the safety, effectiveness and use of natural medicines. They are qualified to prescribe natural progesterone to their patients. They must be able to prescribe this and other currently restricted and "banned" substances which fall within the scope of naturopathic practice. Neither the Canadian Naturopathic Association, the Canadian College of Naturopathic Medicine nor any individual naturopathic practitioner, has been consulted in these decisions or investigations.
TPP Staff Training
It is our understanding, from correspondence from Mr. Dann Michols, Director General, Therapeutic Products Directorate, that Programme staff gain experience and training related to complementary medicines through reference materials, course work and conferences. Naturopathic doctors have not been consulted to participate and provide their expertise in the choice or design of those courses and conferences, nor consulted to make presentations or provide workshops.
Communication
It is important that the Canadian Naturopathic Association be kept informed of proposed initiatives and changes to the regulation of natural remedies that effect the practice of naturopathic medicine. Currently, communication is inconsistent. The CNA often receives information related to issues that don't concern naturopathic doctors and often does not receive information about issues that do. CNA staff and Board members often find out critical information from others outside of the Therapeutic Products Programme. Now we are often referred to the TPP website.
Posting information on the website may be a cost-effective measure to inform the general public. However, as health care professionals providing patient care, the Canadian Naturopathic Association requires a more direct and effective method of communication.
Recommendation: The Canadian Naturopathic Association recommends that:
Naturopathic doctors must be assured of the medicine's content and quality in order to prescribe effective and safe treatment programs. A broad spectrum of the general public purchase natural products on their own for self-care. As with other health professions, it is almost certain that many patients of naturopathic practitioners purchase over-the-counter products for the same reason. Public safety is reliant on the guarantee that what is stated in the list of ingredients is actually in the product.
The Canadian Naturopathic Association does not consider content and quality standards, labelling requirements, or the "black market" for banned substances, safe for patient or self- care.
Content and Quality Standards
The identification, purity, quality and safety of the natural medicines they prescribe is of paramount importance to naturopathic doctors - their clinical results and the safety of their patients depends on the contents of the medicines their patients receive. Currently no standards exist that uniformly address the specialized requirements for natural medicines, e.g. identification and purity of the raw botanicals used, the processes used in extracting and concentration and the content of the final product. Such content and quality standards are essential to provide assurance that products are what they are labelled to be.
Labelling Information
Currently most herbs are available on the market without labelling that clearly indicates what they are to be used for and any cautions in their use (e.g.: pregnancy, heart disease, etc.). This appears clearly to be the result of the cost of the Therapeutic Products Programme administration process and does not adequately address public safety concerns.
If a therapeutic claim (health claim) is to be made for an herbal product, it is defined by the regulations to be a "drug" requiring a Drug Identification Number (DIN). The process of applying for a DIN is a costly one for manufacturers. The same herbal product packaged for sale without a health claim is considered a "food". In this case there exists no requirements to indicate use or cautions on the label. As no DIN is required, it saves the manufacturer money to simply provide the product without usage and caution guidelines and have it treated as a food. This type of regulation and lack of product information cannot possibly be safe for the public and only adds confusion to product selection for the consumer.
Banned Substances and the Resulting "Black Market"
Most of the natural remedies that are illegal or restricted for sale in Canada can easily be obtained over-the-counter in the United States. A three month supply of these substances is legally allowed to be ordered through the mail and brought across the border for personal use. These natural remedies do not need to meet quality or safety standards. It is clear that this policy cannot ensure public safety.
Recommendations: The Canadian Naturopathic Association recommends that:
Since the Food and Drug Act was initially established to regulate allopathic drugs, the regulatory mechanism and staffing of the Therapeutic Products Directorate (formerly the Drugs Directorate) were developed in the Western pharmaceutical model. Most of the 750 people within the Therapeutic Products Programme dealing with these products are scientists and medical officers who are knowledgeable in medical sciences including toxicology, chemistry and biology. However, they do not have the expertise to understand the differences between pharmaceutical drugs and natural health products. They have little or no experience, knowledge or training in the holistic concept that underlies the formulation and use of natural health products in patient treatment or in self-care. There are no naturopathic doctors or academics schooled in alternative or complementary medicine on staff.
In short, the staff at the Therapeutic Products Programme do not have the qualifications necessary to regulate natural substances effectively. Without an appropriate level of knowledge, training and expertise, TPP staff now review therapeutic claims to determine risks (toxicity) and benefits. In their lack of understanding of natural health products, TPP staff incorrectly equate the risk of the product with the severity of the disease it helps to prevent or treat. It is unclear if they know how to use the herbal references and homeopathic pharmacopoeias that they have on hand as resources. They make decisions that declare products which are accessible in other countries to be illegal for sale in Canada. They then create "appropriate" enforcement policies. Across the country, these policies are interpreted and implemented by inspectors who also are not trained in or knowledgeable of natural health products. As a national organization, we are aware of the lack of consistency in interpretation and enforcement of the Therapeutic Products Programme's policies and regulations in the regional offices throughout Canada. Similar problems exist at the borders.
Many problems result from these staffing inadequacies. Naturopathic doctors cannot prescribe the medicines they are trained to use and that they need to treat their patients if they are not available for sale. They can't rely on the availability of the remedies when they are pulled off the shelves unnecessarily (and without explanation or warning) and when they are allowed through the border in one shipment but not in another.
Cost-recovery is a known priority for the Therapeutic Products Programme. Naturopathic practitioners are aware of the effects they will experience if proposed cost-recovery plans are put in place. (See: Establishment Licensing and Cost-Recovery Initiatives.) The Canadian Naturopathic Association questions the cost-effectiveness for a government department to regulate products without trained and knowledgeable staff.
It believes that the first step to ensure financial stability and fiscal responsibility is to have staff in place with the necessary qualifications to be productive in a timely manner, to make informed decisions and to develop and implement initiatives that will not need to be overturned later. The gap in knowledge and resulting financial outlay is evident from the establishment of two Expert Advisory Committees on Herbs and Botanical Preparations. The recommendations put forth in their final reports dated January 1986 and October 1993 were not implemented. Yet another Advisory Panel on Herbal Remedies came into effect May 1997.
Recommendation: The Canadian Naturopathic Association recommends that:
Currently, in Canada, natural health products are being purchased by the public to enhance health. They are being prescribed by natural health practitioners to their patients to treat, manage and prevent disease and to maintain good health.
Natural products which make health claims are regulated as "drugs"; of those that do not, many are regarded and regulated as "foods". Both foods and drugs are regulated under the Food and Drug Act. However, natural health products are neither conventional foods nor are they pharmaceutical drugs. With those products deemed to be "drugs," the regulatory processes they fall under were historically established for the regulation of pharmaceutical drugs.
The current regulatory regimen for natural health products with health claims applies an allopathic risk assessment model. Modern scientific studies in safety and efficacy generally test one variable in a controlled population. Most natural health products are complex substances which cannot be tested in this way. Furthermore, holistic practitioners rely on the value of clinical outcomes because they recognize the variability of the patient population.
Western allopathic medicine focuses on what can be viewed or measured. It also requires that any observation be adequately explained by an accepted theory which explains the physical before the observation can be considered valid, reliable or useable. Holistic systems of medicine are based on empirical study where repeated observation of the real world is viewed as the most important source of knowledge. An observable phenomenon is not discounted because it cannot yet be explained by an acceptable theory.
Pharmaceutical drugs suppress symptoms of illness or disease, or alter the body's ability to fight such conditions. They are either not natural, or administered in a form that is not natural causing the body to have difficulty processing, detoxifying and eliminating them. In contrast, many natural remedies consist of numbers of interdependent chemical entities that are found in nature and that the human body has been familiar with for many thousands of years. They support and stimulate the body's self-healing processes.
Pharmaceutical drugs are designed to achieve a specific therapeutic purpose. Most consist of single molecules and are therefore more powerful, create harsher effects, and often force a much more extreme change in the body that often works against the body's natural processes. Many natural substances, for example those found in plants, consist of a range of molecules which become therapeutically beneficial as a group rather than in isolation. In fact, in many cases, the sum is greater than its parts. The concept of an isolated, active ingredient is foreign to holistic principles. Natural substances often have several valid indications for use because they effect more than one system in the body.
The current regulation of botanical and homeopathic medicines, and dietary supplements do not and can not accommodate the unique nature of natural health products nor do they in any way incorporate or acknowledge holistic principles.
Recommendations: The Canadian Naturopathic Association recommends that:
Lack of Research Funds
The current process in which health claims are accepted for natural health products leans towards the allopathic model of scientific studies to prove safety and efficacy. This is particularly true of new formulations and combinations. As mentioned previously, where scientific research is conducted in the absence of naturopathic or complementary medical theory and when qualified naturopathic or complementary medical practitioners are not included in the studies, the experimental designs are very often inadequate. The outcomes are often not valid, producing controversy and contradicting other available evidence. This can occur when the dosage regimens used are not based on what would be customary for a naturopathic doctor to prescribe.
The lack of naturopathic or complementary medical theory and qualified naturopathic or complementary medical practitioners in research is linked to the lack of funds available for the naturopathic community to do studies.
There is little motivation for many private companies/manufacturers to put funds into research because their products are freely available on the market, and they can sell their products without doing the research. Their customer base is usually educated and well read in the health benefits of particular natural health products for self-care. As most products are not patentable, any long-term financial advantages to investing funds in research and development is questionable.
Research funds are not readily available from government programs such as the Medical Research Council and the National Health Research and Development Program. Research moneys that are available are for more high profile projects such as complementary treatment for breast cancer, HIV/AIDS etc.
Although a significant amount of research data is available, it can be hard to access. Many valuable articles are published in more obscure journals which are not indexed and are often not available in English.
Recommendations: The Canadian Naturopathic Association recommends that:
The Canadian Naturopathic Association thanks the members of the Standing Committee on Health for the opportunity to be heard and to submit this document with the following summary of recommendations for regulatory change.
The following reference materials are enclosed for the Committee members in the attached Canadian Naturopathic Association's information kit:
The key aspect to the recommendations of the Canadian Naturopathic Association to the Standing Committee on Health is ensured availability of natural substances through all areas of regulation, in order that naturopathic doctors are able to prescribe and dispense the medicines they are trained to prescribe and dispense, and that they require for safe and effective treatment of their patients.
In particular, the Canadian Naturopathic Association, in representing its members across Canada, recommends that:
It is the belief of the Canadian Naturopathic Association that a separate category for the regulation of botanical medicines, homeopathic preparations and nutritional supplements, distinct from pharmaceutical drugs and conventional foods, with a separate administrative unit can easily incorporate all of the above recommendations. This initiative will require significant and ongoing consultation with the naturopathic profession. It will result in full access for naturopathic doctors to the natural remedies which they are trained to use and which are essential for effective patient treatment.