Basic Laws and Human Rights (BLHR-E) PDF

‫الرحيم‬ ‫الرحمن‬ ‫هللا‬ ‫بسم‬ ‫بسم هللا الرحمن الرحيم‬ ‫والصالة والسالم على سيد‬ ‫المرسلين سيدنا محمد صلى‬ ‫هللا عليه وسلم‬  Basic Laws and Human Rights (BLHR-E) Medical laws State laws Law 214/ 2020 controlling medical research Law 5/2010 organ...

‫الرحيم‬ ‫الرحمن‬ ‫هللا‬ ‫بسم‬ ‫بسم هللا الرحمن الرحيم‬ ‫والصالة والسالم على سيد‬ ‫المرسلين سيدنا محمد صلى‬ ‫هللا عليه وسلم‬  Basic Laws and Human Rights (BLHR-E) Medical laws State laws Law 214/ 2020 controlling medical research Law 5/2010 organ & tissue donation and transplantation Proposal of medical responsibility and patient safety. Human rights Bill of patient’s rights  Medical Laws Governing Medical Practice Prof. Dina Shokry Prof of forensic medicine and toxicology- Cairo University Head of the department Armed Forces Collage of Medicine (AFCM ) Department of Forensic Medicine Friday, September 6, 2024 3 Intended Learning Outcome (ILOs) By the end of this lecture the student will be able to: 1. Define medical ethics 2. Identify the role of laws and ethics in medical practice 3. Define the basic medicolegal aspects of general medical practice 4. Understand the international Conventions for human rights. 5. Apply Justice to healthcare. 6. List standards for patients’ bill of rights. 4 Laws and Medical Ethics  Egyptian Court System High Supreme Court Court of Cassation (for civil, commercial, and criminal matters) 7 Courts of Appeal Courts of the First Degree Primary Court Courts of Special Jurisdiction Supreme Constitutional Court  ‫القوانين المنظمة لعمل األطباء فى مصر‬ Laws that govern medical practice in Egypt I- General Laws of the State: ‫القوانين العامة للدولة‬: ‫أوال‬ A- The Penal Code..‫قانون العقوبات‬- ‫أ‬ B- The Criminal law;.‫القانون الجنائى‬- ‫ب‬ C- The Civil law..‫القانون المدنى‬- ‫ج‬ D- The Code of Criminal Procedure..‫قانون االجراءات الجنائية‬- ‫د‬ II- Laws and regulations governing ‫القوانين واللوائح التى تنظم العمل‬: ‫ثانيا‬ medical practice..‫الطبى‬  ‫ثانيا ‪:‬القوانين واللوائح التى تنظم العمل الطبى‪.‬‬ ‫‪Laws and regulations governing medical practice.‬‬ ‫‪ -1‬قانون ‪415‬لسنة‪ 1954‬فى شأن مزاولة مهنة الطب‪.‬‬ ‫‪ -2‬قانون‪45‬لسنة ‪ 1969‬الخاص بشروط العضوية و القيد بالنقابة و النظام التأديبى لألطباء‪.‬‬ ‫‪ -3‬قانون ‪ 481‬لسنة ‪ 1954‬المعدل بالقانون ‪ 140‬لسنة ‪ 1981‬بشأن مهنة التوليد‪.‬‬ ‫‪ -4‬قانون ‪198‬لسنة ‪ 1985‬بشأن مزاولة مهنة العالج النفسى‪.‬‬ ‫‪5-‬قانون ‪3‬لسنة ‪56‬بشأن مزاولة مهنة العالج الطبيعى‪.‬‬ ‫‪ -6‬قانون تنظيم تعامل األطباء و الصيادلة بالمواد المخدرة ‪ 182‬لسنة ‪.1960‬‬ ‫‪ -7‬قانون تنظيم المنشأت الطبية القانون ‪ 51‬لسنة ‪.1981‬‬ ‫‪ -8‬قوانين الصحة العامة و تعليمات وزارة الصحة بشأن تنظيم تداول بعض المواد و المستحضرات الصيدلية المؤثرة على الحالة الصحية و النفسية‪.‬‬ ‫‪ -9‬الئحة المهنة الصادرة بقرار وزير الصحة و السكان رقم ‪ 238‬لسنة ‪:2003‬‬ ‫الباب األول ‪ :‬قسم األطباء‬ ‫الباب الثانى ‪ :‬واجبات الطبيب(نحو المجتمع‪ -‬نحو المهنة‪ -‬نحو المرضى‪ -‬نحو الزمالء)‪.‬‬ ‫الباب الثالث التدخالت الطبية ذات الطبيعة الخاصة‬ ‫الباب الرابع‪ -‬إجراء التجارب والبحوث الطبية على اآلدميي‬  ‫قسم االطباء‬ ‫" اقسم باهلل العظيم أن أراقب هللا فى مهنتى ‪ ،‬وأن أصون حياة‬ ‫االنسان فى كافه أدوارها فى كل الظروف واالحوال باذال‬ ‫وساعيا فى استنقاذها من الهالك والمرض وااللم والقلق ‪ ،‬وأن‬ ‫أحفظ للناس كرامتهم وأستر عوارتهم وأكتم سرهم ‪ ،‬وأن‬ ‫أكون على الدوام من وسائل رحمه هللا باذال رعايتى الطبيه‬ ‫للقريب والبعيد ‪ ،‬للصالح والخاطئ والصديق والعدو ‪ ،‬وأن‬ ‫أثابر على طلب العلم وأسخره لنفع االنسان ال ألذاه ‪ ،‬وأن‬ ‫أوقر من علمنى وأعلم من يصغرنى ‪ ،‬وأكون أخا لكل زميل‬ ‫فى المهنة الطبيه متعاونين على البر والتقوى ‪ ،‬وأن تكون‬ ‫حياتى مصداق ايمانى فى سرى وعالنتيتى نقيه مما يشينها‬ ‫تجاة هللا ورسله والمؤمنين ‪ ،‬وهللا على ما أقول شهيد‪".‬‬ Professional Guidance Ministry of Health & Population (MOHP) Egyptian Medical Syndicate (EMS) The Rules Faculty / local guidance More specific Professional guidance Law Egyptian Medical Syndicate (EMS)  The Egyptian Medical Syndicate (1926) Ali_ebrahim_basha Keeping up-to-date registers of qualified doctors Gives limited or extended permission for non- Egyptian physicians to practice in Egypt. Registers all hospitals, medical centers and clinics. It could punish physicians up to revocation.  The Role of Egyptian Medical Syndicate (EMS) According to the EMS law ( 54/1969) and EMS regulation statute (Ministerial Decree – 235/1974) To protect, promote and maintain the health and safety of the public by ensuring proper standards in the practice of medicine and healthcare  ‫‪EMS Guidance‬‬ ‫الئحة آداب المهنة الصادرة بقرارمعالى ‪ /‬وزير الصحة والسكان رقم ‪ 238‬لسنة ‪ 2003‬‬ ‫‪Profession Ethics Regulations 238/2003‬‬ Principles of professional behavior for Medical Doctors Make the care of your patient your first concern Provide a good standard of practice and care Protect and promote the health of patients and the public Treat patients as individuals and respect their dignity Work in partnership with patients Be honest and open and act with integrity Principles of professional behavior for Medical students 1.Good clinical care 2.Maintaining good medical practice 3. Learning, training, appraising & assessing 4.Relationships with patients 5.Working with colleagues 6.Probity 7.Personal Health Summary: EMS Code of ethics for doctors and medical students – Guidance on what is ethically right and in line with existing law Has the power to prevent a doctor from practicing medicine Legal courts take its standards into account Ethics and law Governing Medical Practice Basic Principles of Medical Ethics Beneficence Non Justice Autonomy maleficence Beauchamp and Childress, 2012  Autonomy Of The Doctor Profession Ethics Regulations 238/2003 ) 34 ( ‫مادة‬ ‫للطبيب ابالغ النيابة العامة عن أى‬ ‫اعتداء يقع عليه بسبب أداء مهنته‬ ‫وفى ذات الوقت عليه ابالغ نقابته‬ ‫الفرعية في أقرب فرصة حتى يمكن‬ ‫لها التدخل في األمر متضامنة مع‬.‫الطبيب‬ The doctor can apologize to treat a patient except in emergencies on condition that he referred him/her to a colleague and give him/her full information Consent  Consent Profession Ethics Regulations 238/2003 Expressed Consent (Informed ) Implied Consent Special Circumstances Minors Patients with Impaired Mentation Beneficence Profession Ethics Regulations 238/2003 Beneficence Profession Ethics Regulations 238/2003 Good Standard  Nonmaleficence The concept that professionals have a duty to protect the patient from harm, especially if they cannot protect themselves. This protection is particularly evident in children and older adults as seen in abuse laws. Patient’s abandonment Health care professionals should avoid engaging in personal relationships with their patient (s) that could impair their professional judgment or risk the possibility of exploiting the confidence placed in them by a patient. It is unethical for a health-care professional to practice while abusing controlled substances, alcohol or other chemical agents which impair the ability to practice. If you have first-hand knowledge that a colleague is practicing their profession when impaired, you have an ethical responsibility to report such evidence to the professional assistance committee of the professional society or their professional licensing board  Justice Justice is the obligation to be fair to all people. Individuals have the right to be treated equally regardless of race, sex, marital status, medical diagnosis, social standing, economic level, or religious belief. The notion of justice is sometimes expanded to include equal access to health care for all. As with other rights, limits can be placed on justice when it interferes with the rights of others. Under the principle of Beneficence, professionals have a duty to act for the benefit of others ( timely and competent) The same ethical considerations apply whether the healthcare professional engages in fee-for-service, managed care or some other practice arrangement. Disclosure of Confidentiality Self harm )5 ( ‫مادة‬ ‫على الطبيب أن يبلغ السلطات الصحية المختصة عند االشتباه في مرض وبائى‬ Harm to others ‫حتى تتخذ اإلجراءات الوقائية لحماية المجتمع‬ Court order To other medical team member to improve patient care Public interest Medical practitioner is not allowed (according to Egyptian regulations 415/1954 & 238/2003) to: Medical practitioner is not allowed (according to Egyptian regulations 415/1954 & 238/2003) to: Medical Malpractice , responsibility and errors History of Medical Laws First to issue medical laws traced back to 2030 BC when the code of Hammurabi was set. The 6 royal books of medicine were a part of 42 royal books of ‘Tut the King of Wisdom’ in which they regulated the practice of medicine Egypt Abbas Basha was the 1st to issue the laws of medical service, in 1851 In 1852 barbers were prohibited of practicing medicine and surgery In 1860 Saiid Basha issued a law preventing pharmacies from giving medications without prescriptions. History of Malpractice In Pharaonic civilization it was a punishment if the doctor makes a mistake, it could amount to execution The Assyrian doctor make a mistake, he has to seek an excuse from the high authorities. As for the Greek, the doctor only punished for negligence and incompetence ‫ دار عالء‬،‫ شريعة حمورابي وأصل التشريع في الشرق القديم‬،‫ أسامة سراس‬/‫د‬ 121-125 ‫ص‬، 1222 ،‫ دمشق‬،‫ الطبعة الثانية‬،‫الدين‬ Medical Profession in Egypt Laws And Regulations That Govern Medical Practice Penal Code. The criminal law. Domestic Laws Code of Criminal Procedure. The civil law. Laws of medical profession and practice ( Law no.415/1954). Egyptian Codes of medical Ethics (Ministerial Decree No. Medical Laws 238/2003) ‫قانون العقوبات‪ :‬و هو قانون يصنف ما يرتكبه المواطن من جرم الى مخالفة أو جنحة أو جناية و يضع لكل منها حدود‬ ‫العقوبة وفى ما يمس عمل األطباء مثال‪:‬‬  ‫المواد ‪-: 264 - 260‬‬ ‫عن إجهاض المرأة الحامل "كل من اسقط عمدا امرأة حبلى بضرب او نحوه من انواع االيذاءات يعاقب باألشغال الشاقة المؤقتة" ‪.‬‬ ‫مادة ‪-: 238‬‬ ‫من تسبب خطا فى موت شخص اخر بان كان ذلك ناشئا عن اهمالة او رعونته او عدم احترازه او عدم مراعاته للقوانين والقرارات‬ ‫واللوائح واالنظمة يعاقب بالحبس مدة ال تقل عن سته اشهر وبغرامة ال تجاوز مائتى جنيه او بإحدى هاتين العقوبتين ‪.‬‬ ‫وتكون العقوبة الحبس مدة ال تقل عن سنة وال تزيد على خمس سنين وغرامة ال تقل عن مائة جنيه وال تجاوز خمسمائة جنيه او بإحدى‬ ‫هاتين العقوبتين اذا وقعت الجريمة نتيجة إخالل الجانى إخالال جسيما بما تفرضة عليه اصول وظيفتة او مهنته او حرفتة او كان متعاطيا‬ ‫مسكرا او مخدرات عند ارتكابه الخطأ الذى نجم عنه الحادث او نكل وقت الحادث عن مساعدة من وقعت عليه الجريمة او عن طلب‬ ‫المساعدة له مع تمكنه من ذلك ‪.‬‬ ‫وتكون العقوبة الحبس مدة ال تقل عن سنة وال تزيد على سبع سنين اذا نشا عن الفعل وفاة اكثر من ثالثة اشخاص ‪ ،‬فإذا توافر ظرف أخر‬ ‫من الظروف الواردة فى الفقرة السابقة كانت العقوبة الحبس مدة ال تقل عن سنة وال تزيد على عشر سنين ‪.‬‬ ‫مادة ‪-: 244‬‬ ‫من تسبب خطأ فى جرح شخص او ايذائة بان كان ذلك ناشئا عن اهمالة او رعونته او عدم احترازه او عدم مراعاته للقوانين والقرارات‬ ‫واللوائح واالنظمة يعاقب بالحبس مدة ال تزيد على سنة وبغرامة ال تجاوز مائتى جنيه او باحدى هاتين العقوبتين ‪.‬‬ ‫وتكون العقوبة الحبس مدة ال تزيد على سنتين وغرامة ال تجاوز ثالثمائة جنيه او احدى هاتين العقوبتين اذا نشا عن اإلصابة عاهة‬ ‫مستديمة او اذا وقعت الجريمة نتيجة إخالل الجانى إخالال جسيما ً بما تفرضة عليه اصول وظيفتة او مهنته او حرفتة او كان متعاطيا‬ ‫مسكرا او مخدرا عند ارتكابه الخطأ الذى نجم عنه الحادث او نكل وقت الحادث عن مساعدة من وقعت عليه الجريمة او عن طلب‬ ‫المساعدة له مع تمكنه من ذلك ‪.‬‬ ‫وتكون العقوبة الحبس اذا نشا عن الجريمة اصابة اكثر من ثالثة اشخاص ‪ ،‬فاذا توافر ظرف اخر من الظروف الواردة فى الفقرة السابقة‬ ‫تكون العقوبة الحبس مدة ال تقل عن سنة وال تزيد على خمس سنين ‪.‬‬ The duty of a medical professional is not always the duty to cure or to guarantee a good outcome from treatment. ‫بذل عنايه وليس تحقيق نتيجه‬ )‫أشعة – تجميل‬- ‫تحقيق نتيجه (معامل‬ Medical errors vs Complications Damage is not “44% of serious medical equivalent to a events were preventable” bad outcome. That means 44% of those claimed “known complications” were negligent medical errors.  ‫‪Complications‬‬ ‫‪Medical responsibility‬‬ ‫‪Criminal medical errors‬‬ ‫‪No penalty‬‬ ‫‪Tort‬‬ ‫‪Crime‬‬ ‫‪1. Listed bad outcome of‬‬ ‫‪1. Bad non intentional‬‬ ‫‪1. Bad outcome‬‬ ‫‪medical procedure‬‬ ‫‪outcome of medical‬‬ ‫‪2. Non- Specialized , non-‬‬ ‫‪2. Specialized , skilled‬‬ ‫‪procedure‬‬ ‫‪skilled physician exceeding‬‬ ‫‪physician within the job‬‬ ‫‪2. Specialized , skilled‬‬ ‫‪job description‬‬ ‫‪description‬‬ ‫‪physician within the job‬‬ ‫‪3. In a non- equipped‬‬ ‫‪3. In a well equipped medical‬‬ ‫‪description‬‬ ‫‪medical facility.‬‬ ‫‪facility.‬‬ ‫‪3. In a well equipped medical‬‬ ‫‪4. invalid or absent consent‬‬ ‫‪4. Valid consent‬‬ ‫‪facility.‬‬ ‫‪4. Valid consent‬‬ ‫المضاعفات‬ ‫المسئولية الطبيه‬ ‫األخطاء الطبيه الجنائيه‬ ‫العقوبه‬ ‫تعويض مادي‬ ‫حبس أو‪ /‬و تعويض مادي‬ ‫مضاعفات واردة ومذكورة في‬ ‫أذي نتج عن العالج أو التشخيص ‪.1‬‬ ‫‪.1‬‬ ‫أذي نتج عن العالج أو‬ ‫‪.1‬‬ ‫الدوريات والمراجع‬ ‫غير مقصود وغير وارد‬ ‫التشخيص‬ ‫الطبيب مؤهل ويقع العالج ضمن‬ ‫‪.2‬‬ ‫بالدوريات والمراجع‬ ‫الطبيب غير مؤهل أو غير‬ ‫‪.2‬‬ ‫اختصاصاته‬ ‫الطبيب مؤهل ويقع العالج ضمن‬ ‫‪.2‬‬ ‫متخصص‬ ‫المكان مؤهل لالجراء الطبي‬ ‫‪.3‬‬ ‫اختصاصاته‬ ‫المكان غير مالئم لإلجراء الطبي‬ ‫‪.3‬‬ ‫الموافقه المستنيره متوافقه‬ ‫‪.4‬‬ ‫المكان مؤهل لالجراء الطبي‬ ‫‪.3‬‬ ‫وتدارك المضاعفات منه‬ ‫والقانون‬ ‫الموافقه المستنيره متوافقه‬ ‫‪.4‬‬ ‫التوجد موافقه مستنيره أو غير‬ ‫‪.4‬‬ ‫والقانون‬ ‫قانونيه‬ Malpractice Can Be Divided Into Three Broad Categories Negligence In Malpractice Medical Liability Civil liability Criminal liability  Criminal Action A criminal action is one in which the state or government sues an individual for a wrongdoing considered against public interest. The Egyptian: Penal Code. The criminal law. Code of Criminal Procedure. ‫)‪Egyptian Civil Law (131/ 1948‬‬ ‫‪Article No.163‬‬ ‫ماده ‪ 163 -‬كل من ارتكب خطأ‬ ‫سبب ضررا للغير يلتزم بدفع‬ ‫التعويض"‬ In Cases Of Medical Malpractice, The Patient Has The Burden Of Proof For Four Elements: The physician owed the patient a duty of care. The Physician's care fell below an acceptable standard. The plaintiff had sustained an injury or damages. The negligence was a proximate cause of the injury or damages.  Professional Misconduct Being convicted of a crime. Practicing fraudulently. Practicing beyond the scope of the practice permitted by law. Refusing a client or patient’s service because of creed, color or national origin. Permitting or aiding an unlicensed person to perform activities without a license. Being habitually drunk, being dependent on or a habitual user of narcotics or other drugs with similar effects.  Professional Misconduct If a practitioner is guilty of dishonorable or disgraceful conduct, the medical council takes a disciplinary action against him. According to the gravity of the offence, the ‫قانون الخدمة المدنية رقم ‪ 81‬لسنة ‪2016‬‬ Revocation From Medical Registry Refraining of paying the annual subscriptions. Discontinuity of practicing medicine or death. Conviction of misconduct, malpractice or criminal offence by the disciplinary committees of the syndicate. Restoration of registration is possible after 2 year at least. Research Regulations ‫‪Core Ethical Principles‬‬ ‫مادة (‪ : ) 52‬يلتزم الطبيب بمراعاة تنفيذ كافة المعايير والضوابط األخالقية والقيم‬ ‫االجتماعية والدينية التى تضعها السلطات المختصة إلجراء البحوث الطبية على اآلدميين‬  1- Scientific Merit ‫ يحظر على الطبيب إجراء أية تجارب لألدوية والتقنيات على اآلدميين قبل إقرارها‬: ) 53 ( ‫مادة‬. ‫من الجهات المختصة‬ Justifiable on scientific grounds. The project should be based on : thorough knowledge of the literature on the topic previous laboratory and, animal research (conform to ethical guidelines). minimize the number of animals used prevent unnecessary pain.  0002023B 3- Risks and Benefits The risks to the research subjects should not disproportionate to the expected benefits. A likely risk of a serious harm would be unacceptable unless the project provided the only hope of treatment for terminally ill research subjects. ‫ يلتزم الطبيب الباحث قبل إجراء أى‬: ) 54 ( ‫مادة‬ ‫بحث طبى على اآلدميين أن تتوافر لديه دراسة‬ ‫وافية عن المخاطر واألعباء التى يتعرض لها الفرد‬ ‫أو الجماعة ومقارنتها بالفوائد المتوقع الحصول‬ If the risk is entirely unknown, then ‫عليها من البحث‬ the researcher should not proceed with the project.  Informed Consent Voluntary agreement to participate, based on understanding  Informed Consent The voluntary consent of the human subject is absolutely essential. Nuremberg Code For all biomedical research involving human subjects, the investigator must obtain the informed consent of the prospective subject…or authorized representative. CIOMS guidelines “To the degree subjects are capable, they should be given the opportunity to choose what shall or shall not happen to them”. The Belmont Report  ‫المادة (‪)60‬‬ ‫لجسد اإلنسان حرمة‪ ،‬واالعتداء عليه‪ ،‬أو تشويهه‪ ،‬أو التمثيل به‪ ،‬جريمة يعاقب‬ ‫دستور مصر ‪2014‬‬ ‫عليها القانون‪.‬ويحظر اإلتجار بأعضائه‪ ،‬واليجوز إجراء أية تجربة طبية‪ ،‬أو‬ ‫‪Egyptian‬‬ ‫علمية عليه بغير رضاه الحر الموثق‪ ،‬ووفقا لألسس المستقرة فى مجال العلوم‬ ‫‪constitution , 2014‬‬ ‫الطبية‪ ،‬على النحو الذى ينظمه القانون‪.‬‬ ‫مادة )‪(56‬‬ ‫الئحة آداب المهنة الصادرة‬ ‫يلتزم الطبيب الباحث بالحصول على موافقة كتابية(مبنيه على المعرفة) من‬ ‫بقرارمعالى ‪ /‬وزير الصحة‬ ‫المتطوع على اجراء البحث عليه ‪ ،‬وذلك بطريقة رسمية وفى حضور شهود‬ ‫والسكان رقم ‪ 238‬لسنة ‪2003‬‬ ‫بتاريخ ‪ 5‬سبتمبر‬ ‫أثبات وفى حالة ما ان كان المتطوع قاصرا أو معاقا أو ناقص لالهلية فأنة يلزم‬ ‫‪Egyptian medical‬‬ ‫الحصول على الموافقة من الموصى الرسمى أو القيم‪ ،‬ويشترط أن يكون البحث‬ ‫‪regulations‬‬ ‫خاصا بحالته المرضية‪.‬‬  ‫مادة (‪: ) 58‬‬ ‫كما يلزم ضمان حماية خصوصية األفراد وسرية النتائج‬ ‫والحفاظ عليها والحد من اآلثارالسلبية على سالمة‬ ‫املتطوعين الجسدية والعقلية والنفسية‪.‬‬ ‫‪Confidentiality‬‬  Clash between confidentiality & need to share data Anonymizing data Genetic research raises some particular problems Information is about families, not individuals Duty/right to inform relatives of risks we discover? Medical Responsibilities In Research  Path Of The Review Process And Time Frame Preclinical (Articles 4-9) EDA (15 days for Application and required documents & 60 days for NO response in 60 days in each = approval Decision + 30 days for Notification) IRB EDA 1- Non Supreme Council of International multi interventional or In case of rejection, research center Studies Non CT IRB the decision should In case of rejection, including foreign be justified 2- Interventional the decision should countries CT be justified Security approval 60 days 60 days 60 days Article 18 After the end of the research ( 60 days) After  Higher 3 Supreme Council For Education Ethical Review of Clinical Research public MOHP (SCERCR)- article 6- figures 3 2 law Council of Scientific State research 1 2 Ministry 4 years to be Drug 1 of interior extended once Authority 1 National Defense 1 Security 1  CT Phases (Article -17) Phases III and IV clinical trial Tested in one of the reference countries simultaneously. Reviewing the results of pre-clinical study by the Egyptian Drug Authority (EDA) , and the results of the first and second phases of clinical trial conducted in the country of origin are reviewed and approved by EDA and the Supreme Council. The second phase clinical trial Regional diseases that do not exist in the country of origin and Rare diseases as approved by the Supreme Council.  Penalties and Responsibilities Articles 25-32 Who conduct a study without informed consent imprisonment Permanent infirmity Rigorous imprisonment Death 10 years Rigorous imprisonment Sponsor and PI violation of duties and responsibilities imprisonment and fine (50,000 LE) Refrains from providing medical care 10,00-50,000 LE Doubled in case of adverse effects and complications and Imprisonment and 100,000-500,000 LE in case of Serious Adverse Event (SAE) Escalation of penalties in cases of multiple victims Clinical Research Center (CRC) not conforming the requirements listed by law 100,000-500,000 LE SAE 500,000-1000,000 LE Who transfer human samples without approvals: Human Rights and Patient’s Right Justice and Health Justice And Health Legal justice Rights-based justice Social justice Distributive justice  Justice And Health Justice in relation to healthcare… “Providing access to some level of health care to all members of a society is a requirement of justice because of the importance of health care to people’s opportunity, wellbeing and life itself” Brock, DW, Fairness and Health 2003 Relevant legislations 1. Egyptian Constitution 2014 Egyptian constitution 2014 addresses inequity in health care, social Justice and human rights Egyptian Constitution , 2014 Egyptian Constitution , 2014 Universal Health Coverage Law (2/2018) The beneficiaries of the Universal Health Insurance Law Mandatory subscription to the new health insurance system will be for all Egyptians (optional for Egyptians working or staying with their families aboard). Fees are being set according to income, and Additional sources of funding to include taxes on the tobacco industry and other supplementary areas. The government has committed to provide the policy free of charge to approximately 25% of the population who cannot afford it. Why Human Rights Is A Prominent Issue? History of modern human rights The Universal Declaration of Human Rights (UDHR) Declared by the United Nations General Assembly in 1948 Response to barbarism of World War II Nazi Experiments A prisoner in a compression chamber loses consciousness (and later dies) during an experiment to determine altitudes at which aircraft crews could survive without oxygen. Dachau, Germany, 1942..  The Universal Declaration of Human Rights (UDHR) 1948 Human rights are part of the "foundation of freedom, justice and peace in the world“ A Human Rights Based Approach (HRBA) In Healthcare Involves recognizing that some groups are more vulnerable to abuses or poor protection of human rights and less empowered to challenge this, e.g. ▪ Refugees and asylum seekers ▪ Homeless people ▪ Mental health service users ▪ People with learning disabilities Routinely consider human rights in decision making Avoid discrimination Avoid discrimination Avoid discrimination Treating people fairly Treating people fairly  Everyone is treated the same and provided the same resources to succeed. For example, a health clinic in a small village can be open to everyone. inequity of care Some villagers may lack the means to get to the village, or may not be able to afford medication.  Rather than providing equal resources for all, health equity solutions examine and try to remove the underlying causes of health disparities. In the example above, health care workers might provide mobile care to reach villagers who cannot come to the clinic. The distinction between diversity and Discrimination  Discrimination in providing health care is unlawful and in breach of professional guidelines in most situations However, treating individuals or groups differently might be lawful and desirable in specific circumstances Taking account of diversity... Often referred to as differential rather than discriminatory treatment Examples include: – Services or facilities may sometimes be designed for specific groups – People with serious mental health problems may sometimes be forced to accept treatment We are all protected from unlawful discrimination by Egyptian Constitution Article (53) All citizens are equal before the Law. They are equal in rights, freedoms and general duties, without discrimination based on religion, belief, sex, origin, race, color, language, disability, social class, political or geographic affiliation or any other reason. We are all protected from unlawful discrimination by Egyptian Constitution Article (53) Discrimination and incitement of hatred is a crime punished by Law. The State shall take necessary measures for eliminating all forms of discrimination, and the Law shall regulate creating an independent commission for this purpose.  ‫مشروع قانون تكافؤ الفرص وحظر التمييز‬ law for Equal Opportunities and Prohibition of Discrimination Article 7 7 ‫ماده‬ Areas of occurrence of discrimination: This law applies to all state institutions, to legal persons practicing a state business, and to the actions of legal and natural persons, especially in these areas: 1- Work and working conditions (including advertising, employment, selection and promotion criteria, obtaining equal pay, obtaining training, retraining, and vocational guidance). 2- Education and culture and its activities. 3- Sports. 4- Social Security (including pension, health insurance, and unemployment benefit). 5- Health care. 6- housing. 7- Getting goods and services.  Examples Of Good Practice In Delivering Equitable Healthcare Practitioners can identify common areas of intervention for addressing health equity within practice through: 1 Linking patients with supportive community programs and services Asking questions about a patient’s social and economic 2 circumstances Integrating considerations of social and economic conditions 3 into treatment planning (i.e. cost of medications) Advocating for changes to support improvements in the social 4 and economic circumstances of the community Undertaking advocacy on behalf of individual patients (i.e., 5 letters about the need for safer housing) Adopting equitable practice design (i.e., flexible office hours, 6 convenient practice location)  Patients’ Bill of Rights Historical Background In 1973, the American Hospital Association's House of Delegates adopted A Patient’s Bill of Rights, which was influential in the development of similar documents in other parts of the world. The first revision of the document was approved in 1992. The American Hospital Association encourages health care institutions to tailor this bill of rights to their patient community by translating and/or simplifying the language of this bill of rights as may be necessary to ensure that patients and their families understand their rights and responsibilities. 105 Friday, September 6, 2024  Patients’ Bill of Rights Purposes The Patient's Bill of Rights was created to try to reach 3 major goals: 1. To help patients feel more confident in the health care system; as the Bill of Rights: Assures that the health care system is fair, and it works to meet patients' needs Gives patients a way to address any problems they may have Encourages patients to take an active role in staying or getting healthy 2. To stress the importance of a strong relationship between patients and their health care providers 3. To stress the key role patients play in staying healthy by laying out rights and responsibilities for all patients and health care providers 106  Patients’ Bill of Rights -“Situation in Egypt” Since the late nineties, the accreditation of health programs in Egypt has attempted diverse legal and administrative mechanisms to deal with patients’ rights, and a detailed statement of patients’ rights has been developed. However, in MOH governmental hospitals in Egypt, typically only a short list of rights can be found as follows: The statement of patients’ rights in Egyptian MOH governmental health facilities. Patients have the right to: 1. Privacy: The patient has the right for his privacy to be respected during clinical examination. 2. Knowledge: The patient has the right to receive accurate information concerning diagnosis, treatment, risks involved, and prognosis of an illness or health-related condition. 3. Confidentiality: The patient has the right of confidentiality: the information a patient reveals to a health care provider is private and sensitive and has limits on how and when it can be disclosed to a third party. 4. Respect and Care: The patient has the right to receive humane care and treatment, with respect and consideration. 5. Quality Care: The patient has the right to receive quality health service. 6. Raising Complaints/Suggestions: The patient has the right to file a complaint regarding any concerns related to confidentiality or the quality of his health care. 107 Prof. Dina Shokry Best Wishes [email protected] Thank you