Leading Up To The GCIP: A Chat With Zakir Thomas

Profile: Zakir Thomas is an expert in the field of intellectual property rights, open source innovation, neglected diseases and innovation ecosystem in science and technology in India. He will be giving a keynote address during the inaugural plenary session scheduled for December 15^th.

JMM: How far has the TRIPS regime ensured access to and availability of treatment for neglected diseases?

ZT: TRIPS is an instrument meant to further intellectual property (“IP”) driven innovation. One basic feature of IP driven innovation is that it is market related; thus if the market fails, there is no innovation. There is a whole gamut of areas where innovation is required but does not happen due to lack of a market. The TRIPS regime is meant to address innovation in areas where there is already a market. IP drives innovation in areas that has a market, which will ensure return on investment. In the case of neglected diseases there is no ‘market’ for the innovation drivers to ensure a return on their investment and hence access and availability has been poor in this area. I would say that the TRIPS regime has not dealt with the question of treatment for neglected diseases at all. The fact here is that the TRIPS regime was not meant to ensure access and availability to treatment for neglected diseases.

However it important to look at this question a little closer. There are a lot of areas where innovation has not happened despite the presence of TRIPS-compliant laws. There are countries with stronger IP laws than the US, yet companies have not shifted to those countries. There are many countries in the world today that have TRIPS-complaint IP laws, yet has this resulted in transfer of R&D from the US to local companies in these countries? Even after two decades of TRIPS and links drawn between stronger IP laws and innovation, innovation is confined to a handful of countries. Innovation ecosystem is a complex ecosystem and IP is only one of the factors that have an effect on the ecosystem and not the sole determinant as the current narrative makes it out to be. It is important to challenge the narrative that proclaims that IP drives innovation or that higher IP protection will attract investment and transfer of R&D.

JMM: Given the fact that big pharmaceutical companies are resource-rich to pay hefty sums to people who work with them, how can the open source movement attract the best talent to work for it?

ZT: From my experience in working in this field, I don’t think talent or the lack of it is the real issue. It is important to understand what exactly a pharmaceutical company does in research. In most cases the real innovation, i.e. finding the early stage molecule, which is the core of pharmaceutical innovation, happens in publicly funded academic or research institutions and only in limited cases does it happen within the pharmaceutical company. Once the early stage molecule is discovered then the pharmaceutical companies does some development over these molecules leading up to the clinical trial. There are experts in publicly funded institutions who are willing to work with the open source movement and are in fact working with it. There are Contract Research Organizations who are IP agnostic and deliver quality research to the industry. Talent, therefore, is not difficult to find and is readily available to tap into. Of course, pharmaceutical industry driven drug discovery is a cost-intensive model. Even in the open source model, the costs cannot be brought below a certain level. The open source model will also have to conduct clinical trials and somebody will have to bear these expenses. The difference lies in that fact that the fruits of the innovation will be available to all without the exclusivity of IP attached to it.

JMM: A major concern for the uninitiated will be issues of quality control in an open source drug discovery model. How does open source drug discovery address such concerns?

ZT: To be honest, such a doubt will come from someone not only uninitiated to the model of open source drug discovery but also the process of drug discovery itself. Drug discovery and development is a highly quality controlled work. There are inbuilt regulatory mechanisms which ensure that newly discovered molecules pass certain regulatory standards. We have an independent clinical trial regulatory body called the Drug Controller General, whose experts closely scrutinize all data submitted to it, and only after they are satisfied will they give the nod to go ahead with clinical trials. Further, just because the drug is developed in an open source model doesn’t mean that experts do not closely scrutinize it. Experts, peer reviewers and funders scrutinize the discovery at every single stage and only with the approval of the regulators will things move ahead. Essentially, independent of whether the drug is discovered through the open source or the pharmaceutical model, the kind of regulatory checks and quality controls it goes through will be the same.

JMM: The Department of Biotechnology and the Department of Science and Technology are announcing an open access policy as a major victory for the open access movement in the country. What according to you should be the next objective of the open access movement in India?

ZT: Creating a national depository of open access journals which are properly cited and indexed, organized subject-wise and searchable online by all our academic institutions should be the next step. Essentially a well stocked and organized open access library should be accessible to our researchers. India has a National Knowledge Network (NKN) which provides high bandwidth connectivity to academic institutions. This repository should be made accessible over NKN. It is not enough to declare that Departments go open access. It is important to ensure that the all open access resources are available to our researchers we well.

JMM: How far has the open access movement in India translated to output of quality scientific research studies?

ZT: Open access is about access to knowledge. It will ensure that the work you do at your lab is now accessible by people at large. It does not mean that the quality of work you do in your lab improves. But access to knowledge has the potential to improve the quality of your research. Open access allows for the communication of research findings with taxpayers, which will lead to better returns for the taxpayers as the fruits of the tax money spend is available publicly for everyone to access. Whether this availability leads to better quality of scientific research studies is something unquantifiable as of now. So, open access resulting in output of quality scientific research studies is a correlation that I cannot make. Open Access has been recently adopted in India and there is no data available that allows me to make such a correlation.

The idea behind open access is that one makes public one’s work regardless of its quality or other considerations. Now, the question is whether doing so increases quality of output? There is a possibility that following an open access model will result in better review and feedback of works submitted but this is a very long process and there is no data in India to make such a claim.