The
reason for Peter Pitts' overheated rhetoric in a recent River
Cities' Reader guest
commentary ("We're Taking Your Medicine, Literally," Issue 674,
March 5-11, 2008) would have been a lot clearer if he had disclosed
his multiple entanglements with the brand-name pharmaceutical
industry.
Mr. Pitts alleged that Thailand, Brazil, and other developing-country governments have stolen patented inventions from brand-name pharmaceutical companies.
What these countries have actually done is issue compulsory licenses - authorizations for generic competition, while products remain on patent - that have enabled sick people to get life-saving medicines they would otherwise be denied.
Here is what Mr. Pitts did not explain.
First, the compulsory licenses have yielded major public benefits. Compulsory licenses in Thailand lowered the price of an important HIV/AIDS drug (lopinavir plus ritonavir, brand name: Kaletra) by about three quarters, enabling the government to provide treatment to 8,000 people who would otherwise go without treatment. The generic version of a heart-disease drug (clopidogrel, brand-name: Plavix) is 1/70th the cost of the brand-name product, enabling the government to offer the drug in the public health system. Previously, it was simply unavailable.
The price reductions obtained by Thailand have benefited the rest of the world. After Thailand issued is compulsory license on Kaletra, for example, the maker of the brand-name version, Abbott, lowered its middle-income-country price from $2,200 a year per person to $1,000.
Second, Thailand and Brazil limited the scope of their compulsory licenses to the public sector. In the case of Thailand, the government specifically preserved the right of brand-name drug companies to sell high-priced, monopoly-protected medicines to the upper-income Thais who rely on private medical care.
Third, nothing was stolen. Compulsory licensing is legal under the World Trade Organization's rules governing patent protection, and under the national law of the countries that have issued compulsory licenses. Patent holders are guaranteed adequate remuneration under these rules.
Fourth, the United States issues more compulsory licenses than any other country. The U.S. government commonly issues such licenses to enable government contractors to make use of patented inventions without the permission of the patent holder. U.S. antitrust authorities commonly issue such licenses to remedy abuse of patent cases, including for pharmaceuticals, and in connection with merger approvals. In fact, a recent Supreme Court case effectively integrates a compulsory-licensing approach into the heart of U.S. patent law, making it much easier for firms or individuals to infringe a patent and simply pay a royalty for doing so.
Fifth, Mr. Pitts contends that compulsory licenses and efforts to introduce generic competition will undermine incentives for brand-name drug companies to invest in treatments and cures for diseases unique to developing countries. But as even the brand-name pharmaceutical industry itself acknowledges, this has nothing to do with patent protection: the buying power in developing countries is inadequate to justify investments for diseases unique to poorer countries.
Here's what else Mr. Pitts failed to reveal: Not only is he a former FDA associate commissioner and president of the deceptively named Center for Medicine in the Public Interest, he is senior vice president for health affairs at the public-relations firm Manning, Selvage & Lee. Manning, Selvage & Lee's clients include many of the world's largest pharmaceutical companies, including Novartis and Sanofi-Aventis, two of the companies whose products were compulsory-licensed in Thailand. The Center for Medicine in the Public Interest's board includes a principal with a pharmaceutical investment firm, and its advisory board consists in large measure of representatives of pharmaceutical-industry-funded organizations. Disclosing this information would have helped readers put his hysterical claims in context.
The one thing Mr. Pitts does get right is that the world needs more medical innovation, including but not only for diseases endemic to developing countries. The current system is doing poorly on this score. There are too few resources devoted to priority health R&D needs, from new antibiotics to new tuberculosis drugs.
Discussions are ongoing at the World Health Organization to investigate models to both spur R&D and promote access to essential medicines. One promising idea is prize funds, which would offer rich rewards for those who make important medical discoveries, while de-linking payment to innovators from the price of medicines.
We do need fair-share contributions to R&D by middle-income countries such as Thailand and Brazil (whose per-capita income is, respectively, about one-16th and one-13th that of the United States). But we can and must find ways to support R&D that do not result in the rationing of life-saving medicines in developing countries, and denial of life-saving treatment to people simply because they are poor.
There is growing interest in the U.S. Congress in searching for such win-win arrangements. Senate Resolution 241/House Resolution 525, for example, proposes a U.S. trade policy aiming to promote pharmaceutical innovation and access alike.
Robert Weissman is director of Essential Action, a public-health advocacy group based in Washington, D.C.
