Consultation paper comparison of national access to medicine regimes

Annex B: International Comparison
Subject Canada EU Switzerland Norway India China Korea Netherlands
Implementing Instrument Patent Act, s.21.01-21.2 Regulation 816/2006 Draft Amendment to Federal Law on Patents for Inventions Amendments to Act of 15/12/1967 No.9 relating to patents by Act of 19/12/2003 no. 127/Patent Regulations of 20 December 1996 No. 1162 amended by Royal Decree of 14/05/2004 The Patents (Amendments) Act , 2005 No. 15 of 2005 State Intellectual Property Order #37 Korean Patent Act Policy Rules for the issuance of a compulsory licence under s. 57 of the Patents Act 1995
Date in Effect May 14, 2005
(Royal Assent May 14, 2004)
June 29, 2006 Draft amendment dated November 23, 2005, not enacted. June 1, 2004: Regulations
Dec. 2003: Patent Act
January 1, 2005 January 1, 2006 December 1, 2005 December 23, 2004
Eligible Importers/ Permitted Purchasers

S.21.03: WTO and non-WTO Members who have notified the WTO or Canada of intent to use the Decision and have insufficient manufacturing capacity. Also, any country recognized by the UN as being a LDC.

Eligible countries are listed on Schedules 2-3-4 of the Patent Act.

Schedule 2: Least developed WTO and non-WTO Members.

Schedule 3: Developing country WTO Members.

Schedule 4: WTO Members that have signalled their intention to rely on the Decision in cases of national emergency and non WTO-Members eligible for OECD development assistance.

S.21.04(2)(f): NGOs may purchase products with the permission of an eligible importing country.

Art.4: WTO and non-WTO Members with insufficient manufacturing capacity and any country recognized by the UN as being a LDC.

Art.4: Non-WTO members eligible for OECD development assistance who have notified the Commission of their intention to use the system in a whole or limited way.

Art. 8: All importers except LDCs must establish that they have insufficient or no manufacturing capacity.

Art. 40 d.1: WTO and non-WTO developing Members and LDCs with insufficient manufacturing capacity.

LDCs do not need to establish lack of manufacturing capacity.

Notifications to WTO or Swiss government required.

S. 107.1 Regulations: WTO and non- WTO Members with insufficient manufacturing capacity and countries designated as LDCs by the UN.

S. 107 Regulations: Notifications to WTO or Norwegian Ministry of Foreign Affairs for States that are not party to the WTO Agreement.

Art. 92A.(1): Any country having insufficient manufacturing capacity in the pharmaceutical sector for the required product.

Art.9: WTO members who have notified the WTO and non-WTO LDCs who have notified the government of China through diplomatic channels.

Art. 107(7): Countries that have given notice to the WTO or the government of Korea .

Art. 107 (7) (ii): All except LDCs must establish that they have insufficient or no manufacturing capacity.

Art. 107(7) (iii): Where applicable, the notice must include a confirmation that the importing country intends to grant a licence for the import of the product.

Art. 3: Any LDC or WTO Member that has made a notification as required by the WTO Decision.

Art. 3(3): Non- WTO Member LDC must include the following with its application: a declaration that the country has insufficient or no manufacturing capacity, and a description of the anti-diversionary measures that will be taken.

Permitted purchasers include importing states, groups of importing states, regional organizations and NGOs.

Eligible products

S.21.01: "...pharmaceutical products to address public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics."

S.21.02: "pharmaceutical product" means any patented product listed in Schedule 1.

Schedule 1 lists the products that are eligible for export under the regime. The list can be amended by Order-in-Council.

Art. 1: For the manufacture and sale of pharmaceutical products intended for export to eligible importing countries to address public health problems.

Art. 2: Pharmaceutical products defined as any product of the pharmaceutical sector, active ingredients and diagnostic kits.

Art. 40 d.1: Products needed to fight public health problems, in particular those resulting from HIV/AIDS, malaria and tuberculosis.

Preliminary draft explanatory report: it is suggested to interpret the Decision of 30 August 2003 broadly and include active ingredients, diagnostic kits and vaccines.

S. 108 Regulations: Pharmaceutical products as defined in para 1(a) of the Decision.

Art. 92.A (1): Compulsory licences available for the manufacture and export of patented pharmaceutical products to address public health problems.

Art. 92A. in fine: Pharmaceutical products defined as any patented product, or product manufactured through a patented process, of the pharmaceutical sector needed to address public health problems inclusive of ingredients necessary for their manufacture and diagnostic kits required for their use.

Art.2: Infectious diseases - defined as HIV/AIDS, tuberculosis, malaria and other infectious diseases (as listed in a document called A PRC Measures in Prevention and Treatment of Infectious Diseases) that have led to public health problems.

Art.2: Pharmaceutical products defined as any patented product, or products manufactured through a patented process, of the pharmaceutical sector needed to treat an infectious disease. This includes active ingredients and diagnostic kits.

Art. 107(1)(v) : "...where working the patented invention is necessary to export a pharmaceutical product for the purpose of curing diseases for a number of patients in an importing country."

Art. 107(8): "Pharmaceutical product"means any patented pharmaceutical product, any pharmaceutical product manufactured through a patented process, any patented active ingredient needed for manufacturing the pharmaceutical product and any diagnostic kits needed for the use of the pharmaceutical product.

Art.1: "Pharmaceutical product" means any patented product, or product manufactured through a patented process, of the pharmaceutical sector needed to address public health problems, including active ingredients for the manufacturing of these products and diagnostic kits to use the product.
Health and Safety Review S. 21.04 (3) (b) of the Patent Act and C.07.004 of the Food and Drug Regulations provide for a mandatory review by Health Canada to ensure exports are of the same safety, efficacy and quality as drugs approved for sale in Canada. Art. 18 provides for a voluntary review: Where the application for a compulsory licence concerns a medicinal product, the applicant may avail himself of the scientific option procedure or any similar procedures under national law.

Art.5 (1) Law on Therapeutic Products: Licencee must obtain authorization for the production of the licenced products to ensure their high quality from the Swiss Institute of Therapeutical Products.

Art. 7 Law on Therapeutic Products: licencee must guarantee that the products will be produced in conformity with standards of Good Laboratory Practice.

Not required. Not required. Not required. Not required. Not required.
Application Process

S.21.04(2): applicant submits application to Commissioner of Patents, application must contain:

- name of product, version

-maximum quantity of product to be manufactured and sold

-patentee

-importing country

-name of governmental person/entity to which the product is to be sold.

Art. 6(3): The application shall set out the following:

- name and contact details of applicant

- name and quantity of product

- importing country

- where applicable, evidence of prior negotiation with patentee

- evidence of request (indicating quantity required) from representative of importing country, NGO, UN body or other international health organization acting with formal authorization of the importing country.

Art. 40 d.5: Federal Council specifies the conditions for granting licences (i.e., defines the information or notifications required).

Application must include declaration that importing country will grant a compulsory licence.

Federal Court grants licences. Form and content of application not specified.

Art. 92A.(2): The Controller grants licence

"Controller" means the Controller General of Patents, Designs and Trade Marks (s. 2(1)b. of the Patents Act 1970).

Art. 9: Chinese State Council can request that the State Intellectual Property Office grant a compulsory licence to allow a third party to produce and export the needed product.

Not specified.

Art. 3: Application must be accompanied by an order addressed to the applicant from a permitted purchaser.

Notice to Patentee

S. 21.15: The Commissioner will notify the patentee of the grant of a compulsory licence.

S 21.16: The licencee must provide a copy of the sales agreement with the importing country to the Commissioner of Patents and the patentee.

Art.7: Patent holder will be notified of each application and will have an opportunity to comment to the competent authority.

"Competent authority" is defined in Art. 2(4) as the national authority having competence to grant compulsory licences under this Regulation in a given Member State.
Not specified. Not specified. Not specified. Not specified. Art.107: Applicant must first seek a voluntary licence. Not specified.
Duty to seek voluntary licence S. 21.04 (3) c): applicant must provide the Commissioner with a solemn or statutory declaration in the prescribed form stating that the applicant had, at least 30 days before filing the application, sought from the patentee a licence to manufacture and sell the pharmaceutical product for export

Art. 9: Applicant must provide evidence that it attempted to seek a voluntary licence 30 days prior to submitting application - except in situations of extreme urgency.

Art. 40 e.1: Applicant must seek voluntary licence on reasonable terms within a reasonable time (30 days). This requirement is waived in emergency situations.

S. 49 Patent Act & Art. 108 Regulations:

Applicant must first seek a voluntary licence on reasonable commercial terms within a reasonable period of time. Reasonable is defined with reference to the economic value of the use of the invention to the importing country. This requirement is waived in emergency situations.
Not specified. Not specified. Art. 107: Applicant can apply for a compulsory licence if consultations with patent holder are unsuccessful. S. 57(1) Patents Act 1995, the Minister of Economic Affairs must make certain that the patent holder is unwilling to issue a voluntary licence before issuing a compulsory licence. In urgent cases, the Minister may refrain from making such an investigation.
Duration of licence S.21.09: licence is valid for 2 years. Art. 10(3): duration of the licence will be indicated on the licence by the competent authority.

Art. 40 e.2: limited to the purpose for which it was granted.

Not specified. Art. 92A (2): licence limited to terms and conditions specified and published by Controller. Not specified.

Art. 111: term of licence is set by Commissioner of Korean IP Office.

Licencee may request a modification to the licence.

Not specified.
Royalties

S. 21.08 Patent Act , to be paid by licencee taking into account the humanitarian and non-commercial reasons underlying the issuance of the licence.

S. 8 Use of Patented Products for International Humanitarian Purposes Regulations: prescribes formula for determining royalty rate: [(1+number of countries on UNHDI - importing country's rank) / number of countries on UNHDI] x 0.04.

Art.10(9): To be paid by licencee.

In situations of extreme urgency the royalty shall not exceed 4% of supply agreement.

In all other cases, the royalty is to be determined by taking into account the economic value of the use to the importing country as well as humanitarian circumstances.

Art. 40 e.5: determined considering the economic value of the licence in the importing country and the development level of that country; the Federal Council clarifies the manner of calculation.

Preliminary draft explanatory report: adopts Canada's royalty rate formula

S.50.2 Act & S. 108 Regulations: remuneration shall be determined with reference to the economic value of the use of the invention to the importing country. Not specified. Art. 7 & 11: Adequate remuneration to be paid to patent holder. Art. 106: Reasonable remuneration. Art. 5: The Minister of Economic Affairs shall determine adequate remuneration to be paid by the licencee taking into account the economic value of the product to the importing state.
Good Faith Clause S. 21.17: If the average price of the licenced drug is 25% or more of the average price of the equivalent patent brand name drug in Canada , the patentee may apply to the Federal Court for a number of legal remedies on the grounds that the essence of the agreement is commercial in nature. Preamble, par.6: The system is to be used in good faith and not for industrial or commercial policy objectives. Not specified. S.108 Regulations: Manufacture and export shall cease if the licencee learns that the products are being used to an appreciable degree for purposes that are not in accordance with the conditions for granting the licence. Not specified. Not specified. Not specified. Not codified in the policy rules but the accompanying explanatory notes repeat the Chairperson's Statement.
Quantities exported under licence S. 21.05(2): quantity authorized may not exceed the lesser of either the maximum quantity set out in the manufacturer's licence application, or the quantity indicated in the importing country's notification to the WTO or Canada.

Art. 10(2): amount of product(s) manufactured under licence shall not exceed what is necessary to meet the needs of the importing country/countries cited in the application, taking into account the amount of product(s) manufactured under other compulsory licences granted elsewhere.

Art. 16(4): There is an accelerated procedure for modifications to the amount authorized for manufacture and sale where the importing country's needs were not met by original licence

Art. 40 d.3: Licence limited to quantity necessary to satisfy need, all products produced under licence must be exported. S.108(3) Regulations : The product is only to be produced for export to the eligible importing State in order to cover the said State's current need for the product for health purposes. Art. 92A.(2): Terms and conditions of licence specified and published by Controller. Art. 10: Not specified. The licence must indicate the conditions required by the Decision. Art. 107(4)(ii): All products produced under a licence must be exported.

Art. 2(2): The compulsory licence shall state the type and amount of the pharmaceutical product to which the compulsory licence issued for the purposes of the order applies.

"Order" is defined in Art. 1(h) as a written order for a pharmaceutical manufacturer to manufacture a specified amount of a pharmaceutical product.

Anti-Diversion Measures

S.21.06: requires the licencee to establish a website disclosing the name of the licenced product, its distinguishing characteristics, identity of the importing country and amount to be manufacturer and sold for export.

S.21.07: export notice provided by the licencee to the patent holder, the importing country and the purchaser.

Food and Drug Regulations

C.07.008: Exported products must bear the mark "XCL" (for solid dosage forms), be a colour that is significantly different from the version sold in Canada and include certain information on all labelling to distinguish them from the patented versions available on the Canadian market .

C.07.009: Products are issued an export tracking number by Health Canada which must be printed on the product label.

Art. 10(5): All products must be identifiable as being produced under the Regulation and be distinguished from the patentee's product through packaging and/or colour/shaping.

Preamble, par. 11: To avoid overproduction and diversion, authorities should take into consideration existing licences for the same product and countries.

Art. 10(6): The licencee must establish a website prior to export.

Art. 40 d.4: Product must be distinguished from patented version by means of packaging, colouring, shape provided no major impact on price.

S. 108 (1) 1 Regulations: Product must be distinguished from patented version by means of packaging.

S. 108 (1) 2 Regulations : Product must bear a label indicating it was produced for export.

S. 109 Regulations : The licencee must establish a website listing the name and quantity of the product and identify the importing country.

The Court may stipulate more detailed requirements.

Not specified. Not specified. Art. 110(2)(iii): Product must have packaging or labelling to distinguish it from patented version and website on which appears the matters set by the adjudication must be established.

Art. 3(4): The manufacturer must take measures with regards to packaging, colouring, and/or shaping provided the measures are feasible and there is no impact on price.

Art. 3: Prior to export, the licencee must post, on either its own website or the WTO webpage, the anti-diversionary measures it has taken and the quantity of the pharmaceutical product being shipped.

Termination of Licence

S. 21.14: Federal Court can terminate a licence where the patent holder establishes that the application contained:

-incorrect information

-the licencee has not complied with the requisite anti-diversionary measures or has failed to pay royalties

-product has been re-exported in a manner contrary to the WTO Decision

-one the prescribed terms of the licence has been violated.

Article 5: Licence may be terminated if importing country fails to make proper notifications.

Art. 16: A licence may be terminated if terms of the licence are not met.

Art. 40 e.6: Federal Court may terminate licence when the circumstances that led to its grant no longer exist. S.108 Regulations: Manufacture and export shall cease if the licencee learns that the products are being used to an appreciable degree for purposes that are not in accordance with the conditions for granting the licence. Not specified. Not specified. Art. 114: Commissioner of Korean IP Office may cancel adjudication, inter alia, where working patented invention is no longer within purpose of adjudication. Not specified.
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