PATENTS AND MEDICINE

Pills Cost Pennies—Greed Cost Lives

Health GAP has witnessed and been a part of an enormous mobilization of attention on the impact of patent monopolies on access to affordable HIV/AIDS medicines. While prices for the first-generation of AIDS drugs have gone down for some because of generic competition and multiple sources, what is the fate of countries scrambling to cover the rising cost of treatment as people on 1st line experience treatment failure? There is a crisis in prices of second-generation antiretrovirals (ARVs), most of which are patent protection and are not available in easy to take fixed-dose combinations. The question for the international community and governments is does the movement towards patent flexibility end at first-generation drugs only?

This page will be updated regularly regarding two essential fronts: the search for affordable sources of second-generation ARVs and the ongoing battle at the WTO over the right of countries that lack production capacity to import generic versions of patented medicines.

The attack on access to affordable treatment has manifested itself in the U.S. Congress narrow approval Central American Free Trade Agreement (CAFTA). This agreement severely limits the ability of generic companies to maintain their important role in manufacturing and distributing essential medicines to the hundreds of thousands of individuals with HIV in the region. The provisions of CAFTA which grant data exclusivity to pharmaceutical corporations, limitations on compulsory licensing rights, and extensions on patent protections illustrate the vision USTR has for negotiating Doha rights away from its trading partners. For information on some of the US negotiated free trade agreements, including FTAA, CAFTA, and SACU, and their impact on access to medicines, go to our FTA campaign page.

At the WTO, despite having made a promise at the 4th WTO Ministerial Conference in Doha, Qatar, to uphold the right of countries to protect public health and promote access to medicines for all, the United States Trade Representative (USTR)—with the support of the pharmaceutical industry—continues to push disastrous "solutions" to the problems developing countries face in making use of provisions in the TRIPS Agreement that allow for the production and export of affordable essential medicines. At the WTO, the U.S. negotiating position is so narrow and so restrictive as to be worse than having no solution at all.

And some countries who have been at the forefront of producing drugs for their own population or for sale abroad are now struggling to continue treatment or producing medicines critically needed around the world&3151;second-generation ARVs. Brazil is receiving animosity from the U.S. as it works to negotiate a lower price for key medicines in its national treatment program. In India, the parliment adopted amendments to its Patent Act which could threaten the generic production and export from which has sustained the affordability of many treatment programs around the globe. India and Brazil&3151;as well as other countries&3151; must make full use of the flexibilities in the Doha Declaration such as compulsory licensing and fend off attempts by the US government and their corporate backers to undermine efforts to provide life-saving treatment are only exacerbating the spread of the AIDS pandemic.

BRAZIL AND THE CRISIS OF SECOND-GENERATION ARV PRICES

On March 15 2005, Brazil announced its intent to issue compulsory licenses for four high-priced, patented AIDS medicines if drug companies did not negotiate voluntary licensing agreements. Currently 70% of the budget of the Aids National Programme's for ARVs is spent on the purchase of four patented drugs, Abbott's Lopinavir/Ritonavir, Gilead's Tenofovir, Merck's Efavirenz and Boeringer Ingleheim's Nelfinavir. Brazilian public and private companies are only producing 7 out of 16 drugs that are used in the tri-therapy while there is capacity to produce all of the needed medicines.

• July 15, 2005 Health GAP letter to the Secretary of State of Brazil regarding the country the need for an issuance of a compulsory license for production of generic lopinavir/ritonavir (Kaletra) as well as other medicines whose high prices are threatening the sustainability of the Brazilian National AIDS Program. Download pdf of letter

• JUNE 24, 2005 Health GAP statement on Brazil's authorization of a compulsory license of Kaletra, putting the government one step toward's breaking the Abbot's patent monopoly. Press release | Download Word doc

• May 13, 2005 (Manhattan and Washington, DC) AIDS activists from Health GAP, Student Global AIDS Campaign, ACT UP New York, and Global AIDS Alliance urge Brazil to issue compulsory licenses on expensive patented antiretrovirals. Protestors deliver "spine" and memorandum to Brazil Mission to the UN in New York and to Embassy in Washington, DC. Press Release | Download press release | Civil society memorandum to the government of Brazil: Word | download Portugese

• July 14, 2005 Timeline of events and leading news accounts regarding Brazil's crisis with prices of second line ARV drugs. Download timeline (.doc)

• September 19, 2005 "India's 2005 Patent Act: Death by Patent or Universal Access to Second- and Future-Generation AIDS Medications," by Brook Baker. Background Paper

• ACTION ALERT FOR MARCH 2005: Fax and Email Indian Government & Urge It Preserve Access to Generic AIDS Medicines. India Could Cut-off Africa's Access to Affordable AIDS Drugs; Indian Parliament May Begin Considering the Issue March 9. Go to Action Alert

• February 1, 2005 Health GAP fact sheet addresses the lies and myths on the "The Impact of India's Amended Patents Act on Access to Affordable HIV Treatment":
  • Myth: "The fear that prices of medicines will spiral is unfounded....We must realize the fact that 97% of all drugs manufactured in India are off-patent, and so will remain unaffected."
  • Myth: India's Patents Act amendments are an unavoidable consequence of India's obligations to protect product patents on medicines.
  • Myth: Patent protection in will stimulate investment into R&D that will benefit Indian consumers and will reward India with increased foreign investment.
  Download Fact Sheet

• January 13, 2005 (Mumbai, India) Health GAP, the Affordable Medicines and Treatment Campaign (AMTC) based in India, and a coalition of international activists hold a press conference to call on the Indian Government to repeal the patent law that introduced product patent protection on medicines through an Ordinance. One of the activists stated: "India should be proud to be producing and exporting cheap, generic AIDS drugs for people in need. The changes to the patent law will increase the price of new drugs, as well as some AIDS medicines that are already produced and exported in generic form..." Press Release

• December 12-15, 2004 India is in the process of amending its national patent law (the Patents Act) to come into compliance with World Trade Organization (WTO) rules by January 1 2005. According to Health GAP, India is considering changes to its Patents Act that will block regular production of affordable generic versions of drugs to treat HIV, cancer, and other public health problems.
  • Health GAP and Médecins Sans Frontières host a teleconference for journalists: "Poor Countries' Source of Affordable Indian Generic AIDS Drugs to Disappear--Rising Drug Prices in India will Undermine HIV Treatment Scale-Up Efforts," December 15, 2004. Teleconference transcript: Read transcript online | Download Word | Download PDF | Press Advisory.
  • Health GAP Fact Sheet: Changes to India's Patents Act and Access to Affordable Generic Medicines after January 1, 2005. Download Fact Sheet: PDF file | Word doc
  • International sign-on letter of concern to Prime Minister Manmohan Singh of India regarding the government's proposed amendments to the Patents Act and undermining medicines access for people in need—in India and around the world, December 16, 2004. PDF file
  • On Monday Dec. 13, 1:00 PM, Activists demonstrate at the Indian Embassy in Washington, DC. Health GAP Press Release and Demo photos .

What's at stake with current negotiations over access to medicines at the WTO?

In November, 2001, WTO countries signed an agreement, called the Doha Declaration on TRIPS and Public Health, that affirmed countries' rights to override drug company patent rights in the interest of public health and access to medicines for all.

Now the United States is trying to undermine this Declaration, and developing countries are under enormous pressure to accept a bad deal from the United States on a key issue that the WTO left unresolved.

That issue is, how are poor countries in need of affordable, essential generic medicines going to be able to get access to them?

Most poor countries don't have the capacity right now for local production of generic versions of all the medicines they might need. Because they have small pharmaceutical markets, it's not possible for them to reach the scale of production that would result in the deepest price cuts possible.

But in order to get the price cuts from generic competition that come with "compulsory licensing" of medicines--manufacturing a generic version of a patented product without the permission of the patent holder--WTO rules require countries to produce and consume medicines domestically.

But countries that can't make generic medicines domestically need to get the medicines from somewhere.

Getting around this problem--the inability of countries to export generic versions of patented medicines to countries that can't produce them on their own--is a matter that WTO Members were fighting over all last year. It was a matter that the historic WTO declaration on TRIPS and Public Health, signed in Doha in November 2001, directed the WTO to settle.

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What role does the US play in all this?

But there was no agreement last year, and there is still no agreement. That is because the United States, acting on behalf of U.S.-based drug companies, insisted that any solution be limited to medicines for a random list of diseases. Developing countries rejected this so-called "solution" from the United States.

The Doha Declaration is not limited to a pre-set list of diseases. Therefore many countries rightly saw the U.S. position as putting new restrictions on poor countries' rights to get access to generic drugs. Developing countries blocked the U.S. proposal, but the U.S. refused to budge.

George Bush endorsed generic AIDS drugs access in his State of the Union Address on January 28, 2003. It is contradictory for the U.S. to support access to affordable medicines for some diseases and not for others. Poor countries have the right to decide on their own what the public health needs of their countries are.

But there were other problems with the deal that was on the table at the WTO last year. This deal also would have disqualified many needy countries from using the solution, simply because they were not poor enough.

Also, instead of being easy and quick to use, the deal would have been so complicated to put into practice, countries would have found it impossible to actually use the so-called "solution."

Finally, the deal would not have covered vaccines and diagnostic tests, even though these are critical public health tools poor people need greater access to.

These and other problems should be corrected in the final agreement--or else the agreement will most likely do more harm than good.

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For more information and background

There are a lot of resources on the internet about this issue, including examples of letters that advocates have sent to their trade negotiators, the positions of WTO Member countries, and contact people who can provide you with more detailed information.

http://www.cptech.org/ip/wto/p6/
http://www.accessmed-msf.org/

Statements and Papers

• February 10, 2005 Health GAP responds to USTR fact sheet on the Central American Free Trade Agreement and access to medicines by issuing a "Myths and Realities" briefing paper focusing on U.S. pressure on Guatemala regarding the government's efforts to protect access to clinical data necessary for entry of affordable generic drugs to enter the market. Read briefing paper online | Download Word doc | Download Spanish version

• An Analysis and Response to WTO Action Regarding Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, by Brook Baker for the United Nations Millennium Development Goals (MDGs) Project, Task Force 5: Infectious Diseases and Access to Essential Medicines, Sub-Group Access to Essential Medicines, January, 27, 2005. Issue Paper | Download Word doc

Arthritic Flexibilities for Accessing Medicines: Analysis of WTO Action Regarding Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, Brook Baker of Health GAP, December 16, 2004. Download Word doc

• TRIPS, public health and medicines access: what happened at DohaÉ and why? Asia Russell, June 10, 2004. Download Slide presentation

• USTR's 2004 Special 301 Report Highlights the U.S. Global Ambition to Use Heightened Protection of Innovators' Drug Registration Data to Block and Delay Registration of Competing Generic Drugs, Brook Baker, May 4, 2004. Download Word doc

• Intellectual Property Rights & Access to Medicines: An Update on TRIPS and the Free Trade Area of the Americas (FTAA), Asia Russell, Playa Blanca, Panama, 17 NOVEMBER 2003. Download Slide presentation

• October 23, 2003 (Manhattan) Health GAP reacts to Clinton Foundation announcement generic AIDS drugs deal: $150 a Year. Press Releases

• October 19, 2003 (Bangkok) Health GAP and Thai Network of People Living with HIV/AIDS (TNP+) warn against restrictive bilateral trade agreement with the U.S. which jeopardizes access to affordable generic medicines in Thailand. Press Releases

• October 17, 2003 Canada efforts at reforming patent legislation to allow for export of generic drugs to poor countries is jeopardized. Health GAP suspects backroom pressure from USTR and drug companies, as Canada considers unnecessarily restricting the range of generic drugs to be exported to poor countries. Press Releases

• October 17, 2003 South African Competition Commission announces stunning victory for access to cheaper drugs, holds GlaxoSmithKline and Boehringer Ingelheim responsible for excessive pricing and other anti-competitive practices. Press Releases

• September 15, 2003 (Cancun) Health GAP on the end of the Cancun Ministerial: WTO talks collapse, but poor countries still have to contend with a flawed deal on generic medicines access. Press Statement

• September 11, 2003 (Cancun) Health GAP and ACT UP Paris on WTO's "solution" on cheap generic medicines posing new barriers to access. Press Statement

• September 13, 2003 (Cancun) Health GAP on WTO medicines deal: Lamy and Zoellick clash over terms of new WTO medicines deal. Press Statement

• September 10, 2003 (Cancun) Joint NGO Statement on TRIPS and Public Health: WTO deal on medicines--a gift bound in red tape. Press Statement

• August 28, 2003 Health GAP warns that the Bush Administration, Big Pharma about to secure disastrous "solution" on access to medicines at the WTO. In effort to boost failing pre-Cancun talks, countries are poised for sell-out on public health. Press Statement

• Health GAP on WTO medicines negotiations: "Doha Redux - U.S. Enters New Phase Of Bad Faith Bargaining," Brook Baker of Health GAP, 3 July 03. Read Online | Download: PDF file

• July 2, 2003 Joint NGO letter to Bush calling for exclusion of intellectual property from negotiations over a U.S.- Southern African Customs Union (SACU) Free Trade Agreement. Read the letter

• Health GAP on the new WTO deal on medicines and the right to export medicines: "Clarifying Questions about Coverage," Brook Baker of Health GAP, 27 September 03. Read Online

• Health GAP on WTO medicines negotiations and the right to export medicines: "The incredible shrinking Doha Declaration," Brook Baker of Health GAP, 26 August 03. Read Online

• Health GAP on WTO medicines negotiations and the right to export medicines: "Vows of Poverty, Shrunken Markets, Burdensome Manufacturing and Other Nonsense at the WTO," Brook Baker of Health GAP, 27 September 03. Read Online

• Health GAP on WTO medicines negotiations: "Doha Redux - U.S. Enters New Phase Of Bad Faith Bargaining," Brook Baker of Health GAP, 3 July 03. Read Online | Download: PDF file

• AIDS activism, globalization, and the struggle for global treatment access, Asia Russell, April 1, 2003. Download Slide presentation

• Scaling-up antiretroviral treatment and financing the fight against global AIDS: IPRs, access to medicines and public health. Health GAP Briefing Paper for the 56th World Health Assembly, May 19, 2003. Read Online ," . Read online | Download Word doc

• Health GAP comments submitted to the office of the USTR on the second draft text of the FTAA , 28 February 2003.Read Online | Download Word Doc

Global AIDS and Pharmaceutical Apartheid, Brook Baker, February 26, 2003. Download slide presenation

• FOUR BIG LIES POST-DOHA Health GAP, 23 December 02. Read Online

• U.S. Moratorium a Cruel Hoax Health GAP, 23 December 02. Read Online

• December 20, 2002 Thanks to U.S. bullying, no deal this year on access to medicines at the WTO Poor countries prevent U.S. re-write of Doha agreement on public health. U.S. trade negotiators have left WTO empty handed on the issue of exported versions of affordable generic medicines, despite stubborn efforts by Bush Administration officials to push through a deal Health GAP called friendly to U.S. pharmaceutical companies, but worse for poor countries than no deal at all. Press Statement

• December 16, 2002 Letter to the United States Trade Representative (USTR) on problems developing countries face in making use of provisions in the TRIPS Agreement that allow for the production and export of affordable essential medicines. Press Statement

• Phrma's Relentless Drive for Profits Explains U.S. Trade Negotiations. Health GAP, 10 December 02. Read Online

• November 14, 2002 Health GAP on Doha Plus One: Bush Administration poised to break promises on patents and access to medicines at WTO 'mini-Ministerial' At the start of the WTO's informal Ministerial meeting in Sydney, AIDS activists called on US Trade Representative Robert Zoellick to stop undermining the agreement reached in Doha to widen poor countries' access to cheap, generic medicines. Press Statement

• U.S. Breaks Promises and Undermines WTO Public Health Accord While AIDS Deaths Mount, by Health GAP, 13 November 2002. Read online | Download Word doc

• Barriers to generic drug entryin developing countries, Asia Russell, TACD Committee on Intellectual Property Meeting on the Impact of Intellectual Property Rules on Consumers of Health Care Services, October 31-November 1, 2002. Download Slide presentation

• Rules for the Export of Health Care Technologies with the Permission of Patent Owners: Chart on the Status of Major Doha Proposals by Brook K. Baker, Health GAP, October 31, 2002. Download to Word doc

• The Impact of Intellectual Property Rules on Consumers of Health Care Services, Health GAP Fact Sheet, 31 October 2002. Read Online

• Victory and Betrayal: The Third World Takes on the Rich Countries in the Struggle for Access to Medicines by Asia Russell, Health GAP, June 02. Read Online

• US TRIPS Council Proposal: Pharma First, Strict Conditionalities, Indistinct Waivers, Compulsory Licenses, and Procedural Death Queues by Brook K. Baker, Health GAP, October 31, 2002. Download Word doc | Read Online

• Joint letter from Consumer Project on Technology, Essential Action, Medicines Sans Frontieres, Oxfam International, Health GAP Coalition, and the Third World Network to the World Trade Organization's TRIPS Council, 28 January 2002. Go to letter
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Background Information

Every year 15 million people die from infectious diseases. 40 million people live with HIV/AIDS and the numbers are mounting. Most live in developing countries, many are children, and women are often worse hit. Much of this illness and death could be prevented if poor people had access to affordable medicines. But currently, one third of the world's population does not have regular access to affordable medicines, and only a tiny percentage have access to HIV/AIDS medicines.

Over the last few years controversy has raged over the way in which WTO patent rules, by raising prices, prevent millions of poor people from being able to afford life saving drugs. Developing countries and activist groups around the world have demanded that the WTO puts public health before private patent rights.

The countries where drug companies maintain the biggest, richest markets, and the most intellectual property protection, are the same countries whose governments put up the hardest fight when people with AIDS in poor countries demand access to medicines and sane patent rules. These are: the United States, the European Commission, Switzerland, and Japan.

But intense pressure brought a great result: in November 2001 at the fourth WTO Ministerial meeting at Doha, Qatar, Ministers declared that WTO patent rules should not prevent WTO member countries from taking measures to protect public health or promoting access to medicines for all.

Ministers also agreed to revise a dangerous anomaly in the WTO patent rules. This anomaly allows developing countries to import cheaper generic medicines, but restricts producer countries from exporting them. This restriction limits poor people's access to affordable medicines, and denies generic industries the export markets they need to produce on a scale that would assure the lowest possible price. Unfortunately, rich countries and the multinational drug companies are trying to water down and limit possible solutions to this problem.

Time is running out

The US, the EC, and all the rich Members of the WTO must for forced to honor the commitments they made at Doha and agree to lift WTO restrictions on exports of cheaper generic medicines.

Robert B. Zoellick
U.S. Trade Representative
600 17th Street NW
Washington D.C. 20508
email: rzoellick@ustr.gov
Telephone: +1 202.395.4510


Pascal Lamy
Trade Commissioner
European Commission
Rue de la Loi 200
Brussels
Belgium
commissaire-lamy@cec.eu.int