Support growing for new global drug R&D framework

Looser patent control maybe on the horizon

Momentum is increasing behind a proposed global framework for drug research and development (R&D) that aims to share the benefits of scientific progress in the prevention, diagnosis and treatment of diseases more fairly.

An MSF-organised meeting took place this weekend in New York among about a hundred significant stakeholders, including drug developers, clinical researchers, health professionals, policy-makers, donors, and activists (see below). The symposium focused on TB drug development and highlighted current approaches as inadequate to respond to the urgency of the global TB epidemic:

• TB is the leading killer of people with HIV/AIDS and the inadequacy of tools to diagnose and treat TB are a major threat to the health and lives of HIV/TB co-infected individuals;


• We have inadequate and outdated tools for rapid diagnosis, inadequate and outdated drugs to cure many adults and children with TB today, and an inadequate pipeline to ensure our ability to cure the majority of TB cases in the future;


• We lack the basic biological understanding of this complex disease to anticipate the most efficient routes to prevent and treat TB;


• Clinical trials for drugs and combinations that could be done today are being held back because of a lack of funding and capacity as well as regulatory barriers;


• Meaningful gains in TB control will only be made when the treatment of TB, including drug-resistant TB, can be dramatically shortened and simplified.

The statement that came out of the meeting called upon governments, intergovernmental agencies, researchers, drug and diagnostic developers, nongovernmental organizations, and funders to take action in five key areas:

1. Accelerate drug discovery


2. Expand clinical trial capacity and accelerate clinical development


3. Support new approaches to R&D


4. Commit to global TB R&D leadership


5. Increase funding for TB R&D activities

But in the detail describing new approaches to R&D, the participants also gave their support to mechanisms that have been proposed to stimulate research around neglected and other diseases affecting developing countries. They said:

The lack of TB drug development is a result of the failure of current profit-driven drug research and development model. The TB community must engage in the World Health Organisation’s Intergovernmental Working Group on Innovation, Intellectual Property and Public Health to establish a global R&D framework to help design new ways of setting R&D priorities and financing.

With respect to TB drug development, participants of the New York symposium support current discussion at the WHO for an alternative R&D Framework that addresses the question of who pays for essential medical R&D and de-links incentives from drug prices, instead rewarding the impact of inventions according to health care outcomes.

What do these two points refer to?

In May 2006, a World Health Assembly resolution asked WHO to establish an Inter-Governmental Working Group on Innovation, Public health and Intellectual property. Their first session (in December 2006) considered ways to stimulate R&D for neglected and other diseases affecting developing countries; improve delivery systems and access; and examine sustainable financing mechanisms to ensure long-term benefits – effectively, ways to ‘de-link’ the R&D part of drug development from profit-making and drug sales. The ‘alternative R&D Framework’ is a part of the immediate remit of the group, and a plan of action that aims to find new ways to identify gaps in research on diseases that disproportionately affect developing countries.

So as well as re-stating TB drug development needs, the meeting participants also put their collective weight behind these new mechanisms, sending a clear signal to WHO to keep the momentum towards these new models going. This might not sound that significant, until you look at who was at the MSF meeting. According to a Newswise release just before the meeting, participants included:

Médecins Sans Frontières (MSF), Weill Cornell Medical College, World Health Organization, National Institute of Allergy and Infectious Diseases (NIAID) /National Institutes of Health (NIH), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), GlaxoSmithKline, Novartis AG, Johns Hopkins University Bloomberg School of Public Health, Bill and Melinda Gates Foundation, Columbia University, Rockefeller Foundation, European and Developing Countries Clinical Trials Partnership (EDCTP), Brazilian Society of Respiratory Diseases, St. George's Hospital Medical School of London, Global Alliance for TB Drug Development, University of Illinois at Chicago, Institute for Tuberculosis Research University of Illinois at Chicago, Yale Law School, Drugs for Neglected Diseases Initiative (DNDi), Tibotec, Denver Health and Hospitals, Treatment Action Group, and the Consumer Project on Technology.

In a paper describing the new R&D framework, one of the architects of the new R&D Framework – James Love, Director of the Consumer Project on Technology (CPTech) – nicely summarizes the failure of the current model for drug development and why the new framework is so vital:

Today's high drug prices are a direct consequence of a business model that uses a single payment to cover both the cost of manufacture of a drug and the cost of the research and development (R&D) carried out by manufacturers to discover it. A 20-year patent-based marketing monopoly is then granted to the drug's developers to prevent their prices being undercut by ‘generic’ copies produced by manufacturers who do not have R&D costs to recover.

At the NY meeting, Tido von Schoen-Angerer of MSF told Reuters there had been a "failure" in TB research with only seven drugs to fight the disease in clinical development, compared with 149 drugs for cardiovascular disease and one new HIV drug annually for the past 25 years:

"We have a pharmaceutical market worth $600 billion a year and there's a very clear issue," he said. "Research and development is patented and profit-driven and is not delivering to the patients that are dying."

Watch this space..... Progress of the new WHO Working Group and of the proposed framework will surely be on the agendas of the WHO Executive Board and the World Health Assembly again during 2007. This will likely move centre stage during the coming year.

The Cornell Club in Manhattan, where the MSF meeting took place this weekend.