MPP Drug Licensing Deal Brings Hope For Greater Access To HIV Treatments

The Medicines Patent Pool (MPP) this week announced two new licencing agreements with the private sector joint venture ViiV Healthcare that will increase access to a new antiretroviral in countries hardest hit by HIV.

The licences are for a new drug, dolutegravir (DTG), which has been shown to perform very well as both a first line treatment and in people who have developed resistance to first line medicines, said Greg Perry, MPP executive director.

“Its low dosage means that it will possibly be cheaper to manufacture than some of the currently used drugs,” he told Intellectual Property Watch. More information about DTG can be found in a recent report by UNITAID.

The full agreements can be found on the MPP website, adult agreement here [pdf], and paediatric agreement here [pdf].

The transparency of publishing the agreement was praised by public health advocates.

Details of the Deal

The first agreement is a voluntary licence for DTG for use in adult treatment, royalty free in three categories: sub-Saharan Africa, least developed countries and low-income countries. There are two new features in the licence not seen in past agreements reflecting MPP’s efforts to ensure that more middle-income countries benefit from their work.

Firstly, licencing is extended to six additional middle-income countries (Egypt, India, Indonesia, the Philippines, Turkmenistan and Vietnam) for a tiered royalty fee based on the gross domestic product of each country. There is also market segmentation in six of the countries included in the licence.

“The generic manufacturers will be able to supply the public sector market (which includes not just the large government HIV treatment programmes but also programmes led by non-profit organisations). ViiV keeps its exclusivity for the much smaller, but often more profitable, private market,” Perry told Intellectual Property Watch.

Altogether, the licence encompasses about 93.4 percent of adults living with HIV. In addition to the countries covered, the agreement maintains the right of sublicensing manufacturing companies to supply additional countries in which DTG is not patented, or other territories that have issued a compulsory licence for the drug (see paragraph 2.4 of the adult agreement).

The second agreement is a royalty-free licence for paediatric formulations of DTG in 121 countries where 99 percent of children with HIV live. According to the ViiV press release, “dolutegravir is currently approved for patients 12 years and older. However, this licence also includes a commitment for future lower dose tablets and age-appropriate formulations developed by ViiV Healthcare.”

The MPP press release identifies younger children as one of the most vulnerable and under-served populations of the HIV community.

Philippe Douste-Blazy, chair of UNITAID, said, “incorporating palatable, child-friendly ABC and DTG options into paediatric HIV programmes could significantly enhance and prolong children’s lives.”

The deal will allow generic manufacturers to combine DTG with other drugs and develop fixed-dose combinations for single doses of treatment. One of the possible combinations may be with abacavir, a drug also developed by ViiV and licenced to the MPP in February 2013 (IPW, Public Health, 4 March 2013).

MPP also identified a new drug, TAF, currently being researched by Gilead as another possible option, and for which the MPP is currently in negotiations with Gilead for future licencing. As well as tenofovir, already licensed to the MPP, and darunavir and ritonavir, which appear to be patented in developing countries.

“Dolutegravir is an innovative HIV therapy, and we will be working closely with generic manufacturers over the next few years to make it available to those most in need as quickly as possible,” Perry said. “So far, it seems there is strong interest from generic manufacturers, but we will have a greater understanding over the coming weeks.”

The companies will need to develop the product alone or in combination and obtain regulatory approval before it will be available. This can take a couple of years, but on average it takes 7-9 years before a product approved for use in developed countries reaches patients in developing countries.

The Medicines Patent Pool was founded in 2010 by the WHO-backed organisation UNITAID to increase access to HIV treatment in developing countries and promote innovation of new formulations. The organisation has to date signed eight antiretroviral licensing agreements.

ViiV Healthcare is a joint venture between UK pharmaceutical firm GlaxoSmithKine (GSK) and US firm Pfizer, established in 2009 for delivery of HIV treatments.

Reactions; Others Urged to Follow

The agreement has attracted positive reactions from organisations working in related fields. Nelson Otwoma, executive director of the National Empowerment Network of People living with HIV/AIDS in Kenya (NEPHAK), highlighted the “high effectiveness and low side effects” of DTG.

James Love, director of the nongovernmental organisation Knowledge Ecology International, also praised the deal saying, “this announcement is good news for persons living with HIV… The terms of the new licenses expand access and improve global norms for voluntary licenses.”

Tessel Mellema, policy advisor for Health Action International (HAI), said in their statement: “given that generic competition has consistently proven to be the most effective war of lowering medicine prices, we welcome this news.” She also said that the licence may prove beneficial in setting standards for future voluntary licensing agreements.

Mellema said they would like to see the scope of this agreement be reflected in last year’s deal concerning the abacavir licence. However, she said that key middle-income countries such as Ukraine, Brazil and Mexico, were excluded from the territorial scope of the licence and this “will prevent many people in need from accessing this treatment.”

In response to this, Perry said: “We are always striving to have as many countries as possible in low and middle-income countries included in our agreements and we are pleased that the paediatric agreement with ViiV on dolutegravir includes more countries than last year’s abacavir licence… The use of market segmentation and differentiated royalties were important in that respect for the DTG adult agreement.”

HAI and KEI both called for other companies to follow ViiV’s example and enter into negotiations with MPP to licence their treatments. Both organisations specifically point to Johnson & Johnson who prematurely ended negotiations, and Merck who have to date refused to enter into negotiations with MPP.

Julia Fraser is an intern at Intellectual Property Watch. She is currently training to be a solicitor and will start work at an international law firm in London in 2015. She has a BSc Honours in Biology from Edinburgh University where she developed an interest in public health related intellectual property issues.