tisiwoota

Since I haven’t seen this reported in MSM, thought I would pass along this news from CPTech’s IP-health listserv (from AsiaTimes):

It seems that director general Lee Jong-wook (who died suddenly last month of a cerebral hemorrhage) bowed to US pressure this past March by removing William Addis from his post as WHO’s country representative to Thailand, because he had written editorials highlighting the damaging consequences of Thailand signing an FTA with the US.

Aldis had made the mistake of penning a critical opinion piece in the Bangkok Post newspaper in February that argued in consonance with WHO positions that Thailand should carefully consider before surrendering its sovereign right to produce or import generic life- saving medicines as allowed by the World Trade Organization (WTO) in exchange for a bilateral free-trade agreement (FTA) with the United States, which is currently under negotiation.

Notice that it was “in consonance with WHO positions”– apparently when the US is concerned, it’s dangerous to publicly espouse the official opinions of your own institution!

This comes after a previous scandal, in which an early draft of WHO’s special report on intellectual property rights and public health was apparently leaked to pharmaceutical industry reps for vetting (“[I]n autumn 2005, comments from a pharmaceutical industry representative appeared in the text of a portion of the draft report. . . . In an electronic version of draft report text, the tracking record revealed that comments were made directly into the text by Eric Noehrenberg, a lobbyist with the International Federation of Pharmaceutical Manufacturers and Associations in Geneva.”).

More on the Aldis removal:

The WHO official also wrote that the stricter intellectual-property protection measures in the proposed US-Thai FTA would inevitably lead to higher drug prices and thereby jeopardize the lives of “hundreds of thousands” of Thai citizens who now depend on access to locally produced cheap medicines to survive. He noted too that the Thai government’s current production of generic treatments had allowed the country to reduce AIDS-related deaths by a whopping 79%.

(more…)

CNN Headline: Poor countries win rules extension

This week the World Trade Organization (WTO) agreed to extend the deadline for least-developed countries to update their intellectual property laws to meet the standards of the TRIPS agreement until 2013. (All member nations of the WTO are signatories to the agreement, but deadlines for compliance were staggered according to level of development. The original deadline for LDCs was January 1, 2006).

This is good news– but only for those countries which have not yet updated their laws, since the WTO decision reportedly states:

Least-developed country Members will ensure that any changes in their laws, regulations and practice made during the additional transitional period do not result in a lesser degree of consistency with the provisions of the TRIPS Agreement.

…In other words, no backtracking. Those countries which have enacted stricter regulations will have to enforce them– regardless of the adverse affects this may have on access to medicines, and other related issues.

It’s been a while since I’ve posted anything IP-related. Bloomberg has just reported that the Andean nations are putting up resistance to US-trade talks, and demanding protection for traditional medicines.

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“It’s the law of unintended consequences,'’ said Michael Gollin, founder of Public Interest Intellectual Property Advisors in Washington, which provides free legal counsel to poor countries in patent disputes. For years the U.S. has pushed these nations to strengthen their patent rules, he said, “and now the countries are learning to use these to their own advantage.'’

The Andean nations want “minor'’ protections for their native plants and the ways they are used, such as a rule requiring companies to inform indigenous tribes of any patent applications based on traditional knowledge and negotiate payment, according to Carlos Correa, a Buenos Aires-based consultant to those nations.
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The Andean nations have long been leaders in addressing biopiracy, and five years ago enacted a joint decision on IP issues which addressed “Biological and Genetic Heritage and Traditional Knowledge”:

Decision 486
Article 3.- The Member Countries shall ensure that the protection granted to intellectual property elements shall be accorded while safeguarding and respecting their biological and genetic heritage, together with the traditional knowledge of their indigenous, African American, or local communities. As a result, the granting of patents on inventions that have been developed on the basis of material obtained from that heritage or that knowledge shall be subordinated to the acquisition of that material in accordance with international, Andean Community, and national law.

The trade talks with the US, of course, go far beyond traditional medicine issues.

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In an illustration of how passionate the issue has become, Colombia’s intellectual-property negotiators resigned their posts in protest in September, complaining that the Colombian trade ministry was likely to accede to U.S. political pressure.
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The chutzpah quote of the article belongs to a PhRMA lobbyist:

“Right now there is no evidence of biopiracy,'’ said Mark Grayson, a spokesman for Pharmaceutical Research and Manufacturers of America in Washington, a lobbying and marketing group that represents drugmakers. “But negotiations are trade- offs, so if that is something they want, what are we going to get in return?‘’ [bold added]

What are US pharmaceutical companies getting in return? You’d think that the Andean nations were the ones initiating imposition of IP obligations on the US! A letter by ten members of Congress spells out the extent of our “return” [if by return, you mean ‘what-we-started-with’] demands:

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Some of these provisions.. facilitate the adoption of standards far beyond those provided in US law. Further, imposing such IP provisions in countries that do not currently have a legal and regulatory framework comparable to that of the United States will serve only to undermine access to affordable medicines in these countries.

…The reality is that IP provisions developed and tailored for the US health care system may be entirely inappropriate for poor countries where few have access even to government clinics, let alone to private hospitals, pharmacies or health insurance.

To get a better understanding of the framework of international intellectual property law that relates to the Tamiflu issue, you can check out the WTO’s fact sheet on the TRIPS Agreement, which includes an overview of compulsory licensing:

COMPULSORY LICENSING

The TRIPS Agreement does not specifically list the reasons that might be used to justify compulsory licensing. In Article 31, it does mention national emergencies, other circumstances of extreme urgency and anti-competitive practices — but only as grounds when some of the normal requirements for compulsory licensing do not apply, such as the need to try for a voluntary licence first. Doha declaration 5(b) and (c).

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UPDATE: WTO now also has an FAQ on compulsory licensing, which you might find more accessible reading than the above.

Drug-maker Roche yesterday announced that it would be willing to consider granting licenses for other companies to make its antiviral Tamiflu, after initially refusing to weaken its hold on the patent rights in the event of a pandemic.

Health GAP responds:

Roche’s offer of voluntary licenses is illusory in its present form. First, Roche says that it is prepared to “discuss” licenses, but does
not promise to issue any licenses whatsoever or even to expedite the normal slow pace of licensing negotiations. Second, Roche’s offer does not clarify whether licenses will have restrictive pricing terms whereby Roche can set the selling price and/or require an above-market royalty rate. (Roche could be suggesting that it will cooperate to increase quantities but that it will not reduce price.) Third, Roche does not clarify whether it will impose geographical limitations on sales, thereby limiting access to disfavored markets only. Fourth, Roche does not clarify that it will license manufacturing expertise so that generic products can be brought to market more quickly. Finally, Roche does not clarify that it will assist licensees in obtaining product registration and marketing approval on an expedited basis even where data exclusivity rules might otherwise block registration.

You may recall Michael Crichton’s latest book State of Fear, which argues that climate change is essentially a leftist conspiracy theory.

His success in raising publicity of global-warming skeptics has apparently inspired the pharmaceutical industry to try its hand at fear-mongering novel-writing itself: allegedly the phRMA industry was engaged in negotiations to support a novel about the perils of buying discount drugs from Canada.

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When the project fell through in July, I’m told the drug lobby offered $100,000 to the co-authors and publisher in a vain effort to sweep it under the rug.

…Drug-lobby mouthpiece Ken Johnson, executive vice president of the Pharmaceutical Research and Manufacturers of America, acknowledged the hare-brained scheme but shifted blame. “We did not commission a book,” Johnson argued. “The idea was brought to us by an outside consultant. We explored it, provided some background information … but in the final analysis, decided it wasn’t the right thing for us to do.”

PhRMA reportedly made the following editorial suggestions, which will no doubt do wonders for its PR:

“They said they wanted it somewhat dumbed down for women, with a lot more fluff in it, and more about the wife of the head Croatian terrorist, who is a former Miss Mexico”.

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Not surprising, alas, to hear another tale of the depths to which lobbyists will sink. But it’s a real pity, because this is a genuinely complex issue. During my summer in DC, I happened to sit in on a hearing on the drug importation issue. It gave me an appreciation of the regulatory challenges of ensuring the safety of drugs ordered from Canada– and the even greater dangers of internet scams and websites posing as legit Canadian pharmacies. The FBI is having a hard time tracking down the new fake sites that keep popping up– and even when they discover a scam, often lack authority to pursue cases in the countries where site-operators exist. And US customs is able to check only a very small fraction (we’re talking less than ten percent here; I can’t recall exactly but the figure may even have been low single digits) of all pharmaceutical shipments that enter the country.

So in relaying the above item, I don’t want to put an unfair spin on the issue. But if phRMA is willing to do exactly that on genuinely difficult issues… well, you might just want to think about taking that into account in setting the number of grains of salt to take when reading the industry’s perspective on other matters. Such as say, compulsory licensing and global pandemics…

As it happened, the first lunch seminar for students admitted to the joint degree program was on the same day as the first Constitutional Law class.

In the former, we discussed the ethics of gene patenting,* and how the United States, unlike Europe, does not provide for objection to patents on the grounds of “public morality”.

In the latter, we discussed Congress’ use of the interstate commerce clause to justify a federal law against medical marijuana.

Until this accidental juxtaposition, I’d never thought to compare these issues. But how interesting, that in one case our legal system should be so leery of taking moral concerns into account, yet in the other is perfectly willing– indeed, eager– to stretch legal concepts quite far** in order to regulate morality.

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* Specifically, we met with the author of the study addressed in this article– which I now remember having read when it came out (It’s always a treat to have the chance to get a fuller perspective on people and issues in the media). And thanks to this experience, I’ve now been pointed to a letter in Science in which the authors refute one of the common criticisms that appears at the end of the Economist’s account. ((Basically, the authors were well-aware of the USPTO-guideline change that occurred in 1999; and assert that therefore the genre of patents they chose to analyze did not include any of the problematic kind that led to the policy alteration))

** The ground for invoking the Interstate Commerce Clause is that patients growing medical marijuana for their own use MIGHT sell it to persons in other states. Might? Methinks there must be some situation out there, involving permitted use of controlled substances, where application of a standard of _mere possibility_ of misuse to justify Congress stepping in to ban the activity would be clearly absurd and unthinkable. (Research on diseases that could conceivably be used by terrorists? I’m not immediately coming up with an equivalent involving the activities of private individuals…)

Though I have addressed the issue before, seeing this Economist article misrepresent the WTO-authorized conditions for issuing compulsory licenses, I feel it would be worthwhile to reproduce below an article from the IP-health listserv, which provides a different– and more comprehensive– perspective on the controversy over access to AIDS drugs in Brazil:

Multinational Pharmaceutical Company Backs Down

July 28 2005
Council On Hemispheric Affairs
This analysis was prepared by COHA Research Associate Phil Morrow.

On June 24, Brazil issued an ultimatum to the Illinois-based pharmaceutical corporation Abbott Laboratories that it must lower the price it charged for the AIDS medication Kaletra, or the government would move to break the patent and manufacture the drug generically in its own laboratories. (more…)

Newest update on the Brazil patent-breaking saga: the Brazilian health minister has announced intentions to authorize generic production of the anti-retroviral Kaletra by July 6th unless Abbott, the patent owner, voluntary agrees to slash prices on its own.

Relatedly, I should pass along the observation from CP Tech’s IP-health listserv that there appears to be a widespread misconception that there are no precedents for putting AIDS drugs under compulsory license. As a list from CP Tech shows, compulsory licenses for anti-retrovirals have been issued in Mozambique, Zambia, Malaysia, Indonesia and South Africa. While the Brazil case will have significant ripples for other countries hoping to improve access to essential medicines, it’s important to emphasize that the practice of issuing compulsory licenses based on government discretion (rather than strictly in “emergency” circumstances) is not only legal in theory but is also supported by actual precedent in a number of countries.

In reading this article about a $14.8 million grant awarded by the Gates Foundation to an Arizona researcher trying to create an oral vaccine for bacterial pneumonia, I learned something I didn’t know about vaccine development– namely that the process for approving a vaccine for infant can take quite a long time “because the vaccine first is tested on adults, and if those are successful, then it is tested on a younger group each time until it reaches the infant category.”

It’s certainly reassuring to hear that the process is that thorough– but it also gives me a greater appreciation of the investment required to bring a new vaccine to market. The article also underscores the lack of sufficient incentives in the free market to develop many essential medicines:

“Large for-profit pharmaceutical companies are reluctant to get into the vaccine business because they can’t make as much money on a vaccine that only gets used by a person twice in their lifetime.”

The project is among 43 winners chosen by the Gates Foundation to receive five year grants of up to $20 million (a sum, it is worth pointing out, that is significantly larger than most NIH grants):

“…the 14 goals that the foundation wanted scientists to pursue included: vaccines that need no refrigeration and can be given without needles; vaccines that create immunity with one dose and are safe for newborns; new ways to kill or cripple mosquitoes; more nutritious staple crops; better animal models for human diseases; blood tests that can be done in villages without electricity; and new ways to attack diseases like tuberculosis and hepatitis when they are dormant.”

And the intellectual property angle?

“As part of receiving a grant, the researchers are allowed to patent anything they invent, but they must guarantee that it will be made available to poor countries at low cost or free.”

These terms are identical to what the WHO generally stipulates in contracts with its collaborators– and in contrast, the Times article notes, to patent rights resulting from work associated with NIH grants– which “normally go to the university involved” without requirements to offer preferential access to developing countries.

A good editorial in the Washington Post in favor of changing intellectual property policies to improve access to medicine for poor countries:

Little by little, the world is coming around to two self-evidently good proposals to improve global health. But there’s a third, equally great proposal to which nobody pays attention… Oddly, the two proposals with momentum are the ones that cost a lot. The first is designed to stimulate production of vaccines for diseases such as polio, yellow fever and hepatitis B… The second proposal is about drugs that don’t exist yet — for example, a malaria vaccine.

…So there’s an appetite to spend taxpayers’ money on buying existing vaccines and on a “pull mechanism” for new ones. But there’s a third challenge in this medical battlefield: How to make drugs that have been invented for rich countries available in the poor world.