30 NOVEMBER 2012: Yesterday, Johnson & Johnson announced a new policy not to enforce its patents on its antiretroviral, darunavir, in Sub-Saharan Africa and least-developed countries in some circumstances.
The Medicines Patent Pool welcomes any measure that genuinely improves access to medicines in the developing world. However, with a limited geographical coverage of 64 countries, the policy is a step backward compared to what other companies and Johnson & Johnson itself have announced for other antiretrovirals in the past.
Demand for darunavir is likely to increase over the coming years, as more people need access to second- and third-line treatment in developing countries. But the policy’s limited geographic coverage, combined with prohibitively high prices in developing countries with the highest need for darunavir, is not likely to result in improved access to the medicine where it is most needed.
In issuing the policy, Johnson & Johnson suggested its approach provides greater assurance that the product will be of quality and used in a medically sound manner. It is unclear how a hands-off policy not to assert patents achieves these goals. A better way to ensure that quality products are developed, registered and made available to those who need them is to work through the Medicines Patent Pool.
Under a specific mandate from UNITAID, the Pool collaborates closely with a wide range of stakeholders to ensure that medicines made under its licences are in line with treatment guidelines, meet internationally-recognised quality standards and are developed rapidly to meet urgent needs. The Pool works with its licensees on every step of drug development, from technology transfer to national registration in order to ensure that the licensing of patents truly results in greater access to quality assured treatment for people living with HIV.
The Pool reiterates its call for Johnson & Johnson to enter negotiations to agree on transparent, public health-oriented licensing terms and conditions that will genuinely result in expanded access to quality antiretrovirals in developing countries.