E-DRUG: Indian Civil Society Letter on UNITAID Patent Pool Implementation Plan
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Dear All,
Pasted below is the Indian Civil Society Letter on UNITAID Patent
Pool Implementation Plan.
Best Regards,
Santhosh M.R.
Centad
www.centad.org
santhosh m r <sanspharma@gmail.com>
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*Indian Civil Society Letter on UNITAID Patent Pool Implementation Plan*
11 December 2009
To the UNITAID Board Chair
Dr Philippe Douste-Blazy
Special Adviser on Innovative Financing for Development *
*UN Under-Secretary-General
This is with reference to the Patent Pool that UNITAID is working to
establish to ensure the availability of ARVs to people in developing
countries. The Patent Pool Implementation Plan is to be approved by the
Executive Board meeting on 14-15 December 2009.
As we all know, increasing protection of intellectual property (IP) in
developing countries as a result of the TRIPS Agreement puts the lives of
millions of people living with various diseases including HIV, cancer, heart
disease, asthma, blood pressure, etc. at risk.
TRIPS has created vast inequities in global health by formalizing and
institutionalizing a system where a person’s wealth is the prime determinant
of their health. For example, better anti-retrovirals are already being used
in the treatment of HIV/AIDS by patients in the developed northern
countries. However the same are not available to people living in the
countries of the global south precisely due to prohibitively high prices and
extremely controlled availability of ARVs that have been patented.
Consequently, patients of the global south are compelled to use older,
ineffective treatments. It is in this context that the patent pool is seen
as a mechanism to mitigate the disastrous impact of IP protection on
treatment; in the case of HIV, the hope is –
1) to allow for production of generic versions of second line and newer
antiretroviral drugs
2) to allow for the development of fixed dose combinations of ARV medicines
simplifying treatment for PLHIV
3) to allow for the development of pediatric formulations by generic
producers
Members of Indian civil society have always been and are willing to discuss
the initiative of UNITAID in setting up a patent pool for HIV/AIDS in
detail.
However, we feel that there has been lack of transparency regarding the
drafting and processing of the Patent Pool Implementation Plan. This owes to
UNITAID’s formal refusal to share the Patent Pool Implementation Plan with
civil society stake holders and patient groups in developing countries and
to only allow access after the forth coming Executive Board meeting. We are
disappointed that this is unlike the phase when the Pool was being
conceptualized and the broad outline of the "idea" was discussed with some
civil society organisations and academia. Indeed, this has weakened the
support that is crucial for its success.
Therefore, we are writing to you to share our concerns and apprehensions on
the intent and content of the above said implementation plan:
1. *Undermining India’s section 3(d)* - One issue that is of serious concern
to Indian civil society is the Plan’s casual reference to the development of
FDCs and pediatric formulations as "follow-on innovation". While these may
be important adaptations better suited to the treatment needs of AIDS
programmes of developing countries – they do not deserve patent protection
as is argued by pharmaceutical companies in their ongoing lobbying and legal
actions to weaken one of Indian patent law’s most important public health
safeguards - section 3(d).
Attempts to patent such changes to the original molecule are best
characterized as evergreening or the extension of monopolies on an existing
medicine. Our concern in this regard has increased with the provision for
mandatory grant backs of improvements – the Pool thus creates an additional
revenue stream for generic manufacturers precisely on such patents. The
inevitable fallout of such a provision is an increase in patenting of such
changes not only by multinational pharmaceutical companies who would like to
preserve their monopolies on as many changes and improvements as possible,
but now also by generic manufacturers in the hopes of opening up revenue
streams for themselves.
That voluntary licences form part and parcel of bad patenting practices of
companies is evident from the actions of Gilead Sciences in India and in
Brazil. Groups in these countries are involved in oppositions on multiple
patent and divisional patent applications being filed by Gilead Sciences to
create monopolies on *tenofovir* – a pre-1995 medicine. For civil society
organisations involved in these legal battles, the logic is simple – the
decision of who gets medicines and who does not can never lie in the
shifting priorities or public relations compulsions of one company.
Without addressing this critical issue, what the Patent Pool would then
achieve is the legitimization of bad patenting tactics – companies indulge
in such practices because there are incentives for them to do so and the
Pool will just provide yet another incentive for bad patenting practices.
2. *Undermining support and resources for patent oppositions in India* - The
legal challenge of patent applications by patient groups of known medicines
such as ARVs is technical, difficult but not impossible. In fact, patient
groups have already enjoyed some measure of success with the rejection of
patents on *imatinib mesylate*, *tenofovir* and *nevirapine hemihydrate*. In
other cases, the oppositions have resulted either in withdrawals of
applications such as the one for the *lamivudine/zidovudine* combination or
changes in patent claims. Groups in Thailand and Brazil are also using the
opposition system to safeguard their access to generic medicines and improve
the functioning of patent examination processes.
In fact they played an unacknowledged but crucial role in the production of
second line ARVs by Indian generic producers – even though several
applications were pending before the Indian patent offices. It is in this
regard, that we would like to convey our deep feelings of despair and anger
on the Plan’s approach to the discussion on India’s patent law and patent
oppositions. To discuss this purely as a matter of legal uncertainty for
patent holders and generic manufacturers rather than a key public health
safeguard has done a great disservice to those fighting on the ground, in
the very real battlefield for access to medicines. The analysis of strengths
and weaknesses leads to the inevitable situation of pitting the Pool as a
better choice against such work undertaken by Indian patient and legal
groups in India. Indeed the descriptions on Pg 30 and Pg 128 paint a bleak
picture leading one to interpret that the Pool makes a better choice for
those who have supported such legal work in India till now.
3. *Undermining compulsory licensing* –The Patent Pool naturally reinforces
the patent system; it also bears the political risk of undermining advocacy
and strategies towards mainstreaming of TRIPS flexibilities. If the pool
becomes a reality then ongoing negotiations with the Pool will be used by
pharmaceutical companies to delay and even prevent developing countries from
using public health safeguards like CLs or government use licences.
Safeguards to prevent this from happening are not detailed in the
Implementation Plan. It is crucial that the Patent Pool negotiations are
transparent and time bound.
We are also extremely wary of the suggestion in the Patent Pool
Implementation Plan of the further incentives required for the inclusion of
all developing countries in the Pool. While tiered royalty appears to be one
suggestion, some of the other suggestions seem to be dependent or contingent
on government action. Generating this sort of role for developing country
governments in the inclusion of their countries in the Patent Pool creates
significant barriers for governments considering the issue of compulsory
licences. For developing countries, the bargain for access was their
agreement to implement the TRIPS regime. To create further obligations or
further conditions on developing country governments for access to treatment
is simply unacceptable.
4. *Undermining the 2016 TRIPS deadline for LDCs *– One of the effects of
the Patent Pool and the push by multinational pharmaceutical companies for a
primary focus on LDCs is that patients and governments in these countries
will effectively be paying increased prices (because of royalties) even
though they are not required to enforce patent rights on pharmaceuticals.
The disastrous consequences for LDCs (who rely on imports of key medicines)
of increasing patent protection in developed and developing countries was
noted at the time of the Doha Declaration. The result was the Para 6
solution, which is admittedly an absolute failure. Companies like Gilead
Sciences have exploited this failure by giving out voluntary licences for *
tenofovir* and charging royalties for LDCs where, according to KEI’s FTC
complaint they had not even applied for and/or had not got patents. The
Patent Pool will legitimize this practice. Pharmaceutical companies pay
little attention to the filing of patents in LDCs but there is concern that
the proposed Patent pool will provide additional incentives for aggressive
patenting by pharmaceutical companies in LDCs to seek the maximum royalties.
5. *Faulty and unnecessary classification of developing countries* - The
Patent Pool Plan has adopted the World Bank classification of countries,
which will be used to assess treatment needs. It is unfortunate that the
classification and the objectives of the patent pool are in two different
directions. We apprehend that adoption of this list would leave out millions
of patients in developing countries which have been classified as middle
income countries by the World Bank. It is also not very clear about the
rationale of having such a classification of countries. Ideally, all the
deserving patients across the developing world should benefit from the
generic production that the Pool facilitates. The World Bank classification
will fragment the market further into low income, low-middle income,
high-middle income and high income countries. This shows that the pool will
be driven by the faulty economic principles based on the per capita income
of countries rather than their actual health needs and ability to access
medicines and treatment.
6. *Controlling generic competition* – As with the case of all voluntary
licences, one of the primary motivations for pharmaceutical MNCs to
participate in the Pool will be their ability to control generic
competition. The idea behind a public health oriented Patent Pool should
have been to move away from such business practices regarding developing
countries; instead it gives in to the demand of patent-owners to allow them
to segment even developing country markets; a decision that impacts patients
lives, creates more inequities in access to treatment and considerably more
pressure on developing country governments. The Pool also complicates
considerably the process of negotiations for itself and will eventually
allow pharmaceutical companies to blame, variously, the Pool, its partners,
governments, generic companies and civil society for not creating the right
conditions for the inclusion of all developing countries. In doing so the
Patent Pool Plan also seems unmindful of the current consolidation already
taking place between multinational pharmaceutical companies and Indian
generic producers. By allowing patent owners to further segment the markets
it promotes this consolidation and ultimately undermines the true
competition it seeks to promote. The effects of this consolidation become
even greater when the Patent Pool does not promote local manufacture as
discussed below.
7. *Preventing local production* – The Proposed Patent Pool Plan aims mainly
at the supply of HIV medicines to lower income countries and may include
some of the middle income countries under a different set of conditions.
Thus it is simply a mechanism to address the issue of supply rather than
promoting local production and transfer of technology. The Pool does not
address the question of improving the local manufacturing capacity in these
countries. The beneficiaries of the Patent Pool in terms of production then
appear to be largely the bigger Indian generic companies that have the
technology and expertise in producing generic formulations. But digging a
little deeper, the ability to prevent local manufacture and transfer of
technology is precisely the second primary motivation for pharmaceutical
MNCs to join the Pool.
Indeed, according to their own presentation on the Patent Pool in November
2009, it is a matter where Gilead Sciences wants "consensus" with the Pool
before moving forward i.e. that local production should not be pushed.* This
approach ties the hands of developing countries that rely primarily on local
production for their healthcare programmes. It increases their dependency on
exports to the benefit of MNCs and large Indian generic companies rather
than promoting sustainability and local transfer of technology. For LDCs,
transfer of technology was a primary area where they were supposed to gain
from the TRIPS Agreement; something the Patent Pool undermines by not
promoting local manufacture and transfer of technology.
8. *Transparency is a key concern* – The Patent Pool is not going to publish
licensing agreements but only an overview of the license allowing companies
to escape public scrutiny. Nor is there any discussion of time lines for
negotiations, publishing when negotiations start and when they will end,
patents in which countries are being left out of the pool and hence the
licences and require further negotiations, what additional conditions are
being discussed and when those negotiations are expected to be concluded.
9. *Little bargaining power for the Patent Pool Entity* – By envisioning the
Patent Pool as an independent agency as opposed to one housed within
UNITAID, the only real bargaining power that the Pool had, as a purchaser of
medicines is removed. Thus, as far as Patent Pool negotiations are concerned
there is asymmetry in the bargaining power between patent holders and the
Patent Pool authority which will work to the advantage of pharmaceutical
MNCs. This is already evident from the Patent pool document that makes
concessions on geographical scope and pays scarce attention to the issue of
local production. We are also extremely disappointed by the analysis in the
Plan for where the Patent Pool should be located. We feel it unnecessary to
comment on this as the lack of substance of the analysis is self-evident.
Needless to say the choice of location again undermines the bargaining power
of the Patent Pool by placing it far beyond the access of civil society in
the Global South.
10. No clarity on licensing terms and condition or even the public health
parameters for their negotiation* - Apart from our concerns above, it is not
very clear what kind of licensing and royalty conditions would be agreed to
by the Pool. (a) *Will there be a proper transfer of technology as part of
the licence*? Without this there will be a greater time lag in making
available generic versions and increase in costs as generic companies will
have to spend more time and money on producing the generic versions.
According to a 2007 Oxfam supported study of voluntary licences, including
those of Gilead Sciences, the transfer of technology was in fact
insufficient for speedy and efficient generic production. (b) *Will sales be
restricted to government or also include the private market and vice versa*?
This is a crucial issue decided not by licence terms and conditions but by
the public health infrastructure of a country. Dependence on government
programmes can be a great barrier where such treatment programmes are
restrictive in nature as was the case in India when despite an offer of
fully subsidized second line treatment by the Clinton Foundation and generic
production, the Indian government delayed considerably the rollout of second
line treatment. (c) *How will disputes be settled?* We are extremely
concerned that WIPO is being considered as the forum for dispute settlement.
WIPO has a proven organizational history of approaching public health issues
from a position that only strengthens intellectual property rights and
benefits rights owners. *We do not view WIPO as a neutral or acceptable
forum for dispute resolution for licences whose primary purpose is the
promotion of public health.* (d) *Will licensors be allowed to control API
supply*? (e) *How will the licence terms and conditions address those
countries where there is data exclusivity?* We are greatly concerned by the
lack of clarity on these matters.
We would like to re-iterate, that as a part of the IGWG process, the
undersigned have always supported the use of new and alternate mechanisms
for R&D and access including the Patent Pool. However, we strongly feel that
the UNITAID Patent Pool Implementation Plan has not responded to the
aspirations and concerns raised by the patient groups, civil society
organizations, policy makers and academia in India. We urge the UNITAID
Board to discuss and debate fully the concerns we have raised and to hold
wider consultations with civil society and patients groups before approving
the Plan. We the Civil Society Organisations are formally signing on to this
letter:
1. National Working Group on Patent Laws (NWGPL)
2. Centre for Trade and Development (Centad)
3. LOCOST, Baroda
4. All India Peoples Science Network
5. Drug Action Forum - Karnataka
6. All India Drug Action Network (AIDAN)
7. Initiative for Health, Equity and Society (IHES)
Santhosh M.R.
mob-(91)9868631022
santhosh m r <sanspharma@gmail.com>
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The letter was copied to the following organisations
UNITAID Secretariat
World Health Organization
20, avenue Appia
CH-1211 Geneva 27
Switzerland
Telephone: +41 22 791 55 03
Fax: +41 22 791 48 90
E-mail: unitaid@who.int
Members of the Executive Board
Brazil
Ms Maria Nazareth Azavedo Farani
Ambassador*
*Permanent Mission of Brazil*
*Geneva, Switzerland
Tel: +41 22 332 50 00
Fax: +41 22 910 07 51
Email: *mission.brazil@delbrasgen.org* <mission.brazil@delbrasgen.org>
Chile
Dr Fernando Muñoz
Attaché*
*Permanent Mission of Chile to the United Nations and other International
Organizations*
*Geneva, Switzerland
Tel: +41 22 919 88 00
Fax: +41 22 734 52 97
Email: misionchile@misginchile.org
France
Mr Patrice Debré
HIV/AIDS Ambassador*
*Ministry of Foreign Affaires*
*Paris, France
Tel: +33 1 43 17 71 12
Fax: +33 1 43 17 75 72
patrice.debre@diplomatie.gouv.fr
Norway
Ms Sissel Hodne Steen
Counsellor*
*Permanent Mission of Norway to the United Nations and other International
Organizations*
*Geneva, Switzerland
Phone: +41-(0)22 918 0400
Fax: +41-(0)22 918 0410 and +41-(0)22 918 0411
E-mail: mission.geneva@mfa.no
United Kingdom*
*Mr Gavin McGillivray*
*Head*
*International Financial Institutions Department, DFID*
*London, United Kingdom
African countries*
*Dr Damase Bodzongo
Director General of Health*
*Ministry of Health*
*Brazzaville, Congo
Asian countries*
*Mr Sul Kyung-hoon
Director General*
*Development Cooperation Bureau*
*Ministry of Foreign Affairs and Trade of the Republic of Korea*
*Seoul, Republic of Korea
Nongovernmental organizations* *(NGOs)*
Dr Mohga Kamal Yanni
Sr. Health Officer *
*Oxfam*
*Oxford, UK
Communities living with the diseases*
Ms Carol Nawina Nyirenda*
*Treatment Advocacy & Literacy Campaign, TALC*
*Lusaka, Zambia
Constituency of foundations*
*Mr Joe Cerrell
Director of Global Health Policy & Advocacy*
*The Bill & Melinda Gates Foundation*
*Seattle, United States
WHO*
*Ms Namita Pradhan
Representative of the Director-General for Partnership and UN Reform*
*World Health Organization*
*Geneva, Switzerland