A Petition To Scuttle Gilead Deal With Patent Pool

A Petition To Scuttle Gilead Deal With Patent Pool

October 12th, 2011 // 12:49 pm @ jmpickett

Three months ago, Gilead Sciences agreed to license four AIDS meds to the Medicines Patent Pool, which is an initiative designed to streamline patent licensing for producing generics of patented HIV meds and lower prices in poor countries. The deal marked the first time that a drugmaker took such a step and followed more than a year of criticism from patient advocacy groups and non-government organizations of the pharmaceutical industry for failing to embrace the MPP concept.

The deal came three years after the MPP was launched by UNITAID in hopes of convincing multi-national drugmakers to license their AIDS meds, which would, in turn be licensed to select generic makers that would pay inventors a small royalty and sell copycats only in certain developing countries. The goal is to lower prices substantially, although inventors would still get some revenue. And the Gilead agreement was seen as a way to pressure still more drugmakers to sign on.

Almost immediately, though, the deal prompted mixed reactions. For instance, Michelle Childs, the director of policy and advocacy for Campaign for Access to Essential Medicines, which is run by Medicins Sans Frontieres, also known as Doctors Without Borders, ticked off three problems. One is the deal limits the amount of competition by restricting manufacturing to one country, which is India. The second is that there are narrow for options for finding active pharmaceutical ingredients. And third, people living with HIV in middle and lower-income countries are excluded (see more here).

Concerns have been bubbling for weeks and now a petition is circulating that calls for “substantially” revising or terminating the Gilead deal; instituting an “immediate moratorium” on negotiations of any new license agreements, including any new or pending agreements with Indian generic producers, and reevaluating the current structure of the MPPF and implement reforms so the organization adheres to “core principles of health equity.”

“We believe such steps are critical to address our dissatisfaction not only with the Gilead licensing agreement, but also with the inability or unwillingness of UNITAID and the MPPF to effectively address community concerns about the Patent Pool since it was first proposed,” reads the petition, which is being circulated by representatives of numerous patient advocacy groups, such as International Treatment Preparedness Coalition, from different countries. There are also various detailed steps the petitioners want the MPP to implement, which you can read here.

[UPDATE: At 11 am ET, the MPP issued a response, of sorts, in the form of another deal. Sublicensing agreements were announced with Aurobindo, a generic drugmaker that will attempt to take advantage of a provision in the Gilead licence and possibly sell an HIV med to a larger number of countries, including such middle-income nations as Argentina, Brazil, Chile, Colombia, Malaysia, Peru, Philippines, Ukraine, and Uruguay, and without paying royalties. MedChem also signed a sublicense].

Whether this will assuage the disgruntled is unclear. But not every activist is supporting the petition. A prominent example is Jamie Love of Knowledge Ecology International, a non-profit advocacy group that focuses on intellectual property issues that affect access to medications. His support for the Gilead has been measured and, in an email on an activist listserv, he agrees that the MPP should have been more open about the negotiating process and some other details. But he also questioned what the petition may ultimately accomplish.

“In theory, the licenses could have been better, and indeed, Gilead may agree to further amendments — for example, to allow products from some countries outside of India. However, the sweeping changes in the licenses that are set out (in) the petition, while desirable, were not about to happen, and I think, won’t happen, without something more substantial changing the negotiation,” he wrote.

“People can set the bar higher, but setting the bar too high means no licenses at this point. If the patent pool is stopped from negotiating further licenses, either telling them to stop or by setting the bar too high to get further licenses, I would ask, why is that a good thing?…Even with a transparent process, there is the reality that the major patent owners are not all ready to give up their patent claims in all developing countries. This is not the fault of the patent pool. A good strategy going forward needs to address this reality, and present a feasible path for access to persons living with HIV.”

This prompted an exchange with Jerome Martin of ACT-UP in Paris, who wrote, among other things, that the Medicines Patent Pool “is not an activist project anymore, it is institutional, funded by public money with results expected. There is no reason that we should not treat it the way we treat other programs.”

In response, Love wrote back that, “on the one hand, the MPP is being asked to suck up to patent owners and OECD countries, on the other hand, they are supposed to be a co-conspirator in efforts to strip companies of their exclusive patent rights. It is a tall and confusing order, and at times, I think it is confusing to everyone, including the MPP staff and the readers of this list. I am impressed that the MPP has pulled it off as well as it has.”

Source: Pharmalot