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The international intellectual property standards enshrined in the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have priced many essential drugs out of reach of poor patients by awarding patent holders monopoly rights over these products. Nevertheless, nestled within the folds of the Agreement itself are provisions which do enable governments to override exclusive patent rights in order to secure access to affordable medicines. This Manual examines the TRIPS-consistent policy measures to which states may have recourse for the purpose of producing, importing and exporting lower-priced versions of the patented drugs they need. Detailed suggestions are advanced, by way of model legal provisions, as to how governments may give effect to each of these measures - compulsory licensing, parallel importation, government use and exceptions to patent rights - in their national patent laws. In addition, the Manual discusses the domestic administrative and institutional framework required for the equitable and effective implementation of these provisions. The outcome of a series of expert workshops and consultations organized by the Third World Network, this Manual will serve as a practical guide for policymakers and citizen groups in efforts to formulate intellectual property disciplines which meet not only the legal obligations of the TRIPS Agreement but also the moral imperative of safeguarding public health. Contents Preface
PART I TRIPS-CONSISTENT OPTIONS FOR AFFORDABLE MEDICINES: MEASURES FOR IMPORT, DOMESTIC PRODUCTION AND EXPORT Chapter 1 Import A.
Importation under Government Use Chapter 2 Local Production A.
Manufacture of Non-Patented Drug Chapter 3 Export A. Export of Products Produced under Government Use and Compulsory Licences B. Export under Article 30 of TRIPS PART II MODEL LEGAL PROVISIONS FOR PUBLIC-HEALTH-SENSITIVE PATENT LAWS Chapter 4 Parallel Import Model
Provision A.
Effect of Model Provision Chapter 5 Public, Non-Commercial Use (Government Use) Model
Provision A. Effect
of Model Provision Chapter 6 Exceptions to Patent Rights Model
Provision A.
Effect of Model Provision Chapter 7 Compulsory Licence Model
Provision A.
Effect of Model Provision PART III PROPOSALS FOR AN APPROPRIATE INSTITUTIONAL AND ADMINISTRATIVE FRAMEWORK FOR PUBLIC HEALTH-SENSITIVE PATENT LAWS Chapter 8 The Competent Authority A.
Individual Merits Chapter 9 Adequate Remuneration or Compensation A.
Compensation Committee Bibliography Annex
1 Relevant Provisions of the TRIPS Agreement
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Manual
on Good Practices in Public Health-Sensitive Policy Measures and Patent
Laws