July 13, 2005

International Access to Meds

It seems that there are a number of battles (in Florida, and more recently, in California) over prescription drug benefits for the poor in the U.S., and similar issues are facing people with brain diseases all over the world. We received a notification from an advocate in India (a doctor, and a vocal mental illness advocate) regarding potential patents of psychiatric drugs in India. In her fight to prevent such patents from passing, which would raise the prices of second-generation antipsychotics for patients in India who cannot otherwise afford them, she referred to the World Health Organization Essential Drug List to help make a case that these medicines are essential to the recovery of people with brain diseases. She was appalled to find not a single second-generation (atypical) antipsychotic medication on the list.

She is now calling for action from several prominant leaders of international organizations (for example, the World Psychiatric Association and the World Fellowship for Schizophrenia and Allied Disorders), in an effort to get second-generation antipsychotics included on the Essential Drugs List, and hopefully to prevent the passage of patents in India which would bar access for too many patients in need.

[Editors note: India has, until recently, been operating outside of the international patent system and laws (therefore their drug companies could produce generic versions of patented drugs without any legal issues - and sell those drugs at very low costs to their vast populations of poor and ill people).

This year, however, the government of India is joining the international patent system - in part because India now has many very smart, well-educated scientists who can now develop new drugs to sell to a global population - but to have the financial incentive (that is, to be able to get investors to fund their research) to work on these new drugs they needed international patent protection. So the Indian government decided that it was time to join the global patent system so as to provide for an encouraging environment for further growth of their small, but growing pharmaceutical and biotech educational facilities and industies. If they did not do this, their researchers would continue to leave the country and move to other countries like the US and Europe, as they have traditionally done. The problem with this, however, is that India would lose many of its best-trained researchers and scientists. This is a problem that all developing countries have eventually faced as they develop world-class scientific and business communities. At some point it makes sense for the benefit of the country to adopt global standards for patent protection.

Unfortunately its a trade-off, because while the country (and indeed the world) will eventually get the benefit of important new drugs created by their talented researchers, it seems that under the agreement that the prices of patented drugs will increase, and thus making them less available to many people in India.

We hope that a better balance between the interests of the growing pharma and biological research community, and the poor mentally ill in India who need the drugs, can be met to a greater level of satisfaction for all].

Below is our Indian Advocate's summary of the situation, and the actions she has taken.

Atypical anti-psychotics excluded from the WHO EDL.
By Dr. SN, Action For mental Illness, Bangalore , INDIA

How did it all start?

A Protest March against Patent Ordinance in Delhi , capital city of India, was launched by family groups of persons with MI( Mental Illness), Cancer and HIV/AIDS under the leadership of Lawyers Collective, Delhi on December 21, 2004 . The MI lobby was led by Torchbearers of Delhi and ACMI from Bangalore, provincial capital of the State of Karnataka.

Since then, from ACMI, we have been working in association with Lawyers Collective, Bangalore on devising a strategy to oppose grant of patents for MI drugs along with those of Cancer, HIV/AIDS etc. One such strategy was to get many medicines included in the National Drug List (a list of essential medications in India, modeled after the WHO list), with a view to seek exemption from the inexorable laws of patent royalties.

What happened next?

As a starting point, I referred to the WHO EDL (Essential Drug List, the 13th issue which I believe is the latest). To my utter shock and dismay, I found that not a single atypical anti psychotic was included in this List. By atypical anti psychotics, I mean the SGAs like Respiridon, Zyprexa, Clozapin, and the recent ones like Sertindol, Quetiapin, Abilify etc. [editor: the names of the drugs are slightly different in India, and are frequently available from indian drug companies as generics] We are all aware of the relative advantages of the SGAs as compared with the old drugs like Serenus, Haledol etc. I tried to seek clarifications from WHO and even bolster my arguments with research Reports. WHO said that it is not possible to do anything till 2007 when the next list comes up !

Well, we can assign many reasons and motives underlying this callous omission. Are Pharmaceutical lobbies involved ? One wonders.

Subsequently, I wrote to the WFSAD ( World Fellowship of Schizophrenia and Allied Disorders at Toranto, Canada) President, Dr. Dale Johnson, and also to the Vice President Dr. Radha Shankar. Dr. Dale Johnson’s name even appears in the list of contributors to some WHO publications! Yet he admitted that he was shocked and has written to them twice since last three months. But no reply so far.

The matter was brought to the attention of the Indian Psychiatric Society. Also to the Indian zonal representative Dr.J.K.Trivedi in World Psychiatry Association; WPA has agreed to look into it.

What are the consequences?

India does not have social security benefits for the mentally ill persons; nor any insurance. Under these circumstances, if Patent Law is implemented , the cost of these atypical anti psychotics , most of which are patented in USA, will go up. Lack of affordability will lead to lack of accessibility. Secondly, inclusion of these in WHO EDL would have validated the inclusion of these medicines in the National Drug List. In turn, this would have helped us campaign for exemption of the National List from patents. Now this opportunity is lost. At a more theoretical level, it is pertinent to ask the scientific validity of cross- country application of one single WHO EDL cutting across political and economic and social barriers!


I request the support groups across the world to question WHO on this issue, and help us and others in similar situation. For your kind information, the useful WHO emails are: hogerzeilh@who.int; saracenob@who.int; dljohnson@uh.edu.

More information about the WHO Essential Drug List

Update on results (added July 25, 2005): We have just recieved word from our advocate in India that Dale Johnson, president of WHO, has acknowledged her letter concerning the situation of antipsychotic medications. A similar acknowledgement has come from the head of the World Fellowship for Schizophrenia and Allied Disorders, inviting comments.


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