Claiming that the report of the technical expert group (TEG) on patent law issue has failed to produce a `reasoned analysis for its conclusion', the Indian Pharmaceutical Alliance (IPA) has urged the government to reject the recommendations. TEG, headed by Dr Mashelkar, had submitted its report to the Centre recently.
In a hard-hitting letter to Dr Ajay Dua, Secretary, Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, the IPA said, "By disregarding its terms of reference, the TEG has exceeded scope of its study; and by ignoring the available evidence on interpretation of the TRIPS Agreement, the TEG has failed to provide a reasoned analysis for its conclusion."
"It is tragic that some people who were once a strong supporter of developmental interests and flexibility under the TRIPS Agreement seems to be going to the other side of the equation, for whatever reason'', the letter regretted after putting the report under a detailed scan.
The TEG was asked to study whether the TRIPS Agreement "requires" India to do that. Instead, the TEG relied on its "guiding principles," not on "patent law issues," to conclude that India should grant patents on trivial modifications, the IPA said while noting that to grant patents on trivial modification was a policy question.
"The TEG's interpretation of Article 27 without elaborating its nuances or considering practices followed by other WTO Members or even taking note of decisions of the dispute settlement panel and Appellate Body is unwarranted and unconvincing. Its bias for selectivity in disclosing submissions has become detrimental to its objectivity'', IPA Secretary General D G Shah, said in the letter. While charging the TEG for not recognizing flexibility in the TRIPS Agreement, he said the panel was formed to examine patent law issues and not the "interests of the stakeholders.''
On patent law issues, the committee failed on many counts like not giving details on who and how will the affordable medicines be made accessible.
"The Report implies that by not limiting patenting to "new chemical entity" or "new medical entity," it would encourage innovation by Indian industry. If that was indeed the case, many countries in the developed world should have embarked on the path to innovation in the pharmaceutical industry. But it is not so. The strong IP protection alone does not drive innovation.
"It is not clear as to what was the assessment of TEG in respect of Indian industry's "current capabilities in R&D." However, if the TEG intends to suggest that the Indian pharmaceutical industry is capable of "incremental innovations" only and therefore India should not limit patenting to "new chemical entity" or "new medical entity," it is sadly mistaken.
In a short span of eight years (1998-2006), the industry has already demonstrated its potential for discovery research. The TEG has not cared to research evidence of this potential and rushed to conclude by reference to a list of 215 PCT applications (not 339 as listed in Annexure IV of the Report) filed by 45 private companies, 14 individuals and 4 institutions that Indian pharmaceutical industry is capable only of "tweaking" the known molecules,'' the letter said.