Category Archives: Patent

Compulsory Licensing in India: A historic move to make drugs affordable

The government’s decision to grant a compulsory licence for the manufacture of an important anti-cancer drug should be the first step towards making available essential drugs at little or no direct cost.

Read more: The Hindu, March 14, 2012

Advertisements

Global Week of Action: India- EU Free Trade Agreement (FTA)

GLOBAL WEEK OF ACTION: India- EU Free Trade Agreement (FTA)
6-10 February 2012

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 paediatric AIDS medicines are supplied by Indian generics.

BUT ALL THIS COULD CHANGE IF INDIA DOES NOT SAY NO TO INTELLECTUAL PROPERTY (IP) IN THE INDIA-EU FTA

In January 2012, another round of negotiations on intellectual property was held between Indian and 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.

On the 10th of 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. Groups in India are worried – how have the IP negotiations progressed?

Are the EC and India 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?

WHY THE CALL FOR ACTION? 6th – 10th FEBRUARY 2012!!

Since 2007, people living with HIV in India and across the world have been resisting the pressure of the EC on India to sign an FTA with provisions on intellectual property that will endanger access to generic medicines from India. We must once more show the EC and the Indian government that our lives cannot be traded away!

This is a Call for a week of Action across the globe from 6th – 10th February 2012 on the EU-INDIA FTA.

The week of action is a run up to the EU-India Summit that will be held in Delhi on 10th February 2012.

OUR DEMANDS

REMOVE:

§  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.

DON’T 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. IT’S NOT REQUIRED UNDER THE TRIPS AGREEMENT!

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

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

PLEASE JOIN US -YOUR FRIENDS- IN INDIA!

In the coming days, groups from around the world and in India will demonstrate against the EU-India FTA. We ask you to join us in sending a clear message to the European Commission: our lives cannot be traded away.

1.   Organise your own rally: You can organize rallies or demonstrations in front of European Commission offices in your countries to voice your opposition to their aggressive negotiations on intellectual property in FTAs. Don’t forget that the EU is also negotiating FTAs with many other developing countries and making the same demands.

2.    Raise awareness/media action: Even though you might not be able to support our rally financially or physically you can help us by spreading the word about our concerns. Write an editorial in your local paper. Hold a press conference. Issue a press release or press statement.

3.    Write to the Indian Government: You can also write to the Indian Government asking it to stay strong and not give in to the demands of the European Commission. India, as the pharmacy of the developing world, has an obligation to its citizens as well as patients across the world. Please try and meet the Indian ambassadors in your countries and convey to them how important it is that India reject ALL the demands of the EU. Millions of lives depend on this.

4.    Write to your own government: Public health programmes around the world depend on generic medicines from India. Ask your government to tell the EU and the Indian government to keep IP out of the FTA negotiations.

5.    Share your actions: PLEASE send us photos, articles, videos of all your actions immediately and FOLLOW the actions of other groups on Facebook or at Don’t Trade Away our Lives

6.    Donate: In order to organize these protests, we rely on funding. Any financial support is welcome. No amount is too small – or too big! If you know organizations, which are interested in funding, if you want donate to our protest, please contact us.

We plan to meet the aggressiveness of the European Commission with our peaceful protests. There is too much at stake. Join us NOW!

In Solidarity

Delhi Network of Positive People & Lawyers Collective HIV/AIDS Unit

++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

For information on the India-EU FTA see:

A victory for Novartis could spell death for millions

A reminder that Novartis is still challenging Section 3(d) in the Indian Supreme Court against the sane advice of people from all walks of life from across the world…

Many of you will remember that in 2005, the Indian parliament had to change India’s patent law to comply with the international trade rules. The Indian Parliament knew that AIDS treatment costs dropped from $10,000 to $60 thanks to generic competition from India.

So they inserted Section 3(d) a health safeguard in the Indian patent law that does not let companies get patents on new forms of old medicines or what is know as evergreening.

Evergreening is the practice of pharma companies to extend their patent protection (i.e. a monopoly of 20 years) on old or existing medicines by making minor changes in them.

Since 2005, people living with HIV have been in the patent office using Section 3(d) and other provisions to make sure key HIV medicines are not patented in India. As a direct result of these efforts, generic production of lamivudine/zidovudine, tenofovir, neverapine hemihydrate and other HIV medicines has continued.

Today over 80% of people living with HIV in the developing world are alive thanks to Indian generic ARVs.All this is at risk now with Swiss MNC Novartis challenging Section 3(d) in the Supreme Court – Novartis has sued the Government of India, cancer patients and several generic companies. The case hearing is TOMORROW. Although the case is about a cancer medicine, Novartis wants the Supreme Court to weaken Section 3(d) and its application – something that will have an impact on all medicines including HIV medicines. While health groups like the Cancer Patients Aid Association represented by the Lawyers Collective are part of this case, there is no indication that the government has appointed its top lawyer in this crucial case.The Supreme Court hearings start tomorrow and it is VITAL that the government immediately appoint the Attorney General in this matter of life and death. Unfortunately the current Solicitor General of India has actually appeared for Novartis in this case and so cannot be appointed in this matter.

It would also interest you to know that the current lawyer arguing for Novartis in the Supreme Court is Mr. Gopal Subramanium who till just a few months ago was the Solicitor General of India.

Millions of lives not only in India but across the developing world depend on the whether the government of India puts up a strong defence for this case.The government of India has to fulfill its responsibility of ensuring generic production not just for the people of India but for the people of all developing countries. As a first step, they should appoint the Attorney General on an urgent basis for this case.

You can read news article related to the case like this one:

http://www.thehindu.com/news/national/article2427529.ece

Since 2007 various groups have been asking Novartis to drop its various cases against India’s patent law. You can read more about this at these various sites:

Lawyers Collective: http://www.lawyerscollective.org/news/126-novartis-case-background-and-update-supreme-court-of-india-to-recommence-hearing.html

Cancer Patients Aid Association: http://www.cpaaindia.org/aboutus/theglivecstory.htm

Berne Declaration: http://www.evb.ch/en/p19070.html

Novartis Boycott: http://novartisboycott.org/
For any queries or information, write to: k0b0@yahoo.com

Product monopolies and high medicine prices back in India

“Product monopolies and high prices are back in India. The MNCs have started marketing new patented drugs at exorbitant prices particularly for life threatening diseases such as cancer…….” Read more here.

The paper “Multinationals and Monopolies: Pharmaceutical Industry in India after TRIPS” by Prof. Sudip Chaudhury from IIM Calcutta attempts to look at the MNC’s behaviour in post TRIPS scenario to show that days of product monopolies are back in India. Access this paper here

Source: http://donttradeourlivesaway.wordpress.com

Ensuring affordability, accessibility and safety of medicines through urgent action

Health Action

Health Action

Health Action (HA) has published articles relating to essential medicines, generic medicines, drug price control and other drug related issues in its September 2009 issue. Some of the relevant articles have been uploaded here (with permission from HA).

Dubious Rather Than Spurious Drugs – India’s Real Drug Problem
Dr Anurag Bhargava M D

Access to medicines implies access to medicines of proven efficacy, safety and acceptable quality, prescribed in a rational manner. Governments have a responsibility of ensuring availability and affordability of such medicines. Yet the situation in India with all these issues related to medicines is marked by paradoxes. In spite of having one of the largest pharmaceutical industries supplying low-cost essential medicines globally, India has the largest number of people in the world without access to essential medicines, …………

People’s Initiative for Generic Medicines
Dr. Anant Phadke

In India, medicines are unnecessarily exorbitantly costly. Prices of medicines can be brought down to one half, even to one-fourth immediately, if the government takes appropriate measures to stop reckless profiteering and waste that are prevalent in the manufacture and sale of medicines. Since the early eighties, the All India Drug Action Network (AIDAN) has been advocating these measures, but in vain. While it may take many more years to change the govt…….

Essential Medicines: Economic constraints in access in India
Dr. Purnabrata Gun & Sushanta Roy

Essential medicines are among the most costeffective elements in modern health care and their potential health impact is remarkable. This year alone, there will be over 40 million deaths in developing countries, one-third among children under age five. Ten million deaths will be due to acute respiratory infections, diarrheal diseases, tuberculosis, and malaria. Safe, inexpensive, essential drugs can be life-saving in all these disease conditions……..

Good to be True, but True! Retail Sale of Generic Drugs at Low Prices by the Government in Chittorgarh Dt
S.Srinivasan

We all know that one of the solutions for making medicines affordable to people is to make available only essential generic drugs at lower prices, that is if your doctor prescribes them in the first instance. Procurement prices of generic drugs by Governments like that of Tamil Nadu and Delhi have revealed that prices of generics are 1.5 % to 10 % of the maximum retail price (MRP) of branded equivalents at the retail level. However, to get a retail pharmacist to stock these low-priced generics is easier said than done…..

Drug Price-Control: Problems, Principles and Prospects
Dr Chandra M Gulhati

One way or the other, prices of many sensitive goods and services are subject to some sort of price regulation either through state’s intervention or other mechanisms including competition, negotiated prices by bulk buyers, reimbursement by insurance companies just to mention a few…………

To download the entire issue of Health Action, September 2009 issue, click here

“Mashelkar Report ll underestimates India’s right to define patentability standards”

Mashelkar Report II underestimates India’s right to define patentability standards” – Professor Brook K. Baker, Northeastern U. School of Law, Program on Human Rights and the Global Economy; Health GAP (Global Access Project), October 9, 2009

For the second time, the Mashelkar Committee has misinterpreted India’s flexibility under international law to limit patents of pharmaceutical products to new chemical entities, or new medical entity involving one or more inventive steps………

The Committee has made three fundamental mistakes:

(1) it still incorrectly analyzes India’s flexibilities under TRIPS to define pro-health standards of patentability,

(2) it fails to analyze key TRIPS-minimum patent standards, especially novelty and inventive step, and

(3) it incorrectly concludes that a NCE-only standard of patentability for pharmaceutical products would constitute discrimination against a field of technology and in doing so misinterprets and misapplies the expert analysis of Professor Carlos Correa, an internationally renowned IP specialist.

To read the complete Mashelkar II Report Critique, please visit: http://www.healthgap.org/analysis-of-mashelkar-report.htm