Even as the inter-ministerial committee on data exclusivity is to meet next week, Jan Swasthya Abhiyan (JSA), the Indian circle of the People's Health Movement, a coalition of over 20 networks representing about 1000 grass root level organisations that endorse the Indian People's Health Charter, has urged the Prime Minister Manmohan Singh to go back from any move to introduce 'data exclusivity' legislation on drugs. The JSA petition expressed its concerns and views on the issue of 'Data Exclusivity' and its inclusion in the proposed amendment to the Drug and Cosmetics Act.
According to the petitioners, India should, instead of seeking to further expand the scope and duration of 'exclusive rights' of drugs and agro-chemical products, seek to encourage competition from Indian manufacturers.
"The urgent need of the hour is to improve people's access to drugs and to make drugs affordable. We comprehensively reject the idea of introducing data exclusivity, as it will have serious public health implications. We hope the govt will choose to implement amendments in the Drugs and Cosmetic Act in a manner that will strengthen drug regulation, address the issue of quality and ensure access to essential", the petitioners said.
The JSA alternative suggests a minor addition to the Drugs and Cosmetics Act which says 'test data provided by a company will not be made public or shared with its potential competitors for five years' to meet the requirements of TRIPS. "This does not prevent the Drug Regulatory Authorities from relying on the data to license a generic version of a new drug," they point out.
According to JSA, TRIPS agreement does not refer to data exclusivity at all and only refers to data protection against unfair commercial use.
"Data exclusivity has become a means of preventing generic competition, which greatly restricts access to medicines. The cost of generic drugs and the costs of healthcare are bound to increase, which is a wasteful expenditure, which a country like ours cannot afford. It is unethical to conduct clinical trials on drugs which have already been proven effective. The civil society in the country and even experts from within the Government have opposed the amendment because of the impact it will have on people and people's access to medicines. This move to include 'data exclusivity' is a 'TRIPS-plus' agenda, which is anti-people and against people's interest. It is being pushed by vested interests including large Multi-National Corporations and certain foreign governments, JSA stated.
The national coordination committee of JSA includes organizations like All India People's Science Network (AIPSN), All India Drug Action Network (AIDAN), Asian Community Health Action Network (ACHAN), All India Democratic Women's Association (AIDWA), Association for India's Development (AID), Bharat Gyan Vigyan Samiti (BGVS), Breastfeeding Promotion Network of India (BPNI), Catholic Health Association of India (CHAI), Centre for Community Health and Soc. Medicine, JNU, Christian Medical Association of India (CMAI), Community Health Cell (CHC), Forum for Creche and Child Care Services (FORCES), Fed. of Medical Representative Assns. of India (FMRAI), Health Watch- UP- Bihar, Joint Women's Programme (JWP), Medico Friends Circle (MFC), National Alliance of People's Movements (NAPM), National Federation of Indian Women (NFIW), National Association of Women's Organisations (NAWO), Sama- Resource Group for Women and Health, SATHI-CEHAT and Voluntary Health Association of India (VHAI)