HUMAN CAPITAL AND DEVELOPMENT POLICY1. AbstractThe Ninth Malaysia Plan (9MP) was launched on 20th March 2006. There are various goals and objectives which have been announced by the government in the newly formulated Malaysia Plan. Among the focus of this plan is to develop and ensconce the human capital, as human capital is one of the important elements in any civilization and country development. The conspicuous of a country lies in its strong economy, knowledge, skills and strengths of human capital. Human capital is the ‘wheel’ towards the development of any society and religion.2. IntroductionOn January 22nd, 2009, Benjamin Wing David Uking (2008287888) and Syed Nizamuddin Bin Sayed Khassim (2007278908) students of Faculty of Administrative Science and Policy Studies, MARA University of Technology, Sarawak were assigned an assignment as one of the requirement the Policy Analysis (ADM 654) by Lieutenant Colonel Saiful Anwar, lecturer for our Policy Studies (ADM 654) who gave full commitment in assisting the students in this assignment.For the purpose of our assignment, we have selected HUMAN CAPITAL AND DEVELOPMENT POLICY, which includes the policy historical background, its objectives, basic five steps taken in the process of policy making and the contributions of this policy to the society as a whole.The idea and effort toward the development of human capital was started since the era of the first Prime Minister, Tunku Abdul Rahman. However this idea and effort is given more focus during the fifth Prime Minister, Dato’ Seri Abdullah Ahmad Badawi. His agenda towards the development of human capital has distinguished him from the other Premiers before. The implementation of policies that emphasize human capital is a long term investment, and in most times would not reap any benefit in the short run. Thus, policies which emphasize the development of human capital in the past are at most overlooked by Malaysians. The bane of not having adequate empowered human capital within Malaysia was only made obvious to the Malaysian public upon the creation of KLCC – whereby most of the expertise were made up of foreigners. Although played down by the state controlled media, most Malaysians were dissatisfied with the increasing significance of foreign professionals in local arena.In government sector, the situation is comparably worse than the private sector. Procedures are made lengthier due to government service’s inefficiency. Many wondered why the procedures cannot be made easier, application processes made faster, and the transactions made transparent? Those are the problems or question that the Prime Minister aims to solve by giving more focus on the development of human capital.3. The Term ‘Human Capital’ (Modal Insan)During presenting the Ninth Malaysia Plan (9MP), the Prime Minister, not less than 18 times using the term “Insan”. The term Insan originated from the Arabic word which means human, man, mankind, or human being. In Latin it can be translated as homo or hominess and homo sapiens (wise man) in Science.The term Human Capital was made popular by Dato’ Seri Abdullah Ahmad Badawi even though it has existed prior to his Premiership. The Prime Minister emphasize on human capital as the booster for nation’s economy and development. Human factor (including spiritual) and society are the two important matters in developing human capital. The term Human Resource Development already known to any organizations however what the Prime Minister’s aspiration is the human capital can become the injector in our nation development towards Vision 2020.4. The Application of the Five (5) Steps in the Policy Making Process1. agenda setting2. policy formulation3. policy adoption4. policy implementation5. policy evaluationi. Agenda SettingAn agenda is defined as a standard of artefact of policy-makers which have their own agenda to achieve goals or objectives. Policymakers include legislators, politicians, judges, bureaucratic officials etc. In agenda setting, the main question that needs to be answered is “who decides what will be decided?” Which is the decision is made by who are have an agenda or have a problem that need to be defined and solved in order to achieve particular goals. In the Human Capital and Development, this policy are decided by the government who are plays an important roles.The stages that important in the process of policy making are to define the problem of society which is the crucial part of the process and suggesting alternatives solutions.This policy is made by the Malaysian government responding to the need of knowledge, skills, and abilities (KSA) human capital in order to become full industrialized-developed nation in the year 2020 such as stated in Vision 2020.The Prime Minister foresees human capital as an importance element in development. Human is the main factor in all strategies and action plan to move nation development activities and programs.The significant of human capital in the 9MP has been identified encompass the aspects such as:a. The need for quality human capital.b. Developing human capital through holistic ways.c. Strategy for develop first class human capital.d. The relationship of National Mission and Vision 2020 with human capital.e. The consistency of human capital development by using the concept of Islam Hadhari.f. Human capital and cultures activities.g. Human capital and the role of women.h. Human capital and legislations.i. Human capital and education.j. Human capital and integrity.ii. Policy FormulationIn the policy analysis, policy formulation is same meaning with forecasting which is defined as “a procedure for producing information about the future state or society on the basis of prior information about policy problem or situation”. The purpose of forecasting is tells what happens between now and then and what is going to be achieved within period of time.Through this policy, the government has predict only with first class human capital can bring the nation to the stage of excellent – excellent in economy, excellent in knowledge, excellent in information technology, excellent in culture, excellent in spiritual (religion), excellent in defence or security, excellent in morality – as to become civilized society and nation.In the context of global world, high quality human capital becomes a need, not as a symbol of luxury.According to the Prime Minister, people of a nation are the most precious asset that a nation has. In order to achieve Vision 2020, the government needs to plan thoroughly the strategies towards this national agenda.In uncertainty global environment today, only with quality, effective, and efficient human capital can help the survival of a nation. There are various other alternatives to tackle the current problem, such as giving special amenities to foreign skilled labours to Malaysia to fill in the vacuum, or to sign any diplomatic resolution with foreign nations to enhance the number of skilled foreign professionals within Malaysia.But nonetheless, to promote the generation of Human Capital within Malaysia would be beneficial to the country – especially in the long run. To avoid the tendency of Malaysian industries to rely heavily on foreign professionals – the government has decided that this is the way to go.iii. Policy AdoptionAt this stage, policy adoption is important to collect or gather the data and information in the policy for the policy choices from the policy maker which is consisted of analysis of alternatives, the forecasting of each alternatives and cost and benefit of the analysis of the policy. The data that have been collected will give good impact which can achieve the objective of the policy. Policy adoption is a stage where the selection of the appropriate methods of the policy selected before implementing the policy analysis process.Policy adoption is important to minimize the risk that the policy that might not achieve the objectives and goals, to choose suitable method for the policy implementation.As mentioned before, human capital and development has been implemented since the first Prime Minister, Tunku Abdul Rahman. However, the development of human capital and its implementation put into more focus during our current Prime Minister, Dato’ Seri Abdullah Ahmad Badawi.An example of a Human Capital based policy before Abdullah’s time is the National Economic Policy, first implemented by the government after the May 13th racial riot. Its purpose is to develop the Human Capital of the Malay and Bumiputera races – so as to be able to compete with other races in Malaysia.According to Prime Minister, the development of human capital must include the quality management. Now, as we noticed, Human Capital and Development become the main agenda in the 9MP to achieve the National Mission and Vision 2020.iv. Policy ImplementationThe fourth steps in policy making process are policy implementation or called as monitoring. Implementation, viewed most broadly, means administration of the in which various actors, organizations, procedures, and techniques work together to put adopted policies into effect in an effort to attain policy or program goals. Implementation is the realization, application or execution of plan, idea, model, design, specification, standard or policy.As mentioned before, people not really know the motive of Prime Minister when he first introduces the human capital and development policy. Most people think the strategy not in the right path or inconsistence towards achieving Vision 2020. However, those people now realize and understand and appreciate the rational and reason the Prime Minister put more focus on the development of human capital in the effort of developing our country.In the 9MP, government played proactive important role by taking immediate action to ensconce human capital. Among the ways are the establishment of ten new manufacturing or industrialized institute through the Ministries of Human Resource, the implementation of Terengganu Knowledge Garden (Taman Ilmu Terengganu) which indicate the cost of RM250 million, building two Art School (RM60 million), and produce 1447 Kemas’s kindergarten (Taman Bimbingan Kanak-kanak) to ensure the development of human at early stage. Felcra Berhad allocated RM175 million in its human development programs while MARA allocated RM2.2 billion for producing quality human capital.Malaysians also appreciate the action of Prime Minister in the establishment of National Integrity Institute for the purpose of developing human capital to eradicate corruption, National Service Program organized by the Defence Ministries to develop young generation with discipline, generate leadership attitude, and increase their awareness. The Ministries of Youth and Sports organize Three-K program – skills, leadership, and entrepreneurship (Kemahiran, Kepimpinan, and Keusahawanan), Islam Hadhari program focus on balancing civilization society or humanity, ‘brain-gain’ project, rebranding community college, National Education Master Plan, Youth Development Plan, improve and strengthen the rural education, National Social Policy, and many more.Latest, the Prime Minister established a team to reduce the problem regarding bureaucracy in the government agencies – Pemudah (Pasukan Petugas Pemudah Cara Kerajaan), gives clear signal of his effort to develop human capital in the government agencies. The success of Pemudah in the future will remove the ‘fastness or stronghold’ of bureaucracy which prevent the flow-in of foreign investment and the competent of corporate in the country.v. Policy EvaluationPolicy evaluation is the assessment of the overall effectiveness of a national program in meeting its objectives, or assessment of the relative effectiveness of two or more programs in meeting common objectives. It concern with all of the consequences of public policy.Human Capital and Development Policy already change the mind of Malaysian regarding its importance towards the development of our country. As the result:a. Anti Corruption Agency was replaced by Malaysian Anti Corruption Commission – in order to give more ‘power' to eradicate corruption.b. Training for the graduates to encourage them involves in the entrepreneurship activities and also to reduce the unemployment.c. Professionals are sent to overseas to gain knowledge, skills, and abilities needed to perform better and more competence.d. The use of information technology in schools especially to those schools in rural areas.e. Increase the enrolment of students into colleges and universities.f. Government agencies become more effective and efficient – application of information technology.g. Build more technical and skills institute to provide quality workforce.5. Personal Recommendations Towards the PolicyI. The development of human capital must consider thinking skills and constitute creativity which contributes for the improvement of productivity or service quality; the employees must have initiative to think to get the best desired result.II. The employees should always full of high spirit, and have commitment and believe or confident to perform their task and job.III. Human capital should constitute with communication skills so that the task message given can be achieve.IV. Organization must avoid bureaucracy so the delivering mechanism and system in government agencies and private sectors become more effective.V. Team cooperation must become a culture in any department. It must nourish in all exercises and continually practised in organization.VI. Responsibility attitude towards task and job must always in the heart of every employee. The same also with the value of integrity and trust. They must be always mention and remind.VII. Those employees should have awareness attitude towards their family and society even though they busy with their job.VIII. Those employees must feel a desire for change and grab all the opportunities especially regarding the promotions, job performance, knowledge, skills, and abilities.IX. Those employees must improve their knowledge, information, and skills consistently for the effectiveness of the job.X. Those employees must focus towards the successful and excellent.6. ConclusionHuman capital and 9MP have close relationship towards the achievement of Malaysia as a developed nation in the year 2020. The Prime Minister has higher hope in this matter to see our country’s success, as he said: “Hopefully our aspirations are achieve to build a nation with more prosperity – more developed, more progressive – more dynamic; a nation that able to provide higher life quality to its citizens. Hopefully there exists a great human civilization which respected at the international arena. So let our sincerity and earnest effort get the blessings of ALLAH”.7. ReferencesAmini Amir Abdullah, Human Capital and Development in the Ninth Malaysia Plan, Islamic Centre, Universiti Putra Malaysia.“MEMBINA TAMADUN MENJULANG MARTABAT NEGARA”, the speech of the Prime Minister, YAB Dato’ Seri Abdullah Hj. Ahmad Badawi during presenting the Ninth Malaysia Plan, 2006-2010 in the House of Legislative on 31 March 2006.“STRENGTHENING HUMAN CAPITAL” Chapter 11 page 249-273, Ninth Malaysia Plan. Conley G.; Timothy, Flyer; Fredrick, Tsiang; Grace, ‘Local Market Human Capital and Spatial Distribution of Productivity in Malaysia’, December 2002, University of Chicago, USA. Elsadig; Musa Ahmed, ‘ICT and Human Capital Intensities Effects on Malaysian Productivity Growth’, Multimedia University, Faculty of Business and Law, Malacca, Malaysia.
REPORT BY:1. Norliza binti Zaidi 20061309012. Norissyamsiah binti Mohd. Halid 2008426804INTRODUCTIONThe government will continue to shoulder responsibility in delivering optimal healthcare to the population, with emphasis on maintaining health status, preventing diseases and providing appropriate medical treatment. Changes in demography including an increase in the elderly population and greater incidence of lifestyle-relateddiseases, have led to an increase in the incidence of end stage organ failures. The Ministry of Health has taken initiatives to address these new challenges through health promotion and prevention by developing comprehensive healthcare policies and strategies, one of which is a comprehensive National Transplantation Programme. Organ transplantation is a successful therapy for end stage organ failures of kidney, liver, heart, lung, pancreas and intestine. Transplantations of stem cells and tissues have widened the therapeutic options of many human diseases, and cord blood is an important alternative source of haematopoietic progenitor cells. Organ and patient survival rates continue to improve as a result of advances in donor-recipient selection, better surgical techniques, judicious use of immunosuppressant and better management of post-transplantation infections and other complications. Organs and tissues are obtained from suitable living or cadaveric donors. Historically there has always been a shortfall in the supply of organs and tissues. The success of transplantation has increased demand, thus increasing the gap even more. The shortage of organs for transplantation has led to greater use of organs from living donors. It has also led to unhealthy and unethical practices such as the use of organs from executed prisoners and rampant commercialisation in transplantation. Stem cells of haematopoietic origin are now being successfully transplanted for the treatment of haematopoietic malignancies, marrow failures and some genetic diseases. Presently cell therapy remains unproven and shall be subjected to research protocols. This Policy serves to guide the practice of organ, tissue and cell transplantation in Malaysia. It has been developed after taking into account the prevailing practices in this country, and also the relevant legislations, practices and guidelines in other countries. The policy promotes organ and tissue transplantation as a preferred treatment in end-stage organ failure states. The Ministry of Health together with other relevant government agencies and non-governmental organisations shall take active measures to promote organ, tissue, cord blood and bone marrow donations in this country. This Policy shall be implemented and enforced through various existing mechanisms. This Policy shall be reviewed every three years or as the need arises and necessary amendments shall be made accordingly.REGISTRY All centres performing transplantation shall report to the National Transplant Registry. The report shall include appropriate details on the centre, the surgery and short and long term outcomes. The National Transplant Registry shall report annually on all transplantations in the country. A registry of organ, tissue and cell donors shall be maintained. All centres participating in organ and tissue procurement shall report to the registry. The registry shall record short and long term outcomes of living donors. A National Marrow Donor Registry and a National Cord Blood Registry shall be maintained. They shall serve to provide potential donors for those requiring transplantations where related donors are not available or suitable.OBJECTIVES To promote organ, tissue and cell transplantation in the country. To promote cadaveric organ and tissue donation in the country. To ensure transparent and equitable access to organ, tissue and cell transplantation for those in need. To ensure that organ, tissue and cell transplantation is carried out to the highest ethical and professional standards. To ensure that the rights and welfare of living donors are looked after, in cases where live donations are necessary. To promote the highest quality of care including proper documentation and maintenance of registries.STRATEGIES Strategy 1Research in all aspects of organ, tissue and cell transplantation is encouraged. This includes laboratory based research, clinical trials, outcome and health economic studies. This is to ensure that the practice are well implement, fully utilize and effective for the organization. Strategy 2All research activities must abide by the existing International/National guidelines on ethical conduct of research. Any study involving human subjects must receive prior approval from Institutional Review Board or Ethics Committee of the particular institution and/or the Ministry of Health. It is to confirm that the research activities are done legally and according to the world health organization’s rights and the government’s policy. Strategy 3Research findings shall be made available at appropriate forums (publications etc) in order to benefit the care of transplantation patients. By doing this the patients will feel cared and appreciated. Thus, this will make the patients feel livelier day by day as they have the confident and encouragement from the medical centre. Strategy 4Improve governance, and adoption of appropriate technology and service practices to empower individuals, families and communities towards attaining lifelong wellness whereas everyone has the right to live healthy and lead a normal life. Strategy 5Develop skills and competencies to further reduce mortality and morbidity rates in furtherance of strengthening the quality of healthcare delivery. Strategy 6Establish effective business strategies to enhance organizational performance and the consumption of resources. This is to create successful business in furtherance of achieving higher level of quality in medical treatment. This is to confirm that each of every resource are being fully utilized. Furthermore, it helps to produce greater result and enhancement of our national economy. Thus, this help the government and the private sector create new business or expand their business and help to reduce the unemployment rates among our society.POLICY FORMULATIONThe Strategic Plan for the Ministry of Health (MOH) begun since early 2005 withthe development of the Country Health Plan. The Country Health Plan was a Health Plan for Malaysia for the 9th Malaysia Plan period. In developing this plan all the tools of a strategic plan, such as situational analysis and Strength-Weakness-Opportunity-Threat (SWOT) Analysis were employed. It also involved analysis of the 7th and 8th Malaysia Plan and the garnering of information from the 12 technical Working Groups (TWGs) reports. It required much probing, discussion, as well as examination of the views of the leaders who are responsible for the plan's preparation.As the MOH is the custodian of health for the country, the above document was,in essence, the Strategic Plan for the MOH. Nevertheless, it was also felt necessary forthe MOH to have a document that can give at a glance, a quick guide for all programmes, institutions and state departments under the MOH, so as they will not go astray during the implementation, monitoring and evaluation of the plan. Thus the present document was developed.This Strategic Plan is a summary of the Country Health Plan: 9th Malaysia Plan 2006-2010 documents, released earlier in 2006. It provides a clear destination for all programmes, institutions and state health departments under the Ministry of Health for the 9th Malaysia Plan period. Readers are recommended to refer to the Country HealthPlan: 9th Malaysia Plan 2006-2010 Book 1 and the Programme Health Plan: 9th MalaysiaPlan 2006-2010 Book 2 for further details on the background of its development as wellas the action plans at ground level.The MOH’s Strategic Plan is a 5-year-scheme that charts the path in achieving health’s vision and goals. The objectives of the MOH in the 9th Malaysia Plan have become the underlying principles of its development. It is the ultimate reference to guide all health departments with their respective action plans, programmes and activities for the future. Adherence to this Strategic Plan is indeed a major step towards realising Malaysia as a developed nation of healthy individuals and communities, to correspond with Vision 2020.THE POLICY MODEL(RATIONALISM : POLICY AS MAXIMUM SOCIAL GAIN) A rational policy is one that achieves maximum social gain. By “maximum social gain” we mean government should choose policies which result in gains to society which exceed costs by the greater amount and governments should refrain from policies if causes are not exceeded by gains. There are really two important guidelines included in this definition of maximum social gain. First of all, no policy should be adopted if its costs exceed its benefit. Second, among policy alternatives, decision makers should choose the policy that produces the greatest benefit over cost. In other words, a policy is rational when the difference between the values it achieves and the values its sacrifices are positive and greater than any other policy alternative. One should not view rationalism in a narrow dollars – and – cents framework, in which basic social values are sacrificed for dollar saving. Rationalism involve the calculation of all social, political and economic values sacrificed or achieved by a public policy, not just those that can be measured in dollars. To select a rational policy, policy makers must know all the society’s value preferences and their relative weights. It is also needed that a policy makers need to know all the policy alternatives available. Besides that, the policy makers also must know all the consequences of each policy alternatives. Furthermore they need to calculate the ratio of benefits to costs for each policy alternatives.Many types of rational decision models are found in the literature of economics, political science, management administrative science and budgeting. However, there are many barriers to rational decision making. In fact, there are so many barriers to rational decision making that it rarely takes place at all in government. Yet the model remains important for analytic purposes because it helps to identify barriers to rationality. It assists in posing the question of why is policy making not a more rational process.SEVERAL IMPORTANT OBSTACLES TO RATIONAL POLICY MAKING There are no societal benefits that are usually agreed upon, but only benefits to specific groups and individuals, many of which are conflicting. For example, the societal benefits are usually be given prior towards the richer people rather that the poor ones. This is where, the concept of bias is being practiced whereas, it leads to chaos between the rich and the poor with the particular organization who only prioritize the rich compared to the poor whom actually have their own rights to gain the benefits. The many conflicting benefits and costs cannot be compared or weighted for example, it is impossible to compare or weigh the value of individual dignity against a tax increase. For instant, the government still imposes a high payment on tax to various people in the organization without concern on the people’s needs and giving a concern towards the people. Policy makers are not motivated to make decisions on the basis of societal goals, but instead try to maximize their own rewards, power, status, reelection, money etc. For example, the policy makers may not satisfy with their salary and their personal gains because their job and payment are not aligning with each other. Thus, they tend to create policy that will give them more benefits towards them rather than the society and this will create corruption cases among the policy makers to fulfill other needs with a pay. Policy makers are not motivated to maximize net social gain, but merely to satisfy demands for progress they do not search until they find the one best way but halt their search when they find an alternative that will work. For example, policy makers are not interested on finding the result on the future progression on the policy that they had made instead of satisfying people’s demands. Policy makers accept this rationalism policy in order to achieves maximum social gain. Whereas, THE ORGAN, TISSUES AND CELLS TRANSPLANTATION POLICY shall be promoted as the preferred treatment for end-stage organ failure because it is cost-effective and it provides good quality of life. Similarly tissue and cell transplantation shall be promoted for the treatment of appropriate diseases where evidence of effectiveness exists and the commercialization of organ, tissue and cell transplantation and any act that may indirectly promote or lead to commercial transaction are prohibited.Organ, tissue and cell transplantation recipients shall receive appropriate assistance from the Government and all living organ donors shall be followed up for life.The cost incurred by the family of a cadaveric donor related to the organ and/or tissue procurement process shall be reimbursable by an authorized body or organization recognized by the Ministry of Health. Direct payment by the recipient to the family of the donor is prohibited such as confidentiality regarding the identity and personal details of donors and recipients shall be ensured. All clinicians involved in the procurement and transplantation process shall ensure the highest standards of safety and quality and there shall be a dedicated budget for the implementation of transplantation activities in the country. This rationalism theory assumes that the value preferences of society as a whole can be known and weighted. It is not enough to know and weight the values of some groups and not others. There must be a complete understanding of societal values. Rational policy making also requires information about alternative policies, the predictive capacity to foresee accurately the consequences of alternate policies, and the intelligence to calculate correctly the ratio of costs to benefits. Finally, rational policy making requires a decision making system that facilitates rationality in policy formation.POLICY IMPLEMENTATION Organs and/or tissues procured from donors in Malaysia shall not be allocated to recipients in another country unless there is no suitable recipient locally and there is a prior agreement on organ and/or tissue sharing between such country and Malaysia. Importation of tissues from other countries shall be made through institutions recognized by the Ministry of Health and in accordance with the Guidelines on Importation and Exportation of Human Tissues and/or any Body Part. Each organ and tissue transplantation service shall develop criteria or guidelines for the acceptance of individual organ and/or tissue for the purpose of transplantation. There shall be adequate provision for a comprehensive information and communication technology infrastructure and personnel to ensure efficient data management, record keeping, analysis, auditing, monitoring of outcome measures and research purposes for the transplantation activities. IMPLEMENTATION OF DEVELOPMENT PLAN Organ, tissue and cell transplantations shall only be performed in accredited centres which meet the standards established by the Ministry of Health. Transplantation shall be performed by credentialed personnel. The follow up care of patients who have undergone transplantations shall be provided by trained personnel. Transplantation centres shall maintain high standards of practice. This can be achieved by the regular monitoring of patient and graft survival sand other indices of quality care using internationally accepted criteria.The main governing body of the National Transplantation Programme shall be the National Transplantation Council (NTC). The Council shall consist of the following: The Director General of Health Malaysia as Chairperson. The Deputy Director General of Health (Medical) The Director of Medical Development Division. The Director of Medical Practice Division. Three clinicians from the Ministry of Health. One representative from the Malaysian Society of Transplantation. Two representatives from the Universities (to be nominated by the Deans’ council). One representative from the Association of Private Hospitals Malaysia. One representative from the Malaysian MedicalAssociation. One representative from the Academy of Medicine Malaysia. One representative from JAKIM/IKIM2. One representative from the organization representing all other religious bodies.One representative from a patient support group. One representative from a non-medical lay organisation. 2 JAKIM – Jabatan Kemajuan Islam Malaysia (Department of Islamic Development Malaysia) IKIM – Institut Kefahaman Islam Malaysia (Institute of Islamic Understanding Malaysia) The Minister of Health shall appoint all members of the Council. Members may be nominated by the respective organisations represented on the Council, but will be selected based on their interest, expertise and experience in the field of transplantation.The NTC shall: Recommend policies on organ, tissue and cell transplantation in the country. Promote and monitor the progress of the organ, tissue and cell transplantation programme in the country. Play a major role in the advocacy of organ, tissue and cell transplantation in the country. Ensure the highest ethical and professional standards in the practice of transplantation in the country. There shall be a National Transplantation Technical Committee (NTTC) appointed by the Director General of Health. The NTTC shall be headed by the Deputy Director General of Health (Medical) and consist of four other persons with relevant expertise in the field of transplantation.The responsibilities of the NTTC are: To promote the objectives of the Council (NTC). To advise the NTC on matters related to policy. To advise the National Transplantation Unit (NTU) on matters related to implementation. To consider reports from the Expert Committees. To consult with other relevant experts when necessary.The NTTC shall establish Expert Committees with specific responsibilities and scopes as follow: Training, standards and accreditation. Law and ethics. Public education. Planning and development. Registry of organ, tissue and cell recipients and donors. Any other scope as, and when necessary. The implementation of the organ, tissue and cell transplantation programme shall be coordinated by the National Transplantation Unit (NTU) within the Medical Development Division of the Ministry of Health. National Organ , Tissue and Cell Transplantation Policy 13The NTU shall have the following responsibilities; Secretariat for NTC and NTTC. Establish organ and tissue procurement units in hospitals. Establish a system for organ and tissue allocation and national transplantation waiting lists for potential organ and tissue recipients. Develop and support organ, tissue and cell transplantation units in designated hospitals. Facilitate and support the development of a national transplantation recipients, donors and donor pledgers registries. Implement training programmes for all personnel involved in organ, tissue and cell procurement and transplantation. Work with relevant agencies to ensure the implementation of processes of theaccreditation for organ, tissue and cell procurement and transplantation. Ensure that all practitioners in organ, tissue and cell transplantation are properly credentialed. Monitor standards of practice in organ, tissue and cell procurement and transplantation. Promote public education activities. Facilitate necessary/required amendments to existing legislation and/or enactment of new legislation on transplantation, according to the recommendations of the Law and Ethics Expert Committee and as approved by the NTC and NTTC.DURATIONHistory of Organ Transplantation in Malaysia1. Blood and Marrow Transplantation - There were a total of 1,174 haematopoieticstem cell transplantation reported to the National Transplant Registry between 1987and 2006; 797 were functioning at the end of 2006. There were 124 new transplantation done in Malaysia in 2006 with 11 centres of follow up for transplant recipients.2. Corneal Transplantation - One hundred and seventy four new cornea transplantation was reported in Malaysia in 2006. In 2006, 55% of donated corneaswere from the USA, 24% from Sri Lanka and 20% from local sources.3. Heart and Lung Transplantation - There were a total of 17 heart transplantationreported to the Registry between 1997 and 2006; 7 grafts were functioning at the endof 2006 and all were followed up in Institut Jantung Negara.4. Liver Transplantation - There were a total of 88 liver transplantation reported to theRegistry between 1993 and 2006; 50 grafts were functioning at the end of 2006. There were 8 new liver transplantation done in Malaysia in 2006.5. Renal Transplantation - There were 132 new renal transplants in 2006. The number of functioning renal transplants has increased steadily from 1,083 in 1997 to 1,728. The transplant prevalence rate was 65 per million population in 2006.6. Heart Valve Transplantation - There were a total of 167 heart valve homograftsreported to the Registry between 1996 and 2006; 148 grafts were functioning at theend of 2006.7. Bone and Tissue Transplantation - In 2006, 127 bone allografts and 379 amnioticmembranes were supplied by National Tissue Bank, USM.8. Cadaveric Organ and Tissue Donation - There were 25 donors in 2006 of which14 were brain dead multi organ and tissue organs and 11 were post cardiac deathtissue donors. The donation rate was 1.01 donations per million populations, a twofoldrise from 0.53 donations pmp in 2005.(Source: Third Report of the National Transplant Registry 2006, Report Summary,National Transplant Registry)Since the beginning of organ transplantation as a form of treatment, it has been plaguedby ethical considerations and human rights violations, which have not been fully resolved. The prime medical dictum has been doing no harm and the acceptance of liveorgan donation in principle was clearly counter to this dictum. The possible risks for some individuals, who are medically fit and volunteer to donate an organ for transplantation, were one of the first issues which troubled ethicists. After much debated an agreed position was reached to safeguard the donating individual as much as possible. A communiqué released by the transplantation society stated - The person who gives consent to be a live organ donor should be competent, willing to donate, free of coercion, medically and psychosocially suitable, fully informed of the risks and benefits as a donor, and fully informed of risks, benefits, and alternative treatment available to the recipient. Though the medical community has come to a consensus on the definition of brain death there is still much apprehension and scepticism among the public. Recently even the pope cautioned the early removal of organs.METHODOLOGIES OF NATIONAL ORGAN, TISSUE AND CELL TRANSPLANT POLICYa. GeneralThe facilities of the establishment should be of suitable size and location, and should be designed and equipped for the specialised purposes for which they are to be used. Where tissues or cells are processed in open containers facilities should have:– Floors, walls and ceilings of non-porous smooth surfaces that are easily sanitised;–Temperature control; for sterile processing, air filtered through high-efficiency particulate air (HEPA) filter with an appropriate pressure differential between zones that can be documented;– A documented system for monitoring temperature, air supply conditions,particle numbers and bacterial colony-forming units (environmental monitoring);– A documented system for cleaning and disinfecting rooms and equipment;– A documented system for gowning and laundry;– Adequate space for staff and storage of sterile garments;– Access limited to authorized personnel.b. DesignLaboratories should be designed to prevent errors and cross-contamination. Critical procedures should be performed in designated areas of adequate size.c. SecurityAccess to restricted areas of the establishments should be limited to authorized persons.d. Environmental monitoringEnvironmental monitoring procedures should be established, when appropriate, as part of the quality assurance programme. The procedures should include acceptable test parameters. The monitoring may include particulate air sampling and work surface culture. Each monitoring activity should be documented.e. SanitationFacilities used for retrieval, processing or preservation, where there is potential for cross-contamination of material or exposure to blood-borne pathogens, should be subjected to routine, scheduled and documented cleaning and disinfection procedures.f. EquipmentEquipment and instruments should be of a quality appropriate to their intended functions. Equipment and non-disposable supplies that come into contact with tissue or cells should be constructed so surfaces do not alter the safety or quality of the biological material. Equipment should be designed, manufactured and qualified for appropriate cleaning and should be sterilized or decontaminated after each use. A separate set of clean, sterile instruments (disposable, where appropriate) should be used for each donor. There should be SOPs for monitoring, inspection, maintenance, calibration and cleaning procedures for all equipment. Refrigerators, freezers and other equipment required to maintain a specific temperature should be inspected on a regularly scheduled basis. Appropriate certification and maintenance records should be maintained for instruments and equipment.POLICY EVALUATIONThe Achievement of National Organs, Tissues and Cells Transplantation PolicyOrgan transplantation started more than half a century ago with the first successful kidney transplantation performed in Boston USA. Since then other organs, tissues and cells have been transplanted successfully and transplantation has been one of the most significant therapeutic advancement in the history of medicine. The current interest in the therapeutic potential of stem cell therapy has overshadowed the achievements of organ and t issue transplantation in rescuing patients from near death in daily human stories of hope, determination, sacrifice and grit.In Malaysia we had our first organ transplantation when kidney transplantation was carried out in December 1975. The recipient who received a kidney from his brother survived for thirty years before succumbing to a major infection.Since then we have had liver, heart and lung transplantation. Corneal transplantation was carried out even before kidney transplantation, with corneas brought in from other countries. The major issue with organ transplantation in the country is, as in all other countries, the lack of organs. Cadaveric organ donation rate has been minimal (about one per million population) despite public education and publicity campaigns. In kidney transplantation, living related donors are the main source of kidneys for transplantation especially in the early years of the development of kidney transplantation in the country. In liver transplantation, live donors are still the main source of organs. In fact, in liver transplantation there had been several donors whowere not biologically related to the recipients. In End Stage Renal Disease, the lack of kidneys from both cadaveric and live related donors has led to two major developments: 1) The rapid development of dialysis facilities – there are now about 15,000 patients on this treatment .2) Malaysian patients going overseas to purchase either live donor or cadaveric kidneys. The latter development has led to a number of ethical and moral issues which are continuingly being debated across the world.The outcome of organ transplantation has seen major improvements in graft and patient survival over the last two decades. In a large part this is due to the better immunosuppressive drugs but prevention, early diagnosis and effective management ofcomplications such as infection and cardiovascular disease have also contributed significantly.The care of transplantation recipients continues to require specialized skills and knowledge and thus only credentialed personnel practicing in accredited centres should be allowed to perform organ transplantation and post transplantation care. This National Organ, Tissue and Cell Transplantation policy is developed to guide practitioners in the field and all other stakeholders to further develop this therapeutic option to treat endstage organ failure states. It has taken into consideration the development of transplantation in this country so far, issues and concerns, resources required and their shortfall. Above all the policy hopes to guide all involved to practice transplantation to the highest professional and ethical standard.Organ transplantation is now the most cost-effective treatment for end-stage renal failure, and for end-stage failure of organs such as the liver, lung and heart it is the only available treatment. Risk-benefit analysis is thus of major importance. Transplantations of tissues such as corneas, cardiovascular tissues, bone, tendons and skin are all well-established therapeutic techniques. Although not all of these tissues are necessarily lifesaving, such transplants nevertheless offer major therapeutic benefits to a wide range of patients.The demand for bone transplantation is increasing very rapidly, particularly for secondary revision of hip replacement operations. Demand for skin for treatment of burns has also increased. Cell transplantation, for example bone marrow (BM) transplantation, is also well established and can be lifesaving in the treatment of severe immunodeficiency syndromes and many types of haematological malignancy and is now used to treat some auto-immune diseases.Interest in other types of cell transplantation is also rapidly growing (e.g. transplantation of pancreatic islet cells). If, in the future, it becomes feasible to replicateor to expand cells in vitro, or to genetically modify them to overcome inherited defects, then cell transplantation will be a new treatment modality. In addition, there are some products that incorporate human cells in synthetic matrices: the safety of the originating human cells should be assured to prevent disease transmission. Successful transplantation, even when not lifesaving, offers recipients major improvements in their quality of life. Life with a kidney transplant has been shown to be preferable to life on dialysis. Restoration of sight with cornea transplantation or of mobility using allograft bone in revision hip replacement surgery, and the replacement of heart valves, removing the need for long-term anticoagulation, offer major benefits to the recipient.The Weaknesses of National Organs, Tissues and Cells Transplantation PolicyTransplantation, whether of organs, tissues or cells, is not without some risk to the living donor, the recipient, and the health care professionals involved. Transplantation carries the risk of the operative procedure itself and, for example, of the lifelong immune suppression necessary in organ transplantation. In each case the potential benefits of the transplant procedure should outweigh the risks. The factors influencing the clinical outcome of transplantation are complex and there is an interaction between 2 different biological systems, that of the donor and the recipient. Therefore when assessing the risk of transplantation, aspects of both donor and recipient should be considered.DonorLiving donors of organs, tissues or cells will face risks associated both with testing to ascertain their suitability as a donor and the procedure to obtain the organ, tissue or cells. Complications may include medical, surgical, social, financial or psychological problems and, in the worst case scenario, could seriously incapacitate the donor or even lead to the donor’s death. As donors are volunteers and otherwise healthy individuals, all possible measures must be taken to minimise the risks to the donor. In most cases of removal of surgical residues, there is no additional risk for the donor. If, however, procurement does result in additional risks for the donor, the donor has to give informed consent concerning these risks.RecipientIn most circumstances, the major risk to the transplant candidate is failure to obtain transplantation through, for example, organ shortage. Other risks for the recipient may include:– failure of the transplant because the graft is inadequate, damaged or poorly preserved and fails to function (primary graft failure);– risks associated with the transplantation procedure;– rejection of organs, tissues or cells, either acutely or over the longer term (chronic rejection);– disease transmission such as an infection or a malignancy;– contamination or damage of the graft in some other way during transport, processing or storage;– complications of immunosuppression and other concomitant therapies;– recurrence of primary disease.To minimise the risks to the recipient, it is essential to screen donors and establish the presence or absence of disease transmission risk in their organs and tissues. A patient may be willing to risk becoming infected by a donor known to have hepatitis, for example, if the choice is between life with infection or death. Scarce organs, tissues and cells which carry a specific risk should not be rejected out of hand but offered in case there is someone who could benefit. However, the transplantation of materials from a high risk donor for non-life-threatening conditions cannot be justified.Health care workersTransplantation procedures can result in the infection of health care professionals involved in the donation or transplant process. Testing, prophylactic measures for transmissible agents and regular follow-up should be available for all health care workers involved in transplantation.With the shortage of human organs available for transplant, some work has been done to use pig and nonhuman primate tissues and organs instead. Some critics charge that this could lead to new, dangerous forms of disease if a pathogen that now only affects animals becomes communicable among humans.Xenotransplantation (xeno- from the Greek meaning "foreign") is the transplantation of living cells, tissues or organs from one species to another such as from pigs to humans (see Medical grafting). Such cells, tissues or organs are called xenografts or xenotransplants. The term allotransplantation refers to a same-species transplant. Human xenotransplantation offers a potential treatment for end-stage organ failure, a significant health problem in parts of the industrialized world. It also raises many novel medical, legal and ethical issues. A continuing concern is that pigs have different lifespans than humans and their tissues age at a different rate. Disease transmission (xenozoonosis) and permanent alteration to the genetic code of animals are also a cause for concern.Because there is a worldwide shortage of organs for clinical implantation, about 60% of patients awaiting replacement organs die on the waiting list. Recent advances in understanding the mechanisms of transplant organ rejection have brought science to a stage where it is reasonable to consider that organs from other species, probably pigs, may soon be engineered to minimize the risk of serious rejection and used as an alternative to human tissues, possibly ending organ shortages.Other procedures, some of which are being carefully investigated in early clinical trials, aim to use cells or tissues from other species to treat life-threatening and debilitating illnesses such as cancer, diabetes, liver failure and Parkinson's disease. If vitrification can be perfected it could allow for long-term storage of xenogenic cells, tissues and organs so they would be more readily available for transplant.There are only a few published successful xenotransplant procedures. Some patients who were in need of liver transplants were able to use pig livers that were on a trolley by their bedside successfully until a proper donor liver was available.Immune rejection remains the biggest challenge for xenotransplantation. The problem exists even for human to human transplants (known as allotransplantation), but is more serious for transplants between different species. Nearly all mammalian cells have markers which enable the immune system to recognise them as being foreign. The more different the genetic code between the donor organ and recipient, the greater the difference between a "self" marker and a "foreign" marker. Some companies are currently developing transgenic animals such as pigs that produce human markers to try and lessen the chance of rejection.A worrisome element of xenotransplantation is the potential for infectious disease to spread from the donor animal, which is called xenozoonosis. One example is porcine endogenous retroviruses (PERVs) which are viruses within pigs that pigs are immune to, but can infect isolated human cells in cell culture. Some recipients of pig neural cell transplants have had to agree to never donate blood take frequent blood tests and use safe sex methods for the rest of their lives due to the risk of spreading such viruses.Many, including animal rights groups, strongly oppose killing animals in order to harvest their organs for human use. Legitimate medical concerns exist about possible disease transfer between animals and humans, such as the porcine endogenous retrovirus found in pig tissues. Religious beliefs, such as the Jewish and Muslim prohibition against eating pork, have been sometimes thought to be a problem.POLICY RECOMMENDATIONThe retrieval and distribution of organs, tissues and cells should be properly regulated. Whether the material is to be used for therapeutic, research or other purposes, it is important that those receiving or using the material have confidence in the quality and safety of the organs, tissues, cells and processing batches. An effective traceability system and adverse event reporting must be in place that will respect the mutual anonymity of the donor and the recipient.Role of the stateThe primary role of the state is to establish a legal framework within which transplant services can operate, monitor and report and ensure that some mechanism is in place for regulating the various elements required for an effective transplant service, including traceability. The legal framework should include transplant law, the circumstances in which organs, tissues and cells can be retrieved, the consent or authorisation needed, death certification and the regulation of health service providers or other bodies involved in transplant services. The designation of a non-commercial national or international body responsible for the allocation and distribution of organs, and where necessary also for tissues and cells, has been recommended. Member states should set up a system of authorisation and inspection of procurement organizations and tissue establishments. Education and trainingStates should ensure that a system is in place to provide education and trainingfor all personnel involved in the various steps of the transplant process to maximise the skills that are available.Standard settingAgain, the state should ensure that a legal framework is in place so that appropriate standards are set and adhered to.Vigilance systemThe state has a duty to ensure mechanisms are in place for the protection of donors and recipients. This should ensure rapid investigation of any untoward incidents occurring in relation to the transplantation services, so timely corrective and preventive actions can be taken.Organ allocationAn effective allocation system is essential. This system has to take into account the short time that some organs can be maintained in good condition prior to transplantation, and the necessity to ensure that the organ is assigned to the most suitable recipient, according to pre-defined criteria. The rules for allocation are organ specific and they should be transparent and duly justified, taking particular account of medical criteria. Every state should ensure that there is a waiting list of potential recipients, and a legally recognised allocation organisation. There should be a mechanism in place to ensure that patients are not on more than one transplant waiting list. Transplant allocation may be co-ordinated by regional, national or international organizations.Time frame in organ, tissue and cell transplantationThe time between retrieval and transplantation can vary from hours to years depending on the nature of organs, tissues and cells retrieved. Safety and quality evaluation procedures will take those differences into account.International co-operationWhere matched tissue-typed organs are needed for sensitised patients it may be very difficult to find matches. For some renal patients or bone marrow (BM) recipients, it is unlikely that they will find a match within their own country. In these cases co-operation between states is necessary and in some cases it may be necessary to identify suitable donors worldwide. International cooperation and organ exchange is necessary to increase the chances of providing an organ for patients in life-threatening situations. For these reasons states should ensure that there is good co-operation between their allocation organizations and those set up in other countries.CONCLUSIONAs a conclusion, before starting any transplant programme, an appropriate organizational framework should be established. Personnel should be adequately trained in the field of transplantation. Implantation procedures should be carried out according to national rules by an authorized hospital transplant service. It is recommended that the results of transplant procedures be reported on a regular basis to relevant organizations to allow periodic evaluation of the effectiveness of corresponding transplant centres and of the procedures undertaken. Written standard operating procedures (SOPs) should exist for detailed preoperative evaluation and management, the transplant procedure and the post transplant follow-up of transplant recipients and donors. Transplant services should implement an effective quality management system in order to ensure that the entire operation is compliant. Institutional procedures should be reviewed on a regular basis and whenever modifications are necessary. Appropriate facilities should be available for grafting or implanting in this National Organ, Tissues and Cells Transplantation Policy.BIBLIOGRAPHY Consensus of Convention of Human Rights and Biomedicine, Council of Europe, April 1997 Directive 2004/23/EC of The European Parliament and of the council on setting standards of quality and safety for the donation, processing, testing, processing, preservation, storage and distribution of human tissues and cells, Official Journal of the European Union, 31 March 2004 Ethics, Access and Safety in Tissue and Organ Transplantation; Issues of Global Concern, World Health Organization, Madrid Spain, 6-9 October 2003 Guidance on the Microbiological Safety of Human Organs, Tissues and Cells Used in Transplantation, Department of Health United Kingdom, August 2000 Guidelines on Importation and Exportation of Human Tissues and/or any Body Part (Garispanduan Pengimportan dan Pengeksportan Tisu National Or g a n , Ti s sue and Cell Transpl ant a t i on P o l i c y 41 Manusia atau Mana-mana Bahagiannya), Disease Control Division, Ministry of Health Malaysia, August 2006 Guidelines on Living Donation (Garispanduan Mengenai Pendermaan Hidup), Medical Development Division, Ministry of Health Malaysia, 2000 Guidelines on Stem Cell Research, Medical Development Division, Ministry of Health Malaysia, June 2006 Guiding Principles on Human Organ Transplantation, World Health Organisation, www.who.int Human Organ and Tissue Transplantation, Report by Secretariat, World Health Organization, EB113/14, November 2003 Human Tissue Act (1974), Malaysia Liver Transplantation – Guidelines in Clinical Practice, Malaysian Liver Foundation, 2000 National Or g a n , Ti s sue and Cell Transpl ant a t i on P o l i c y 42 National Liver Transplant Standard, United Kingdom Department of Health, August 2005 Policies on Organ/Tissue Donation and Transplantation, United Network for Organ Sharing (UNOS)/ Organ Procurement and Transplantation Networking (OPTN), 2004 Report of Consultation Meeting on Transplantation with National Health, Authorities in the Western Pacific Region, World Health Organization, November 2005 Resolutions and Decision of Fifty Seventh World Health Assembly; Human Organ and Tissue Transplantation, World Health Organisation, WHA57.18, May 2004 The Bellagio Task Force Report on Transplantation, Bodily Integrity and International Traffic in Organ, International Committee of the Red Cross, January 1997 The Donor Family Care Policy, Department of Health United Kingdom, October 2004
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