MEDICINES (AMENDMENT) BILL

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MEDICINES (AMENDMENT) BILL: Order for Second Reading read.

The Acting Minister for Health (Mr Khaw Boon Wan): Mdm Deputy Speaker, I beg to move, "That the Bill be now read a Second time."

Like the earlier Bills that were debated in this House this afternoon, this Bill is to enable us to fulfill certain obligations arising from the US-Singapore FTA. The FTA's chapter on IPR includes several obligations related to pharmaceutical products. While most of the IPR-related amendments have just been made in intellectual property laws, including the Patents Act, some amendments to the Medicines Act are also required. There are three obligations in the FTA which impact the Medicines Act.

First, where a pharmaceutical product is a subject of a patent, we commit not to grant marketing approval to any third party prior to the expiration of the patent term, unless with the consent of the patent owner.

Second, where a pharmaceutical product is the subject of a patent, the patent owner shall be notified of the identity of any third party requesting marketing approval effective during the patent term.

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Third, where marketing approval has been granted for

a pharmaceutical product, any information submitted on the product's safety and efficacy may not be used as the basis for granting marketing approval to another party for a similar product for a period of five years from the earlier grant.

The first obligation effectively means that no marketing approval should be granted to a generic product before the expiration of the patent term of the innovated product unless with the consent of the patent owner. In order to fulfill this obligation, a new section 12A will be inserted into the Act to allow the Health Sciences Authority to consider the patent status of the product when deciding whether or not to grant marketing approval. Section 12A will also allow HSA to request an applicant to submit patent-related information when he makes an application for marketing approval.

The second obligation effectively means that there must be a mechanism whereby a patent owner will be notified of the identity of any party seeking marketing approval of a generic product while the innovated product's patent is still in force.

The new section 12A will also serve to fulfill this obligation by enabling HSA to request the applicant to notify the proprietor of the patent. This will apply mainly in situations where the generic product owner challenges the validity of the patent and HSA will take into account the action taken by the patent owner to defend his patent before continuing to process the application.

Another amendment related to the second obligation concerning notification and disclosure is the new section 19C which will allow HSA to publish information on the product licence's application it has received should it be necessary to do so.

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The third obligation effectively means that HSA may not approve a generic product based on the safety and efficacy data of the innovated product during the period specified. In order to comply with this obligation, a new section 19B will be inserted, stating that the HSA may not grant marketing approval for a similar product on the basis of the grant of an earlier approval for a period of five years from the date of the earlier approval unless with the consent of the holder of the earlier approval.

In addition to the proposed new sections 12A, 19C and 19B, section 16 of the Act will be amended to allow HSA to revoke the marketing approval of a product if it is subsequently established that a product does indeed infringe a patent or when the declaration on patent-related information is found to be false. To further strengthen the integrity of the approval mechanism, section 20 of the Act will also be amended to make it an offence for an applicant to submit a false declaration in support of this application.

Besides these IPR-related amendments, this Bill also makes a technical amendment to section 54 of the Medicines Act in relation to the control of oral dental gums. These are chewing gums intended for use in promoting dental health or oral hygiene. This also arose from our obligation under the US-Singapore FTA to allow the sale of some medicinal and oral dental gums subject to Singapore's health laws and was in fact implemented earlier in January this year. This amendment is intended to clarify for the avoidance of doubt that the powers conferred on the Minister to make orders under section 54 of the Act do also apply to oral dental gums and include powers to restrict their sale and supply only by prescription or under the supervision of a pharmacist.

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Madam, this Bill is to enable Singapore to comply with certain obligations under the US-Singapore FTA mainly on the protection of intellectual property rights in respect of pharmaceutical products. These amendments will also strengthen Singapore's protection of pharmaceutical patents and bring us in line with international practices.

Madam, I beg to move.

Question proposed.

Dr Lily Neo: Mdm Deputy Speaker, I support the Medicines (Amendment) Bill. This Bill seeks to amend the Medicines Act (Chapter 176) to implement certain obligations undertaken by Singapore under the United States-Singapore Free Trade Agreement conducted in 2003.

Given Singapore's focus on being a medical and research and development hub, the safeguarding of rights on patented drugs, ie, the protection granted to an innovator to prevent others using copying or making the invention, would be highly desirable even if these were not a requirement under the United States-Singapore FTA. Research and development activities are laborious, time-consuming and expensive. Innovators should be encouraged and protected by our laws to safeguard their efforts. Moreover, advancement and new discovery would mean better drugs to comb the frontier of diseases. This will auger well for us in our endeavour to excel in research and development in the pharmaceutical field. This Bill thus will bolster Singapore's resolve to create a suitable environment for a medical and research and development hub. In point of fact, Madam, quite a number of pharmaceutical giants have set up their regional hubs in Singapore with research units, a moving factor for their doing so being the good regulatory environment

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apart from the high quality medical technology and the remarkable infrastructure.

Clause 6 amends section 54 to allow chewing gum for sale to promote dental health or oral hygiene. May I ask the Minister whether this will result in proliferation of many varieties of chewing gum flooding the market? Madam, manufacturers may take advantage of this relaxation and vend them aggressively in a lucrative market of a previously-banned product. How is the Minister going to address this potential environmental hazard by amending this Bill concerning chewing gum? May I ask the Minister why such chewing gums are already available in the market even before the implementation of this Bill? In order to prevent inconsiderate discarding of chewed gum, will the Minister require the manufacturers of gum for sale in our market to print environment-friendly messages on the wrappers to remind users on proper disposal of used gums?

The penalty for offences under section 20(1), (2), (3) and (3A) is a fine of $5,000 and/or imprisonment of up to two years. Madam, this penalty is rather low for offences under section 20(3) and (3A). This may seem reasonable based on the maximum penalties allowable under the Medicines Act, but offenders under this section who may be caught under the Penal Code or other Acts, ought to have their penalty based on the more established Acts so that there can be consistency in the imposition of penalty for such similar category of offences.

This Bill and the current Medicines Act, Madam, do not provide for situations where it calls for additional data to be given to the licensing authority even after granting of a product licence. Will the Minister consider inserting an additional new clause for such a requirement?

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Madam, situations may arise when such an action is necessary and I would like to cite, as an example, the case of New York State suing a drug giant recently over a drug called "Paxil". The civil lawsuit contends that the drug company engaged in persistent fraud by not telling physicians that studies showed that Paxil not only did not work in adolescents but may also be linked to cases of suicide.

Madam, there is a need to address intentional selective disclosures to the detriment of consumers at any time. How does the Minister plan to ensure this? Do our regulations provide safeguards against the dumping of disputed drugs in our market, especially after they have been rejected by those countries with more stringent rules? Madam, this Bill should not be drafted only to comply with the commitments made under Article 16.8(1) of the USSFTA. It should be drafted, more importantly, to have the interests and the safety of the consumers in mind.

The amendments to section 16 state that the licence can be revoked by way of a request to the licensing authority. I feel that to revoke the licence, it should be done by way of a written request. This is to prevent any dispute as to whether that request was made by the licensee.

I hope the Minister can clarify the points raised.

Mr Khaw Boon Wan: Madam, let me first thank Dr Lily Neo for her strong support of the Bill. She did raise a number of questions. Let me respond to them.

First, chewing gum. We banned chewing gum in 1992 for very good reasons. Irresponsible disposal of the gum created an unnecessary problem for our cleaners and when it led to jamming of MRT train doors, it even posed a public safety risk for the passengers. We have now had 12 years of freedom from this sticky problem. We have no intention of

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welcoming them back. In fact, some foreign cities are seriously contemplating banning chewing gum as we have done. The concession we made on chewing gum for the bilateral FTA is therefore a very limited one. It certainly will not lead to a flooding of our market with the gums.

First, what we have done is merely to create an exception for gums with therapeutic value. Their sale will then be subject to our health laws and regulation. In this way, we can expect a slight increase in consumption of gums but this will be for their therapeutic value and not for their recreational value.

Second, the Environment Ministry and the Transport Ministry have, in parallel, introduced stiffer penalties for any indiscriminate disposal of used gum. This is to remind all that we have no intention to return to the bad, old sticky days.

Dr Lily Neo suggested that we require gum manufacturers to print environment-friendly messages on the wrappers. I happen to have one here with me and it has a pictorial message on responsible gum disposal with a tagline "Keep your country clean". But whether such a message will be effective, frankly speaking, I doubt it very much, because unlike cigarette packs, which are large enough to enclose lively pictures and pictorial messages, the wrapper is really too small to provide for any effective messages. Therefore, I think the most effective method of preventing these old problems from coming back is to continue to ban those chewing gums and only to make a small concession for those with therapeutic value. In any case, it will not be appropriate to use the Medicines Act to enforce environment-friendly messages. The Medicines Act can only enforce product labelling requirements which address health and safety concerns.

As for the timing of this particular FTA obligation, the concession on chewing

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gum was implemented in January this year through a set of subsidiary legislation under the existing section 54 which is actually legally adequate. But just to avoid any doubt, the proposed section 54 (1A) will make it crystal clear that the existing powers under section 54 do apply to dental chewing gums.

Let me now reply to the questions on the main amendments pertaining to greater IPR protection for patent holders. On the question of penalties, Dr Lily Neo felt that a fine of $5,000 seems rather low. The maximum penalty, as currently prescribed in the Medicines Act, is a fine of $5,000 or two years' imprisonment or both. For the current amendments, we have merely followed this prescription. But I take Dr Neo's comment that the existing penalty quantum seems low. We will review the penalties of all the offences as part of a larger review of the existing medicine legislation to bring them in line with other health and environmental protection laws in due course.

On new section 16, Dr Neo felt that the licensee's request to revoke a product licence should be a written request. I agree. In fact, this is the intent. Any revocation of a product licence is a process not to be taken lightly. And any such request will need to be made formally in writing supported by appropriate documents. This is actually implied, as all official correspondences with the Health Sciences Authority have to be in writing.

Finally, Dr Neo raised the question of additional data. Let me clarify that new section 19D covers all safety and efficacy data provided by the applicant regardless of whether it is data submitted at the point of application or additional data requested by HSA in order to approve the application. The current clause is therefore sufficient. But the obligation on

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protection of safety and efficacy data does not extend to additional data submitted after a product has been registered, as this was not included under our obligation for the bilateral FTA. When applying intellectual protection measures, it is necessary to balance the interest of the innovator companies with that of the companies producing generic medicines. I think we heard a fair bit of this question of balance about an hour ago when other Bills were being debated.

Currently, there is no uniform international practice with regard to the protection of additional data submitted after the initial registration of a product.

Dr Neo mentioned the Paxil case with Merck Sharp & Dohme. The two issues are quite separate. This protection of data is a concession given to a patent holder, so that if I am the patent owner, whatever safety efficacy data I supplied to the regulator, no third party can come in and free ride on my data. It has nothing to do with consumer safety.

The Paxil case is quite different. It is not a case of IPR dispute. The legal proceeding is being processed. So we do not know what the outcome will be. But from press reports, the New York Attorney-General's point of view is that certain information has not been fully disclosed to the public, and therefore he is now taking up the case with the drug company.

Dr Lily Neo: Clarification, Madam. Does the Minister agree with me that the majority of the dental chewing gums do not have much therapeutic value? Therefore, will the Minister be more discerning in approving the licences of the many varieties of chewing gums in the market?

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Mr Khaw Boon Wan: In general, I can agree. The concession that we granted under the bilateral FTA requires chewing gums to be divided into two groups. The gum with therapeutic value has to be strictly controlled with prescription requirements. But in the process of bilateral negotiations, and because of lobbying by certain companies in the US, we made a concession for dental gums to be sold under the supervision of pharmacists. But we stood firm on our requirement that we are banning chewing gum and therefore it will not be possible for anybody to just walk into any pharmacy and purchase gum, such as an over-the-counter drug sale. And that is why we put in procedures which will make it more difficult to purchase such chewing gum, and that is why we require, for example, buyer's particulars to be taken down by the pharmacist. Occasionally, we do auditing to make sure that there is no excessive sale of this particular oral dental gum.

Dr Lily Neo: Clarification again, Madam. The Minister said earlier that this Bill does not require to have safeguards for the interest and safety of consumers. May I ask the Minister which regulations provide safeguards against the dumping of disputed drugs in our market?

Mr Khaw Boon Wan: That was not quite what I said. What I meant was that the protection of data supplied by patent owner has nothing to do with safety of consumers. Patent rights and data protection rights are two different pieces of intellectual property rights. Most patent Acts allow for a period of 20 years' protection. If I invented something, over the 20-year patent period, nobody can infringe my patent. So this is one IP right.

The second right is data protection which concerns the drug registration process. Having secured a patent, you still need what is called marketing

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approval for a product licence from the drug regulator of any country that you want to market to. And when you submit the application, you have to produce all the clinical trial results to show that the product is, firstly, safe; and, secondly, effective. So safety and efficacy data will have to be produced to the regulator. But having produced the data to the regulator, the regulator has a certain obligation, which is to make sure that the data are not openly disclosed, because otherwise trade secrets may be released to third parties who can then free ride on this.

So, data protection is provided in that light. The data are derived from clinical trials on safety and efficacy. This amendment is about protecting these rights of the patent owner.

Question put, and agreed to.

Bill accordingly read a Second time and committed to a Committee of the whole House.

The House immediately resolved itself into a Committee on the Bill. - [Mr Khaw Boon Wan].

Bill considered in Committee; reported without amendment; read a Third time and passed.