TO: H.E Ambassador Dr Roberto RIDOLFI
Head of the European Union Delegation to Uganda

RE; India – European Union Free Trade Agreement to deprive Ugandans of access to life saving medicines
Dear Sir,

We (the undersigned) are writing this Letter as Civil Society Organisations in Uganda working in areas of Health, Trade, Intellectual Property and access to Medicines.

The purpose of this letter is to express our concerns over the Free Trade Agreement being negotiated between India and the European Union. We understand that there has been intense activity on this FTA in the past few months and there is significant pressure on the Indian government to announce “trade-offs” at this Summit. We are extremely concerned that our access to medicines may be traded away in this FTA. It has come to our notice that the India-EU FTA as currently drafted may have drastic consequences for the accessibility and affordability of medicines in Uganda because the EU is unyielding on the inclusion of provisions on intellectual property that exceed India’s obligations under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) and that, if not corrected, will endanger access to generic medicines—in India as well as in importing countries such as Uganda, where our lives depend on access to Indian generic medicines.

If such provisions on intellectual property are introduced in India, the ability of Indian generic companies to produce affordable medicines required not only in India but in Uganda as well would be severely compromised.

It should be noted that almost 90% of drugs in Uganda are imports of which most are generic versions from India. India like Uganda is a party to the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). As per requirements under TRIPS, India today grants product patents for drugs and pharmaceuticals. This has impacted the accessibility and affordability of cheap life saving drugs.

However, as confirmed by the Doha Declaration that all the governments of the European Union are signatory to, several provisions of the TRIPS Agreement can be interpreted and applied in a manner that ensures “access to medicines for all.” The Indian Parliament has accordingly included health safeguards in its patent law by using the Doha Declaration and have ensured that the door has not been completely shut on India’s generic drugs manufacturers. The Indian law uses multiple TRIPS flexibilities like strict patentability criteria, compulsory licence, parallel imports, no data exclusivity and several others to ensure that generic production continues.

Our concern is primarily that you ensure ELIMINATION OF THE FOLLOWING PROVISIONS IN THE EU-INDIA FTA:
• Investment Rules, as they enable foreign companies to take the Indian government to private courts over domestic health policies like measures to reduce prices of medicines.
• Border Measures, as they will deny medicines to patients in other developing countries with custom officials seizing generic medicines in transit.
• Injunctions, as they undermine the independence of the Indian judiciary to protect right to health of patients over the profits of drug companies.
• Other Intellectual Property Enforcement Measures, as they put third parties like treatment providers at risk of police actions and court cases.

AND DO NOT BRING BACK:
• Data Exclusivity, as it delays the registration of generic medicines and will not permit the placing of affordable versions of pediatric doses and combinations of “off-patent” medicines on the market.
• Patent Term Extension, as it will extend patent life beyond 20 years.

We note that the European Commission has stated that data exclusivity and patent term extension have been excluded from negotiations—and we are calling on your support to keep your promise.

The India – EU Free Trade Agreement must take maximum advantage of the flexibilities detailed under the TRIPS Agreement as affirmed by the Doha Declaration and August 30th decision on Public Health. As currently drafted, this FTA reverses the TRIPS flexibilities used by the Indian government and as such impedes access to medicines initiatives of Ugandans.

We are therefore looking forward to working with you to address our Concerns in this Free Trade Agreement prior to its being signed.

Sincerely;

1. Action Group For Health, Human Rights and HIV/AIDS (AGHA) Uganda
2. Community Integrated Development Initiatives (CIDI)
3. Health Global Access Project (Health GAP)
4. International Community of Women Living with HIV/AIDS East Africa
5. Southern and Eastern African Trade Information and Negotiations Institute (SEATINI)
6. The AIDS Support Organisation (TASO)
7. The Center for Health, Human Rights and Development (CEHURD)
8. Uganda Coalition for Health Promotion and Social Development (HEPS)
9. Uganda National Health Users’/Consumers’ Organisation (UNHCO)

Cc; Lady Catherine Ashton,
Vice President of the European Commission and EU High Representative for Foreign Affairs and Security Policy (VP/HR)

CC: Hon. Eriya Kategaya, Minister for East African Affairs Uganda,

Dear All,

In an earlier TWN IP Info., a NGO protest letter addressed to Mr. Francis Gurry was sent around. This protest letter is available at http://www.ghwatch.org/sites/www.ghwatch.org/files/AfricaIPSummit2012_0207.pdf

Below are some NGO views on the Africa IP Summit that will take place in April 2012.

Sangeeta Shashikant
Third World Network

NGO views on Africa IP Summit:

Catherine Tomlinson, Treatment Action Campaign, South Africa:
“The proposed agenda for the Africa WIPO Summit clearly shows that the summit is being used as a vehicle to drive the agenda of the US, the EU and the pharmaceutical industry to ramp up protection and enforcement of intellectual property. We urge ours and other African governments to reject the proposed agenda, which puts the profits of pharmaceutical companies ahead of the lives and health of people living in Africa. We call on ours and other African governments to take leadership in developing a balanced agenda which seeks to promote and protect development and affordable access to medicine in our countries.”

Mulumba, Moses, Center for Health, Human Rights and Development, Uganda:
“Its a shame that the Africa IP Forum is putting emphasis on IP enforcement agenda. One would expect the continent to be discussing the Development Agenda in light of its social economic challenges in the areas of health, education and agriculture. Over emphasis on IP enforcement is iniquitous of the continent’s population that still badly needs to utilise the policy space provided for by the TRIPS Agreement”

Andrew Rens, South African intellectual property expert and an academic currently carrying on research at Duke University:
“The event is being marketed as the first ever contintent wide Africa Intellectual Property forum so one would expect the topics discussed to be those issues in Intellectual Property which have been of most concern to Africans. In the years since TRIPS the single most important issue involving Intellectual Property for Africans has been gaining access to medicines. There is no track nor even an single session on access to medicines, but there is an entire track on the management and administration of intellectual property.

The South African government which is co-hosting the event has been a strong proponent of a treaty on exceptions to copyright for education. There is no session on educational exceptions but there is an entire track on enforcement.

Although proponents of ever more ambitious enforcement measures may have been temporarily halted in the United States with the rejection by Congress of SOPA and PIPA they continue to push for these measures in other countries including Africa. South Africa and other African countries have urgent problems that involve access to medicines and access to education. Why are these urgent problems that directly concern intellectual property rights not on the agenda?”

Teresa Hackett, Electronic Information for Libraries (EIFL):
“It’s as if the last five years didn’t happen – no WIPO Development Agenda, no discussion on copyright limitations and exceptions, no proposals in favour of libraries and archives, education, blind and visually impaired people. But they did happen, and we will work to ensure that delegates attending the African IP Forum hear a diversity of opinion and perspective, and have the opportunity to debate these issues that are critically important to libraries in Africa and around the world”.

Dr. Jeremy Malcolm, Consumers International:
“Intellectual property is a highly contested topic in the West, where many feel that governments have been excessively deferential to powerful rights-holder lobby groups, to the detriment of ordinary consumers. But in Africa, there are even bigger questions around the appropriateness the intellectual property paradigm to meet the continent’s health, education, and social and economic development needs. Therefore Consumers International was alarmed that the draft programme for the African Intellectual Property Forum entirely ignores these important questions. Such a forum will be seen by all not as a bona fide attempt at open discussion on the pros and cons of robust intellectual property protection in the African context, but rather as a cynical effort by foreign governments and multinational corporations to control the framing of these issues for African policy-makers.”

James Love, Knowledge Ecology International:
“The world community should be supportive to the development concerns of persons living in Africa whose population is largely comprised of poor persons and avoid unfair exploitation.

By organizing a high level meeting on intellectual property that is dominated by big corporate right holder interests, the US government is taking a step backwards, to exploit consumers rather than to promote development.

On May 10, 2000, President Clinton issued Executive Order 13155, on Access to HIV/AIDS Pharmaceuticals and Medical Technologies, which was designed to protect African consumers from trade pressures on intellectual property and medicine. The 2012 high level meeting shows no recognition of the policy set out in EO 13155, and would extend anti-consumer trade pressures to other sensitive areas for development, such as agriculture, climate change and access to knowledge and culture. Secretary John Bryson and other Obama Administration officials need to take a step back and change the format of the meeting, or cancel the event.”

Sangeeta Shashikant, Legal Advisor Third World Network:
“The US is well known for pressuring developing countries to adopt TRIPS plus standards. The Africa IP Summit is another attempt by the US to advance its aggressive agenda on IP protection and enforcement such as Anti-Counterfeit Agreement (ACTA), that favours the interests of certain powerful multinational companies. The US concept paper and programme totally disregards the numerous developmental and socio-economic challenges facing Africa. Issues of access to affordable medicines, access to knowledge, misappropriation of genetic resources and associated traditional knowledge, farmers’ rights are totally disregarded. Equally absent is a discussion on the value of public interest flexibilities in the IP system to achieve developmental objectives and address social needs. The US agenda is clear. It is about not about development. It is about protecting the interests of its companies, many of which are sponsoring the meeting, proliferating IP propaganda and misinformation. Unless steps are taken to fully reflect development and public interest considerations, and to eliminate actors only interested in an anti-development agenda, the event should not go ahead.”

Professor Brook K. Baker, Health GAP (Global Access Project) Northeastern U. School of Law
“It is deeply problematic that the Obama administration continues to pursue efforts to strengthen, widen, and lengthen patent, data, and copyright monopolies in African countries that desperately need expanded access to medicines, educational materials, and climate control technologies and that it simultaneously seeks even stronger enforcement of IP protections than what is currently required under international law. Carrying the policy portfolio of Big Pharma and other IP-based multinationals under the guise of addressing Africa’s needs, the proposed African IP Summit is a chilling example of US duplicity and conflict of interest at its worst. However, it is equally problematic if Africa leaders and policy makers, some of whom are already complicit with the US agenda, continue to drink the IP coolaid as they’ve done with proposed anti-counterfeiting legislation and with their long-lasting lethargy in amending their IP laws to take full advantage of TRIPS flexibilities and thereafter to use those flexibilities to access medicines and other essential technologies. Africa needs to develop innovative capacity focused on its unique needs, but it also needs to remain vigilant to guard against uncritical acceptance of IP fundamentalism that will ultimately increase foreign monopoly power and decrease Africa’s ability to compete in the global economy and secure the interests of its students, patients, and consumers.”

February 7, 2012 | by Els Torreele

This week, in a global week of action, health activists worldwide are out on the streets in an eleventh-hour effort to push back on EU pressure to lure India into trading away access to medicines. On February 10, a new and possible final round in the four-year negotiations on a Free Trade Agreement (FTA) between India and the EU is starting in Delhi. And the stakes are high. Last September, the EU threatened to break off the negotiations for lack of flexibility—read concessions—on the Indian side. And India wants the trade agreement as badly as the EU.

The EU-India FTA is expected to help India’s rapidly growing companies, in particular in the service industries, expand into the wealthy EU market, while Europe wants access to a vast, young, vibrant market of 1.3 billion potential customers. Looking at who’s going to be at the table next week, there’s no doubt the pressure to deliver is high: Herman Van Rompuy, President of the European Council, José Manuel Barroso, President of the European Commission, EU Trade Commissioner Karel De Gucht, and India’s Prime Minister Dr. Manmohan Singh.

While negotiators have allegedly reached a broad agreement on most issues, “last-mile” give and take still remains. And that is where the danger for unhealthy trade-offs lies, especially as the negotiations are largely shrouded in secrecy, a conduct for which the EU has been taken to court by transparency activists.

So what do we need to be afraid of?

The key issue is this: Europe is keen to include a variety of measures favoring the business interests of pharmaceutical companies at the expense of millions of people in developing countries whose lives depend on India’s supply of cheap generic medicines. And while the EU representatives keep repeating that this agreement will not hamper people’s access to medicines, the fragments of the negotiating text that have been leaked clearly indicate otherwise. I have previously described some of the potential threats of this FTA to access to medicines—in particular patent extensions and data exclusivity. As explained further in this video, the ultimate effect of these measures would be a delay in the availability of cheaper generics. In the case of lifesaving drugs, this means that many more people will die while waiting for affordable medicines.

In the past decade, India—often referred to as “the pharmacy of the developing world”—has played a pivotal role as the main producer and supplier of cheap generic drugs for HIV/AIDS and many other diseases, including cancer, diabetes, and asthma. In 2005, India was required to adapt its patent legislation to comply with the World Trade Organization’s TRIPS agreement that set minimal standards for intellectual property rights, including 20-year pharmaceutical patents. As a consequence, India’s capacity to continue producing low-cost generics, particularly for new and better treatments that are under patent, has been seriously curtailed. However, the Indian legislation still contains a number of public health safeguards, which health activists helped to secure, including a strict definition of the patentability criteria to forbid evergreening of patents (watch this fun video) and other provisions to facilitate the timely and widespread availability of generic medicines. And these are now under threat.

While India has so far resisted the EU’s request for more intellectual property protection and enforcement, it remains to be seen whether the world’s health interests will prevail over business interests once the secret horse-trading begins. Because this much is clear: recent statements from the European Commission reveal a vision on development policy that continues to emphasize serving European corporate interests ahead of combating poverty.

The EU is also proposing investment rules that would allow foreign companies to take the Indian government to court over domestic health policies, such as price regulation of medicines or other pro-health policies. We have already seen how such rules can lead to absurd situations, for instance when Philip Morris threatened to sue the Australian government over its plans to ban branded cigarette packaging to reduce the attractiveness of smoking.

And the EU is not the only governmental body negotiating trade agreements that could seriously hamper access to medicines for people in developing countries. The U.S. is currently pushing for similar intellectual property and investment rules in its negotiations for a Trans Pacific Partnership Agreement with eight Pacific countries including Malaysia, Vietnam, Chile, and Peru.

Meanwhile, as if in a concerted effort to weaken India’s pro-public health approach to pharmaceutical patents—even if it remains well within the boundaries set by the WTO— the pharmaceutical giant Novartis has taken the Indian government to court over its refusal to grant evergreening patents. The case has reached the Supreme Court, in which hearings are expected to start late February.

In the coming negotiations, it will be critical for India to stand strong against relentless pressures from the EU and U.S.—and the pharmaceutical giants—and remain committed to its laws protecting public health. We need to raise more voices of support to ensure the Indian government retains its prime role as generics supplier for the developing world. Sign on to this petition, join the campaign Facebook page, and get involved in protest actions all over the world.

source: http://blog.soros.org/2012/02/no-trade-offs-on-access-to-medicines/