Organ Transplantation Donor Referrals: What Does the Law State? 7 May 2011 On behalf of Roche Wanderers Club By Esmé P

Organ Transplantation • Donor Referrals: • What Does the Law State? • 7 May 2011 • On behalf of Roche • Wanderers Club • By • Esmé Prins-Van den Berg • Benguela Health © Benguela Health (Pty) Ltd 2011

Questions - Framework • Donor referral becomes a problem: Can mortuary staff inform a coordinator of a death and can the coordinator approach the family for cornea / bone? • Can we set up a toll free tel number for donor referral in the country? If someone phones and refers an ICU case, have they breached the constitution? Are there prerequisites before they can phone, or can they phone and leave it to the coordinator to make the approach - direct to family or via physician? Can the Primary physician object and go to council? • Who may refer? May coordinators scout ICU's? May clinics generate a potential donor info sheet i.e. record of all deaths in a hospital for improving donor referral? May a coordinator bypass the primary physician and approach family directly? • Basically what are the rules that govern donor referral - hospital and mortuary? © Benguela Health (Pty) Ltd 2011

Agenda • Different Approaches to Organ Procurement • Constitution • Relevant Legislation • Relevant Ethical Rules • Practical Application © Benguela Health (Pty) Ltd 2011

Different Approaches to Organ Procurement © Benguela Health (Pty) Ltd 2011

Different Approaches Internationally • Explicit consent • SA, USA • Scarcity of Organs • Routine salvaging upon death • No patient consent • Procurement of organs even if patient objected before his/her death • Right to self-determination disregarded • Direct contravention of section 12 of SA Constitution • China • Presumed consent or “opting out” system • Unless objection raised during lifetime • Consent assumed upon death for organ removal • Failure to indicate refusal = implicit statement of consent • Austria, France, Belgium, Spain © Benguela Health (Pty) Ltd 2011

Constitution of SA © Benguela Health (Pty) Ltd 2011

Right to Bodily and Psychological Integrity: Section 12 • Protects Right to Bodily and Psychological Integrity • Which includes the right • To make decisions concerning reproduction • To security in and control over their body and • Not to be subjected to medical/scientific experiments without informed consent • Implies right to give or refuse informed consent • No person’s organs may be procured for transplant purposes without lawful consent • Human Tissue Act and National Health Act: Organ procurement requires explicit consent • If organs are procured without explicit consent, doctor/health care centre liable for assault, breach of contract and iniuria • Cadaveric organ donors: Removal without consent = violating corpse © Benguela Health (Pty) Ltd 2011

Right to Privacy: Section 14 • Right to Privacy • Everyone has right to privacy • Includes right not to have • Their person / home searched • Their property searched • Their possessions seized or • Privacy of their communications infringed • Various pieces of legislation e.g. National Health Act, Protection of Personal Information Bill (POPI)(in pipeline) • Does a deceased person have a right to privacy? © Benguela Health (Pty) Ltd 2011

Right of Access to Information: Section 32 • Right of Access to Information • Section 32: Everyone has the right of access to • Any information held by the state and • Any information held by another person and That is required for exercise or protection of any rights • National legislation must be enacted to give effect to this right and may provide for reasonable measures to alleviate administrative and financial burden on state……Promotion of Access to Information Act © Benguela Health (Pty) Ltd 2011

Privacy Protection • Constitutional rights not absolute…competing rights e.g. right to privacy vs right of access to information…..balance • Limitation of Rights: Section 36 • Rights in Bill of Rights may be limited by law of general application to extent that limitation is reasonable and justifiable in open and democratic society based on human dignity, equality and freedom, taking into account all relevant factors, including • Nature of right • Importance of the purpose of limitation • Nature and extent of limitation • Relation between limitation and its purpose and • Less restrictive means to achieve purpose • Examples • Promotion of Access to Information Act (PAIA) • Protection of Personal Information Bill (POPI) © Benguela Health (Pty) Ltd 2011

Relevant Legislation © Benguela Health (Pty) Ltd 2011

Protection of Privacy in Legislation and Ethical Rules • Extensive regulatory and ethical framework e.g. • National Health Act • Promotion of Access to Information Act • Medical Schemes Act • Protection of Personal Information Bill • Children’s Act • Mental Health Care Act • Medicines and Related Substances Act • Choice on Termination of Pregnancy Act • Sterilisation Act • Electronic Communications and Transactions Act • Ethical Rules and relevant Acts (e.g. Health Professions Act) pertaining to practitioners such as doctors, nurses, pharmacists and allied health practitioners • Patients’ Rights Charter © Benguela Health (Pty) Ltd 2011

National Health Act • Section 14 • All information concerning user, including information relating to health status, treatment or stay in health establishment = confidential • E.g. state of health, in ICU, deceased • No person may disclose such information unless • Written consent by user (or person authorised) • Required by court order or any law or • Non-disclosure presents serious risk to public health • Definitions • User • Health establishment © Benguela Health (Pty) Ltd 2011

Definition of User • User = • Person receiving treatment in health establishment, including receiving blood/blood products or using health service and • If person receiving treatment or using health service is • Below age contemplated in section 39(4) of Child Care Act (Children’s Act), it includes person’s parent or guardian or another person authorised by law to act on patient's behalf or • Incapable of taking decisions, it includes person’s spouse/partner or in absence of spouse/partner, person’s parent/grandparent/adult child/brother/sister or another person authorised by law to act on patient’s behalf • = Patient or next-of-kin © Benguela Health (Pty) Ltd 2011

Definition of Health Establishment • Health establishment = • Whole or part of public or private institution, facility, building or place, whether for profit or not, that is operated or designed to provide inpatient or outpatient treatment, diagnostic or therapeutic interventions, nursing, rehabilitative, palliative, convalescent, preventative or other health services • E.g. Hospital, consulting rooms, but not a mortuary © Benguela Health (Pty) Ltd 2011

Protection of Personal Information Bill • Tabled in parliament • Regulations to be issued • Implementation • Give effect to Constitutional right to privacy • Safeguarding of personal information • Comprehensive regulation of processing, storage and disclosure of confidential information • Significant implications for persons / entities receiving, processing and/or storing personal information © Benguela Health (Pty) Ltd 2011

Application of Act • Act applies to • Processingof personal information entered into a record • Public and private bodies • Certain exemptions • National security, public defence, etc. • Information in purely household activity • Cabinet and Committees • De-identified information that cannot be re-identified • Exemption granted by Information Protection Regulator • Processing = Any operation or activity concerning personal information, including: • Collection, receipt, recording, organisation, collation, storage, updating, modification, retrieval, alteration, consultation or use • Dissemination, distribution or making available in any other form • Merging, linking, blocking, degradation, erasure or destruction of information © Benguela Health (Pty) Ltd 2011

Application of Act • Record • Any recorded information regardless of form or medium, including • Writing on any material • Information produced, recorded or stored by means of tape-recorder, computer equipment, etc. and material subsequently derived from information so produced, recorded or stored • Label, book, map, plan, graph or drawing • Photograph, film, negative, tape • Irrespective of by whom and when created © Benguela Health (Pty) Ltd 2011

Personal Information: Definition • Information relating to identifiable, living natural person / existing juristic persons, including, but not limited to • Information relating to race, gender, sex, pregnancy, marital status, national, ethnic or social origin, colour, sexual orientation, age,physical or mental health, well-being, disability, religion, conscience, belief, culture, language and birth of the person • Information relating to education or medical, financial, criminal or employment history • Any identifying number, symbol, e-mail address, physical address, telephonenumber or other particular assignment to person • Blood type or any other biometric information • Personal opinions, views or preferences of person • Correspondence sent by the person that is implicitly or explicitly of private or confidential nature or further correspondence that would reveal contents of original correspondence • Views or opinions of another individual about person • Name of person if it appears with other personal information relating to person or if disclosure of name itself would reveal information about person © Benguela Health (Pty) Ltd 2011

Processing of Special Information • Processing of info about child under parental control or person’s healthonly permitted in certain circumstances • General exceptions • Parental consent provided • Necessary for exercise or defence of right / obligation in law • Obligation in international public law • Information Protection Regulator has granted authority • Consent of data subject • Info in public domain (disclosed by data subject) • Specific exceptions related to health • Medical professionals, health care institutions permitted if necessary for proper treatment and care of data subject or for administration of institution / professional practice • Processing only allowed by virtue obligation of confidentiality by profession (e.g. Ethical Rules) • If no such obligation, obligation of confidentiality imposed © Benguela Health (Pty) Ltd 2011

Regulator Allows Processing • Regulator may allow processing if • Public interest • State security • Prosecution of offences • Important economic or financial interests of state • Compliance with legal provisions • Historical, statistical or research activity • Processing involves clear benefit to data subject or third party which outweighs any interference with privacy © Benguela Health (Pty) Ltd 2011

Ethical Obligations © Benguela Health (Pty) Ltd 2011

Ethical Obligations • Ethical Rules of HPCSA • Rule 13: Professional confidentiality • Practitioner may only divulge verbally or in writing information regarding patient which he/she ought to divulge • In terms of statutory provision • At instruction of court of law or • Where justified in public interest • Other information may only be divulged • With express consent of patient • In case of minor <12 years with written consent of his/her parent or guardian or • In case of deceased patient with written consent of his/her next-of-kin or executor of the estate • Other statutory councils have similar obligations © Benguela Health (Pty) Ltd 2011

Guidelines for Good Practice (HPCSA): Protecting and Providing Information (Booklet 14) • Any practitioner receiving personal health information has legal duty of confidence to protect confidentiality • Practitioners must always be able to justify their actions • Obtain consent where possible • Automatic transfer of personal health information to registry whether by electronic or other means = unacceptable unless patient informed thereof • Practitioner to be satisfied that appropriate arrangements for security of personal health information when stored, sent or received by electronic means © Benguela Health (Pty) Ltd 2011

Personal Information: Definition • Information relating to identifiable individual including, but not limited to • Information relating to race, gender, sex, pregnancy, marital status, national, ethnic or social origin, colour, sexual orientation, age,physical or mental health, well-being, disability, religion, conscience, belief, culture, language and birth of the person • Information relating to education or medical criminal or employment history • Any identifying number, symbol or other particular assignment to person • Address, fingerprints or blood type • Personal opinions, views or preferences of person • Correspondence sent by the person that is implicitly or explicitly of private or confidential nature or further correspondence that would reveal contents of original correspondence • Views or opinions of another individual about person • Name of person if it appears with other personal information relating to person or if disclosure of name itself would reveal information about person BUT: Excludes info of individual who has been dead for more than 20 years • Includes information about deceased for purposes of organ transplants © Benguela Health (Pty) Ltd 2011

Promotion of Access to Information Act • Prohibits unreasonable disclosure of personal information about 3rd party • Compulsory ito PAIA for public and private persons/bodies to allow access to records under their control if prescribed requirements met • Forms • Fees • Access to recordsmust be given to a requester if • Record is required for exercise or protection of any right • Requester complies with procedural requirements pertaining to request for access and • Access is not refused on any legal ground as provided for in Act © Benguela Health (Pty) Ltd 2011

Promotion of Access to Information Act • General rule is that person whose personal information is recorded in records or his/her authorised representative must consent to disclosure • Special provisions relating to disclosure of health records to patients/requesters on their behalf • In certain instances access to records must be refused as it would result in disclosure of: • Commercial information of third party and private body • Records privileged from production in legal proceedings • Research information of third party and private body or • It would amount to unreasonable disclosure of personal information about third party, which includes deceased person © Benguela Health (Pty) Ltd 2011

Promotion of Access to Information Act • Disclosure of records may not be refused in certain prescribed instances such as: • Person concerned has provided written consent as required in terms of Act or otherwise for disclosure • Information is already publicly available • Information contained in record concerns physical or mental health or well-being of person who is under care of requester and who <18 years or unable to understand nature of request and giving access would be in person's best interest and • Information concerns deceased person and request is made by next-of-kin or with their written consent • Application to organ transplants © Benguela Health (Pty) Ltd 2011

Principles • Privacy of personal (health) information is protected by law • Health care practitioners have legal and ethical duties to protect confidentiality • Disclosures require informed consent of relevant person • Consent should preferably be in writing • All processes, procedures and agreements should reflect commitment to safeguard confidentiality of personal health information • Staff should be aware and contractually bound to safeguard privacy of personal health information © Benguela Health (Pty) Ltd 2011

Questions • Donor referral becomes a problem: Can mortuary staff inform a coordinator of a death and can the coordinator approach the family for cornea / bone? • No • Breach of privacy • Mortuary staff should rather contact the family to make contact with the coordinator or ask permission to provide info about deceased to coordinator © Benguela Health (Pty) Ltd 2011

Principles • Can we set up a toll free tel number for donor referral in the country? If someone phones and refers an ICU case, have they breached the constitution? Are there prerequisites before they can phone, or can they phone and leave it to the coordinator to make the approach - direct to family or via physician? Can the Primary physician object and go to council? • Toll free number without empowering legislation will not be effective due to potential breaches of privacy • Basic principle of privacy protection applies • Health care practitioners should rather discuss a particular case with the family • Obtain permission for coordinator to contact them or ask family to contact coordinator © Benguela Health (Pty) Ltd 2011

Principles • Who may refer? May coordinators scout ICU's? May clinics generate a potential donor info sheet i.e. record of all deaths in a hospital for improving donor referral? May a coordinator bypass the primary physician and approach family directly? • Principle of privacy protection • Health care practitioners have access to info • Health care practitioners should approach families • Coordinators scouting ICUs – breach of privacy • List of deaths for donor purposes: Consent • Doctor-patient relationship © Benguela Health (Pty) Ltd 2011

Principles • Basically what are the rules that govern donor referral - hospital and mortuary? • Right to privacy • Consent • Public interest? • Require specific legislative dispensation to improve donor referrals e.g. presumed consent unless otherwise indicated © Benguela Health (Pty) Ltd 2011

Organ Transplantation Donor Referrals: What Does the Law State? 7 May 2011 On behalf of Roche Wanderers Club By Esmé P