domingo, 5 de febrero de 2012

New Letter to the European Union (February 2012) PLEASE SIGN!



                                                                                                                      Latin America, February 2, 2012.

Dear members of the Negotiating Team of the European Union;

We write as networks of people living with HIV and NGOs from Latin America and the Caribbean to ask the EU to cease their harmful demands in the free trade agreement (FTA) negotiation that is taking place between India and the European Union. This negotiation clearly favors the pharmaceutical industry and puts financial gain - in the name of free trade - above human rights.

India plays a key role in the production and supply of essential medicines - not only to Indian citizens, but for many in need of medicines in the countries of Latin America and the Caribbean. The FTA could put an end to India's important role as a provider of affordable medicines for people living with HIV as well as those living with other diseases worldwide.

In our previous letter dated 8 November 2010 we clearly outline our concerns about the negotiations, but as the text of the agreement is kept in absolute secrecy, we cannot rely on the previous response of the European Union that nothing in the agreement could affect access to medicines.

Although the text of the agreement has not been released, since negotiations are conducted behind closed doors - despite the impact it will have on all people not just in India but throughout the developing world - some provisions have became public. That is why we express our deep concern about the pressure that the EU continues to exert to achieve the inclusion of higher levels of protection of intellectual property rights in the FTA.

The provisions that have become public seek intellectual property provisions that go beyond international standards of protection established in the TRIPS Agreement of the World Trade Organization (WTO), violating the principle of primacy of international human rights and international commitments to ensure universal access to essential medicines.

These provisions are known as TRIPS-Plus provisions and the pressure for their inclusion in this FTA by the EU shows contempt for the lives of millions of people around the world who currently rely on medications that come from India. The interruption of treatment will cause irreparable harm that will accelerate drug resistance, a situation that is already being created by Patents on newer medicines and other intellectual property provisions that limit access to second-and third-line drugs due to the pharmaceutical monopolies that keep medicine prices high.

The adoption of the European Union's proposals would make an already bad situation much worse. We are demanding that the European Union immediately withdraw all provisions in the EU-India FTA that will impact access to medicines.

In particular we demand:

The following provisions are eliminated from the EU-India FTA:

·         Investment rules, which allow foreign companies to sue the Indian government for adopting national health policies, such as measures to reduce drug prices.

·         Border measures, which will deny access to medicines in developing countries, aware that empower customs officials to seize generic drugs in transit.

·         Injunctions, which undermine independence of the Indian judiciary to protect the right to health of citizens over benefits of pharmaceutical companies.

·         Other intellectual property enforcement measures, as they put even third parties, such as treatment providers at risk of litigations and subject to judicial actions.

WE ALSO DEMAND that the EU not bring back to the negotiating table measures such as:

·         Data exclusivity, which will delay registration of generic drugs and will not allow the placing on the market for affordable versions of pediatric doses and combinations of "non-patented drugs." THIS MEASURE IS NOT REQUIRED BY THE WTO TRIPS AGREEMENT!

·         The extension of patent term, as it prolongs the life of patents beyond the 20 years required by the TRIPS agreement.

We urge the EU to set aside this aggressive and shameful agenda, so as to ensure that the generic medicines industry in India can continue its role of provider of affordable medicines and quality guaranteed to Latin America, Asia and Africa.

We demand that all TRIPS-plus provisions be removed from the negotiations and that the FTA negotiating text is made public immediately.

Likewise, we demand that the EU does not pressure the MERCOSUR to adopt TRIPS-Plus provisions in the FTA negotiations between the two regional blocs and that European Union's proposals in this FTA negotiation are also made public
To sign go

viernes, 7 de enero de 2011

European Commission Response

Brussels, 6th JAN, 2011

Subject: Letter of 6 November 2010 from Latin America to European Union - India-

Dear Ms. Di Giano,
I refer to the petition that you sent me on 8 November 2010 in which you express concern
about the potential impact of the intellectual property provisions in the EU-India Free Trade
Agreement (FTA) on access to medicines.

The Commission recognises that India is an important source of generic medicines which the
world's poorest heavily depend on. And I can reassure you that this is duly taken into account
in the bilateral trade negotiations between the EU and India.

First of all, the agreement under negotiations will not undermine India's right to protect the
public health and interests of its citizens, as the petition is suggesting. Nothing in the
agreement will prevent India from using compulsory licensing for manufacture and export of
medicines to other developing countries in need. To this effect, the Commission has already
proposed an explicit reference to the Doha Declaration on the TRIPS Agreement and Public
Health so as to ensure that the flexibilities granted by the TRIPS Agreement, especially as
regards patents on medicines, can be fully used by India. Moreover, the Commission has
proposed a provision stating that "nothing in this Agreement shall be construed as to impair
the capacity of the Parties to promote access to medicines".

Furthermore, with regard to so-called "TRIPS Plus provisions", it is important to differentiate
between the potential provisions you may have in mind. While the issue of patent term
extension is no longer under negotiation with India, the issue of data exclusivity is still being
discussed. The purpose of data exclusivity is to taL· into account the fact that the development
and marketing of a new medicine requires the originator to conduct extensive research and
testing. In these ongoing discussions, the EU will fully taL· into account the specificities of the
Indian legal system, the policy developments on this issue within India, its developing country
status and the role it plays with regard to production of essential generics for the developing

Regarding potential provisions on enforcement of intellectual property rights and border
measures, the agreement will not hamper the trade of generic medicines in transit. The
enforcement provisions will be construed in a way so as to ensure the smooth flow of generics
in transit, thereby not deterring generic competition nor making export of medicines from
India to other developing countries more difficult.

To conclude, I hope I could reassure you that the reality of the negotiations with India should
not give raise to concerns set out in the petition. The intellectual property chapter of the FT A
with India is still under negotiation. Certain elements have been put on the table for
discussion, and the Commission together with India is looking into these elements in order to
reach afinal outcome which will satisfy both sides.

Promoting access to medicines is an essential pillar of the Commission's policy on intellectual
property, and I assure you that it is also fully taken into account in the negotiations with

Yours sincerely,

 MH/amw/A res

lunes, 13 de diciembre de 2010

Letter to GF Executive Director from Developed Countries NGO Delegation

13 December 2010

Dear Michel ,
We are writing to you as Developed Countries NGOs delegation, to attract your attention to a critical issue that will have huge impact on the Global Fund critical role in access to medicines. We have serious concerns about the EU negotiating position in the EU-India Free Trade Agreements (FTA).
As you know, India is the pharmacy of the developing countries where millions of people depend on affordable medicines manufactured in India. Over 80% of the medicine purchased by the Global Fund are manufactured in India. The EU is demanding that India adopts stricter intellectual property rules for pharmaceuticals such as data exclusivity and IP enforcement. These measures, which are TRIP+ would reverse years of hard-gained advances in the treatment of HIV, TB , and malaria.
We welcome the EU indication that it would place a legally binding reference to the Doha declaration on TRIPS and public health. However it would be mostly irrelevant if a legally binding, stricter level of IP protection is introduced in the FTA.
Therefore we urge you to use the influence of the Global Fund to ensure that the EU would not introduce these damaging measures and we urge you to put out a public statement regarding the Global Fund position from such negotiations.
Yours sincerely,
Joanne Carter, Board member Developed Country NGO delegation
Dr. Mohga Kamal-Yanni, Alternate Board member Developed Country NGO delegation

Letter to Global Fund Executive Director by Communities Delegation

13th December 2010
Dear Dr. Kazatchkine,

The Communities Delegation recognises the significant progress accomplished with respect to access to life-saving treatment, of which the availability of affordable generic versions of HIV-related treatments has played a critical role in achieving.

India plays a key role in producing, registering and supplying essential medicines to all countries.  According to the study published by the Journal of the International AIDS Society, in 2008 alone, Indian-produced generics accounted for a staggering 91% of paediatric ARV and 89% of adult nuceloside and non-nucleoside reverse transcriptase inhibitor markets.  Furthermore, an estimated 4 million people to start on treatment between 2003 and 2008, and 96 of 100 countries purchased Indian generic ARVs in 2008, including high HIV-burden sub-Saharan African Countries.

The EU is pushing an aggressive trade agenda, and using the current Free Trade Agreement (FTA) negotiations with India to pursue 'TRIPS plus' provisions and enforcement rules that go beyond the international World Trade Organisation's (WTO) TRIPS agreement standard protections of intellectual property, such as patent extensions, border measures, data exclusivity, etc.  This will further restrict India from producing and selling affordable generic versions.

This FTA agreement and its discussions will clearly reduce the vital role of India as a provider of life-saving treatments for millions of people.

The current economic climate presents significant challenges to the Global Fund.  Without the resources necessary for the significant expansion of necessary funding, we must redouble our efforts on achieving maximum value for money.

Those in need of treatment continues to eclipse supply.  The proposed TRIPS plus provisions under the India-EU FTA has the potential to significantly impact on the capacity of Global Fund supported programmes to procure high quality and low cost ARVs, and will erode any progress made by the Market Dynamics and Commodities Ad-hoc Committee.

Most importantly, millions of lives will be affected, and HIV-related deaths will result.
We strongly welcome the recent UNAIDS statement (released 9th December 2010) which calls for all countries to increase efforts towards achieving Universal Access and refers to the negative impacts of TRIPS plus by stating that "...Trade agreements that place additional burdens on the manufacture, import or export of lifesaving medicines - so-called 'TRIPS plus' measures such as 'data exclusivity -- and incorrect interpretations of the term 'counterfeit' should be avoided...", a statement that has been echoed by the World Health Organisation.

The EU Commission has defined its role in Global Health in regards to TRIPS Plus provisions (in the Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions, Brussels, 31st March 2010) as "... The EU should work to ensure more effective use of TRIPS provisions to increase the affordability and access to essential medicines.  The EU should continue to ensure that EU bilateral trade agreements avoid clauses which may undermine access to medicines.  Generic competition and rational use of medicines are of major importance to ensure the sustainability of healthcare systems..."

The Communities Delegation would like to raise awareness on this issue amongst the Global Fund Board delegations, so as to work with the EU to ensure TRIPS plus provisions are excluded from its FTA with India.

We firmly believe that your role as the Executive Director of the Global Fund is critical in raising this vital issue during the Board Meeting during your Report of the Executive Director, to ensure Global Fund Board Members and Delegations are aware of the importance of this issue and the severe implications and consequences for the Global Fund and its supported programmes -- for less people will be able to access essential life-saving treatments at a time when resources available are severely under pressure.

Carol Nyirenda
Outgoing Board Member

Morolake Odetoyinbo
Incoming Board member

Shaun Mellors
Incoming Aternate Board Member
Communities Delegation on the Global Fund Board

sábado, 30 de octubre de 2010

Call to Action

Do you know where your drugs come from?
As a result of globalization, every day we use products from around the world; flowers from Colombia, Mexican tortillas, coffee from Costa Rica, Chilean and Argentine wines, Peruvian asparagus and medicines from India.
Most of us every day of the year take two or three pills that are produced in India which allows us to regain our health and continued development of our life. In Peru, Bolivia,  Ecuador, Costa Rica, Nicaragua, El Salvador, Honduras, Guatemala, Argentina, Venezuela, Dominican Republic and other countries in Latin America, most antiretroviral drugs we take come from the Asian country as they have very low cost and proven quality.
However, the European Union intends to put their hands on our medicines and to limit our access. How? Through a trade agreement that would limit the production of quality drugs at a low price in India.
We believe it is necessary to support the campaign initiated by Doctors Without Borders to require Europe to desist in their attempts to limit the production of quality generic medicines at low prices through strict intellectual property laws which seek to include in its trade agreements.
Colombia and Peru were able to make Europe desist in these claims, India can do it too.
This is one of the actions we will be motivating. We have prepared a letter to the embassies of India that supports our request. The more letters received, the stronger will be our request.
Here we extend some of the addresses of embassies in Latin America.
Just sign the letter and send it by e-mail, fax, or mail.
It is important to do it soon as 8th November 2010 negotiations between India and UE will recommence.