On Thursday, 25 September 2014, Knowledge Ecology International (KEI) delivered this statement on agenda item 17(i), Reports on other WIPO Committees, (i) Standing on the Law of Patents (SCP).
WIPO General Assembly 2014
17. Reports on other WIPO Committees
(i) Standing Committee on the Law of Patents (SCP);Statement of Knowledge Ecology International
The 2001 WTO Doha Declaration on TRIPS and Public Health says patent laws “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 work of the SCP should help countries find a way to achieve this goal, one that was reached by consensus among all members of the WTO.
KEI is among those exploring models for delinking R&D costs from drug prices. In order to do this, laws on patents and other intellectual property rights need to accommodate new business models for funding innovation, including those that feature innovation inducement prizes rather than drug monopolies as the reward for successful innovation, or measures such as patent buy-outs.
The US Senate and the US National Academies have proposed a study of full delinkage, as an alternative to drug monopolies. This month, the US White House issued a statement asking to explore delinkage in the context of antibiotic drug development, an approach endorsed by some of the leading European R&D focused drug companies. The World Health Organization is also experimenting with delinkage drug development models, for a wide range of diseases for which market failures exist.
KEI suggests the SCP undertake a review or ask for a study of the provisions in national patent laws that would enable full delinkage of drug prices and R&D costs.
KEI also notes that some proposals in regional or bilateral trade agreements may present significant barriers to the introduction of full delinkage drug development models.
ANNEX, not read
In the field of antibiotic resistance, the White House has shown leadership and highlighted de-linkage as feasible option for attracting innovation into developing new antibiotics (in its Report to the President on Combating Antibiotic Resistance). The report noted,
Under such schemes, a successful developer of an antibiotic that addresses an important public health need would receive a financial reward that is not directly tied to the usage of the drug. A variety of incentive models have been proposed, including user licenses, lump sum prizes, patent buy-outs, and payments to hold drugs in strategic reserve These models would provide reduced risk to potential developers (the economic reward is defined), reduced risk to users (their cost is contained), and would allow the resulting antibiotics to be managed as a strategic resource so as to preserve their effectiveness for critical uses. In addition, these models would not create incentive for a drug maker to increase sales of the antibiotic in order to make more money.
The White House also announced the launch of a $20 million prize by the US National Institutes of Health and Biomedical Advanced Research and Development Authority to facilitate the development of of a rapid, point of care diagnostic test to identify highly resistant bacterial infections.