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REGULATION, 2011

CODE OF ETHICS OF PRACTICE FOR MEDICAL AND DENTAL PRACTITIONERS,
REGULATIONS, 2011

[Gazette of Pakistan, Extraordinary, Part-II, 16th July, 2011]

S.R.O. 80(KE)/2011, dated 3.6.2011.–In exercise of the powers conferred by sub-section (1) (i) of Section 33 of the Pakistan Medical and Dental Council. Ordinance, 1962 (XXXII of 1962), the Pakistan Medical and Dental Council, with the previous sanction of the Federal Government, is pleased to make the following regulations, namely:

PART I

PRILIMINARY

 

1. Short title and commencement.–(1). These regulations may be called the Code of Ethics of Practice for Medical and Dental Practitioners, Regulations, 2011.

(2) They shall come into force at once

(3) They shall extends to whole of Pakistan

PART II

GENERAL

 

2. Declaration before registration.–Each applicant, at the time of making an application for registration with the Council, shall submit a declaration that he has read, understood and agreed to abide by these regulations on the format set out in the Annexure I of these regulations.

 

3. Duties of physicians in general.–A physician shall always maintain highest standards of professional conduct and shall actively participate in continuous medical education and as such a physician shall,–

(a)        not permit motives of profit to influence the free and independent exercise of professional judgment on behalf of patients;

(b)        in all type of medical practice, be dedicated to providing competent medical services with full technical and moral independence, with compassion and respect for human dignity;

(c)        deal honestly with patients and colleagues and strive to expose those physicians deficient in character or competence or who engage in fraud or deception;

(d)       respect the rights of patients, colleagues and of other health professionals and shall safeguard patient confidences;

(e)        act only in the patient's interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient;

(f)        use great caution in divulging discoveries or new techniques or treatment through non-professional channels; and

(g)        certify only that which he has personally verified.

 

4. Duties of Physicians to the Sick.–A physician shall–

(a)        always bear in mind the obligation of preserving human life;

(b)        owe his patients complete loyalty and all the resources of his science;

(c)        summon another physician who has the necessary ability when ever an examination or treatment is beyond the former physician's capacity;

(d)       preserve absolute confidentiality on all he knows about his patient even after the patient has died; and

(e)        give emergency care as a humanitarian duty unless he is assured that others are willing and able to give such care.

 

5.  Duties of Physicians to each other.–A physician shall–

(a)        behave towards his colleagues gently;

(b)        not entice patients from his colleagues; and

(c)        observe the principles of the "Declaration of Geneva" approved by the World Medical Association.

 

6. Medical Ethics and religion.–A medical or dental practitioner shall respect the beliefs of the patients and shall not impose his beliefs on the patient.

 

7. Practice of medicine, surgery and dentistry prohibited without registration etc. with Council.–(1) No person shall practice modern system of medicine or surgery unless that person is a doctor or dentist having registered qualification and valid registration with Pakistan Medical and Dental Council.

(2)  Every medical or dental practitioner has to ensure that his registration with the Council is valid.

 

8. Display of registration numbers.–(1) Every medical or dental practitioner shall, in his clinic or place of practice, display a copy of valid registration certificate issued to him by the Council and refer his registration number in all his prescriptions, certificates, money receipts given to his patients.

 

(2)  No medical or dental practitioner shall display suffixing to his name those degrees or diplomas which have not been registered by the Council. A medical or dental practitioner shall not be considered a specialist unless an additional qualification of that specialty has been registered by the Council against his name.

 

9. Rational use of drugs.–(1) Every Medical or dental practitioner shall adopt practice with good and rational practices to prescribe drugs.

(2)  A medical or dental practitioner shall:–

(a)        be free to choose whom to serve, with whom to associate and lay down the timings and place of professional service for the patients;

(b)        not be bound to treat each and every person asking his services, but he shall not only be ever ready to respond to the calls of the sick and the injured, if in his opinion the situation warrants it as such, but shall be mindful of the high character of his mission and the responsibility he discharges in the course of his professional duties;

(c)        in his treatment, never forget that the health and the lives of those entrusted to his care depend on his skill and attention; and

(d)       if not available due to any reason and the patient requires continuous monitoring or care, then the Medical or dental practitioner shall arrange for another Medical or dental practitioner of sufficient proficiency as an alternate and inform the patient.

(3)  For a medical or dental practitioner to advise a patient to seek service of another medical or dental practitioner is acceptable, however, in case of emergency, the medical or dental practitioner must treat the patient first.

(4)  No medical or dental practitioner shall normally refuse treatment to a patient, however for good reason if the medical or dental practitioner thinks it would not be appropriate to provide his professional services to a particular patient or when a patient is suffering from an ailment which is not within the range of experience of the treating medical or dental practitioner, the medical or dental practitioner may refuse treatment and refer the patient to another medical or dental practitioner.

PART III

TEACHING ETHICS TO STUDENTS

10.  The Teaching of medical ethics.–(1) The curriculum committee of the Council will ensure that adequate information on this Code of Ethics is included in the undergraduate medical college curriculum and that case studies have been prepared and disseminated to provide guidance to medical or dental practitioners.

(2)  The goal of teaching medical ethics shall be to improve the quality of patient care by enhancing professional performance through a consideration of the clinician's values, beliefs, knowledge of ethical and legal construct, ability to recognize and analyze ethical problems and interpersonal and communication skills and consideration of the patient, whereby students shall be able to identify, analyze and attempt to resolve common ethical problems of medical and clinical nature.

(3)  All medical and dental colleges running MBBS and BDS courses, College of Physician and Surgeons of Pakistan and universities running the postgraduate medical courses in Pakistan may incorporate medical ethics into their curriculum.

(4)  Relevant books and journals shall be made available in the central and departmental libraries of the medical institutions, and publication of papers on issue related to medical ethics.

(5)  All medical or dental practitioners may develop strategies for dissemination of information about ethics and ethical issues to their colleagues and students, public and patients, specifically when teaching medical and dental students.

PART IV

EXPECTATIONS

 

11.  Council's expectations.–The Council expects each medical or dental practitioner to–

(a)        promote fundamental principle of responsibility of physicians to the right of individuals and societies to stated standards of professional competence, appropriate care, conduct and integrity of medical or dental practitioners;

(b)        uphold the ethical principles of medical practice that is to say autonomy, beneficence, non-maleficience. and justice;

(c)        ensure the protection of individual patients against harassment, discrimination and exploitation;

(d)       take their responsibilities as a teacher seriously;

(e)        be responsive to cultural and religious sensitivities;

(f)        declare in a transparent manner, any potential conflict of interest;

(g)        inculcate these values in students, through instruction and role modeling;

(h)        promote the education of the public on (a) health issues and (b) their rights to quality care;

(i)         ensure continuation of practice only when in normal physical and mental health; and

(j)         bring colleagues to comply with these generally accepted norms of practice and expose physicians and dentists deficient in competence, care and conduct.

PART V

FUNDAMENTAL ELEMENTS OF PATIENT – PHYSICIAN RELATIONSHIP

 

12.  Rights of the Patient.–(1) To share with physicians the responsibility for their own health care, the patient:–

(a)        has right to receive information from physicians and to discuss the benefits, risks, costs of appropriate treatment, alternatives and optimal course of action:

(b)        is entitled to obtain copies or summaries of their medical records, to have their questions answered and to receive independent additional professional opinions;

(c)        has the right to make decisions regarding the health care that is recommended by his physician and as such the patients (or his next of kin) may accept or refuse any recommended medical treatment in writing;

(d)       has the right to Courtesy, respect, dignity, timely responsiveness to his health needs, and respect of his gender and sanctity;

(e)        has the right to confidentiality; and

(f)        has the right to continuity of health care.

(2)  The physician has an obligation to cooperate in the coordination of medically indicated care with other health care providers treating the patient.

 

13. Second opinion.–Patients are entitled to a second or further medical opinion about their illness and on request, medical or dental practitioner must either initiate or facilitate a request for this and provide the information necessary for satisfactory referral.

 

14. Rights of the medical or dental practitioner.–It is obvious that patients and their attendants shall respect the privacy of the medical or dental practitioner. Patient shall call the medical or dental practitioner on telephone only in a dire emergency and not otherwise and on telephone, patients shall restrict themselves to their medical or dental problem only and not use this factlity for seeking other information.

 

PART VI

ETHICAL STANDARDS OF PROFESSIONAL COMPETENCE, CARE AND CONDUCT

 

15.  Conduct of medical or dental practitioner.–In all dealings with patients, it is expected that the interest of patient and advantage to the patient's health will be the major consideration to influence the medical or dental practitioners' conduct. The physician-patient-relationship shall be developed as one of trust. A professional shall always maintain and demonstrate a high standard of professional conduct by,–

(a)        being in conformity with the principles of honesty and justice;

(b)        not permitting motives of profit to influence (free and independent exercise of professional judgment;

(c)        working with colleagues in ways that best serve patient's interests;

(d)       not paying or receiving any fee or any other consideration solely to procure the referral of a patient or for prescribing or referring a patient to any source:

(e)        maintaining the honorable tradition by which the physician is regarded as a friend to all persons of any class, caste, color, religion, sex, ethnicity, occupation, creed, religion and social status; and

(f)        being honest, factual, objective, unbiased as a reviewer for scientific material for publication; for funding purposes; and when providing reference, ensuring that comments are honest, justifiable, unbiased and contain evidence on the subject's competence, performance, reliability and conduct, taking steps to ensure the accuracy of any public communications including the communication of degrees, institutional affiliation, extent of services offered and credentials.

16. Statement to patients and their relatives or representatives.—All statements to the patients or their representatives shall be made only by the consulting medical or dental practitioners and not by any associates or assistants etc.

17. Examination, consultation or procedures on a female patient.–(1) A female patient shall be given consultation either by a female medical or dental practitioner or shall be examined in the presence of a female attendant by a male doctor. Under no circumstances a male attendant, assistant or husband or relative etc shall be allowed during a gynecological and obstetrical consultation, examination or during normal delivery being conducted by a female medical practitioner. However in exceptional circumstances a patient may file a request with the medical practitioner to allow her husband to witness a normal delivery and the medical practitioner may consider the request and shall ensure that sanctity of the female patient is preserved during procedures and consultation and there is no unnecessary exposure.

18. Assistance of unregistered person prohibited.–(1) a medical or dental practitioner will not assist an unregistered person to practice or teach medicine or dentistry or associate professionally with such a person performing the functions as a medical or dental practitioner and knowingly assisting such an individual shall make a registered medical or dental practitioner liable to disciplinary action. This does not preclude a medical or dental practitioner from imparting proper training to medical students, nurses, midwives and other paramedical personnel, provided the doctor concerned keep a strict supervision over such individuals when treating patients.

(2)  A medical or dental practitioner shall use great caution in divulging discoveries or new techniques or treatment through non-professional channels.

(3) A medical or dental practitioner shall not allow his name to be used by any other person or let any other person sit in his place of practice if that person is not a registered medical or dental practitioner.

(4) A physician shall owe his patients all the resources of his science. Whenever an examination or treatment is beyond the physician's capacity he shall consult another physician who has the necessary ability.

19. Prisoners.–Prisoners who are ill must be treated in the same manner as other sick people. However, doctors have a right to take appropriate precautions if they think there is a possibility of physical violence by the patient. Where a suspect refuses consent to a medical examination, the doctor unless directed to the contrary by a Court of law, shall refuse to make any statement based on his observation of the suspect other than to advise the police whether or not the suspect appears to require immediate treatment or removal to hospital. This does not of course, preclude the doctor from making a statement in Court based on such observation in circumstances where the accused later gives his consent to disclosure.

20. Permission of patient before examination.–A doctor shall normally take permission from a patient before making a physical examination. In case of minors, the child's guardian shall be present or give permission for the examination. For any intimate examination the patient, irrespective of age, patient is entitled to ask for an attendant to be present. Such requests shall be acceded to whenever possible.

21. Care.–(1) The patient-physician or patient dental practitioner relationship constitutes a fiduciary obligation, requiring physicians to be responsible to serve the interests of patients above their own financial or other interests. The medical or dental practitioner is expected to provide a quality of care for a patient which is timely, compassionate, respecting human privacy and dignity, non-discriminating and does not exploit vulnerable situations. Negligence in respect of professional duties may justify suspension or removal from the Register.

(2) The medical or dental practitioner shall bear in mind the obligation of preserving life and will not discriminate on the basis of age, sex, gender, class, race, ethnicity, national origin, religion, sexual orientation, disability, health conditions, marital discord, domestic or parental status, criminal record, or any other applicable bias as proscribed by law, and ensure that personal beliefs do not prejudice patient care.

(3) The Medical or dental practitioner shall not exploit persons over whom they have direct or indirect supervisory, evaluative, management or other authority, such as students and patients, supervisees, employees or research participants, whether for personal, professional or economic reasons.

(4) The medical or dental practitioner shall delegate to a student or other physician, only those responsibilities that such persons, based on their education, training and experience, can reasonably be expected to perform either independently or with the level of supervision provided.

(5)  The Medical or dental practitioner shall additionally–

(a)        identify themselves to patients whom they are treating;

(b)        treat all patients with dignity and respect;

(c)        listen to patients and respect their views;

(d)       give patients (and provided patient agrees, family members) information (about their illness) in a way that they can understand;

(e)        respect the rights of patients to be involved fully in decisions about their care;

(f)        ensure that conflict of interest does not prevent them from performing their professional work in an unbiased manner; and

(g)        adhere to veracity (truth telling) as judged in the patient's interest.

22.  Details, of information.–It is obvious that patients do not always fully understand the information, and advice given to them by doctors. They shall be encouraged to ask questions. These shall be answered carefully in non-technical terms if necessary with or without information leaflets, as the aim is to promote understanding and to encourage compliance with recommended therapy. The doctor shall keep a note of such explanation and if it is felt that the patient still does not understand, it may be advisable to ask the patients permission to speak to a relative. The medical or dental practitioner shall break all news to the patient and relatives etc. himself and shall not allow his coworkers to do that.

23.  Maternity care.–Registered medical practitioners who agree to undertake the antenatal and delivery care of a woman shall clearly inform her, in advance, the arrangements for delivery. In Pakistan, according to law a pregnancy can be terminated only if there is a serious risk to the life of the pregnant women. The choice of gender of baby by any means shall be illegal and the gender of the foetus shall not be disclosed unless it is absolutely sure that no harm shall come to the baby and mother as a result of this disclosure.

24.  Information about doctor or dentist conducting procedures.—Patients undergoing procedures or treatment of any sort have the right to be informed as to which doctor or doctors are to be involved and what will be nature of the procedure with its advantages, disadvantages, risks and alternative, Options.

25. Competence.–(1) A medical or dental practitioner in active clinical practice is expected to continuously strive for improving his knowledge and keep abreast with the latest advancements in the field. He shall seek out sources of such knowledge and try to attend professional meetings or activities for advancement of professional knowledge. He shall maintain knowledge of CME programmes by Council and try to participate in them to gain CME credits. CME credits shall be provided by specialist boards authorized by Council for the purpose.

(2)  The medical or dental practitioners will attempt to maintain the highest levels of competence in their work more specifically the skill in diagnosing, clinical decision-making, planning, implementation, monitoring and evaluation of intervention and teaching; and shall accept responsibility for their actions. They shall therefore,–

(a)        only undertake tasks for which they are qualified allowed by virtue of education, training or experience and know their limitations;

(b)        keep abreast of latest information about their subject through continuing education;

(c)        ensure that their approach to patient management is consistent with current research, literature and practice;

(d)       have an approach that favours competent clinical care through a careful assessment of the patient's problem, based on elicitation and analysis of the patient's history and physical examination; careful decisions on need for further investigation and request for additional consultation, appropriate management and prompt action where indicated, an approach that shuns internet prescribing or telephonic prescribing except when the physician is cognizant of the individuals past medical history;

(e)        acquire the knowledge and skills to provide proper training and supervision to their students so that such persons perform services responsibly, competently and ethically; and will be honest and objective in the assessment and certification of performance of students supervised;

(f)        monitor and maintain an awareness of the quality of the care provided by himself through a review of carefully recorded data and respond constructively to assessments by self and peers which identify need for further training or education;

(g)        recognise the realistic efficacy of investigation and medication and use technology and medicine only where appropriate; and

(h)        restrict prescription of drugs, appliances or treatments to only those that are beneficial to the patient.

26.  Treatment without direct patient contact.–Prescribing of medications by medical or dental practitioners requires that the physician shall demonstrate that a documented history and physical examination and drug reaction history are available and that there has been a sufficient dialogue between the patient and the doctor on options in management, and a review of the course of the illness and side effects of the drug but the Council accepts that in an emergency, during on call or cover call, or when in a partnership the case records are available, a physician may prescribe a new prescription without seeing the patient but only emergency single dose shall be prescribed and the patient shall be called over for a checkup. Telemedicine to the extent of radiological reporting is allowed.

27.  Confidentiality.–The physician has a right to and shall withhold disclosure of information received in a confidential context, whether this is from a patient or as a result of being involved in the management of the patient, or review of a paper, except in the following specific circumstances where he may carefully and selectively disclose information where health, safety and life of other individual may be involved, namely,–

(a)        The medical or dental practitioner cannot seek to gain from information received in a confidential context (such as a paper sent for review) until that information is publicly available;

(b)        There is no legal compulsion on a doctor to provide information concerning a criminal abortion, venereal disease, attempted suicide, or concealed birth regarding his patients to any other individual or organization. When in doubt concerning matters, which have a legal implication, the medical or dental practitioner may consult his/her legal adviser;

(c)        The professional medical record of a patient shall not be handed over to any person without the consent of the patient or his/her legal representative. No one has a right to demand information from the doctor about his patient, save when the notification is required under a statutory or legal obligation and when in doubt, the medical or dental practitioner or a dentist may consult a legal advisor;

(d)       confidences concerning individual or domestic life entrusted by patients to a medical or dental practitioner and defects in the disposition or character of patients observed during medical attendance shall never be revealed unless their revelation is required by law;

(e)        a medical or dental practitioner who gains access to medical records or other information without consent shall be guilty of invasion of privacy; and

(f)        the medical or dental practitioner who grants access of an information of a patient to a third person except, Council or law enforcing agencies, without consent shall be guilty of breach of confidentiality, but where a medical or dental practitioner is of the opinion to determine it his duty to society requiring him to employ knowledge about a patient obtained through confidence as a medical or dental practitioner, to protect a healthy person against a communicable disease to which he is about to be exposed, the Medical or dental practitioner shall give out information to concerned quarters.

28. Conflicts of interest.–For guidance of medical or dental practitioner a detail on conflict of interest is given at Annexure-II of these regulations.

29. Dealing with conflict of interest.–(1) A medical or dental practitioner must act in patient's best interests when making referrals and providing or arranging treatment or care and no inducement, gift or hospitality which may affect or be seen to affect judgment may be accepted and nor shall such inducements offered to colleagues.

(2)  Financial commercial interests in organizations providing health care or in pharmaceutical or other biomedical companies must not affect the way that patients are prescribed, treated or referred.

(3) Financial or commercial interest in an organization to which a patient is to be referred for treatment or investigation must be declared to the patient

(4) Before taking part in discussions about buying goods or services, any relevant financial or commercial interest which the medical or dental practitioner or the medical or dental practitioner's family might have in the purchases, must be declared.

30.  Truth telling.–In the practice of medicine, it is obvious that truth telling involves the provision of information not simply to enable patients to make informed choices about health care and other aspects of their lives but also to inform them about their situation. Patients may have an interest in medical information regardless of whether that information is required to make a decision about medical treatment.

The physicians shall strive to create a true impression in the mind of the patient which requires that information be presented in such a way that it can be understood and applied. Patients shall be told the truth because of the respect due to them as persons as patients have a right to be told important information that physicians have about them.

31. Advertising.–(1) When publishing or broadcasting information the medical or dental practitioner must not make claims about the quality of services nor compare services with those provided by colleagues. Announcements must not, in any way, offer guarantees of cures, nor exploit patients' vulnerability or lack of medical knowledge.

(2) Published information about services must not put pressure on people to use a service, for example by arousing ill-founded fear for their future health. Similarly, services must not be advertised by visiting or telephoning prospective patients, either in person or through a deputy.

(3) Medical or dental practitioners may announce any change of address or hours of practice in the local press either once in three papers or three times in the same paper, on three consecutive days, and the announcement shall be made in a normal manner and not unduly prominently as by big advertisements.

(4)  Name plates may be fixed at the residence and on the premises where the medical or dental medical or dental practitioner practices and at his residence. The name plate shall not be ostentatious.

32. Certificates, reports and other documents.–When medical or dental practitioners are requested for certificates, medical reports birth or death certificates and any other documents, such documents shall be factual to the best of their knowledge. Due care shall be taken in regard to stating the date on which the patient has been examined etc.

33. Business and contractual obligations.–Physicians and dentists must ensure that they do not engage in any behaviour that negatively impacts directly or indirectly on patient care. Business and contractual obligations must never interfere with clinical decisions or negatively impact on patient care in any way. Physicians are discouraged from entering into business or other arrangements that include financial incentives; sharing of fees including refund based on successful outcomes and payments for referral of patients for laboratory investigations or other procedures except when a partnership is publicly known to exist.

34. Informed Consent.–For guidance of medical or dental practitioner a detail on informed consent is given at Annexure-III of these regulations.

35. Medical and dental students.–It is obvious that medical and dental students must identify themselves by name and must obtain permission from patients before examining them. It is advisable to limit the number of students examining any one patient.

36. Taking of photographs or videos for teaching purposes.–Taking of patients' photographs and videos shall be done in such a manner that a third party cannot identify the patient concerned. If the patient is identifiable, he or she shall be informed about the security, storage and eventual destruction of the record.

37. Adoption.–Doctors shall remember that in cases of proposed adoption there are several parties involved all of whom need continued support and counseling. Pregnant women who are considering giving up their babies for adoption shall be helped to approach advisory bodies or attorneys as the circumstances may be.

38. Leader of the medical or dental team.–The Medical or dental practitioner shall take his responsibilities as leader of the medical or dental team seriously as all responsibility of the care of the patient rests on him and not the Paramedical staff. The medical or dental practitioner shall not accept any paramedical staff to be in his team if he is not comfortable with him and this opinion shall be binding on the employer.

PART VII

PROFESSIONAL FEE AND TIMINGS

39. Fees and other charges.–(1) The fee charged from the patient for the treatment or consultation shall be as decided by the medical or dental practitioner. The treatment shall commence if the fee is acceptable to the patient, medical or dental practitioner and the hospital or clinic. If there is any disagreement the patient may seek care elsewhere. For poor or non-affording patients, the medical or dental practitioner may make a concession if he so desires. However, the medical or dental practitioner is bound to provide first aid to the patient in emergency and only then refer him.

(2) The medical or dental practitioner shall ensure that the fee is commensurate with his qualification and level of services offered and the hour at which his time was spent in providing the services.

(3) A Medical or dental practitioner shall announce his fees before rendering service and not after the operation or treatment is under way. Remuneration received for such services shall be in the form of currency only and its amount specifically announced to the patient at the time the service is rendered.

(4) The fee shall not be in the form of a favour of any kind.

(5) Medical or dental practitioners rendering service on behalf of the Government shall refrain from anticipating or accepting any consideration.

(6) A medical or dental practitioner shall clearly display his fees and other charges in his chamber and/or the hospitals he is visiting.

(7) A medical or dental practitioner can receive compensation of any medicine dispensed by him.

(8) A medical or dental practitioner shall write or stamp his name and designation in full along with registration number in his prescription letter head.

(9) A medical or dental practitioner shall consider it as a pleasure and privilege to render gratuitous service to all Medical or dental practitioners and their immediate family dependants.

40. Rebates and Commission.–A medical or dental practitioner shall not give, solicit, or receive nor shall he offer to give solicit or receive any gift, gratuity, commission or bonus in consideration of or return for the referring, recommending or procuring of any patient for medical, surgical or other treatment.

41. Communication with Patients.–To address many complaints to the Council refered due to lack of communication, or disCourtesy, on the part of the doctor, where differences have arisen between the doctor and the patient or the patients relatives there is much to be gained and rarely anything to be lost by the expression of regret by the doctor and feeling that any such expression would amount to an admission of liability may have inhibited doctors.

42. Maintenance of medical records.–Every medical or dental practitioner shall ensure proper documentation of his professional services along with necessary reports results maintained an easily discernable scientific method.

PART VIII

RESEARCH ETHICS AND CONSENT

43. Research Ethics and Consent.–(1) When conducting medical research involving human subjects, investigators shall remember their obligations with respect to individual patients. Ethical conduct of research requires that a human subject must participate willingly, having been adequately informed about the research and given consent that there is a favourable balance between the potential benefit and harm of participation; and that protection of vulnerable people is ensured. The validity of findings must address questions of sufficient importance to justify any risks to participants. In any clinical trial there must be genuine uncertainty as to which treatment arm offers the most benefit, and placebo controls shall not be used if equally effective standard therapies exist. When doubt exists, researchers shall consult the existing literature and seek the advice of experts in research ethics.

(2) All research projects involving human subjects, whether as individuals or communities, or the use of fetal material, embryos and tissues from the recently dead, shall be reviewed and approved by an Ethical Review Committee of the institution before the study begins.

(3) Written consent shall be obtained if patients are to be involved in clinical trials. The aims and methods of the proposed research, together with any potential hazards or discomfort, shall be explained to the patient. The consent document must be clearly written using non-technical language as to be understandable to subjects and use local language in addition wherever applicable.

(4) In situations where study subjects are too young or too incapacitated, as well as the mentally ill or unconscious person, consent to take part in research may be unobtainable. Research is best avoided unless it can be shown to be relevant and potentially beneficial to the patient and there is no objection from parents or relatives.

(5) Medical research involving human subjects shall be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person.

(6) The right of research subjects to safeguard their integrity must always be respected. Every precaution shall be taken to respect the privacy of the subject, and the confidentiality of the patient's information.

(7) Research results must always preserve patient anonymity unless permission has been given by the patient to use his or her name.

(8) Volunteers and patients may be paid for inconvenience and time spent, but such payment shall not be so large as to be an inducement.

(9) Refusal of a patient to participate in research must not influence the care of a patient in any way.

44.  Decisions of national bio-ethic committee and declaration of Helsinki.–The Council endorses the decisions of national bio-ethic committee and declaration of Helsinki resolutions as adopted by the 18th World Medical Assembly and revised by the 48th World Medical Assembly shall be binding on all medical or dental practitioners.

45. Organ Transplantation and Consent–A doctor involved in organ transplantation has duties towards both donors and recipients. Prior to considering transplant from the dead donor, brain death shall be diagnosed, using currently accepted criteria, by at least two independent and appropriately qualified clinicians, who are also independent of the transplant team. If family of the dead donor cannot take care of the funeral of donors body, then the transplant doctor involved in organ transplantation shall take car of transplantation and funeral. Living donors shall be counseled as to the hazards and problems involved in the proposed procedures, preferably by an independent physician. All statutory human organ transplant rules and orders shall apply.

46. Resource Allocation.–All resource allocation decisions must be transparent and defensible. Questions of resource allocation are difficult and can pose practical and ethical dilemmas for clinicians. The unequal allocation of a scarce resource may be justified by morally relevant factors such as need or likelihood of benefit. To what extent the physician's fiduciary duty towards a patient shall supersede the interests of other patients and society as a whole is also a matter of controversy. However, the allocation of resources on the basis of clinically irrelevant factors such as religion or gender is prohibited.

PART IX

MISCELLANEOUS

47. End-of-life care.–(1) End-of-life care requires control of pain and other symptoms, decisions on the use of life-sustaining treatment, and support of dying patients and their families. Futile treatment need neither be offered to patients nor be provided if demanded. A treatment is qualitatively futile if it merely preserves permanent unconsciousness or fails to end total dependence on intensive medical care or when physicians conclude, either through personal experience, experiences shared with colleagues, or consideration of reported empiric date that a medical treatment has been useless.

(2)  The physician is not compelled to accede to demands by patients or their families for treatment thought to be inappropriate by health care providers.

48. Genetics in Medicine.–For guidance of medical or dental practitioner or a dentist a research study of various characteristics of genetic information is given at Annexure-V of these regulations.

PART X

PUNISHMENT AND DISCIPLINARY ACTION

49.  The following acts of misconduct commission or omission on the part of a Medical or dental practitioner shall constitute professional misconduct rendering him/her liable for disciplinary action, namely:–

(a)        if he/she commits any violation of these Regulations;

(b)        forgery, theft, fraud, plagiarism indecent behavior or any other offence, liable to be seen as moral turpitude is liable to disciplinary action;

(c)        Any form of sexual advance, to a patient or colleague or coworker with whom there exists a professional relationship, is professional misconduct. A registered medical medical or dental practitioner or dentist's professional position must never be used to pursue a relationship of an emotional or sexual nature with a patient, the patient's spouse or a near relative of a patient. Sexual contact or intent there of with patient or patient's spouses, partners, parents, guardians, or other individuals involved in the care of the patient is liable to lead to exclusion from the Register. A registered medical or dental practitioner or dentist will ensure that they do not engage in sexual harassment of any person, including employees, patients, students, research assistants and supervisees. The following constitute harassment that is to say single, multiple or persistent acts of abusive verbal language or gestures, demeaning speech, insult in front of juniors, sexual innuendoes, sexual solicitation, physical advance, throwing objects, and other threatening unacceptable gestures and these shall render a medical or dental practitioner liable for disciplinary action and cancellation of registration. The administration shall also be held responsible for any such untoward event. Physicians shall not use language that will interfere with the work of others;

(d)       Abuse of professional knowledge, skills and privileges is unacceptable conduct. Any registered medical or dental medical or dental practitioner found guilty of causing an illegal abortion or prescribing drugs in violation of any law or who becomes addicted to a drug or is convicted of driving under the influence of alcohol or any other drug, is liable to be suspended or have his name removed from the Register;

(e)        No medical or dental practitioner shall accept illegal gratification and such acts shall be cognizable;

(f)        The following practices are deemed to be unethical conduct namely:–

            (i)         self advertising by physicians, unless permitted by the laws of the country and the code of ethics of the Pakistan Medical Association; and

            (ii)        paying or receiving any fee or any other consideration solely to procure the referral of a patient or for prescribing or referring a patient to any source.

(g)        Conviction by Court of Law for offences involving moral turpitude / Criminal acts

(h)        Any substance abuse or addiction

50. Other misconduct.—(1) It must be clearly understood that the instances of offences and of Professional misconduct which are given above do not constitute and are not intended to constitute a complete list of the infamous acts which calls for disciplinary action, and that by issuing these regulations is the Pakistan Medical and Dental Council is in no way precluded from considering and dealing with any other form of professional misconduct on the part of a medical or dental practitioner. Circumstances may and do arise from time to time in relation to which there may occur questions of professional misconduct which do not come within any of these categories. Every care shall be taken that the code is not violated in letter and spirit. In such instances as in all others, the Council has to consider and decide upon the facts brought before it.

(2) Professional negligence or incompetence shall be judged by the peer group known as the disciplinary committee of the Council.

(3) It is made clear that any complaint with regard to professional misconduct and violation of these regulations can be brought before the Council for disciplinary action. Upon receipt of any complaint of professional misconduct and violation of these rules, in the first instance, the Registrar PM&DC shall call the practitioner over and counsel him/her. Upon non-settlement and failure to comply despite counseling, the Council would hold an enquiry and give opportunity to the registered medical or dental practitioner to be heard in person or by pleader under Council rules. If the medical or dental practitioner is found to be guilty of committing professional misconduct, the Council may award punishment under the rules or as the case may be, including removal altogether or for a specified period, from the Register of the name of the delinquent registered medical or dental practitioner. Removal of name from the Register shall be widely publicized in local press including conveying to different medical associations or societies or bodies internationally or nationally.

PART XI

MATTERS RELATING TO PHARMACEUTICAL INDUSTRY

51. Accepting gifts, inducements or promotional Aids.–(1) Registered medical or dental practitioners shall ensure that they do not compromise their professional autonomy or integrity once any gift, benefit in kind or economic advantage is offered to them as an inducement to prescribe, supply, administer, recommend, buy or sell any drug or medical equipment as the case may be.

(2) Notwithstanding anything to the contrary contained herein, registered medical or dental practitioners may occasionally accept promotional aid items (e.g. stethoscope, BP apparatus, weight machine, tongue depressor, hand wash etc.) from drug manufacturers or distributors as the case may be, provided that these items are primarily for the benefit of patients.

(3) In addition to items listed in sub-regulation (2), registered medical or dental practitioners may accept from drug manufacturers or distributors as the case may be text or reference-books, medical journals. CDs and other educational materials if they are satisfied that these serve a genuine, demonstrable and direct educational function.

(4) Registered medical or dental practitioners may not enter into a written or verbal agreement of any kind, with any manufacturer or distributor of drugs or medical equipment, for personal gain of any kind whatsoever other than employment.

52. Drug Samples.–(1) Registered medical or dental practitioners must appreciate that free drug samples are provided to them for the benefit of patients only and to raise awareness of the drug and that they do not accept such samples as an inducement to prescribing any drugs or as reward for having done so.

(2) Registered medical or dental practitioners should accept free drug samples for patient use only and not for the personal gain or re-sale.

(3) Notwithstanding anything to the contrary contained herein, registered medical or dental practitioners may purchase drugs at a discount directly from the manufacturer provided that this discount is duly passed on to the patients.

53. Meetings, conferences and hospitality.–(1) If registered medical or dental practitioners wish to engage in or undertake any academic pursuits they should make all possible efforts to generate their own funds either through institutions with which they are affiliated or from personal contributions.

(2) Since continuing medical education (CME) or scientific and educational conferences or professional meetings contribute to the improvement of patient care, registered medical or dental practitioners may accept support from manufacturers or distributors of drugs or medical equipment in this regard provided that any financial support provided is strictly through cheque or bank draft deposited in a duly designated account rather than in their personal bank accounts and shall be disclosed to the institution and to the Council on demand.

(3) Registered medical or dental practitioners should also ensure that the primary purpose of any educational meeting is the enhancement of medical knowledge and they should participate in these events with the objective of gaining current, accurate and balanced medical education in an ethical and professional manner.

(4) In organizing an educational meeting, congress or symposium the organizing medical or dental practitioners should ensure that a minimum of eighty percent of the time allocated for such meeting, congress or symposium is spent on core educational activities and only a maximum of twenty percent of the total time is devoted to recreational activities which are in accordance with the dignity of the medical profession.

(5) Registered medical or dental practitioners may accept an invitation and financial support for a domestic or international trip from manufacturers or distributors of drugs or medical equipment subject to the following conditions, namely:–

(a)        the trip is primarily for an academic purpose and preferably the selected medical or dental practitioner is presenting a paper in the course of the trip or participating in the proceedings in a similarly meaningful manner;

(b)        the trip is to attend an event of international nature featuring Pakistani as well as non-Pakistani participants;

(c)        the invitation and financial support is for the registered medical or dental practitioner only and not for his or her spouse or children; and

(d)       the medical or dental practitioner shall disclose the purpose and invitation to the institute and to the Council.

54.  Endorsement.–(1) No registered medical or dental practitioner below the rank of a professor may endorse any drug or medical equipment publicly or in the print, air or electronic media and shall make all possible efforts to ensure that any study conducted on the efficacy or otherwise of any drug or medical equipment is communicated to the public through appropriate scientific bodies or published in the appropriate scientific literature.

(2) A registered medical or dental practitioner may, however participate in celebrity based disease-awareness programs or customer driven campaigns to create public awareness on matters of general hygiene or measures for disease prevention. A medical or dental practitioner may appear in any media event or program if is so duty bound to do so.

(3) A registered medical or dental practitioner shall not promote a drug or medical equipment or a manufacturer or distributor in the course of scientific presentations in any manner whatsoever, including but not limited to by.–

(a)        stating the name of the drug or equipment brand in the slides; or

(b)        stating the name or logo of the drug or equipment manufacturer or distributor in the slides; or

(c)        All medical or dental practitioners shall abide the drug laws.

(4)  Any registered medical or dental practitioner presenting a paper at a conference, seminar or symposium shall issue or announce a disclaimer in respect of any personal financial rewards from interest in or association of any kind with the manufacturer or distributor sponsoring the conference, seminar or symposium.

55. Medical Research.–(1) No registered medical or dental practitioner may accept direct payments from any drug manufacturer or "distributor for conducting research studies of any nature whatsoever and all such research funding should only be received through approved institutions in accordance with the rules and byelaws of such institutions.

(2) Every clinical trial conducted by a registered medical or dental practitioner must meet the current scientific and ethical requirements and the existing legal regulations and must conform to the internationally recognized principles of Good Clinical Practice.

(3) All financial sources of research shall be disclosed to the Council on demand.

(4) Every registered medical or dental practitioner must ensure that the funding party does not influence the research agenda, methodology employed, participant selection, data analysis or publication of findings. All research proposals must be assessed and approved prior to initiation by the ethical review committee (ERC) of the relevant institution.

(5) At the time of publishing any papers or making a presentation which provides the results of any medical research the relevant registered medical or dental practitioners shall make a declaration of any funding provided by manufacturers or distributors of drugs or medical equipment to carry out such research.

(6) Registered medical or dental practitioners may accept an honorarium from their institutions and not directly from any donors providing funding for such research, against the time of their involvement in a clinical trial or research study ensuring complete disclosure and without any conflict of interest, in the following cases, namely:–

(a)        Industry initiated trials or studies; and

(b)        Investigator or doctor initiated trials or studies.

56.       Decisions regarding pharmaceutical industry and its interaction with the medical or dental practitioners and the funding by the pharma-industry, various guidelines and decisions including those for continuous medical education events as developed by the National Bio Ethics Committee shall also apply.

Part-XII

REPEAL

57.  Repeal.–The Code of Ethics made by the Council in its 98th meeting at Karachi on 24th and 25th August 2002 and any regulation in these matters made earlier are hereby repealed.

[No.                    ]

Registrar
Pakistan Medical and Dental Council

Annexure I

At the time of registration, each applicant shall be required to make following declaration agreeing to abide by the same.

DECLARATION

(See Regulation 2)

(a)        I solemnly pledge myself to consecrate my life to the service of humanity:

(b)        I will give to my teachers the respect and gratitude which is their due;

(c)        I will practice my profession with conscience and dignity;

(d)       The health of my patient will be my first consideration;

(e)        I will respect the secrets which are confided in me, even after the patient has died;

(f)        I will maintain by all the means in my power, the honour and the noble traditions of the medical profession;

(g)        My colleagues will be like my sisters and brothers and I will pay due respect and honour to them.

(h)        I will not permit considerations of age, disease or disability, creed, ethic origin, gender, nationality, political affiliation, race, sexual orientation, or social standing to intervene between my duty and my patient;

(i)         I will protect human life in all stages and under all circumstances, doing my utmost to rescue it from death, malady, pain and anxiety. To be, all the way, an instrument of Allah's mercy, extending medical care to near and far, virtuous and sinner and friend and enemy;

(j)         I shall abide by the medical or dental practitioners of medicine and dentistry (code of ethics) Regulation, 2011 of the Council and understand that I shall be punished upon its violation by me;

(k)        I make these promises solemnly, freely and upon my honour.

Signature………………………..date…………………………..

Name……………………………………………………………

Council's Registration number …………………………………

e-mail ……………………………………………………………

Address Current …………………………………………………

Permanent: ………………………………………………………

Contact number Mobile …………… land line …………………

Annexure II

A conflict of interest

(See Regulation 28)

A conflict of interest "is a set of conditions in which professional judgment concerning a primary interest tends to be unduly influenced by a secondary interest." In the clinical context the primary obligation of physicians shall be to their patients, whereas in the research context scientific knowledge may be the primary interest. A secondary interest may be of a financial nature, but it may also consist of personal prestige or academic recognition and promotion. In research involving patients, the research interests, although often in concordance with it and is above mentioned definition the reference to "a set of conditions" is important – having a conflict of interest is an objective situation and does not depend on underlying motives. Stating that someone has a conflict of interest does not imply a moral condemnation per se. It is the person's action in the context of a particular situation or a lack of transparency that may be a cause for concern.

Annexure III
Informed Consent

(See Regulation 34)

(1) Consent is the "autonomous authorization of a medical intervention by individual patients." Patients are entitled to make decisions about their medical care and have the right to be given all available information relevant to such decisions. Patients have the right to refuse treatment and to be given all available information relevant to the refusal. Consent may be explicit or implied. Explicit consent can be given orally or in writing. Consent is implied when the patient indicates a willingness to undergo a certain procedure or treatment on him or his behaviour. For example, consent for venipuncture is implied by the action of rolling up ones sleeve and presenting one's arm. For treatments that entail risk or involve more than mild discomfort, it is expected that the physician will obtain explicit rather than implied consent. Signed consent forms document but cannot replace the consent process. There are no fixed rules as to when a signed consent form is required. Some hospitals require that a consent form be signed by the patient for surgical procedures but not for certain equally risky interventions. If a signed consent form is not required, and the treatment carries risk, clinicians shall seriously consider writing a note in the patient's chart to document that the consent process has occurred. When taking consent the physician shall consider issues of adequate disclosure, the patients capacity, and the degree of voluntariness. In the context of patient consent, "disclosure" refers to the provision of relevant information by the clinician and its comprehension by the patient. Disclosure shall inform the patient adequately about the treatment and its expected effects, relevant alternative options and their benefits and risks, and the consequences of declining or delaying treatment and how the proposed treatment (and other options) might affect the patient's employment, finances, family life and other personal concerns. "Waiver" refers to a patient's voluntary request to forego one or more elements of disclosure. For example, a patient may not wish to know about a serious prognosis (e.g., cancer) or about the risk of treatment.

(2) "Capacity" refers to the patient's ability to understand information relevant to a treatment decision and consequences of a complying or not complying with a treatment decision. A person may be "capable" (have adequate capacity) with respect to one decision but not with respect to another. When any doubt exists, a clinical capacity assessment by a third party may be required. In addition to assessing general cognitive ability, specific capacity assessment, determines the patient's ability to appreciate information and implications of action. "Voluntariness" refers to a patient's right to make health care choices free of any undue influence. However, a patient's freedom to make choices can be compromised by internal factors such as pain and by external factors such as force, coercion and manipulation. In exceptional circumstances — for example, involuntary admission to hospital — patients may be denied their freedom of choice; in such circumstances the least restrictive means possible of managing the patient shall always be preferred. Clinicians can minimize the impact of controlling factors on patients' decisions by promoting awareness of available choices, inviting questions and ensuring that decisions are based on an adequate, unbiased disclosure of the relevant information.

(3) An informed consent can be said to have been given based upon a clear appreciation and understanding of the facts, implications, and future consequences of an action. In order to give informed consent, fulfill the legal standard of informed consent with a completed, dated and signed consent form. True informed consent requires a number of elements:

(a)        that the patient is competent;

(b)        that appropriate information is presented to the patient by the medical and dental practitioner; and

(c)        that the patient understand the material presented by the medical and dental practitioner;

(d)       that the patient acts voluntarily (without coercion or under duress) and that the patient agree to the plan presented.

(4)        Special circumstances affecting the consent process are listed below:–

            (a)        The unconscious patient's,- consent may be implied or assumed on the grounds that if the patient were conscious they would consent to their life being saved.

            (b)        A doctor asked to examine a violent patient is under no obligation to put him in danger but shall attempt to persuade the person concerned to permit an assessment as to whether any therapy is required.

            (c)        The mentally ill of the doctor is in any doubt as to the patient's capacity to consent it is advisable to seek specialist opinion as well as discussing the matter with parents, guardians or relatives.

            (d)       For Mentally Handicapped patients the doctor shall attempt to obtain consent but, depending on the degree of handicap, may have to consult with the patient's parents or guardians, and, in particularly difficult cases to obtain a second opinion.

            (e)        Children are entitled to considerate and careful medical care as are adults. If the doctor feels that a child will understand a proposed medical procedure, information or advice, this shall be explained fully to the child. Where the consent of parents or guardians is normally required in respect of a child for whom they are responsible, due regard must be given to the wishes of the child. Also, the doctor must never assume that it is safe to ignore the parental or guardian interest.

Annexure V

Genetics in medicines

(See Regulation 48)

Molecular genetics is concerned with the process by which the coding sequences of DNA are transcribed into proteins that control cell reproduction, specialization, maintenance and responses. Inherited or acquired biologic factors that result in an error in this molecular information processing can contribute to the development of a disease. Medical genetics involves the application of genetic knowledge and technology to specific clinical and epidemiologic concerns. Although many common diseases are suspected of having a genetic component, few are purely genetic in the sense that the genetic anomaly is adequate to give rise to the disease. In most cases, genetic risk factors must be augmented by other genetic or environmental factors for the disease to be expressed. Moreover, the detection of a genetic anomaly not help us to predict the severity with which the syndrome will be expressed. Certain ethical and legal responsibilities accompany the flood of genetic knowledge into the current practice of medicine. This is because of three general characteristics of genetic information, that is to say the implications of genetic information are simultaneously individual and familial genetic information is often relevant to future disease; and genetic testing often identifies disorders for which there are not effective treatments or preventive measures.