Influenza A (H1N1): Generic production must be part of solution for access to influenza medicines

Only WHO can determine global stockpile needs and coordinate the fair allocation of the supply of flu drugs.

While uncertainty still prevails over the severity of a possible influenza pandemic, many developing countries do not have stockpiles of medicines or advanced purchase commitments with manufacturers to ensure access to protect their populations if the pandemic does take hold.

“If a pandemic were to occur, the test of global solidarity will be whether there is a focus on developing countries who would likely be hit worst, since they would be the least prepared,” said Michelle Childs, Director of Policy and Advocacy at Médecins Sans Frontières’ Campaign for Access to Essential Medicines. "The production of generic versions of influenza medicines will be crucial to ensure these countries can not only get hold of these drugs but also at an affordable price Rich countries cannot just buy their way out at the expense of developing countries.”

Populations in many developing countries will be far more vulnerable to the Influenza A (H1N1) virus because they are already affected by malnutrition and high burdens of other diseases such as tuberculosis, HIV and malaria.

But focusing solely on negotiations to boost supply and reduce prices with the current manufacturers will not solve the problem. Generic producers will have a crucial role to play. Generic production of oseltamivir in India can be scaled up as the patent on this drug has already been rejected there and there is no patent in several other developing countries.

“As part of its mandate for pandemic preparedness, the World Health Organization needs to take action to increase generic drug supply for the treatments that it is recommending,” warned Childs. “Only WHO can determine global stockpile needs and coordinate the fair allocation of the supply of flu drugs.”

In countries where recommended treatments are patented governments and/or patent holders need to assure generic companies that patents will not be a barrier. Governments can do this by issuing compulsory licenses whereby the patent holder receives royalties.

So far, patent holders have been issuing voluntary licenses with several manufacturers, but these can come with conditions attached.

“Patent holders could make the whole process easier by publicly declaring that they will not assert their patent rights to prevent access to generic products,” said Childs.

Alternatively companies could agree to place their patents into a ‘patent pool’ – a mechanism that allows generic manufacturers to produce medicines on equitable licensing terms.

It is also important to remember that while a flu pandemic is a threat, thousands die of HIV/AIDS and other diseases every day in developing countries.

“Patents should not stand in the way of access to essential drugs: not with influenza, and not with HIV/AIDS or any other illness,” emphasised Childs. “We need to see the same level of attention that is now paid to influenza for diseases that already kill millions of people in the developing world.”