The Standards and Regulation Division was established in March 1999 under the Health Reform process of the Ministry of Health. The role and functions of the Division are regulatory and administrative in nature and are executed through three (3) Branches, namely:
- Standards Research and Development
- Investigation and Enforcement
- Pharmaceutical and Regulatory Affairs
The mission statement of the Division is:
“To improve the quality of health care services in Jamaica through standards development and monitoring in consultation with public and private health care providers; to regulate healthcare facilities, pharmaceuticals and other designated products; and to facilitate the recognition of the rights of all clients.”
Roles and Function
The mandate of the Standards and Regulation Division is to lead the process for quality improvement through standard setting and monitoring of the health sector (public and private). The core functions therefore include:
- Assess and evaluate narcotics, psychotropics, herbal products and other drugs, cosmetics, foods and medical devices for safe use by the public;
- Assess and evaluate all chemicals for safe application and use by the public;
- Development of healthcare standards and guidelines;
- Monitoring and enforcement of standards, regulations and guidelines; and
- Resolution of complaints in the public health sector.
The following laws and regulations primarily govern the functions of the Division:
- Food and Drugs Act, 1964 and Regulation, 1975
- Precursor Chemicals Act, 2005 and Regulation, 2014
- Nursing Homes Registration Act, 1934 and Regulation, 1934
Standards Research and Development
The main function of Standards Research and Development is to develop new and update existing standards and guidelines relevant to the operation of health care facilities in both the public and private sectors. Quality assurance also resides in this Branch where audit tools are developed and used to asses compliance with standards established for health care facilities in the public and private health sectors.
Investigation and Enforcement
Investigation and Enforcement is responsible for maintaining an efficient client satisfaction mechanism through its complaint management system. It facilitates the conduct of investigations on complaints made on the public health sector. This is through the network of Regional Health Authorities, their hospitals, health centres and health departments as well other umbrella Departments and Agencies of the Ministry. They support external Civil Society Organizations (CSO’s) as redress partners for the timely resolution of complaints for their members. The Branch analyses complaint data to inform policy and programmes for quality improvement in the sector. The Branch is also the focal point for customer service improvement within the Ministry.
Pharmaceutical and Regulatory Affairs
Pharmaceutical and Regulatory Affairs focuses on the following three (3) areas:
- Product Registration
- Import Permit Processing
- Registration and Monitoring of Institutions and Facilities
Most products require registration with the Ministry of Health prior to importation, distribution and sale in Jamaica as outlined in the Food and Drugs Act, 1964. These include pharmaceuticals (prescription and over the counter drugs), herbal preparations, natural health products, products containing vitamins and minerals. The following categories of products are assessed:
- New Drug Moieties
- Generic Drugs, Drug Line Extensions, Herbal products, Vitamins and Minerals
- Drugs for treatment of life threatening illnesses e.g. Cancer, HIV
Import Permit Processing
Approval is required for products regulated under the Food and Drugs Act, 1964 and Precursor Chemicals Act, 2005 before they can be imported into the country. Before importation, the customer should fill out the appropriate application form and pay the application fee. Permission to import is granted only if the product being requested has been reviewed and approved for importation before sale or use in Jamaica.
A permit is required for the importation of the following items:
- Precursor Chemicals, Psychotropic Substances, Narcotic Drugs and other controlled Substances (Yellow Form)
- Foods and Drugs (Blue Form)
- Cosmetics, Chemicals and Medical Devices (Pink Form)
Registration and Monitoring of Institutions and Facilities
A nursing home, pursuant to Section 2 of the Nursing Homes Registration Act, 1934 is any house or building and grounds used for or intended to be used for receiving into the premises, persons suffering from any illness, injury or infirmity and providing the care of a nurse to such person. Facilities covered by the Act include:
- Private Hospitals
- Professional Practices (including doctor’s offices)
- Home for Senior Citizens
- Nursing Homes (24 hour)
- Adult Day Centres
- Homes of Charitable Organizations
- Convalescent Homes
- Ambulatory Services
- Dialysis Services
Psychiatric Nursing Homes are regulated under the Mental Health Act, 1999, however, they are jointly monitored by the MOH Mental Health team and the Health Facilities and Institution Unit.
An Advisory Panel Mechanism was created in 2000 to pull internal and external experts to provide a collaborative network supporting the Division in the development of systems and programmes, which will advance the quality of healthcare and provide inputs for health policy formulation. These are the:
- Medical Review Panel (serious clinical complaints); and
- Ethics and Medico-Legal Affairs Panel (research on human subjects).
The Complementary and Alternative Medicine Advisory Panel was also created and operational however it is currently on hold.