11/01/2005 01:15 pm ET Updated May 25, 2011

What Bush did not Explain About Bird Flu

George Bush’s presidential address on avian flu was welcome, even if it was clearly designed to achieve some public relations purposes. But it left out any coherent explanation as to how the US will deal with the woeful state of stockpiles of antiviral drugs. And, he did not explain why the US is actually embracing trade policies that make things worse -- for the United States.

As Bush pointed out, if a pandemic hits, it will likely take several months before an effective vaccine can be made available. In the meantime, the first line of defense against avian flu will be antiviral drugs. Despite its known shortcomings, oseltamivir, sold by Roche under the brand name of Tamiflu, is the best drug we have, for now. The Infectious Diseases Society of America recommends a stockpile large enough to treat half the population. The US stockpiles today are tiny -- enough to treat only 1 to 2 percent of the population. This is far lower than many other high-income countries, many of which have stockpiles large enough for 10 to 25 percent of their populations.

And these figures are based upon the assumption that each person will only need 10 doses of Tamiflu. But the actual course of treatment may require more doses, and use to prevent rather than treat avian flu could require ten times as much.

The situation is far worse in developing countries, most of which have no stockpiles of antiviral drugs at all.

Roche cannot meet the exploding demand for Tamiflu, and it is still trying to fight off or limit efforts by generic producers in Argentina, Canada, India, Korea, Taiwan and Thailand to produce cheap copies of the drug.

However, even if these countries succeed in issuing compulsory licenses to the Roche/Gillead patents on Tamiflu, to enable generic competition for the drug, the US will still have problems importing the medicine. This is because of a little known provision in a 2003 WTO agreement on patents and medicine. The United States elected to "opt-out" of the WTO provisions that would have allowed foreign countries to export generic medicines to the US, when there is a compulsory liciense on a patent.

The US "opt-out" was extreme. It covers every conceivable case, including cases of national emergency, such as flu pandemic, an anthrax attack, SARS, or anything else. Now the Bush Administration seeks to make this policy permanent, in negotiations taking place right now, so that it can be announced a the December WTO meeting in Hong Kong. This policy, which is coordinated with the European Commission, is designed to undermine compulsory licensing, and pressure poor countries not to use this tool. But now it will prevent the US from effectively harnassing the power of the market to produce needed stockples of generic Tamiflu.

As a consequence, we will wait years before we have the stockpiles, putting our citizens at risk.
This is the letter we sent to USTR about the WTO issue, and here is an earlier story I posted in the HuffPo, which describes the key role of White House official Karl Rove in the clause that prevents the US from importing generic medicines in a time of emergency.

Of course if we really wanted to get this right, we would adapt a much different policy toward stockpiling of medicines for emergencies. This is a proposal I recently wrote for the Financial Times.

For those who care about the rest of the world, you should know that the US government is also putting pressure on countries to stop compulsory licensing of Tamiflu, making prices higher and shortages worse. US trade officials are also asking poor countries to errect very significant barriers for the registration of generic drugs, using aggressive new demands for intellectual property rights in the scientific evidence from clinical trials that drugs are safe and effective. All of this is deeply resented and fuels anti-american sentiments. The US is also opposing a global treaty on medical R&D, that would promote global cooperation in funding new treatments for infectious diseases and other global public health problems, because it wants to focus on higher intellectual property rights as the only mechanism to address innovation in new medicines.