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. 

At the UNESCO World Conference on Higher Education, a roundtable session on Africa brought Blade Nzimande, South Africa's new Minister of the new Higher Education Ministry to the fore.

In the official online report on the round table, his speech is reported as follows:

Encouraging the production of indigenous knowledge is indispensable to meet the continent’s development challenges. “The term ‘knowledge society’ means two different things in developed and developing countries: one is the producer and one is the consumer”, said Blade Nzimande, Minister of Higher Education and Training, South Africa. Speaking on behalf of the 53-member conference of Education ministers in Africa he delivered some pithy observations on the challenges facing the Second Decade of Education for Africa: lack of access to indigenous knowledge (as “there had been no significant break with the colonial era”); gender imbalance, especially at the leadership level, and the interconnected challenges of gender, racial and ethnic discrimination.

Mr Nzimande criticized the overemphasis on basic education to the detriment of higher education. “Education must not be approached in an atomized or fragmented manner but in a holistic manner”. While he believed that academic freedom was under threat, and that governments needed to guarantee it, responsibility for academic freedom went both ways and institutions had to be accountable too.

Nzimande is also given prominence in the Inside Higher Education report on the conference. This   report details how Philip Altbach spoke of a revolution in higher education and John Daniel of the Commonwealth of Learning talked about how the use of transformative technology can bend the 'iron triangle' of access, quality and cost for developing country knowledge.  

In the roundtable on African higher education, however, Blade Nzimande, South Africa’s minister of higher education and training, lamented the continent’s overall status as a consumer of knowledge, as opposed to a producer. “Over the last few decades, some things have not changed. There’s been no significant break in relations of knowledge production between the colonial and post-colonial eras. African universities are essentially consumers of knowledge produced in developed countries,” he said.

“Virtually all partnerships tend to be one-sided. This is not only negative for the African continent, but we believe it also deprives global higher education of access to the indigenous knowledge of Africa,” Nzimande said.

This is an encouraging sign that the new ministry might be looking at effective and democratic research dissemination and publication as one of its key strategies.

More in Inside Higher Education, An Academic Revolution 7 July 2009

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.

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.