Bill C-366

2nd Session, 40th Parliament,

57-58 Elizabeth II, 2009

house of commons of canada

BILL C-366

An Act to establish and maintain a national Breast Implant Registry

Her Majesty, by and with the advice and consent of the Senate and House of Commons of Canada, enacts as follows:

SHORT TITLE

1. This Act may be cited as the Breast Implant Registry Act.

INTERPRETATION

2. The definitions in this section apply in this Act.

“medical practitioner” means a person lawfully entitled to practise medicine in the place in which the practice is carried on by that person.

“prescribed” means prescribed by regulation.

“Registry” means the Breast Implant Registry established under subsection 4(1).

“user” means a person who has had the breast implant implanted, whether or not it has been explanted.

BREAST IMPLANT REGISTRY

3. The Minister of Health shall appoint a Registrar for the purposes of this Act.

4. (1) The Registrar shall establish and maintain a registry, to be known as the Breast Implant Registry, containing

(a) information submitted by medical practitioners on persons who have undergone breast implant surgery, including surgery to explant a breast implant;

(b) a record of information supplied by the manufacturer, importer or distributor of a breast implant that identifies any health risk to the user; and

(c) any other prescribed information.

(2) The Registrar is responsible for the day-to-day operation of the Registry.

(3) The Registrar may destroy information kept in the Registry at the times and in the circumstances that may be prescribed.

5. (1) A medical practitioner who performs breast implant surgery on a person, including surgery to explant a breast implant, shall as soon as possible after completing the surgery submit to the Registrar the following information:

(a) the name, date of birth and address of the person who underwent the surgery;

(b) the medical practitioner’s name, the date of the surgery and the name and address of the health care facility at which the surgery was performed;

(c) in respect of each breast implant that was implanted or explanted,

(i) the name and address of the manufacturer of the breast implant,

(ii) the lot or serial number and the nomi- nal and actual volume of the breast implant,

(iii) the type of filler used in the breast implant, and

(iv) whether the surgery was to the right or left breast;

(d) in the case of an implant, the technique used for the implantation, the position of the breast implant, the type of incision and the indications for the implantation;

(e) in the case of an explant, any intra-operative findings related to the breast implant and the indications for the explantation; and

(f) any other prescribed information.

(2) The information submitted under subsection (1) shall be in a format established by the Minister of Health.

(3) The medical practitioner referred to in subsection (1) shall inform the person who is to undergo the surgery of the existence and purpose of the Registry, the requirement to submit information to the Registrar and the subsequent opportunity under section 6 to correct the personal information on file.

6. The Registrar shall, on receipt of the information submitted under subsection 5(1), provide the person in respect of whom the information is submitted, by notice in writing delivered personally or sent by registered mail, with a copy of the information and a statement advising the person to notify the Registrar of any change in the person’s personal information.

7. (1) A manufacturer, importer or distributor of a breast implant that has been sold shall notify the Registrar immediately after becoming aware that the implant may present a health risk to the user.

(2) The manufacturer, importer or distributor shall, as soon as possible after notifying the Registrar in accordance with subsection (1), provide the Registrar with the following:

(a) information as to the nature of the health risk that has been identified in respect of the breast implant and the date on and circumstances under which the health risk or potential health risk was discovered;

(b) an evaluation of the health risk associated with the breast implant;

(c) a copy of any communication issued with respect to that risk; and

(d) any other prescribed information.

8. (1) When the Registrar receives a notification under subsection 7(1), or otherwise has reasonable grounds to believe that a breast implant may pose a health risk to the user, the Registrar shall, without delay, contact each user listed in the Registry.

(2) When the Registrar contacts a person under subsection (1), the Registrar shall provide to the person any information that the Registrar considers necessary to assist the person in assessing the risk to their health.

ELECTRONIC FILING

9. Subject to the regulations, information, notices and documents that are sent to or issued by the Registrar under this or any other Act of Parliament may be sent or issued in electronic or other form in any manner specified by the Registrar.

10. Information that is required to be kept by the Registrar under subsection 4(1) may

(a) be in bound or loose-leaf form or in photographic film form; or

(b) be entered or recorded by any system of mechanical or electronic data processing or by any other information storage device that is capable of reproducing any required information in intelligible written or printed form within a reasonable time.

PRIVACY AND DISCLOSURE OF INFORMATION

11. Despite section 8 of the Privacy Act but subject to sections 12 to 14, information contained in the Registry respecting the identity, personal characteristics and medical history of a person who has undergone breast implant surgery, including surgery to explant a breast implant, is confidential and shall be disclosed only with the written consent of the person, which may not be given unless the person giving the consent has been informed of the purpose for which the consent is sought.

12. The Registrar shall disclose confidential information contained in the Registry

(a) for the purpose of complying with a subpoena or warrant issued or order made by a court, person or body with jurisdiction to compel the production of information, or for the purpose of complying with rules of court relating to the production of information; and

(b) to the extent required by the provisions of any federal or provincial law respecting health and safety that are specified in the regulations.

13. (1) The Registrar may disclose confidential information contained in the Registry

(a) for the purposes of enforcing this Act;

(b) to the extent required for the administration of a health care insurance plan within the meaning of the Canada Health Act; and

(c) for the purposes of disciplinary proceedings undertaken by any professional licensing or disciplinary body established under the laws of Canada or a province and specified in the regulations.

(2) The Registrar may disclose confidential information contained in the Registry to an individual or organization for scientific research or statistical purposes, other than information that identifies any person or information that can reasonably be expected to be used in the identification of any person.

14. The Registrar may disclose to a medical practitioner the identity of a person whose name is recorded in the Registry if, in the Registrar’s opinion, the disclosure is necessary to address a risk to the health of the person. The medical practitioner may not disclose that identity.

OFFENCES

15. Every person who contravenes any provision of this Act is guilty of an offence and

(a) is liable, on conviction on indictment, to a fine not exceeding $250,000 or to imprisonment for a term not exceeding five years, or to both; or

(b) is liable, on summary conviction, to a fine not exceeding $100,000 or to imprisonment for a term not exceeding two years, or to both.

16. A court that imposes a fine or term of imprisonment on a person in respect of an offence under this Act may, on application by the Attorney General of Canada, order the person not to engage in any activity that, in the court’s opinion, may lead to the commission of an offence under this Act.

17. A prosecution for an offence under this Act may be instituted only with the consent of the Attorney General of Canada.

REGULATIONS

18. The Governor in Council may make regulations for carrying out the purposes and provisions of this Act, including regulations

(a) for the purposes of paragraph 4(1)(c), specifying information to be contained in the Registry;

(b) for the purposes of subsection 4(3), respecting the destruction of information kept in the Registry;

(c) for the purposes of paragraph 5(1)(f), specifying information to be submitted by a medical practitioner;

(d) for the purposes of paragraph 7(2)(d), respecting information to be provided by manufacturers, importers or distributors;

(e) for the purposes of paragraph 12(b), specifying the provisions of any federal or provincial law;

(f) for the purposes of paragraph 13(1)(c), identifying professional licensing and disciplinary bodies; and

(g) excluding any type of breast implant from the application of this Act if the Governor in Council is of the opinion that the exclusion is in the public interest and consistent with public health and safety.

19. Schedule I to the Access to Information Act is amended by adding the following in alphabetical order under the heading “Other Government Institutions”:

20. Schedule II to the Act is amended by adding, in alphabetical order, a reference to

and a corresponding reference to “section 11”.

21. The schedule to the Privacy Act is amended by adding the following in alphabetical order under the heading “Other Government Institutions”: