Today and tomorrow, December 14-15, the executive board of UNITAID will vote on whether to move forward with plans for a patent pool. A patent pool is a consortium of companies that share a license to a particular product or technology. In this case, manufacturers of AIDS drugs would give a limited number of generic manufacturers the right to produce those drugs. Competition between the generic manufacturers would then drive down the price of drugs in countries where many people currently cannot afford AIDS drugs.
Controversy has roiled over the patent pool idea since some have suggested that middle-income countries should be excluded. A lot of those countries are in Asia; see this letter from APN+, the network of people living with HIV in Asia, which clearly lays out the issues.
10th December, 2009
UNITAID Executive Board
World Health Organization
20, avenue Appia
CH-1211 Geneva 27
Switzerland
Dear UNITAID Executive Board,
I write to you on behalf of the Asia-Pacific Network of People living with HIV (APN+). APN+ is the network of PLHIV living in Asia Pacific region. It was established in 1994 at a meeting in Kuala Lumpur by 42 PLHIV from eight countries. Among our key objectives is to provide a collective voice for PLHIV in the region and to support better access to treatment and care.
APN+ is deeply concerned about the Implementation Plan for the UNITAID Patent Pool. We apologise for writing to you so close to the Board meeting; however we did not have any opportunity prior to this to convey our concerns or be consulted on the actual plan for setting up the Pool.
We understand that on 14-15 December 2009, the UNITAID Executive Board will take the important decision on the Patent Pool after careful and detailed scrutiny of the Patent Pool Implementation Plan. We are also aware that the objective of such a Patent Pool is to address the lack of affordable medicines for a disease predominantly affecting millions of poor people in the developing world.
In this regard, we put down our main concerns:
WILL ALL DEVELOPING COUNTRIES BE COVERED BY THE POOL? UNDER WHAT CONDITIONS?
We are extremely concerned that the UNITIAD Patent Pool should not exclude any developing countries; it should further not impose additional conditions or requirements on governments of these countries to take actions to ensure that their country is included in the Pool.
This issue is critical; we know this because from the 29 countries from where APN+ members are drawn, 15 are classified as middle income countries. These are:
China, Fiji, India, Indonesia, Iran, Malaysia, Mongolia, Pakistan, Papua New Guinea, Philippines, Samoa, Sri Lanka, Thailand, East Timor, Vanuatu
In this regard, we appreciate the recent statement of the UNITAID Board Chairperson that, “the Patent Pool plan aims to enable both low- and middle-income countries to benefit from the work of the Patent Pool.”
However, our concerns in this matter have increased since MSF has put out a press release that states: “International medical humanitarian organisation Médecins Sans Frontières (MSF) is concerned that a number of pharmaceutical companies are seeking to exclude developing countries categorised as ‘middle-income’ from benefiting from medicines made under licence from the Pool. If they are successful, people living with HIV/AIDS will be made to pay the price.”[1]
Further, an article in the Lancet reporting an interview with UNITAID confirms that, “”a big sticking point” for stakeholders, is the scope of the patent pool in terms of countries. Patent owners seek to make profits from sales to middle-income countries and would like restrictions on generic sales to these countries, while generic manufacturers are keen that such countries are included in the pool to increase the volume of their sales. One option under discussion is an opt-out clause for patent owners specifying certain countries. UNITAID is keen for stakeholders to define the terms of the patent pool themselves, given what experience and concerns each party “brings to the table.”[2]
We trust that based on the statement of the UNITAID Board Chairperson, this opt-out clause will now be removed from the Patent Pool Implementation Plan. We are also compelled to state once again that the Pool should not create additional requirements on governments of developing countries to convince patent owners to put their patents in the Pool. This is the reason we ask under what conditions will all developing countries be included in the Pool. We must avoid a situation where patent-owners can blame governments of developing countries for not creating the conditions necessary for them to be part of the Pool.
In this regard, we would also like to point out that including all developing countries in the Pool is important not just from the point of view of access to the medicines in the pool but also for production of these medicines. For many of the countries in the Asia-Pacific region, local manufacturing is the key to ensuring access to treatment in those countries. Thus, the Pool should avoid creating a system that relies only on the import of generic medicines and must take concrete steps to ensure local production as well.
Countries in the Asia-Pacific region have seen the impact of allowing companies to pick and choose countries for their voluntary licences. We bring to your attention Gilead’s voluntary licence for tenofovir that has excluded key countries in Asia . For some that have been included like Thailand , Gilead has also used the VLs as an opportunity to prevent local production in Thailand by not offering the VL to the Thai GPO and only offering it to Indian generic companies. This means that Thailand has to import generic tenofovir from India and cannot make it within the country.
WILL THE POOL UNDERMINE THE USE OF PUBLIC HEALTH SAFEGUARDS?
The governments and positive networks of many of the APN+ members are struggling with the implementation of the TRIPS regime and its impact on access to medicines.
Again we express our appreciation for the statement of the UNITAID Board Chair that the Patent Pool, “in no way means to replace or override” the Doha Declaration and that it is an “additional tool,” for increasing access to HIV treatment. However, the experience for countries in using TRIPS flexibilities has shown that those whose interests lie in the promotion of an inequitable patent system will use every possible avenue to put pressure on developing country governments to prevent the use of these flexibilities.
Our concern remains that patent-owners, associations of multinational pharmaceutical companies and even the governments of some developed countries will use the existence of the Patent Pool to oppose the use of safeguards like compulsory licensing, pre-grant oppositions, and patent revocations. We look forward to hearing from the Board what specific safeguards will be included in the Patent Pool Implementation Plan to prevent this misuse by patent owners.
The experience of Thailand in trying to negotiate with patent owners would be a useful guide in this regard. These negotiations got extended to two years. One of the measures the UNITAID Patent Pool could take is to have strict time restrictions on negotiations. The other could be to ensure absolute and complete transparency so that we, as civil society and patients waiting for the drugs and our governments know exactly where we stand in these negotiations.
We hope you will appreciate our concerns in this regard as many of us have experienced first hand the result of the manipulation of multinational pharmaceutical companies through greater enforcement of their patents or voluntary licensing to keep crucial medicines out of the reach of patients. Voluntary licensing in our experience has had limited benefits for a limited time for a limited number of people. We appreciate that the UNITAID Patent Pool will attempt to correct some of these issues with voluntary licences and in doing so, we hope that they will rely on some of our experience in this regard.
What is being considered by the UNITAID Executive Board is the investment of several millions of dollars to create a mechanism to ensure greater access to treatment. This investment will be wasted if the actual functioning of the Pool is unable to escape or improve on some of the worst aspects of the TRIPS regime.
From APN+ we request that the UNITAID Board examine critically what the impact of the Patent Pool will be on the use of TRIPS flexibilities by developing countries and to ensure that it does not inadvertently legitimise the actions of the multinational pharmaceutical industry to use patent monopolies to control our access to treatment. Thus, we still believe that the UNITIAD Board has to consider carefully the questions and concerns we have raised in this letter.
Sincerely yours,
Shiba Phurailatpam
Regional Coordinator
On behalf of APN+
Tel: +66 (0) 2255-7477
Fax: +66 (0) 2255-7479
Email: shiba@apnplus.org
[1] MSF, UNITAID Patent Pool: Key Developing Countries at Risk of Being Excluded, 8 December 2009
[2] Kelly Morris, HIV drug patents in the spotlight, The Lancet Infectious Diseases, Volume 9, Issue 11, November 2009
