The Health Sciences Authority Bill

22 Feb 2001

By Mr Lim Hng Kiang

Mr Speaker, Sir, I beg to move, "That the Bill be now read a Second time".

Objective of the Bill

The Government intends to establish a new statutory board, the Health Sciences Authority, by integrating five departments of the Ministry of Health, namely the Centre for Drug Evaluation, Institute of Science and Forensic Medicine, National Pharmaceutical Administration, Product Regulation Department and Singapore Blood Transfusion Service. The proposed Health Sciences Authority Bill 2001 is to provide the legislative framework for the formation of the new statutory board.

Background to the formation of HSA

The five departments to be integrated provide a wide range of highly specialised health scientific expertise and services. Our departments have achieved professional excellence in many of these areas of expertise and have been accorded international recognition. Our objective now is to build on the technical synergies and keep abreast with the rapid developments in the healthcare and life sciences industries.

The National Pharmaceutical Administration (NPA) is responsible for ensuring the quality, safety and efficacy of medicines and other health-related products in Singapore. In January this year, the NPA achieved international recognition for its Good Manufacturing Practice (GMP) when Singapore became the first Asian country to be accepted into the Pharmaceutical Inspection Cooperation Scheme, an international benchmark organisation for GMP based in Geneva.

The Singapore Blood Transfusion Service (SBTS) is responsible for the safe and adequate supply of blood and blood products for patients in Singapore. SBTS has consistently applied the latest state-of-the-art technology for the testing of blood for infectious diseases to ensure that the risk of transmission is as low as the best blood banks worldwide. SBTS has achieved international recognition as a WHO Collaborating Centre in Transfusion Medicine since January 1992.

The Institute of Science and Forensic Medicine comprises the Department of Forensic Medicine (DFM) and Department of Scientific Services (DSS) which serve as national reference agencies for forensic medicine, forensic science, radiation science and statutory scientific services. The standard of forensic pathology expertise provided by DFM to the police and the courts for the investigation of death is well respected by the international forensic fraternity.

The Forensic Science Division of DSS provides a wide range of scientific expertise to the police for the investigation of crime such as trace evidence analysis, DNA profiling, document examination and toxicology. The Narcotics Laboratory supports the Central Narcotics Bureau in the investigation of drug offences under the Misuse of Drugs Acts. This Division has achieved international recognition by being one of the few non-US laboratories accredited by the American Society of Crime Laboratory Directors since June 1996 and was also awarded the Excellence for Singapore Award in August 1999. The Radiation Science Division of DSS is the national authority on radiation safety and control and administers the requirements of the Radiation Protection Act. The Health Science Division of DSS comprises a group of specialised analytical laboratories that provide scientific testing services to support pharmaceutical, food, cosmetics, occupational and environmental safety. The Division is accredited under the Singapore Laboratory Accreditation Scheme of the Singapore Accreditation Council and is internationally recognised as a WHO Collaborating Centre for Drug Quality Assurance and Food Contamination Monitoring.

Rationale for the formation of HSA

Mr Speaker, Sir, the formation of the Health Sciences Authority (HSA) will build on our existing strengths and achievements by enhancing the management autonomy and scientific synergy of the five departments. Government has recognised the need to ensure the continued presence of a strong and progressive regulatory and scientific agency to perform these essential functions. In an era of rapid change in medical practice and increasing complexity of regulatory issues, the formation of HSA as a new statutory board will allow more timely and effective development, harnessing and integration of professional capabilities necessary to meet the challenges of the future. This will allow Singapore to keep pace with the best international practices and to be world class in our regulatory and professional expertise in the Health Sciences.

Benefits from the formation of HSA

The formation of HSA will result in a larger and stronger critical core of medical, pharmaceutical and scientific expertise to provide the synergy for professional and regulatory excellence. Developments in the biomedical sciences, both internationally and locally, will lead to the discovery of novel health care products that will require new expertise and systems to make good evaluations before they can be used by patients. The evaluation of a biotechnology product derived from genetically engineered human blood, tissue or cells and delivered by special miniaturized devices will require close scientific interaction of a range of professionals skilled in the evaluation and testing of drugs, devices and blood products. New capabilities in molecular biology, genetics, toxicology and pre-clinical evaluation will have to be developed. Combining the professional strengths in HSA will ensure that Singapore continues to have a capable and credible regulatory agency that is able to rigorously evaluate and approve these new and innovative products.

The formation of HSA will also result in a one-stop regulatory agency that will administer a seamless regulatory process for all therapeutic products. Convergence in the application of medical technology has increasingly blurred the boundaries between health care products. There is already a trend towards products that combine multiple technologies for example, medical devices that also release drugs. As a multi-disciplinary agency, HSA will be able to deliver a well-coordinated regulatory process efficiently and effectively. The medical and pharmaceutical industry will now only need to interact with a single agency which will have the full range of professional expertise necessary to evaluate and approve their therapeutic product.

The key to HSA's success is knowledgeable and well-trained professionals who are able to discharge their regulatory and statutory responsibilities with competence, integrity and commitment. With the growth of the health care and biomedical sectors in Singapore, there will be increasing competition for good doctors, pharmacists and scientists. MOH has already faced difficulty in attracting these professionals into the highly specialised fields of expertise in the five departments. As a statutory board, HSA will now have greater flexibility to be competitive so as to recruit and retain its fair share of professional talent. With more competitive recruitment policies, HSA will also be able to attract foreign talent to augment and enrich the local talent pool.

Main features of the HSA Bill

Mr Speaker, Sir, I will now highlight the main features of the Bill:

The composition of the Authority shall consist of a Chairman and six to ten other members as provided in Section 5(1). All members including the Chairman shall hold office for such term not exceeding three years as specified in the appointment by the Minister.

The main functions of the Authority as provided in section 11(1) are:

to regulate the consumption and use of medicines, cosmetics, medical devices, tobacco products, radioactive materials, irradiating equipment and other health-related products in Singapore in accordance with statutory requirements;

to maintain a safe and adequate national blood supply;

to provide professional, investigative and analytical services in health sciences; and

to the Government and to any other person or body.

All staff in the five departments will be absorbed into the service of the Authority on terms no less favourable than those enjoyed by them immediately prior to their transfer as provided in Section 31.

All other Parts of the Bill are similar to the Acts of other statutory boards

Conclusion

Sir, in conclusion, the formation of the Health Sciences Authority as a new statutory board will establish a comprehensive and integrated regulatory and scientific agency to support the Health Sciences. HSA will build a strong and credible world-class professional capability to regulate all health care products and to provide specialised scientific expertise to support essential statutory functions. As the national regulatory agency, HSA will provide seamless service to the health care industry and effectively safeguard public confidence in the quality, safety and efficacy of all health care and blood products in Singapore. HSA will forge strategic alliances and partnerships with world-class regulatory and scientific agencies eg. in US, Europe and Australia, to achieve global recognition of its capability and expertise for Singapore.

Mr Speaker Sir, I beg to move.