COMPARATIVE STUDY OF INDIA AND UK: INFORMED CONSENT

Comparative study of India and UK

Doctors, owe their clients a duty to disclose any conflict of interest that has arisen and to inform their clients. There are many ways in which this may arise in practice—for example, if a doctor has conducted a client's case negligently. Doctors are in breach of their professional code of conduct if they fail to comply with these duties.

A patient approaching a doctor expects medical treatment with all the knowledge and skill that the doctor possesses to bring relief to his medical problem. The relationship takes the shape of a contract retaining the essential elements of tort. A doctor owes certain duties to his patient and a breach of any of these duties gives a cause of action for negligence against the doctor. The doctor has a duty to obtain prior informed consent from the patient before carrying out diagnostic tests and therapeutic. Though a doctor may not be in a position to save his patient's life at all times, he is expected to use his special knowledge and skill in the most appropriate manner keeping in mind the interest of the patient who has entrusted his life to him. Therefore, it is expected that a doctor carry out necessary investigation or seeks a report from the patient. Furthermore, unless it is an emergency, he obtains informed consent of the patient before proceeding with any major treatment, surgical operation, or even invasive investigation. Failure of a doctor and hospital to discharge this obligation is essentially a tortious liability. A tort is a civil wrong (right in rem) as against a contractual obligation (right in personam) – a breach that attracts judicial intervention by way of awarding damages. Thus, a patient's right to receive medical attention from doctors and hospitals is essentially a civil right. The relationship takes the shape of a contract to some extent because of informed consent, payment of fee, and performance of surgery/providing treatment, etc. while retaining essential elements of tort.

The liability of a doctor arises not when the patient has suffered any injury,

but when the injury has resulted due to the conduct of the doctor, which has fallen

below that of reasonable care. In other words, the doctor is not liable for every injury

suffered by a patient. He is liable for only those that are a consequence of a breach of

his duty. Hence, once the existence of a duty has been established, the plaintiff must

still prove the breach of duty and the causation. In case there is no breach or the

breach did not cause the damage; the doctor will not be liable. In order to show the

breach of duty, the burden on the plaintiff would be to first show what is considered

as reasonable under those circumstances and then that the conduct of the doctor was

below this degree. It must be noted that it is not sufficient to prove a breach, to merely

show that there exists a body of opinion which goes against the practice/conduct of

the doctor.

With regard to causation, the court has held that it must be shown that of all

the possible reasons for the injury, the breach of duty of the doctor was the most

probable cause. It is not sufficient to show that the breach of duty is merely one of the

probable causes. Hence, if the possible causes of an injury are the negligence of a

third party, an accident, or a breach of duty care of the doctor, then it must be

established that the breach of duty of care of the doctor was the most probable cause

of the injury to discharge the burden of proof on the plaintiff

.

 However, in some cases like a swab left over

the abdomen of a patient or the leg amputated instead of being put in a cast to treat the

fracture, the principle of 'res ipsa loquitur' (meaning thereby 'the thing speaks for

itself') might come into play. The following are the necessary conditions of this

principle.

• Complete control rests with the doctor.

• It is the general experience of mankind that the accident in question does not

happen without negligence. This principle is often misunderstood as a rule of

evidence, which it is not. It is a principle in the law of torts. When this

principle is applied, the burden is on the doctor/defendant to explain how the

incident could have occurred without negligence. In the absence of any such

explanation, liability of the doctor arises

Normally, a doctor is held liable for only his acts (other than cases of vicarious

liability). However, in some cases, a doctor can be held liable for the acts of another

person which injures the patient. The need for such a liability may arise when the

person committing the act may not owe a duty of care at all to the patient or that in

committing the act he has not breached any duty. A typical example of a case where

such a situation may arise is in the case of a surgery. If a junior doctor is involved as

part of the team, then his duty, as far as the exercise of the specialist skill is

concerned, is to seek the advice or help of a senior doctor. He will have discharged his

duty once he does this and will not be liable even if he actually commits the act which

causes the injury. In such a case, it is the duty of the senior doctor to have advised him

properly. If he did not do so, then he would be the one responsible for the injury

caused to the patient, though he did not commit the act.

In India in the case of Dr. Laxman Balkrishna Joshi vs. Dr. Trimbark Babu Godbole and Anr[1]., and A.S.Mittal v. State of U.P[2].,

the appellant had performed reduction of the fracture, that in doing so he applied with the help of three of his assistants excessive force, that such reduction was done without giving any anesthetic but while the patient was under the effect of the morphia injection, that the said treatment resulted in the embolism, or shock, which was the proximate cause of death, that the appellant was guilty of negligence and wrongful acts, and awarded Rs. 3,000 as damages.

 It was laid down that when a doctor is consulted by a patient; the doctor owes to his patient certain duties which are:

(a) Duty of care in deciding whether to undertake the case,

 (b) Duty of care in deciding what treatment to give, and

 (c) duty of care in the administration of that treatment.

 A breach of any of the above duties may give a cause of action for negligence and the patient may on that basis recover damages from his doctor. In the aforementioned case, the apex court interalia observed that negligence has many manifestations – it may be

 1.) active negligence,

2.) collateral negligence,

 3.) comparative negligence,

4.) concurrent negligence,

5.) continued negligence,

6.) criminal negligence,

7.) gross negligence,

8.) hazardous negligence,

9.) active and passive negligence,

10.) willful or reckless negligence,

11.) or negligence per se.

Black's Law Dictionary defines negligence per se as “conduct, whether of action or omission, which may be declared and treated as negligence without any argument or proof as to the particular surrounding circumstances, either because it is in violation of statute or valid Municipal ordinance or because it is so palpably opposed to the dictates of common prudence that it can be said without hesitation or doubt that no careful person would have been guilty of it. As a general rule, the violation of a public duty, enjoined by law for the protection of person or property, so constitutes.”

In the case of Samira Kohli vs. Dr. Prabha Manchanda and Ors[3]., the apex court held that consent given for diagnostic and operative laparoscopy and “laparotomy if needed” does not amount to consent for a total hysterectomy with bilateral salpingo opherectomy. The appellant was neither a minor nor mentally challenged or incapacitated. As the patient was a competent adult, there was no question of someone else giving consent on her behalf. The appellant was temporarily unconscious under anesthesia, and as there was no emergency. The respondent should have waited until the appellant regained consciousness and gave proper consent. The question of taking the patient's mother's consent does not arise in the absence of emergency. Consent given by her mother is not a valid or real consent. The question was not about the correctness of the decision to remove reproductive organs but failure to obtain consent for removal of the reproductive organs as performance of surgery without taking consent amounts to an unauthorized invasion and interference with the appellant's body. The respondent was denied the entire fee charged for the surgery and was directed to pay Rs. 25000/- as compensation for the unauthorized surgery[4]. http://www.imlindia.com/content/Samira.Kohli.v.Dr.Prabha.Manchanda.pdf

Such cases bring to light the situations in India and its patients and doctors  how much am I as a doctor under pressure and my patients need how much to consider and trust me and my opinion, why so much emphasis on these areas why lack of trust?

Why are the friendly neighborhood doctor skipped and a surer specialist approached even for a minor headache? Why fancy life insurances? And health and wellness packages available in corporate hospitals and fancy clinics all over the globe?

One doctor travelling all over the globe and handling maximum number of patients?

International and national consumer running towards a handful few and expecting maximum care, how can an overworked doctor give equal time to all his patients?

What about those who are below the poverty line and cannot afford these treatments,

In India, majority of citizens requiring medical care and treatment

Fall below the poverty line. Most of them are illiterate they cannot comprehend medical terms, concepts, and treatment

Procedures. They cannot understand the functions of various organs or the effect of removal of such organs. They do not have access to effective but costly diagnostic procedures. Poor patients lying in the corridors of

Hospitals after admission for want of beds or patients waiting for days on the roadside for an admission or a mere examination, is a common sight at all major hospitals all around Mumbai where I have worked and experienced,

For them, any treatment with reference to rough and ready diagnosis based on their outward symptoms and doctor’s experience or intuition or so called expert judgment  is acceptable and welcome so long as it is free or cheap; and whatever the

Doctor decides as being in their interest, is usually unquestioningly accepted. They are a passive, ignorant and uninvolved in treatment procedures. The poor and needy face a hostile medical environment - inadequacy in the number of hospitals and beds, non-availability of

Adequate treatment facilities, utter lack of qualitative treatment, corruption, callousness and apathy. Many poor patients with serious

Ailments (eg. heart patients and cancer patients) have to wait for months

For their turn even for diagnosis, and due to limited treatment facilities,

Many die even before their turn comes for treatment. What choice do these poor patients have? Any treatment of whatever degree is a boon or a favor, for them. The stark reality is that for a vast majority in the

Country, the concepts of informed consent or any form of consent, and choice in treatment, have no meaning or relevance. With my personal experience since I have majorly worked in the area of chronic disease and Cancer management, even the slightest hope of recovery makes the patient rally behind me , being an ethical person I will always follow my ethics and although sometimes when the clear picture of the condition is communicated and found that the hospital hasn’t done anything but simply relieving the symptoms doesn’t make any difference to the the patients although they are spending over this unrequired treatment, this state makes me remember the internship days when I was posted at the hospital IPD, where we are supposed to be working in shifts for Day and Night , the one problem we would face during our work was FAKE DISEASES, the patient would learn some classic symptoms and present them to us and ask for admission in the hospital this was a dilemma we would face ? The reason being that those were RAINY SEASON days and there wasn’t any shelter from rains outside, thus these people would flock towards hospitals and fake diseases symptoms and stay and occupy these beds!

The position we doctors face in Government and charitable hospitals, is also unenviable. They are overworked, understaffed, with little or no diagnostic or surgical facilities and limited choice of medicines and

Treatment procedures. They have to improvise with virtual non-existent facilities and limited dubious medicines. They are required to be committed, service oriented and non-commercial in outlook. What choice of treatment can these doctors give to the poor patients? What informed

consent they can take from them?

This condition was very beautifully portrayed in an HINDI FEATURE FILM

Munna Bhai M.B.B.S. is a 2003 Indian comedy directed by Rajkumar Hirani and produced by Vidhu Vinod Chopra. The story involves protagonist Munna Bhai (Sanjay Dutt), a goon, going to medical school. 

While Munna Bhai's skills as a medical doctor are minimal, he transforms those around him with the "Jadoo Ki Jhappi" ("magical hug") and the compassion he shows towards those in need. Despite the school's emphasis on mechanical, Cartesian, impersonal, often bureaucratic relationships between doctors and patients, Munna constantly seeks to impose a more empathetic, almost holistic, regimen.

IS THIS POSSIBLE IS YET A QUESTION MARK.

 On the other hand, we have the Doctors, hospitals, nursing homes and clinics in the private commercial sector. There is a general perception among the middle class public that these private hospitals and doctors prescribe avoidable costly diagnostic procedures and medicines, and

subject them to unwanted surgical procedures, for financial gain. The public feel that many doctors who have spent a crores  for becoming a specialist, or nursing homes which have invested several crores on diagnostic and infrastructure facilities, would necessarily operate with a purely commercial and not service motive; that such

Doctors and hospitals would advise extensive costly treatment procedures and surgeries, where conservative or simple treatment may meet the need; and that what used to be a noble service oriented profession is slowly but

steadily converting into a purely business.

 But unfortunately not all doctors in government hospitals are paragons of service, nor fortunately, all private hospitals/doctors are commercial minded. There are many a doctor in government hospitals who do not care about patients and unscrupulously insist upon ’unofficial’

payment for free treatment or insist upon private consultations. On the other hand, many private hospitals and Doctors give the best of treatment

without exploitation, at a reasonable cost, charging a fee, which is reasonable recompense for the service rendered. Of course, some doctors, both in private practice or in government service, look at patients not as

persons who should be relieved from pain and suffering by prompt and proper treatment at an affordable cost, but as potential income-providers/

customers who can be exploited by prolonged or radical diagnostic and treatment procedures. It is this minority who bring a bad name to the entire profession.

 What we are considering in this case, is not the duties or

obligations of doctors in government charitable hospitals where treatment is free or on actual cost basis. We are concerned with doctors in private practice and hospitals and nursing homes run commercially, where the

relationship of doctors and patients are contractual in origin, the service is in consideration of a fee paid by the patient, where the contract implies that the professional men possessing a minimum degree of competence

would exercise reasonable care in the discharge of their duties while giving advice or treatment.

Here arises a question of having a menu card for a doctor is it possible to centralize the costs of treatments and diagnostics?

Even the Clinicians who are engaged in research in a variety of ways, both directly and indirectly are not out of this obligation. Ethical review and approval should be obtained in all cases of research on human subjects. The primary justification for research is the expected benefit in improved treatments or prevention of disease. Thus, the justification is overwhelmingly utilitarian and the ethical judgment involves assessment of likely benefits and potential harms. All engaged in clinical trials have duties of care and should consider how best these can be discharged.

In UK also the scenario is same. During the 1980s in England, the Department of Health issued a circular allowing practitioners, under limited circumstances, to discuss with and apply family planning procedures to minors (<16 years of age) without the express consent of their parents. Mrs. Gillick, a mother, challenged this in a court of law to get this advice declared illegal. The judgment in Gillick v West Norfolk and Wisbech Area Health Authority [1984] was in favor of the Health Authority ruling that a minor was capable of giving consent to contraceptive therapy provided she was of sufficient mental maturity to understand the implications. This ruling was overturned by the Court of Appeal on consideration of the duties and rights of parents and their right to be informed sufficiently to carry out these duties. The Department of Health with the support of the British Medical Association (representatives of medical practitioners in the UK) appealed to the House of Lords (The highest appeal court in the UK) who backed the original judicial decision by a majority of 3:2 allowing practitioners to make a judgment about the maturity of a minor and to give contraceptive advice and treatment without the consent of the parents

In 1982 Mrs. Victoria Gillick took her local health authority (West Norfolk and Wisbech Area

Health Authority) and the Department of Health and Social Security to court in an attempt

to stop doctors from giving contraceptive advice or treatment to under 16-year-olds without

parental consent.

The case went to the High Court where Mr. Justice Woolf dismissed Mrs. Gillick’s

claims. The Court of Appeal reversed this decision, but in 1985 it went to the House of

Lords and the Law Lords (Lord Scarman, Lord Fraser and Lord Bridge) ruled in favor of

the original judgment delivered by Mr. Justice Woolf:

"...whether or not a child is capable of giving the necessary consent will depend on the

child’s maturity and understanding and the nature of the consent required. The child must

be capable of making a reasonable assessment of the advantages and disadvantages of

the treatment proposed, so the consent, if given, can be properly and fairly described as

true consent."

The ‘mature minor’ principle is now commonly referred to as ‘Gillick-competence’ and is widely applied in practice, although it is fraught with difficulties. Essentially a practitioner may be justified in providing advice and treatment without the expressed consent or knowledge of the parents where:

1) the girl concerned is considered capable of understanding advice

2) she could not be persuaded to inform her parents or to allow the doctor to inform them  (implicit in this is that the practitioner should try to persuade her to inform her parents)

3) she is very likely to have sexual intercourse with or without contraceptive treatment or advice (withholding such treatment or giving it is unlikely to influence her sexual behavior)

4) Without contraceptive advice or treatment her physical and mental health is likely to suffer (she is at risk of sexually transmitted disease or may become pregnant)

5) Overall it is considered to be in her best interest on the balance of probable benefits and potential harms. The obligation is firmly imposed on the doctor to attempt to persuade the girl to inform her parents or to allow him/her to do so.

This approach is an attempt to act in the ‘best interest’ of the girl considering that where possible it is best that parents are involved. It balances this with the right of parents to be informed to carry out the duty of care to their child. The paramount concern, however, is the best interest and health of the child.

In the UK the healthcare system is not like India

Let’s enumerate the differences and see what we achieve

Healthcare in England is mainly provided by England's public health service, the National Health Service, that provides healthcare to all permanent residents of the United Kingdom that is free at the point of use and paid for from general taxation. Though the public system dominates healthcare provision in England, private health care and a wide variety of alternative and complementary treatments are available for those willing to pay.

The National Health Service (NHS) is free at the point of use for the patient though there are charges associated with eye tests, dental care, prescriptions, and many aspects of personal care.

The NHS provides the majority of healthcare in England, including primary care, in-patient care, long-term healthcare, ophthalmology and dentistry. The National Health Service Act 1946 came into effect on 5 July 1948.

 quality of care and environment; access to treatments, medicines and screening programmes; Respect, consent and confidentiality; informed choice; patient involvement in healthcare and public involvement in the NHS; and complaints and redress. The constitution:-

Defines rights regarding access to health care which will be

·         free of charge

·         non-discriminatory

·         never refused on unreasonable grounds

·         obtainable from any UK NHS provider or with pre-approval from any EEA or Swiss public provider

·         assessed by the local NHS to meet locally assessed needs

and pledges that access to health care will be convenient and easy to access within defined waiting times; based on decision making that will be clear and transparent, and that transfers from one provider to another will be as smooth as possible and that patients will be involved in all relevant discussions.

With regard to rights regarding Respect, consent and confidentiality the NHS gives patients the right to

·         be treated with dignity and respect.

·         accept or refuse treatment that is offered, and not to be given any examination or treatment without valid consent.

·         be given information about your proposed treatment in advance, including any significant risks and any alternative treatments which may be available, and the risks involved in doing nothing.

·         privacy and confidentiality and to expect the NHS to keep their confidential information safe and secure.

·         access to their own health records. This will always be used to manage treatment in the patient’s best interests.

And pledges that it will share with patients any letters sent between clinicians about their care.

Patients are given rights in relation to informed choice including the right to

·         choose their own GP practice, and to be accepted by that practice unless there are reasonable grounds to refuse

·         express a preference for using a particular doctor within your GP practice and for the practice to try to comply.

·         make choices about their NHS care and to information to support these choices.

The NHS also pledges to inform patients about the healthcare services available locally and nationally and will offer easily accessible, reliable and relevant information to enable patients to participate fully in their own healthcare decisions and to support them in making choices. This includes information on the quality of clinical services where there is robust and accurate information available.

Doctors status in the UK

Doctors in training

Doctors in training earn a basic salary and will be paid a supplement if they work more than 40 hours and/or work outside the hours of 7am-7pm Monday to Friday.

In the most junior hospital trainee post (Foundation Year 1) the basic starting salary is £22,636. This increases in Foundation Year 2 to £28,076. For a doctor in specialist training the basic starting salary is £30,002. If the doctor is contracted to work more than 40 hours and/or to work outside 7am-7pm Monday to Friday, they will receive an additional supplement which will normally be between 20% and 50% of basic salary. This supplement is based on the extra hours worked above a 40 hour standard working week and the intensity of the work.

Specialty doctors

Doctors in the specialty doctor grade earn a basic salary of between £37,176 and £69,325.

Consultants

Consultants can earn a basic salary of between £75,249 and £101,451 per year, dependent on length of service. Local and national clinical excellence awards may be awarded subject to meeting the necessary criteria. 

General practitioners

Many general practitioners (GPs) are self-employed and hold contracts, either on their own or as part of a Clinical Commissioning Group (CCG). The profit of GPs varies according to the services they provide for their patients and the way they choose to provide these services.

Salaried GPs who are part of a CCG earn between £54,863 to £82,789 dependent on, among other factors, length of service and experience.

Private Practice in UK

‘Independent Practice’ and ‘Private Practice’ are synonymous terms meaning practicing medicine out with the umbrella of the NHS. Private practice existed long before the creation of the NHS, and it continues today in parallel with the NHS.

Private practice does allow surgeons to practice more independently of NHS targets and diktats. Private Practice allows more direct one-to-one care for patients, without a need to rush. Private practice can indeed be greatly rewarding, both emotionally and professionally, but like most worthwhile things, it does require hard work and commitment.

Patients receiving private healthcare fall into two groups: those with private medical insurance policies (about 80% of patients) and those who self-fund (about 20%).

Of those doctors undertaking private practice, the large majority also work in NHS Consultant posts, doing their private work in their spare time, outside of and on top of their NHS commitments. A small proportion of doctors work in full time private practice only.

The amount of private practice varies considerably across the country, with the greatest density being around London and the South-East.

Any registered medical practitioner can, in theory, undertake work privately. However, in reality, there are a number of practical barriers.

First, private medical insurance companies do not have their own mechanisms for assessing quality and suitability of doctors for being recognized as specialists. They therefore rely on specific benchmarks, including the need to be on the GMC’s Specialist Register and to have successfully gone through an Advisory Appointments Committee (AAC), which is part of the NHS Consultant appointment process. Second, by law, private hospitals have very strict criteria for awarding practicing privileges to doctors using their facilities. These help assure patients that they are being seen by experienced and fully trained registered specialists.

Balancing Private and NHS work

Whether a surgeon decides to undertake work in the private sector is a personal decision, which can be influenced by many factors.

Under the new consultant contract, there are rules governing how you balance NHS work with private practice. If you do not have 11 or more programmed activities in your job plan, you are expected to offer the first portion of any spare time to the NHS in preference to any private work.

There is a Code of Conduct for Private Practice, jointly agreed by the DH and BMA. This code ensures that your private work does not disadvantage NHS patients.

When a surgeon has patients under their care within the NHS, the patients tend to be looked after by a large team, including a variety of grades of trainees. Care in the private sector is generally delivered entirely by the consultant. Private practice is therefore a significant commitment, which has to be handled effectively on top of all the many commitments of the busy NHS Consultant.

Factors such as geography and specialty can also influence a surgeon’s decision to undertake private practice. Some specialties have relatively low rates of private practice whilst others, such as cosmetic surgery, feature very strongly.

 I thus find a stark difference in the conditions in UK and India in variety of areas which sums up to the total care standards at both the places.

MEDICAL LAWYER AND ETHICS CONSULTANT http://www.healthlibrary.com/helptalks.php?action=list&speaker_id=739