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ISIS Press Release 23/05/05
A Reprieve for EU Vitamins and Minerals
A legal challenge to rescind the controversial European Food
Supplements Directive claims its first success, but this is only a temporary
respite from a systematic corporate takeover of herbal medicine and natural
remedies Sam Burcher
Sources
for this report are available in the ISIS members site.
Full details here
First-round win against Codex
A lawsuit brought by the Alliance of Natural Health (ANH) contesting the
ban of over three hundred vitamin and mineral ingredients used in food
supplements began in the High Courts of Justice in London, 2004. The case was
referred to the European Courts of Justice in Luxembourg, where, more than a
year later, the Advocate General and senior advisor to all the European Court
judges, ruled in favour of the ANH.
Judge Geelhoeds’ opinion is that the FSD is illegal under EU law.
The FSD infringes the principle of proportionality because basic principles of
community law such as the requirements of legal protection and sound
administration were not taken into account. In other words, the FSD’s "
Positive List" of permissible vitamins and minerals that excludes natural
substances contained in five thousand products is perceived as too narrow,
restrictive, and based on flawed science.
Dr Robert Verkerk, executive director of the ANH is delighted. "All
that the ANH is campaigning and working co-operatively for is the right of
consumers to have access to safe, natural healthcare and for legislation to be
based on good science and good law." He said, "This is a great day for the tens
of millions of people who believe passionately in the benefits of natural
preventative healthcare." Verkerk believes overturning the FSD will set a
precedent across Europe that assures the availability of food supplements and
prevents their reclassification as drugs.
The European Court delivers its final judgement on the FSD in August
2005. The Advocate Generals’ recommendations are generally adopted by the
residual European Court Judges. If the ANH wins, this will scupper the
long-term agenda of the Codex Alimentarius Commission to set legal standards
for vitamins and minerals at very low doses across its 163 member countries.
The Codex Alimentarius Commission is the body that draws up international food
standards in conjunction with the Food and Agriculture Organisation (FAO) and
the World Health Organisation (WHO). Although these standards are supposed to
be voluntary, they are nevertheless adopted by the World Trade Organisation
(WTO), which levies draconian fines and sanctions on countries failing to
comply with the rules.
Traditional medicines and remedies under threat
"Harmonising" standards of vitamins and minerals hands control of many
traditional remedies over to the pharmaceutical companies and, in turn, to the
supermarkets and big pharmacies. This would prevent independent companies and
practitioners from supplying appropriate supplements for nutritional purposes
to patients and consumers. Under the Human Medicinal Product Directive (HMPD),
and the Traditional Medicinal Products Directive (TMPD) (a subset of the
Pharmaceutical Directive), health claims made on dietary products will be
outlawed.
Restrictions on natural products are widely seen as an encroachment on
civil liberties and threaten some of the oldest traditional healthcare
practices in the world, such as African, Ayurvedic, Chinese, Tibetan, and South
American medicine, on which some eighty percent of the world’s population
are dependent. Codex guidelines for vitamin and mineral food supplements
destroy effective remedies and give regulators the power to choose whichever
product they want and call it a drug. Further proposals restricting amino
acids, essential fatty acids, enzymes, plant extracts, and probiotics are
planned for an expanded FSD scheduled for 2007.
The ANH points out that most of the natural forms of vitamins and
minerals such as mixed carotenoids, vitamin E, folic acid and selenium along
with the most digestible and safest forms of vitamin C and magnesium are
excluded from the "Positive List". Conversely some of the few vitamin and
mineral forms associated with adverse effects are allowed; for example iron in
the form of ferrous sulphate that can cause stomach cramps and bowel problems.
There is also concern that a ban on natural nutrients will encourage the use of
synthetic alternatives and genetically modified (GM) substances in food
supplements. Pharmaceutical giants have been buying up small vitamin and
mineral companies recently. For example, Merck has acquired Lamberts and Wyeth,
a global pharmaceutical and biotechnology company, has bought Solgar.
Corporate feudalism fuelled by patents and fees
In fact the drug companies have gained control of natural products
altogether, through PharmaPrinting, the result of collaborations between
PharmaPrint Inc and the University of Miami. PharmaPrinting is a technology
that isolates and measures the bioactivity of the active compounds of any plant
or natural remedy and replicates it in the laboratory. These compounds are
standardised as a pharmaceutical for government approval. Patents are currently
pending on pharmaceutical versions of some of the most useful and widely
available herbal remedies such as St Johns wort - (depression), Echinacea -
(immune function), ginkgo biloba - (brain booster), saw palmetto - (prostate
function), and mistletoe - (alternative cancer treatment). Even the dietary
herb ginger is under patent for use as a treatment for motion sickness.
Under Good Manufacturing Practice (GMP), PharmaPrinting involves
clinical trials costing up to $6.5million per product and patent protection
costing $0.5million, which takes five years to complete. Investors are
reluctant to commit to such costs unless market exclusivity is assured. One way
of creating an exclusive market is to ban or invalidate natural remedies. The
existing US healthcare market including health foods and drinks is estimated to
be worth $1.5 trillion. This staggering amount makes it a market worth
manipulating. Synthetic supplements also provide a royalty to drug companies
each time a patented product is purchased.
The Health Protection Branch (Canada’s equivalent of the US FDA)
has called for any product registered as a "natural therapeutic" to be
registered as a drug. Fish oils (lubricating joints), cranberry capsules
(treating urinary problems), and hawthorn berries (for the heart) have all been
issued with a DIN, a "Drug Identification Number", which cost $720. Without a
DIN, natural products cannot be sold; and doing so is an offence under Canadian
law. DIN entails still further costs: annual licensing fee, GMP annual
inspection, yearly assessment fees, foreign assessment fees, an analysis fee,
and Health Protection Branch inspection fees.
Strict controls and fees are unwarranted for natural products with no
record of adverse health effects in Canada. In contrast conventional drugs kill
six hundred hospital patients in Ontario alone while prescription drugs are
responsible for ten thousand deaths every year.
Foods are not drugs
"Food as drugs" guidelines laid out by Codex were adopted by Australia,
Denmark, Germany and Norway and many products have been co-opted by the
pharmaceutical companies and repackaged as drugs. (See "European Directive
against vitamins and minerals" http://www.i-sis.org.uk/vitamins2.php).
India has resisted Codex, so has Japan, and in the US, Congressperson Ron Paul
has put forward the Health Freedom Bill (HR 4004) which prevents the Federal
Government from restricting the distribution of a dietary supplement or other
nutritional food because the manufacturer makes health claims unapproved by the
Food and Drug Administration (FDA)
The South African government also oppose Codex and highlight the role
of vitamins and minerals in accordance with the World Health Organisation
report, "Diet, Nutrition, and Prevention of Chronic Diseases" (2003).
Codex rejects the report, despite its close links to the WHO. Dr
MantoTshabalala-Msimang, South African health minister, told her department, "I
would like to avoid the pitfall of putting such products in the same regulatory
environment as pharmaceutical drugs, whose testing and control is very
different." She allocated six million rand into testing the safety and quality
of traditional medicines used as immune boosters by people living with
"Nutritionally Acquired Immune Deficiency Syndrome (NAIDS), usually referred to
as HIV/AIDS.
Recent action by the WHO, UNICEF and an AIDS activist group promoting
drug therapy in South Africa attack vitamin therapy that exceed Recommended
Daily Allowance (RDA).
In Unravelling AIDS, a new book from ISIS published later this
year, we examine how numerous essential nutrients are effective in preventing
and treating NAIDS, HIV/AIDS, and other chronic diseases. The WHO and the
United Nations (UNICEF) appear to be backing the sole use of drug therapy at a
time when drug resistant strains of HIV are on the increase.
ISIS opposes the Codex agenda of restricting access to natural products
by treating them as pharmaceutical drugs. It takes away our rights to food and
health-promoting nutrition, and allows the pharmaceutical corporations to
profit from pirating and expropriating herbal remedies that have been the
mainstay of traditional healthcare systems for millennia.
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