An Indian Policy for Gene Mapping

An interesting learning experience I had last year was the Technology Policy Course by Takshashila which I attended. Starting off with an overview on public policy, we specifically studied frameworks to analyse technology, primarily from a policy/ governance perspective. I found this area of study to be fascinating because it requires complex, system thinking but the nice thing is that we can easily adopt a lot of relevant frameworks to different scenarios.

The framing of a gene mapping policy for India was the ask for the final assignment submission, and I am glad to have scored decently on this assigment. I believe it was relevant to convert the assignment slides into a long , written format. As usual, any comments and suggestions are welcome, particularly from experts or students of this area.

The assignment was structured using a blend of two frameworks. One of these was specifically used throughout the technology policy course while the other is something I’ve learnt a long while ago from one of my bosses and have been using for sometime now. While the more generic framework I use is the 5 W, 1 H approach (Why, Who, What, Where, When and How in roughly the same order), the Bardach Eightfold Path has been popular among public policy thinkers for sometime now and can be graphically illustrated as below:

A Gene mapping policy is relevant as a final exam topic for our course because it is intertwined with various aspects of our syllabus like the public policy matrix, information matrix and politics and policy of the information age. Additionally, it is relevant as a policy matter for India for the following reasons:

The need to start identifying the causes of many rare diseases in the Indian sub-continent to find cures for them.
The fear that this project will cut across issues of religion, caste, language and regionality.
The multiplicity of stakeholders involved
The questions of ownership, collection, storage, commercial exploitation and litigation around the data collected by this project.
The need for identification of suitable business models with participation from public and private players.

Gene mapping is an imminently important tool which is becoming more viable. To illustrate this(1),

70 million Indians (around 6% of the population) suffer from rare genetic diseases.
40% of patients with such diseases are misdiagnosed.
Close to 10,000 diseases are caused due to the malfunctioning of a single gene.
Close to 90% of Indians marry within their caste, resulting in higher probability of genetic diseases in offspring.
Prices of gene mapping are 1/10th of what they used to cost a decade ago.

Additionally, countries around the world seem to be actively pursuing gene mapping goals for rare diseases particularly.

We are also witnessing the emergence of multiple business models(3) in gene mapping, not just restricted to rare diseases but also to lifestyle changes, (nutrition, allergies, etc), cosmetic changes (eyesight, balding), forensic sciences and so on. We also foresee that the mode of interaction will very quickly evolve from 1-1 type of services to n-n types. However, the creation of a policy becomes pertinent because of the many questions that emerge around these business models and the associated value chain. These questions are primarily around the nature of data transfer, data ownership, the use of financial incentives in collecting and sharing data, the extent to which unaggregated data can be transferred to private players and so on.

To answer these questions, we have additionally mapped stakeholders, their response to a policy and risk. For the former, we believe that the most critical stakeholders in terms of levels of interest and the levels of power are the India Genome project, the scientists and rsearchers, private gene mapping companies and drug companies who are the recipients of the research around gene mapping. Positive responses to such a policy would primarily revolve around the ability to find cures, create cost effective and reliable data sets and help individuals monetize their data. Apprehensions would be around the flow of data, the need to adhere to existing laws about information and the chances of misuse of data.

From all the above, we derive a set of questions based on the roles and responsibilities of different stakeholders, measures to encourage a stronger India Genome project and a private gene mapping industry while protecting data and privacy. These questions will help in creating alternatives and evaluating them.

The alternatives chosen were to continue with a status quo (do nothing), completely privatise the genome mapping industry, completely nationalize it and an intermediate solution which consists of identified rare diseases being the responsibility of the government while the rest of the activities could be privatized. These were evaluated on the basis of 7 criteria, the most important of which were the cost of implementing the policy (25%), the ability to achieve the national goal of mapping 10,000 genomes (20%) and enable the growth of a large private genomics industry(15%).

The chosen option was the intermediate one. Below is a list of measures which make up the policy proposal, in my opinion. It would be interesting to see how we as a nation actually go ahead in using this emerging technology for public good.