Open Source Biotechnology

Prospects

 

Realising the promise of open source biotechnology

In chemistry, a phase transition involving the formation of new crystals may be triggered when a nucleation site (e.g., a dust particle) is introduced into a supersaturated solution. Clouds, bubbles and ice can form in the same way: they appear suddenly, seemingly out of nothing, then rapidly take over.


The metaphor of a phase transition is particularly apt in the case of  open source biotechnology.  All the key elements of this approach are present in existing innovation systems, and the economics of open source are such that a small shift in industry practice could ultimately lead to big changes.


But it is not yet clear whether nucleation will take place - and if it does, whether current sites of experimentation will be the nucleation points.


What would it take to bring about a phase transition in biotechnology? The following observations are not definitive, but may provide food for thought about the future of open source biotech.


Harnessing the power of the Internet

One notable difference between conventional biotech R&D and open source software development is the extent to which each relies on, and makes use of, the Internet.


Arguably, the success of open source biotech does not depend on its becoming as thoroughly digitized and widely distributed as open source software development.


Nevertheless, use of the Internet as a means of coordinating contributions from a range of innovators is an important feature of the open source model.


Over time, the gap between software and conventional biotech is likely to close, as web-based collaboration tools are increasingly used in mainstream biotechnology R&D. 


However, there is still much work to be done in exploring how biotech collaborations can be designed and managed to effectively harness the power of the Internet.  This is a major focus of several existing open source biotech initiatives.


Aligning traditional “bazaar” incentives with open source collaboration

In the early days of biotechnology, publicly funded research set the stage for the growth of a new industry.  Even now, contributions to biotech innovation from public and non-profit sectors continue to play an extremely important, though often undervalued, role in the development of new products and services.


On one hand, this proves that the profit motive is not the only driver of socially valuable innovation. Non-proprietary incentives can be sufficiently powerful to induce substantial investments of time and talent on the part of individual scientists.


On the other hand, the institutional settings in which these incentives currently operate are not always directly conducive to open source-style collaboration of the kind that exists in the software sphere.


In many cases, academic and other non-profit institutions have bought into the proprietary paradigm to the extent that employees may be prevented from contributing to open source initiatives.


But even where employees are free to contribute, academic reward systems have developed over many decades (and even centuries) to value some types of contribution over others - even where the less valued contribution is actually extremely helpful to other scientists.


For example, published papers reporting successful experiments are typically valued much more highly in an academic setting than informal sharing of the results of failed experiments, even though such sharing avoids wasting time, effort and resources.


Academic “rules of the game”  may render other actions that support open source-style collaboration professionally risky.  For example, junior scientists may be reluctant to criticise their seniors in open peer review. Senior scientists may be reluctant to release data that could form the basis of a student’s PhD thesis, for fear of the student’s results being “scooped”.



Because the future of open source biotech is likely to depend in large part on the involvement of scientists currently employed by academic and non-profit organisations, proponents should take active steps to identify and defuse such incentive misalignments.


Commercial engagement

A key difference between traditional or academic production in biotech and the open source model is that open source seeks to integrate both non-commercial and commercial contributions on the same non-monopolistic terms. 


In principle, there is no reason why commercial players would not be motivated to contribute to open source biotechnology development in the same ways that they have helped to drive open source software development.


(Regarding the difference in costs between software and biotech R&D, see “Rethinking regulation”, this page.)


But until a substantial number of profit-motivated corporations or individuals come forward as sponsors or participants, we cannot know precisely when the trade-offs between monopolistic and non-monopolistic business models, and between open access/public domain strategies and open source licensing, will come out in favour of open source biotech. 


In the mean time, the uncertainty associated with open source biotech as a relatively untested approach may deter innovators who might otherwise perceive advantages in adopting an open source strategy. 


One goal of scholarly research and writing in this area - including this website - is to break down the barrier of unfamiliarity and encourage those who might have something to gain from this novel approach to give it a try.  Only by trial-and-error learning in situ will it become clear which aspects of the open source model are workable in which environments.


Creative financing

Actors who wish to encourage such experimentation by technological innovators could do so in a range of ways. For example:


(1) Government agencies and other institutions that sponsor biotech R&D could consider giving overall priority and/or targeted funds to projects that incorporate aspects of the open source model.  Ideally, such funding would be provided on terms that encourage project leaders to reflect on their experience and communicate it to others, creating a learning loop. 


(2) Patent offices could adopt a policy of expediting the patent application process in relation to applicants who undertake to make their intellectual property available on open source terms.


(3) Intellectual property experts could provide free advice to would-be licensors to help them develop appropriate licence terms.


(4) Industry associations whose members would benefit from access to cheap, high quality technologies could offer financial or in-kind support to new open source biotech businesses.


(5) Charities and independent patient advocacy groups could facilitate micro-financing campaigns to raise funds for projects meeting open source criteria.


(6) Agents who act on behalf of end users of biotech products (eg, government procurers and health insurance companies) could signal a preference for products developed using open source methods, using their bulk purchasing power to create market demand.


As these examples illustrate, there is a need to think laterally about funding for open source biotechnology.  This is because conventional means of raising much-needed capital for new biotech ventures tend to rely heavily on monopoly rights.


This is not to say that open source entrepreneurs will never be able to access mainstream sources of finance; after all, some open source software companies have been successful in attracting venture capital funds.  But they will likely have greater barriers to overcome. 


Rethinking regulation

Some people say that open source biotech could not work because biotechnology R&D costs much more than software development.

While it is true that biotech goods and services are inherently somewhat more costly to produce than software, for some such products the same basic economic principles apply as in software.  This is because in both cases, human creativity is the salient input. 


(In fact, the more inherently expensive the process, the stronger the case for an open source approach, assuming it entails more efficient use of resources.) 


The real challenge for open source biotech relates to products and services, such as pharmaceutical drugs, that are required to undergo costly and time-consuming regulatory approval before being marketed to consumers.


This difficulty is sometimes thought to be insurmountable, on the basis that regulatory costs can only be recovered if firms are able to charge monopoly prices for new drugs.  However, this overlooks both


  1. (1)the potential for new open source-compatible business models to arise in the pharmaceutical industry, and


  1. (2)the fact that the current regulatory system has co-evolved with existing business models.


To elaborate: the current regulatory system is not the product of rational design principles applied with the single-minded purpose of maximising social welfare.  Rather, it represents a (more or less) ad hoc accumulation of rules and procedures.  Collectively, these embody a tenuous political settlement among various competing ideologies and interest groups.


To the extent that open source biotechnology cannot be accommodated within the existing system, it may indeed call for renegotiation of that settlement. 


While there is no reason to think this is impossible, it is one of the major challenges faced by proponents of open source biotechnology - in common with advocates of a range of other proposals for reform of the health care system. 


Formulating working licences

Intellectual property management is an integral aspect of open source biotech. There are two major challenges associated with developing open source licences for biotechnology.


The first challenge is to interpret the principles of open source software licensing in ways that

  1. make sense in a different legal, technical and commercial environment,

  2. while still preserving functionally important design elements. 


Some experimentation has already taken place along these lines. However, in the absence of any open source licensing standard specific to biotech, it is difficult for prospective licensors and licensees to judge the quality and impact of these experimental licences. 


The second challenge is to develop a body of licensing practice and a set of standards that could address this problem.  In the software context, the Open Source Initiative administers a certification program for software licences based on compliance with a written standard: the Open Source Definition (OSD).


The OSD is widely accepted among free and open source software developers as a codification of many years’ trial-and-error learning about which terms best permit developers to harness “the power of distributed peer review and transparency of process”. 



Fostering a community of interest

In developing an equivalent standard for biotechnology, it will be important for proponents of the open source approach to foster a community of interest within which such iterative learning can take place.


At present, social networking around particular initiatives exists but is relatively sparse, while attempts to bring people with relevant expertise together under an overarching banner of “open source biotechnology” (or some equivalent rubric) have not yet reached critical mass. 


In the coming months and years, up-front investments in community building will be needed so that open source biotech can be adequately coordinated at a social and political as well as a technological level. 

Janet Hope, Australian National University, 2009-