Opening Remarks at An International Conference on Health Research and Access to to Medicines in Asia and the Western Pacific: Forum for Ethical Review Committees in Asia and the Western Pacific - FERCAP/SIDCER, Chiang Mai, Thailand, 13-14- December 2004

Opening Remarks by Dr Samlee Plianbangchang Regional Director, WHO/SEARO at An International Conference on Health Research and Access to Medicines in Asia and the Western Pacific: Forum for Ethical Review Committees in Asia and the Western Pacific – FERCAP/SIDCER Chiang Mai, Thailand 13-14 December 2004 An International Conference on Health Research and Access to Medicines in Asia and the Western Pacific: Forum for Ethical Review Committees in Asia & the Western Pacific – FERCAP/SIDCER Chiang Mai, Thailand, 13-14 December 2004 Opening Remarks by Dr Samlee Plianbangchang Regional Director, WHO South-East Asia Mr Chairman, Distinguished participants, Ladies and gentlemen, • I am very pleased to have the opportunity to attend this International Conference. • The impressive list of co-sponsors, the wide range of countries represented, the large and diverse group of health researchers, and those professionals involved in health care; signify the interest and the importance of the topics being covered by the conference. • Medicines are a vital element of medical care and public health interventions. • If used rationally, medicines can bring us a long way in curing diseases and cutting transmission of disease agents. • However, to make quality medicines available and accessible to all people is really a formidable challenge indeed. 2 • It is estimated that about 30 per cent of the population in Asia and the Pacific who are in need of medicines do not have access to them. • There is a wide range of accessibility to quality medicines by peoples living in different parts of the world. • The percentage of this accessibility is definitely much lower in Asia than in the developed countries. • It is therefore important in this respect to focus our attention on the issues of accessibility and availability. • To a significant extent, the accessibility is also relating to the management of health service delivery, which is to ensure access to medicines by whoever in need. • In general, access to medicine is influenced by a wide-range of factors, socio-economic and political, to the lack of knowledge on the part of people themselves. • Strategies for ensuring access to medicines should be formulated through a multidisciplinary approach, embedded with the prevailing ethical and moral principles. • No less importance, such a formulation must also take into priority consideration the locally specific situations and circumstances. Ladies and gentlemen, • The availability and accessibility of medicines depend on the demand for quantities and different varieties as well as on the procurement and distribution system. • To fulfil the requirement for different varieties, new drugs have to be developed. 3 • Development of a new drug has to be undertaken through a long process of research and development, which also involves clinical trials. • Ethical considerations in this process are of paramount importance for both researchers and manufacturers in ensuring availability and accessibility of quality drugs. • Once the drugs are available in the market, there is a need to monitor drug reaction, and to pursue clinical studies to ensure their continued efficacy and safety. • Clinical trials used to be conducted mainly in the industrialized world. • During the past many years, an increasing number of these trials has been conducted in the developing countries. • Today, a multicountry study in this area would invariably involve at least one developing country, if not more. • There are also trials for new drugs used in prevention and control of tropical diseases. • These, naturally, should be conducted in the developing world, where the diseases are prevailing in the poor population. • However, recent clinical trials by a manufacturer on drugs to control Leishmaniasis, a tropical disease, have given hope of a breakthrough in the treatment of a condition that has affected millions of disadvantaged people for ages. • Let us be optimistic that this exemplary initiative will be followed by other manufacturers for other neglected tropical diseases. 4 • Providing quality drugs for these diseases which are widely prevalent in developing world is a moral and ethical imperative of both researchers and manufacturers. Colleagues, • Clinical trials are different from other scientific experiments due to the involvement of human subjects. • The fundamental rights of these subjects have to be adequately respected throughout the process of the trials. • Here, the ethical committees can play a vital role as guardians of the interest of the subjects. Ladies and gentlemen, • The Asia Pacific region, which accounts for about a half of the world’s population, presents a wide variety in socio-economic and health care settings. • Therefore, ethical committees need to be aware of locally specific circumstances, and be adequately creative and innovative in protecting human subjects, through an acceptable standard procedures, while respecting the local context. • Certainly, there are many more important points to be examined during the course of this meeting. • Let me finally, wish the Conference productive deliberations and successful conclusions. Thank you. Q:\RD-OFFICE\Speeches\2004\FERCAP 13 Dec 04 Welcome.doc– 30 Dec.04 / 9.00 am