Now, though, after extensive lobbying and negotiations another drugmaker has signed on. ViiV Healthcare, which is a joint venture between GlaxoSmithKline (GSK) and Pfizer, has agreed to license abacavir, also known as Ziagen,for children. MPP and ViiV have also agreed to negotiate licensing rights for other drugs in the ViiV pipeline, notably dolutegravir, for which the joint venture is currently seeking regulatory approval in the US and Europe (here is the license).
The agreement is significant because it marks the second time that a large drugmaker has agreed to work with MPP, which was rebuffed by Johnson & Johnson last year when the healthcare giant agreed not to enforce patent rights for its Prezista HIV drug. As part of its go-our-own-way plan, J&J (JNJ) is licensing the medicine to generic drugmakers for distribution in 64 poor countries (read more here).
And unlike the agreement with Gilead Sciences, this latest deal is being met with a level of acceptance. MPP was chastised for the Gilead deal because it limits the amount of competition by restricting manufacturing to one country, which is India; there are narrow options for finding active pharmaceutical ingredients, and people living with HIV in middle and lower-income countries are excluded (read more about the criticism here and here).
The agreement with ViiV, however, does not include any restrictions on where ViiV HIV medicines can be made, or where active pharmaceutical ingredients can be made or sold, as long as the final product is destined for sale in the 118 countries that are covered in the deal. "This is an improvement over the Gilead deal," says Judit Rius Sanjuan, US manager of the Access Campaign at Medecins Sans Frontieres, also known as Doctors Without Borders.
But there are still issues. For one, she says the list of countries does not include several developing nations, such as Ukraine, Mexico and Peru, where there are intellectual property barriers to making low-cost generics. She adds that it should have been possible to add pipeline products to the licensing deal.
"While it’s encouraging to see ViiV taking steps towards greater collaboration on access to pediatric formulations, the real breakthrough we’re looking for is an agreement to make the company’s promising new drug dolutegravir available to both adults and children in all developing countries," says Aziz ur Rehman, MSF's intellectual property advisor.
However, MPP maintains that the 118 countries that are part of the agreement with ViiV account for 98.7 percent of the nations where children with HIV are living.