PRESS RELEASE

Medico Friend Circle*

MFC LODGES PROTEST AGAINST PROPOSED
‘DATA EXCLUSIVITY’ DRUGS AMENDMENT

The Medico Friend Circle, a 35-year-old all-India body of persons and professionals concerned with appropriate health policy, has lodged a strong protest against the Indian Government’s proposed amendment to include ‘data exclusivity’ in the Drugs and Cosmetics Act.  In an open letter to the Prime Minister, the MFC asserts that the amendment is ‘a TRIPS-plus measure with disastrous public health implications’. This assertion comes after intense consideration at the body’s national meeting at Sevagram, Wardha on 7^th and 8^th July 2006. The members noted with concern that a meeting of some concerned Ministries will take place at the Prime Minister’s office on 12^th July to deliberate and decide on the amendment.

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

· The TRIPS agreement does not mandate data exclusivity, mentioning only ‘data protection 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 people’s interest.

The MFC additionally emphasises that:

1) India has already amended its Patent Act according to the WTO-imposed TRIPS conditionalities, which 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) Regarding clinical trials, the guidelines (in line with CONSORT and ICMR 

guidelines) stipulate

a) that all clinical trials be registered,

b) that all pre-clinical and clinical trial data (positive, negative or equivocal) be put in the public domain (peer reviewed in scientific journals and open access web-sites).

c) that, from the time patent is granted, all data behind approval of marketing should be public, not exclusive to the innovator company or drug regulatory authority.

This open system ensures the option of independent data scrutiny for scientific merit by other researchers. In no way will these guidelines undermine the requirements of fair competition.

3) On the contrary, ‘data exclusivity’ means that after patent expiry, any other company wishing to make and market the generic version of the same medicine will be forced to repeat the full range of clinical trials. Not only would this delay manufacture of the generic version and thereby cheaper availability to the people, but in case of diseases for which there are few effective and safe medicines, data exclusivity would mean repeating placebo-controlled trials (rather than testing against the innovator’s patented drug). Further, it would unethically withhold a proven medicine from patients in the placebo arm of the trial. Here let us recall that, unlike in developed countries, families in India spend more than 50% of healthcare costs on medicines.

It is to the Indian Government’s credit that its past proactive steps led to the creation of a generics-based industry which did display a dramatic increase in access to essential medicines and reduction in healthcare costs. For instance, generic anti-retroviral drugs (ARV drugs for HIV/AIDS) lowered the therapy cost by over 95%. Worldwide, the increasing use of generics 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, increases in drug prices affect our people gravely.

In light of these concerns, the MFC urges the Government to refrain from amending The Drugs and Cosmetics Act and from including ‘data exclusivity’ in any other legislation.

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Members of the Executive Committee, Medico Friend Circle	Other member signatories
1. Dr. Ritu Priya	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 Apartment, Solapur Road, Hadapsar, Pune- 411028 masum@vsnl.com