Policy issues in Pharma manufacturing

I dont claim to have thorough understanding about policy issues related to Pharmaceuticals Manufacturing but i just thought of sharing some interesting findings. It all started with the blog about LoCost. Last sunday (6/17), as part of AID-LA, we organized a talk by Dr. Anant Phadke. During our pre-talk discussion, I got to know that he is one of the Board of Directors of Locost and was highly appreciative of them. He brought up the issue of increasing difficulties that arise after the patent bill was passed by Indian legislature that brought India into compliance with the WTO's Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS). I did some basic study about this act and whatever little findings i got, were interesting enough to post a short blog.
India became TRIPS compliant from January 1, 2005. Recent controversy between Novartis and Indian government over the grant of patent for its Leukaemia drug, Glivec has spurred huge controversy. The case is still under trial under Madras High Court. Novartis has also issued an open letter clearing its stand on the issue. Without delving into the issue and taking any stand, I would just like to mention that the bureaucracy, combined with such laws may hinder availability of basic drugs for poor and marginalized people not just in india but in other developing (and under developed) countries. Interestingly, the only reason that big pharma companies give in support of the patent act is the huge spending that goes into the research and development of these drugs. One look into the recent report by US Government Accountability Office, and you will realize the truth. As per the report:
"Although the pharmaceutical industry reported substantial increases in annual research and development costs, the number of New Drug Applications (NDAs) submitted to, and approved by, Food and Drug Administration (FDA) has not been commensurate with these investments. From 1993 through 2004, industry reported annual inflation-adjusted research and development expenses steadily increased from nearly $16 billion to nearly $40 billion—a 147 percent increase. In contrast, the number of NDAs submitted annually to FDA increased at a slower rate— 38 percent over this period. Similarly, the number of NDAs submitted to FDA for NMEs increased by only 7 percent over this period. FDA approved most NDA applications—76 percent overall, but the numbers of NDAs and NDAs for New Molecular Entities (NMEs) it approved annually have generally been declining since 1996. "
Another interesting thing is that UN recognizes 50 countries in the category of Least Developed Countries (LDCs). These countries are exempted from abiding by TRIPS until 2016. Bangladesh and Myanmar, two of India's neighbours are in that category. Gonoshasthaya Pharmaceuticals Limited (GPL) is a company in Bangladesh committed to providing low cost medicines for poor people (similar to LoCost). I got to know from Dr. Anant that talks are in the process between the two for possible collaboration.