The New York Times has published an article about the use of ghost writers from drug companies to produce journal articles that then go out under the names of academics in US universities. This is yet another example of problems in the ethical standards of the big journal publishers and the morality in pockets of the global scholarly prestige system.

 Senator moves to block medical ghostwriting

 

A growing body of evidence suggests that doctors at some of the nation’s top medical schools have been attaching their names and lending their reputations to scientific papers that were drafted by ghostwriters working for drug companies — articles that were carefully calibrated to help the manufacturers sell more products.

Experts in medical ethics condemn this practice as a breach of the public trust. Yet many universities have been slow to recognize the extent of the problem, to adopt new ethical rules or to hold faculty members to account.

Read the rest of the article here

Business Day yesterday published my story on the clash between WHO's Public Health strategy and the South African IPR Act (see the gray area blog article on the same topic a few weeks ago for a different version of the same argument). I am glad that there is at last some discussion of these issues in the media, which tends to treat IPR issues as too arcane to engage with, although the Treatment Action Campaign has gone a long way towards dissipating that view.

In the mean time, the discussion on IPR and public health in developing countries continues unabated. There is an interview in the IP Watch newsletter with Ellen t'Hoen, the senior advisor on intellectual property and medicines patent pool at UNITAID, a financing mechanism for the scale-up of treatments for HIV/AIDS, tuberculosis and malaria.  t Hoen recently published a book entitled, The Global Politics Of Pharmaceutical Monopoly Power.

The concern t'Hoen expresses relates to potential problems with the availability of cheaper generic medicines in developing countries. The countries that use the DOHA provisions for the import of generics for public health reasons (mostly for HIV AiIDs) rely heavily on imports from India.  Now , she says, there is a change looming that is likely to threaten this (perfectly legal) supply:

Indian producers are able to make generic versions of these medicines because of the 1970 Indian Patents Act which excluded product patents for medicines. As of 2005, India has to comply with the TRIPS Agreement and has started to grant product patents on medicines. So very soon this is going to change. Generic versions of newer drugs will not become available automatically until after the 20-year patent term has run out. Unless of course India starts granting compulsory licences or other mechanisms are put in place to ensure that generic producers can continue to play this role, such as the patent pool.

't Hoen has sharp words to say about the fact that special provisions for affordable drugs in developing countries, at the insistence of the rights holders,  apply only to neglected diseases and exclude non-communicable diseases. Asked whether there was significance in this distinction, she replied, 'Well from a medical point of view, of course there isn’t – it’s whether you die of AIDS or whether you die of heart disease… well, you’re dead. It’s just as serious.'  She is equally sharp with the argument that patent protection is needed to ensure research and development of new drugs and limit the supply of new drugs for developing country diseases:

In the past pharmaceutical companies have en masse abandoned research into neglected diseases. That’s why they became neglected diseases. Much of the innovation for tropical diseases comes from military research and government research that comes out of the old colonial systems: the tropical disease centres and the Vietnam War, which gave for example a number of malaria drugs.

So I don’t quite see that argument. I don’t think that if we close down the generic industry in the developing world that big pharma will spontaneously start reinvesting in tropical neglected diseases.

This is disturbing but very cogent stuff about why IPR does matter - read it. 

June was a hectic month. (That sounds like a parody of TS Eliot, but it really was a hectic month.) There is a lot to catch up with, so I will provide a series of posts, on a variety of topics. The general message seems to be that times are a-changing and that there is an increasing dynamic weight behind open access and open innovation approaches, particularly (but not only) for developing countries. With the major international organisations weighing in and with our new Minister of Higher Education joining the debate at UNESCO, these are indeed interesting times.

As a follow-on from the discussion of innovation and the SA IPR Act in recent blog postings, a  week-old UN debate is relevant, showing up yet again how much the SA legislation seems to be going against global trends.

The  Intellectual Property Watch Newsletter 0f 6 July reported that 'innovation and technology will be key to emergence from the global economic crisis, according to speakers at a recent United Nations conference on innovation-based competitiveness. However, innovation should be collaborative and involve resources inside and outside companies and institutions.'
The “International Conference on Technological Readiness for Innovation-based Competitiveness” was organised by the UN Economic Commission for Europe (UNECE) on 29-30 June. According to the IP Watch report, a number of speakers at this conference spoke about the need for collaborative innovation, or what  Paula Wasowska, director for Central and Eastern Europe market development for Cisco Systems, described as “connected innovation.”  Connected innovation requires cultural change to collaborative sharing of information, skills and perspectives within organisations and between them, the customers and the partners. “Innovation happens when people work together,” she is reported as saying.

“Innovation is moving from the in-house to the connected global market place, from the isolated individuals to collaborative environment…from proprietary control to open source, from single specialties to multidisciplinary perspective,” she said, and customers have become a critical force of competitive data as they are an invaluable force of information.

In general, this conference seemed to signal the  general acceptance of a shift from a competitive approach to innovation to a collaborative one, even where the mega-corporations like Microsoft and Intel are concerned. This collaboration takes place in and between companies and non-commercial organisations. The ethos, as Wasowska points out, is one of open sharing.

Even more striking was the statement by Claran McGinley, controller at the European Patent Office, that the patent system for ICTs is not working. The important thing about open innovation McGinley is reported as saying, is that “it is a team effort and crosses boundaries.”

The full IP Watch report can be found here.

The Australian federal government has just completed a review of its National Innovation system. Australian research and innovation policy-making tends to be broadly consultative, wide-ranging  and forward-looking, so I was interested to compare this with what the South African government is doing. Our IPR Act of 2008 is Bayh-Dole on steroids, insisting on commercialisation and patenting wherever possible, and apparently treating open innovation as the exception, not the rule. And speaking of rules, the Regulations impose layers of bureaucratic filters between the researcher and the innovation outcome.

I am still working through the Australian document to absorb its detail but it has some valuable insights and the overall thrust is clear: there needs to be a balanced system, in which commercialisation is but one strand of the innovation role that universities can play. Far from taking Bayh-Dole as gospel, there is a critical evaluation of such strategies and a re-evaluation of  what innovation policy should look like in the 21st century.

Moreover, the Australian government and the participants in the policy process are aware of the pitfalls in excessive patenting. They review the past record, warn against the damage that can be done by patent law that is not rigourous enough and advise against policies that could create patent thickets. Most interesting, there is a strong argument for this arena to be opened up, so that the participants in the innovation system have a strong say, rather than this being the exclusive domain of lawyers. This is a lesson that I think South African universities might need to learn – it appears that our academics are not engaging with the South African legislation, thinking that this is the domain of professionals.  

This Australian policy document reminds me of a recommendation from Arie Rip at an  early stage of the South African higher education policy process (2000):

The common mimetic route is to define the nature of capacity-building in terms of what is now seen as important. This may well be a recipe to become obsolete before one’s time … [T]he world (of science and more generally) may well evolve in such a way that present-day exemplars will be left behind. So developing countries should set their sights on what is important in 2010, rather than what appears to be important now – however difficult this will be politically. 1

The IPR Act of 2008 is unfortunately trapped in the 'mimetic route' that Rip warns about here. But what about Australian thinking in 2009? Here are some extracts that give some insight into the thinking that will inform policy review down south:

On the commercialisation of research:

Research commercialisation is not a core role for universities. Nevertheless, universities can play a vital role in the commercial process. In cases where the benefits of research are best achieved through commercial engagement, universities should, where possible, attempt to partner with appropriate stakeholders to achieve these goals. Such instances are in the minority and universities more commonly play a role of commercial significance through provision of vital research advancement, workforce training and substantial international links.

On the protection of intellectual property rights:

[T]here is a caveat which is increasingly important: The development of intellectual property is cumulative. In the words of Sir Isaac Newton, we stand on the shoulders of giants. Because new knowledge always builds on old knowledge, the property rights we have erected to encourage innovation can actually obstruct it.

On the need to open up the question of patenting and IP beyond the legal profession and the IP industries:

Nevertheless the consideration of policy ... is dominated by IP practitioners and by the beneficiaries of the IP system. We need the expertise of lawyers in this as in many other areas of policy but it is imperative that IP policy make the transition that competition policy made over a decade ago now, from a specialist policy area dominated by lawyers, to an important front of micro-economic reform.

On access and dissemination for social and economic benefit

Along with the rise in support for access to information has come a growing recognition of the need for users to be able to search and interact with data and content. Legal frameworks must also be developed to facilitate access and reuse. This points to the need for an Australian National Information Policy (or Strategy) that optimizes the generation and flow of ideas and information in the Australian economy. As the National Competition Policy (NCP) involved systematically scanning Australian institutions to optimize the operation of competition to enhance outcomes so National Information Policy would scan Australian institutions to optimize the generation and dissemination of information for social and economic benefit.

Thus for instance, unless it seriously undermines its commercial objectives of sale of product, the ABC should err on the side of making its content available over theinternet unless this has large opportunity costs. The presumption against free availability might be overcome where it would involve the foregoing of substantial commercial revenue from the sale of the content or there are large costs of hosting the necessary internet bandwidth (although in this latter case, peer to peer means of distribution should also be explored as should the diversion of funding from other activities and/or additional funding).

The advantages of  open science

To drive cumulative knowledge creation researchers and others must have access to high quality data and information on developments not just in their field but beyond. For instance, Jeff Furman and Scott Stern have calculated that Biological Resource Centres that are repositories of biological materials (including cell lines, microorganisms and DNA material) have boosted cumulative scientific knowledge by three times more than alternative institutional structures 2.Australian physicist Michael Nielsen has stressed the importance of unlocking scientific information in scientific journals to make it more easily discoverable, searchable and useable to enable the cross-disciplinary search for knowledge:

We should aim to create an open scientific culture where as much information as possible is moved out of people’s heads and labs, onto the network, and into tools which can help us structure and filter the information. This means everything - data, scientific opinions, questions, ideas, folk knowledge, workflows, and everything else - the works. Information not on the network can’t do any good.3

There is a lot more in this report – I recommend that South African researchers read it as they engage with our legislative process with an eye to preserving their expertise and independence in the process of ensuring that their research has maximum national impact.

1. Rip, A. (2000) Fashions, Lock-ins and the Heterogeneity of Knowledge Production. In Kraak, A. (ed.) Changing Modes: New knowledge production and its implications for Higher Education in South Africa. Pretoria: Human Sciences Research Council.

 2. Furman, J. and Stern, S., Standing Atop the Shoulders of Giants: The Impact of Institutions on Cumulative Research, National Bureau Economic Research Working Paper. 2004. 

3. http://michaelnielsen.org/blog/?p=448 

Derek Keats. the Deputy Vice-Chancellor of Knowledge management at Wits University has posted a series of blogs in the proposed Regulations for the implementation of the IPR Act. He thinks - and I agree - that they will probably be unworkable and that they will almost certainly act as a hindrance and not a help to research effectiveness in the country.

Some of his comments: 

 Most importantly, innovation thrives in the absence of impediments. Every time a researcher must go to NIPMO for permission, there is another barrier to innovation. More barriers equates to less innovation. This is a sine quo non, and cannot be changed... These regulations will stiffle innovation, not just in software, but in almost every sphere of research endeavour. They are bad for innovation, they are bad for research, they are bad for business, and they are bad for South Africa.

Research innovation is something that is made from a harvest of passion and energy, and the capacity for the unfettered creativity that universities make possible. Anything that reduces that capacity for unfettered creativity, and creates the risk of a passion drought will undermine innovation and lead to less, not more, innovation. This is something that I know with as much certainty as I know I have 10 fingers (currently).

Much as software patents favour existing large companies, and make it difficult for a new company to become large, these regulatins will have a small negative impact on the research superstars, but will make it much more difficult to become a new superstar, and will drive passionate people away from research into other carreers. Academic freedom is important to people, and people do innovation. Trample on it at your peril!

 ......

If you look at the range of work that these regulations cover, which is effectively all knowledge work undertaken with public funds, the range of knowledge needed to make non-spurious decisions is enormous. The level of talent that will be needed for the imlementing body, NIPMO, to work is very high. These are not decisions that can reasonably be expected to be taken by inexperienced people who have just completed a masters degree. They need experienced researchers, with doctorates and many years of research and development experience.

Such people simply do not exist in South Africa. They could be taken out of the Universities, but then that would undermine the innovation process they are supposed to be managing. So where will they come from?

Finally, he makes a set of useful suggestions on how things could and should work: 

• Leave critical decisions close to the site of the action, where people are most familiar with the challenges and opportunities and can act in an agile manner with the minimum of delays;
• Ensure that the services are available to assist with commercialization of research, including legal services, product development assistance, and that these are available with minimum of fuss whether a proprietary or open source business model is followed;
• Ensure that there is a National fund to help startups fight patent challenges from patent trolls and other holders of spurious patents, especially large multinational corporations with large patent portfolios which may contain numerous dubious patents;
• Recognize that the vast majority of researchers are not doing research that will lead to commercial products, and do not bring the whole innovation regime in South Africa under these regulations, where social and cultural innovation will be stiffled; rather provide means to assist and inform such researchers to find commercially or socially beneficial uses for their research when they tell you they would like your help;
• Where software and documentation in various forms are concerned, accept the National Policy on Free and Open Source as also being an important guide for action among responsible, knowledgeable researchers.

I hope Wits University's reposnse to the Regulations will incorporate all o of this.