Network for Monitoring the Impact of Globalization and TRIPS on Access to Medicines, Meeting Report, 19-21 February 2001, Chulalongkorn University, Bangkok, Thailand - Health Economics and Drugs Series No. 011
(2002; 67 pages) View the PDF document
Table of Contents
Open this folder and view contents1. Introduction
View the document2. Highlights of opening address of Dr Supachai Panitchpakdi
Close this folder3. 1Globalization, TRIPS and Access to Pharmaceuticals
View the documentA new era in global trade
View the documentWTO Agreements
View the documentImplementation and dispute settlement
Close this folderKey requirements of the TRIPS Agreement
View the documentPatent protection
View the documentRights conferred
View the documentTransitional arrangements
View the documentPublic health and TRIPS
View the documentPatentability
View the documentGeneric drugs
View the documentCompulsory licensing
View the documentParallel imports
View the documentTRIPS-plus provisions
View the documentNon-WTO Members
View the documentEvaluating impacts of trade agreements
Open this folder and view contentsWHO Perspectives on Access to Drugs
View the document4. Further Reading
View the document5. Template of selected model indicators for studying the impact of globalization and TRIPS on access to medicines
Open this folder and view contents6. Selected indicators for studying the impact of globalization and TRIPS on access to medicines
View the document7. The Collaborating Centres
 

Generic drugs

Promotion of generic drugs requires appropriate legislation and regulations, reliable quality assurance capacity, professional and public acceptance of generic drugs, and economic incentives and information for both prescribers and consumers. The TRIPS Agreement does not prevent Members from requiring generic labelling and allowing generic substitution.

Trade liberalization can increase competition and reduce prices for generic drugs that are already on the market. But if the wording and implementation of TRIPS-compliant national legislation and regulations are inappropriate, the introduction of new generic drugs can be delayed. The economic cost to governments, households and public health can be enormous.

Prompt introduction of generic drugs can be facilitated by: drafting appropriate legislation and regulations on patentability; use of exceptions to exclusive rights which permit early testing and approval of generics (“Bolar” provision) (including allowing access to pre-registration test data); and compulsory licensing.

Box 2. Articles of the TRIPS Agreement of greatest relevance to pharmaceuticals

Box 2. Articles of the TRIPS Agreement of greatest relevance to pharmaceuticals

Topic (TRIPS Article)

Key phrasing from TRIPS agreement
(Note that a number of articles contain further specific conditions, exceptions and exemptions which are spelled out in TRIPS or other referenced agreements.)

Nondiscrimination (Articles
3 and 4)

“National Treatment...Each Member shall accord to the nationals of other Members treatment no less favourable than that it accords to its own nationals with regard to the protection of intellectual property...”
“Most-Favoured-Nation Treatment...With regard to the protection of intellectual property, any advantage, favour, privilege or immunity granted by a Member to the nationals of any other country shall be accorded immediately and unconditionally to the nationals of all other Members...”

Parallel importation (“exhaustion of patent rights”) (Article 6)

“Exhaustion...For the purposes of dispute settlement under this Agreement, subject to the provisions of Articles 3 [National Treatment] and 4 [Most-Favoured-Nation Treatment], nothing in this Agreement shall be used to address the issue of the exhaustion of intellectual property rights.”

Objectives of TRIPS (Article 7)

“Objectives...The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.”

Protection of public health (Article 8)

“Principles...Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement.”

Process and product patents (Article 27)

“Patentable Subject Matter...patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application...[P]atents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.”

Subject matter which may be excluded from patentability (Article 27)

“Patentable Subject Matter...Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health...”
“Members may also exclude from patentability:
(a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals;
(b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes.
However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.”

Exceptions which facilitate prompt marketing of generic drugs (“Bolar” provisions) (Article 30)

“Exceptions to Rights Conferred...Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.”

Compulsory licensing (Article 31)

“Other Use Without Authorization of the Right Holder...Where the law of a Member allows for other use of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government, the [twelve] provisions shall be respected.”

20-year minimum term of protection (Article 33)

“Term of Protection...The term of protection available shall not end before the expiration of a period of twenty years counted from the filing date.”

Reversal of burden of proof for process patents (Article 34)

“Process Patents...Burden of Proof...For the purposes of civil proceedings in respect of the infringement of the rights of the owner...if the subject matter of a patent is a process for obtaining a product, the judicial authorities shall have the authority to order the defendant to prove that the process to obtain an identical product is different from the patented process.”

Data protection and Exclusivity (Article 39)

“Protection of undisclosed information...In the course of ensuring effective protection against unfair competition...Members shall protect undisclosed information...and data submitted to governments or governmental agencies...”

Transitional arrangements for developing country WTO Members (Articles 65 and 66)

Specific transitional arrangements are provided for developing and least-developed countries (see TRIPS text).

Transfer of technology and technical cooperation (Articles 66 and 67)

“Developed country Members shall provide incentives to enterprises and institutions in their territories for the purpose of promoting and encouraging technology transfer to least-developed country Members in order to enable them to create a sound and viable technological base...[and] shall provide, on request and on mutually agreed terms and conditions, technical and financial cooperation in favour of developing and least-developed country Members.”

Mailbox filings (Article 70/8)

“Where a Member does not make available as of the date of entry into force of the WTO Agreement patent protection for pharmaceutical and agricultural chemical products commensurate with its obligations under Article 27, that Member shall:
(a) notwithstanding the provisions of Part VI, provide as from the date of entry into force of the WTO Agreement a means by which applications for patents for such inventions can be filed...”

Review (Article 71/1)

“The Council for TRIPS shall review the implementation of this Agreement after the expiration of the transitional period referred to in paragraph 2 of Article 65. The Council shall, having regard to the experience gained in its implementation, review it two years after that date, and at identical intervals thereafter. The Council may also undertake reviews in the light of any relevant new developments which might warrant modification or amendment of this Agreement.”

Box 3. Checklist for policy-makers

Government process and resources:

• Identify trade-and-pharmaceuticals focal point within Ministry of Health.
• Establish contacts, perhaps a working group, with trade and other key ministries.
• Obtain reliable specialized legal advice.
• Develop a mechanism to monitor the health impact of new trade agreements.

National patent and related legislation should:

• Promote standards of patentability that take health into account.

• Establish process and product patents for 20 years.

• Incorporate exceptions, trademark provisions, data exclusivity and other measures to support generic competition.

• Permit compulsory licensing, parallel importation and other measures to promote availability and ensure fair competition.

• Permit requests for extension of transitional period for TRIPS implementation, if needed and if eligible.

• Carefully consider national public health interests before instituting TRIPS-plus provisions (see text).

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