New Delhi: An Association of Biotechnology-Led Enterprises (ABLE) team led by its President, Dr P M Murali and Chief Operating Officer (COO), Mr Narayanan Suresh attended the annual meeting of the International Council for Biotechnology Association (ICBA) in San Francisco on Sunday, June 5, 2016.
ABLE is a founder member of ICBA which is a consortium of more than 26 national biotechnology associations from the US, Europe, Africa and Asia Pacific. The Biotechnology Innovation Organization (BIO) of the US had anchored ICBA so far and the leadership has now passed to Europe. ICBA is an influential global consortium that represents the interests of biotechnology companies around the world.
Currently, ICBA is discussing a major proposal by the United Nations that seeks to take over global research and development (R&D) work in pharma and healthcare under its wings from corporations and devise new funding mechanism to continue to the work under public financing to ensure greater access to medicines.
Some parts of the summary of the UN High-Level Panel on Access to Medicine has come out. The report is likely to be taken up for discussions for adoption at the UN General Assembly in September. The report’s major recommendations, if adopted by the UN, will have significant impact in the way pharmaceutical and biotechnological innovation system works currently.
The highlights of some of the recommendations are:
New models to finance R&D
- There should be the progressive introduction of an alternative funding mechanism that would move toward the gradual transition toward a “de-linkage model of R+D financing.”
- The process would start with the immediate public health threatsAMR ( anti-microbial resistance), Zika, rare and orphaned diseases, and then move to all public health technology and medicines for NCDs
- The cost of R+D (inclusive of clinical trials) should be disclosed in detail, together with any public funding received as well as actual and projected costs of marketing. All would go into an International database of prices for innovative and generic medicines to be maintained and updated by the WHO( World Health Organization)
- All clinical trials should be “global public goods” so all member states should require that data on trials be made available in a searchable public register etc. There should be an international institution established under WHO to conduct trials of new health technology or alternatively contract with public institutions to do so.
- All approved new technology developed with the support of publicly funded clinical trials would not be eligible for patent or data or market exclusivity. These patent databases should be user friendly and searchable.
- The Medicines Patent Pool and other voluntary patent licensing arrangements should expand to include the full WHO Essential Medicines List (EML).
- Countries should design/adopt an automatic Compulsory Licensing(CL) process for medicines on the WHO EML
- All countries shouldexempt medicines on WHO EML from patentability.
- A waiver and permanent revision of the relevant provisions of TRIPS should be implemented to be consistent with the above guidelines
- WTO ( World Trade Organization) members should adopt and apply rigorous definitions of inventions and patentability to limit and preclude ever-greening and limit the patent tools for research/data.
- The patentability of publicly funded research (inventions and data) developed with public funding should be made available publicly or subject to irrevocable non-exclusive licensing arrangments.
- WTO should adopt an amendment to TRIPS to remove any obligation by WTO members to grant patents for public-funded research tools and data.
- Establishment of interagency task force on health technology and access under the UN Development Group
- Task force would start the negotiation of a binding R+D treaty or binding agreement for financing and sharing the “fruits” of R+D for health technology.
- This treaty’s process would be funded by member states and therefore, there is a request for an irrevocable commitment of member states to participate in the funds and sharing results in order to ensure that final products are available at socially acceptable prices.
These recommendations are from the High-Level Panel on Access to Medicines set up in November 2015 by the UN Secretary-General Mr Ban Ki-Moon. The overall proposed scope of the panel was “to review and assess proposals and recommend solutions for remedying the policy incoherence between justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.”
The UNDP in collaboration with UNAIDS agency coordinates the work of this panel. The panel held public hearings in 2016 and issued a draft report in May 2016. The report has yet to be released publicly for discussions.
(This news update was first shared by Mr Narayanan Suresh, Chief Operating Officer of ABLE)