December 13-15, 2010

Cape Town, South Africa

AEMI

Context and objectives

The classical “Western” model of profit-driven drug development, in which medicines are considered consumer goods and patients (consumers) are expected to pay high prices for drugs to recoup corporate investments in R&D as well as pay for a highly profitable pharmaceutical business model is under increasing pressure.

In a rapidly globalising world, it is clear that the current market-driven innovation model does not work for the large majority of those in need, who only gain access to new medicines after patents have expired (10-15 y after their introduction). For life-saving medicines such as ARVs or cancer drugs this is an intolerable situation. In addition, most current R&D efforts focus primarily on the health needs of the affluent, leaving many health needs of the rest of the population unaddressed (e.g. treating HIV-infected children, or tackling poverty-related and tropical diseases, or coping with coinfections, or ensuring that treatments are optimised for use in resource-poor settings).

The new area of biologics, a major growth area for the R&D-based pharmaceutical industry, is delivering therapies that typically require a high-tech health care environment and are invariably priced much higher than classical chemotherapeutics. With moreover no agreed upon pathway for generics, biologics are unlikely to contribute to addressing the health needs of the majority of the world’s population in an affordable way.

In many countries, it is considered a public responsibility to marshal science and technology to address the people’s heath needs, necessitating a re-thinking of the incentives structure that currently governs pharmaceutical R&D (mainly patent monopolies). Certain governments have started to explore different routes of innovation to overcome the limitations of the current profit-driven corporate model, but efforts are still fragmented. Moreover, the current R&D-based pharmaceutical industry, eager to maintain it dominant position in this field especially in view of their own growth potential in emerging markets, is pushing for a strengthening of the intellectual property (IP) systems and IP enforcement frameworks on a global scale, upholding that strong IP is the best incentive for health R&D.

While pharmaceutical R&D capabilities have long been concentrated in private companies in a handful of industrialised countries, which have remained the main innovators and source of most new medicines, vaccines and diagnostics, this situation is gradually changing. Several countries in Asia, Latin-America, and Africa have started to develop selected areas of competence related to the pharmaceutical development pathway, involving both public and private sectors. The biology, chemistry and technologies underlying drug discovery have become well established in multiple countries in the South. India and China are now renowned for their chemical and pharmaceutical manufacturing capabilities, and at least India seeks to develop its domestic innovator R&D capacity. The globalization of clinical trials has created a worldwide capacity of clinical researchers ready to be active players in clinical development. Brazil is adopting a domestic pharmaceutical technology development program that targets its major public health challenges. The World Health Organization, through its Intergovernmental Working Group (IGWG) on innovation, public health and intellectual property has also recognized the need to formulate new models to ensure adequate health-need-driven R&D, including models that de-link incentives for R&D from the price of the health product.

While policy proposals and actual initiatives to foster needs-driven R&D are mushrooming, especially from the US and Europe, and are accompanied by vigorous debates on their pros and cons and potential for success, only few voices from the South are being heard in the discussion.

The objective of this South-South convening among Access to Medicines and health activists, researchers, and R&D policy experts, is to provide a forum for exchange and strategizing between countries that are be expected to become leaders in promoting health-needs driven R&D models, and define ways forward for civil society to contribute to making this happen.