Bioscope ‘05

by Dr. Barbara Price

Public Health vs Patent Protection: Politics behind the Avian Flu Pandemic

           With reports that up to 150 million people may die from avian flu, public health officials around the world are examining their country’s preparedness for the potential expansion of the current H5N1 to human transmission and the possibilities of a potentially devastating pandemic. Several countries have announced they are close to producing or have produced vaccines for the avian flu, including Hungary, the UK, the US. Estimates for vaccine availability run from a few months to two years. Until a vaccine is available, the WHO recommends each country get enough anti-virals, such as Tamiflu produced by the Swiss company Roche, to cover 10% of its population. Anti-virals shorten the length of the illness and may reduce the severity of the symptoms by interfering with viral replication. Tamiflu may also work as a preventive, but there are also concerns that some of the H5N1 strains are resistant to it.
           The UK has stockpiled 2.5 million doses and needs 12.1 million more. The US has stockpiled 4.3 million doses. Many other countries have been contacting Roche to buy and stockpile Tamiflu. In response to individual country concerns, India’s drug maker Cipla, and the governments of Argentina, Taiwan and Thailand are among those that say they will manufacture the drug if it is needed for their populations or Roche cannot meet production requirements. Roche donated 3 million doses to WHO in August and has given a small amount to Romania.
Tamiflu (generic oseltamivir) was developed by Gilead Sciences for Roche and is patented to Roche until 2016. Roche currently has 12 plants that make Tamiflu, 6 of its own and 6 with partner companies. Roche does not want to give up its patent, which is worth about 1 billion dollars to the company. However, under pressure from countries around the world, Roche says that it will consider sub-licensing. Four generic manufacturers discussing production with Roche are Teva Pharmacuetical Industries (Israel HQ), Barr Pharmaceutical (USA HQ), Mylan Laroatories (USA HQ) and Ranbaxy Laboratories (India HQ). Of course, none of these generic manufacturers makes the drugs for free, and in fact, one was charged with restraint of trade and conspiracy to create a monopoly, but later settled with states and insurance companies for over $100 million. Tamiflu costs $54.25 and Relenza (zanamir by GlaxoSmithKlein) costs $61.30 on the internet.
           How much patent protection is appropriate when public health is at risk? If Tamiflu works even some of the time, the world cannot wait until 2016 to legally make the generic version. Roche may jeopardize the future of patent protection around the world if they do not come up with arrangements with other companies. However, if governments do not respect patents, pharmaceutical companies may decide the costs of R&D are not worth the risks; if they are too successful, will governments take over production? How much should Tamiflu cost? If dire predictions about the pandemic come true, Roche will never get to collect its $1 billion because of the resulting global economic depression. And finally, as history has already shown, governments responding to a pandemic will assume control over drug production, quarantines and information.