By Ellen ‘t Hoen, Global Health Unit Department of Health Sciences, UMCG Groningen, e.f.m.t.hoen@umcg.nl

This year the World Health Organization (WHO) added dolutegravir, an antiretroviral medicine for the treatment of HIV infection, to its Model List of Essential Medicines in response to the recent evidence showing the medicine’s safety, efficacy, and high barrier to resistance. A recent study  HIV drug resistance report 2017  launched by the WHO at the IAS2017 shows that in 6 of the 11 countries surveyed in Africa, Asia and Latin America, over 10% of people starting antiretroviral therapy had a strain of HIV that was resistant to some of the most widely used HIV medicines. This is a worrying trend and such levels of resistance demand a review of the treatment practices including switching to more robust ARV regimen.

The WHO has identified dolutegravir (an integrase inhibitor) as a key component in the fight against resistance and recommends that countries with pretreatment non-nucleoside reverse transcriptase inhibitor (NNRTI), such as nevirapine and efavirenz, resistance above 10% to switch to dolutegravir combinations for first line treatment.

The Medicines Patent Pool negotiated patent licences for dolutegravir and signed agreements with ViiV Healthcare for both paediatric and adult use of dolutegravir in 2014. Such licences ensure the production and sale of generic versions of dolutegravir without legal risks of patent infringement suits. The licences for paediatric products allow for sale in 121 countries, which accounts for 99.3% of the children with HIV and in 92 countries where 90% of adults with HIV live. This leaves the question how do countries not included in the agreement gain access to affordable dolutegravir? A much-overlooked feature of the agreements is that they allow generic companies to sell their products in the 54 countries where there is no dolutegravir patent. They can also supply generic products in countries where this does not infringe on an existing patent, for example when a compulsory licence has been issued. As a result, generic dolutegravir can be made available today in 131 countries representing 93.4% of people living with HIV in the developing world. (I have written about such provisions in licence agreements in relation to sofosbuvir, a medicine for the treatment of hepatitis C.)

Today’s price of generic dolutegravir is US$ 44 – 60. The WHO notes that the price of dolutegravir has come down in many low and middle-income countries and that it expects the price to drop further once the demand for it increases. All good news. However, treatment activists denouncing ViiV Healthcare’s pricing policy for dolutegravir in certain middle-income countries draw attention to the fact that the company asks US$ 1,500 in South Africa and US$ 2,317 in Belarus. These are indeed prohibitive prices for such countries. But any country that buys from ViiV at a high price while prequalified generic product is available for US$ 60 is stealing from its own budget. This would certainly be the case for South Africa, which is included in the territory of the licence agreement. So is Moldova. Belarus, where the dolutegravir patent will only expire in 2030, can access generics by issuing a compulsory licence. A careful look at the patent status in each country on medspal.org is also helpful in determining where generic products can be made available now. Thailand and Peru do not seem to have DTG patents and can buy from generic suppliers. In Malaysia, the base patent expired in 2016 but an application for patent restoration is pending. Malaysia could reject this. For more details on the options of the dolutegravir licence agreements see this (https://medicineslawandpolicy.org/tools/voluntary-licences/) case-study on voluntary licences and dolutegravir. For a good description of direct and indirect territorial coverage of voluntary licenses for dolutegravir see the article by Prof. Brook Baker.

Treatment campaigners are right to ask the companies to expand their licence territory. But the focus should also turn on the role of governments in the procurement of HIV medicines. The licences allow all countries to benefit from the generic production. Governments that can make this happen and we know from history that governments can be persuaded to act when prodded by campaigners and treatment activists.

Disclosure: Ellen ‘t Hoen was the founding executive director of the Medicines Patent Pool.

This article was initially posted on (https://medicineslawandpolicy.org/2017/07/dolutegravir-patent-licences-smoke-screen-or-breath-of-fresh-air/) Medicines Law & Policy.