On Monday, December 14, the UNITAID board passed a resolution to establish a Patent Pool for AIDS medicines. The decision caped a dramatic debate on the proposal, which had been before UNITAID since 2006, and had been discussed in other fora since 2002. The following is a statement by KEI on the UNITAID decision, followed by background on the UNITAID patent pool proposal, including a copy of the UNITAID press release.
Statement of James Love, Director of KEI, on the UNITAID Patent Pool:
“The decision by UNITAID creates an opportunity to scale up efforts to promote access to newer AIDS drugs in developing countries. UNITAID will invest in the creation of a new licensing agency for patents on AIDS medicines, with a broad geographic scope. The pool will be voluntary, and its success or failure will depend upon the actions of owners of patents, but also the governments and civil society that influence patent owners.
The decision of December 14 was essential to authorize the creation of the legal entity that will manage and implement the patent pool, and it sets into motion a series of subsequent actions and policy decisions. In the more than 7 years the patent pool for AIDS has been debated, a number of persons, governments and other organizations (both non-profit and for-profit) have played an important role. The UNITAID press release notes the role of MSF and KEI in proposing the patent pool to UNITAID in 2006, and many others played key roles in advancing the patent pool concept, including the NGO representatives from the public health and patient communities to the UNITAID board, and the broader community of activists, experts and company and government officials who were supportive of this effort, many of whom submitted comments to the UNITAID board during the years when the proposal was under consideration.
KEI, operating then as CPTech, first proposed “An Essential Health Care Patent Pool” at the XIV International AIDS Conference in Barcelona, Spain, on July 8, 2002, modeled after the Manufacturers Aircraft Association (MAA) that was created in the United States in 1917, to facilitate access to patents on aircraft. The MAA was created in order to fight a conventional war, and the patent pool for medicines was proposed to help fight a war against AIDS and other diseases. Over several years, various versions of the patent pool were presented, including proposals to the African Union, CARICOM, UK Commission for Africa, to the WHO, the Global Fund and UNITAID, and to many national governments and at countless intergovernmental, academic or NGO meetings, to the point where the “new idea” was sometimes described as an “old idea.”
MSF’s leadership in moving the pool forward was quite important, beginning in 2006 with a series of presentations and collaborations involving UNITAID. On the KEI staff, many people have worked on the patent pool concept, including Manon Ress, Terry Gardiner, Jon Merz and David Serafino, who worked on early research and design issues for patent pools, as well as Michelle Childs, who led the KEI collaboration with MSF involving UNITAID, and Judit Rius Sanjaun, who headed the cluster that produced the Essential Medical Inventions Licensing Agency proposal, which remains an important plan for how to implement a pool, including model licenses for patents and data. KEI worked with a large number and diverse group of experts and stakeholders to develop the EMILA proposal and the UNITAID submissions, and benefited much from the collaborations with the many others who have worked so hard on the UNITAID patent pool initiative. There is simply no fair way to adequately note everyone’s contributions.
The UNITAID decision will launch a new phase of the implementation, and it will be a challenge for the patent pool to acquire rights from patent owners. Recently there has been greater awareness that decisions about geographic coverage of the market will be very important. Many pharmaceutical companies and some donors have tried to limit the patent pool to only very low income and smaller market countries. Some NGOs have expressed concern that UNITAID would allow patent owners to exclude some markets.
On December 14, UNITAID was clear that the patent pool would include all developing countries, but this decision does not answer the practical issue of responding to offers to license that are more limited. It is the view of KEI that UNITAID should ask for rights in all developing countries, but accept whatever the patent owner offers. Others want UNITAID to make a non-negotiable offer for all developing countries. If KEI thought a non-negotiable offer for all developing countries would be successful, we would endorse such an approach. We do not, without significant changes in the way the pool is structured.
KEI believes it would be a mistake for UNITAID to negotiate against itself, and limit its initial requests to only some countries, and we think that any classification of developing countries will be counterproductive. But KEI endorses an approach that would allow patent owners to license only in the countries where they are willing to make offers. To the degree that this will result in exclusions of countries with large markets or higher incomes, as it certain will, other measures will have to used to expand access to the patents. These will include actual or potential compulsory licensing actions in the countries that are excluded, something the UNITAID board clearly endorsed, as well as consideration of new incentives to license to the pool, which UNITAID also will consider. In regard to incentives, KEI is a strong supporter of the so called “donor proposal” as was submitted to the WHO by Bangladesh, Barbados, Bolivia and Suriname, that would combine donor funded prize funds with licensing to the patent pool. KEI believes it is possible to have inclusive coverage of all important patents for AIDS and other diseases addressed by UNITAID to all developing countries, if the donor proposal is implemented and supported by the United State and European governments to the degree that developing countries are no longer subject to pressure and trade sanctions on medical patent issues.
UNITAID and all supporters of the UNITAID patent pool have been clear that the pool should not tolerate discriminatory licensing as regards to generic producers. The pool should and we predict will follow an open licensing model, offering access to patents and other intellectual property on a non-discriminatory basis to qualified manufactures of products.
None of the forward looking challenges will be easy. UNITAID is blessed with a talented and courageous staff and enlightened and innovative board of directors, and we look forward to working with both going forward.
A number of NGOs have recently raised important criticisms about the patent pool and the process, and as the pool moves forward it is important to expand the transparency of the patent pool initiative, and to ensure that all patient and public health groups, generic drug producers, academic experts, governments and other concerned about, interested in and impacted by the pool will have the effective opportunity to review, comment and influence outcomes, including the many policy decisions will be made in the next 12 months.
KEI will publish a number of technical notes on the patent pool in coming months, and will also explore the use of patent pools and other collective management approaches to intellectual property for areas outside of the treatment AIDS or access to anti-retroviral drugs.
The following is the UNITAID press release on the pool:
PATENT POOL COULD SAVE OVER ONE BILLION DOLLARS A YEAR
Geneva, 14 December 2009 — Today UNITAID’s Executive Board made a landmark decision to establish a Patent Pool for AIDS medicines. The pool, scheduled to start operating in mid-2010, aims to make newer medicines available in patient-adapted form, at lower prices, for low- and middle-income countries. UNITAID has committed to provide start-up funds of up to US$ 4 million over the next year. Expected savings exceed one billion dollars a year, which will make more medicines available for more people.
“This is an historic day,” said Philippe Douste-Blazy, Chair of UNITAID’s Executive Board. “UNITAID has now put in place a mechanism that will make medical advances work for the poor, while compensating companies for sharing their technology.”
The Patent Pool will allow generic companies to make lower cost versions of widely patented new medicines by creating a common space for patent holders to license their technology in exchange for royalties. This will spur competition and further bring down the price of vital new and effective medicines, giving hope to millions of patients. Companies with which UNITAID has had consultations include Gilead, Tibotec, Merck and Sequoia.
UNITAID has identified 19 products from nine companies for potential inclusion into the pool. The pool will facilitate the development of fixed-dose combinations (FDCs). For some years now clinical evidence has revealed that these combinations are the best way for patients to access safe, effective treatment. Until now, patents have created barriers to developing FDCs combining newer and more effective drugs from different companies. Today, with the first concrete step in the realisation of the Patent Pool, the door is open for new FDCs to enter the market.
“FDCs are especially important in the treatment of children, who make up 10% of current treatment needs,” said Jorge Bermudez, UNITAID Executive Secretary. “The Patent Pool will greatly help us accomplish our mission of scaling up treatment access, particularly for specific target groups otherwise neglected by the market – that is, children and people who fail on older therapies.”
The idea of a Patent Pool has been in discussion for a number of years. In 2006, Knowledge Ecology International and Médecins Sans Frontières proposed it to UNITAID. Today UNITAID has become the first international body to translate this idea into reality.
“Today is a good day for people living with HIV/AIDS in developing countries,” said Nelson Otwoma, the HIV/AIDS community representative on UNITAID’s Executive Board. “When my son was a baby we had to break pieces of adult tablets for him – treating him was guess work. The Pool gives me hope that we’ll have better medicines to treat children in the future.”
“We’ve had enormous interest from companies and political support from numerous constituencies around the globe,” said Ellen ‘t Hoen, in charge of the Patent Pool for UNITAID. “We’re now ready to move to the next phase – reaching agreements with companies to get the drugs out.”
Contact: Daniela Bagozzi, UNITAID Communication, Te. +41 22 791 45 44; Mob. +41 79 475 54 90; Email email@example.com
Ellen ‘t Hoen, UNITAID Patent Pool, Tel. +41 22 791 18 20; Mob. +41 79 509 06 79; Email firstname.lastname@example.org