Intellectual Property and Access to Medicines: An Introduction to Key Issues – Some Basic Terms and Concepts
Intellectual property and patents in particular, have become one of the most debated issues on access to medicines, since the creation of the World Trade Organization (WTO) and the coming into force of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Patents are by no means the only barriers to access to life-saving medicines, but they can play a significant, or even determinant, role. During the term of patent protection, the patent holder’s ability to determine prices, in the absence of competition, can result in the medicine being unaffordable to the majority of people living in developing countries. This first issue of the “South Centre Training Materials” aims, in its first part, to provide an introduction to key issues in the field of access to medicines and intellectual property. The second part describes and defines some basic terms and concepts of this relatively new area of pharmaceuticals policies which are the trade related aspects of intellectual property rights that regulate the research, development and supply of medicines and health technologies in general.
The worldwide problem of the rise in antimicrobial resistance (AMR) is a serious threat to global public health. The loss of efficacy of antibiotics and other antimicrobials affects everyone. Yet the threat is greater in developing countries, due to the higher incidence of infectious diseases. Developing countries will be unequivocally affected by AMR, deteriorating the health of the population, reducing economic growth and exacerbating poverty and inequalities. The blueprint for addressing AMR as a global problem is advanced. Countries are progressing in developing and implementing national action plans and overall the public awareness of AMR is increasing.
However, we are at the tip of the iceberg of response. AMR is not yet a key priority of most governments, and global coordination and resource mobilization to enable all countries to do their part are lagging. The Secretary-General of the United Nations (UN) in the upcoming 74th UN General Assembly (UNGA) will be reporting on the implementation of the UN resolution on AMR of 2016, including the recommendations of the Interagency Coordination Group (IACG) on Antimicrobial Resistance. The UNGA will also host a High-Level Meeting to build support for advancing Universal Health Coverage (UHC), that is essential for AMR response. Expanding primary health care services, strengthening the health work force, improving infection prevention and control and measures to secure access to essential medicines and others to reduce health inequities can help contain AMR in developing countries. Developing countries need to be actively involved in shaping the global agenda on antimicrobial resistance, including the new global governance mechanisms that are being set up for AMR.
Mainstreaming or Dilution? Intellectual Property and Development in WIPO
In 2007 Member States of the World Intellectual Property Organization (WIPO) unanimously adopted a set of 45 recommendations which constitute the WIPO Development Agenda. Developing countries sought to give new direction to WIPO through the Development Agenda, away from the pursuit of facilitating and strengthening protection, acquisition and enforcement of intellectual property (IP) rights as an end in itself towards an approach that would be sensitive to the impact of IP on development, both in terms of opportunities as well as costs. This paper explores whether development considerations have been adequately addressed by WIPO since its creation as the United International Bureau for the Protection of Intellectual Property (BIRPI) in the nineteenth century. The paper also analyses whether the implementation of the WIPO Development Agenda adopted in 2007 has shaped the current vision of the WIPO Secretariat and its Member States to address the impact of IP on development; and whether implementation of the Development Agenda has facilitated the use of IP law and policy as a tool that responds to advancing innovation, industrial, health, agricultural, education and other development policies in developing countries. The paper finds that the approach towards IP in WIPO continues to be dominated by a perspective that pursues acquisition, protection, management and enforcement of IP rights as an end in itself. Conflicting interpretations of development orientation have adversely impacted the implementation of the Development Agenda in the spirit in which the developing countries had proposed the Development Agenda. The paper recommends developing countries to undertake cross regional coordination to enhance their level of engagement on IP and development, advance specific suggestions for achieving greater impact on addressing development challenges through specific activities including projects in the areas of technical assistance as well as norm-setting, pursue governance reforms in WIPO to ensure greater representation of developing countries in the decision making bodies of WIPO and in the staff composition of the WIPO Secretariat, amend the WIPO Convention to align its mandate on IP promotion to the development needs and challenges of its Member States and the development goals of the United Nations (UN), and also pursue a review of the relationship between the UN and WIPO as a UN specialized agency in the UN Economic and Social Council.
Title: Regional training for patent office representatives
Date: 4 June, 2019
Venue: Kyiv, Ukraine
Organizers: The South Centre, International Treatment Preparedness Coalition (ITPC Global), Scientific Research Institute of Intellectual Property (National Academy of Law Sciences of Ukraine) and All-Ukrainian Network of People Living with HIV