Download LEGAL ASPECTS OF COMPLEMENTARY MEDICINE

LEGAL ASPECTS OF COMPLEMENTARY MEDICINE
Jonathan Davies
The public demand for both mainstream and complementary medicine has expanded so
rapidly that it has pushed the demand for these commodities far beyond the need for immediate
care and treatment. Today’s demand for complementary and cosmetic medicine is so great that it
already equals the demand for mainstream medicine.1 However, despite this dramatic growth rate,2
complementary medicine has not achieved the mature professional autonomy of conventional
medicine because of the latter’s refusal to recognize it as anything more than an inferior stepsister. The prevailing attitude of biomedical doctors is that complementary medicine, lacking any
scientific basis, is trying to encroach on the territory of established medical science and obstruct its
progress. Let it be remembered that the American Medical Association tried to prevent alternative
practitioners from treating clients by chiropraxy.3 Many American newspapers have also printed
ferocious critiques of alternative therapies on the grounds that the theories they base themselves
on have not been scientifically investigated and the therapies are liable to do their patients more
harm than good.4
There is confusion as to how non-conventional therapies should be classified. Some prefer
the collective term ‘alternative medicine’; others prefer ‘complementary medicine’, arguing that this
accurately reflects the interaction between non-conventional and conventional therapies. This
paper also prefers the second term.
The most widespread form of complementary medicine has been physical activity and, after
that, in descending order of frequency of lifestyle change, food additives, verbal therapies
(psychological or other), herbal remedies, high doses of vitamins, and prayer of various kinds.5
For a comprehensive survey on the subject see the report of the British House of Lords’ Science and Technology
Select Committee, Complementary and Alternative Medicine, 21/11/2002. See the website:
www.publications.parliament.uk/pa/id199900/idselect
2 A much-quoted survey of the phenomenon in the USA is David M. Eizenberg et al., Unconventional Medicine in the
United States: Prevalence, Costs and Patterns of Use, 328 New England J. Med., 246,246 (1993), from which it
appears that more Americans sought the therapies offered by complementary medicine than conventional medicine. In
1998 a follow-up study was published: David M. Eizenberg et al, Trends in Alternative Medicine Use in the U.S.,
1990-1997, 280, JAMA 1569, 1575 (1998), which indicated a further significant growth in the demand for alternative
medicine. It found that in 1997 42.1% of Americans had sought out at least one of the sixteen alternative therapies on
offer, an increase of 33.8% on the figure for 1990. The American public paid 425 million visits to alternative
practitioners, paying out $10.3 billion. Over 75 major medical schools had begun teaching alternative-medicine-related
courses. Alternative medicine had become a substantial industry, with its own scientific infrastructure, professional
literature, performance standards and academic training.
1
3
4
See Wilk v. American Med. Ass. 719 F. 211 (7th Cir, 1983) cert, 467 U.S 1210 (1984), 2d 207.
Richard Saltus, Medical Journals Rip Alternative Remedies, Boston Globe, Sept. 17, 1998.
The British House of Lords’ Science and Technology Select Committee recommended classifying the areas of
practice of alternative and complementary medicine into three groups: in the first, the therapies recognized by the
5
Whereas alternative practitioners regard the body as a single complete entity and regard
illness has having a general, overall impact on the body, conventional practitioners treat the body
as an assemblage of mechanical sub-units, each requiring autonomous and non-dependent
treatment. Another division between the two approaches is their understanding of the term ‘medical
treatment’. Conventional medicine aims to cure the body of an illness. Medicine is an external,
directly-operating tool designed to cure by means of a range of diagnostic methods followed by the
application of medical treatments and medications. In contradistinction, alternative medicine aims
to cure illness from within the body, a concept based on the notion of achieving perfect mentalphysical-emotional balance. The objective is to activate the body’s own internal, autonomous
therapeutic capacities, in a context of synthesis between the body and its environment.
Complementary medicine accepts the situation of the patient and his/her illness as a given which it
will try to treat from within the body and not by external means.
Any attempt to devise a definition of alternative or complementary medicine which will
comprehend all varieties of currently existing therapies plus all the new ones springing up like
mushrooms every other day of the week, is doomed to failure. I propose to make do with current
definitions in order to distinguish between complementary and alternative medicine. Under
‘complementary medicine’, I shall list, without any ambition to make the list exhaustive, all the
physical (that is, working through physical contact), verbal and medicational therapies, such as
chiropraxy, acupuncture and Chinese medicine, homeopathy, biofeedback, reflexology, dietetics,
chiropody and podiatry, hypnosis, osteopathy, the various forms of massage, and so on. Under the
heading of ‘alternative medicine’ I list, again without any ambition to completeness, all the
remaining therapies whose aim is not curative but to improve the quality of life ― the therapies
working though herbal medicines, creative artwork and other forms of self-expression, the various
exercise systems (Alexander, Feldenkrais, Pilates, Tai Chi) and so on.
As I say, neither of these two lists can be deemed closed: a particular therapy might be
includable on both. A key criterion is whether the therapy is definable as a “medical treatment”
within the general meaning of the Patients’ Rights Act, 1996, namely, an activity designed to
provide “medical treatment, including procedures for medical diagnosis, preventive medical care,
and psychological or nursing care” or, more specifically, under the National Insurance regulations,6
as treatment for the purposes of “cure, including laboratory tests, physical therapies, examination
and treatment by means of X-rays, radium therapy, including treatment by isotopes and similar
materials, tests and examinations by professional physicians, psychoanalytic and
psychotherapeutic care, hospitalization, medication, convalescence, medical rehabilitation, the
provision of orthopedic and therapeutic appliances, including prostheses of various kinds,
dentures, hearing aids, spectacles, orthopedic shoes and other personal appliances and
accessories approved by a physician”.
The above distinction also has importance for the way the law regards complementary
medicine as a whole and the issue of professional responsibility in particular. This issue is divisible
into four aspects:
First, with respect to the recognition of a profession in terms of training and experience
requirements, licensing examinations, professional ethics (including advertising restrictions),
medical establishment and subject to some form of oversight; in the second, alternative and complementary therapies
lacking such regulation; and in the third, all other therapies.
6 See National Insurance [Provision of Medical Treatment to the Occupationally Injured] Regulations, 1968.
practitioner health and internal disciplinary procedures.7 Second, with respect to establishing
professional standards to cover every area of performance, including guidelines as to collaboration
with the members of other professions or the referral of patients to them for consultation or
treatment. Third, for determining the Ministry of Health’s responsibility for and oversight over a
profession or field of practice, including laying down rules and regulations to govern its ethics (to
include appointing a public complaints commissioner) and regularizing communications between its
practitioners’ professional association and their client-public. Fourthly, the above distinction also
has importance with regard to practitioners’ professional responsibility for injury caused to patients.
After all, the practice of complementary medicine and all its sub-professions entails its own sideeffects and risks. Damage may result from therapeutic massage, for instance, or from infection
consequent upon the insertion of needles, or from a blunder, such as not warning a patient of
potential treatment risks and, in consequence, treating them without having obtained informed
consent.
As things stand today, no patient injured by a complementary therapist has any legal remedy
short of suing for negligence in the courts. In the absence of any oversight mechanism or any
licensing requirement or obligation to fix minimal standards, the list of alternative therapies and
alternative practitioners grows and grows and any ‘therapist’ can entitle themself a ‘specialist in
alternative medicine’ and administer potentially harmful treatment.8 As things stand, there is a huge
difference between injury caused by regulated medical care and injury caused in the course of an
alternative therapy, and for this reason every therapy offered the public needs to be clearly defined,
so that clients can know in advance to what sort of therapy and therapist they are entrusting their
bodies.
Another example of the need for legislative regularization is the commercial battle being
waged by esthetic medicine over the public wallet. Because Israel’s Basic Law of Freedom of
Occupation allows commercial entities, for instance, to employ physicians to perform cosmetic
surgeries designed to improve our external appearance and quality of life, we are exposed to
medical institutes offering the public a wide variety of medical and cosmetic treatments. These
institutes are not run by doctors, their goals are purely commercial and they employ doctors who
are not always qualified to perform the surgeries on offer. The behind-the-scenes battle for the
public’s disposable income involves these cosmetic surgery supermarkets advertising their wares
in the media ― breast augmentations, hair removal, liposuction and every other sort of esthetic
procedure, performed by the latest technologies and at everyman and everywoman prices. At the
same time, the same institutes are behind negative advertising campaigns offering to repair the
‘blunders’ of other plastic surgeons and casting slurs and aspersions on competing specialists. 9
See Memorandum on Regularized Health Professions Bill, 2001, which proposed recognizing seven healthcare
professions (clinical genetics, nutritional dietetics, chiropraxy, medical laboratory work, podiatry, speech therapy,
medical records maintenance).
8 See for example, Arnon Avni vs. State of Israel 8241/98 (Miscellaneous Criminal Petitions, Tel Aviv, unpublished):
according to the indictment summary, the accused practiced both as realtor and as complementary Shiatsu therapist
and committed the alleged offenses on young women he was treating.
9 For example, I found a press announcement which called on any one who had undergone failed plastic surgery to
apply by fax to lawyers representing certain of these institutes, whose lawyers offered their services in representing the
applicants against the doctors responsible for the failed procedure. The advertisement pronounced that a plastic
surgeon was not a specialist in esthetic medicine, citing a 1982 decision of the Israel Medical Association’s Scientific
Council that “the training period for plastic surgery requires trainees to carry out one breast reduction, one breast
augmentation and two facelifts”. The advert goes on to state that “There are plastic surgery specialists who have
never been required to perform nose or eyelid surgery, liposuction, peeling, abdominal firming, hair implant, etc.” The
7
The Physicians’ Ordinance [New Version] prohibits the practice of medicine without a licence
but the reality is that the Ordinance’s definition of ‘medical practice’ does not furnish a satisfactory
answer to the competence of practitioners in all the multifarious branches of complementary
medicine (homeopathy, cosmetics, acupuncture, reflexology, chiropraxy, etc.). Complementary and
cosmetic medicine flourish today in private hands to the extent that one can without difficulty find
an esthetic medicine institute which for a small price will remove unwanted hair by laser, furnish
you medical-cosmetic treatments and perform alternative therapies in the guise of complementary
medicine and all without any Ministry of Health oversight whatsoever, for the Ministry of Health
supervises only bodies established in law. Since complementary medicine is not legally regularized
it is not supervised.
The current state of affairs in complementary and alternative medicine is one of total legal
and ethical anarchy, a state which it is entirely reasonable to define as one of ‘Do what you like’.
Anyone can declare themselves a therapist and, as such, do anything that comes into his or her
head. Nor is that all, unlicensed and unsupervised esthetic medicine is actually trying to gain
control over licensed and supervised mainstream medicine and deploy slanted advertising like the
example quoted to shoulder it out of the way. Despite the 1994 Alon Committee report on
complementary medicine, despite the State Comptroller’s 2002 and 2004 reports, despite court
verdicts that have deplored the situation, to this day the status of alternative and cosmetic
practitioners has not been defined in law, and likewise those who declare themselves to possess
supernatural curative powers. In practice the Israel Ministry of Health exercises no licensing or
oversight powers. Nor are there any criteria or stipulations as to who may publicly declare
themselves a therapist or healer.
The said statutory anarchy discriminates against the plastic surgeons who operate under
restrictions and requisites as to training, licensing, ethics and advertising and it favors the
complementary medicine practitioners who, being unlicensed, suffer no restriction at all. It is a state
of affairs which injures the standing of doctors as a whole and of specialists in particular. Give the
public a choice between practitioners and it will opt for cash over quality. Moreover, this same
public falls prey to misleading advertising like the specimen cited, so that any treatment that
produces disappointing results must be a case of malpractice.
The Supreme Court has already pronounced on this state of affairs by ascribing
responsibility to the State in its twin roles as regulator and, via the Ministry of Health, the
responsible authority for all medical care institutes, even when the state agency has itself no part in
delivering the care. In State of Israel vs. John Doe and others (Civil Appeals 8526/96) issued on
23/6/2005, the Supreme Court reviewed the State’s appeal against a Jerusalem District Court
judgment (Justice Y. Tzur) which examined the responsibility of the Yona Institute-Medical Center
Ltd., for impotency treatment, performed by injecting silicon into the sexual organ. The District
Court not only convicted the doctors who ran the institute and the attending doctor of negligence
after it found that they were not specialists in the medical treatment administered and that some of
them did not even have an Israeli licence to practice medicine. It also imposed 30% of the
responsibility for the damage done on the Ministry of Health for having failed in its duty of oversight
over the institute, as laid down in the People’s Health [Registration of Clinics] Regulations, 1987.
innocent reader will take from the advertisement that they should place no trust in their plastic surgeon and should
have any esthetic surgery procedure carried out only in the cosmetic care institute advertised.
The Supreme Court rejected the State’s appeal, stating that the evidence presented to the
lower court included newspaper advertisements which clearly set out the treatments the institute
provided. The institute labeled itself “the biggest center in Israel for plastic surgery and esthetic
treatments”, employing “the best specialists” and “the world’s most advanced medical equipment
and appliances”. It further trumpeted that “We take responsibility for your health”. Among the
treatments performed ― said its promotional material― was treatment of the sex organ, including
augmentation and lengthening, and the treatment of impotency. Questioned about these
advertisements, the institute manager, who was not a doctor, responded that “as for the impotency
treatments, I did not take care of those, some of the doctors did those and I did not get involved in
the treatment area”. It transpired that the institute’s promotional claims regarding its professional
direction, its specialist physicians, and its “full responsibility” were quite false.
Among the District Court’s findings was that the negligent (to put it mildly) treatment was
administered to the plaintiff by a doctor who on the witness stand admitted to having not the
slightest acquaintance with that particular field of medicine and that the institute’s professional
“direction” was provided not by a “team of experts” but by none other than the institute manager.
The lower court made it clear that the institute “employed the doctors, organized and coordinated
the medical activity carried out in the institute”. The High Court determined that the injections were
given by a doctor in the Yona Institute who had no Israeli licence to practice medicine, as required
by the Physicians’ Ordinance, and that he bore responsibility for the results of these treatments.
His partner in this responsibility was the institute manager, both by dint of his role as “the central
and dominant figure in the Yona Institute’s management” and not less by dint of the active part he
played in setting up the “therapeutic” arrangements between the institute and the plaintiff.
With respect to the State’s duty of oversight over such institutes, the Supreme Court issued
important findings which introduced some firm footing into the anarchy around us. The Court found
that the State’s duty to license gives rise to a duty to oversee the implementation of this licensing
and of all that follows from it. Any person injured by the nonfeasance of this duty of oversight may
well have cause of action on the grounds of breach of statutory duty (Torts Ordinance, Article 63)
or of negligence (Torts Ordinance, Articles 35-36).
The Yona Institute had represented itself in eye-opening press advertisements as a “medical
center” which was “the biggest in Israel for plastic surgery and esthetic treatments”, no less. “Only
in the Yona Institute”, so ran the advertisement, could one get surgery of all kinds, such as breast
surgery, nose and ear surgery, eyelid surgery, chin-lifting and jaw line sculpting, facial sculpting
and reshaping, liposuction, abdominal firming ― and this was just a partial list. The list also
included impotency treatment. All in all, as the advertisement proclaimed, the Yona Institute was
“the place to realize your dreams”. But ― and here was the fly in the ointment ― the permits and
licenses needed by a medical institute such as the one described in the advertising material were
nowhere to be found. The Ministry of Health, on which regulations imposed the duty of oversight,
was well aware of this fact. Insofar as concerned the oversight of clinics which required a license to
operate, the State was negligent in the performance of its duties and, the content of the institute’s
advertising showed that it did indeed require a licence. The place did not meet even the minimal
threshold requirements for performing the procedures which its advertising said it performed. The
State was, therefore, in breach of its duty of oversight.
The cases described above point to the urgent need to push ahead with imposing legal
regulation on alternative medicine professions. The whole field needs to be thoroughly regulated by
statute, so that it satisfies all requirements as to licensing, staff training and experience, ethical
conduct, the maintenance of confidentiality, indemnity insurance, implementation of the Patients’
Rights Act, and disciplinary boards and tribunals. The first steps should be the promulgation of
regulations prohibiting private institutes and clinics from employing doctors to perform plastic
surgery who do not have the necessary specialist qualifications and to subordinate these institutes
to Ministry of Health oversight. The very point of the prohibition in the Physicians’ Ordinance
against the practice of medicine without a licence is to protect the public against those who pretend
to be medically trained and qualified and have ambitions to cure our medical problems but who in
truth have no such qualification.