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PRESS RELEASE- Demand for compulsory licensing for Trastuzumab, a life-saving drug for women with HER2+ breast cancer #womensday

CAMPAIGN FOR AFFORDABLE TRASTUZUMAB

8 March 2013

 

The Campaign for Affordable Trastuzumab has called on the Commerce Minister to mark International Women’s Day 2013 with an announcement of compulsory licensing for Trastuzumab, a life-saving drug for women with HER2+ breast cancer. Trastuzumab, the patent for which is held by Swiss pharma giant Roche, is currently priced at Rs.6-8 lakhs for a full course of 12 injections, and is out of reach for all but the most privileged. An estimated 25,000 new cases of HER2+ breast cancer are recorded in India every year, with younger women in the majority among patients.

Trastuzumab has been recommended for compulsory licensing by an Expert Committee set up by the Health Ministry. The recommendation is currently under the consideration of the Department of Industrial Policy and Promotion in the Ministry of Commerce.

The Campaign has urged the Minister to issue a notification under Sections 92 and 100 of the Indian Patents Act, which will end Roche’s monopoly and open the door for local manufacturers to enter the market with affordable biosimilar versions that can compete with Roche’s product.

The letter cites evidence to show that Roche’s pricing policy is irrational and unethical, reflecting its strategy of pushing the pricing envelope to the maximum extent possible.

The Campaign has also cited compelling evidence to show that measures such as negotiated price reductions and voluntary licensing floated by the Ministry of Chemicals and Fertilisers are weak in comparison to the option of compulsory licensing, which can bring prices down four times more than price negotiations. Moreover, while negotiated prices will apply only in India, Indian generics/biosimilars have the potential of increasing access across the developing world.

The letter expresses concern at the Government of India’s apparent reluctance to use the compulsory licensing option to ensure access, even though this measure is available under the Indian Patents At which was amended in 2005 to make it TRIPS-compliant. The first compulsory licence awarded in India – for production of a generic competitor to the liver cancer drug Sorafenib – has been recently upheld by the Intellectual Property Appellate Board.

The Campaign is endorsed by more than 150 Indian and global groups of cancer survivors, health rights activists, women’s groups, treatment activists and public interest organisations.

The full text of the letter is given below.

 

To the Hon’ble Minister for Commerce, Government of India

 

Compulsory licensing for breast cancer drug Trastuzumab

Respected Minister,

Greetings from the Campaign for Affordable Trastuzumab on International Women’s Day.

We are writing to you to enquire about actions taken by your Ministry on the recommendation from the Expert Committee set up by the Ministry of Health to explore the possibility of issuing compulsory licences (CLs) for encouraging the entry of low-cost generic/biosimilar versions of cancer drugs in cases where patents and predatory pricing policies of multinational pharma companies continue to block access to these medicines for the vast majority of patients in India.

Breast cancer drug Trastuzumab on short list for compulsory licensing

Trastuzumab, a patented drug that can save the lives of women suffering from HER2+ breast cancer, has been recommended for compulsory licensing by the Expert Committee set up by the Health Ministry. The patent for the drug is held by Roche and is valid for another seven years. This patent, weak though it is, is discouraging local manufacturers from investing in the development of biosimilars of Trastuzumab that can provide affordable alternatives to Roche’s product.

The recommendation for compulsory licensing of Trastuzumab was welcomed by us as a huge relief to the thousands of women with HER2+ breast cancer whose lives can be saved by Trastuzumab, but who are unable to access this drug because of predatory pricing by Roche.

We surely do not need to remind you that breast cancer is now the second most common form of cancer in the country, and that young women constitute the majority of those affected by the aggressive HER2+ variant of the disease. An estimated 25,000 new cases of HER2+ breast cancer are reported each year.

Trastuzumab, often called a miracle drug for its efficacy in preventing recurrence and extending life in cases HER2+ breast cancer, is currently priced at between Rs.55,000/- and Rs 75,000/- per 440 mg dose, and is therefore out of reach for all but the wealthiest. An oncologist at the Tata Memorial Cancer Centre has been quoted as saying that less than 10% of the patients he sees are able to afford Trastuzumab at all, and even fewer are able to complete the recommended course of 12 injections. This is borne out by the testimonies of other survivors and their families1.

The recommendations of the Expert Committee were under consideration by the Department of Industrial Policy & Promotion (DIPP) under your Ministry. Since then, we – and thousands of women who are battling HER2+ breast cancer – have been waiting for a notification from DIPP that will open the door for domestic manufacturers to invest in the development, testing and marketing of biosimilars of Trastuzumab.

We are mystified by the delay in the issuance of a notification under Section 92 of the Patents Act to initiate the process of compulsory licensing for Trastuzumab. The case for compulsory licensing presented by us in our letter to the Prime Minister in November 2012 (see attachment) have been endorsed by over 150 organisations and citizens including cancer survivors, women’s groups, human rights organisations, health NGOs and treatment activists from around the world and eminent jurists. Our argument has now been validated by the recommendations of the Expert Committee of the Ministry of Health.

Discount schemes are no match for generic competition

There is plenty of evidence to show that Roche’s pricing and marketing policy is completely arbitrary and unethical. The so-called “voluntary price reductions” announced by Roche – from Rs.1.2 lakhs to Rs.92,000/- and then to Rs.75,000/- – each time the issue of over-pricing is raised, are merely pre-emptive measures to ward off competition and retain their control of the market. Roche is also using market segmentation to protect its monopoly. Trastuzumab is being sold under two different brand names – Herceptin (Roche) at Rs.1.2 lakhs for 440 mg, and Herclon (Emcure) for Rs.75,000/-.

There is also evidence of a nexus between Roche and doctors in private hospitals – patients are being pressurised to buy the drug from the hospital pharmacy at the official price of Rs.75,000/- per dose, rather than from retailers and agents who offer the drug at prices as much as 25% lower than the MRP.

The Indian Railways has been procuring Trastuzumab for the last three year at Rs.86,957/- per dose2. This is also the amount reimbursed under the CGHS3.

These figures leave little doubt that Roche’s pricing policy is determined primarily by their assessment of how much they can push the price envelope rather than by the idea of an ethical profit margin.

Perhaps the Honourable Minister for Chemicals & Fertilisers was not aware of these details when he stated in the Lok Sabha that Roche would be bringing the price of Trastuzumab down to Rs.75,000/- per dose4 under an upcoming deal with Emcure for local manufacture. Considering that the present MRP of the drug is Rs.75,000/-, and it is already being offered by retailers for 55,000/- per dose, we fail to see anything to cheer about in the Roche-Emcure deal. In fact, there are reports that Roche has imposed anti-competitive terms such as a ceiling on volume of sales and a mandatory minimum price.

Negotiated prices do not expand access

Respected Minister, you are no doubt aware that the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers has recently released a report by a committee set up to examine the issue of price negotiations for patented drugs. We are concerned about the fact that this report being released at a time when a compulsory licence for Trastuzumab is under active consideration by both the Health Ministry and your Ministry.

While Roche’s actions in blocking any attempts at competition are understandable even if not justifiable, we are shocked that a government entity should seriously propose to negotiate with pharma majors without any reference to other concerned Ministries, and in complete disregard of global experience, which confirms that measures such as negotiated price reductions do not result in any significant expansion of access, since prices continue to remain beyond the reach of most citizens. Generic competition on the other hand can bring prices down to four times lower than negotiated prices 5.

Apart from yielding only limited benefits, time-consuming price negotiations with pharma companies can delay action on more rational options such as compulsory licensing, thereby putting thousands of lives at risk. The Government of Thailand, which began issuing compulsory licences in 2007, noted that “Prior negotiation with the patent holders is not an effective measure and only delays the improvement in access to patented essential medicines and puts more lives in less healthy or even dangerous situations.”

What is more, negotiated price reductions will be applicable only in India – a biosimilar of Trastuzumab from Indian manufacturers on the other hand have the potential for a global impact and can expand access to this life-saving drug across the developing world. India’s scientific and technical capacity in this sector is well recognised. The announcement of a compulsory licence for Trastuzumab will encourage local pharma firms to step up their investments in ongoing research projects for biosimilar development, and will facilitate the speedy entry of biosimilars into the market.

We have been greatly encouraged by the recent decisions of the Intellectual Property Appellate Board (IPAB) in revoking the patent for the Hepatitis-C drug pegylated interferon Alpha 2A, and now in upholding the compulsory licence for a generic competitor to Sorafenib. These decisions have been applauded and welcomed by health rights groups and public interest groups around the world, for whom they are an assurance of India’s political will to resist arm-twisting by pharma companies.

When India amended its patent laws in 2005 to make them TRIPS-compliant, there was widespread concern about the possible adverse impacts of this move on access to treatment. The then Union Minister of Commerce & Industry, Shri Kamal Nath had said at the time that “the government has built in enough safeguards in the Patents (Third Amendment) Act 2005 passed by Parliament to protect the interests of consumers by ensuring availability of medicines at affordable prices6. We are disappointed that eight years later, despite sharp increases in the number and prices of patented drugs, the Government of India is so reluctant to use the provision of compulsory licensing under Sections 92 and 100 of the Patent Act to expand generic competition, bring down prices and expand access.

We urge you to mark Women’s Day 2013 with the announcement of a compulsory licence for Trastuzumab – a progressive and principled step that will bring relief to thousands of Indian women and their families who are struggling to deal with HER2+ breast cancer and its economic, social and personal costs.

Thousands of lives are at stake – we look forward to your immediate and decisive action.

 

KALYANI MENON-SEN (on behalf of the Campaign for Affordable Trastuzumab)

1See for instance an interview with the husband of a cancer survivor who describes his experiences in accessing Trastuzumab. <http://newsclick.in/india/recounting-personal-experiences-accessing-herceptin>

5See attached press note for details.

6 ‘ENOUGH SAFEGUARDS IN PATENTS ACT TO PREVENT PRICE RISE’, Press Release, Ministry of Commerce,  04 April 2005, http://commerce.nic.in/pressrelease/pressrelease_detail.asp?id=1610

 

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Press Release- Campaign for Affordable Trastuzumab

The Department of Pharmaceuticals, Ministry of Commerce has just released a report by a committee set up to examine the issue of price negotiations for patented drugs.  Comments are being invited from stakeholders.

 

The Campaign for Access to Affordable Trastuzumab is shocked that the Department of Pharmaceuticals is even considering the option of negotiating with multinational pharma companies for price discounts.

We note with concern that this report comes at a time when the Ministry of Health is actively exploring options such as compulsory licensing for bringing down prices of life-saving patented drugs through allowing market competition by generics and biosimilars. Trastuzumab is one of the drugs being considered for compulsory licensing.

This ill-timed move by the Department of Pharmaceuticals will benefit none other than big pharma companies whose patents on life-saving drugs are the main barrier in access to health for millions of Indians.

Global experience shows clearly that measures such as negotiated price reductions and “managed competition” through voluntary licenses (which usually incorporate stringent conditions to protect the interests of the originator company) do not result in any significant expansion of access, since prices continue to remain beyond the reach of most citizens.

A case in point is Brazil, which tried to use price negotiations with multi-national pharmaceutical companies to bring down the price of patented HIV drugs. As a result, the price of Efiverenz (Merck) came down to  USD760 per person per year in 2003.  In contrast, when Efiverenz was brought under compulsory license in 2007, the price came down to USD170 per person per year – less than one fourth the negotiated price.

 

Similarly, a World Bank supported process of negotiated price decreases in Central America and the Caribbean in 2002 brought prices of HIV drugs down to USD 1100-1600 per patient per year. In contrast, 10 Latin American countries independently adopted an open competition-based model involving both generic manufacturers and originator companies, resulting in prices coming down from USD 5000 to USD 400 per patient per year.

 

The Government of Thailand, which began issuing compulsory licences in 2007, considered and dropped the option of negotiated price reductions, noting that “Prior negotiation with the patent holders is not an effective measure and only delays the improvement in access to
patented essential medicines and puts more lives in less healthy or
even dangerous situations.”

 

India plays a key role as a supplier of affordable medicines to other countries in the global south. Unlike negotiated prices, which apart from being unacceptably high would apply only in India, compulsory licensing of a drug like Trastuzumab would benefit millions of people across the developing world through global marketing of cheap generic versions.

 

The Campaign for Affordable Trastuzumab urges the Government of India to follow through on the strong political will it has shown by initiating the process of compulsory licensing for Trastuzumab. With 25,000 new cases of HER2+ breast cancer being recorded every year with most patients being young women, there is no time to waste. We look forward to a speedy notification and an accelerated process to bring biosimilars of Trastuzumab into the market.

 

We call on our policy-makers to ensure that big pharma companies do not continue to hold our health hostage to their greed for profits.

For further information, contact <[email protected]> and <[email protected]>

 

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India’s cancer burden: Why the govt’s CL ruling is so important #drugpricing #goodnews

Jan 15, 2013, First post

Early last year, when the Union government allowed the production of
Nexavar, a liver and kidney cancer drug, by an Indian company against
the wishes of multinational pharma major Bayer, the prices of several
indigenously made cancer drugs tumbled.

It was a complete game-changer in affordable healthcare in India,
which not only reduced the price of Nexavar from a prohibitive Rs. 2.8
lakh a month to Rs. 6,600, but also led to the reduction of prices of
a few other cancer drugs as well.

The step that led to this dramatic fall of prices was by an
intervention of the Union government called “compulsory licensing
(CL), by which a national government can allow somebody to produce a
patented drug without the consent of the patent owner.

After Nexavar, the government of India has begun steps to issue
compulsory license for three more cancer drugs – Trastuzumab,
Dasatinib and Ixabepilone.

Compared to Nexavar, the impact of this move is going to be
unprecedented because Trastuzumab is a wonder drug against a certain
type of breast-cancer that affects about 100,000 women in India.
Breast cancer tops the cancer burden in urban India, and an aggressive
HER+2 type of cancer is increasingly more prevalent among young women.

Indian companies don’t have a generic alternative to the breast
cancer drug yet. Reuters About 28-35 per cent of all cancers among
women in major cities is breast-cancer. Trastuzumab not only reduces
the mortality of patients with HER+2 cancer, but also is effective
against the spread of malignancy to other parts of the body.

So far, there is no other drug against HER+2 cancer with such
efficacy. It can be administered alone, along with chemotherapy and
after surgery. In many cases, it even helps avoid surgery, which many
find disfiguring.

However, majority of women with HER+2 breast cancer do not benefit
from the wonder-effect of the drug because of the prohibitive prices
by its manufacturer and patent-holder, Roche, the multinational drug
company. A full course of the drug costs anywhere between Rs six to
eight lakhs. A generic version – in this case a bio-similar product –
should not cost more than a tenth of this price.

Unlike Nexavar (chemical name Sorafenib), no Indian company has yet
started making generic versions of Trastuzumab. According to available
information , three Indian companies are currently involved in
creating this molecule, but it is a difficult process because they
have to take the biotechnological route to replicate it.

Commonly, generic versions of patented drugs are chemical copies made
by reverse engineering of the final molecule through chemical
processes. In simple terms, what it entails is taking the final
molecule (of the drug) and working backward to create the same
molecule through an alternative process.

Technical expertise, research facilities, appropriate investment and
availability of high quality human resources are important for such
processes. Endowed with all the four, India is a leader in generic
production of drugs. What it requires, however, is an enabling
environment, most of which is legal and patent-related.

In the case of Trastuzumbad, the generic version will be a biological
equivalent and not a chemical copy because this drug cannot be
replicated chemically. A biological process is trickier and more
expensive.

The government decision on Trastuzumbad and the other two cancer drugs
will be significant because Indian companies are reluctant to invest
on developing a bio-equivalent, if the drug is still under patent. The
patent on this wonder drug is due to expire in 2014, but Roche has
filed several patent applications to Indian patent offices to block
any such development even beyond 2014.

Under such uncertain patent regimes, no company would risk its
investment. If the government issues a CL, the Indian drug companies
can safely invest and fast track the process. Apparently, one of the
Indian companies developing the drug is in the third stage of the
process and hence if a compulsory license comes through, the Indian
version will be out in the market sooner than later.

The latest development is yet another example of informed civil
society pressure leading to concrete results as seen in countries such
as Brazil and Thailand. In November 2012, the Campaign for Affordable
Trastuzumab, a citizens’ collective, wrote an open letter to the Prime
Minister, signed by around 200 cancer survivors, women’s groups, human
rights and health rights campaigns and treatment activists from around
the world, urging the government to make the drug affordable and
freely available to patients.

Drug companies are holding our health hostage to their greed for
profits” said Kalyani Menon-Sen, coordinator of the Campaign. “Roche
should not be allowed to get away with such predatory prices. Courts
and other authorities like the Competition Commission must take suo
moto action against Roche for abusing its dominant position in the
market.”

She also called on Indian manufacturers to expedite the production of
bio-similars of Trastuzumab.

Compulsory licensing is one of the two flexibilities provided under
the TRIPS (Trade Related Intellectual Property Rights) to allow member
countries of WTO (World Trade Organisation) to prevent the abuse of
patents. Contrary to the general belief, compulsory licenses are
issued not only by developing countries, but also by countries such as
Canada, USA, UK, France and Australia, whenever it suits them.

India joined TRIPS and complied with its rules in 2005 by amending the
patent act of 1970, which also meant giving up a lot. However, it does
have flexibilities such as CL to ensure that its citizens have access
to affordable care and multinational companies don’t get away with
predatory pricing. All that it takes for such a move is immunity from
vested interests and political will.

“Such a move will not only make healthcare more affordable, but will
also lead to domestic competition among generic manufacturers, which
in turn will lead to further fall in prices” said KM Gopa Kumar, legal
advisor and senior IPR researcher at Third World Network, a global
think tank on development issues.

The other TRIPS flexibility that WTO allows its members to protect its
citizens’s health is parallel importing, under which countries without
technical capability to produce the generics can import from other
countries. India may not be a beneficiary of this provision, but it
can help other countries. Indian generic drugs are imported by several
countries in the world.

Generic manufacture of potent MNC drugs against HIV and multi-drug
resistant TB and their dramatic price falls are the inspiring success
stories of the last decade. Cancer seems to be the new frontier. There
are also illnesses such as hepatitis-C, the treatment of which can
become affordable if a generic version of the MNC drug is available.
The MNC drug at present costs about Rs. 6 lakhs and the country has a
huge hepatitis -C burden.

In the coming years, the generic intervention and similar price cuts
will have considerable impact on treatment of cancers and other
non-communicable illnesses as well as infections such as hepatitis-C.

Without being apologetic to anybody – the MNCs and their parent
countries – the government just has to take proactive steps that are
vital for its citizens.

http://www.firstpost.com/india/indias-cancer-burden-why-the-govts-cl-ruling-is-so-important-589051.html

 

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FAQ -Copyright Amendment Act and impact on print Impaired persons

English: A collection of pictograms. Three of ...

English: A collection of pictograms. Three of them used by the United States National Park Service. A package containing those three and all NPS symbols is available at the Open Icon Library (Photo credit: Wikipedia)

Some Frequently Asked Questions to the Amendment to the Copyright Act of India, 1957 and its Impact on Print Impaired Persons


1. Who benefits?

All print impaired persons be they totally blind, low vision, learning disabled or orthopedically challenged in certain ways are covered by this clause.

2. What can be done now that was not possible earlier?

Print impaired individuals, or authorized service providers / organizations can suitably modify a work under Copyright so as to make it accessible to meet the specific needs of the print impaired person concerned. This means that a standard printed book, for example may be converted to an alternate format (not necessarily a special format) including Braille, large font, text readable by screen reader, audio (be it synthetic audio or human voice recording) without seeking the permission of the rights holder.

3. How is this different?

In the past, any alternate format creation could have been defined as an infringement unless it was backed up by prior written permission from the rights holder. One had to seek the permission if one had to be on the right side of the law. Now thankfully we do not need permissions.

4.  Are there any restrictions?

Yes, there are reasonable restrictions such as
– conversion should be a not for profit activity. In case it is a for profit activity, there is a separate clause under which a special license can be obtained.
– the beneficiaries has to be a bonafide print impaired person or organizations that serve them.
– reasonable precaution need to be taken by all that the accessible copy is not misused commercially.

5. Does this mean that the publisher has to give soft copy?

No. The copyright law does not cover the delivery of books which is the purview of another department and another law. We are planning to take it up as well. For the present, these exemptions allow an existing work which is not accessible to be made accessible without permission.

6. Can accessible copy be shared?

Effectively yes, as long as it is not misused for commercial purposes and is available to print impaired persons only.

7. What is the wording of the clause?

It runs as follows.

Section 52 (1)The following act shall not be an infringement of copyright, namely:
(zb) the adaptation, reproduction, issue of copies or communication to the public of any work in any accessible format, by —
(i) any person to facilitate persons with disability to access to works including sharing with any person with disability of such accessible format for private or personal use, educational purpose or research; or
(ii) any organization working for the benefit of the persons with disabilities in case the normal format prevents the enjoyment of such works by such persons:
Provided that the copies of the works in such accessible format are made available to the persons with disabilities on a nonprofit basis but to recover only the cost of production:
Provided further that the organization shall ensure that the copies of works in such accessible format are used by persons with disabilities and takes reasonable steps to prevent its entry into ordinary channels of business.
Explanation. For the purposes of the sub-clause, “any organization” includes an organization registered under section 12A of the Income Tax Act, 1961 and working for the benefit of persons with disability or recognized under Chapter X of the Persons with Disabilities (Equal Opportunities Protection of Rights and Full Participation) Act, 1995 or receiving grants from the Government for facilitating access to persons with disabilities or an educational institution or library or archives recognized by the Government.

8. What provisions affect the creation of accessible cop[ies when it is undertaken as a not for profit activity?

The following new section involving a compulsory license would be applicable

³31B. (1) Any person working for the benefit of persons with disability on a profit basis or for business may apply to the Copyright Board, in such form and manner and accompanied by such fee as may be prescribed, for a compulsory license to publish any work in which copyright subsists for the benefit of such persons, in a case to which clause (zb) of sub-section (1) of section 52 does not apply and the Copyright Board shall dispose of such application as expeditiously as possible and endeavor shall be made to dispose of such application within a period of two months from the date of receipt of the application.

(2) The Copyright Board may, on receipt of an application under sub-section (1), inquire, or direct such inquiry as it considers necessary to establish the credentials of the applicant and satisfy itself that the application has been made in good faith.

(3) If the Copyright Board is satisfied, after giving to the owners of rights in the work a reasonable opportunity of being heard and after holding such inquiry as it may deem necessary, that a compulsory license needs to be issued to make the work available to the disabled, it may direct the Registrar of Copyrights to grant to the applicant such a license to publish the work.

(4) Every compulsory license issued under this section shall specify the means and format of publication, the period during which the compulsory license may be exercised and, in the case of issue of copies, the number of copies that may be issued including the rate or royalty:
Provided that where the Copyright Board has issued such a compulsory license it may, on a further application and after giving reasonable opportunity to the owners of rights, extend the period of such compulsory license and allow the issue of more copies as it may deem fit.

 

Compiled By:

The Xavier’s Resource Centre for the Visually Challenged (XRCVC)
Dr. Sam Taraporevala
St. Xavier’s College, 5 Mahapalika Marg, Mumbai 400001
#+91-22-22623298/22626329

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