This statement was developed at the Increasing Access to Essential Drugs in a Globalised Economy Working Towards Solutions conference, which was organized by Health Action International, Médecins Sans Frontières, and Consumer Project on Technology, and took place in Amsterdam, the Netherlands, November 25-26, 1999.
Background:
- 1.3 billion people in the world live on less than US$1 per day
- Twenty percent of the world’s population consumes eighty percent of the world’s resources
- Every three seconds a child dies of diseases of poverty
- Seventeen million deaths per year are due to infectious disease
- Currently 33 million people live with HIV, 7-8 million with active TB
- More than 90 percent of all death and suffering from infectious diseases occurs in the developing world
- Twenty percent of the world’s population uses eighty percent of the world-wide production of medicines
- 0.2 percent of pharmaceutical research is devoted to acute respiratory infections, TB, diarrhoea, while 18 percent of deaths are attributable to these diseases.
In the developing world, a lucrative or “viable” market for lifesaving drugs simply does not exist. But clearly what does exist is need. The market has failed both to provide equitably priced medicines and to ensure research and development for infectious disease. This lack of affordable medicines and research and development for neglected diseases is causing avoidable human suffering. Market forces alone will not address this need: political action is demanded.
At the Amsterdam conference, participants called for health to be made a priority at the WTO Seattle negotiations and demanded a balance between the rights of patent holders and the rights of citizens in intellectual property rights regulations. These views were shared by representatives of UNDP, the WHO, the WTO, members of the Dutch and Thai governments, and NGOs which attended the Amsterdam conference. The meeting brought together 350 participants from 50 developing and developed countries, from both the private and public sectors.
Organisers of the Amsterdam meeting call for:
The WTO to create a Standing Working Group on Access to Medicines
This working group would work with the Council for TRIPS and other WTO bodies to review a number of issues concerning intellectual property rules, as they relate to access to medicines.
The Standing Working Group on Access to Medicines should work within the WTO to consider the impact of trade policies on people in developing and least developed countries, and provide a public health framework for the interpretation of key features of WTO agreements. The WHO and other relevant international organizations should play an active role to support the activities of the working group. The TRIPS Agreement is meant to protect intellectual property rights while also protecting and advancing various public interest objectives. This balance must be addressed to ensure that people have access to essential and life-saving medicines. As countries implement the TRIPS agreements the WTO will be asked to resolve disputes in areas that are subject to numerous different interpretations. The WTO is also constantly evaluating proposals for changing the TRIPS Agreement. The Standing Working Group on Access to Medicines would provide a forum for considering public health issues and rights of people in both of these processes.
The proposed working group on access to medicines would examine a number of important issues in the implementation of the existing TRIPS Agreement, such as:
- Compulsory licensing of patents, as permitted under Article 31 of the TRIPS Agreement. The working group should look for ways to best operationalise this article;
- Allowing for exceptions to patent rights (under Article 30 of TRIPS) for production of medicines for export markets, when the medicine is exported to a country with a compulsory license. This would ensure that countries with small domestic markets can benefit from compulsory licensing;
- Allowing for exceptions to patent rights (under Article 30 of TRIPS) for medical research, so that patents are not used to stop research and hamper the introduction of generic medicines;
- Avoiding overly restrictive and anti-competitive interpretations of TRIPS rules regarding protections of health registration data or other unnecessary regulatory barriers to competition;
- Avoiding restrictive interpretations of trademark rights on issues such as generic labelling and prescribing practices;
- Assessing the impact of inadequate reviews of patentability standards (novelty and usefulness) on access to medicines;
- Recommending differential rules for essential medicines, such as simplified and fast track compulsory licensing procedures;
- Examining new paradigms for intellectual property rights and health care, including “burden sharing” approaches for R&D that permit countries to consider a wider range of policy instruments to promote R&D;
- Assessing the practical burdens on poor countries of administrating patent systems and resolving disputes over rights.
National governments need to develop mechanisms to ensure funding for R&D for neglected diseases
New and innovative approaches to stimulating research in essential medicines need to be devised, including:
- Increased public and donor funding of health care research:
- Compulsory research obligations, such as requirements that companies reinvest a percentage of pharmaceutical sales into R&D, either directly or through public or private sector R&D programs;
- Development of a “Neglected Disease Act” that could be used to stimulate private investment for communicable disease vaccines and medicines.