A/63/263 28. The company should not impede those States that wish to implement the World Trade Organization Decision on Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (2003) by issuing compulsory licences for exports to those countries, without manufacturing capacity, encompassed by the Decision. 29. Given that some least developed countries are exempt from World Trade Organization rules requiring granting and enforcing patents until 2016, the company should not lobby for such countries to grant or enforce patents. 30. As part of its access to medicines policy, the company should issue non-exclusive voluntary licences with a view to increasing access, in low-income and middle-income countries, to all medicines. The licences, which may be commercial or non-commercial, should include appropriate safeguards, for example, requiring that the medicines meet the standards on quality, safety and efficacy set out in Guideline 20. They should also include any necessary transfer of technology. The terms of the licences should be disclosed. 31. As a minimum, the company should consent to National Drug Regulatory Authorities using test data (i.e., the company should waive test data exclusivity) in least developed countries and also when a compulsory licence is issued in a middle-income country. 32. In low-income and middle-income countries, the company should not apply for patents for insignificant or trivial modifications of existing medicines. Commentary: The preceding Commentary recognizes the major contribution made by the intellectual property regime to the discovery of life-saving medicines. Crucially, this regime contains various “flexibilities” and other features that are designed to protect and promote access to existing medicines. Carefully constructed, they were agreed, after protracted negotiations, by the world community of States. Because they protect and promote access to existing medicines, which is a key component of the right to the highest attainable standard of health, these “flexibilities” and other features should not be limited, diminished or compromised. Some of the key “flexibilities” and other features are addressed in Guidelines 26-29. In brief, pharmaceutical companies should not seek to limit, diminish or compromise the “flexibilities” and other features of the intellectual property regime that are designed to protect and promote access to existing medicines. Voluntary licences have a vital role to play in extending access to medicines (Guideline 30). Consistent with a company’s responsibility to enhance shareholder value, commercial voluntary licences are designed to generate revenue for the patent holder. The terms of the licences should include appropriate safeguards, for example, relating to the quality, safety and efficacy of the product. Non-exclusive licences are more likely to extend access than exclusive licences. Voluntary licences respect, and depend upon, the intellectual property regime. Because data exclusivity has the potential to hinder access to medicines, companies should waive such exclusivity in all appropriate cases; while Guideline 31 identifies two occasions when the company should waive data exclusivity, there will be other occasions when a waiver is appropriate as a way of enhancing access to medicines for disadvantaged individuals, communities and populations. Access to medicines may be hindered when a company applies for a patent for improvements to an existing medicine; Guideline 32 is designed to mitigate this problem in low-income and middle-income countries. 22 08-45647