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REPUBLIC OF SINGAPORE
GOVERNMENT GAZETTE
ACTS SUPPLEMENT
Published by Authority
| NO. 22] | Friday, July 2 | [2004 |
The following Act was passed by Parliament on 15th June 2004 and assented to by the President on 24th June 2004:—
Medicines (Amendment) Act 2004
(No. 26 of 2004)
I assent.
S R NATHAN,
President. 24th June 2004. |
Date of Commencement: 1st July 2004
An Act to amend the Medicines Act (Chapter 176 of the 1985 Revised Edition).
Be it enacted by the President with the advice and consent of the Parliament of Singapore, as follows:
1. This Act may be cited as the Medicines (Amendment) Act 2004 and shall come into operation on such date as the Minister may, by notification in the Gazette, appoint.
2. The Medicines Act is amended by inserting, immediately after section 12, the following section:
12A.
—(1) Subject to the provisions of this Part, in dealing with an application for a product licence, the licensing authority shall consider whether a patent under the Patents Act (Cap. 221) is in force in respect of any medicinal product to which the application relates and, if so —
(a)
whether the applicant is the proprietor of the patent; or
(b)
if he is not the proprietor of the patent, whether —
(i)
the proprietor has given his consent to or has acquiesced in the grant of the licence to the applicant; or
(ii)
the patent is invalid or will not be infringed by the doing of the act for which the licence is sought.
(2) Unless the licensing authority otherwise determines, an applicant for a product licence shall, at the time of his application and at such other time as the licensing authority may require, make and furnish to the licensing authority a declaration in the prescribed form —
(a)
stating whether a patent under the Patents Act is in force in respect of any medicinal product to which the application relates;
(b)
if he states that there is such a patent, stating whether he is the proprietor of the patent; and
(c)
if he states that he is not the proprietor of the patent, stating —
(i)
the name and other particulars of the proprietor of the patent;
(ii)
whether —
(A)
the proprietor has consented to or has acquiesced in the grant of the licence to the applicant; or
(B)
in his opinion and to the best of his belief, the patent is invalid or will not be infringed by the doing of the act for which the licence is sought; and
(iii)
such other information as may be prescribed.
(3) The licensing authority may, if the applicant has declared that in his opinion and to the best of his belief the patent is invalid or will not be infringed by the doing of the act for which the licence is sought, or if the licensing authority considers it appropriate in any particular case, require the applicant to do the following within such time as the licensing authority may determine:
(a)
serve on the proprietor of thea patent under the Patents Act that is in force in respect of a medicinal product to which the application relates, a notice in the prescribed form of his application; and
(b)
furnish to the licensing authority such evidence of the service as the licensing authority may require.
(4) The licensing authority need not determine the application until the applicant has complied with subsection (2) and, where applicable, subsection (3), to the reasonable satisfaction of the licensing authority.
(5) If the licensing authority is satisfied that a notice referred to in subsection (3)(a) has been served on the proprietor of the patent, the licensing authority may grant the licence to the applicant if the proprietor has not, before the expiration of the period prescribed for the purposes of this subsection —
(a)
applied for the order or declaration by a court or the Registrar of Patents or a Deputy Registrar of Patents holding office under the Patents Act (Cap. 221), as specified in that notice; and
(b)
given written notice to the licensing authority stating that such application has been made.
(6) The licensing authority may grant the licence to the applicant if —
(a)
application for the order or declaration referred to in subsection (5)(a) has been made; and
(b)
at the endxpiration of the period prescribed for the purposes of this subsection, the order or declaration has not been obtained.
(7) For the purpose of subsection (1), the licensing authority may rely upon, and shall not be concerned to inquire into the truth of any statement made in athe declaration furnished under subsection (2).
(8) This section applies only to an application for a product licence made on or after the date of commencement of the Medicines (Amendment) Act 2004.”.
3. Section 16 of the Medicines Act is amended —
(a)
by inserting, immediately after subsection (1), the following subsections:
“(1A) Without prejudice to the generality of subsection (1), the licensing authority may, upon the request of the holder of a licence, revoke the licence.
(1B) Without prejudice to the generality of subsection (1), the licensing authority may, upon an application by any interested person, revoke a product licence if he is satisfied that —
(a)
a court, or the Registrar of Patents or a Deputy Registrar of Patents holding office under the Patents Act (Cap. 221), has determined that the doing of an act authorised by the licence infringes a patent under the Patents Act;
(b)
the person who made athe declaration referred to in section 12A(2) in support of the application for the licence has been convicted for an offence under section 20 in respect of the declaration or any document furnished in support of a statement made in the declaration; or
(c)
a court has determined that the declaration —
(i)
contains a statement that is false or misleading in a material particular; or
(ii)
omits to disclose any matter that is material to the application,
and the determination or conviction (as the case may be) is final.”; and
(b)
by inserting, immediately after subsection (3), the following subsection:
4. The Medicines Act is amended by inserting, immediately after section 19B, the following sections:
19C.
—(1) Notwithstanding any restriction on the disclosure of information imposed by any written law or rule of law, the licensing authority may from time to time publish, for the information of the public and in the manner determined by it, such particulars of applications for licences which it received as it may determine.
(2) The particulars referred to in subsection (1) excludes —
(a)
any trade secret; and
(b)
any information that has commercial value that would be, or would be likely to be, diminished by disclosure.
19D.
—(1) Where —
(a)
information has been provided by an applicant for a product licence to the licensing authority relating to the safety or efficacy of a medicinal product in support of such application; and
(b)
a product licence has been granted in respect of that medicinal product (referred to in this section as the earlier licence),
the licensing authority may not, for a period of 5 years from the date of such grant, grant a product licence to another person in respect of that or a similar medicinal product on the basis of the grant of the earlier licence unless the holder of the earlier licence has given his consent to the grant on that basis.
(2) This section applies where the earlier licence is granted —
(a)
on or after the date of commencement of the Medicines (Amendment) Act 2004; or
(b)
at any time between the date that is before the date of commencement but no earlier than 5 years before that date, and that date.”.
5. Section 20 of the Medicines Act is amended by deleting subsection (3) and substituting the following subsections:
“(3) Any person who, when making an application under section 11 or a declaration under section 12A(2) or giving any information he is required to give under section 19, makes a statement which he knows or has reason to believe is false in a material particular, shall be guilty of an offence.
(3A) Any person who, when required to furnish to the licensing authority any evidence or document under section 12A(3), furnishes to the licensing authority any thing which he knows or has reason to believe is forged or altered, shall be guilty of an offence.”.
6. Section 54 of the Medicines Act is amended by inserting, immediately after subsection (1), the following subsection: