Tag Archives: Innovation

The plan for innovation, IPR and public health is adopted at the WHO. How can this be reconciled with the IPR Act?

It is not unusual in national policy for the right hand not to know what the left hand is doing. There is now a looming clash of priorities for the new Cabinet that goes to the very heart of the ‘better life for all’ mandate on which President Zuma’s government came to power. This  could cause embarrassment to a number of new ministers, in the DST, Higher Education, the DTI and Health. What is at stake is the way the South African government secures benefits from its investment in public research and how the country and its universities make research work for national development and the betterment of people’s lives.

What has happened is the IPR  Act, with its Draft regulations (due for final comment tomorrow) is on a collision course with a landmark resolution passed after years of debate at the  61st World Health Assembly at the World Health Authority. The South African delegation at the Assembly was headed by the Deputy Minister, Dr M. Sefularo and was attended by a delegation of 16 delegates and alternates from the Department of Health. The problem is a radical difference of views on how best to achieve benefit through innovation and intellectual property management.  The IPR Act requires universities and other publicly funded research organisations to secure intellectual property rights and patent as much research as possible, frowning upon open innovation and open source. The WHO, on the other hand promotes the idea of a collaborative world public health regime that uses patenting, but in a responsible way, and combines this with support for a number of open approaches to the shared dissemination of public health research.

The WHO resolution, passed on 22 May, finally agreed the way forward on the recommendations made to the Assembly by the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property. The purpose of the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property that has now been voted through, aims to  ‘secure.. an enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries, proposing clear objectives and priorities for research and development.’ While many people glaze over as soon as intellectual property is mentioned, it is clear that this is a vitally important issue for South Africa, quite literally a matter of life and death.
The recommendations of the Global Strategy contain a vision of the scientific endeavour that stresses global collaboration and the sharing of research information and data. This is also the way forward that President Barack Obama proposed in his speech to the National Academy of Sciences in the US a few months ago. The way forward that he sees for US  science is a vision of collaborative science for the public good:

In biomedicine… we can harness the historic convergence between life sciences and physical sciences that’s underway today; undertaking public projects — in the spirit of the Human Genome Project — to create data and capabilities that fuel discoveries in tens of thousands of laboratories; and identifying and overcoming scientific and bureaucratic barriers to rapidly translating scientific breakthroughs into diagnostics and therapeutics that serve patients.

The WHO plan of action, which the South African government is now called upon to implement, contains a number of provisions that provide for the use of open source development, open access to research publications and data, voluntary provision of access to drug leads, open licensing, and voluntary patent pools. This runs alongside a more traditional approach to the patenting of drug discoveries and vaccines, but with the proviso that there must be measures in place to ensure that patents are managed in such a way as to be appropriate to public health goals. This includes delinking the costs of research from the price of health products, so that they can be affordable in developing countries.

The burning question now is how this can be implemented – presumably by the Department of Health – when the IPR Act and its Regulations will effectively block the WHO provisions for sharing research results and using open licensing and open access for the benefit of public health delivery.

It would perhaps be appropriate for public health departments in our universities and their researchers to submit a request to the DST for the withdrawal of the Regulations for further consideration of the issues at stake by all the government departments that might be involved in this potentially embarrassing clash.

India Bayh-Dole legislation – a conspiracy theory?

An article by Latha Jishnu in the Business Standard in India in mid 2008 provides a succinct account of the secretive progress of a piece of Bayh-Dole legislation in India. It sounds rather similar to our experience in South Africa. The Indian Act has subsequently been submitted to Parliament. The Bill was apparently being passed around the various ministries without much transparency when the text of the Bill was published on SpicyIP, an Oxford-based blog. Similar secrecy seems to have been reflected in the South African, process. Although the original draft of the SA Bill was published for comment and the universities’ criticisms of what many considered an unworkable system were noted, it was very difficult to lay hands on subsequent drafts. People I know trying to track the final draft only saw it after the Act was passed, although it appears from personal accounts that industry players were probably consulted in a workshop (in India there appears to have been a workshop for the chambers of commerce and industry).

Jishnu’s article concludes: Technology transfers can and do happen through many channels, and the diverse methods now in use would be restricted by the new law, says Abrol. Nistads is one of the one of the 38 institutes grouped under the Council of Scientific and Industrial Research (CSIR) whose chief, Samir Brahmachari, has been advocating the open source system (reported several times in this column) of collaborative, incentive-based research. What we need is some informed debate on what is India’s best interest at this particular stage instead of going for a wholesale import of an American system that could prove ineffectual. Otherwise, we could be headed for a nuclear deal in our science establishment — corrosive, divisive and ultimately ineffective. A series of SpicyIP blogs goes into the Indian legislation in some detail. It sounds much like what we are facing: The Indian bill, much like its US equivalent is premised on the assumption that intellectual property rights are the best way to drive innovation. The more IP, the better for innovation. There is plenty of literature that casts strong doubt on this lopsided view. Additionally, we’re seeing some great alternatives to the IP model emerging. Indeed, even as we speak, international scholars and activists are debating the merits of incentivising innovation through a variety of alternative means including “prizes”, “advance purchase contracts” etc. Closer home, Dr Samir K Brahmachari, Director General of CSIR, India’s premier R&D body, has been advocating an open source model in drug discovery. This is not to suggest that intellectual property rights (IPR’s) are bad in any way, but only to caution that IPR’s are but one way of incentivising innovation. Given that we are dealing with innovation and creativity, we must be open to trying out some of these alternatives i.e. we need to innovate within our innovation regimes! Particular stress is placed on the damaging effect that this legislation could have on access to medicines in India, given the above. Like our South African legislation, the draft Indian Bill also takes away the discretion of researchers and universities to make their own decisions on how best to make their research work for the public good. Both the decision to patent or a decision to use open approaches are subject to decision by a government office.

The Indian Acr aims to generate revenue through its provisions; however, SpicyIP argues, ‘In fact, the cost of operating a technology transfer office (TTO) often exceeds the money made from technology licensing. CSIR bears out this point well. While it generated approximately US$1 million in licensing revenues in 2004–2005, it spent more than twice that amount on filing patents.’

What is different in India is that there has been a strong activist movement, with a number of individuals and organisations tracking the progress of the Bill, unearthing copies of successive drafts, providing links to commentaries and analysis on Bayh-Dole in other countries  and generating debate. Useful for those who want to explore this issue in more depth.

But this particular budding conspiracy theorist, down on the southern tip of Africa, is asking why the secretive processes in both countries? And why does this legislation seem unstoppable? Is this a big-industry driven initiative and if, so given Obama’s view on scientific research development in last week’s speech, is this Reagon-style legislation what the US still wants?(1) And what of our new pro-poor government? What will our new Cabinet make of what they have been landed with?  Watch this space!

(1) It is to be noted that Professor Arti Rai, one of the authors of a very good article critical of  Bayh Dole’s relevance to developing countries is one of Obama’s IP advisors.