When a doctor is required to go to court, he does so with some amount of trepidation. The degree of trepidation increases in direct proportion as to whether he is required to be a witness or a defendant. The practice of medicine on the other hand requires the patient to have full confidence and open out his secrets to the doctor. If you hold back vital information, the diagnosis may be entirely different to the disease that you have. Lawyers who enter hospitals may also do so with some trepidation, maybe even more so than doctors who enter courts, as their lives are at stake. There is a perception that medico-legal matters are on the rise. We may put forward a few reasons for this: 1. A better educated and increasingly assertive public with greater awareness of the medical and legal systems; 2. Rising expectations of medical results; 3. Commercialization of medical care with erosion of the doctor-patient trust relationship. This paper will discuss the reasons for and the ways to address medical errors as well as explore the reasons for defensive medicine. The argument is put forward that public education programs on the risks inherent in some of the new advances in treatment modalities and surgery and professional education programs on the need for obtaining the patient's informed consent to such treatment is needed. Public advocacy programs to demonstrate the problems in medicine and the delivery of health care resulting from strict cost containment limitations should be carried out. There is also the need to enhance the level and quality of medical education for all physicians, including improved clinical training experiences. Doctors' must manage their clinical affairs in a professional manner without being dictated to by the legal system. However, it would be wise to take note of the views expressed by learned counsel and judges in their courts. The middle road is always the best and we must never be extreme in our viewpoints. We must always remember the patient is why we are here and the patient must never suffer in the process while we formulate our responses to the medico-legal challenges that lie ahead.
Matched MeSH terms: Legislation, Medical*; Medical Errors/legislation & jurisprudence*
Medico-legal problems experienced by histopathologists differ from those of other clinicians as they are rarely in direct contact with patients. Nevertheless, the pathologist owes a duty of care to the patient and is liable for medical negligence. In the absence of local guidelines, it is prudent to follow guidelines published by learned Colleges elsewhere. This is also true when delegating duties to non-pathologists, technical and other support staff. Errors in diagnosis and documentation pose the most common problems in histopathology. In this, liability also depends on many factors including the provision of adequate clinical information by clinicians and competence of laboratory staff. Clinicopathological discussions, participation in quality assurance programmes and adherence to standard operating procedures are important audit activities to minimize and detect errors as well as prevent grievous outcome to patients. Issues also arise over the retention of specimens and reports. In general, wet, formalin-fixed tissues should be kept until histopathological assessment is finalized and preferably after clinicopathological sessions, and even longer if there is potential litigation. Reports should be archival. Paraffin blocks should be kept for at least the lifetime of the patient, and histology slides for at least 10 years, to facilitate review and reassessment. Despite adverse publicity in the foreign press over the use of human organs and tissues for research and education, it is accepted that processed tissues can be used for research and educational purposes provided the patient's identity is kept confidential. Nevertheless, it would be prudent to revise consent forms for surgery and autopsies to include the possibility that tissues removed can be stored or used for research and education. Good medical practice in pathology encourages a willingness to consult colleagues when in doubt, but advises that the treating clinician be informed if histopathological material is referred away for a second opinion. The Telemedicine Act of Malaysia (1997) requires practitioners outside Malaysia providing diagnosis through telepathology to hold a certificate to practice telemedicine issued by the Malaysian Medical Council. It is likely that the medico-legal scene in histopathology will change in the coming years with the advent of other new ancillary investigative techniques.
Cyberattacks have changed dramatically and have become highly advanced. This latest phenomenon has a massive negative impact on organizations, such as financial losses and shutting-down of operations. Therefore, developing and implementing the Cyber Security Operations Centre (SOC) is imperative and timely. Based on previous research, there are no international guidelines and standards used by organizations that can contribute to the successful implementation and development of SOC. In this regard, this study focuses on highlighting the significant factors that will impact and contribute to the success of SOC. Simultaneously, it will further design a model for the successful development and implementation of SOC for the organization. The study was conducted quantitatively and involved 63 respondents from 25 ministries and agencies in Malaysia. The results of this study will enable the retrieval of ten success factors for SOC, and it specifically focuses on humans, processes, and technology. The descriptive analysis shows that the top management support factor is the most influential factor in the success of the development and implementation of SOC. The study also contributes to the empirical finding that technology and process factors are more significant in the success of SOCs. Based on the regression test, the technology factor has major impact on determining the success of SOC, followed by the process and human factors. Relevant organizations or agencies can use the proposed model to develop and implement SOCs, formulate policies and guidelines, strengthen human models, and enhance cyber security.
The concept of informed consent specific to medical research and treatment is still alien to many medical researchers and practitioners and to millions of Indians. The doctor-patient relationship in India is governed more by trust where the doctor is the authoritative person. Therefore, the benefit of informed consent does not reach all patients in day-to-day medical practice. To complicate the issue, the Indian law is not specific about the age at which a person can give valid consent. The Indian Penal Code is silent about the legal validity of consent given by persons between 12 and 18 years of age. Similarly, the age at which the 'Right to Confidentiality' begins is yet to be defined either by the statute or by the courts. Hence, there is a need for a clear statutory provision to remove the anomalies and ambiguities regarding the age of consent to undergo invasive therapeutic or investigative procedures, participate in clinical trials, as well as define the age at which a person's right to medical confidentiality begins.
When instances of fraud in biomedical publishing come to light there is widespread indignation, not least because the consequences seem usually only to be internal enquiries and professional displeasure. A number of bodies have been constituted to improve publishing ethics and but these are largely advisory. Potentially though, actions in the tort of deceit and negligence, possibly misfeasance in a public office, and loss of chance could be brought against those responsible. These aspects are examined in the context of English law. In addition the new Fraud Act (2006) appears to be wide enough in scope to cover publishing fraud as a criminal offence. Any organisation such as a drug company financing clinical trials which produce spurious results could face serious losses and might well look to remedies in contract as well as in tort. A theoretical scenario centered on a drug trial is presented in order to explore these issues.
Different regulatory guidelines recommend establishing stability profile of pharmaceuticals at the time of drug development. The expiry date, retesting period and storage conditions of active drugs or products are established through stability analysis. Several regulatory guidelines exist for stability testing of pharmaceuticals. Mostly, ICH stability guidelines are followed in practice. This guideline recommends to validate stability indicating method using forced degradation samples that contains all possible degradation impurities. ICH guidelines provide general recommendations for inclusion of stability indicating parameters in a stability testing protocol. However, those guidelines do not provide specific requirements and experimental methodology to be followed for stability studies. Due to this gap, often confusion arises in the scientific community in designing stability testing protocol. Therefore, significant variations are observed in reported literature in selection of stability indicating parameters. Procedural dissimilarity amongst reported stability studies is also evident. This review discusses the regulatory guidelines and procedures to follow in performing stability testing of pharmaceuticals. Scope of this review also includes recommendations on practical approaches for designing stability testing protocol to fulfill current regulatory requirements for drug substances and their formulations.
Medical negligence suits have become an issue of concern for doctors as well as for the health service departments. The main objectives of medical malpractice law are to compensate patients who are injured by negligence and to improve the quality of medical care. The amount of money and time spent on these cases may not be an effective allocation of social resources to minimize patient safety. Though physicians generally win more malpractice suits, much time and money are spent and results in much stress to those concerned. There are certain controllable events in practice that render a physician more or less vulnerable to malpractice claims. Attempts by physicians to understand and prevent unwanted situations that can lead to litigation is important. The risk factors for medical negligence suits are discussed. The practice of good medicine will be the best form of risk management.
This review includes the situation of nutrition labelling and claims in six countries in South-East Asia: Brunei, Indonesia, Malaysia, Philippines, Singapore and Thailand. With the exception of Malaysia, there is no mandatory nutrition labelling requirements for foods in these countries except for special categories of foods and when nutritional claims are made for fortified or enriched foods. Nevertheless, several food manufacturers, especially multinationals, do voluntarily label the nutritional content of a number of food products. There is, therefore, increasing interest among authorities in countries in the region to start formulating regulations for nutrition labelling for a wider variety of foods. Malaysia has proposed new regulations to make it mandatory to label a number of foodstuffs with the four core nutrients, protein, carbohydrate, fat and energy. Other countries have preferred to start with voluntary labelling by the manufacturers, but have spelt out the requirements for this voluntary labelling. The format and requirements for nutrition labelling differ widely for countries in the region. Some countries, such as Malaysia, closely follow the Codex guidelines on nutrition labelling in terms of format, components to be included and mode of expression. Other countries, such as the Philippines and Thailand, have drafted nutrition labelling regulations very similar to those of the Nutrition Labeling and Education Act (NLEA) of the United States. Nutrition and health claims are also not specifically permitted under food regulations that were enacted before 1998. However, various food products on the market have been carrying a variety of nutrition and health claims. There is concern that without proper regulations, the food industry may not be certain as to what claims can be made. Excessive and misleading claims made by irresponsible manufacturers would only serve to confuse and mislead the consumer. In recent years, there has been efforts in countries in the region to enact regulations on nutrition claims. Recently enacted regulations or amendments to existing regulations of almost all the countries reviewed have included provisions for nutrition claims. Malaysia is in the process of gazetting regulations to clearly stipulate the permitted nutrition claims and the conditions required to make these claims along the guidelines of Codex Alimentarius Commission. Only two countries in the region permit health claims to be made - Indonesia and Philippines. Other countries in the region are following developments in Codex and examining the need for allowing these claims. There are more differences than similarities in the regulations on nutrition labelling and claims among countries in the South-East Asian region as no previous efforts have been made to address these. Hopefully, through this first regional meeting, countries can initiate closer interaction, with a view to working towards greater harmonization of nutrition labelling and health claims in the region.
Four formal rounds of Trans-Pacific Partnership Agreement (TPPA) negotiations took place in 2010. They involved over 200 officials from Australia, the United States, New Zealand, Chile, Singapore, Brunei, Peru, Vietnam and Malaysia. Future negotiations officially are set to include three issues with public health and medicines policy implications for Australia and our region: ways to approach regulatory coherence and transparency; how to benefit multinational and small-medium enterprises; and multilateral investor-state dispute settlement. US-based multinational pharmaceutical companies are lobbying for TPPA provisions like those in the Australia-US Free Trade Agreement, which reduce government cost-effectiveness regulatory control of pharmaceuticals, threatening equitable access to medicines. They also advocate increased TPPA intellectual monopoly privilege protection, which will further limit the development of Australian generic medicine enterprises and restrict patient access to cheap, bioequivalent prescription drugs. Of particular concern is that proposed TPPA multilateral investor-state dispute settlement procedures would allow US corporations (as well as those of other TPPA nations) to obtain damages against Australian governments through international arbitral proceedings if their investments are impeded by Australian public health and environment protection legislation.
Matched MeSH terms: Commerce/legislation & jurisprudence*; Health Policy/legislation & jurisprudence*; Public Health/legislation & jurisprudence; Environmental Policy/legislation & jurisprudence
Twelve-member countries of the Asia Pacific Economic Cooperation (APEC) are negotiating the Trans-Pacific Partnership Agreement (TPPA), a free trade agreement to facilitate international trade and investment. As reported by multiple sources, the TPPA would grant the same trade benefits and legal protections to tobacco products, services and investments that it would provide to other sectors. Malaysia proposed excluding tobacco control measures from the scope of all TPPA chapters while the US proposed only to establish a consultation process in tobacco-related disputes and to declare that tobacco control measures serve a health objective within the scope of the general exceptions.
The permissibility and lawfulness of withdrawing and withholding medical treatment has attracted considerable debates and criticisms, as the legal issues are drawn into entering the slippery slope of euthanasia. Proponents of "sanctity of life" views that withdrawing and withholding medical treatment with knowledge that death would result is still within the sphere of euthanasia, whereas proponents of "quality of life" argue that it is not, as death is not intended. Their arguments maintain that for patients who are totally dependant on machines to ensure the work of some bodily functions, living may amount to little more than survival as dying is prolonged. Furthermore, the prolonging of life of the dying patient has profound implications on patients themselves, their relatives, dependants and medical providers. Thus, withdrawing and withholding medical treatment would not only respect a patient's right to self-determination, by allowing them to die in their underlying condition, but will ensure that medical providers are able to concentrate on more worthwhile treatments. This paper discusses the intractable difficulties with the moral distinction between withholding and withdrawing treatment and euthanasia, as well as makes a comparative study between the present state of law in Malaysia and England on this issue. The paper further highlights the differences between civil law and Islamic law in this controversial area.
Possible duplicate publication in: Kassim PHJ, Adeniyi OB. Withdrawing and withholding medical treatment a comparative study between the Malaysian, English and Islamic law. The University of Ilorin Law Journal. 2009;5:42-56
HTTP://WWW.UNILORIN.EDU.NG/EJOURNALS/INDEX.PHP/UILJ/ARTICLE/VIEW/988
The ease and affordability of international travel has contributed to the rapid growth of the healthcare industry where people from all around the world are traveling to other countries to obtain medical, dental, and surgical care while at the same time touring, vacationing and fully experiencing the attractions of the countries that they are visiting. A combination of many factors has led to the recent increase in popularity of medical tourism such as exorbitant costs of healthcare in industrialized nations, favorable currency exchange rates in the global economy, rapidly improving technology in many countries of the world and most importantly proven safety of healthcare in selected foreign nations. Nevertheless, the development of medical tourism has certainly awakened many ethical and legal issues, which must be addressed. Issues pertaining to malpractice, consumer protection, organ trafficking, alternative medicine and telemedicine need comprehensive legal regulatory framework to govern them. Ethical issues are also been raised by the promotion of medical tourism in particular those pertaining to doctor and patient relationship. A future, where medical law is subsumed into various legal and ethical dimensions, poses serious challenges for the practice and ethics of medicine.
Matched MeSH terms: Malpractice/legislation & jurisprudence; Medical Tourism/legislation & jurisprudence*
The decision of the Federal Court of Malaysia in abandoning the Bolam principle in relation to doctor's duty to disclose risks has clearly marked the decline of judicial deference to medical opinion in medical negligence litigation in Malaysia. It is undeniable that the Bolam principle has acted as a gatekeeper to the number of claims against medical practitioners. This has always been seen as necessary to protect the society from unwanted effects of defensive medicine. However, will these changes contribute significantly to the growth of medical negligence cases in Malaysia? This article will trace the development of the Bolam principle in medical negligence litigation in Malaysia since 1965 and analyse the influence of selected Commonwealth cases on the development. The implications of the Federal Court ruling will also be discussed.
Organ transplantation has become increasingly routine as a means of saving and improving the quality of lives of thousands of people each year. However, transplant activity is increasingly constrained by the shortage of organs. The major impediment in procuring organs for transplant in Malaysia is the lack of cadaveric donors. The lack of cadaveric donors has encouraged patients to go to countries like India and China to purchase organs especially kidneys for transplantation. The inadequacies of the existing Malaysian Human Tissues Act 1974 has also contributed to this problem. For instance, the word 'tissue" is not defined under the Act. This raises complex and ethical questions as to the scope of the definition for "tissue". There is also no definition of "the person lawfully in possession of the body." This is significant as he is the person who is empowered by the Act to authorise removal of tissue. Further, there is also no articulation of a hierarchy of relatives who are deemed the next of kin. In a situation involving a large number of relatives, asserting different opinions, this may pose a problem. The articulation of a priority list is particularly difficult in Malaysia as it is a multi-cultural society where the hierarchy of relatives with the right to claim decision-making powers may vary in different cultures. Furthermore, there is also a pressing need for a legislation to ensure that the rights of potential live donors are protected. At the moment, the Human Tissues Act 1974 only relates to cadaveric donors whereas live donors fall within the purview of the common law. The system of "opting out" should be considered in Malaysia whereby every individual is presumed to be a donor unless he or she registers an objection. But this system can only be fair if every person in the community is given notice of the law and understands its implications. For the system to work, there must also exist a simple and effective way of registering objections. There is a need for continuous intensive public education and counselling. A nationally co-ordinated mechanism must be in place to ensure effectiveness of identifying potential donors and recipients.
Matched MeSH terms: Tissue and Organ Procurement/legislation & jurisprudence*; Organ Transplantation/legislation & jurisprudence*