Bill 192, Breast Implant Registry Act, 2005

Versions

Bill 192 2005

An Act to establish and maintain a provincial Breast Implant Registry

Her Majesty, by and with the advice and consent of the Legislative Assembly of the Province of Ontario, enacts as follows:

Interpretation

1. In this Act,

"health care practitioner" means a health care practitioner within the meaning of the Personal Health Information Protection Act, 2004; ("praticien de la santé")

"health risk" includes a potential health risk; ("risque pour la santé")

"Minister" means the Minister of Health and Long-Term Care; ("ministre")

"user" means a person who has had a breast implant implanted, whether or not it has been explanted. ("utilisateur")

Registrar

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

Breast Implant Registry

3. (1) The Registrar shall establish, maintain and operate a registry known in English as the Breast Implant Registry and in French as Registre des implants mammaires.

Registry to contain

(2) The Registry shall contain,

(a) information submitted by health care practitioners under section 4;

(b) information submitted by the manufacturer, importer or distributor of a breast implant under section 6;

(d) any other prescribed information.

Format of records

(3) Information that is required to be kept by the Registrar under subsection (2) may be,

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

(b) 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 a legible written or printed form within a reasonable time.

Electronic filing

(4) Any information submitted to or provided by the Registrar under this Act or its regulations and any other Act may be submitted or provided,

(a) in electronic form; or

(b) in any other form specified by the Registrar.

Indexing

(5) The Registrar shall cause the information contained in the Registry to be indexed separately according to calendar year.

Destruction of information

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

Health care practitioner to submit

4. A health care 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:

1. The name, date of birth and address of the user on whom the surgery was performed.

2. The health care practitioner's name, the date of the surgery and the name and address of the health care facility at which the surgery was performed.

3. 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 nominal and actual volume of the breast implant,

iii. the composition of the filler used in the breast implant,

iv. whether the surgery is to the right or left breast.

4. 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.

5. In the case of an explant, any intra-operative findings related to the breast implant and the indications for the explantation.

6. Any other prescribed information.

Copy of information to user

5. The Registrar shall, on receipt of the information submitted under section 4, provide to the user in respect of whom the information is submitted a copy of the information and a statement advising the user to notify the Registrar of any change in the user's permanent address.

Manufacturer, importer or distributor to notify Registrar

6. (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 a user.

Information to be provided

(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:

1. Information as to the nature, extent and seriousness of the health risk that has been identified in respect of the breast implant.

2. The date on and circumstances under which the health risk was discovered.

3. A copy of any public communication issued with respect to the health risk.

4. Any other prescribed information.

Health risks to user

7. (1) Where the Registrar receives a notification under subsection 6 (1), or otherwise has reasonable grounds to believe that a breast implant may pose a health risk to a user, the Registrar shall immediately contact,

(a) the user; and

(b) any health care practitioner who performed breast implant surgery, including surgery to explant a breast implant, on the user.

Information to be provided

(2) When the Registrar contacts a user or health care practitioner under subsection (1), the Registrar shall provide to the user or health care practitioner any information that the Registrar considers necessary to assist in assessing the risk to the user's health.

Research findings to be reported

8. A researcher that obtains personal health information from the Registrar under section 44 of the Personal Health Information Protection Act, 2004 shall submit a copy of any findings arising from the use of or reliance on the personal health information to the Registrar as soon as the findings are made public.

Disclosure, other

9. The Registrar may disclose information, other than personal health information within the meaning of the Personal Health Information Protection Act, 2004, that is contained in the Registry under such circumstances and in such manner as may be prescribed.

Publication by Registrar

10. (1) The Registrar may collate, publish and distribute such statistical information regarding breast implant surgery, related health risks or research and findings submitted during any period as he or she may consider to be necessary and in the public interest.

Annual report

(2) The Registrar shall, after the close of each calendar year, submit to the Minister a report as to the number of breast implant implants and explants performed in Ontario during the preceding calendar year, based on information submitted under section 4.

Offences

11. (1) A person is guilty of an offence if the person,

(a) fails to submit information under section 4;

(b) fails to notify the Registrar under subsection 6 (1);

(d) fails to report research findings under section 8.

Penalty

(2) A person who is guilty of an offence under subsection (1) is liable, on conviction,

(a) if the person is a natural person, to a fine of not more than $50,000; and

(b) if the person is not a natural person, to a fine of not more than $250,000.

Court order

(3) 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, 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.

Commencing a prosecution

(4) A prosecution for an offence under this Act shall not be commenced without the consent of the Attorney General.

Regulations

12. (1) The Lieutenant Governor in Council may make regulations,

(a) prescribing anything that this Act describes as being prescribed, described, provided for, authorized or required in the regulations made under this Act;

(b) specifying information to be contained in the Registry;

(d) specifying information to be submitted by a health care practitioner to the Registrar;

(e) specifying information to be provided by manufacturers, importers or distributors to the Registrar;

(f) prescribing circumstances under which the Registrar may disclose information other than personal health information, and describing in what manner;

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

Same

(2) A regulation made under subsection (1) may be general or particular in its application.

Consequential Amendments

Personal Health Information Protection Act, 2004

13. (1) The definition of "health information custodian" in subsection 3 (1) of the Personal Health Information Protection Act, 2004 is amended by adding the following paragraph:

7.1 The Registrar of the Breast Implant Registry established under the Breast Implant Registry Act, 2005.

(2) Subsection 43 (1) of the Act is amended by adding the following clause:

(f.1) for the purposes of the Breast Implant Registry Act, 2005;

Commencement and Short Title

Commencement

14. This Act comes into force on the day it receives Royal Assent.

Short title

15. The short title of this Act is the Breast Implant Registry Act, 2005.

EXPLANATORY NOTE

The Bill creates a Breast Implant Registry, whose Registrar is appointed by the Minister of Health and Long-Term Care. The Registry contains specified information from health care practitioners regarding each breast implant surgery performed, from manufacturers, importers and distributors of breast implants on any relevant health risks they identify, and from researchers regarding findings they make public if they accessed the Registry in order to conduct their research. The Registrar may contact users of breast implants and the health care practitioners who performed breast implant surgery on them in specified circumstances in order to provide them with any information the Registrar considers necessary to assist in assessing the risk to the user's health.

The Registrar shall submit an annual report to the Minister of Health and Long-Term Care setting out the number of implants and explants performed in the preceding year, based on information collected by the Registry. The Registrar may also issue statistical information relating to the information contained in the Registry as the Registrar determines to be necessary and in the public interest.

The Bill amends the Personal Health Information Protection Act, 2004 to make the Registrar a health information custodian under that Act with respect to personal health information and to make a related consequential amendment. The Bill provides that information contained in the Registry that is not personal health information may be disclosed by the Registrar as prescribed by regulation.

This Registry is a measure to protect women's health.