Tag Archives: public health

Public Health and IPR Act in the headlines – at last

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.

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.

Genocide by Denial – An open access book from Uganda

I have posted a blog in the PALM Africa blog site on an open access book from Fountain Publishers in Uganda, created as part of the PALM project. The timing of this publishing initiative is telling for us in South Africa, as the book deals with an issue that is directly releant to the Department of Science and Technology’s legislation and proposed Regulations aimed at forcing the commericlialisation of research. The impact of profit-driven commercialisation of public health research is an issue that this book takes apart in a searing critique.

From the PALM blog:

Fountain Publishers in Uganda has launched as its first open access book a powerful and moving indictment of the price in human lives that the global innovation system has extracted in sub-saharan Africa, written by the internationally respected AIDS specialist, Peter Mugyenyi. The book is Genocide by Denial: How profiteering from HIV/AIDS killed millions. This is the first demonstration project in the PALM Africa initiative and the response to the open acess book as well as its impact will be tracked and researched by the PALM team…

The book is a powerful indictment of a failed system, written with passion and clarity. from the AIDS disaster should help the world find a way of incorporating justice and human rights in business. It is glaringly clear that the ills of the present system need to be fixed. He appears to be vindicated by the fact that the WHO is now aligning itself with this approach. of – developing global policy. Mugyenyi’s book needs to be read by the South African bureaucrats who are trying to enforce widespread and rigid commercialization of public research. Mugyeni’s conclusion to his book puts the issues succinctly: The timing is impeccable, as the release of the open access version of the book coincides exactly with a breakthrough at the World Health Organisation, which has finally reached agreement on a global strategy and plan of action on public health, innovation and intellectual property. The WHO initiative, after long negotiations driven by developing countries, aims to address exactly the problem that Mugyenyi addresses – the excessively and unaffordably high prices of the drugs needed to treat neglected diseases in developing countries, driven by the global patenting system. In addition, it addresses the lack of adequate research on neglected diseases, also spawned by the profit-driven Intellectual propoerty regime supported by the developed world. Among the recommendations in the WHO  plan of action is government intervention to ensure voluntary sharing or research, open access publication repositories and open databases and compound libraries of medical research results. Thus Fountain’s engagement with open access publishing on a public health topic is right in line with – and ahead Laws that deny or delay access to life-saving and emergency drugs should be urgently addressed on the humanitarian principle of lives above profits, but without hurting the businesses. Innovation in the crucial area of human survival should not be entirely dependent on money-making and big business, but should primarily aim at the alleviation of all human suffering and saving lives as a basic minimum. This does not contradict fair trade. Business success and humanism are not incompatible It is just a big lie to suggest that humanity is too dim to find ways of rewarding innovation and discovery other than by holding the very weakest of our society at ransom. It is also untrue that the only way businesses can thrive is by cutthroat pursuit of profits under powerful and insensitive protective laws, irrespective of the misery caused and the trail of blood in their wake. Lessons learns more from thePALM blog, with further details of the book and its contents…