Interim Order Respecting the Immediate Distribution of the Vaccine for the Novel Influenza A H1N1 Virus

Expired October 23, 2010

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Whereas the Minister of Health believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment;

Therefore, the Minister of Health, pursuant to subsection 30.1(1)^a of the Food and Drugs Act^b, hereby makes the annexed Interim Order Respecting the Immediate Distribution of the Vaccine for the Novel Influenza A H1N1 Virus.

Ottawa, October 23, 2009

Original signed by:
Leona Aglukkaq
Minister of Health

Interim Order Respecting the Immediate Distribution of the Vaccine for the Novel Influenza A H1N1 Virus

Interpretation

1. The following definitions apply in this Interim Order.

• "Act" means the Food and Drugs Act; (Loi)
• "brand name" has the same meaning as in subsection C.01.001(1) of the Regulations; (marque nominative)
• "Chief Public Health Officer" means the Chief Public Health Officer appointed under subsection 6(1) of the Public Health Agency of Canada Act; (administrateur en chef)
• "common name" has the same meaning as in subsection C.01.001(1) of the Regulations; (nom usuel)
• "lot number" has the same meaning as in section A.01.010 of the Regulations; (numéro de lot)
• "manufacturer" includes an importer; (fabricant)
• "proper name" has the same meaning as in subsection C.01.001(1) of the Regulations; (nom propre)
• "Regulations" means the Food and Drug Regulations; (règlement)
• "serious adverse reaction" has the meaning assigned by the definition "serious adverse drug reaction" in section C.05.001 of the Regulations; (réaction indésirable grave)
• "vaccine" means an immunizing agent used to provide protection against the novel influenza A H1N1 virus in humans. (vaccin)

Application

2. (1) The quantity of the vaccine specified in the authorization for immediate distribution is, as of the date the authorization takes effect, exempt from section 12 of the Act.

(2) The exemption ceases to apply if the authorization for immediate distribution is cancelled.

3. (1) The Regulations do not apply, as of the date the authorization for immediate distribution takes effect, to the quantity of the vaccine specified in the authorization.

(2) The Regulations apply to the quantity of the vaccine if the authorization for immediate distribution is cancelled.

Application for Authorization

4. The Chief Public Health Officer may submit to the Minister an application for authorization for immediate distribution, dated and signed, that includes the following:

1. the name, address and telephone number of the manufacturer, together with the facsimile number and electronic mail address, if any, and the name and telephone number of a contact person designated by the manufacturer who can be reached to obtain information related to the vaccine;
2. the addresses of the locations to which the vaccine is to be delivered by the manufacturer, and the name and title of the person at each location who will be responsible for receiving the vaccine;
3. the brand name of the vaccine, if any, and any of its proper name, common name, chemical name or identifying name, and any code, number or mark;
4. the use for which the vaccine is required;
5. the total quantity of the vaccine that the Chief Public Health Officer wishes to obtain and the reason why that quantity is considered necessary, together with supporting information or documents;
6. an attestation dated and signed by the Chief Public Health Officer certifying that the following conditions are met, together with sufficient supporting information or documents to enable the Minister to determine that those conditions are met:
   1. the public has been exposed to, or is at significant risk of being exposed to, the novel influenza A H1N1 virus,
   2. exposure to that virus is likely to result in a disease that has the potential to be life-threatening or serious in humans,
   3. immediate action is required to provide protection against that virus,
   4. there is no vaccine available, or available in sufficient quantity, for sale in Canada that is for the use provided under paragraph (d), and
   5. the known and potential benefits associated with the use of a vaccine outweigh the known and potential risks associated with the novel influenza A H1N1 virus; and
7. any information in the possession of the Chief Public Health Officer with respect to
   1. any use of the vaccine, and its safety or effectiveness, and
   2. the regulatory status of the vaccine in other countries.

5. The Minister may require the Chief Public Health Officer to submit any supplementary information or documents that are necessary to enable the Minister to determine if the authorization for immediate distribution must be issued.

Authorization

6. The Minister shall issue an authorization for immediate distribution if

1. the application for authorization for immediate distribution complies with section 4 and, if applicable, section 5;
2. the Minister has reasonable grounds to believe that the conditions specified in paragraph 4(f) are met; and
3. the Minister has reasonable grounds to believe that the known and potential benefits associated with the use of the vaccine, as provided under paragraph 4(d), outweigh the known and potential risks associated with that use.

7. The authorization for immediate distribution shall include the following information:

1. the brand name of the vaccine, if any, and any of its proper name, common name, chemical name or identifying name, and any code, number or mark;
2. the use for which the distribution of the vaccine is authorized;
3. the quantity of the vaccine that may be distributed;
4. the name and address of the manufacturer that is authorized to sell the vaccine;
5. the addresses of the locations to which the vaccine is to be delivered by the manufacturer, and the name and title of the person at each location who will be responsible for receiving the vaccine; and
6. the date on which the authorization takes effect.

Obligations of the Chief Public Health Officer

8. The Chief Public Health Officer shall notify the Minister and the manufacturer, in the following manner and within the following times, of any serious adverse reaction to the vaccine that occurs in Canada, specifying the nature of the reaction, the circumstances, the lot numbers implicated and any corrective action taken

1. in the case of a serious adverse reaction that is life-threatening or that results in a neurological disorder or death, by verbal notice given within 24 hours of the time the Chief Public Health Officer becomes aware of the reaction, followed by a written report given within 24 hours of the verbal notice; and
2. in any other case, by a written report given within 15 days after the Chief Public Health Officer becomes aware of the reaction.

9. The Chief Public Health Officer shall, on request, submit a written report to the Minister respecting the use of the vaccine, including information respecting any serious adverse reactions.

10. The Chief Public Health Officer shall provide the Minister with any new information regarding the safety or effectiveness of the vaccine, for any use, as soon as possible.

11. The Chief Public Health Officer shall make available to persons identified in the authorization for immediate distribution as the persons responsible for receiving the vaccine, the following information:

1. the brand name of the vaccine, if any, and any of its proper name, common name, chemical name or identifying name, and any code, number or mark;
2. the use for which the distribution of the vaccine is authorized;
3. the name and address of the manufacturer that is authorized to sell the vaccine;
4. its composition, including a quantitative list of each medicinal ingredient designated by its brand name, if any, and any of its proper name, common name, chemical name or identifying name, and any code, number or mark;
5. the concentration of the vaccine and of each medicinal ingredient;
6. the dosage form;
7. the recommended dosage;
8. the recommended route of administration;
9. any contra-indications or side effects; and
10. the conditions of use recommended.

12. The Chief Public Health Officer shall account to the Minister, on request and by the date specified, for the total quantity of the vaccine that was distributed to the persons identified in the authorization for immediate distribution as the persons responsible for receiving the vaccine, including the outcome of each quantity of the vaccine and each location to which it was distributed.

Obligations of the Manufacturer

13. The manufacturer named in an authorization for immediate distribution may sell to the Chief Public Health Officer the vaccine specified in the authorization in a quantity that does not exceed the quantity specified in the authorization.

14. The manufacturer shall only deliver the vaccine to the locations specified in the authorization for immediate distribution and shall only leave it in the care of the person identified in the authorization as the person responsible for receiving the vaccine.

15. The manufacturer shall, on request, submit to the Minister protocols of tests together with samples of any lot of the vaccine.

Cancellation of Authorization

16. The Minister may cancel an authorization for immediate distribution if the Minister has reasonable grounds to believe that

1. information or documents contained in or referenced by the application for authorization for immediate distribution are incomplete, inaccurate, false or misleading;
2. a condition specified in subparagraphs 4(f)(i) to (iii) is no longer met; or
3. the manufacturer has contravened a provision of this Interim Order.

17. The Minister shall cancel an authorization for immediate distribution if

1. the Minister has reasonable grounds to believe that the known and potential benefits associated with the use for which the distribution of the vaccine has been authorized do not outweigh the known and potential risks associated with that use; or
2. the vaccine is subsequently authorized for sale in Canada, except under this Interim Order, for the use specified in the authorization for immediate distribution and that vaccine is available in sufficient quantity in Canada.

18. The Minister shall send the Chief Public Health Officer and the manufacturer a written notice of cancellation that sets out the reason for the cancellation and the effective date.

19. On receipt of a notice of cancellation, the Chief Public Health Officer shall forward a copy of the notice to the persons identified in the authorization for immediate distribution as the persons responsible for receiving the vaccine.

20. Despite subsection 3(2), a person to whom a quantity of the vaccine has been distributed may return it to the person from whom it was obtained, the Chief Public Health Officer or the manufacturer.

Explanatory Note

(This note is not part of the Interim Order.)

Under the current Food and Drug Regulations (the Regulations), in order for a new drug to be sold in Canada, the manufacturer must submit information that demonstrates the drug is of high quality and is safe and effective under the prescribed conditions of use. If the information is sufficient, Health Canada will issue a Notice of Compliance, which will allow the manufacturer to sell that drug. The current regulatory framework is suitable for most drugs.

Because the development of the influenza A H1N1 vaccine could not begin until the pandemic strain was identified in the spring and it is anticipated that the vaccine will be needed almost immediately after it is manufactured, there is limited time for traditional clinical trials. The global outbreak of the influenza A H1N1 virus and its rapid spread have led to a situation in which the need for a vaccine must be weighed against the time required to collect and assess the safety and effectiveness data needed to authorize the sale of the vaccine under the Regulations.

This Interim Order provides a means by which Health Canada can allow the immediate distribution of a specific quantity of vaccine based on a public health need to access a vaccine that is not authorized for sale or is not available in sufficient quantity in Canada. This Interim Order is also required to enable access to a vaccine licensed by a regulatory authority in another country, should additional doses or an alternate form of the vaccine be required, such as an unadjuvanted vaccine.

Under the Interim Order, the Chief Public Health Officer (CPHO) - and not the manufacturer - submits an application requesting a specified quantity of the vaccine. The application requires the CPHO to sign an attestation certifying the urgent need for the vaccine in order to address the immediate risk to public health posed by the influenza A H1N1 pandemic, and that the known and potential benefits associated with a vaccine outweigh the known and potential risks associated with the novel influenza A H1N1 virus. The CPHO must provide any information in his possession with respect to any use of the vaccine and its safety or effectiveness, as well as the regulatory status of the vaccine in other countries.

The Minister will issue an authorization for immediate distribution of a specified quantity of the vaccine if the application complies with the requirements of the Interim Order and the Minister has reasonable grounds to believe that the conditions to which the CPHO has attested are met, and that the known and potential benefits associated with the use of the vaccine outweigh the known and potential risks associated with that use. As of the date the authorization takes effect, the sale of the specified quantity of vaccine is exempt from section 12 of the Food and Drugs Act, and the provisions of the Regulations. If the authorization is cancelled, section 12 of the Act and the Regulations will apply to the quantity of the vaccine.

Once authorization for immediate distribution is issued, the CPHO must provide to the persons identified in the authorization as responsible for receiving the vaccine information related to the recommended dosage, route of administration, any contra-indications or side effects, and the conditions of use recommended.

The CPHO must, on request, submit a written report to the Minister respecting the use of the vaccine, and provide the Minister and the manufacturer with information respecting any serious adverse reaction to the vaccine, specifying the nature of the reaction, the circumstances, lot numbers implicated and any corrective action taken within the timeframes specified in the Interim Order.

The CPHO must account to the Minister, on request, for the total quantity of the vaccine distributed, and provide the Minister with any new information related to the safety and effectiveness of the vaccine, for any use, as soon as possible..

The manufacturer can only sell the specified quantity of the vaccine to the CPHO, and deliver the vaccine only to the locations specified in the authorization. In addition, the manufacturer is required to submit to the Minister, on request, protocols of tests together with samples of any lot of the vaccine.

The Minister may cancel an authorization if the need for the immediate distribution of the vaccine no longer exists, or if the manufacturer has contravened a provision of the Interim Order. The authorization will be cancelled if the Minister has reasonable grounds to believe that the known and potential benefits associated with the use of the vaccine do not outweigh the known and potential risks, or if the vaccine is subsequently authorized for sale in Canada and is available in sufficient quantity.

Once an authorization is cancelled, the CPHO must notify the persons identified in the authorization as responsible for receiving the vaccine. Despite the application of the Regulations to the quantity of the vaccine once the authorization is cancelled, a person to whom the vaccine was distributed may returned it to the person from whom it was obtained, the CPHO or the manufacturer.

a S.C. 2004, c. 15, s. 66
b R.S., c. F-27