The World Trade Organization meetings in Doha, Quatar21 confirmed what was clear to many, that TRIPs allows compulsory licensing to provide patented medicines, including FDCs, to low income countries22. Therefore, one short-term way out of the multiple ownership problem exemplified by “Triomune” would be, under TRIPS imprimateur, forcing availability of FDCs when IPR issues become too complex. Compulsory licensing is only obviously useful for that group of “rich” poor countries that have both domestic expertise and domestic pharmaceutical manufacturing capacity (Brazil, India, South Africa). However, there is nothing in the TRIPs agreement to prevent a country without significant local manufacturing capacity from importing the or its ingredients from a country where no patent protection exists on that drug. Until recently, it was not settled if TRIPs will be interpreted to cover the same situation if the drug or ingredient was under a valid patent in the exporting countryi. It has, however, become clear since the August 2003 WTO meeting in Cancun, Mexico that TRIPS compulsory license provisions will be interpreted broadly enough to cover the situation where a country lacking domestic production capacity can import a drug from a producer in a third country. The Cancun agreement does not limit the scope of diseases for compulsory licensing, and it also does not require high standards such as epidemics or emergencies. Routine public health problems can be addressed. New proposed amendments to domestic Canadian law (Section 4) make export of patented medicines a possibility for Canadian generic drug manufacturers.
i This was true notwithstanding the 14 November 2001 Doha Declaration on TRIPS and Public Health, which said: We agree that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members right to protect public health and, in particular, to promote access to medicines for all. The Doha Declaration also said: Each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted.
Those middle and lower income countries capable of producing FDCs (Brazil, India, Eastern Europe, probably Thailand, South Africa, Egypt, Jordan and a few others) are required by TRIPS to ensure full product patent protection by 2005. Thus, countries like India must provide patent protection for FDC components and can no longer “design around” method patents. Thus is likely to fundamentally change the nature of the pharmaceutical industries in those countries that have previously relied on weak domestic patent protection to make cheap copies of important drugs that are patented elsewhere. Now, these medicines will have to be patented in-country. There are, at least, three consequences of the post-2005 IP world for FDC manufacture, use and sale:
a) Voluntary licensing and the threat of, if not actual use of, compulsory licensing will become more important;
b) Prices of patented FDCs in these “post-2005” countries are likely to remain high or increase, as pharmaceutical companies continue to try and recover their sunk costs of R&D;
c) Combinations of off-patent drugs or combinations containing at least one off-patent drug will become of interest;
d) More creative ways to incentivize development of new FDCs and provide R&D funding (open sourcing, R&D consortia and so on) without exacerbating IP and market failures will be needed.