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.

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written by Nonoy Oplas, Philippines, March 24, 2008

Assume there are 100 different medicines to cure AIDS. About 1/4 of them can cure AIDS in 7 to 10 years; another 1/4 can cure eradicate the disease in 5 to 6 years; another 1/4 can do the job in 3 to 4 years; another 1/4 can control the disease in 1 to 2 years. But among the "top 25" medicines, about half are effective but have some adverse side-effects to people who have other diseases (diabetic, have hypertension, etc.) and the other half are plain effective.

Which of those medicines will be issued compulsory license (CL) by governments? The bottom 3/4, even if they are cheap and can also fight the disease? Not a bit. It's those in the top 10 or 15 most effective medicines, which are also among the most expensive. And this tells us one thing: the selective application of CL is driven by envy, by the simple desire for more government intervention.

Huge investments by innovator companies don't matter. What matters is to spot who among those innovator companies have the most effective medicines, then disrespect their patent and intellectual property rights, copy the effective medicines for use by government corporations or selected (if not crony) generics manufacturers who spent very small, if ever, in expensive R&D. Then the state that issued the CL is now a "hero" and the innovator companies who invented the effective drugs are now the "villains". Wow, great deal!

This is the business environment that Mr. Weissman and his fellow activists want to be propagated.

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“Limited Compulsory Licensing as an Solution to Patented Green Technologies”
written by Jeong Chun Phuoc, November 02, 2009

“Limited Compulsory Licensing as an Solution to Patented Green Technologies”


The article “Hot Debate Over Technology Issues” by Martin Khor (The Star newspaper, Malaysia--26th Oct 2009 at page N43) raised a crucial discussion concerning the issue of patented green/climate-friendly technologies.



Several notable leaders have raised pertinent concerns over the barriers posed by patented green technologies which should not be subjected to criticism in the first place because the whole objective of the patent system is to provide incentive towards wealth & knowledge creation in the area of sciences & technologies as guaranteed under the TRIPS Agreement i.e. Trade-Related Aspects of Intellectual Property Rights.



The proposal that patented green technologies be exempted from patent protection is tempting but legally destructive in the long-term period as this run counter to private R&D market demand which calls for strict adherence to full patent protection granted under the respective national patent law.



Further proposal that such patented green technologies be considered as ‘global public goods’(GPGs) is also an anti-thesis to the objectives of a global patent system even for green technology. If accepted at all, the other equally problematic issue is in identifying what constitutes GPGs taking into view the fact that there is currently no global consensus pertaining to the characterization and scope of such GPGs even within developed bloc.



Another issue raised by proponents for relaxation of patented green technologies is the possible use of Compulsory Licensing(CL) under the patent law in the respective country by the government. If this issue is raised at the upcoming Copenhagen Conference (Dec 2009), which is highly possible, the counter-argument is that such patented GPGs can only be acquired by the government if it can proved that the patented GPGs in question has not been made available to the public at a fair price and that there is a national emergency that necessitate such compulsory acquisition, which is an onerous burden indeed notwithstanding such allowance under national patent law.


Although limited compulsory licensing is possible, it is not to be considered as an effective solution at all due to equal legal protection granted to patent rights holder during the CL period.



These are amongst the contentious issues that must be resolved if there is to be any real progress towards a more sustainable agreement in carbon reduction and global climate salvation.





……………………………..
Jeong Chun Phuoc*
Lecturer-in-Law
This e-mail address is being protected from spambots. You need JavaScript enabled to view it

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