Roche Seeks Deals On Bird Flu Drug As Compulsory Licenses Loom

Roche, the Swiss-based company with rights to a medicine believed to be the most effective in the event of an avian influenza pandemic, has expressed openness to discussing arrangements with companies or governments to produce more of its flu treatment known as Tamiflu.

But sceptics argue that the offer, made on 18 October, is too vague and merely a reaction to calls from governments and public interest groups to issue compulsory licenses, which allow nations to get around patent rights without consent in order to produce the item.

Roche says it was approached by “several companies and governments” during the first 24 hours after it published the offer for sub-licensing deals for the production of Tamiflu (oseltamivir, the active substance of Tamiflu).

Some governments have indicated that they are interested in production, either through sub-licensing deals with Roche, voluntary or compulsory licenses. In order to issue a compulsory license, governments would need to notify the World Trade Organization council on the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS). The WTO said on 19 October that so far no government has notified its intent to issue a compulsory license.

David Reddy, head of a pandemic task force at Roche, told Intellectual Property Watch that the ongoing discussions were not related to governments issuing compulsory licenses under the 2001 WTO Declaration on TRIPS and Public Health. It affirms that governments may issue compulsory licenses for public health reasons such as national emergencies. In 2003, a waiver was introduced to the TRIPS agreement, allowing countries to import drugs produced under such licenses if they did not have the production capacity themselves.

Instead, Reddy said, Roche would negotiate the sub-licenses bilaterally. He argued that Roche had shown flexibility in the offer and said that it was open to discussing deals. “We have opened the door” and are “open to sub-licensing,” Reddy said.

Reddy said he was not too concerned that many countries would opt for compulsory licenses because “it would take a significant amount of time to come to production,” he said, adding that very few companies had all the production facilities that it took to produce Tamiflu. These include processes such as bioferminisation and acid chemistry, in addition to regular production facilities. Roche itself has outsourced some of the process and has collaborated with others for its production of Tamiflu.

But there are three conditions attached to a possible sub-licensing deal, which excludes many governments and companies: The product has to be produced within a certain time span, to which Reddy attached “urgency,” it must meet production quality, and it must be able to be produced in a “sizeable” quantity.

European Commission Brings Industry To Table

The European Commission is also consulting the industry on the issue. Philip Tod, the European Union spokesman for health and consumer protection, said that EU had recommended its member states adhere to a World Health Organisation recommendation to consider stockpiling influenza treatment. The EU has specified that stocks should cover 25 percent of the population.

The Commission has been in talks with the pharmaceutical industry, but the issue was not expected to be raised at meetings on 20 and 21 October, Tod said. But further meetings with the industry about scaling up its production of vaccines and anti-viral drugs and about distribution will follow.

Public-private partnerships between EU member states and industry will be considered, with “each side bringing something to the table,” Tod said. He noted that the Commission`s role in this issue was to “support, complement and co-ordinate” the work of member states. As this is a national-level patent matter, the EU cannot issue any kinds of licenses, a spokesperson said.

The European office of the Consumer Project on Technology sent a letter on 19 October to the Commission urging a change in its trade policy to allow member governments to import medicines made under compulsory license elsewhere. Many developed countries committed to not using a waiver allowing such imports, agreed at the WTO in August 2003. The waiver was intended for developing countries in need that lack production capacity. The consumer group warned that hundreds of millions of European could be left without access to the necessary medicine if an outbreak occurs unless the policy change is made.

Nations Begin To Work With Roche

In its offer, Roche stated a willingness to “discuss all available options, including granting sub-licenses, with any government or private company who approach us to manufacture Tamiflu or collaborate with us in its manufacturing.” Before this announcement the company had not been contacted by anyone, a spokesperson said.

In June, US pharmaceutical company Gilead Sciences charged Roche with failing to adequately promote and produce the drug, and invoked a contract clause to demand the return of all commercial and manufacturing rights. Roche has denied the charges, according to the Associated Press.

Reddy said that Roche was not making a distinction between generic versus brand-name companies for the agreements on sub-licensing.

He confirmed the Taiwanese and a member of the US government had approached Roche for possible collaboration.

In Taiwan, Health Minister Hou Sheng-mou has written to the CEO of Roche, Franz B. Humer, asking him to negotiate whether to allow Taiwanese drug manufacturers to produce Tamiflu. Taiwan’s National Health Research Institute has already produced small amounts of the drug. A Taiwanese official in Geneva said that Taiwan had not had any cases of bird flu in humans so far, but it is very vulnerable because it is an international hub for transport in the region, where cases of the bird flu have occurred in humans.

In India, the health ministry set up a high-level committee to examine the legal impacts of issuing compulsory licenses under the TRIPS agreement, the Hindu Business Line reported earlier this week. The committee comprises the Indian drug controller general, the director general of health services, and the officials of the department of chemicals and fertilizers and the industry ministry. The committee was expected to advise the government shortly.

Reddy noted that Roche had not been approached by Cipla, the Indian generic pharmaceutical company, which has indicated that it is ready to proceed with the production of Tamiflu. A patent for Tamiflu is pending in India, Reddy said.

The Government Pharmaceutical Organisation in Thailand has indicated that it will issue compulsory licenses and start producing a generic version of Tamiflu which will be available to the public from October next year, according to the Bangkok Post. The chief of the Disease Control Department, Thawat Sundarachan, has indicated that the country has ordered oseltamivir from India.

In the United States, the Consumer Project on Technology’s Washington office on 14 October sent a letter to US Trade Representative Rob Portman stating the same argument as the group made to the European Commission.

US Senator Charles Schumer, a New York Democrat, has sent two letters to Roche demanding that Roche license production of Tamiflu to five US drug companies within the next 30 days.

WHO Response

The WHO has issued guidance for member countries saying they should “consider” stocking up on anti-virals. A spokesperson noted that although different numbers regarding what percentage of a country’s population should be covered by its stock of anti-viral drugs had been attributed to different WHO officials, the organisation as such had not issued a formal figure.

The WHO is in intensive discussions with other parties than Roche for the production of Tamiflu, according to a spokesman. But WHO officials declined to share more details.

A WHO official noted at a press conference early this week that the UN body is striving to distinguish the issue of avian influenza from human pandemic influenza. “This disease at the moment is in birds and a very small number of cases, just over 100 [117], we’ve seen exposure in humans leading to serious infection.” So far it has not been proven that avian influenza is transmittable from human being to human being, he added.