C-255
First Session, Forty-first Parliament,
60 Elizabeth II, 2011
HOUSE OF COMMONS OF CANADA
BILL C-255
An Act to establish and maintain a national Breast Implant Registry
first reading, June 23, 2011
Ms. Mathyssen
411119
SUMMARY
This enactment requires the Minister of Health to appoint a Registrar who must establish and maintain a national Breast Implant Registry. The Registry will contain information relating to persons who have undergone breast implant surgery, including surgery to explant a breast implant, along with a description of the implant and other prescribed information. The information in the Registry will be available only to the Registrar for the purpose of notifying those persons of a risk to their health.
Also available on the Parliament of Canada Web Site at the following address:http://www.parl.gc.ca
1st Session, 41st Parliament,
60 Elizabeth II, 2011
house of commons of canada
BILL C-255
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
Short title
1. This Act may be cited as the Breast Implant Registry Act.
INTERPRETATION
Definitions
2. The definitions in this section apply in this Act.
“medical practitioner”« médecin »
“medical practitioner” means a person lawfully entitled to practise medicine in the place in which the practice is carried on by that person.
“Minister”« ministre »
“Minister” means the Minister of Health.
“prescribed”Version anglaise seulement
“prescribed” means prescribed by regulation.
“Registry”« Registre »
“Registry” means the Breast Implant Registry established under subsection 4(1).
“user”« utilisateur »
“user” means a person who has had the breast implant implanted, whether or not it has been explanted.
BREAST IMPLANT REGISTRY
Registrar appointed
3. The Minister must appoint a Registrar for the purposes of this Act.
Breast Implant Registry
4. (1) The Registrar must 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 investigate, adjust or 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.
Operation
(2) The Registrar is responsible for the day-to-day operation of the Registry.
Destruction of information
(3) The Registrar must destroy information kept in the Registry at the times and in the circumstances that may be prescribed.
Reporting by medical practitioners
5. (1) A medical practitioner who performs breast implant surgery on a person, including surgery to investigate, adjust or explant a breast implant, must 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 materials used for the casing and filler of the breast implant, and
(iv) whether the surgery was to the right or left breast;
(d) in the case of an implant, the indications for the implantation, the technique used for the implantation, the position of the breast implant and the type of incision for the implantation;
(e) in the case of an explant, the indications for the explantation and any intra-operative findings related to the breast implant; and
(f) any other prescribed information.
Format of report
(2) The information submitted under subsection (1) must be in a format established by the Minister.
Obligation to inform
(3) The medical practitioner referred to in subsection (1) must 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.
Change in personal information
6. The Registrar must, 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.
Obligation of manufacturer, importer or distributor to report
7. (1) A manufacturer, importer or distributor of a breast implant offered for sale in Canada must notify the Registrar immediately after becoming aware that the implant may present a health risk to the user.
Information to be provided
(2) The manufacturer, importer or distributor must, 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.
Obligation of Registrar to notify persons of risks to health
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 must, without delay, contact each user listed in the Registry.
Information to be provided
(2) When the Registrar contacts a person under subsection (1), the Registrar must provide to the person any information that the Registrar considers necessary to assist the person in assessing the risk to their health.
ELECTRONIC FILING
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.
Records of 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
Consent to disclosure
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 is to 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.
Obligation to disclose
12. The Registrar must 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.
Discretion to disclose
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 or disciplinary body established under the laws of Canada or a province and specified in the regulations.
Research and statistics
(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.
Disclosure to address health risk
14. (1) 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.
No further disclosure
(2) The medical practitioner must not disclose the identity referred to in subsection (1).
OFFENCES
Offence and punishment
15. Every person who contravenes any provision of this Act is guilty of an offence and liable
(a) 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) on summary conviction, to a fine not exceeding $100,000 or to imprisonment for a term not exceeding two years, or to both.
Court order
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.
Consent of Attorney General
17. A prosecution for an offence under this Act may be instituted only with the consent of the Attorney General of Canada.
REGULATIONS
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 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.
CONSEQUENTIAL AMENDMENTS
R.S., c. A-1
Access to Information Act
19. Schedule I to the Access to Information Act is amended by adding the following in alphabetical order under the heading “OTHER GOVERNMENT INSTITUTIONS”:
Registrar of the Breast Implant Registry
Directeur du Registre des implants mammaires
20. Schedule II to the Act is amended by adding, in alphabetical order, a reference to
Breast Implant Registry Act
Loi sur le Registre des implants mammaires
and a corresponding reference to “section 11”.
R.S., c. P-21
Privacy Act
21. The schedule to the Privacy Act is amended by adding the following in alphabetical order under the heading “OTHER GOVERNMENT INSTITUTIONS”:
Registrar of the Breast Implant Registry
Directeur du Registre des implants mammaires
Published under authority of the Speaker of the House of CommonsAvailable from:Publishing and Depository ServicesPublic Works and Government Services Canada