Tag Archives: Draft regulations

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.