How the German Proposal at Codex would
limit global access to herbs & botanicals
Copyright ©1996 The Law Loft
Johnstown, CO
The Life Extension Foundation, a non-profit alternative
health consumer organization, submits the following position
paper in response to the United States Food and Drug
Administration's invitation for public comment from interested
Organizations in preparation for the finalization and presentation
of the official position of the United States of America at the
meeting of the Codex Alimentarius Committee on Nutrition and
Foods for Special Dietary Use in Bonn, Germany 7-11 October
of 1996.
This submission is directed specifically to agenda item
number 8, "Sale of Potentially Harmful Herbs & Botanical
Preparations as Foods" prepared by Canada, submitted to the
Codex Co-ordinating Committee for North America and the
Southwest Pacific now under referral to NFSDU and to such
other agenda items to which remarks herein are applicable.
Agenda Item Number 3: Sale of Potentially Harmful Herbs and
Botanical Preparations as Foods:
At the Third Session of the Codex Coordinating
Committee for North America and the South-west Pacific in
1994, Canada submitted "Sale of Potentially Harmful Herbs
and Botanical Preparations as Foods" (CX/NASWP 94/12.)
Within this document, Canada raised the following points:
- that the bales of herbs and botanicals as foods has
become an area of concern for regulatory authorities in a
number of countries;
- that because the drug regulatory systems of many
countries are not adapted to handing herbal and botanical
preparations because it is difficult to provide safety and
efficacy data. herb and botanical preparations default to a
food classification;
- that because of the costs associated with generating
safety/efficacy data and the lack of proprietorial rights
(e.g. patent protection) for these products, manufacturers
and distributors are inhibited from seeking drug
classification for herbs and botanicals;
- sales of "health foods" (including herbs and botanicals)
have increased dramatically in a number of countries
including Canada and the United States; and that although sale as
"health foods" generally inhibits the use of therapeutic
indications on labels for herb and botanicals, therapeutic
indications are generally provided by "reference centers" located
within the same retail establishment.
Finally, Canada has suggested that the creation of a
"negative list" to protect consumers from herbs and botanicals
that have either short term or long term toxicity should be
given serious consideration. Canada points out in its closing
remarks that "the availability of such an internationally
recognized list would serve as a very useful reference and
would, of course, have obvious implications under the SPS
provisions of both the NAFTA and the GATT."
Is Canada's suggestion a good one? In order to evaluate the
Canadian suggestion, we need to:
- understand that Codex guidelines and standards are
used by countries with vastly different populations, health care
systems and regulatory framework and that Codex decisions
have new import under the SPS provisions of NAFTA and GATT;
- look at the needs and resources of different kinds of
countries, not just industrialized ones but developing countries as
well:
- determine the role that herbs and botanical have played in
a variety of cultures;
- determine the availability of safe and effective
pharmaceuticals; and
- ask ourselves whether it would be feasible or
advisable for all of the nations within the Codex community to
restrict access to herbs and botanicals with therapeutic
indications or uses.
I. Can the world's health systems deliver safe and effective
pharmaceuticals in the absence of herbal and botanical remedies?
The World Health Assembly of 1994 (the 47th) concluded
that less than 50 percent of the world's population has access
to safe, essential drugs.(1) The developing world with 75 percent
of the world's population gets only 21 percent of the world's
pharmaceuticals. Even that 21 percent is poorly distributed. (2)
Half of that 21 percent goes to only seven countries. Even within
those seven developing countries, only about 50 percent of the
drugs delivered contain the labeling essential for proper use.
Delivery problems are further compounded by counterfeiting and of
expired products or sale of products that fad! to conform to
minimum manufactured standards. Although DAP, WHO's Action
Programme on Essential Drugs, is hard at work on solutions this
problem, real solutions are not going to be achieved in the
foreseeable future. Clearly the present day delivery of standard,
well manufactured pharmaceuticals to the developing world falls far
short of need.
Even in the developed nations, the high price of medical care,
including the high price of pharmaceuticals, is causing stresses
and strains on nations' economies. Oftentimes, delivery to the poor
and the elderly is especially inadequate. In the United States
where delivery to the elderly is an acknowledged problem and where
the elderly are the primary consumers of pharmaceuticals, the aging
of the population will make delivery problems even worse in the
near future.
Although the high price of pharmaceuticals is a multi
factorial problem, the high cost of bringing a new drug product
through development to market a significant cost factor. Current
estimates of the cost of R & D through actual marketing range from
$ 140 to $ 500 million per drug.(3)
II What role do herbs and botanicals play in the world's health
care systems?
In 1985 the World Health Organization estimated that 80
percent of the world's population use herbal medicines in some
aspect of primary health care.(4) Even in developed countries
like the United States, there has been a shift toward herbs,
botanicals and 'natural remedies.' Although available figures are
inconclusive estimates based on surveys, these figures seem to
indicate that about 60 percent of America's population now turns to
alternative remedies on a regular basis.
Why is there such dependence on herbal and botanical
remedies? In some countries, herbs and botanicals are part of a
well established system of traditional medicine. In part, the
contemporary emphasis on traditional medicine in developing
and/or non-western countries has been part of a post-colonial
reassertion of the inherent value and validity of traditional
cultural patterns. In other countries, the use of traditional herbs
and botanicals recognized as a necessary "fail-safe" against either
shortages or outright unavailability of modern pharmaceuticals. In
many parts of the developing world, traditional remedies are true
and familiar while western pharmaceuticals are viewed as alien
and suspect. (5)
As Canada has pointed out, even within the fully
industrialized parts of North America, significant proportions of
the population have turned to alternative remedies in an effort to
take charge of their own health, promote better health and
prevention and avoid the well publicized side effects associated
with ingestion of pharmaceutical drugs. Apparently Europeans are
taking a similar growing interest in herbs and botanicals. In 1992,
the European Scientific Cooperative on Phytotherapy reported a
growth rate in the sale of herbal medicines of from 5% to 22%.
Similar developments have been noted in Japan as well.
If then, herbs and botanicals are here to stay at least for
the foreseeable present, the questions become:
- Should we leave herbs and botanicals as a separate track
that is not included in national health care systems but
remains available to the public?
- Should we make an effort to expedite the flow of herbs
and botanicals in international commerce by creating
international guidelines for the harmonization of national
standards on import and export of herbs and botanicals as
foods?
- Should we work toward the integration of herbs and
botanicals as foods into national health care systems?
- Or, should we work toward integration of herbs and botanicals as
drugs into national health care systems?
- How do we successfully integrate the good herbs and botanicals
into national health care delivery systems given the fact that
national systems vary greatly from country to country?
Clearly, in the global economy a "successful integration"
requires harmonization so that products can travel easily from
system to system without encountering unnecessary and
incompatible regulatory barriers
- Which international entity or entities should take the lead in
this process? DAP? ICH? ICDRA? Are all international
entities created equal or does Codex have something unique
to over? Given the fact that the WHO has been working on
herb/botanical integration issues for years, should Codex
leave the field of herbs and botanicals entirely to WHO and
its subsidiary and related bodies?
III. WHO has taken the lead in the movement to integrate safe and
effective herbal and botanical remedies into the world's national
health systems.
With the promulgation of the Declaration of Alma Alta in
1978, the World Health Organization announced to the world at
large its commitment to the idea that "proven traditional remedies
should be integrated into national drug policies and regulatory
measure." As stated in the prior section, the rationale for such a
position is obvious: there is a critical short fall of
pharmaceuticals that are safe and effective, many nation's health
care systems are based in whole or in part whether formally or
informally on traditional remedies, the interest in and use of
traditional remedies is growing across the planet not shrinking.
In the years following the Declaration of Alma Alta, the
WHO has struggled with the problems that 'integration' presents.
These problems include considering:
- if herbal and botanical remedies are to be classified as
drugs, does this mean that the requirements for drug
approval have to be lowered or that a new drug category has
to be created,
- should traditional treatises be used as verification of
safety and efficacy;
- should all herbs and botanicals be prescreened using the
same rigorous testing that applies to new drugs;
- do standard new drug testing parameters 'work' for
botanicals and herbs? Is the testing model appropriate;
- should herbs and botanicals be transferred to drug
companies who can afford to do sophisticated testing;
- if herbs and botanicals are transferred to drug companies,
how are costs to be contained?
Although WHO has run into serious conflicts, differences
of opinion, and differences in approach to the problems posed
by integration, virtually all proposals agree that herbs and
botanicals should be treated as drugs. Most proposals favor
subjecting herbal and botanical remedies to rigorous
pharmacological testing that is identical to that required for
new drugs. Most seem to presume that there is now and always
must be a hard and fast line between foods and drugs.
Is the assumption that foods and drugs are now and should
always been distinct and separate categories correct? Is it
supported by modern science? Even a brief look at
contemporary research indicates that the line between foods
and drugs is blurring.
IV. Food or Drug? Is the line of demarcation between the two
axiomatic, obvious and immutable?
Even the briefest look at contemporary research on the role of
foods, even common, ordinary foods, in the prevention,
amelioration, or cure of disease will show us that there is no
longer a scientific justification for drawing a hard and fast line
between foods and drugs.
Let's start out here by taking a look at the humble garlic
clove. For many millennia, the folk medicine of a number of
countries have "prescribed garlic" for its therapeutic effect in
the prevention of heart disease and the treatment of infections. As
recently as World War II, garlic was used successfully by British
physicians to ward off septic poisoning and gangrene in battle
wounds. (7)
Modern research conducted in accord with accepted
scientific principles is confirming the age old belief that garlic
can prevent heart disease and does, indeed, have powerful
anti-infectious properties. It is hard to read today's newspaper
without finding some new scientific reference that establishes or
at least strongly suggestion that ordinary foods can have
extraordinary applications as preventive or therapeutic agents in
the battle against disease. Last week, Brazilian researchers at the
European Conference on Cardiology meeting in Birmingham, England
disclosed that the results of their study of the cardiovascular
effects of red wine ingestion on rabbits showed a definite
prophylactic effect against atherosclerotic plaquing with regular
ingestion of red wine. (8)
Although we could fill this submission with endless or almost
endless references to seemingly valid scientific research either
establishing or suggesting the preventive, ameliorative, or
curative effects found in ordinary foods, the essential point is
obvious: this is not the time in the history of science to lock
Codex, an entity that depends on good science into restrictive
unscientific definitions of foods versus drugs. Such a course would
defeat Codex's twin mandates to promote international trade and
ensure the delivery of safe, good quality foods in international
commerce by setting appropriate standards based on good science.
Apparently the Executive Committee of the Codex Alimentarius
Commission is aware of the issue, that is, of the need to
re-examine the 'interface between foods and medicines.'
[CX/3 CL1996/20-NFSDU, June 1996]
Unfortunately, at present, Codex is in the process of nailing
down the safety valves and ambiguities in its essential operative
definitions in favor of unscientific and unworkable definitions of
foods and drugs that would result in the classification of the more
potent vitamins, minerals, herbs and botanicals as drugs. [The
Committee may wish to take into account the botanical preparations
sold as food in the Guidelines (on Dietary Supplements.)"
CX/3 CL1996/20-NFSDU]
V. If the goal here is to expand access to safe and effective herbs
and botanicals, does it follow that herbs and botanicals with
preventive, ameliorative or therapeutic indications should be
treated in the same manner as new pharmaceutical drugs?
If the goal is to expand access to safe herbs and botanicals
on an international basis and to develop a rational approach to
harmonization of regulations and guidelines, we need to take a look
at the history of the use of herbs and botanicals before we a
assume that in order to render them safe and assure that they are
effective then we must submit them to the same form of testing
that has been developed for new pharmaceutical drugs.
Perhaps we should start our inquiry by asking ourselves why,
we all got talked into that expensive, prolonged drug paradigm in
the first place. (The paradigm that nobody but a government or a
drug company can afford.)
One of the primary reasons for testing a new drug is just
because its new. We cannot know in advance whether a new drug:
- will operate in the therapeutic manner intended because
a new drug has no track record;
- will have either obvious or non-obvious acute or subacute
toxicity. Again, nobody knows for sure because its new.
The terms safety and efficacy are the nomenclature
conventionally assigned to describe these issues.
Because of these two considerations safety and efficacy, we
have made the societal judgment to allow drug companies to:
- spend enormous amounts of money in drug testing;
- reward themselves with exclusive patent rights and a
monopoly over sales for 20 years from the date of first patent
application; and
- reward themselves with very high prices indeed so that they
can "recoup" the costs of research, development,
administrative applications and advertising.
When one starts to think about this issue afresh, one sees
that either this reasoning does not apply in the case of herbs and
botanicals or applies but in not quite the same way in the case of
the average herb or botanical.
Thus reversing the coin, in the case of traditional herbs and
botanicals which are not new and are often a millennium or more
old:
we have a good idea at the very start how the substance will
work by looking at the traditional texts. In the case of our
earlier example, garlic, we can look at the almost 3,500 year
old Eber papyrus that tell us that garlic is probably an
immune function enhancer. Or, we can look at another 2000
year old text that tells us that garlic is probably effective as an
antibiotic. Or, we can look at a 1,900 year old text from
another part of the world that tells us that garlic has an effect
on heart disease. Or, looking at the clinical records of our
own century, we can look at evidence drawn from World War
I and World War II clinicians that tells us again that garlic has
antibiotic effects.
And the point of all of this? Not, that no testing should ever
be done but rather than using modern modeling techniques, we
can confirm therapeutic indications and efficacy for a substance
like garlic without years of expensive testing. (In the case of
garlic, we will see that some modern scientific testing has in fact
been done.)
And, what about toxicity, acute and subacute? Certainly we
are entitled to make some assumptions based on millennia of use
per se. After all, one of our sources on garlic is an ancient
Indian medical manuscript that is part of a medical system that not
only considered the issue of toxicity, but specifically forbade the
cross utilization of certain plant medicines because of their
synergistic toxicity. It is not a really radical notion to assume
that if there were serious toxicity associated with the use of
garlic, the ancients would have noticed it and written about it.
Shouldn't we think seriously about abbreviating our
premarket toxicity studies and combine approval with a
compulsory system of international postmarketing surveillance?
Certainly such an approach would help:
- eliminate unnecessary costs of development;
- keep products in the public domain when competition
should help to keep the price down;
- facilitate free trade in plant, herbal and botanical products.
Perhaps we can help ourselves consider the idea of a making
a rebuttable presumption of safety and efficacy by comparing the
present medical reliability of two 'remedies' one herbal and one a
synthetic pharmaceutical used for the same condition.
the condition: benign prostate enlargement
the herbal treatment: saw palmetto (serenoa repens)
the drug treatment: proscar (finasteride)
the cost: saw palmetto - $ 12.00 per month
proscar - $ 60.00 per month. (9)
efficacy: 60 - 90% with saw palmetto
37% to zero with proscar (10)
(per the New England Journal of
Medicine, August 22, 1996
which found proscar to be no more
effective than a placebo)
side effects: saw palmetto - none to slight
proscar 5% suffer from
decreased libido, ejaculation
disorders, impotence
Had we taken the traditional literature more seriously, many
more patients would have been helped at lower cost with fewer side
effects.
VI. There is some evidence, albeit theoretical, that conventional
drug screening does not work in the case of herbs and botanicals
There is even evidence not so theoretical that conventional
premarket drug screening doesn't work very well period.
A recent WHO publication by a respected, pro-drug
researcher 11 has strongly suggested that standard drug research
models do not work well for botanicals and herbs taken from
traditional therapies for the following reasons:
- errors in nomenclature are common (Either the plant has
more than one name or the name given the plant is applied to
more than one plant);
- if the plant extract studied isn't fresh, it's
pharmacological activity may be gone before it's studied;
- in some cases, more than one part of the same plant is part
of the active ingredient(s);
- in some cases, the medium for delivery of the traditional
remedy is part of the active combination of ingredients;
- the plant extract isn't prepared according to the classical
formulation;
- fractionating the sample is destroying its
chemical/therapeutic activity.
In 1990, the Government Accounting Office (GAO) released
FDA Drug Review, Postapproval Risks 1976-1985, Report to the
Chairman, Subcommittee on Human Resources and
Intergovernmental Relations, Committee on Government
Operations, House of Representatives in which the GAO reviewed
all 198 drugs approved from 1976 to 1985 and subsequently
marketed for a substantial period. Of the 198 drugs reviewed, 102
were found to have sufficiently serious side effects to warrant
either complete withdrawal from the marketplace or significant
label changes so as to advise physicians and the public of new
dangers associated with their use.
We can clearly conclude here that a fresh approach to the
question of what kind of review and testing should precede the
approval of herbs and botanicals either as medicines or as foods
with preventive or therapeutic indications is warranted.
However, we have yet to consider the question whether any
of WHO's many affiliated organizations and subdivisions should
perform this task of whether it should be addressed by Codex.
VII. Although at present WHO virtually occupies the field of
standard setting and harmonization of guidelines to integrate
traditional remedies in the form of herbs and botanicals into
nations' health care systems and international commerce, given the
special relationship of the Codex to standard setting for
international food trade, Codex is clearly the better body to
perform this task.
As stated above, WHO has been at work on development of
research guidelines and technical requirements for the registration
of herbs and botanicals as drugs since 1978. This multifaceted
project is now far advanced with work in progress in the following
areas relating to herbs and drugs:
- licensing of herbals as drugs with guiding principles for
small nation regulatory authorities as part of the WHO Revised Drug
Strategy;
- continuing development of INN's, International
Nonproprietary Names and preparation of monographs for the
International Pharmacopeia;
- the WHO Certification Scheme which creates quality control
standards, anti-counterfeit provisions, and systems to assure
compliance with certification requirements;
- the WHO International Drug Monitoring Programme
which includes international post marketing surveillance and the
WHO Data Base on International Drug Monitoring;
- DAP, the WHO Action Programme on Essential Drugs and
the WHO Model List of Essential Drugs;
- WHO Guidelines for the Assessment of Herbal Medicines;
- WHO Research Guidelines for Evaluating the Safety and
Efficacy of Herbal Medicines; and
- the non-WHO International Conference on Harmonization
which brings together European, Japanese and American Drug
Regulators and representatives of the pharmaceutical industry in
order to harmonize drug standards.
Part of the problem with the established WHO approach is
that it has now departed from its earlier seeming flexibility and
has settled on the principle that herbs and botanicals must be
subjected to the same standards for efficacy, quality and safety as
synthetic pharmaceuticals. WHO has also determined that the same
type of pre-marketing investigations must be performed on herbals
and botanicals as are used on new synthetic drugs. What we see
here is a progressive hardening of WHO's position as we move
forward from document to document. Thus the promise of a more
expeditious, inexpensive and benevolent regulatory scheme as
partially described in the 1991 WHO Guidelines for the
Assessment of Herbal Medicines published in Geneva, had
hardened into more outmoded 'classical new drug kinds of thinking'
by the time of the 6th ICDRA Conference in Ottawa that same year
and showed still further hardening into new synthetic new drug
model thinking by the time of publication of the 1993 WHO
Research Guidelines for Evaluating the Safety and Efficacy of
Herbal Medicines.
Thus not only is WHO moving in a progressively more
restrictive, expensive, and outmoded direction at odds with the
new directions of foods as drugs research at a time when the
world community desperately needs greater access to inexpensive
herbs and botanicals as an adjunct to synthetic pharmaceutical
products, but WHO is not now and never has been the appropriate forum for
the setting of such standards and guidelines for international
commerce in foods. This is because only Codex has the necessary
nexus to the Sanitary/Phytosanitary Agreements of the GATT and
NAFTA to make a firm and positive contribution to the
international trading of safe, inexpensive herbs and botanicals as
foods.
VIII. In order to understand the full effect of decisions taken at
Codex Alimentarius or at WHO, it is absolutely necessary to
understand the new interrelationships between WHO and The
Agreement on Technical Barriers to Trade [GATT] and the
relationships between Codex Alimentarius and the Agreement on the
Application of Sanitary and Phytosanitary Measures [GATT] and the
[Agreement on] Agriculture and Sanitary and Phytosanitary
Measures [NAFTA].
If ever there was a time when the activities of WHO and
Codex Alimentarius were of purely theoretical interest, that time
is now past. With the ratification of the North American Free Trade
Agreement and the ratification of the Results of the Uruguay Round
of the General Agreement on Tariffs and Trade, we have entered
into a new era when the direct and indirect ramifications of
decisions (and even decisions to abdicate decision making
authority) of either of these organizations have taken on a far
reaching and profound significance under international and
domestic laws around the globe.
One of the very first things that has to be grasped about
these new relationships is that they have not set up a directly
binding international low that acts or functions in the same way as
or penalizes "misconduct" in the same way as national laws and
nation based court systems.
Under the new system, many significant preliminary steps are
taken by consensus. In the absence of consensus there is no forward
movement.
However, other important steps are taken based upon principles
of coercion. That is to say that if accommodation and conciliation
fail, then arbitration (an informal form of litigation with looser
rules of procedure and generally "relaxed" rules of evidence)
occurs followed by formal decision, followed by the imposition of trade sanctions (or the
withdrawing of trade privileges) which remain in place until they
have coerced compliance with the arbitrators' decision or have
compelled settlement of the dispute between the parties.
In a world where nation functioned based upon the principle
of autarky (self
-sufficiency and self-reliance in all essential
things with no real economic dependence on trade with others),
then the coercive effect of trade sanctions would be insufficient
to compel compliance. That is to say, that as a practical matter,
they would not have coercive force.
However, in a world in which nations move progressively
toward complete or substantial economic integration, no nation
can long afford to fail to comply with the decision of an
arbitration panel. As a matter of simple economics, it simply
cannot afford not to comply.
It is the later situation that we face with GATT and NAFTA.
Thus we must understand that entities like WHO and Codex Whose
rule making activities are integrated within GATT and NAFTA have
profound effects. Although the office of the American Trade
Representative has feigned not to understand these realities, WHO
has directly acknowledged the importance of these new
relationships:
"The new trade agreements issuing from the Uruguay Round of
multilateral negotiations are intended to further liberalize
international trade and provide greater access of all parties
to markets...
The recommendations and guidelines established by the
Joint FA/WHO Codex Alimentarius Commission are
specifically cited in the Agreement on the Application of
Sanitary and Phytosanitary Measures as the reference for
national food safety regulations. With world food trade
amounting to some $ 250 billion a year, there are strong
economic reasons for countries to ensure that their food
exports meet these norms."
THE WORLD HEALTH REPORT 1996
[The Report of the Director General of WHO]
In general and somewhat simplified terms these
interrelationships between WHO and Codex and NAFTA and
GATT can be explained as follows:
WHO and the Agreement on Technical Barriers to Trade:
As part of the GATT agreement, nations signed an agreement
called the "Agreement on Technical Barriers to Trade," (TBT).
The TBT is nothing less than a call for the harmonization of laws,
regulations and rules that govern human health and safety (among
other things) on a global basis. The idea was and is that national
laws (including laws of states and localities) would be remade in
the images set for them not by elected representatives in
legislative bodies, but by delegates drawn from subject matter
bureaucracies representing their respective countries meeting with
international bureaucrats and representatives of private industry,
all of whom working together would craft the new regulations and
rules which would then be adopted by each country that had signed
on to the TBT.
While the WHO is not mentioned by name anywhere in the
TBT, the references within the TBT to 'standardizing body' and
'international body or system' which is defined within the TBT as
'body or system whose membership is open to the relevant bodies
of at least all Members' is commonly understood to include WHO,
and WHO has described itself as being within the parameters of
these definitions:
"For instance, WHO's quality standards for pharmaceutical,
biological and food products are the kind of internationally
agreed standard that the Agreement on Technical Barriers to
Trade encourages governments to adopt as a basis for
national regulations."
THE WORLD HEALTH REPORT 1996
Apparently WHO has had some success in getting regional
common markets to adopt its standards as the standards of the
market group:
"The South American countries belonging to the Mercosur
common market, for example, adopted WHO's requirements
for good manufacturing practices for pharmaceutical products
in order to harmonize regulations within their trade group,
and a number OECO countries decided to eliminate customs
duties on pharmaceutical ingredients bearing a WHO
international nonproprietary (generic) name."
THE WORLD HEALTH REPORT 1996
It is to be emphasized here that while the final meanings of
many key features of the TBT have yet to be fleshed out, the
coercive/enforceable nature of TBT commitments was
specifically referenced in the Message from the President of the
United States transmitting the Uruguay Round Trade
Agreements, 103 Congress, House Document 103-316, Volume I:
"Second [drawing distinctions to the earlier 1979 Agreement
on Technical Barriers to Trade] will be enforceable
through the provisions of the WTO Dispute Settlement
Understanding. [The agreement that created the adjudicative
body, the DSB of the WTO] (emphasis added)"
at page 777
While the importance of the Agreement on Technical Barriers
to Trade can hardly be overstated, it is important to note before
moving on that it does not apply to sanitary and phytosanitary
issues,
Sanitary and Phytosanitary issues are covered by the
Agreement on Sanitary and Phytosanitary Measures, one of two
agreements within which Codex Alimentarius takes on a new role.
As quoted from The World Health Report above, Codex
Alimentarius is the reference for national food safety regulations
under the Sanitary and Phytosanitary Agreement of the GATT
[SPS]. Like the TBT, the SPS is an agreement whose terms are
enforceable at the WTO's Dispute Settlement Body, an
adjudicative body with coercive enforcement powers via the
mechanism of trade sanctions.
Some of the principal effects that arise from this relationship
are:
- Nations that set their food safety standards in conformity
with Codex standards are presumed to be in compliance with the
SPS agreement;
- Nations that set higher standards that Codex standards must
take into account the risk assessment techniques established by
Codex on food safety; and
- Nations which set higher standards for food safety than
those set forth by Codex run the risk that the DSB will determine
that the standards set exceeded that nation's "appropriate level of
protection" and face the concomitant risk of imposition of trade
sanctions.
According to the interpretive notes contained in the
President's transmittal to the Congress (House Document 103316),
the TBT relies primarily on a test of whether a measure
discriminates against imported products while by contrast, the S&P
agreement focuses on whether a measure is based on scientific
principles and on a risk assessment.' [at page 120]
In addition to those portions of the GATT discussed above, in
order to more fully understand Codex new role, we need to look at
the NAFTA as well. Some of the key features of NAFTA's
Sanitary and Phytosanitary [Agreement] are:
- Codex is a specified reference international standard
setting organization, however, it is not necessarily the only one
due to the presence of an escape clause which says: "[standard.
guideline or recommendation] established by or developed under
any other international organization agreed on by the Parties"
Thus it does not necessarily follow that Codex will occupy the
field of international standard setting organization alone. In
addition, the agreement references North American standardizing
organizations without
providing an all encompassing definition of what
organizations are meant. [At least not within the text of the
SPS agreement, See paragraph 5.] Thus while the NAFTA
agreement is like the GATT in making Codex a reference
standard setting international organization, it is unlike the
GATT in that it does not necessarily follow that Codex will
be or remain the only standard setting organization for food
safety.
- Codex sets standards for food safety, including
additives, contaminants, hygienic practice and methods of
analysis and sampling. Unlike GATT, there is no direct reference
to setting standards for food labeling as it relates to safety
although this may be implicit in the NAFTA SPS.
- Like GATT's SPS, nations whose food safety
standards are identica1 to Codex standards are presumed to
be in compliance with their obligations under NAFTA's SPS.
- Like GATT's SPS, NAFTA's SPS is enforceable under
procedures created by the Free Trade Commission.
- Like GATT, NAFTA's SPS requires that risk
assessments take into account relevant risk assessment
technologies developed by Codex.
Thus if Codex chooses to preserve its jurisdiction over
herbs and botanicals and to create labeling standards that
permit preventive or therapeutic claims and to create
standard for quality control and select those herbs and
botanicals (and foods in general) that may carry preventive
or therapeutic indications or be specifically manufactured to
enhance therapeutic values, then Codex standards for
medicinal foods will have significant international legal
effects.
If, however, Codex decides to abdicate the field
leaving it entirely to WHO, then we can expect that WHO's
standards will sooner or later take on significant international
legal effects under the TBT or as part of WHO's general convention
making powers or simply as a part of the current wave of
harmonization of laws throughout the world.
IX. What can we expect down the road if Codex abdicates its
responsibility for herbs and botanicals simply because some are
therapeutic or preventive?
Given the totality of international trends' it can be assumed:
- herbs and botanicals will become less available and much
more expensive;
- herbs and botanicals will gradually disappear out of the
public domain and become proprietary products (whether under
patent protection or otherwise) of large pharmaceutical companies
and a few European (principally German) natural remedies
companies:
- health care and nutrition options around the world will be
deprived of a significant proportion of this valuable resource; and
- sooner of later, the FDA's new regulatory scheme for
vitamins, minerals, herbs and botanicals will be under a
significant and probably overwhelming attack (While it cannot be
said that either GATT or NAFTA per se will compel this result
(because neither GATT nor NAFTA compels replacement of standards
that are lower than relevant international standards), the
overwhelming pattern of recent health and food safety related
legislation is that it is patterning itself of emerging
international and regional standards. We need to recall here too
that the WHO Constitution, Articles 19 and 20, gives the WHO a kind
of treaty making power and gives each member 18 months within which
to adopt the new 'convention or agreement.' Remember also that
other non-UN harmonizing organizations that are relevant to these
issues exist like the International Conference on Harmonization.)
X. Some suggestions on what to do now:
- Resist all efforts to truncate Codex jurisdictional base down to
low potency vitamins, minerals, herbs and botanicals and/or to
restrict labeling for foods to purely non-therapeutic, non
preventive, non-ameliorative claims.
- Defeat the German proposal on dietary supplements.
- Defeat the Canadian proposal on herbs and botanicals.
- Start work in the Codex labeling committee, at a time when the
USA has the chair, on a positive list of structure/function claims
for a new foodstuffs with indisputable pedigree and good scientific
research behind them. Do not lock yourselves into a negative list
or a self limiting positive list.
- Start work in the Codex labeling committee, at a time when the
USA has the chair, on creation of a new classification of labeling
claim that covers preventive and/or medicinal claims for foods for
general dietary use.
- Develop support among developing nations and the British for a
gradual growth of positive structure/function claims
- Redesign America's position on who qualifies for non-voting
delegate status at Codex so as to include genuine representatives
of grassroots organizations and persons knowledgeable in the
interstices of the law/political/international regulations issues
along with the customary representatives of the larger companies
and industry.
- Be alert to all legislation in the American Congress that would
lock us into approval of standards derived from the International
Conference on Harmonization and WHO entities that would harden
the line between foods and drugs and/or set up expensive
scientifically unwarranted restrictions on food trade.
- Resist all efforts, whether overt or disguised, to make
unnecessary subject matter transfers to drug companies from the
public domain of preventive or therapeutically useful foods that
already have a reasonable backing of traditional literature and/or
scientific studies performed using good science.
- Resist setting NRVs or RDAs at fixed levels that are
premature, especially in cases where these standards can
automatically become binding upper level limits on generally
available dietary supplements or herbal or botanical preparations.
- Consider an interface with the Office of Alternative Medicine
that would support the completion and issuance of good scientific
research in support of preventive or medicinal foods. [Check the
records of the Department of Agriculture for databases that would
support the creation of a preventive or medicinal foods category.]
- Be alert to all opportunities to assume a leadership role in
these areas either alone or in conjunction with other nations that
have a vital stake in the preservation of inexpensive, safe,
generally available medicinal foods.
- Develop and maintain a database that tracks and monitors the
creation of other standard setting entities (e.g., a standard
setting entity for foods within the NAFTA context) in the food
area.
- Monitor all efforts to expand the number of 'reference setting
entities' by agreement of the parties such as is provided for in
the NAFTA framework.
- Never forget that while national efforts to create preferential
and unfair trade barriers are subject to attack in international
adjudicative bodies, those same efforts conducted within the
context of international standards, guidelines and recommendation
are probably not subject attack as unfair trade barriers. Expect
that from here on out, many seemingly neutral, innocuous, or purely
scientific proposals may have an intentional preferential trade
barrier built into the proposal.
Submitted by,
SUZANNE HARRIS, J.D., on behalf of the Life Extension
Foundation
Pertinent addresses:
The Political Office of the Life Extension Foundation
2411 Monroe Street, # 2
Hollywood, Florida 33020
Life Extension Foundation
995 S.W. 24th Street
Fort Lauderdale,Florida 33315
Suzanne Harris
c/o The Law Loft
P O. Box 709
Johnstown, Colorado 80534
Footnotes:
(1) EDM-17 DISCUSSIONS AT 47TH WORLD HEALTH ASSEMBLY (1994)
http//www.who.ch/programmes/dap/dm17b.html
(2) Drug Labeling in Developing Countries, USOTA (1993)
(3) WALL STREET JOURNAL, Nov 9, 1993, "Vital statistics: disputed
cost of creating a drug
(4) Farnsworth, N.R., et al, "Medicinal plants in therapy," BULL.
WORLD HEALTH ORGAN., 63(6) 985-981 (1985)
(5) Chaudhury, Ragit Roy, (1992 Herbal Medicine for Human Health,
WHO, (SEARO, No.2O)
(6) While it can certainly be argued that there is evidence that
WHO showed signs of commitment to integration of herbal remedies
prior to the declaration of Alma Alta, WHO's activities in 1978 and
the Alma Alta Declaration are commonly perceived to be crucial
commitment making events.
(7) See Chapter 1, "Herbal Medicine" of Alternative Medicine
(1992), NIH (USA), 183.
Even popular literature shows some well documented insight into
this issue. See for example, Carper, Jean, 1888,. The Food
Pharmacy, 199.
(8) REUTERS, August 26, 1996, "More evidence of benefits of Red
Wine"
(9) LIFE EXTENSION UPDATE, Vol. 7, No.l2, 12/94
(10) On saw palmetto, see: Braeckman, "The extract of serenoa
repens in the treatment of benign prostatic hyperplasia" 55/7 CURR.
THER. CLIN. EXP.(USA), 776-785, (1994),
Bruhwryler, l9/5 DRUG FUTR (Spain), 452-453 , (1994). On proscar
see Lepor, "The efficacy of.. finasteride., 335/8 NEW ENGLAND
JOURNAL OF MEDICINE, (1996)
(11) Chaudhury, op. cit.
LEF/USFDA/NFSDU
Copyright ©1996 The Law Loft
Johnstown, CO
(Information provided by John C. Hammell, legislative advocate,
Life Extension Foundation Political Office, 2411 Monroe St. #2,
Hollywood, FL 33020 USA, john@lef.org, 800-222-2553
954-929-2905, 954-929-0507 FAX, http://www.lef.org)
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