After India, Australia too eyes tighter drug patent standards #Novartis judgement Impact

Rema Nagarajan, TNN | Apr 11, 2013, 05.31 AM IST

NEW DELHI: India is not alone in raising the bar for granting patents on pharmaceutical products. Australia, having reviewed pharma patents, has questioned the benefit of allowing patent extension beyond 20 years and is looking to tighten patent standards which have been found to be “less than rigorous” in the past. The draft report of Australia’s pharmaceutical patents review released recently also raised doubts about Australia necessarily getting more R&D investments from giving patent extensions.

While Novartis and the Big Pharma have threatened that they would not make R&D investment in India because of inadequate patent protection, the Australian review panel says: “It is difficult to see why a pharmaceutical firm would choose to conduct R&D in Australia, merely because the government decided to offer an extension of (patent) term here.” The panel report noted that it was fundamental issues such as relative costs of R&D and skill availability which influenced the location of R&D spending.

The report recommended that the current model of using the patents system to subsidise pharmaceutical R&D indirectly through patent extensions should be replaced with a direct subsidy. It observed that direct subsidy also had an additional benefit because it could be directed towards investment in pharmaceuticals which were not well addressed by the patent scheme, such as too little research for newer antibiotics, pharmaceuticals to address rare diseases, paediatric illnesses and endemic health issues in low income countries.

The patent review panel pointed out how the life of patent protection in Australia has been extended beyond even the 20 years mandated by the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property RightsTRIPS) because of a separate free trade agreement (FTA) that Australia signed with the US.

According to the review report, this FTA was signed “without careful regard to whether this was in our own economic interest” .



Don’t Let Your Governments Trade Away Our Lives

In an open letter to the citizens of Europe, the Chairperson of South Africa’s world famous Treatment Action Campaign appeals for collective action to stop European leaders pursuing harmful intellectual property provisions in the EU-India free trade agreement. India supplies 80% of the HIV medicines used in developing countries – the free trade agreement threatens this live saving supply.

An Open Letter to the Citizens of Europe

from Nonkosi Khumalo, Chairperson, Treatment Action Campaign, South Africa

Dear Citizens of Europe:

We are writing to you as people living with HIV/AIDS, who rely on access to affordable medicines to stay alive. We are writing to you because your governments are pushing to limit our access to medicines through a Free Trade Agreement the EU is negotiating with India, which is the world’s largest producer of affordable generic medicines. This week, as the EU and India meet for a summit in Delhi, our lives hang in the balance as the two sides make trade-offs to come to an agreement. Don’t let your governments trade away our lives.

The Treatment Action Campaign (TAC) was launched in South Africa in 1998 at a time when people across Africa were dying from AIDS because they couldn’t afford the high price of life-saving antiretroviral medicines. Over the past decade, TAC has campaigned with our international partners for affordable access to these medicines – seeing a nearly 99% drop in the price of a standard triple drug combination, from roughly 9,000 EUR per patient per year in 2000 to below 115 EUR per patient per year today. These prices came down primarily because of market competition among generic drug producers in India. Yet the battle for medicines access is not over, and many medicines, including cancer drugs and newer HIV medicines that people need after time, remain inaccessible to people in the developing world because of their high price.

We implore you, as citizens of the European Union, to stand with us against policies that are being pursued by your governments through the EU-India Free Trade Agreement (FTA) that will block our access to affordable medicines – putting our health and lives at risk. The agreement is being negotiated in secret, without opportunity for input by the citizens of EU member states and India. The EU has threatened to back out of the negotiations if the FTA is not signed by February – an attempt to force India to accept many of the harmful provisions the EU demands.

Ensuring that access to HIV medicines is protected is crucial to save lives and also reduce transmission of the virus. Last year, a landmark clinical trial showed that HIV treatment reduces by 96% the risk that the virus will be passed on. It is imperative that medicines remain available and affordable so that we can begin to turn the epidemic around.

India is often called the ‘pharmacy of the developing world.’ A study found that between 2003 and 2008, India supplied more than 80% of the HIV medicines used for the treatment of people living with HIV in developing countries. Beyond HIV, India is a vital supplier of affordable generic medicines to treat many other diseases.

But all this could change if the EU continues to pressure India to agree to more stringent intellectual property protection than that required by international trade rules. The United Nations, the World Health Organisation, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and UNITAID have all warned against the adoption of these stringent measures that exceed India’s obligations. The adverse impact these excessive intellectual property provisions have on access to medicines is well documented.

The harmful measures pushed by the EU include: so-called ‘data exclusivity’ that will delay the registration of generic medicines; investment rules that will allow multinational companies to sue the Indian government for implementing pro-health policies, and intellectual property enforcement measures that will, for example, block legitimate medicines from leaving India on their way to patients in other developing countries. The EU’s own experiment in increasing the enforcement of intellectual property has already had harmful consequences on access to medicines, with generic HIV medicines made in India being detained by European Customs officials on their way to Africa on allegations of intellectual property violation. The very real consequence of these seizures is stock-outs of medicines in clinics in poor countries and the interruption of life-saving treatment. The EU is now trying to legitimize these measures through trade agreements.

The European Parliament itself has recognised the role of India in supplying medicines to the developing world and understands the policies the European Commission (EC) is pushing through the FTA will have “a detrimental impact … on the availability of generic medicines.” Since the FTA negotiations started in 2007, health and public interest groups have repeatedly written to the European Commission asking them to remove these harmful demands. Across Latin America, Asia, Africa and Europe, people living with HIV have taken to the streets demanding that the EC withdraw its demands. Yet the EC persists.

As people living in developing countries, we are deeply dismayed that EU governments are pushing policies that prioritize profits of the already extremely profitable pharmaceutical industry at the expense of our lives.

For the first time in the history of the epidemic, we can now talk about reversing HIV/AIDS. We now know that HIV treatment itself—which TAC and countless other groups across the developing world have fought for over the past decade—holds the key to stopping infections. As citizens of the EU, we ask you to stand with us in solidarity by calling on your leaders not to pursue harmful intellectual property provisions in the FTA that will take this treatment out of our hands.

We ask you to stand up for our lives.

Nonkosi Khumalo, Chairperson, Treatment Action Campaign, South Africa

Free Medicines in Rajasthan, India

India is known as the pharmacy of the world but 65% of Indians have no access to essential medicines. Watch this video to see how the State of Rajasthan in India is tackling the problem by promoting generic medicines and providing these free of charge in the public sector.

This week negotiations continue on the EU-India Free Trade Agreement. Worldwide there are serious concerns that the deal will include stricter intellectual property rules than necessary and result in a deadly escalation in medicine prices for developing countries. Such a deal would also threaten innovative and progressive schemes like this one in India itself.


Watch the Video here 

Open letter to the prime minister expressing concern over the EU-Trade negotiations

English: Manmohan Singh, current prime ministe...

Image via Wikipedia


Dr. Manmohan Singh, Prime Minister of India

South Block, Raisina Hill, New Delhi-110 011
Tel: 91-11-23012312 Fax: 91-11-23016857/91-11-23019545; email:

Dear Mr. Prime Minister,

All India Drug Action Network (AIDAN) members express grave concern with regard to the round of negotiations on intellectual property that continues to be held between Indian and European Union (EU) negotiators as part of the India-EU Free Trade Agreement (FTA) talks. News reports in India quote the EU Ambassador as stating that discussions on Pharmaceuticals have progressed significantly.

It is reliably learnt from media reports that on the 10th February 2012, at the India-EU Summit to be held in Delhi, the EU & India will agree on and finalize the political framework for the FTA.

We express grave concern that these negotiations between the EU and India are progressing towards an agreement which includes provisions that will seriously hamper India’s ability to manufacture safe, effective and affordable generic medicines and export these to other developing countries.


Indian generic industry is rightly known as the “Pharmacy of the Developing Country” because:-
In 2001, India’s generics brought prices down from $15000 per person per year to $350 for first line AIDS medicines.
80% of people living with HIV in developing countries are on Indian generic ARVs.
Over 90% of pediatric AIDS medicines are supplied by Indian generics.

For millions of people in the developing world, access to essential medicines is often a question of life and death. Most of them rely on the affordable generic medicines being produced by countries like India. Backed by the big multinational pharmaceutical companies, US, European Union and European Free Trade Association are pushing for aggressive trade policies to restrict the supply and production of the generic medicines. The attack is taking various forms but with a single handed objective: Pushing for TRIPS plus provisions through Free Trade Agreements and other international agreements. The impact of such actions could be devastating and result in loss of millions of lives in absence of affordable medicines.


AIDAN demands:-


§ Investment Rules, which enable foreign companies to take the Indian government to private courts over domestic health policies like measures to reduce prices of medicines.

§ Border Measures, which will deny medicines to patients in other developing countries with custom officials seizing generic medicines in transit.

§ Injunctions, which 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, which put third parties like treatment providers at risk of police actions and court cases.


§ 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. IT’S NOT REQUIRED UNDER THE TRIPS AGREEMENT!

§ Patent Term Extension, as it will extend patent life beyond 20 years.

The EU states that these two provisions are off the table. It must keep its word!

We urge you to look into this important issue and save the Indian generic industry from the onslaught of the multinationals, which in turn will save millions of lives all over the world!

Yours truly

(Dr Mira Shiva) – 09810582028

(Mr Srinivasan S) – 08056292350

(Dr Anant Phadke) -09423531478

(Dr Gopal Dabade) – 09448862270

(Mr Naveen Thomas) – 09342858056

Towards a people oriented, rational, drug policy!


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