A global aim is to provide access to affordable medicines on a sustainable basis in developing countries. The past decade has seen a strong policy emphasis on public health and access to medicines in the WTO, including making needed medicines available − especially anti-retroviral drugs to combat HIV/AIDS − at lower prices, enhancing international funding and creating an additional pathway for access to medicines.
On 6 December 2005, WTO Members approved a Protocol that proposed an amendment to the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement) to make it easier for poorer countries to obtain cheaper generic versions of patented medicines. The amendment sets aside a provision of the TRIPS Agreement that could otherwise limit exports of pharmaceuticals manufactured under compulsory licenses to countries that are unable to produce them. For the amendment to enter into force, acceptance by two thirds of WTO Members was required. The WTO received 32 instruments of acceptance of the amendment over the past two years alone – a marked increase from the average rate of slightly over five per year from 2005 to 2014.The amendment to the Agreement entered into force on 23 January 2017, when the two thirds threshold was reached. It applies to all Members who have accepted it.
Members who have yet to accept the amendment can use the system on the basis of an earlier WTO Decision of 30 August 2003. They currently have until 31 December 2017 to submit their instrument of acceptance to the WTO. While the Members concerned are still expected to accept the amendment, WTO rules do not require them, nor any other Member for that matter, to take any domestic legislative action in order to implement the system in domestic law. An overview of measures taken by individual Members to implement flexibilities can be found on WIPO's database.
- Governments and the private sector must refrain from explicit or implicit threats, tactics or strategies that undermine the right of WTO members to use TRIPS flexibilities. WTO members must register complaints against undue political and economic pressure, and take punitive measures against offending members;
- Governments must urgently increase their current levels of investment in health technology innovation to meet unmet needs and enter into negotiations for a binding Research & Development treaty that delinks the costs of innovation from the end prices of health technologies in order to address unmet health needs;
- There must be much greater transparency to ensure that the costs of research and development, production, marketing, and distribution, as well as the end prices of health technologies are clear to consumers and governments;
- The Secretary-General should establish an independent review body tasked with assessing progress on health technology innovation and access and call for a High-Level meeting on Health Technology Innovation and Access to be convened by 2018.
- The report has been welcomed by the Secretary-General, several UN Member States and civil society groups and was included in a resolution of the UNGA in December 2016 as well as a 2016 resolution of the Human Rights Council. The Report’s recommendations are being further discussed at the Human Rights Council, WHO, WTO and WIPO.