Our News Bureau – Mumbai
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| (L-R) Thomas Watkins, Kiran Mazumdar-Shaw, Alan Eisenberg and PM Murali at BIO India 2012 |
The 3rd annual BIO India conference, recently organised 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 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 Kiran Mazumdar—Shaw, Chairman and MD, Biocon, H Thomas Watkins, Former President and CEO, Human Genome Sciences, along with industry organisation heads—Alan Eisenberg, Executive Vice-President, Emerging Companies and Business Development, BIO and PM Murali, President, ABLE laid 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, they said. Indiscriminate use of compulsory licenses would thus jeopardise 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 recognise 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.
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| H Thomas Watkins, Former President and CEO, Human Genome Sciences |
However, he pointed out that India needs to recognise 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 saw both large and small biotech companies engage in partnering discussions with biotech leaders from around the world. It also featured a fireside chat on the future of development and production of vaccines in India with Dr Cyrus Poonawalla.
BIO, in partnership with ABLE and the Confederation of Indian Industries (CII) held a roundtable to discuss ways that US and Indian industry can work together to facilitate the development of new biotechnology products and commercialisation. Participants in the roundtable representing US and Indian industry, academia, and government shared their views on critical issues important to the development of the Indian biotechnology sector, including intellectual property, R&D collaboration, and regulation of biotechnology products. A joint statement encapsulated key findings of the round table, focusing on R&D collaboration, biosimilars regulations and intellectual property.
On the R&D collaboration, the statement reiterated that success in biotechnology collaboration requires shared risk, shared incentives and shared rewards. Importantly, in collaborations involving US and Indian partners, there should be a balance of risks and rewards by both sides, recognising that each provides key contributions to the partnership, and each wishes to minimise risks while maximising rewards. To enable R&D collaborations, it is necessary to have a legal framework for translating discoveries into products and creating incentives for those who are willing to take on the necessary risks.
Commenting on India’s recently issued new guidelines for biosimilars regulations, the statement urged that while these guidelines are generally accepted to be well-crafted and science-based, they need continued refinement over time. Industry and other stakeholders should provide feedback to the Indian government in its application of these regulations.
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| Kiran Mazumdar—Shaw, Chairman and MD, Biocon |
The statement also recommended that regulations should not be so onerous as to make innovative products or biosimilars unaffordable to Indian patients and urged that a first priority is to streamline and rationalise the necessary clearances in order to eliminate unnecessary processing delays.
On the Intellectual Property front, the statement commented that recent legal developments in the India have raised key questions that will impact the biotechnology industry, particularly the development of new, innovative products for Indian consumers. It was pointed out that biotech product R&D and commercialisation is a capital-intensive endeavour, which requires both incentives such as intellectual property rights to develop these needed products and a system for providing them to those who need them.
The second day focused on stem cells, featuring a session ‘Commercialising Stem Cell Therapies and Regenerative Medicine’ with BN Manohar, MD and CEO, Stempeutics Research, Virender Sangwan, Associate Director, LV Prasad Eye Institute (LVPEI) and Chandra Viswanathan, Head of Regenerative Medicines Group, Reliance Life Sciences as panelists.
A keynote and plenary luncheon on ‘Strategies for Success: India’s Global Role in Innovation’ had Achin Gupta, Director, Strategic Planning, Abbott Laboratories, Phil Kearney, Director, External Scientific Affairs, Worldwide Licensing, Merck, Chaitanya Saxena, CEO, Shantani Proteome Analytics, Renu Swarup, Adviser, Department of Biotechnology, Ministry of Science & Technology, Government of India and Holly Vineyard, Deputy Assistant Secretary for Africa, the Middle East, and South Asia, US Department of Commerce, International Trade Administration as panelists.
EP News Bureau
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