Canada Gazette, Part I, Volume 148, Number 51: Order Amending Schedule 1 to the Patent Act (2014-1)
December 20, 2014
Statutory authority
Patent Act
Sponsoring departments
Department of Industry and Department of Health
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Order.)
Issues
The World Health Organization (WHO) maintains a Model List of Essential Medicines (EML) that is composed of medicines that are considered necessary to satisfy the priority health care needs of national health care systems. The medicines on the list are selected with due regard to public health relevance, evidence of efficacy and safety, and comparative cost-effectiveness. A Canadian generic pharmaceutical manufacturer is seeking to update Schedule 1 of the Patent Act (i.e. the list of patented pharmaceutical products which are eligible to be exported under compulsory licence to countries unable to manufacture their own medicines pursuant to Canada's Access to Medicines Regime [CAMR]), by adding three pharmaceutical products that appear on the EML.
Background
On August 30, 2003, the members of the World Trade Organization (WTO) agreed to waive two patent licensing provisions of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) that appeared to prevent the export of generic drugs and medical devices to developing countries faced with public health problems. The August 30, 2003, decision allows WTO member countries with pharmaceutical manufacturing capacity to authorize the non-consensual use of a patented invention (i.e. compulsory licences) to manufacture and export generic versions of patented drugs and medical devices to developing countries unable to manufacture the products themselves.
The CAMR implements the August 30, 2003, decision by permitting the grant of “export-only” compulsory licences to Canadian pharmaceutical manufacturers who wish to supply drugs and medical devices to countries unable to manufacture their own. When the CAMR received royal assent in May 2004, Schedule 1 was primarily composed of the pharmaceutical products on the World Health Organization's EML that were patented in Canada. The EML represents the minimum medicine needs for a basic health care system and, at the time, provided a baseline to ensure that the CAMR was able to meet the basic health care needs of developing and least-developed countries in a clear and transparent manner. Since that time, Schedule 1 has been amended twice. The first amendment added the name of a fixed-dose combination consisting of three anti-retroviral agents used in the treatment of HIV/AIDS and the second added the name of a treatment for type A and type B influenza.
Both the August 30, 2003, decision and the CAMR anticipate that the procedure for applying for an export licence is to be initiated internationally by an eligible importer posting a notice on a dedicated WTO Web site. That notice must identify the name and quantity of the required product. The products that are eligible for export under the CAMR are listed on Schedule 1 of the Patent Act (the Act). The CAMR also contains safeguards against inappropriate or illicit use of the Regime, to ensure the interests of patent holders are taken into account, and to ensure the safety of drugs exported under the regime.
Aside from Canada, several other countries and the European Union have implemented the August 30, 2003, decision, yet developing countries have shown little interest in using the mechanism. Canada is the first and only country to successfully issue an export-only compulsory licence authorizing a generic manufacturer to export an HIV/AIDS therapy to Rwanda over the course of two shipments in 2008 and 2009.
Objectives
The Government is proposing to amend Schedule 1 to add the names of three additional HIV/AIDS treatments. The objectives of the proposed amendment are twofold. First, it would ensure that Schedule 1, and by extension the CAMR, remains current with the evolving public health needs of developing and least-developed countries. The three treatments proposed to be added to the schedule are considered by the World Health Organization as essential to the minimum needs of a basic health care system and are listed on the current EML. Second, adding these treatments to Schedule 1 now ensures that, should a generic manufacturer come forward with an application under the CAMR for an authorization to manufacture and export these products to an eligible country, the Commissioner of Patents would be in a position to issue an authorization without delay.
Description
Pursuant to subparagraph 21.03(1)(a) of the Act, the Government is proposing an amendment to Schedule 1 of the Act to add to the list of patented pharmaceutical products the following three names: “efavirenz + emtricitabine + tenofovir disoproxil” in tablet form and in the specified strength of 600 mg, 200 mg, and 300 mg respectively; “emtricitabine + tenofovir disoproxil” in tablet form and in the specified strength of 200 mg, and 300 mg respectively; and “tenofovir disoproxil” in tablet form and in the specified strength of 300 mg. The pharmaceutical products so named are anti-retroviral agents and are among the leading therapies to treat HIV/AIDS in developing and least-developed countries, especially when combined in a single, once-daily pill, as this simplifies dosing schedules and leads to improved patient adherence. The addition of these products to Schedule 1 could potentially benefit developing and least-developed countries that are eligible to import pharmaceutical products under the CAMR. There are no costs associated with this measure.
“One-for-One” Rule
The “One-for-One” Rule does not apply to this proposal, as it would not impose any administrative burden on businesses.
Small business lens
The small business lens does not apply to this proposal, as it would not impose any costs on small businesses.
Consultation
Officials from Industry Canada have been in contact with the generic manufacturer that has requested the amendment of Schedule 1 and the brand name manufacturer marketing the requested products. Prepublication in the Canada Gazette, Part I, will be followed by a 30-day period during which interested members of the public may submit written representations on the proposed amendment.
Rationale
The stated purpose of the CAMR is to increase access to lower-cost, Canadian-made generic versions of patented pharmaceutical products in order to address public health problems in developing countries. The proposed amendment, which adds three additional treatments for HIV/AIDS to Schedule 1, is in line with this purpose by ensuring that the CAMR is able to respond to evolving public health needs.
Implementation, enforcement and service standards
The proposed amendment does not impose any new requirements; it adds three names to the list of products eligible for export under the CAMR.
Contact
Paul Halucha
Senior Director General
Marketplace Framework Policy Branch
Industry Canada
East Tower, 10th Floor
235 Queen Street
Ottawa, Ontario
K1A 0H5
Telephone: 343-291-2710
Fax: 343-291-2660
Email: paul.halucha@ic.gc.ca
PROPOSED REGULATORY TEXT
Notice is given that the Governor in Council, pursuant to subparagraph 21.03(1)(a)(i) (see footnote a) of the Patent Act (see footnote b), proposes to make the annexed Order Amending Schedule 1 to the Patent Act (2014-1).
Interested persons may make representations concerning the proposed Order within 30 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Paul Halucha, Director General, Marketplace Framework Policy Branch, Industry Canada, 10th Floor, East Tower, 235 Queen Street, Ottawa, Ontario K1A 0H5 (tel.: 613-952-0211; fax: 613-948-6393; email: paul.halucha@ic.gc.ca).
Ottawa, December 11, 2014
JURICA ČAPKUN
Assistant Clerk of the Privy Council
ORDER AMENDING SCHEDULE 1 TO THE PATENT ACT (2014-1)
AMENDMENT
| Medications | Dosage |
|---|---|
| efavirenz + emtricitabine + tenofovir disoproxil | tablet, 600 mg + 200 mg + 300 mg |
| emtricitabine + tenofovir disoproxil | tablet, 200 mg + 300 mg |
| tenofovir disoproxil | tablet, 300 mg |
COMING INTO FORCE
2. This Order comes into force on the day on which it is registered.
[51-1-o]