University Patent Managers Versus Developing Countries

Officials charged with managing patent portfolios in U.S. universities have found a new cause. In addition to opposing patent reform in the US Congress, they are opposing proposals being discussed in the World Health Organization that are aimed at increasing R&D for neglected diseases and other global health needs, and expanding access to new medicines in developing countries.

On April 16, the Association of University Technology Mangers (AUTM) asked its members to "Sign the Institute for Policy Innovation's Open Letter to the World Health Organization. . . in advance of the WHO's Intergovernmental Working Group (IGWG) on Public Health, Innovation and Intellectual Property."

According to AUTM, "Prize systems, a medical R&D treaty, and compulsory patent pools are being advocated as alternatives to patents and IP protections at the April 28 meeting. These solutions could pose a challenge to our current and very successful system of innovation and tech transfer." Adding "This letter will be published as a full page advertisement in a major international newspaper a few days before the IGWG process resumes on April 28."

The letter is part of a PR campaign by the pharmaceutical industry to stop the introduction of new models for supporting R&D for new medicines, or more transparency of the system.

The WHO has already tentatively agreed to further discussions about a possible biomedical R&D treaty. Such a treaty would likely involve commitments from countries to provide funding for research into diseases that primarily impact low income people living in developing countries, and for which there is almost no private sector R&D. The treaty might also raise R&D levels for funding of antibiotics or other global health needs, improve the transparency of clinical trials, and address a number of other important issues. The drug companies oppose such a treaty on several grounds, including a fear that an R&D treaty would provide an alternative global model to support R&D that would eventually compete with the notion of pushing for super-strong intellectual property rules in developing countries, a policy that has been harshly criticized by development and health groups like Oxfam and MSF.

The issues of prizes is also a concern for big pharma. Former presidential candidate John Edwards wanted to end monopolies on new drugs, and reward drug developers with large cash prizes, linked to the impact of new medicines on health care outcomes. A number of experts agree with this approach, which is also set forth in S.2210, the Medical Innovation Prize Fund.

The debate in the WHO is actually much more limited. For example, Barbados and Bolivia recently proposed five different medical innovation prize programs. Four were targeted at the unmet global health needs, such as the prize funds for a low cost tuberculosis diagnostic test, or for new treatments for Chagas disease, a terrible illness of very poor people in Latin America.

One can understand why big pharma does not want a debate on new models for financing innovation -- if prizes work for Chagas disease or TB diagnostics, maybe the idea will spread to more lucrative markets. For lots of the wrong reasons, big pharma wants to avoid a system that links their rewards to actual impacts on health outcomes, and which enables generic competition of products.

But why would University Technology Managers side with big pharma in the WHO debates? Do they really think the current system is working well in developing countries?

Quoting from a recent country submissions to the WHO, here are five proposals on medical innovation prizes. Four involve large prizes that are linked to the voluntary licensing patents to enable generic competition. (Developers have to give up their IP to get the prize). One would expand access to cancer drugs in developing countries.

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Prize Fund for Development of Low-Cost Rapid Diagnostic Test for Tuberculosis. This is an example of the use of a prize fund to address a discrete public health need.

Prize Fund for the Development of New Treatments for Chagas Disease. This is an example of how a prize fund might be designed to increase treatments for a single neglected disease.

Priority Medicines and Vaccines Prize Fund (PMV/pf). This is a more ambitious proposal for a sustainable system of prizes to stimulate innovation in four areas of public health need, including R&D for Type III and Type II diseases (diseases that primarily impact low income persons living in developing countries), new antibiotics, and treatments for emerging public health threats.

Prizes as a Reward Mechanism for New Cancer Treatments. This is a proposal for a sustainable system of rewards for an important Type I disease (a disease with a large market in the US, Europe, Japan and other high income countries), as it relates to the use of these products in developing countries.

Licensed Products Prize Fund (LP/pf) for Donors. This proposal presents a possible solution for donor-supported markets. It would link an R&D reward system to voluntary agreements to license the competitive supply of products for AIDS, TB and malaria and for other humanitarian uses. This proposal would address the need for donors that support humanitarian programs to have access to medicines at competitive generic prices, while providing sustainable rewards to innovators.

For more on prizes for innovation, see here.

Links to the five prize proposals are here:
http://www.keionline.org/misc-docs/b_b_igwg/prop1_tb_prize.pdf
http://www.keionline.org/misc-docs/b_b_igwg/prop2_chagas_prize.pdf
http://www.keionline.org/misc-docs/b_b_igwg/prop3_pmv_pf.pdf
http://www.keionline.org/misc-docs/b_b_igwg/prop4_cancer_prizes.pdf
http://www.keionline.org/misc-docs/b_b_igwg/prop5_donor_drugs_prizes.pdf

Comments

[canadapundit]

I fail to see why the IGWG needs to remove drug patent protection for Prize Funds to be effective. Could a lab not choose to work towards the prize fund regardless of the patent model on other previously developed drugs? It seems to me that you want to take what you see as a pharma monopoly and make it into a government monopoly. Why not allow these systems to compete instead of legislating existing treatments out of the hands of those who invested in their development?

[Clinton]

It's no surprise that universities would align themselves with the pharmaceutical industry since they have already been infected by industry funding to such an extent. They hope to benefit further from the same monopolies. Developing countries should pursue their research interests without regard to international pharma tactics. They should focus on growing their own research infrastructure and create their own IP. They don't need 'guidance' (really nothing more than interference in the name of profit) from foreign institutions know by all to be somewhat corrupt.

[tompoe]

Hmmm. Still don't see the obvious solution being raised. Wonder why?

Were the FDA to return to the original Accelerated Approval Policy of 1992, implement requirement that all human clinical research utilize capture/playback feature that enables a handful of monitors in a monitor center actively participate in electronic oversight, and include the pharma industry acceptance of active involvement of FDA in bringing products into a "controlled market place", which grows as the merits of the drugs permits, it would be a win-win situation for everyone. Apparently, no one is willing to permit a nonproprietary automated clinical trial data collection system to be used. Too bad. It would lower R&D costs across the board by a minimum 70%. Prices for drugs would drop dramatically. Patients would be protected at levels not now possible. Exclusivity in the market place would lengthen by years. Small drug companies would no longer need to sell out to larger firms to attract capital. And, interestingly, with the price of R&D lowered, governments would no longer be dependent on the private sector for R&D, instead, relegating them to marketing tasks.

Oh, well. Consultants, nonprofit consumer oriented groups, pharma industry, management companies, and the other stakeholders that benefit from our present pathetic drug approval system can look forward to continuing a "stay the course" strategy. Keep up the good work, Jamie, and make sure you don't let your readers know there's a better way.