As cases of swine flu in humans pile up and fears that a more serious outbreak could occur in the future, member states, drug manufacturers and public health advocates gather Friday and Saturday to see if they can come up with a way to facilitate sharing of both viruses and vaccine related materials.

Intellectual property laws are a key point of contention at the reconvened meeting, at the World Health Organization, of the Intergovernmental Meeting on Pandemic Influenza Preparedness taking place 15-16 May, as some governments seek assurance that they will have access to strains of virus needed to manufacture vaccines, and others – primarily those concerned they have inadequate vaccine manufacturing or purchasing capacity to procure the drugs they need – seek assurance that they will have access to vaccines once they are manufactured.

A report by the WHO director general dated 30 April has been submitted since the last meeting in December, at which discussion of IP issues was studiously avoided, in tacit recognition of the often diametrically opposite stances over them (IPW, WHO, 15 December 2008).

The report from the director general includes a new version of the technical aspects of a Standard Material Transfer Agreement, in which provisions over intellectual property rights in connection with transferred materials are still options “for consideration.” It also includes information on needs and priorities of benefits that can be provided under the WHO system. Intellectual property issues likely to come up under the benefit-sharing system are on technology transfer and are still bracketed – that is, as yet not agreed. The report is available here [pdf].

Member states, too, have been working in the interim, trying to bridge gaps on these contentious issues informally since the last formal meeting of the PIP from 8-13 December was suspended (IPW, Public Health, 8 April 2009).

Meanwhile, the WHO is working behind the scenes to procure funding and doses of treatments for swine flu, an influenza strain that has shown pandemic potential though – while spreading rapidly – has yet not proven particularly fatal to those that contract it.

But those looking back to the infamous influenza pandemic of 1918 are not comforted by this fact, as that too began with a mild first wave in the spring, to be followed by a much more serious and deadly outbreak that winter.

The backdrop of a potentially dangerous pandemic this year puts added stress on this week’s meetings over a possible vaccine for the flu, with the WHO estimating that “the number of available doses to immunise the world population within the first six to nine months of a pandemic will still fall short by several billion doses.”

This figure is especially disturbing in developing countries which, the WHO says, often lack domestic production capacity and are therefore “totally dependent on the availability and accessibility of vaccine produced by multinational manufacturers.”

Access to Needed Treatment

The need to treat those who already have contracted flu is also an issue.

WHO is currently discussing with member states and pharmaceutical companies ways to get more funding and more doses in order to increase distribution of available drugs to treat swine flu, a WHO spokesperson told Intellectual Property Watch.

A generic version of oseltamivir, the compound of the popular flu drug produced by Roche under the name Tamiflu, is expected to become available soon following the announcement Wednesday that Indian generic drugmaker Cipla was granted WHO prequalification status for the drug. This means Cipla’s version has met WHO standards of “quality, safety and efficacy” for procurement by UN agencies.

“That’s good news,” Tido von Schoen-Angerer, executive director of the Médecins Sans Frontières (MSF) Access to Medicines campaign, told Intellectual Property Watch. With the rapid increase in influenza cases “it is critical to rely on as many as possible producers, and not just those that are under the Roche umbrella.”

Cipla’s WHO approval makes it the first producer of a generic oseltamivir product to receive the prequalification. The company already had the freedom to manufacture the drug within India, after a late March ruling denied Tamiflu patent-holder Gilead’s request for a Indian patent on the drug.

Why Oseltamivir Matters

To date, oseltamivir is the best-known cure for pandemic strains of influenza. The patent on the drug is owned by US biopharmaceutical company Gilead and is marketed and distributed under the brand name Tamiflu by Swiss healthcare company Roche.

Another drug, zanamivir (marketed under the brand-name Relenza by GlaxoSmithKline), also has proven effective against flu, but had not been the focus of public health campaigns as it is more difficult to administer. Oseltamivir is taken orally, while zanamivir must be inhaled.

Roche has donated several million doses of oseltamivir to the WHO, and has said it could begin producing [pdf] 36 million treatments a month by the end of 2009 if needed.

But public health advocates question whether Roche’s donations will be enough to serve all those who would need medical attention in the case of a pandemic, and if the brand-name version will be affordable.

“I don’t think a donation of some quantities resolves the problem,” said von Schoen-Angerer. “These drugs need to be much more affordable” as well, and this will require the use of generics.

Other sources have raised the concern that the donation by Roche is just an attempt to stem the purchasing of generic drugs, so that their own brand-name products are not undercut in the market.

Limited Patent Protection

Roche “has always stated that patents are not an impediment to ensuring treatment is available to patients in need,” Claudia Schmitt of Roche’s communications team told Intellectual Property Watch.

Furthermore, “Tamiflu does not have patent protection in the world’s poorest countries; and where there is no local patent protection, governments can explore their options regarding the purchase or manufacturing of Tamiflu,” she said.

“To our knowledge,” said von Schoen-Angerer separately, “in many developing countries there’s not a patent, so generics can be used right away.”

But some developing country advocates have raised an additional concern about possible complications from strong terms of protection in bilateral trade agreements with the United States and European Union of the test data needed to receive approval to produce generics. Patent holders obtain years of protection of their test data under such agreements.

In 2006, Schmitt said, Roche issued sub-licences on oseltamivir to four companies in developing countries: Hetero Drugs in India, which has a licence allowing them to export to developing countries, Aspen Pharmacare, which has a licence allowing export but only to countries in sub-Saharan Africa, and to Shanghai Pharmaceutical Group and HEC Group for the manufacture of the drug within China. These licences have been updated as needed, she said, adding that Aspen Pharmacare also received knowledge transfer from Roche to help with their manufacturing of the drug.

The problem could be with who has the capacity to manufacture the drugs.

“Ten to fifteen companies said they were able to produce the drug,” a WHO spokesperson told Intellectual Property Watch. “But it is not clear whether they will really be able” to do so, as only one has thus far provided materials to WHO.

The WHO reported 7520 cases and 65 deaths as of Friday morning.