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M. Chan Park, Executive Director ad interim at the Medicines Patent Pool
The governance board members of the Medicines Patent Pool
The Expert Advisory Group of the Medicines Patent Pool

Dear M. Park,

Dear governance board members of the MPP,

The above mentioned French organizations involved in the response to
HIV/AIDS, are writing to you ahead of the meeting to be held in Johannesburg on November 9th, 2012. Among us, only the Act Up-Paris representative will be able to attend this event. However, our organizations have been supporting UNITAID, and following closely the Medicines Patent Poolʼs work and impact over the last years. Thus, based on the lessons from the first license signed between GILEAD Sciences Inc. and the MPP, we would like to express our concerns, along with recommendations and principles we believe should be applied in the future.

Since the launching of the MPP, and the signing of the first MPPʼs licenses,
our organizations have been following the outcomes of the Medicines Patent
Poolʼs work. We believe that the MPP – as a non-profit foundation focused on
public health interests and funded by UNITAID (an organization hosted by
WHO) – should respect the following principles.

Supporting all developing countries’ access to medicines

The MPP should find/develop its added-value in the negotiations on
voluntary licensing: it should ensure the licenses it signs to bring a significant improvement in access to medicines, and especially in geographical coverage. Several companies such as GILEAD Sciences Inc., had already signed voluntary licenses with developing countries for their products before the creation of the MPP. So far, the licences signed by the MPP have barely improved these medicinesʼ scope: in the case of GILEADʼs TDF, it has been extended to less than 17 countries and islands with non significant or no data on HIV[[Anguilla (British overseas territory), Armenia, Aruba, BritishVirgin Islands, Ecuador, El Salvador, Fiji Islands,
Georgia, Kazakhstan, Montserrat (British overseas territory), Nauru, Palau, Southern Sudan, Sri Lanka, Tonga, Turkmenistan, Turks and Caicos (British overseas territory)]]. The sole improvement of the status quo should not be the MPPʼs only motivation to sign a license.

Furthermore, by signing its first license in 2011 with GILEAD Sciences
Inc., the MPP – a foundation supported by UN agencies – has officially
signaled that excluding some Middle-Income countries is acceptable. Knowing that such exclusions are becoming increasingly common in other mechanisms aiming to reduce medicinesʼ prices, we are extremely concerned about patients living in those countries, as most of them cannot afford expensive medicines.

Moreover, since least developed countries still benefit from an extra
transitional period that runs until 2016 to implement TRIPS, the main concern regarding intellectual property rightsʼ enforcement is Middle Income Countries, where patents are indeed huge obstacles to access to medicines. Thus, in order to resolve the problems caused by patents, the Medicines Patent Pool should focus on countries and medicines which access is impeded by patents.
In other words, we consider that the MPPʼs real added value should be to
improve the access in these MICs.

Rejecting extensive restrictions on licensees

The MPP should not accept any geographical restriction on suppliers or
on Active Pharmaceutical ingredients (API)ʼs suppliers, as it did with GILEAD
Sciences Inc. Principal criteria for the supplier selection has to be pre
qualification by WHO or by a stringent national medicine regulatory agency.

Promoting a more transparent and inclusive negotiation process

Ahead of negotiations, the MPP should investigate developing countriesʼ
Patent landscape and real needs in order to better take them into account in
negotiations with patent holders. Market studies cannot be considered as
sufficient! Additionally, the MPP should improve the database available on its
website, which has become a valuable resource for activists working on patent landscapes.

When engaging in negotiations with patent holders, the MPP should
require from the latter not to simultaneously negotiate or sign other deals
covering the same products, which would result in market disturbances and/or additional barriers to access medicines.
Additionally, licensesʼ negotiation process should be more inclusive.
Civil society organizations and their representatives at the EAG should be able to disclose licensesʼ content to their constituencies in order to validate them. Countries, especially those excluded from licences, should also be involved in the discussion, especially on the impact of such licences on access to medicines.

Finally, once licenses have been signed, the MPP should develop meaningful indicators (such as those mentioned in the I-MAK / ITPC position paper on Voluntary Licenses[[Cf. Voluntary Licensing: Optimizing Global Efforts and Measuring Impact, September 10, 2012, P.4.]]) to assess its impact on prices and access to treatment.

Retaining some leverage beyond the negotiation phase

The MPP should not renounce its arbitrary and mediation functions in
case of disputes between a patent holder and a supplier (as it agreed to in the MPP/TDF licence). The MPP should be able to play its part in such case, as well as promote and protect public health and the public interest in such

Supporting existing alternatives

Finally, the MPP should ensure its work does not hamper excluded
countriesʼ ability to import medicines, or undermine countriesʼ implementation of TRIPSʼ flexibilities. Broadly speaking, the MPP should clearly show its compliance with and support to the exceptions and flexibilities included in the TRIPS agreement and related Declarations.

Act Up-Paris, Sidaction and Solthis have different mandates and
strategies but each of us have been campaigning for the universal access to
HIV treatments worldwide for a long time. Act Up-Paris has been campaigning in the past decade against TRIPS-plus provisions in international and bilateral trade agreements, and on the issue of patentsʼ and IPʼs consequences on access to medicines. Sidaction is an organization providing support and funding to groups providing care, prevention and services to HIV+ people and/or promoting access to care in their countries. Solthis has been setting up programs in several African countries (including: Mali, Niger, Madagascar, Guinea, Sierra Leone, Burundi) to develop new strategies and better practices to improve health systems and the quality of care in the field of HIV/AIDS.

Our organizations have been pushing for Franceʼs involvement in global
initiatives against HIV/AIDS such as UNITAID since its creation. To keep
promoting such a stance, we have to be able to defend and support one of its main projects, in this case Medicines Patent Pool.

If the MPPʼs impact does not appear more clearly in the next months and years, and if the MPP does not take into consideration our concerns and recommendations, unfortunately we would have to recommend the money
from the airplane ticket tax to be used in a more effective way.

We strongly advise that the Medicines Patent Pool takes our concerns and
recommendations into consideration. For our organizations, the Medicines
Patent Pool should not cross the above mentioned red lines in future licensing.

Sincerely yours,

Frédéric Navarro, Président, Act Up-Paris

Eric Fleutelot, Deputy CEO, Sidaction

Louis Pizarro, Executive director, Solthis

The governance board members of the Medicines Patent Pool :
Charles Clift, Bernard Pécoul, Paulo Teixeira, Malebona Precious Matsoso,
Sigrun Møgedal

Expert Advisory Group members :
Labeeb Abboud, Jonathan Berger, Alexandra Calmy, Shing Chang, Carlos
Correa, Nelson Juma Otwoma, Eun-Joo Min, Lita Nelsen, Achal Prabhala,
Gracia Violeta Ross, Maximilliano Santa Cruz & Wim Vandevelde