Displaying publications 81 - 100 of 291 in total

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  1. Bas TG, Oliu Castillo C
    Biomed Res Int, 2016;2016:5910403.
    PMID: 27213153 DOI: 10.1155/2016/5910403
    The development of biological products has experienced continuous growth over the past three decades. The expiration of patent protection for many biological medicines has led to the development of biosimilars in many countries around the world. This paper reviews the literature on biosimilar drugs and covers their therapeutic status, clinical trials, approved biosimilars, and regulatory guidelines in Japan, South Korea, and Malaysia. The literature suggests that biosimilars are comparable but not identical to the reference product. They are not a generic version of an innovative product and do not ensure therapeutic equivalence. Biosimilars present more challenges than conventional generics and their marketing approval is also much more complicated. Guidelines for biosimilars were published in Japan in July 2009 by the Ministry of Health, Labour and Welfare (MHLW), in South Korea in March 2009 by the Ministry of Food and Drug Safety (MFDS), and in Malaysia in July 2008 by the National Pharmaceutical Control Bureau (NPCB).
    Matched MeSH terms: Government Agencies/legislation & jurisprudence*; Pharmacology, Clinical/legislation & jurisprudence; Drug Approval/legislation & jurisprudence*
  2. Gaveau DL, Sheil D, Husnayaen, Salim MA, Arjasakusuma S, Ancrenaz M, et al.
    Sci Rep, 2016 Sep 08;6:32017.
    PMID: 27605501 DOI: 10.1038/srep32017
    New plantations can either cause deforestation by replacing natural forests or avoid this by using previously cleared areas. The extent of these two situations is contested in tropical biodiversity hotspots where objective data are limited. Here, we explore delays between deforestation and the establishment of industrial tree plantations on Borneo using satellite imagery. Between 1973 and 2015 an estimated 18.7 Mha of Borneo's old-growth forest were cleared (14.4 Mha and 4.2 Mha in Indonesian and Malaysian Borneo). Industrial plantations expanded by 9.1 Mha (7.8 Mha oil-palm; 1.3 Mha pulpwood). Approximately 7.0 Mha of the total plantation area in 2015 (9.2 Mha) were old-growth forest in 1973, of which 4.5-4.8 Mha (24-26% of Borneo-wide deforestation) were planted within five years of forest clearance (3.7-3.9 Mha oil-palm; 0.8-0.9 Mha pulpwood). This rapid within-five-year conversion has been greater in Malaysia than in Indonesia (57-60% versus 15-16%). In Indonesia, a higher proportion of oil-palm plantations was developed on already cleared degraded lands (a legacy of recurrent forest fires). However, rapid conversion of Indonesian forests to industrial plantations has increased steeply since 2005. We conclude that plantation industries have been the principle driver of deforestation in Malaysian Borneo over the last four decades. In contrast, their role in deforestation in Indonesian Borneo was less marked, but has been growing recently. We note caveats in interpreting these results and highlight the need for greater accountability in plantation development.
    Matched MeSH terms: Agriculture/legislation & jurisprudence; Conservation of Natural Resources/legislation & jurisprudence; Farms/legislation & jurisprudence
  3. Ng S, Kelly B, Yeatman H, Swinburn B, Karupaiah T
    Nutrients, 2021 Jan 29;13(2).
    PMID: 33573100 DOI: 10.3390/nu13020457
    Mandatory nutrition labelling, introduced in Malaysia in 2003, received a "medium implementation" rating from public health experts when previously benchmarked against international best practices by our group. The rating prompted this qualitative case study to explore barriers and facilitators during the policy process. Methods incorporated semi-structured interviews supplemented with cited documents and historical mapping of local and international directions up to 2017. Case participants held senior positions in the Federal government (n = 6), food industry (n = 3) and civil society representations (n = 3). Historical mapping revealed that international directions stimulated policy processes in Malaysia but policy inertia caused implementation gaps. Barriers hindering policy processes included lack of resources, governance complexity, lack of monitoring, technical challenges, policy characteristics linked to costing, lack of sustained efforts in policy advocacy, implementer characteristics and/or industry resistance, including corporate political activities (e.g., lobbying, policy substitution). Facilitators to the policy processes were resource maximization, leadership, stakeholder partnerships or support, policy windows and industry engagement or support. Progressing policy implementation required stronger leadership, resources, inter-ministerial coordination, advocacy partnerships and an accountability monitoring system. This study provides insights for national and global policy entrepreneurs when formulating strategies towards fostering healthy food environments.
    Matched MeSH terms: Food Labeling/legislation & jurisprudence*; Nutrition Policy/legislation & jurisprudence*; Mandatory Programs/legislation & jurisprudence*
  4. Perehudoff SK, Alexandrov NV, Hogerzeil HV
    PLoS One, 2019;14(6):e0215577.
    PMID: 31251737 DOI: 10.1371/journal.pone.0215577
    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; Universal Coverage/legislation & jurisprudence*
  5. Brosius JP
    Am Anthropol, 1999;101(1):36-57.
    PMID: 19280759
    Matched MeSH terms: Economics/legislation & jurisprudence; Employment/legislation & jurisprudence; Jurisprudence/history; Social Conditions/legislation & jurisprudence; Forestry/legislation & jurisprudence
  6. Murshid ME, Haque M
    J Popul Ther Clin Pharmacol, 2020 06 11;27(2):e87-e99.
    PMID: 32621461 DOI: 10.15586/jptcp.v27i2.677
    The United States of America (USA) is one of the largest bilateral donors in the field of global health assistance. There are beneficiaries in 70 countries around the world. In 2015, the USA released US$638 million for the improvement of global health status by promoting family planning services. Unfortunately, in 2017, Trump administration reinstated Mexico City Policy/Global Gag Rule (GGR). This policy prevents non-US nongovernmental organizations (NGOs) from receiving US health financial assistance if they have any relationship with abortion-related services. This restriction pushed millions of lives into great danger due to the lack of comprehensive family planning services, especially lack of abortion-related services. This article has attempted to let the readers know about the impacts of GGR around the world and how global leaders are trying to overcome the harmful effects of this rule. Finally, it proposes some solutions to the impacts of the extension of Mexico City Policy.
    Matched MeSH terms: Abortion, Induced/legislation & jurisprudence*; Delivery of Health Care/legislation & jurisprudence*; Family Planning Services/legislation & jurisprudence*; Organizations/legislation & jurisprudence; Global Health/legislation & jurisprudence*; Reproductive Health Services/legislation & jurisprudence
  7. Ahmad A, Khan MU
    Res Social Adm Pharm, 2016 04 23;12(5):811-2.
    PMID: 27157865 DOI: 10.1016/j.sapharm.2016.04.003
    Matched MeSH terms: Community Pharmacy Services/legislation & jurisprudence; Education, Pharmacy/legislation & jurisprudence; Pharmacists/legislation & jurisprudence; Rural Health Services/legislation & jurisprudence
  8. Tiong JJ, Mai CW, Gan PW, Johnson J, Mak VS
    Int J Pharm Pract, 2016 Aug;24(4):302-5.
    PMID: 26777986 DOI: 10.1111/ijpp.12244
    This article serves as an update to the work by Shafie et al. (2012) which previously reviewed the benefits of policies separating prescribing and dispensing in various countries to advocate its implementation in Malaysia. This article seeks to strengthen the argument by highlighting not only the weaknesses of the Malaysian health care system from the historical, professional and economic viewpoints but also the shortcomings of both medical and pharmacy professions in the absence of separation of dispensing. It also provides a detailed insight into the ongoing initiatives taken to consolidate the role of pharmacists in the health care system in the advent of separation of dispensing. Under the two tier system in Malaysia at present, the separation of prescribing and dispensing is implemented only in government hospitals. The absence of this separation in the private practices has led to possible profit-oriented medical and pharmacy practices which hinder safe and cost-effective delivery of health services. The call for separation of dispensing has gained traction over the years despite various hurdles ranging from the formidable resistance from the medical fraternity to the public's scepticism towards the new policy. With historical testament and present evidence pointing towards the merits of a system in which doctors prescribe and pharmacists dispense, the implementation of this health care model is justified.
    Matched MeSH terms: Delivery of Health Care/legislation & jurisprudence; Pharmaceutical Services/legislation & jurisprudence; Pharmacists/legislation & jurisprudence; Physicians/legislation & jurisprudence
  9. Low WY, Yusof K
    Child Welfare, 1991 Mar-Apr;70(2):293-302.
    PMID: 2036882
    With 25% of its population living in over 148 squatter settlements, with a high incidence of communicable diseases, teenage pregnancies, and psychological and familial stress, the city of Kuala Lumpur has sought ways to improve conditions. This article describes one particularly promising approach: community-based centers integrating three socioeconomic components--preschool education, maternal and child health clinics, and income-generating activities.
    PIP: The accomplishments of the Sang Kancil Intervention program, a project designed to improve the living conditions of squatter communities in Kuala Lumpur, Malaysia are described. 25% of Kuala Lumpur's population lives in 148 squatter settlements, where life is especially difficult for women and children. Hoping to improve the living conditions of the urban poor, Kuala Lumpur's City hall initiated the Sang Kancil Intervention program. This program contains 3 components: preschool education, maternal and child health, and income generation. The preschool component provides education, food supplements, and medical checkups and treatment to children in the squatter settlements. In order to foster community participation, the teachers of the preschool program are chosen from among the squatter community, and mothers are encouraged to become involved. Evaluations of the preschools reveal positive attitudes from mothers and teachers, high attendance rates, and higher IQ test scores among children attending the preschool than among children not in the program. Sang Kancil has also provided maternal and health services to the squatter communities. Once a week, nurse practitioners set up a clinic providing the following services: immunization, prenatal and postnatal care, health education, nutrition, family planning, and treatment of minor illnesses. Sang Kancil's income-generation program seeks to raise the living standards of poor families by creating employment opportunities for women. Sang Kancil has established companies staffed, owned, and managed entirely by women. Among other things, these companies manufacture toys, batik items, and ceramics. The success of the companies has pushed shareholders above the poverty line.
    Matched MeSH terms: Child Welfare/legislation & jurisprudence*; Maternal-Child Health Centers/legislation & jurisprudence*; Medical Indigency/legislation & jurisprudence*; Public Assistance/legislation & jurisprudence
  10. Blum JD, Talib N, Carstens P, Nasser M, Tomkin D, McAuley A
    Med Law, 2003;22(3):451-71.
    PMID: 14626880
    Recognition and articulation of patient rights are core issues in the medical jurisprudence of most nations. While the nature of rights in medical care may vary from country to country, reflecting the idiosyncrasies of domestic law and health delivery, there are commonalities in this area of law that cut across borders. This paper presents five case studies in the patient rights area from Malaysia, Ireland, South Africa, Indonesia and the United States, respectively. The case discussions range from ongoing and fundamental concerns over broad patient rights issues, such as access to health care and informed consent, to rights concerns of those suffering from HIV/AIDS, to a novel consideration over ethical and legal issues concerning ownership of infant organs. It is the hope of the authors that individually, and collectively, the cases will provide helpful insights into this core area of medical law.
    Matched MeSH terms: Health Services Accessibility/legislation & jurisprudence*; Informed Consent/legislation & jurisprudence; Tissue and Organ Procurement/legislation & jurisprudence; Patient Rights/legislation & jurisprudence*
  11. Lunze K, Lermet O, Andreeva V, Hariga F
    Int J Drug Policy, 2018 09;59:10-15.
    PMID: 29966803 DOI: 10.1016/j.drugpo.2018.06.009
    BACKGROUND: Several Southeast Asian countries have implemented compulsory drug detention centres in which people who use or are suspected of using drugs, mainly amphetamine-type stimulants, are confined without their consent and in most cases without due process and clinical evaluation of their substance use disorder. Given these facilities' lack of access to evidence-based drug dependence treatment, and the human rights implications of peoples' arbitrary detention under the pretext of "treatment", international organizations have called for their closure. The aim of this study was to estimate recent numbers of compulsory drug treatment centres and of people in these centres in the region.

    METHODS: We conducted an analysis of cross-sectional governmental data collected from seven countries in the region with compulsory drug detention centres, namely Cambodia, China, Lao PDR, Malaysia, the Philippines, Thailand and Viet Nam. We computed descriptive data provided by government representatives for the period between 2012 and 2014.

    RESULTS: The total number of people in compulsory detention centres overall decreased by only 4% between 2012 and 2014. In 2014, over 450,000 people were detained in 948 facilities in the seven countries. While only two countries decreased the number of compulsory detention centres, most countries increased the number of people detained.

    CONCLUSIONS: In spite of international calls for the closure of compulsory detention centres, the number of facilities and detained people remained high in the seven countries included in the analysis. These officially reported figures are concerning regarding access to effective drug dependence treatment and given the potential for additional human rights abuses within compulsory detention centers. Further concerted policy and advocacy efforts should support transition of treatment for people with drug dependence towards human rights-based and evidence-based drug dependence treatment. Expansion of existing drug and HIV services in the community rather than compulsory treatment modalities will effectively address the region's drug and HIV burden.

    Matched MeSH terms: Substance Abuse Treatment Centers/legislation & jurisprudence*; Mandatory Programs/legislation & jurisprudence*; Human Rights Abuses/legislation & jurisprudence; Drug Users/legislation & jurisprudence*
  12. Svevo-Cianci KA, Hart SN, Rubinson C
    Child Abuse Negl, 2010 Jan;34(1):45-56.
    PMID: 20060588 DOI: 10.1016/j.chiabu.2009.09.010
    (1) To identify which United Nations Convention on the Rights of the Child (CRC) recommended child protection (CP) measures, such as policy, reporting systems, and services for child abuse and neglect (CAN) victims, individually or in combination, were most important in establishing a basic level of child protection in 42 countries; and (2) to assess whether these measures were necessary or sufficient to achieve basic child protection in developing and industrialized countries.
    Matched MeSH terms: Child Abuse/legislation & jurisprudence*; Child Advocacy/legislation & jurisprudence*; Child Health Services/legislation & jurisprudence; Child Welfare/legislation & jurisprudence*; Violence/legislation & jurisprudence*
  13. Chung FJ
    J Ethnopharmacol, 1996 Apr;51(1-3):201-4.
    PMID: 9213617
    Sarawak, on the island of Borneo, is known internationally for its rich rain forests, flora and fauna. Its rain forests, occupying two-thirds of its geographical area shelters 2500 tree species, 5500 flowering plants and over 20 000 different kinds of animals and insects. Such abundance of plants, and in particular, in the variety thereof, have attracted the attention of scientists involved in the field of research into their potential medicinal value. Recent discovery that two species of Calophyllum tree in the rain forests of Sarawak produce active anti-HIV agents, has, no doubt, intensified interest in the State's plant resources for scientific research.
    Matched MeSH terms: Conservation of Natural Resources/legislation & jurisprudence*; Drug Industry/legislation & jurisprudence; Patents as Topic/legislation & jurisprudence; Pharmacognosy/legislation & jurisprudence*; Forestry/legislation & jurisprudence
  14. Assunta M, Dorotheo EU
    Tob Control, 2016 May;25(3):313-8.
    PMID: 25908597 DOI: 10.1136/tobaccocontrol-2014-051934
    OBJECTIVE: To measure the implementation of WHO Framework Convention on Tobacco Control (FCTC) Article 5.3 at country level using a new Tobacco Industry Interference Index and to report initial results using this index in seven Southeast Asian countries.

    METHODS: Score sheet based on WHO FCTC Article 5.3 Guidelines sent to correspondents in seven Southeast Asian countries, using a scoring system designed with the help of tobacco control experts and validated through focused group discussions.

    RESULTS: The seven countries ranked from the lowest level of interference to the highest are Brunei, Thailand, Lao PDR, Cambodia, Philippines, Malaysia and Indonesia. Countries that face high levels of unnecessary interaction with the tobacco industry also face high levels of tobacco industry influence in policy development. Most governments do not allow any tobacco industry representatives on their delegation to sessions of the Conference of the Parties or its subsidiary bodies nor accept their sponsorship for delegates, but most governments still accept or endorse offers of assistance from the tobacco industry in implementing tobacco control policies. Most governments also receive tobacco industry contributions (monetary or in kind) or endorse industry corporate social responsibility activities. Governments do not have a procedure for disclosing interactions with the tobacco industry, but Lao PDR, Philippines and Thailand have instituted measures to prevent or reduce industry interference.

    CONCLUSIONS: This Tobacco Industry Interference Index, based on the WHO FCTC Article 5.3 Guidelines, is a useful advocacy tool for identifying both progress and gaps in national efforts at implementing WHO FCTC Article 5.3.

    Matched MeSH terms: Commerce/legislation & jurisprudence; Public Health/legislation & jurisprudence*; Smoking/legislation & jurisprudence*; Smoking Cessation/legislation & jurisprudence*; Tobacco Industry/legislation & jurisprudence*
  15. Hussain A, Ibrahim MI, Baber ZU
    Int J Pharm Pract, 2012 Jun;20(3):183-90.
    PMID: 22554161 DOI: 10.1111/j.2042-7174.2011.00178.x
    The study evaluated the compliance of community pharmacies with legal requirements as laid down by the drug regulatory framework in Pakistan.
    Matched MeSH terms: Pharmacies/legislation & jurisprudence*
  16. Abas A
    Biologicals, 2011 Sep;39(5):339-42.
    PMID: 21784655 DOI: 10.1016/j.biologicals.2011.06.009
    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*
  17. Nemie P, Kassim J
    J Law Med, 2009 Aug;17(1):59-73.
    PMID: 19771987
    Strategically located at the crossroads of Asia, Malaysia has become one of the key players in the fast-growing and lucrative market for health care services in Asia. Medical travel across international boundaries has been made possible through affordable airfares and the favourable exchange rates of the Malaysian ringgit has contributed to the rise of the "medical tourism phenomenon" where medical travel is combined with visiting popular tourist destinations in Malaysia. Further, competitive medical fees and modern medical facilities have also made Malaysia a popular destination for medical tourists. Nevertheless, the increased number of foreign patients has opened up possibilities of Malaysian health care providers being subjected to malpractice claims and triggering a myriad of cross-border legal issues. Presently, there is no internationally accepted legal framework to regulate medical tourism and issues of legal redress in relation to unsatisfactory provision of treatment across international boundaries. The economic benefits of medical tourism must be based upon a solid legal regulatory framework and strong ethical standards as well as upon high-quality medical and health care services. It is therefore important to assess the existing legal framework affecting the development of medical tourism in Malaysia in order to explore the gaps, deficiencies and possibilities for legal and regulatory reform.
    Matched MeSH terms: Malpractice/legislation & jurisprudence*
  18. Rozali A, Khairuddin H, Mohd Sidik S, Zin BM, Sulaiman A
    Med J Malaysia, 2008 Jun;63(2):166-9.
    PMID: 18942312 MyJurnal
    Occupational divers are exposed to hazards which contribute to the risk of developing decompression illnesses (DCI). DCI consists of Type I decompression sickness (DCS), Type II DCS and arterial gas embolism (AGE), developed from formation of bubbles in the tissues or circulation as a result of inadequate elimination of inert gas (nitrogen) after a dive. In Malaysia, DCI is one of the significant contributions to mortality and permanent residual morbidity in diving accidents. This is a case of a diver who suffered from Type II DCS with neurological complications due to an occupational diving activity. This article mentions the clinical management of the case and makes several recommendations based on current legislations and practise implemented in Malaysia in order to educate medical and health practitioners on the current management of DCI from the occupational perspective. By following these recommendations, hopefully diving accidents mainly DCI and its sequalae among occupational divers can be minimized and prevented, while divers who become injured receive the proper compensation for their disabilities.
    Matched MeSH terms: Accidents, Occupational/legislation & jurisprudence*
  19. Ngah AC
    Taiwan Yi Xue Ren Wen Xue Kan, 2005 Sep;6(1-2):39-48.
    PMID: 16538765
    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: Tissue and Organ Procurement/legislation & jurisprudence*
  20. Woodman GH, Wilson SC, Li VY, Renneberg R
    Mar Pollut Bull, 2004 Dec;49(11-12):964-73.
    PMID: 15556182
    Little is known about the spatial and temporal distribution of blast fishing which hampers enforcement against this activity. We have demonstrated that a triangular array of hydrophones 1 m apart is capable of detecting blast events whilst effectively rejecting other sources of underwater noise such as snapping shrimp and nearby boat propellers. A total of 13 blasts were recorded in Sepangor bay, North of Kota Kinabalu, Sabah, Malaysia from 7th to 15th July 2002 at distances estimated to be up to 20 km, with a directional uncertainty of 0.2 degrees . With such precision, a network of similar hydrophone arrays has potential to locate individual blast events by triangulation to within 30 m at a range of 10 km.
    Matched MeSH terms: Explosions/legislation & jurisprudence*
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