|Theme Paper for Discussion - Effective Drug Regulation: What Can Countries Do?, Geneva, 16-19 March 1999
(1999; 53 pages) [French
Table des matières
Annex 4. Examples of mission statements concerning drug regulation
Safe and affordable pharmaceutical care to all is the principle upon which the Dutch government’s medicine policy is based. The policy takes the quality, preparation, canalization and supply of medicines as its primary focus. The second policy objective is to control the cost of medicines. Thirdly, the policy is geared towards encouraging responsible use amongst patients and stimulating a judicious and cost-effective approach to the prescription and supply of medicines.
In response to the National Health Development and Economic and Social Development plans, Thai Food and Drug Administration offers the policy on quality services, consumer’s health protection and human resources development for the sake of the public health and overall development of the country.
Quality services are guaranteed with fastness, safety, clarity, unity and reliability. The policy on consumer’s health protection consists of the following:
1. Control of quality, safety of the health products and services with fair sales prices through regular inspection, testing, monitoring. Surveillance and taking immediate action to offenses against regulations.
2. Efficient dissemination of information to inform, educate, and alter the public awareness on protection of their own rights.
3. Improvement of laws and organizations to cope with the increasing and changing world situations.
4. Decentralization of the authorities to provincial and regional offices for effective and coverage control, services and problem solving.
5. Development of both central and regional officers’ potential through training and seminars for improving their capabilities on serving the needs and solving problems of their own areas.
6. In meeting this policy the roles and responsibilities of the FDA will be:
a) pre-marking control of locally produced and imported health products and household hazardous substances;
b) post marketing monitoring and surveillance;
c) consumer education and dissemination of information:
d) promotion of technological development, researches and manufacturing for export.
The mission of the National Drug Authority (NDA) is to ensure the availability of essential efficacious, safe and cost-effective drugs to the entire population of Uganda as a means of providing health care and safeguarding the appropriate use of medicines.
The mission of the Medicines Control Agency (MCA) of the United Kingdom (UK) Department of Health is to safeguard public health by ensuring that all medicines on the UK market meet appropriate standards of safety, quality and efficacy. This is achieved through a system of licensing and monitoring medicines after the licence has been granted. The MCA has separate divisions dealing with licensing, post-licensing, inspection and enforcement of medicines, executive support and finance.
The Food and Drug Administration of the USA
According to the Food arid Drug Administration Modernization Act of 1997 the amended mission of the FDA reads as follows:
“The Administration shall:
1. promote public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner
2. with respect to such products, protect public health by ensuring that -
a) foods are safe, wholesome, sanitary and properly labeled;
b) human and veterinary drugs are safe and effective;
c) there is reasonable assurance of the safety and effectiveness of devices intended for human use;
d) cosmetics are safe and properly labeled; and
e) public health and safety are protected from electronic product radiation
3. participate through appropriate process with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements; and
4. as determined to be appropriate by the Secretary, carry out paragraphs (1) through (3) in consultation with experts in science, medicine, and public health, and in cooperation with consumers, users, manufacturers, importers, packers, distributors and retailers of regulated products”.
The amended Act requires the Secretary, after consultation with appropriate scientific and academic experts, health care professionals, representatives of the patient and consumer advocacy groups, and the regulated industry to develop and publish a plan which is to be reviewed biannually. The plan is required to establish objectives and mechanisms to achieve such objectives. The Secretary is also required to prepare and publish an annual report providing detailed data on performance, achievements made as compared to the objectives set out in the plan, and identifying any regulatory policy that has negative impact on compliance.