Medicines (Amendment) Bill 2004: Parliamentary Speech for Second Reading, 15 June 2004

15 Jun 2004

By Mr Khaw Boon Wan

SPEECH BY MR KHAW BOON WAN

ACTING MINISTER FOR HEALTH

MEDICINES (AMENDMENT) BILL 2004

PARLIAMENTARY SPEECH FOR SECOND READING

15 JUNE 2004

Mr Speaker, Sir, 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 fulfil certain obligations arising from the US-Singapore Free Trade Agreement (USSFTA).

Protection of Patented Pharmaceutical Products

The FTA's chapter on Intellectual Property Rights (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 regulation of pharmaceutical products and the Medicines Act:

Firstly, where a pharmaceutical product is the 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.

Secondly, 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.

Thirdly, 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 innovator product, unless with the consent of the patent owner. 

In order to fulfil this obligation, a new section 12A will be inserted into the Act to allow HSA 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 it 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 innovator product's patent is still in force.

The new section 12A will also serve to fulfil 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 its 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 applications it has received, should it be necessary to do so.

The third obligation effectively means that HSA may not approve a generic product based on the safety and efficacy data of the innovator product during the period specified.

In order to comply with this obligation, a new section 19D will be inserted into the Act, 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, without the consent of the holder of the earlier approval.

In addition to the proposed new sections 12A, 19C and 19D, 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 the application.

Regulation of Chewing Gum with Therapeutic Value

Besides these 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 USSFTA 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 apply to oral dental gums, and include powers to restrict their sale and supply only by prescription or under supervision of a pharmacist.

Conclusion

Sir, this Bill, is to enable Singapore to comply with certain obligations under the USSFTA, 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.

Sir, I beg to move.