Medico Friend Circle*

To

The Prime Minister
Government of India
Nirman Bhavan
New Delhi 10^th July, 2006

Subject: Proposed Amendment to the Drugs and Cosmetics Act
–Risks arising out of ‘Data Exclusivity’

Dear Mr. Prime Minister,

We write to you on behalf of the Medico Friend Circle (a 35-year-old all-India body of persons and professionals concerned with appropriate health policy) with regard to the proposed Amendment to include ‘data exclusivity’ in the Drugs and Cosmetics Act, 1940. It is our assertion that the proposed amendment is a TRIPS-plus measure – not only is it not required, but it will have disastrous public health implications. This assertion of ours comes after intense consideration at MFC’s national meeting at Sevagram, Wardha on 7^th and 8^th July 2006.

As a participant organisation in the Jan Swasthya Abhiyan (national people’s health campaign), MFC stands by their position that:

· The TRIPS Agreement does not mandate data exclusivity, mentioning only that data be protected against ‘unfair commercial use’.

· ‘Data exclusivity’ would mean preventing generic competition, restricting access
to cheaper medicines with disastrous consequences for the Indian people.

· Making it mandatory (as amended) to conduct fresh clinical trials on drugs which have already been shown to be effective and safe is unsustainable and unethical.

· Including ‘data exclusivity’ is an unrequired ‘TRIPS-plus’ agenda clearly against
the Indian people’s interest.

In addition, the MFC emphasises the following points:

1) India has already amended its Patent Act according to the WTO-imposed TRIPS conditionalities, and this is sure to hike up new drug prices for Indian consumers, as seen all over the world. In this light, agreeing to this TRIPS-plus proposal is especially unwarranted.

2) All clinical trials must be registered, and it should be made mandatory that data generated through pre-clinical and clinical trials, whether positive or negative, or equivocal be made available in the public domain (peer reviewed, scientific journals and open access web sites). From the time a patent is granted, all data generated through scientific studies providing the basis of the approval for marketing should be in the public domain and not under the exclusive knowledge of the innovator company or the drug regulatory authority. This is so that other researchers will have the option of independently scrutinising the data and assessing for themselves the scientific merit. Further, this open system will enable other experts to assess whether the approval granted for registration by the drug regulatory authority was scientifically justified or not. This open system will in no way undermine the requirements of fair competition. These guidelines are in line with the CONSORT as well as the ICMR guidelines. Any measure to protect clinical trials data from ‘unfair commercial use’ must not affect the public’s access to this information.

3) On the contrary, ‘data exclusivity’ would mean that, if any other company is to make and market the generic version of a medicine, it will be forced to repeat the full range of clinical trials. This mandatory repeating of trials would delay manufacture of the generic version by other companies, and thereby cheaper drug availability to the people.This would violate the national and international ethical guidelines for bio-medical research currently in force as well, since if the drug is compared with the same molecule whose patent has expired it is an unnecessary waste of resources, and if done with a placebo (or proven less-effective drug) in the control arm as it would unethically withhold a proven medicine from patients in the control arm of the trial.

Finally, we wish to state that proactive steps taken in the past by the Indian Government led to the creation of a generics-based industry which displayed a dramatic increase in access to essential medicines and lowered healthcare costs. For instance, generic anti-retroviral drugs (ARV drugs for HIV/AIDS) lowered the therapy cost by over 95%. The increasing use of generics worldwide provides a countervailing force against monopolistic pricing practices of ‘innovator’ companies even after patent expiry. Without generics, even for off-patent drugs, patients in India would have to pay 10-100 times more for treatment. Since a great proportion of Indians subsist in poverty, drug price increases affects the people gravely. Here let us recall that, unlike in developed countries, families in India spend more than 50% of their healthcare costs on medicines.

In the light of these concerns, we urge you to refrain from amending The Drugs and Cosmetics Act, and further from including ‘Data Exclusivity’ in any other legislation.

Thanking you for your serious consideration of our submission,

Sincerely yours,

Dr. Ritu Priya,
Convenor

Members of the Executive Committee, Medico Friend Circle	Other member signatories
1. Dr. Ritu Priya, Pune	Dr. Amar Jesani, Mumbai
2. Ms. Manisha Gupte, Pune	Ms. Neha Madhiwalla, Mumbai
3. Dr. Mira Sadgopal, Pune	Dr. Alpana Sagar, New Delhi
4. Dr. Abhay Shukla, Pune	Dr. Ulhas Jajoo, Wardha
5. Ms. N. B. Sarojini, New Delhi	Dr. S.P.Kalantri, Wardha
6. Mr. S. Srinivasan, Vadodara	Mr. Abraham Thomas, Bangalore
7. Dr. Anant Phadke, Pune	Dr. Biju Soman, Trivandrum
8. Dr. Anand Zacharaiah, Vellore	Dr. Mala Ramanathan, Trivandrum
9. Dr. Binayak Sen, Raigarh	Dr. Anurag Bhargava, Bilaspur
10. Dr. Prabir Chatterjee, Kolkata
11. Dr. C. Sathyamala, New Delhi

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* Convenor – Dr. Ritu Priya, 147-A Uttarakhand, Jawaharlal Nehru University, New Delhi-110067 ritupriya@vsnl.com

Regd Office: c/o Manisha Gupte, 11 Archana Appartment, Solapur Road, Hadapsar, Pune- 411028 masum@vsnl.com