Trade & Access to Medicines

Universal access to safe and affordable medicines is a key step toward global health equity. In solidarity with allies in low and middle-income countries, Health GAP campaigns for increased access to medicines, particularly antiretroviral therapy for individuals living with HIV, by exposing corporate interests and opposing harmful trade agreements.

THE ISSUE

After ten years of progress in expansion of affordable medicines, even during the Bush Administration, which was generally hostile to the interests of health consumers, we are now facing renewed and dangerous assaults on access to medicines. In key countries Free Trade Agreements could eliminate the flexibilities in enforcement of intellectual property rights (IPRs) agreed to as a result of worldwide pressure on the most powerful WTO member states at the 2001 WTO meeting in Doha, Qatar. Public pressure in 1999 also extracted an Executive Order from President Clinton on trade and access to medicines in sub Saharan Africa, which was upheld by President Bush. 

This hard-fought consensus promised countries could implement TRIPS in a manner consistent with promoting public health and access to medicines for all—using flexibilities such as compulsory licensing, narrow scope of patentability, and alternatives to data exclusivity.  Subsequent bilateral trade deals undermined this agreement, such as the DR-CAFTA. But many of the most egregious attempts in Asia (e.g. the US-Thailand Free Trade Agreement) and Africa (e.g. the US-Southern African Customs Union agreement), as well as the Free Trade Area of the Americas, have been fought off.


THE REALITY TODAY

Generic production of essential medicines has flourished in key producing countries for both domestic use and exportation. Production in India, especially, has been the driver for the scale up of access to AIDS treatment, malaria drugs, and spread affordable medicines throughout the world. The PEPFAR program, for example, is projected to save over $300 million this year by purchasing mostly India-based generics. India’s 2005 WTO-required patent law changes created serious concerns regarding production of generic versions of newer medicines. However, a range of safeguards demanded by civil society, including a narrow patentability (described under section 3d of the Patent Act) and resistance to non-patent IPR barriers such as data exclusivity have preserved important protections. Yet reliance on Indian generics has created an opening for PhARMA to try to turn off this tap of competition and foreclose other countries’ progress through:

    1. Direct efforts to change Indian laws to enact data exclusivity, eliminate Section 3d, etc.  The India-EU FTA should be understood in this context as a continued assault on production of affordable Indian generics;  
    2. In a striking tactic, originator companies are outright purchasing India’s generic industry leaders. Matrix, Ranbaxy, Aurobindo, and others have been bought by US & European companies— paying up to 9 times their valuations to bring some of the biggest generic voices under big PhARMA control.
    3. Working to ensure that other countries with emerging generic production capacity are prevented from following India’s model by FTAs, which set draconian new regional IP rules that foreclose the exact flexibilities that have allowed Indian generic production.
The renewed vigor and effectiveness of three-pronged effort has created a real challenge for civil society and there is a strong need to involve a greater number of groups in the advocacy. Simply fending off a harmful FTA in India is not enough to guarantee continued flow of generic medicines. We will prioritize ensuring that efforts to implement anti-access IPR policies in emerging countries with generic capacity fail. 

THE TRANS-PACIFIC PARTNERSHIP (TPP) 

"The U.S. will be engaging with the Trans-Pacific Partnership countries with the goal of shaping a larger regional agreement that will have broad-based membership and the high standards worthy of a 21st century trade agreement." -President Obama

The TPP—currently incorporating Vietnam, Malaysia, Peru, along with several higher income countries—will be a key battleground in the coming year.  The US/Pharma proposals are actively seeking to set a new paradigm in IP enforcement.  With the stated intention to follow negotiation of the TPP with expansion to other APEC countries such as Thailand, the quiet agreement has grown into a real threat. The proposals currently tabled and/or under discussion dramatically exceed the already TRIPS-plus standards of previous texts—including expected demands, such as data exclusivity and patent linkage, but also new provisions designed to prevent countries from adopting narrow patentability standards similar to India’s model 3d text. The scope of patentability provisions especially would end up requiring the countries involved to grant patents rejected by India—and at times even by Europe.

The TPP also provides an important opportunity. Vietnam is especially important as it has a nascent generics industry. With Vietnam being among the 15 PEPFAR focus countries, we have an opportunity to highlight the impact of TRIPS-plus IPR rules on US-financed AIDS efforts, at the same time “efficiency” in program implementation is the most common US government talking point on development assistance. The US PEPFAR strategy specifically calls for Vietnam to become increasingly self-sufficient in its procurement and purchase of ARVs—which will be nearly impossible under key elements of the proposed TPP.


COMMUNITY ORGANIZING 

Health GAP, in solidarity with Public Citizen's Access to Medicines Campaign and KEI, are partnering to expose the Trans-Pacific Partnership's (TPP) dangerous provisions that limit access to medicines. Health GAP is also working with grassroots AIDS activists and students around the United States to provide pressure on Congress to reject the TPP. to elected officials who determine the funding amounts from the U.S. for both PEPFAR and the Global Fund. To get involved in Health GAP's TPP & Access to Medicine campaign, please visit our Stay Connected page, or contact the Health GAP staff working on the TPP campaign:  

Hilary McQuie ([email protected]) Washington, DC
Emily Sanderson ([email protected]) New York, NY


DOWNLOAD & PRINT OUR TPP LOBBYING KIT

  1. TPP Endangers Global Access to Medicine (Health GAP leave-behind), May 2016
  2. Sign on letter from SGAC, Health GAP and other Public Health groups calling for Congress to reject TPP, April 2016 
  3. Trading Away Health, Médecins Sans Frontières Access Campaign’s excellent TPP briefing note, August 2016
  4. The Trans-Pacific Partnership: A Deal That Will Make America Sick, Cancer Families for Affordable Medicine leave-behind, September 2016
  5. The High Health Costs of TPP’s "Free Trade", Op-ed by Nobel Prize winning economist Joseph Stiglitz, June 2016
  6. EpiPen and the Trans-Pacific Partnership, Op-ed by renowned economist Dean Baker, September 2016

 


 HEALTH GAP'S POLICY ANALYSIS 

 


 

HEALTH GAP IN THE MEDIA 

Health GAP's Brook Baker in STAT News: Pharma industry ‘getting away with murder’ abroad thanks to Trump’s policies | August 21, 2017

 

Health GAP's Brook Baker says an important new antiretroviral medicine, dolutegravir (DTG), will soon be available via generic competition in all low- and lower-middle-income countries, and a significant number of upper-middle-income countries as well. | May 24, 2017

Health GAP's Brook Baker pens a guest blog in Madhyam: Eli Lilly’s ISDS Patent Claim against Canada Defeated | April 6, 2017

 

In May 2016, Health GAP joined KEI, Oxfam, and Public Citizen in writing a Letter to Senator Orrin Hatch challenging congressional and USTR threats against Colombia.

Does Colombia really have to choose between peace and public health? | Oxfam America | May 26, 2016
Dear Senator: Do you really want cancer drugs to be super-expensive? | Huffington Post | May 19, 2016 

 

In April 2016, Health GAP joined over 50 public health groups to call on Congress to reject the Trans-Pacific Partnership, the trade agreement between the United States and 11 other Pacific Rim nations because it would limit access to affordable medicines worldwide by extending the monopolies of pharmaceutical corporations, keeping drug prices high and precluding the production of generics.

Public health groups call for Congress to reject TPP | The Hill | Apr. 12, 2016

 

Health GAP, Médecins Sans Frontières (MSF)/Doctors Without Borders, and UNITAID have called on the Global Fund to use its influence to promote the use of generic competition, and to supplement those efforts by leveraging its purchasing power to lower the price of medicines by negotiating voluntary licenses for key commodities and expanding access to generics to low- and middle-income countries. 

  • Amicus Curiae Re: Eli Lilly and Company v. The Gov't of Canada | Submission | Petition | Feb. 12, 2016

  • Find more of our trade & medicine work in the archives.


CONTACT FOR MORE INFORMATION

Asia Russell ([email protected])
Brook Baker ([email protected])
Hilary McQuie ([email protected])
Matthew Kavanagh ([email protected])