It consists mainly of:
- compulsory licences, which allow a state to authorise the exploitation of a patent by a third party without the consent of the holder (but with remuneration);
- parallel imports, the possibility for a country to import the same product sold more cheaply in another country by the holder of the patent, without authorisation of the latter;
- exemption from obligations of the TRIPS Agreement for Least Developed Countries, as well as a specific exemption to issue patents on medicines for these countries.
Although progress in the coverage of anti-AIDS treatments have been observed in the southern hemisphere, thanks in particular to these “flexibilities” and to the competition from generic medicines, this situation only rarely applies to non-infectious diseases (cancer, diabetes, cardio-vascular diseases, etc.), which are on the increase.
While compulsory licences represent an essential instrument for guaranteeing access to these patients to patented medicines, it is still too seldom used. The topic remains sensitive at a political level, and the threats of commercial reprisals by countries hosting pharmaceutical companies often discourage countries with low and modest incomes to resort to these flexibilities.
Resorting to TRIPS flexibilities therefore presents many obstacles. When a country such as India implements one of the allowed flexibilities, the pharmaceuticals multinationals do not hesitate to prosecute the state concerned, with the passive complicity of their governments (as with Novartis for the anti cancer drug Glivec). This denial of the right of developing and emergent countries to fully exploit the flexibilities contained in the TRIPS Agreement reached its zenith at the end of the 1990s, during the lawsuit filed by 39 pharmaceuticals companies – most of them supported by their respective governments – against South Africa for presumed violation of the TRIPS Agreement. The South-African state had, however, only used the flexibilities allowed for in the Agreement to manage an urgent public health issue – the pandemic of HIV/AIDS. Following the international scandal triggered by this lawsuit, the issue of flexibilities was brought back to the negotiating table within the WTO, thus opening the political way for the Doha Declaration.
The difficulty experienced by the Least Developed Countries (LDCs) in obtaining a time-limited exemption from the obligations of the TRIPS Agreement, although allowed for in its article 66.1 (renewable exemption without conditions), shows that the industrialised countries put their own interests – and those of their multinationals – before the fundamental rights of the poorest countries on the planet. Alongside other NGOs, Public Eye appealed in 2013 and 2015 to the WTO and Switzerland regarding this matter.