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Intellectual Property Watch
By William New
The 61st annual World Health Assembly on Monday opened auspiciously with speeches on the world’s biggest political issues, current disasters and looming global threats, but little room for intellectual property issues.
IP issues did arise in a press briefing with US Health and Human Services Secretary Michael Leavitt, however.
Some 2,500 people from around the world are at the UN in Geneva for the 19-24 May assembly, according to the WHO.
WHO Director General Margaret Chan in her afternoon opening speech highlighted the health problems of the natural disasters in Myanmar and China, praising the outpouring of support but cautioning, “We must all brace ourselves for more humanitarian crises in the immediate and near future.”
Chan also warned of the coming negative health effects, especially on the poor, of looming global crises in food security, climate change and pandemic influenza.
She raised IP issues optimistically, as an opportunity for the organisation to make a difference. Chan highlighted a report due out later this year from the Commission on Social Determinants of Health, which she “should help us address the root causes of inequities with greater precision.”
She then commended members for the “tremendous progress” made in meetings of the Intergovernmental Working Group on Public Health, Innovation, and Intellectual Property (IGWG).
“This is one of those rare opportunities when public health can take a proactive role in shaping at least some of the forces that influence equity in health,” she said, noting the reduction from nearly 200 to 18 unresolved paragraphs in the mandated global strategy for stimulating research on neglected diseases predominantly affecting poor countries.
[Note: Updated Tuesday morning] The assembly on Tuesday morning established a working group on the remaining IP paragraphs, however (IPW, WHO, 19 May 2008). The group started immediately to work alongside the larger committee (Assembly Committee A), with periodic updates to the committee during the week.
Chan raised the many other diseases and health matters facing the world, saving perhaps her toughest talk for tobacco. “This industry has long described WHO as its biggest enemy,” she said. “I am pleased by every opportunity to enhance this reputation.”
Leavitt Stresses IP, Trade Issues
Meanwhile, US Health Secretary Leavitt accentuated the IP issues underlying the assembly. He said the US is willing to show flexibility in its positions on the IP provisions of the global strategy.
Asked why the US has stood alone in obstructing the most provisions in the global strategy, Leavitt said, “We obviously have very strong views that intellectual property is the seed or foundation for innovation, and that compromising to the point that innovation is in any way stymied will ultimately cost lives, and that’s not an area where we think compromise should be made.”
But, he said, “We also recognise that we need to come to an agreement,” he said. “As I indicated, we will work hard during the rest of the week to assure we’re able to do that.”
Leavitt said the US is hopeful work on the global strategy can be completed. “We think that within the context of what’s been presented that we could find agreement. So we’ll be pursuing that hard during the balance of this week,” he said.
Asked about US flexibility on the IP issues, he said: “We have a well defined position. We think we are flexible. We want to find a way to resolve this. There are certain principles, of course, that we have to maintain. But we’re committed over the course of the remaining days here to find a solution.”
Separately, Leavitt referred at length to efforts to create an international certification process for verifying the quality and safety of products entering countries like the United States, in part to catch counterfeits. The US imports from 825,000 different sources, coming into more than 300 different ports of entry and valued at nearly two trillion dollars a year, he said. Any shipments that without the certification could be subjected to additional scrutiny at the border, he said.
He said that on a recent visit to India he became aware of how closely integrated the American pharmaceutical industry has become with production facilities in India. “There are 90 to 100 facilities producing drugs for consumption in the United States,” he said. “We need to inspect those facilities on a regular basis.” Similar economies like Canada, Australia and Europe likely also would like to inspect them, so they are discussing a unified approach, he said.
“There is need here for us to begin working together to determine how best to accomplish this type of independent certification,” he said. “We are inventing new tools for the global economy. This is pioneering.” Along that line, the US recently set up a Food and Drug Administration office in China, he said.
Some have raised concern that this new approach could be used to impair imports from competing foreign firms. But Leavitt downplayed concerns, encouraging government collaboration. A government role would be to accredit certifiers, he said. In general, he predicted a greater emphasis on standards related to health products.
Avian Flu Virus Sharing
Another key issue for the United States is the sharing of avian influenza virus samples with the established WHO system for developing vaccines. Some developing countries, led by Indonesia, have raised strong concerns that when they share their virus samples into the system, all the labs are controlled by developed countries and lead to the developed countries lining up sufficient quantities for their own populations while even the hardest hit developing countries have had trouble getting access or sharing the benefits from avian flu treatments even as patent filings rapidly rise. Such developing countries are arguing for a firm arrangement on access and benefit sharing.
Leavitt generally agreed with the characterisation of their concern, but firmly disagreed with connecting sharing with compensation. “We have engaged in and will continue to engage in finding solutions to that dilemma,” he said, but there is “a separate discussion in our mind related to the sharing of samples.”
“We have a desire to be involved in both conversations,” he added. “What we object to is linking them.” Leavitt held a bilateral meeting this week with the Indonesian health minister, a follow-on meeting from one he had earlier with the minister and the Indonesian president, he said. But there has been little change in positions so far.
A WHO meeting on the pandemic flu issue last November did not achieve any breakthroughs, and plans to meet again next November. A meeting is expected on Thursday as part of the multilateral process where governments are working to develop the specifics of how an improved system could work, Leavitt said.
“There are many parts of the sample sharing process that need to be improved. We’re open to that improvement,” Leavitt said. “What we aren’t willing, of course, to do is to engage in any system that would involve compensation for virus samples. This is based on a 60-year tradition [referring to the WHO system]. That’s one of the great public health successes in history. We’re anxious to not see that compromised in any way.”
WHO Publication Policy
A background issue this week is a proposal to increase scrutiny of WHO publications that has stirred concern. The publication topic did not come up on the first day of the assembly, including in the agenda adoption or the Executive Board report, according to sources.
On Monday, US Representative Henry Waxman (Democrat-California), chairman of the House Committee On Oversight and Government Reform, sent a letter, available here, to Chan raising concern about the proposed tightening of the WHO publication policy. Waxman, an influential congressional watchdog, said the new policy of exercising greater central control over publications would politicise WHO’s publications process.
Waxman supported the WHO objectives of minimising costs, maximising availability, and ensuring the reliability and validity of scientific information in WHO documents. But he warned against an extra layer of review for publications naming specific national policies or addressing potentially controversial topics, which Waxman said “could introduce a similar level of protest, obstruction, or delay.” This kind of scrutiny of publications, he said, “could produce a chilling effect on researchers and experts, discouraging the exploration of topics that could trigger an extra layer of review.”
Sarah Rimmington, a staff attorney at public health group Essential Action echoed this concern. “The WHO publications policy discussion is a US power play disguised as a bureaucratic nicety,” she said in a statement. “Over the years, the United States has repeatedly interfered in WHO efforts to advance a public health agenda where it conflicts with commercial or ideological interests.”
The extra layer of review for controversial topics would be an “invitation for further US interference,” Rimmington said, and would “subvert WHO’s ability to issue evidence-based public health materials, undermine the agency’s flexibility, and interfere with country offices’ ability to respond quickly to local circumstances. It should be redrafted.”
The policy change, which appears to have been initiated by a 2006 US government complaint, is not slated for discussion during this week’s assembly but rather for the Executive Board meeting that follows next week.
Government delegates are being kept busy with a steady stream of bilateral meetings, receptions and information sessions.
One such information session is planned by Médecins Sans Frontières on Wednesday evening entitled, “Putting IGWG into action: Harnessing alternative mechanisms to boost R&D for tuberculosis.”
[Updated Tuesday morning] Industry groups also are holding events, including a pharmaceutical industry event on partnerships Tuesday evening, and a panel and reception on Wednesday evening. The Wednesday panel will focus on developing new medicines for malaria and will include speakers from Novartis, Drugs for Neglected Diseases Initiative, and Medicines for Malaria Ventures.
William New may be reached at email@example.com.