Are Patents for PrEP Coming at the Expense of Public Health?

by Greg Tartaglione, Sr. Communications Officer

It is critical that pharmaceutical companies commit first to meet the needs of financially under-privileged communities in the fight against HIV.

With recent advances in technology for anti-retroviral therapies (ART) and pre-exposure prophylactics (PrEP), the field of medicine has become fraught with investors trying to turn a profit at the cost of communities that may not be able to afford essential life saving medicines for diseases such as HIV and hepatitis.

MSMGF Board Co-Chair and International Treatment Preparedness Coalition (ITPC) Intellectual Property and Access to Medicines Lead Othman Mellouk recently spoke out against U.S.-based Gilead Sciences at the closing of the International AIDS Conference in Paris this July. As the patent holder of tenofovir/emtricitabine, often known under its brand name Truvada, Gilead has held a monopoly on advances in PrEP in several countries.

According to Mellouk, “For the gay community and other key populations, too, [the use of tenofovir/emtricitabine as PrEP] is a life-saving development. For Gilead, it was an opportunity to file additional, evergreening patents and exploit our communities.”

Mellouk criticized the company for using its sponsorship of the event as an opportunity to bolster its public relations, while in actuality “its pricing practices and patenting policy leave millions of people out of access to lifesaving treatment” for diseases like Hepatitis C with the drug sofosbuvir (Gilead brand named Sovaldi).

The Make Medicines Affordable campaign brings together several organizations from middle-income countries under the lead of ITPC, which aims to fasten market entry of affordable generic medicines and bring down the price of antiretroviral drugs to increase treatment access for people living with HIV. By bringing attention to the pharmaceutical phenomenon of “evergreening” (as defined in the video below) the campaign works to challenge companies’ attempts to protect patents at the expense of public health:

According to the campaign, because of patent monopolies, many governments are paying more than $3,000 USD per patient per year for essential antiretroviral drugs – a cost that they have to cover with little support from international donors. Because of this insurmountable cost, many people in middle-income countries are not receiving HIV treatment they need. In middle-income countries, gay men are 19 times more likely to be living with HIV than the general population, and homophobia and discriminatory laws pose formidable barriers to accessing treatment. This means that gay men are undoubtedly disproportionately affected by patents that will limit availability and cap ART access to people living with HIV.

Earlier this year, the U.S. Federal Drug Administration (FDA) approved generic tenofovir/emtricitabine for HIV treatment and PrEP given the close expiration of the original patent on the drug, but Gilead genuinely sought a patent term extension that could put off this change in access to the drug until the year 2021 or later. The company insisted in a public statement that “A generic version of Truvada will not be immediately available. It’s important to note that there are several factors involved in commercialization that are not tied directly to FDA approval” including patent laws and other factors.

In May of this year, activists in Argentina successfully challenged and halted an attempt by Gilead to patent Truvada in the country. The patent application did not meet legal and regulatory requirements, and would have caused the unsustainable investment in Truvada in Argentina to continue. ARVs tend to be patented more frequently in middle-income countries, and many of these countries cannot afford patented life-saving medicines.

Mellouk’s impassioned speech was welcomed and applauded by attendees of the event, and he concluded with demands for Gilead Sciences to address this systemic issue:

“Drop your prices and stop excluding people from middle-income countries from accessing lifesaving drugs.

Stop blocking local manufacturing and registration of generics of sofosbuvir and tenofovir/emtricitabine.

We urge you to respect the initial duration of the patent expiring now. Stop pressuring patent offices worldwide to obtain abusive patents.”

Read Mellouk’s full speech from the IAS closing session here

For more resources on this topic:

UNDP. 2014. Using Competition Law to Promote Access to Health Technologies:  A Guidebook for Low- and Middle-Income Countries. 

UNAIDS, WHO, UNDP. 2011. Using TRIPS Flexibilities to Improve Access to Treatment:  Policy Brief

UNDP. 2010. Good Practice Guide:  Improving Access to Treatment by Utilizing Public Health Flexibilities in the WTO TRIPS Agreement

Global Commision on HIV and the Law. 2012. HIV and the Law: Risks, Rights & Health

About MSMGF:
MSMGF is an expanding network of advocates and other experts in sexual health, LGBT/human rights, research, and policy, working to ensure an effective response to HIV among gay men and other men who have sex with men. We are directly linked with more than 120 community-based organizations, across 62 countries.