Transparent Project Funding Mechanism

The projects of OSDD are executed and funded through a transparent and open process. Projects are funded through open peer review that takes place on the Sysborg 2.0 portal. The procedures adopted by CSIR in awarding of work to industry, is followed in partnership funding. These are open, transparent and merit based evaluation mechanisms.

A study conducted by London School of Economics surveying  major pharmaceutical industry involved in drug discovery revealed that most of the research based pharmaceutical enterprises are  not willing to invest in risky clinical trials for neglected diseases, particularly as these trials conducted in the developed world are expensive. In this background, the pipeline of drug candidates will remain dry in tropical diseases.

 OSDD model believes that the governments and public funded institutions in the countries with high burden of disease has a responsibility to contribute to the drug development. OSDD alternative is to conduct publicly funded clinical trials involving public institutions. These trials will have to be conducted with internationally accepted standards. Infrastructural and other capacity may have to be built up for conduct of trials, but there are countries like India where such facility already exists in many diseases. Global pharma majors are using Contract Research Organisations (CROs) in countries like India to conduct clinical trials on diseases of their interest, thereby creating competencies to carry out such work.OSDD will collaborate with such CROs to carry out its clinical trials with the participation of public funded institutions. The cost of trials can therefore be brought down considerably on the open source platform. CSIR has brought many drugs to the market after clinical trials. The experience of CSIR in conducting clinical trials is a guiding point.

 Two important points govern the principles under which clinical trials will be conducted under the CSIR/OSDD umbrella but with the Open source concept. The main features guiding success:

• Appropriate processes and documentation required for clinical trials and during the conduct of it, are maintained to internationally acceptable standards, in collaboration with CRO’s or industry partners with experience in the field.
• Private pharma will be inducted as a stake holder in the process of conducting clinical trials. The arrangements with the different stakeholders will be with the understanding that the drug will be made available to the generic industry for manufacture which in turn ensures ‘affordable pricing’.

In all cases where clinical trials are conducted by OSDD, the data will be available in the open and high standards will be adhered to. Thus, OSDD has a clear alternative approach for the expensive clinical trials conducted in secrecy and at high cost.

 OSDD de risks clinical trials for tropical diseases by investing public sector funds and involving public institutions in the countries where disease occurs. This will bring down the cost of clinical trials. OSDD ensures that clinical trial data, sans personal details, is made public so that community inputs are available while conducting clinical trials and for later designing of new trials. OSDD will also make the commitment that these trials will be conducted following all national regulations, following the best ethical practices in a transparent manner and will be monitored by an independent group appointed by the OSDD.

 OSDD Approach to Intellectual Property

A key premise of OSDD is that when it comes to health we need to have a balance between health as a right and health as a business. In the case of tropical diseases, the market based incentive mechanisms do not operate. Patents as a mechanism to ensure Return on Investment (ROI) from the market fail to play the role it plays as a driver of innovation in the pharma industry. In the absence of a market size that attracts the interests of the pharmaceutical industry, Intellectual Property (IP) Rights as a legal system has limited role to play in fostering innovation in tropical diseases. Therefore the OSDD approach to drug discovery and development is IP neutral.

Affordability and accessibility remain the core concerns of delivery of drugs for tropical diseases. The only successful market based model ensuring both is the generic drug industry business model where the market competition is driving the prices to affordable levels and makes competitors seek extended market reach ensuring accessibility.The fundamental principle of OSDD is affordable healthcare to the developing world. Anything that is developed in OSDD will be available to the developing world in open source, generic mode, without price monopolies. This means that there will be no market monopoly associated with OSDD drugs, diagnostic or delivery mechanisms.  

Markets are the key determinants for delivery of drugs. The drugs will be discovered and developed with public funding. Once a drug is approved for use by the regulatory agencies, OSDD will depend on the business model of generic drug industry which made drugs affordable in the developing countries. OSDD developed drugs will be available for any industry player with appropriate manufacturing practices to distribute the drugs to the market. The market competition will ensure accessibility and affordability.

OSDD also understands that researchers may be contributing patented inventions to OSDD or there may be cases where the inventors worked in an open source environment yet would like to file patents. OSDD will encourage such patenting only for ensuring attribution to the inventors and for proving the non-obviousness of the research.

 In cases where OSDD inventions are covered by patents, it will be used to ensure:

    i.                Affordability and Accessibility, by ensuring that the drugs are licensed non exclusively, utilizing open competition in the market, removing the monopolistic nature of IP for access in developing countries

   ii.                For ensuring quality control of downstream drug manufacturing, by licensing to only those entities who employs quality processes

   iii.              That the subsequent innovations which follow on the existing patent remain openly accessible through the OSDD community through its viral clauses.

 At no circumstances will OSDD hamper further research on any of its patents by any group anywhere as these patents will be available with an open source license which enables further research.While OSDD approach to research and development is IP neutral, it shall respect the intellectual property of others.

 There may be situations where OSDD may have to enter into collaborations with industry partners who works on the IP based model. In such situations the OSDD approach shall be to ensure that research on tropical diseases progress and result in drugs and that such drugs are available like a generic drug to the developing world. OSDD will honor the IP of its partners and will work with those partners who are IP holders but align with its vision of affordable healthcare to the developing world.

 Attribution and Authorship

When a community collaborates, it does so with some basic rules that governs such collaboration. These rules are laid out in the OSDD license which all community members signs in when they join the sysborg portal. OSDD license treats the entire information available on the portal as ‘protected collective information’. It mandates common ownership of the data and research results, sharing of such data, contribute back of improvements to the protected collective information. Such Protected Collective Information is held on behalf of OSDD community by CSIR as a trustee holder with legal powers and authority for legal action.

A cornerstone of any scientific investigation is attribution. OSDD ensures that all contributions made on OSDD are attributed to the concerned. Intellectual Property, in addition to its other roles, plays a role in attribution (of authorship, invention, etc). Therefore in an open source scientific environment of drug discovery for tropical diseases IP could have a limited role to ensure attribution. Therefore if individual researchers would like to patent their inventions for this purpose, they are welcome to do so, but will need to provide worldwide royalty free non exclusive license to OSDD to work further. OSDD will take forward such molecules in the drug discovery pipeline and make it available without IP encumbrances. Thus IP may play a limited role but within the premises of affordability and accessibility.

Since the inception of OSDD in September 2008, a large number of activities have been initiated with several results being produced and some of these have been already published.OSDD encourages the Principal Investigators (PI) to publish their results in peer reviewed publications. OSDD Consortium, in keeping with the spirit of collaboration, has further reiterated the following policy for authorship of various papers for further clarification.

• In the cases where data that is used in the paper or in the execution of the project, has been generated by the OSDD Community, the OSDD Consortia needs to be given authorship

• When the OSDD Consortium is given authorship, it should be before the Corresponding author(s).

•  For example, if P1, P2, P3,...Pn are the PIs of the OSDD Consortium; S1,S2, S3,...Sn are the student researchers participating in the project, then the following authorship pattern may be followed: S1,S2...        P1,P2, OSDD Consortium, Corresponding PI(s).

• There may be projects where the Chief Mentor has actively contributed and merits authorship. In such cases, his express consent should be taken to include him as an author.

• If there are specific and significant contributions of individual students or Principal Investigators of the OSDD Community they need to be given authorship.

• As there are a large number of projects being pursued under OSDD, it is likely that there will be many publications. To avoid duplication and to ensure that the micro attribution system has been followed, the manuscript should be submitted to the OSDD portal prior to sending the publication.

• The Title, Abstract and Author List should be uploaded on the OSDD portal by the corresponding author before submission of the manuscript.

•  All the projects have to acknowledge OSDD for grants and resources if any used.

All projects of OSDD are required to follow this authorship policy.