Ethan Guillen of the non-profit Medicines Patent Pool met the NGO Delegation at the 28th UNAIDS Programme Coordinating Board where he was a civil society observer. In this guest article, he explains his organization’s key objectives and recent success and how civil society can engage in HIV-related patent issues. You can reach Ethan at [email protected].
The world at long last has the knowledge needed to stop the HIV epidemic that has devastated communities around the globe over the last 30 years. But to translate that knowledge into real lives saved – in line with UNAIDS vision of zero new infections and zero new deaths – access to affordable, appropriate medicines has to be scaled up dramatically. This week, a critical step towards making that access a reality was taken when the Medicines Patent Pool signed a licensing agreement with Gilead Science. The Gilead licences should pave the way for more generic competition – and therefore lower prices – as well as more innovation on at least 5 important products. These include the existing Gilead antiretrovirals tenofovir (TDF) and emtricitibine (FTC), and products in development – cobicistat (COBI), elvitegravir (EVG) – and the Quad (a fixed-dose combination of TDF-COBI-EVG-FTC). In particular this deal will speed access to potentially more effective pipeline products COBI and EVG once they are approved for market.
Since the implementation of World Trade Organization rules on intellectual property, many developing countries, particularly those with the capacity to produce HIV treatment, have implemented patent laws for medicines. The consequence of this recent change is that unlike early HIV medicines, there are new barriers to robust generic competition for newer medicines which in the early days of the epidemic helped bring the price down from over $10,000 per person per year to less than $100 per person per year today. Patents on many recent medicines will not run out until 2020 or later.
The Medicines Patent Pool is working to overcome these new barriers to generic competition by negotiating licences with patent holders including companies, governments and universities. Unlike current industry practice, the licences the Medicines Patent Pool negotiates are public health oriented and are publicly available for all to scrutinize and assess on our web site here and here. This will ensure accountability and allow for informed input to improve on future licences.
While we are pleased with the public health friendly provisions included in the first licenses, including the protection of TRIPS flexibilities and the ability of generic companies who receive the license to supply countries that issue compulsory licenses, there are areas we would like to see improved in the licenses. Our mandate is to aim for the inclusion of all low- and middle-income countries as defined by the World Bank. However, there were a number of important countries not included in the Pool. The restriction on the sourcing of active pharmaceutical ingredient is a provision that also needs to be improved. Nonetheless, the licences cover the vast majority of patients needing treatment and we have started to change the norms and practices around transparency and the inclusion of other public health safeguards.
UNAIDS executive director Michel Sidibé has been a strong supporter of the Medicines Patent Pool and we have been grateful for the support of civil society working with UNAIDS, particularly at the recent Programme Coordinating Board. Given the important areas of overlap between UNAIDS and the Medicines Patent Pool, as well as the inclusion of the Medicines Patent Pool in the WHO HIV Strategy 2011-2015 and the UN High Level Meeting Declaration (Political Declaration on HIV/AIDS: Intensifying our Efforts to Eliminate HIV/AIDS), we hope to continue and deepen our collaboration with both UNAIDS and the civil society delegation regarding patent issues related to HIV treatment.
There are ample opportunities for civil society to engage in discussions of HIV-related patent issues including at the upcoming International AIDS Society Meeting, the ongoing deliberations of the Consultative Expert Working Group established by WHO and others. Civil society can also communicate their desire to see patent barriers brought down directly to the companies who hold patents on HIV medicines. Critical HIV medicines are held by companies such as Johnson & Johnson/Tibotec and Merck, both of which the Medicines Patent Pool would like to be in negotiations with. You can see a quarterly update of companies who are negotiating with the Medicines Patent Pool here.
We at the Medicines Patent Pool appreciate the tremendous support we’ve seen from governments and civil society across many sectors. The Pool is a voluntary mechanism so the support of civil society is welcome and needed to help create the best possible licences that benefit the greatest number of patients. Given the very concrete goal of putting 15 million people on HIV treatment by 2015 adopted at the recent UN High Level Meeting on HIV/AIDS in New York, one important part of the solution is to ensure access to appropriate and affordable treatment. The Medicines Patent Pool is working to contribute to this goal.