Washington, D.C. and Mumbai, India (September 12, 2012)– The 3rd annual BIO India International Conference, organized by the Biotechnology Industry Organization (BIO) in partnership with the Association of Biotechnology Led Enterprises (ABLE) saw the industry body addressing key issues in tandem with major industry players. At BIO India, views were expressed on public policies that are intended to bring about innovation, collaboration and investment in the biotech sector, in particular strong intellectual property (IP) protections and regulatory mechanisms.
The industry captains led by Kiran Mazumdar–Shaw, Chairman and Managing Director, Biocon, H. Thomas Watkins, Former President & CEO, Human Genome Sciences, Inc along with industry organization heads – Alan Eisenberg, Executive Vice President, Emerging Companies and Business Development, BIO and P. M. Murali, President, ABLE – discussedsuch hot topic issues as strong intellectual property laws, patent enforcement, a strong tax and regulatory system, streamlined safety and efficacy testing and drug approval processes.
The participants agreed that they do not believe that the compulsory licensing of innovative products or technology generally is an effective means of promoting access or affordability of healthcare. Moreover, it undermines incentives for companies and individuals to innovate in India, since it creates uncertainty about receiving economic returns for their innovations. Indiscriminate use of compulsory licenses would thus jeopardize India’s goal of developing a research oriented biotechnology industry, and is unsound policy, according to participants.
All participants agreed that the issuance of India’s Guidelines on Similar Biologics is a step in the right direction. “The guidelines recognize the scientific and regulatory complexities presented by the development and manufacture of biologic medicines. What follows next is industry collaboration in the implementation of these guidelines in a manner that continues to protect patient safety and ensure continued research and development of new cures and treatments,” said Alan Eisenberg. However, he pointed out that India needs to recognize scientific differences between small molecule therapeutics and biologics. The U.S. industry represented by BIO urged the Government of India to include substantial non-patent data exclusivity in its policy and respect intellectual property and other legal rights. All participants agreed that there is scope for continued discussion and collaboration on these key issues.
The two-day conference offers the opportunity for large and small biotech companies to gather in one place and engage in partnering discussions with biotech leaders from around the world.
ABLE – Association of Biotechnology Led Enterprises is a national forum that represents the Indian Biotechnology Sector. The primary objective of ABLE is to accelerate the pace of growth of the Biotechnology Industry in India, through partnering with the Government of India in their Biotechnology initiatives to deliver optimal policies and create a positive regulatory environment, encouraging entrepreneurship and investment in the sector, providing a platform for domestic and overseas companies to explore collaborations and partnerships, forging stronger links between academia and industry and showcasing the strengths of the Indian biotech sector. ABLE thus catalyses a symbiotic interface between the industry, the government, academic and research institutes and domestic and international investors.