Vol. 149, No. 13 — July 1, 2015

Registration

SOR/2015-154 June 17, 2015

PATENT ACT

Order Amending Schedule 1 to the Patent Act (2014-1)

P.C. 2015-821 June 17, 2015

Whereas the patented products named in the annexed Order Amending Schedule 1 to the Patent Act (2014-1) may be used to address a public health problem afflicting many developing and least-developed countries and therefore, in accordance with subparagraph 21.03(1)(a)(i) (see footnote a) of the Patent Act (see footnote b), may be added to Schedule 1 to that Act;

And whereas the Governor in Council considers it appropriate to add to Schedule 1 a dosage form and strength in respect of the patented products;

Therefore, His Excellency the Governor General in Council, on the recommendation of the Minister of Industry and the Minister of Health, pursuant to subparagraph 21.03(1)(a)(i) (see footnote c) of the Patent Act (see footnote d), makes the annexed Order Amending Schedule 1 to the Patent Act (2014-1).

ORDER AMENDING SCHEDULE 1 TO THE PATENT ACT (2014-1)

AMENDMENT

1. Schedule 1 to the Patent Act (see footnote 1) is amended by adding the following in alphabetical order:

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.

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 comprised of medicines that are considered necessary to satisfy the priority healthcare needs of national healthcare systems. The medicines on the list are selected with due regard to public health relevance, evidence on 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 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 without the capacity to manufacture the products themselves.

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 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 CAMR was able to meet the basic healthcare 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 a name of a treatment for Type A and Type B influenza.

Both the August 30, 2003, decision and 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 CAMR are listed on Schedule 1 of the Patent Act. CAMR also contains safeguards to guard 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 amending Schedule 1 to add the names of three additional HIV/AIDS treatments. The objectives of the amendment are two-fold. First, it ensures that Schedule 1, and by extension CAMR, remains current with the evolving public health needs of developing and least-developed countries. The three treatments being added to the schedule are considered by the World Health Organization as essential to the minimum needs of a basic healthcare 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 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)(i) of the Act, the Government is amending 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 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 business.

Small business lens

The small business lens does not apply to this proposal, as it would not impose any costs to small business.

Consultation

Officials from Industry Canada have been in contact with the generic manufacturer that requested the amendment of Schedule 1 and the pharmaceutical manufacturers marketing the requested products. No objections were raised. The proposed amendments were prepublished in Part I of the Canada Gazette on December 20, 2014, followed by a 30-day period during which interested members of the public could submit written representations on the proposed amendments. Two submissions were received from stakeholders representing the generic pharmaceutical industry and an innovative pharmaceutical manufacturer. The generic representative expressed support for the proposal. The innovative pharmaceutical manufacturer also expressed support for the objectives of the amendment and the overall goal of providing access to affordable medicines in developing countries. To that end, the innovative pharmaceutical manufacturer urged that, in the event the newly listed products become eligible for export under a compulsory licence, the Government continues to observe all of the measures built into CAMR that ensure that only products that meet Health Canada’s health and safety standards are exported and that, once exported, those products will not be diverted from their intended destination. The amendment does not modify these measures.

Rationale

The stated purpose of 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 amendment, by adding three additional treatments for HIV/AIDS to Schedule 1, is in line with this purpose by ensuring that CAMR is able to respond to evolving public health needs.

Implementation, enforcement and service standards

The amendment does not impose any new requirements; it adds three names to the list of products eligible for export under CAMR.

Contact

Denis Martel
Director
Patent Policy Directorate
Marketplace Framework Policy Branch
Industry Canada
235 Queen Street, 10th Floor, East Tower
Ottawa, Ontario
K1A 0H5
Telephone: 343-291-2686
Fax: 613-952-1980
Email: denis.martel@ic.gc.ca