13 Sep 2012, BioSpectrum Bureau , BioSpectrum
Mumbai: The 3rd annual BIO India conference, organized by Biotechnology Industry Organization (BIO) in partnership with Association of Biotechnology Led Enterprises (ABLE) saw the industry body addressing key issues in tandem with major industry players. At the two day BIO India International Conference 2012, views were expressed on public policies that are intended to bring about innovation, collaboration and investment in the biotech sector, particularly strong intellectual property (IP) protections and regulatory mechanisms.
The industry captains led by Dr Kiran Mazumdar-Shaw, chairman and managing director, Biocon; Dr H Thomas Watkins, former president and CEO, Human Genome Sciences, along with industry organization heads, including Mr Alan Eisenberg, executive vice president, emerging companies and business development, BIO; and Mr P M Murali, president, ABLE, lay thread bare issues like strong intellectual property as well as patent enforcement, strong tax and regulatory system, strong support for R&D, streamlined safety and efficacy testing, and approval process.
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, the participants revealed. 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 R&D of new cures and treatments," said Mr Alan Eisenberg.
However, he pointed out that India needs to recognize scientific differences between small molecule therapeutics and biologics. The US 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 will offer opportunity for large and small biotech companies to gather in one place and engage in partnering discussions with biotech leaders from around the world.