The biosimilars sector continues to attract huge interest and controversy. Biosimilars are new biopharmaceuticals that are "similar" but not identical to the innovator product. Characteristics of biopharmaceuticals are closely related to the manufacturing process, which implies that the products cannot be exactly duplicated. Minuscule differences in the product's structure and manufacturing process can result in different clinical outcome. This raises concerns over the safety, efficacy and even pharmacovigilance of biosimilars. Thus, biosimilars are unique - they are not a true chemical generic and are regulated via a distinct regulatory framework. This report discusses the features of Malaysian regulatory oversight of biosimilars and experience acquired in the evaluation of some products from various countries. Ensuring regulatory position adequately reflects scientific advancement, expertise/resources is key. The regulatory situation is an evolving process. Various guidance documents are being prepared with the aim of developing a uniform global framework towards assuring the dual goal of lower costs and patient safety while expediting the availability of important biosimilar products.
Matched MeSH terms: Drug Industry/legislation & jurisprudence*; Legislation, Drug/standards*
The 2nd International Conference on East-West Perspective on Functional Foods held in Kuala Lumpur, Malaysia, on November, 2007, discussed the current work on some traditional Asian foods and new technologies that offer both challenges and opportunities for functional foods. The highlight of the conference was on the current regulatory status of nutrition and health claims related to functional foods and the experiences in some countries on the substantiation of claims. Attention was also given to strategies for effective communication of functional foods to consumers. The conference concluded with recommendations to strengthen R and D efforts and harmonization of protocols and methodologies on functional foods within the region.
Human Rights traditionally refer to rights and freedom that are inherent to every human being. They are based on Human Rights Law and concern the respect for dignity and worth of a person. These rights are universal, inalienable, indivisible, inter-related and interdependent. Members of Societies are detained for varied reasons and are made up of different age groups and gender. The United Nations through its numerous agencies, associated Conventions, Treaties and Resolutions have laid down guidelines that govern the rights of those under detention. Article 5 of General Assembly Resolution 45/111 clearly stipulates that except for those limitations that are demonstrably necessitated by the fact of incarceration, all prisoners shall retain the human rights and fundamental freedom set out in the Universal Declaration of Human Rights. As such, the Medical and Health Care of People under Detention should not be any different from the other members of societies. The Right to Health and Medical Care is stipulated under various Articles contained in the UN Bill of Human Rights (UDHR, ICCPCR and ICESCR) as well as other Conventions, e.g. Convention against Torture (CAT), Convention on Rights of the Child (CRC) and Convention for the Extinction of all Forms of Discrimination against Women (CEDAW). The United Nations have also developed specific guidelines and instruments for Treatment of People under Detention. These include the General Assembly Resolution 45/111 December 1990 elucidating the Basic Principles for Treatment of Prisoners, ECOSOG resolution 663C and 2076 regarding the Standard Minimum Rules for the Treatment of Prisoners which covers rules pertaining to accommodation and Medical Services, General Assembly Resolution 37/194 on Principles of Medical Ethics relevant to the role of health personnel, particularly Physicians, in the Protection of Prisoners and Detainees against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment.
Matched MeSH terms: Delivery of Health Care/legislation & jurisprudence*; Human Rights/legislation & jurisprudence*; Prisoners/legislation & jurisprudence*
Sustainability standards for seafood mainly address environmental performance criteria and are less concerned with the welfare of fisheries workers who produce the seafood. Yet human rights violations such as slavery and human trafficking are widespread in fisheries around the world, and underscore the need for certification bodies and other seafood supply chain actors to improve social performance, in addition to addressing environmental challenges. Calls for socially responsible seafood have referenced human rights law and policy frameworks to shape the guiding principles of socially responsible seafood and to provide the legal machinery to implement these aspirations, but practical guidance on how to achieve this is lacking. To provide clarity on this challenge, we reviewed the literature concerning human rights in the seafood supply chain, and prepared an analysis of opportunities and challenges to implement socially responsible seafood through relevant human rights, legal and policy instruments. We observe that human rights laws are generally framed in favour of addressing violations of civil and political rights, but there remains considerable scope for applying economic, social and cultural (ESC) rights in this context. Other challenges include weakly defined ESC rights infringements, a lack of straightforward mechanisms to enforce human rights entitlements, and practical difficulties such as resources to support and secure rights. On the positive side, governments can draw on international instruments to inspire national policies and legislation to eliminate illegalities from the seafood supply chain. However, for socially responsible seafood principles to translate into tangible actions, these objectives must be rooted in clear legal obligations and be supported by sufficient national capacity and political will.
Matched MeSH terms: Fisheries/legislation & jurisprudence*; Human Rights/legislation & jurisprudence*; Human Trafficking/legislation & jurisprudence
This paper sets out the practice of traditional, alternative and/or complementary medicine in Malaysia. It gives an overview of the types of alternative medicine available, and the legal regulation, or lack of it within the current setting. The relevant policies and governmental action in this area are highlighted. Relevant case law decisions in this area are also included. The practice of spiritual healing as one form of traditional medicine, and its role within the spectrum of alternative medicine is dealt with briefly. The significant question of integration of alternative medicine within the existing allopathic system is addressed. The paper concludes that as interest in, and usage of alternative medicine is not likely to decrease, certain measures must be taken by the relevant authorities to ensure among others, the safety and efficacy of these medicines.
In western societies where the principle of autonomy is jealously guarded, perhaps active euthanasia is more often the focus of public concern and debates rather than any other forms of euthanasia. However due to the advance in technology and its corresponding ability in prolonging life, in Malaysia passive euthanasia presents more of a dilemma. For those concerned and involved with end of life decision-making, it is generally agreed that this is an area fraught with not only medical but legal and ethical issues. In Malaysia where the society is not homogenous but is multi-cultural and multi-religious, in addition to medical, legal and ethical issues, religious principles and cultural norms further impact and play significant roles in end of life decision-making. This paper seeks to identify the issues surrounding the practice of passive euthanasia in Malaysia. It will be shown that despite applicable legal provisions, current practice of the medical profession combined with religious and cultural values together affect decision-making which involves the withholding and/or withdrawing of life-saving treatment.
Occupational safety and health is one of important issues for workforce movement among ASEAN countries. The objective was to study laws, main agencies, and law enforcement regarding occupational safety and health in Thailand, Indonesia, Malaysia, Philippines, and Singapore. This documentary research covered laws, main agencies' duties, and occupational safety and health law enforcement in Thailand, Indonesia, Malaysia, Philippines, and Singapore. Thailand has its Occupational Safety, Health, and Work EnvironmentAct 2011. Its main agency was Department of Labor Protection and Welfare. Indonesia had WorkSafety Act (Law No. 1, 1970). Its main agency was Department of Manpower and Transmigration. Malaysia had Occupational Safety and Health Act (OSHA) 1994. Its main agency is the Department of Occupational Safety and Health. The Philippines has its Occupational Safety and Health Standards. Its main agency was Department ofLabor and Employment. Singapore has its Workplace Safety and Health Act 2006. Its main agency is Occupational Safety and Health Division. Occupational safety and health law enforcement among each county covers work environment surveillance, workers' health surveillance, advice about prevention and control of occupational health hazards, training and education of employers and employees, data systems, and research. Further in-depth surveys of occupational safety and health among each ASEAN county are needed to develop frameworks for occupational safety and health management for all ASEAN countries.
Good communication in all aspects of medical practice is essential. Effective communication with your patient not only enables you to take an accurate history but also helps the patient to understand their illness and no doubt assists the healing process. Communication with other health professionals allows the team approach to healthcare to succeed. It reduces the chances of a breakdown in continuity of care, builds relationships and understanding between different disciplines and specialties and helps professionals to learn from each other. In the medico-legal field poor communication is the underlying problem in the most of cases that MPS deals with. The majority of negligence cases are not related to the clinical quality of care but are triggered by inadequate communication. A breakdown in the doctor-patient often occurs before the incident that leads to a claim. It is as if the patient is just waiting for their moment to sue. In a busy clinic or GP surgery it is often easy to forget the human needs of the patient and concentrate on their medical needs. First impressions are vital not just with the doctor but also with other staff and even the clinic or hospital itself. During the consultation careful listening, giving sincere empathy early in the consultation and an expression of understanding of their concerns will go a long way to instill confidence in the patient and reduce the likelihood of a complaint should things go wrong.
In October, 1993, 16 months after the United Nations approved the International Convention on Biodiversity held in Rio de Janeiro, June, 1992, the Philippine Congress ratified and adopted the Convention. This is a manifestation of the full support of the Philippines for the principles and policies adopted by the UN body on the conservation of biodiversity, sustainable development of biological resources and equitable sharing of benefits between users and owners of biodiversity resources. The Philippine scientific community has long recognized the need for and importance of a national guideline and policy with regard to the collection of plants and animals in the Philippines for scientific or commercial purposes. A series of consultative meetings were held by representatives of government agencies, non-government organizations, private organizations, academic and private persons concerned with biodiversity conservation to formulate national guidelines that regulate the collection of plant and animal specimens in the country. Guidelines were unanimously adopted by various government agencies and academia and a Memorandum of Agreement (MOA) was signed on September 28, 1990. Very recently a new document was drafted, specifically to serve as a guideline for those who desire to undertake sample collecting in the Philippines for biodiversity prospecting. The document is now being reviewed by government departments and agencies and will be presented to the President of the Philippines for signing as an Executive Order (EO). Once signed, this EO will serve as a national policy for bioprospecting in the country. The Philippines is one of the countries in Southeast Asia that has endorsed the adoption of regional guidelines on the collection of plant and animal organisms for drug development. The ASEAN Agreement on the Conservation of Nature and Natural Resources (1985). The Manila Declaration (1992) and lately, the Melaka Accord (1994), all of which were signed by various countries in Asia, are manifestations of this interest.
Persistent barriers to universal access to medicines are limited social protection in the event of illness, inadequate financing for essential medicines, frequent stock-outs in the public sector, and high prices in the private sector. We argue that greater coherence between human rights law, national medicines policies, and universal health coverage schemes can address these barriers. We present a cross-national content analysis of national medicines policies from 71 countries published between 1990-2016. The World Health Organization's (WHO) 2001 guidelines for developing and implementing a national medicines policy and all 71 national medicines policies were assessed on 12 principles, linking a health systems approach to essential medicines with international human rights law for medicines affordability and financing for vulnerable groups. National medicines policies most frequently contain measures for medicines selection and efficient spending/cost-effectiveness. Four principles (legal right to health; government financing; efficient spending; and financial protection of vulnerable populations) are significantly stronger in national medicines policies published after 2004 than before. Six principles have remained weak or absent: pooling user contributions, international cooperation, and four principles for good governance. Overall, South Africa (1996), Indonesia and South Sudan (2006), Philippines (2011-2016), Malaysia (2012), Somalia (2013), Afghanistan (2014), and Uganda (2015) include the most relevant texts and can be used as models for other settings. We conclude that WHO's 2001 guidelines have guided the content and language of many subsequent national medicines policies. WHO and national policy makers can use these principles and the practical examples identified in our study to further align national medicines policies with human rights law and with Target 3.8 for universal access to essential medicines in the Sustainable Development Goals.
Matched MeSH terms: Government Programs/legislation & jurisprudence*; Health Policy/legislation & jurisprudence; Legislation, Drug; Universal Coverage/legislation & jurisprudence*
Medical malpractice cases are a matter of much concern in many countries including Malaysia where several cases caught the attention of the public and authorities. Although comprehensive annual statistics on medical negligence claims are not available in Malaysia since such data are not collected systematically in this country there are indications of an upward trend. Medical malpractice cases have been publicized by the media, academic researchers and in government annual reports prompting government policy makers, oversight agencies and the medical profession itself to take appropriate action. The increasing dissatisfaction with the current tort litigation system requires exploring alternatives and new approaches for handling medical malpractice cases. This study aims to examine the difficulties inherent in the tort system in Malaysia for solving medical malpractice claims and evaluates the structure of this system from the perspective of effectiveness, fairness, compensation, accessibility, and accountability.
The right of a person to control his body is a concept that has long been recognized in Malaysia under the law of torts. The purpose of requiring informed consent is to preserve that right in medical decision-making. Informed Consent is a relatively new concept in medical litigation cases. However in the late 1990's, it has become one of the important claims under negligence made against the doctor for failure to disclose relevant information to patients in respect of the treatment proposed. Whether Malaysia has begun to recognize patient's right to decision-making is yet to be seen. Furthermore the social-cultural relationship between doctors and patients had to be considered. In this respect, the researcher had conducted interviews with doctors and patients to gauge their reaction towards a shared process of decision-making, which is the central issue in the doctrine of informed consent. Findings suggest that in society where primary health care is the main thrust to achieve health for all, the possibility of recognition of the rights of patients to receive information before making decisions about treatment appears remote. The findings also underscore the importance of incorporating aspects of informed consent as part of providing quality service to patients.
Kidney and corneal transplants have been undertaken since the seventies although other forms of organ transplantation were lesser known. To date more than 1000 kidney transplants, the majority from living related donors have been performed. Nevertheless heart, lung and liver transplant only had an impact in the nineties. The main reason being, the lack of cadaveric donors, which has hampered the development of organ transplantation in Malaysia. It is instructive to note that the Malaysian society has been rather conservative when it comes to organ transplantation. This is compounded by the Asean culture and value system, which are directly derived from our historical background and religious convictions. However attempts had been made by various organisations such as The Malaysian Society of Transplantation, which was set up in 1994 to create greater awareness on organ donation & transplantation amongst both the healthcare professionals and the public.
Matched MeSH terms: Legislation, Medical; Tissue and Organ Procurement/legislation & jurisprudence*