The United States National Institutes of Health has become the first patent holder to join the newly created Medicines Patent Pool, a project of drug purchasing mechanism UNITAID. Public health organisations hailed the move as key step in the right direction but said there is still much work to do.

“Today we take the first step in what we expect to be a productive collaboration with the NIH and other patent holders to come, that will help us improve access to medicines in developing countries,” Charles Clift, chair of the Medicines Patent Pool Board, said in a UNITAID press release. “This licence underlines the US government’s commitment to the Medicines Patent Pool and its goal to increase the availability of HIV medicines in developing countries,” NIH Director Francis Collins, said in the release.

NIH today gave royalty-free licences on patents related to treatments for drug-resistant HIV infection to the pool. But on its own the NIH contribution is not enough for public health groups “to produce or sell any specific existing medicine,” the UNITAID release said. For that to happen, other patent holders also need to buy into the patent pool.

The pool is intended to be a “one-stop shop” for licensing on generic versions of patented HIV medicines. The hope is that by cutting down on the complexity and cost that often surrounds the licensing process – particularly when one drug can carry several patents from several different places – that the pool will reduce the cost and increase the speed at which generic medicines can be made available.

It is also hoped that the ease of licensing will help ease also the development of affordable formulations specific to children and to conditions in poorer countries where they are often needed.

The final steps in the creation of the patent pool as an independent legal entity, separate from UNITAID, were taken in June (IPW, Public Health, 8 June 2010). Negotiations with patent holders were at that time cleared to begin. The pool itself was launched in July, the press release said.

“The price of first generation HIV medicines dropped by more than 99 percent over the past decade, from over $10,000 per patient per year in 2000 to less than $70 today,” UNITAID said, adding that, “this dramatic drop was driven by competition among generic drug manufacturers in key producing countries such as India, where medicines were previously not patented.”

“However, increased patenting of medicines in developing countries due to international trade rules is drastically limiting generic competition on newer generations of HIV medicines. At the same time, the need for newer medicines is on the rise,” as resistance to first-line treatments grows, UNITAID added. It is these problems the pool is intended to help solve.

The Obama administration too came out with a statement in support of NIH’s move, noting that last week it had released a Presidential Policy Directive on Global Development intended to “leverage innovation to solve long-standing development challenges, encourage new models for innovation and to increase developing countries’ utilization of science and technology.”

In taking steps to support the patent pool, NIH “embodies these commitments [and] builds on the president’s previous commitment to support humanitarian licensing policies to ensure that medications developed with US taxpayer dollars are available off-patent in developing countries,” the White House’s press release said.

Health Group Reactions

Public health organisations across the board hailed the move, and encouraged other research organisations to follow the NIH’s lead.

“This demonstrates serious political backing for the Medicines Patent Pool to benefit all developing countries, and the fact that the NIH has also agreed to review its entire ARV portfolio with the intention of putting other patents in the pool is very promising,” said Dr. Tido von Schoen-Angerer, director of the Médecins Sans Frontières (Doctors Without Borders) Campaign for Access to Essential Medicines. “But this single patent isn’t enough to allow a cheaper version of the medicine to be produced. We need to build on this – the onus is on the drug companies that own patents on this and other key AIDS medicines to put their patents in the pool.”

The MSF release added that “significantly, the licence terms offered by the NIH include middle-income countries,” which often have high HIV levels but are not eligible for drug discounts often given poorer nations. MSF has been a leading advocate of the patent pool throughout its formation.

The move was a “welcome political statement that the Obama Administration recognises the importance of a competitive supply of low cost generic medicines in the struggle to make AIDS treatment sustainable,” said James Love, director of Knowledge Ecology International, another key supporter of the patent pool. “This is the beginning of a campaign to obtain licences voluntarily,” he said, adding the alternatives were struggling with non-voluntary licences or reducing the number of people who receive treatment.

“This decision could be a real breakthrough in making new HIV medicines available and affordable to poor people,” said Mohga Kamal-Yanni, senior policy adviser at Oxfam. Also praising the move as a promising first step were the French government, Universities Allied for Essential Medicines, the Joint United Nations Programme on HIV/AIDS (UNAIDS) [pdf], and the Trans-Atlantic Consumer Dialogue.

“There is an increasing trend towards open innovation in R&D to create new medicines, and the UNITAID Patent Pool is one of a number of different mechanisms or approaches to achieve this,” said Guy Willis of the International Federation of Pharmaceutical Manufacturers and Authorities (IFPMA).

“It is up to each IP holder to determine how best to maximise the utility of each piece of IP it owns: to further develop it by itself, to sell it, to licence it, to share it, and with whom,” Willis said. These choices will “be influenced by the nature of the innovation protected by the IP,” he said. “Can it be used on its own or, if not, which complementary innovations are needed to make a useful product, and their ownership and IP status…. There is no one-size-fits-all solution for open innovation.”