As soon as the Agreement comes into force in a Member State, unauthorized copies of patented drugs can only be produced and commercialized with the authorization of the patent holders. However, among other measures, a system of compulsory licensing and parallel imports may be applied in order to protect public health through access to affordable essential drugs.
The TRIPS Agreement requires WTO Member States to grant patent protection to all inventions in any branch of technology (article 27.1). This provision was expressly aimed at pharmaceutical products, for which certain developing countries, as well as developed countries, had refused to grant patents. Because of the high prices of patented drugs and the large amount of expenditure required for research and development (R&D) in the pharmaceutical field, some countries had chosen to imitate products patented in industrialized countries in order to meet their national requirements for drugs at a lower cost and to develop their local industry. Other countries with no pharmaceutical industry could also buy these copies of patented drugs at competitive prices.
If national regulations on patents do not provide for the protection of pharmaceuticals, or if they are not respected, the Member State in question may, pursuant to the disputes settlement process, incur commercial sanctions imposed by the WTO Dispute Settlement Body.