MEDICINES BILL

Order Second Reading read.

4.00 p.m.

The Minister of State for Health (Dr Ang Kok Peng): Mr Speaker, Sir, I beg to move, "That the Bill be now read a Second time."

It is perhaps a sad commentary on present-day living that there is such a large consumption of medicines. And because of this tremendous appetite for drugs, a vast pharmaceutical industry exists today. In Singapore the total value of trade in pharmaceutical products in 1973 was $170 million. For the four years 1969-1973, imports increased by over 80% while exports increased by 400%.

In earlier times, medicines were of simpler chemical substances or derivatives of herbs. They were consumed in the form of powders prepared by pounding or in the form of liquid obtained by brewing the medicinal preparations. The advancement of science has made it possible for us to extract the active ingredients from these medicinal preparations, synthesising them and even modifying their structures to make them more potent and specific. In these forms they are then made available to the public in elegant pills, capsules, injectionables and suppositories.

Even preparations used as home remedies in the traditional systems of treating ailments have changed beyond recognition. No longer do they conic only as dried parts of plants or animals; they are now sold in powder form or liquid extracts and some of them have been found to be mixed with dangerous substances making them no longer harmless remedies but potent poisons.

The existing bewildering array of medicines of high potency and diverse effects has created certain problems of control. Whilst on the one hand the public needs to be protected and assured that the medicines that are available are safe and useful; on the other hand, those who are in the pharmaceutical industry should not be unduly discouraged from introducing new and more useful medicines.

The existing controls are no longer adequate in dealing with a pharmaceutical trade that has grown tremendously and a situation where complex chemicals with far-reaching effects on the human being now form the bulk of medicines available in Singapore.

The proposed Medicines Act is an omnibus act designed to bring together controls which were formerly exercised under various separate Acts. Most of the provisions of the Poisons Act will now be incorporated into the Medicines Act. Only a residual portion on the control of industrial poison will remain. The Medicines Act will supersede the Sale of Drugs Act and the Medicines (Advertisement and Sale) Act, both of which will be repealed. As the control of opium and other similar narcotic drugs is subject to international conventions because of international illegal trafficking, special controls will continue to be exercised under the Misuse of Drugs Act.

The primary purpose of the Medicines Act is to protect the persons who use drugs, that is the customers who, by and large, have no knowledge of factors influencing the safety and usefulness of a medicine. The Act is to ensure that the medicine which a consumer obtains is safe and useful and of a quality he should expect. Since he is generally not knowledgeable in this matter, the influence brought to bear on him through advertisements must be fair. The drug he obtains, be it from a doctor who prescribes it or bought over the counter from a medicine shop, should comply with certain quality and safety standards. Conversely, neither should he have access to drugs for which he has no need of; nor should he consume drugs which he has no knowledge of their potency or safety.

Under the Act, all medicinal products will come under strict scrutiny. Medicinal products prepared from herbs, animals or insects which have been used in traditional systems of treating ailments and which were largely not controlled previously will now be subject to similar scrutiny under the law. This is essential. These products are more often than not supplied as pills and potions where the original herb or animal part is no longer recognisable. It has been discovered that unscrupulous manufacturers and charlatans have resorted to adding highly active chemical substances to lend potency to their medicine. Arsenic discovered in several brands of preparations used widely in the treatment of asthma is an example. Potent hydrocortisones have been found in others and so too have mercury and lead. We can no longer ignore the large numbers and brands of medicinals which are freely available in the market, nor can we rightly assume that they are harmless. More often than not they are mixed with poisons and arc compounded by persons with no knowledge of basic pharmacy or pharmacology and distributed by persons whose sole interest is profit. Even cosmetics which may contain harmful or deleterious substances can also be brought under the purview of the Act.

The simplest method of achieving the objective of protecting the public in regard to medicines is to impose a ban on advertisements of medicines anti couple this with a complete control over the dealing in medicines by only allowing sales by prescription and restricting the import or manufacture of medicines to a few types of brands. In fact such controls are practised in some countries. Such a measure would reduce considerably the expenditure on drugs and drug control. It would eliminate malpractices and unscrupulous dealings in drugs. However, we cannot adopt this simplistic attitude as we are an important centre of communications and trade. Nevertheless, we must exercise certain controls and restrictions while permitting legitimate pharmaceutical trade without compromising on the efficacy and quality of medicines available in Singapore. This Act attempts to do just that.

The Act accordingly provides close control at all levels of the pharmaceutical trade - from the import and manufacture of drugs to the sale of drugs and even to the dispensing of drugs by practitioners and pharmacists. Strict regulations will be aimed at ensuring public safety. This is paramount. Further, in view of the general ignorance about medicine there are controls over advertisements and other techniques for promoting drug sales since doctors and patients are normally not in a position to verify the claims of manufacturers.

The Act lays down in considerable detail the authority and the principles of control while the procedures for implementation will be set out in the regulations.

The basic instrument to effect the objectives will be the product licence. Any persons wishing to import or manufacture any medicinal products will have to satisfy the licensing authority who is the Director of Medical Services that the product complies with certain quality standards. Medicinal products will be classified under two categories, (a) non-general sales list medicines and (b) general sales list medicines. Only qualified persons, i.e, doctors, dentists, pharmacists and veterinary surgeons, may deal with non-general sales list products. Medicines on the general sales list which are relatively harmless will be subject to less stringent control and may be sold as it is now being sold in our medicine shops, over the counter and without a prescription.

Medicinal products will now be screened by the Ministry before they appear on the local market. Where necessary, the screening will be done by advisory committees. The evidence that is to be provided by applicants for a product licence will include details of pharmaceutical, bio-chemical and chemical formulation, conditions and locality of manufacture, details of qualified person supervising its manufacture, and results of trials carried out, and whether it complies with the laws of the country of manufacture if this is not manufactured locally. It shall be an offence to misrepresent any of these facts and the licensing authority is authorised to refuse to grant or revoke a licence and vary any or all of the conditions upon which the product licence has been granted. Penalties are provided for those who breach the law.

Manufacturers of medicinal products will be required to apply for licences. The issuance for such a licence will be conditional on, amongst other requirements, suitability of personnel, equipment and premises, as well as adequacy of storage facilities.

Only qualified persons should be employed by manufacturers to supervise production at each stage and deal in medicinal products. No person may manufacture a product if that product is not so licensed.

Wholesale dealers will also be subject to licensing. The issuance of such a licence will be tied to amongst other requirements suitability of premises as well as the employment of qualified personnel. Their premises will have to be adequate with suitable storage and distributing space and equipment. Persons supervising the dealing of medicinal products at wholesale dealer's premises arc to be suitably qualified if dealers wish to deal in the sale and supply of non-general sales list products.

It shall be mandatory for all licence holders to maintain adequate records for their transactions as well as ensure that such records are well and safely kept for inspection at reasonable times by the Ministry officials. Adequate records are required also to facilitate easy recall of drugs.

The Bill also protects the purchaser from fraudulent representation on the safety, efficacy and quality of medicinal products. Medicinal products shall have to comply with the standards of relevant monographs if they are claimed to be sold or supplied in accordance with such specification.

The Act has provisions for it to be brought into effect in parts. Thus one of the first parts to be implemented will be the notice categorising medicines on a general sales list and a non-general sales list. The next would be the regulations on registration of all medicines and medicinal products. The regulations would be for provisional licensing of medicinal products so that medicinal products on the market can continue to be available.

In the advanced countries, research establishments undertake research into drugs, including clinical testing of their toxicity, effectiveness and side-effect. While our facilities and expertise in this field are not adequate for such comprehensive investigations of drugs, we are able for the time being to concentrate on testing the toxicity of drugs for which we can enlist the assistance of the Ministry of Science and Technology. We will also rely on the independent reports published regularly by the World Health Organisation and internationally renowned research centres for making rational judgments on the safety and efficacy of particular drugs and their use in Singapore.

To administer the law will require a large expansion of the section of the Poisons Inspectorate of the Ministry of Health. This section will be responsible for the keeping of the registers, issue of licences and inspections. There are provisions in the law for the Minister to appoint committees. Perhaps the one which would be of more immediate interest would be a Committee to deal with appeals against decisions taken administratively on licensing. Other expert committees such as a committee on safety may be introduced in due course.

Because of the complexity of the Act and its far-reaching controls which will affect the fabric of medical practice and the pharmaceutical trade, it is recommended that the Bill be committed to a Select Committee.

Sir, I beg to move.

Question proposed.

4.15 p.m.

Dr Tan Eng Liang (River Valley): Mr Speaker, Sir, arising from an oral question which I asked the Minister of State for Health sometime last year, I am glad to note that he has kept his promise by referring the Bill to a Select Committee.

However, I would like to give some general observations why this Medicines Bill should be sent to a Select Committee. The Minister of State has correctly brought out the point which I intended to raise, and that is, it appears extremely restrictive that an appeal is decided by the Minister alone. I think he has indicated just now that it would be better that an appeal committee consisting of knowledgeable representatives from the relevant authorities be appointed to assess all appeals and makes its recommendations to the Minister for a final decision.

In Part II, clause 10 (3) the definition of "product licence" is not clear for it does not positively say whether it is the brand or trade name or whether it is the chemical or generic name. Therefore, the question of issuing third party licence on patented products becomes relevant. It is reasonable to accept that products with patent protection still in force, third parties should not be allowed to apply for the licence. However, product licence holders can assign the right to a third party.

A few medicinal authorities in the United States have questioned the adequacy of the United States Pharmacopoeia (USP) standards. As with the British Pharmacopoeia (BP) or the European Pharmacopoeia (EP) bio-availability standards are generally not available. Hence in clause 12 (1), the safety efficacy and quality of medicinal products should be thoroughly reexamined.

Clause 18 (a), (b) and (c) allows the Minister to make regulations for clinical trials and for medicinal tests. It is recognised that we have limited clinical and testing facilities. It is therefore unlikely that we are in a position to conduct tests on tetratogenic effects or congenital deformities. In view of this, the licensing authority should be flexible in assessing submitted literature for medicinal products. An example of this test in case is the experience relating to the introduction of thalidomide in Germany resulting in thousands of babies being deformed. It is therefore essential to establish whether local manufacturing facilities provide certain safeguards on the consumers in case of such an unfortunate event for if they should seek monetary compensation, how do the manufacturers intend to meet these requirements? I think this is one area which is worth looking into.

Again in Part III, clauses 34 and 35, and Part IV, clauses 37 (3) and 41(1), these provisions appear to discriminate against practising pharmacists or pharmacies. It appears reasonable that these similar provisions should also be extended to all those handling and dispensing medicinal products.

Part V, clause 47 (1), this provision is not practical as most imported medicinal products are already produced by multi-national pharmaceutical corporations for the international market. Therefore, it may be difficult for the Minister to make regulations stipulating distinctive colours, shapes and markings of medicinal products.

The whole of Part VI of the Bill deals with the promotion of sales of medicinal products and medical advertisements. This has extremely wide implications and requires closer study. Representations by interested and knowledgeable parties will be made to the Select Committee.

The good intention of any Bill or Act will be thwarted and cannot achieve its required effects if the implementation process is not as effective and sensibly carried out. Hence proper consideration should be given to the formulation of various regulations by the licensing authority for the practical implementation of the Medicines Act, 1975, when it is finally passed.

Dr Ang Kok Peng: Mr Speaker, Sir, I wish to thank the Member for River Valley for his views which will be conveyed to the Select Committee for consideration.

Question put, and agreed to.

Bill accordingly read a Second time.

Resolved,

"That the Medicines Bill be committed to a Select Committee consisting of Mr Speaker as Chairman and the following Members: Dr Ang Kok Peng Mr Ivan Baptist Mr Chan Chee Seng Mr Ch'ng Jit Koon Mr P. Govindaswamy Haji Sha'ari Bin Tadin Dr Tan Eng Liang."-[Dr Ang Kok Peng].

Mr Speaker: Order. I propose to suspend the Sitting and will take the Chair again at 4.55 p.m.

Sitting accordingly suspended at 4.22 p.m. until 4.55 p.m. Sitting resumed at 4.55 p.m.