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Big Pharma Digs In

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The nations of the world are currently debating how to design new medical research and development (R&D) mechanisms to serve the twin goals of promoting innovation to meet the particular needs of developing countries and ensuring that important medicines are accessible to people in the developing world, regardless of their income.

A successful conclusion to ongoing negotiations at the World Health Organization (WHO) -- scheduled to conclude at the end of this week -- could yield dramatic public health benefits in the years and decades ahead. Long-ignored research needs of poor countries might be addressed. Important new products might become affordable for all patients, not just those who live in rich countries or happen to be wealthy. New collaborative systems of conducting R&D might yield scientific breakthroughs for emerging public health threats that might otherwise be delayed, or never occur.

Big Pharma is watching the WHO talks with trepidation. The brand-name pharmaceutical companies are open to new government resources being invested to find treatments for diseases endemic to developing countries -- this represents a new business opportunity, after all. But they fear losing their pricing prerogatives, including to charge exorbitant rich country prices in middle-income countries. The companies are also very concerned that new R&D mechanisms may displace the global patent-monopoly system around which they have built their business models -- and which enable them to earn enormous profits.

In an effort to direct the WHO negotiations away from bolder measures that would advance public health objectives but might threaten its parochial interests, the industry is deploying the diverse set of instruments in its policy-influencing toolbox.

Predictably, Big Pharma is heavily influencing the positions of rich country governments in the WHO talks. Recent reports indicate disappointing intransigence from the United States, the European Union and Japan -- a shift from earlier negotiating rounds.

Industry finagling managed to get the Biotechnology Industry Organization, the U.S. biotech trade association, designated as "experts" for the WHO negotiations -- a designation that gives BIO representatives seats in the WHO negotiating room.

The global pharmaceutical industry confederation -- the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) -- has filled the corridors outside the talks with lobbyists. IFPMA has 59 persons officially registered to participate in the meeting.

More insidiously, the industry's funded patient group and think tank allies have waged a propaganda campaign to discredit the WHO initiative -- without revealing their financial entanglements with the industry.

An entity called Patients and Patents has circulated a "Patient Declaration on Medical Innovation and Access." This declaration insists on the importance of patient group involvement in WHO negotiations before "recommending changes to international patent protection (IPP)."

Patients and Patents is governed by a seven-member advisory board. Six of the seven members of the advisory board are linked to the brand-name pharmaceutical industry, either directly as an individual or through their primary organization, and the seventh member has at least a weak tie to the industry.

One member of the governing advisory board, for example, is Durhane Wong-Rieger. Wong-Rieger is chair of the Consumer Advocare Network, which is funded by Canada's pharmaceutical industry trade association Rx&D. Wong-Reiger is also president of the Canadian Organization for Rare Disorders, which is funded by Actelion Pharmaceuticals, Amicus Therapeutics, Apo Pharma, BioMarin Pharmaceutical, BIOTECanada, Debiovision, Genzyme Canada, Hoffmann-LaRoche (Roche), Merck Frosst Canada, Neurochem, Novartis, Orfagen, Ortho Biotech, Pfizer, Rare Disease Therapeutics, Shire Human Genetics Therapies, Sigma-Tau Pharmaceuticals and YM Biosciences.

A high proportion of the signers of the Patient Declaration are also connected to the brand-name pharmaceutical industry. A review by Essential Action (an organization I direct) found 61 of 110 of the signers of the Declaration have industry ties.

A global network of industry-affiliated -- and frequently industry-funded -- libertarian think tanks have placed misleading op-eds in news outlets around the globe, denouncing the WHO negotiations. The authors do not disclose their industry ties.

Tim Wilson, for example, placed op-eds in the Business Standard (India) and in the Times of India, arguing that the WHO talks would undermine innovation and hurt people in developing countries. These articles identified him as affiliated with the Institute of Public Affairs in Melbourne, Australia. They did not note that at least half of Institute of Public Affairs' board of directors is comprised of individuals with financial ties to the pharmaceutical industry.

Other op-eds by industry-allied think tanks and academics have appeared in recent days in Malawi, Rwanda and Colombia. These followed a series of op-eds by industry-connected nonprofits and academics in the United States over the previous month. The U.S. op-eds focused on Thailand's issuance of compulsory licenses -- government authorizations of generic competition for products that remain on patent -- to make cancer, heart disease and HIV/AIDS drugs available to poor people in Thailand.

Big Pharma's effort to curtail or contain the WHO negotiations on medicine innovation and access is a comprehensive one. The industry is not at all shy about exercising its political power, and it is doing so. But Pharma execs also know that the industry suffers from enormous public relations problems that undermine its influence. Industry-funded or -connected organizations that trot out to propagate Big Pharma's myths and deceptions can be far more effective in muddying policy debates.

As the WHO talks began this week, Dr. Christophe Fournier, president of the International Council of Médecins Sans Frontières/Doctors Without Borders, said, "This week is not just about countries signing checks. It's about changing the rules of medical innovation -- coming up with new proposals that ensure the drugs we need are developed and are made affordable. But with so many vested interests involved, will governments be bold enough to take that step?"

Thanks to Big Pharma's multi-faceted pressure campaign, that remains an open question.

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