It gives me great pleasure to address this International Conference of Drug Regulatory Authorities, which is being held for the first time in a developing country. I would thus like to express our great appreciation to the Government of Bahrain and to His Excellency the Minister of Health for hosting this important Conference and for setting an example for other international conferences to be held in developing countries.
The WHO Regional Office for the Eastern Mediterranean, recognizing the importance of these meetings, took the initiative in organizing regional conferences for drug regulatory authorities in preparation for this international conference. This initiative has since been followed by other regions of the Organization.
This conference is being held at a time when we are preparing to bid farewell to the twentieth century; a century which leaves us to face a number of serious problems and challenges. Foremost among these is the so-called 'global change' - a term that refers to the great changes that have taken place in political relations between the major powers in our world; changes which have had far-reaching effects on the socioeconomic conditions and the behavioural and ethical values that prevail in practically every country of the world.
Countries, international agencies and organizations of all kinds have responded to these changes. Likewise, the health sector, including the pharmaceutical sector, has had to deliver its response. Indeed, it has perhaps the most reason to lead the way in trying to cope with the new conditions. This is particularly the case in the developing countries, as they find themselves having to decide on issues of far-reaching consequence, such as the movement towards open market economy, massive increases in the cost of health care provision, privatization, free trade, the establishment of the World Trade Organization, increasingly sophisticated technology and advanced machinery, innovative techniques in telemedicine and biotechnology, and the revolution in global communications and information access. As a result, many countries are undergoing a process of health sector reform.
These issues also have a significant impact within the pharmaceutical field. It is therefore of crucial importance to identify the role of drug regulatory authorities within the ongoing health sector reform process. The Regional Office in the Eastern Mediterranean Region is working closely with drug regulatory authorities in Member States to study the impact of the changes and to develop appropriate approaches to deal with them.
Drug regulatory authorities should take responsibility for ensuring that ongoing reforms will respect the right of all people to have access to essential pharmaceutical services. Drug regulatory authorities also have a duty to promote the well developed concepts of a national drug policy, essential drugs, a generic drug policy, rational use of drugs and ethical drug promotion. Regional consultation is going on within EMRO to study the potential impact of the General Agreement on Tariffs and Trade, Trade-Related Intellectual Property Rights, and other relevant global agreements. In considering these concepts, the appropriate mix between the public sector and the private sector should be developed in a way that will both support development of the pharmaceutical sector and promote the achievement of national and global health objectives.
Drug regulatory authorities should also ensure the formulation of sound national drug policies with well-defined objectives and targets, and the development of a comprehensive national master plan. Within this framework, the public and private sectors can contribute to the overall achievement of national goals and objectives.
In this respect, I would like to emphasize the role of drug regulatory authorities in setting standards and regulating the various activities in the pharmaceutical sector. At global level, WHO has taken the leading role and several guidelines and standards have been published, including The International Pharmacopoeia, Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP). The Regional Office has supported several Member States in developing national guidelines and strengthening national capabilities in standards setting and improving compliance. We have also supported an initiative to adopt regional guidelines, such as good manufacturing practices for the Arab countries and guidelines for conducting stability studies.
As a consequence, we expect the national drug regulatory authorities to support our initiative for self-reliance at regional level in the production of essential drugs and biologicals. It is important in this respect that drug regulatory authorities, in both producing and non-producing countries, work together to achieve this objective. Mutual trust and recognition by drug regulatory authorities in our countries is essential to promote regional cooperation. The successful experience in bulk procurement of essential drugs and vaccines by the Gulf and Maghreb countries represents a very good example which I hope will be followed in other regions. It is also important to note that an efficient drug regulatory system benefits not only the pharmaceutical services, but it is also of great benefit to local and regional drug industries. In the meantime, we would appreciate the support of the drug regulatory authorities from developed countries, in particular in the areas of training and facilitating technology transfer.
I wish you a productive meeting and success in your endeavours, and a very pleasant stay in this beautiful city of Manama.
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