U.S. blocks trade agreement on generic drug access in poor countries.

On December 20, international trade talks in Geneva, Switzerland failed to resolve the major remaining issue on access to generic versions of patented medicines in developing countries to meet public-health needs. All 143 other countries were ready to accept a compromise text negotiated on December 16. But the U.S. insisted on an additional restriction--to limit the agreement to AIDS, tuberculosis, malaria, and similar major epidemics. Cancer, heart disease, asthma, and hundreds of other illnesses would have been excluded. Developing countries would not accept this restriction, and European countries did not want to re-open the difficult negotiations.

All treatment activists we have heard from think that the compromise, which was reluctantly agreed to by poor countries, would have been harmful. They feared that it would create a cumbersome process, easily open to obstruction, that would rarely or never be used to help anyone obtain medicine while damaging some of the understandings in place. Some feared it could threaten or even end the historic consensus reached last year by the world's governments that trade rules should not be an obstacle to public health. Negotiations will start again in early 2003, attempting to reach agreement by February 11.

Background

Traditionally patent laws were decided separately by each nation, not by international organizations. And until about 1995, while patents on pharmaceuticals were widely recognized among rich countries, they were not uniformly binding on developing countries. But starting with the World Trade Organization (WTO) treaty in 1995, almost every country on Earth was pressured to sign on to a set of trade rules that included pharmaceutical patents. These rules established deadlines for developing countries, and required full compliance by 2006 (later extended to 2016 for least-developed countries). Patent holders can set whatever price they want, and apparently no thought was given to the fact that major corporations would regularly price life-critical new drugs totally out of reach of most of the world's people.

Current WTO rules allow a country to override a patent to meet a legitimate public need, under certain conditions, through a mechanism called compulsory licensing. But within a few years the existing rules may block export for compulsory licensing, stopping its use in any country not big enough and rich enough to have its own domestic pharmaceutical industry. The Geneva negotiations that just failed were called to deal specifically with this production-for-export problem.

In November 2001 in Doha, Qatar, all the countries in the trade negotiations agreed that WTO rules would not prevent countries from taking measures to protect public health (the United States reluctantly signed on in order to keep the negotiations moving). Developing countries were promised that the export problem would be corrected in 2002, presumably in accordance with the Doha agreement. But several rich countries--the U.S., Canada, Japan, the European Union, and Switzerland--pushed for restrictions on behalf of their pharmaceutical companies. Developing countries this month were pressured to accept these harmful restrictions. But they drew the line at caving in to the disease limitation finally demanded by the United States.

Shortly after rejecting the agreement, the U.S. said it would not bring action against certain drug exports while the talks continued. This statement was widely seen as a public-relations move unlikely to have any practical effect. For generic manufacturers must get drug approvals in each country, and deal with other time-consuming and expensive obstacles as well, before export can happen. They need stability and are unlikely to base business decisions on a unilateral statement designed to look good, but that can be taken back any time.

For more information see news reports in the Washington Post ("Talks on Low-Cost Drug for Poor Nations Stall," by Paul Bluestein, December 21), The New York Times ("Trade Talks Fail to Agree on Drugs for Poor Nations," by Elizabeth Becker, December 21), The Guardian (UK) ("U.S. Wrecks Cheap Drugs Deal," by Larry Elliott and Charlotte Denny, December 21--which reported that Vice President Cheney apparently made the decision not to accept the compromise), The Wall Street Journal ("U.S. Retreats from Earlier Move to Keep Drugs from Poor Nations," by Michael M. Phillips, December 23), or other newspapers and wire services. For a more detailed description of the negotiations see Inside U.S. Trade ("TRIPS Draft Strikes Balance on Many Issues, but Isolates U.S. on Scope," December 20).

Quotes

"We're basically talking about a system that could help save millions. If a good system isn't created, you can imagine a world a few years from now where multinational companies control the patents for everyone." (Ellen 't Hoen of Doctors Without Borders, quoted in The New York Times, December 21.)

"President Bush wants to argue that the diseases American children receive treatment for are off limits to poor children in poor countries, but they cannot win that argument." (James Love, director of the Consumer Project on Technology, quoted in The New York Times, December 21).

"You have to ask yourself, are you going to have a patent system or not? If you're going to permit people to import drugs to treat cancer, diabetes and heart disease, what are you going to do when someone says, I want Viagra on the list?" (Unnamed U.S. trade official, quoted in the Washington Post, December 21.)

Comment: Issues Needing Attention

* Pharmaceutical patents are unique in ways that need more recognition. For example, they rely on human trials where patients may risk their health or even their lives to test an experimental drug. And if the trial is successful, it cannot be repeated for another drug for the same illness, as that would involve giving people a treatment then known to be less than the standard of care. Vaccines in particular may be tested in thousands of people; once they are known to work, how could a similar vaccine ethically be tested on other thousands? In addition, patents today often claim natural substances that are part of the human body, for which there may be no biological workaround. And needless to say, medical patents are more likely than others to be life-critical.

We do not argue that pharmaceutical patents should be abolished, but that they involve, unique social responsibilities--which the multinational corporations have so far largely dismissed. If industry continues to obstruct instead of helping to build systems that work for people, it is our duty as citizens (of the United States especially) to prevent our government from being used as a tool by irresponsible corporations to bully others.

* The Geneva negotiations that failed in 2002 will continue in 2003, writing rules that may become law all over the world for years to come. In developing these rules, everyone needs to be aware that we are near the beginning of an era of unprecedented progress in medicine. So far the great advances in biological understanding have been poorly translated into practical treatments, but that will change. Imagine the consequences if penicillin and all other antibiotics had been denied to most of the world for ten to 20 years for intellectual-property reasons; then imagine this happening again and again in cancer, Alzheimer's, diabetes, and other major diseases.

* Patent or no patent, companies are not interested in regions too poor to support a lucrative market. And in the poorest countries, most people cannot pay even generic prices out of pocket. What patents do in these areas is to deprive both governments and non-governmental organizations of tools they need to reduce the burden of disease--with little or no compensating benefit to anyone. Trade negotiators, in seeking "balance" between pharmaceutical companies and poor people needing treatment, may have overlooked the extent to which the world's richest companies can litigate a molehill into a mountain.

* Patents might conceivably be made to work in poor countries, with successful drugs being licensed to international agencies for regional or worldwide use. But this possibility remains unproven so far.

* Drug patents are said to support public interest by creating incentive for innovation. This is true in rich countries, but the full truth is more interesting. Pharmaceutical corporations do pay for expensive clinical trials, but otherwise do much less science than generally believed. They are primarily marketing organizations.

* For a report on how patent misuse seriously blocks research, see "Drug Abuse: Where Have All the New Meds Gone?" in The New Republic, October 7, 2002. For example, it noted that Bristol Myers Squibb was not working on over 50 proteins that might be involved in cancer, "because the patent holders either would not allow it or were demanding unreasonable royalties." The article is currently online at: http://www.biohope.org/media/article.cfm?articleid=3054&state=na

* Another major cause of the disappointing progress in translating huge scientific advances into practical treatment progress is that medical research is mostly divided between academics interested in pure science and corporations interested in pure profit. Research also needs a middle ground. It needs top scientific teams committed to practical results, but allowed to develop anything they choose in order to advance human health, and to communicate freely about their work. Then they can look for the best opportunities anywhere in their field of competence, instead of being caged into some corporate purpose that might not have a good path forward just then--or being stuck in an academic environment where they can do basic science and publish their findings, but not develop them for human health.

We can begin reform by asking researchers what real obstacles they face, what support they need to be effective, and how the systems must be changed.

* It should be unthinkable that thousands of people die every day because they cannot afford the medicines they need--in part because of government rules made to "balance" their interests against those of a handful of huge corporations that contribute lavishly to politicians, think tanks, and other "thought leaders." We had thought there was consensus for change. But this is the Age of Abuse, and the consensus did not include Washington. Clearly millions in the U.S. alone would object if they understood, yet not one in a thousand of them has ever made their voice heard on this matter. Activists must do much better in preparing this issue so that not only specialists but also people anywhere can pick it up and run with it.